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The Labelling Handbook

An applicant’s guide to labelling requirements for pesticides and plant protection products approved

under the Control of Pesticides Regulations (COPR) 1986

and the Plant Protection Products Regulations (PPPR)

1995

Issued by the Pesticides Safety Directorate (PSD) on 31 October 2002 (amended 25

November 2004)


Contents Definitions 1

Introduction: The Product Label and The Labelling Handbook 1

1. The Labelling Handbook 1 2. What is the Product Label? 2 3. The Product Label and the UK Regulations 2

Part A: How To Use The Labelling Handbook 1

1. Purpose of the guidance 1 2. Scope of the guidance 1 Annex 1: Summary of Handbook contents 3 Annex 2: How to draft a professional Product Label 5 Annex 3: How to draft an amateur Product Label 7

Part B: Summary of labelling requirements 1

1. Content of text on the Product Label 1 2. ‘Approved Text’ on the Product Label 1

2.1 Definition of ‘Approved Text’ 12.2 ‘Approved Text’ for professional and amateur products 22.3 Submission of draft ‘Approved Text’ to PSD 22.4 Content of ‘Approved Text’ on the final printed Product Label 32.5 Format of ‘Approved Text’ on the final printed Product Label 3

3. ‘Other Text’ on the Product Label 3

3.1 Definition of ‘Other Text’ 33.2 Company Advisory Information 43.3 Safety Data Sheet 43.4 Non-pesticidal recommendations 4

07/06/2005 Contents i


Part C: Professional Product Label: ‘Approved Text’ 1

1. Introduction 1 2. Product Identity 1 3. Statutory Area 1 4. Safety Information 2 5. Directions For Use 2 Annex 1: Product Identity - Professional Product Label 4

1. What is Product Identity? 42. Compulsory Formatting Requirements 43. Content 4

3.1 Product tradename 43.2 The product registration number 43.3 Approval holder and/or marketing company details 53.4 Formulation type 53.5 Amount and name of the active substance(s) 53.6 Identity of any ‘dangerous’ coformulants 53.7 Net quantity of product 63.8 Product batch number 63.9 Biological use phrase 63.10 The ‘COSHH phrase’ 6

Annex 2: Statutory Area - Professional Product Label 7

1. What is The Statutory Area? 72. Compulsory Formatting Requirements 73. Content 8

3.1 Field of use 83.2 Crops/situations 83.3 Maximum individual dose 83.4 Maximum number of treatments or Maximum total dose 83.5 Latest time of application 93.6 Other specific restrictions 9

4. Examples of Statutory Area format 9

Working Document 1: Field Of Use Phrases - Professional Product Label

10

Working Document 2: Statutory Area Examples -

Professional Product Label 11

Annex 3: Safety Information - Professional Product Label 15

1. What is Safety Information? 152. Format and Content 153. Classification 15

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3.1 Hazard Symbol 163.2 Risk Phrase 17

4. Safety Precautions 174.1 Safety Precautions on Product Label 174.2 Safety Precautions on treated seed sack labels 19

5. Medical Advice 196. Examples of Safety Information on labels 19

Working Document 1: Hazard Symbols - Professional

Product Label 20

Working Document 2: Risk Phrases - Professional Product

Label 21

Working Document 3: User Protection Safety Phrases -


Working Document 4: Consumer Protection Safety

Phrases - Professional Product Label

27

Working Document 5: Environmental Protection Safety

Phrases - Professional Product Label

29

Working Document 6: Storage & Disposal Safety Phrases -


Working Document 7: Treated Seed Sack Label Safety

Phrases - Professional Products 35

Working Document 8: Medical Advice - Professional

Product Label 36

Working Document 9: Safety Information Examples -


Annex 4: Directions For Use - Professional Product Label 46

1. What are the Directions For Use? 462. Compulsory Requirements 463. Content 46

3.1 Introduction 463.2 Examples of possible formats 47

Working Document 1: Directions For Use Examples -


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Part D: Amateur Product Label: ‘Approved Text’ 1

1. Introduction 1 2. Product Identity 2 3. Safety Information 2 4. Instructions For Use 3 Annex 1: Product Identity - Amateur Product Label 4

1. What is Product Identity? 42. Compulsory Formatting Requirements 43. Content 4

3.1 Product trade name 43.2 Product Registration number 43.3 Approval holder and/or marketing company details 53.4 Formulation type 53.5 Amount and name of active substance(s) 53.6 Net quantity of product 53.7 Product batch number 53.8 Biological use phrase 63.9 Field of use phrase 63.10 Statement of users obligation in following label

instructions 6

Annex 2: Safety information - Amateur Product Label 7

1. What is safety information? 72 Format and content 73 The safety instructions 8

3.1 Safety instructions on product label 83.2 Phrases must be presented in either of the following

formats 9

4 Medical Advice 95 Examples of safety information on labels 9

Working Document 1: Protection during/in use Phrases –

Amateur Product Label 10

Working Document 2: Other General Protection Phrases –

Amateur Product Label 11

Working Document 3: Environment Protection Safety

Phrases – Amateur Product Label 12

Working Document 4: Storage and Disposal Safety

Phrases – Amateur Product Label 13

Annex 3: Instructions for use - Amateur Product Label 14

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1. What are the Instructions for use? 142 Compulsory Requirements 143 Content 14

3.1 Introduction 143.2 Examples of possible formats 15

Working Document 1: Instructions for use examples– Amateur Product Label

17

Part E: Acceptable changes to ‘Approved Text’

1. Is It possible to make changes to ‘Approved Text’? 1 2. Changes that may not be made to text without a new application 1 3. Changes that may be made to text without an application 1 Annex 1: Examples of acceptable alternatives to ‘Approved Text’ 3

1. Contents statement 32. Biological use phrases 33. Pest control claims, application doses and timings 44. Application method, water volume and spray quality 55. Tank cleaning instructions 66. Restrictions and warnings 67. Agronomic advice/general recommendations for use 78. Positive and convenience tank mixtures 7

Part F: Avoidance of false and misleading statements 1

1. Obligations on applicants 1 2. Examples of false and misleading statements 1

Part G: Structure and layout of Product Label on the Container 1

1. Introduction 1 2. Text on Container Label 1 3. Text on separate Leaflet 2 4. Labelling different parts of the packaging 3

4.1 What other types of packaging have specific labelling requirements?

3

4.2 Labelling of outer packs 34.3 Labelling of inner containers 34.4 Labelling of inner liners not intended to be removed 34.5 Labelling of product containing two or more separate components 4

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(e.g. ‘twin-packs) 4.6 Labelling of refillable containers 4

Annex 1 Labelling of products supplied in Water Soluble Bags 5

1. Introduction 52. Labelling of Water Soluble Bags 53. Labelling of outer packaging 6

Annex 2: Labelling of Multi-Packs 7

1. Introduction 72. Labelling requirements for two or more pesticides

packaged together 7

2.1 Tradename 72.2 Requirements for each component container 72.3 Requirements for outer pack 8

3. Labelling requirements for pesticide(s) packaged with non-pesticide(s)

8

Part H: Use of Artwork 1

1. Introduction 1 2. Acceptable graphics & symbols 1 3. Unacceptable graphics & symbols 1

Part I Legibility of Text 1

1. Introduction 1 2. Legibility Requirements 1

2.1 Label size 12.2 Text and background colours 12.3 Graphics 12.4 Font and font size 12.5 Hazard symbol size 22.6 Legibility of Product Label for refillable containers 22.7 Other requirements 2

Part J: Company Advisory Information - Professional Product

Label 1 1. What is Company Advisory Information? 1 2. Location of Company Advisory Information 2 3. Format of Company Advisory Information 2

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4. Content 24.1 Additional Health and Safety Information 24.2 Guidance relating to the use of the product 34.3 Other information not directly related to use 4

5. Checking and changing the content of Company Advisory

Information 5

5.1 Converting existing labels to include a Company Advisory Information section

5

5.2 Implementing a Company Advisory Information section on new Product Labels.

5

5.3 Subsequent changes to the Company Advisory Information section

6

Annex 1: Company Advisory Information - Examples 6

1. General agronomic advice (advice on pest and crop biology, threshold levels, mode of action and pesticidal effect.

6

2. Application equipment (use and calibration of equipment, nozzle selection, etc).

7

3. ‘Good Agricultural Practice’ 84. Resistance issues 8

Part K: Safety Data Sheets 1

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Definitions The following gives definitions of terminology used commonly throughout this document. Phrase

Definition

Applicant Within the terms of this guidance, this term is used to describe the party that is responsible for either the drafting of the label for submission to PSD and/or the printing of the final label for sale and supply onto the market. In practice, it may therefore be the (proposed) approval holder or marketing company or a third party acting on behalf of these (e.g. registration consultants).

Approved Text Information on the Product Label that is governed by legislation. The proposed label must be submitted to PSD in the form of a draft label with an application for approval and be used as the basis of the product evaluation. PSD may require amendments to the text on the final printed label.

Container Label The part of the Product Label (q.v.) that is affixed permanently to the product container.

Leaflet Any part of the Product Label that is supplied in the form of a detachable or separate leaflet(s), booklet(s) or similar rather than attached permanently to the container (i.e. Container Label q.v.).

Notice Of Approval The document which sets out the approval for a product and specifies the conditions under which it can be stored, advertised, sold, supplied and used. The conditions of ‘sale and supply’ include the conditions on the text and format of the final printed label.

Other Text Information on the Product Label that may appear at the discretion of the Applicant to provide additional advice for the user but is not required under the Regulations (q.v.)

Product Label The written, printed or graphic matter on, or attached to, or accompanying the pesticide or any of its containers or wrappers. It comprises information presented on the container itself (Container Label q.v.) a separate or detachable leaflet (Leaflet q.v.) and any additional outer packaging or separate inner packs.

Regulations The Control of Pesticides Regulations (COPR) 1986 (as amended) which implement The Food and Environment Protection Act 1985 (FEPA) or the Plant Protection Products Regulations (PPPR) 1995 (as amended) which implement Council Directive 91/414/EEC.

07/06/2005 Definitions 1


Introduction

The Product Label and The Labelling Handbook 1. The Labelling Handbook 1.1 Previous guidance on labelling was contained in ‘The Registration Handbook’/

Volume II/Part Four. Further to a review of labelling requirements by PSD (in consultation with other government departments, the agrochemical industry, user groups and other interested parties), revised requirements for labelling were agreed resulting in the drafting of this Labelling Handbook. Changes have been implemented to aid users in the safe use of products and to help applicants to produce labels as follows:

(a) Expanded and updated guidance on every aspect of production of draft and

final printed labels. (b) Revision and standardisation of the label structure to ensure that information

is presented in a user-friendly format and that all statutory and other safety information is clearly highlighted.

(c) Implementation of new procedures to allow the applicant additional scope in

formatting and making amendments to the final printed label Approved Text (see Definitions) without an application to PSD (but within the criteria set out in this Handbook).

(d) Addition of a new label section containing user advice where such advice is

not routinely monitored by PSD (follow the guidelines set out in Part J of this Handbook).

1.2 The Labelling Handbook currently is applicable only to professional products.

Guidance for amateur products will be available in the near future. 1.3 Guidance on how to use this Handbook is set out in Part C and its Annexes. 1.4 CD-ROM copies of the Labelling Handbook may be obtained from:

Approvals Support Group, Pesticides Safety Directorate Mallard House Kings Pool 3 Peasholme Green YORK YO1 7PX

Tel: 01904 455715 (International: (+44) 1904 455715) Fax: 01904 455722 (International fax: (+44) 1904 455722) e-mail: [email protected]

07/06/2005 Introduction: The Product Label and The Labelling Handbook 1

mailto:[email protected]

The Labelling Handbook 2. What is the Product Label?

2.1 The Product Label is defined as: “The written, printed or graphic matter which is printed on, attached to, or otherwise accompanies the pesticide container(s) and other packaging, and by which the user is informed of the requirements for the safe, humane and efficacious use of the product.”

2.2 It is the primary source of information and advice to the user of a product. If read,

understood and followed correctly, the product should be used safely and efficaciously. It is therefore essential that the content and design of the label ensures that all information, claims and recommendations for use are: • supported by safety, humaneness and efficacy data evaluated by PSD (other than

certain specific advice which may be added at the discretion of the applicant); and,

• legible, unambiguous and user-friendly. 3. The Product Label and the UK Regulations 3.1 Approval for the sale, supply, storage, advertisement and use of pesticides is

governed by the Control of Pesticides Regulations (COPR) 1986 or, following the introduction of Council Directive 91/414/EEC, the Plant Protection Products Regulations (PPPR) 1995. The registration of pesticide products is in a transitional period and the applicable Regulations depend on the active substance(s) in the product.

3.2 The safe, humane and efficacious use of pesticides is enabled by the general

conditions on sale, supply, storage, advertisement and use of all pesticides (as set out in the Regulations), specific conditions in the product approval (which set the requirements for the label text) and other guidance for the end-user such as the ‘Code of Practice for the Safe Use of Pesticide on Farms and Holdings’.

3.3 The general ‘conditions of sale and supply’ that apply to all products, state that:

“No person shall sell, supply or otherwise market to an end user an approved pesticide [plant protection product] other than in the container which has been supplied for that purpose by the approval holder and labelled in a manner consistent with the approval.”

3.4 The product specific ‘condition of sale and supply’ on the final Notice of Approval will

specify the following: • the product must be supplied with ‘Approved Text’ in line with that on a

referenced draft label text (as submitted by the applicant and used in PSD’s evaluation) and amended in line with any amendments specified on the Notice;

• the final printed label must meet the requirements for formatting as specified in the relevant sections of this Labelling Handbook; and

• changes may be made to the ‘Approved Text’ and formatting of the label without an application to PSD in line with the criteria set out in relevant sections of this Labelling Handbook

The final printed label and subsequent changes must comply with these conditions.

07/06/2005 Introduction: The Product Label and The Labelling Handbook 2


Part A

How To Use The Labelling Handbook 1. Purpose of the guidance 1.1 The guidance in this Handbook provides the information required for an applicant for

approval of a pesticide (as defined in paragraph 2.2 below) to:

(a) prepare a draft label text containing the information required under the Regulations (i.e. ‘Approved Text’ - see Part B/section 2) for evaluation by PSD;

(b) in line with any subsequent approval, to print the final label with the correct

content and format of ‘Approved Text’; (c) prepare and supply other information/advice on the Product Label which is not

required under the UK Pesticide Regulations but which is either required under separate legislation or provides additional useful advice to the user (‘Other Text’ - see Part B/section 3); and

(d) make changes to the label without the need for new application for approval.

1.2 This section includes the following Annexes to aid applicants in using this guidance

correctly when preparing draft and final printed labels.

(a) Annex 1 summarises the content of each section of the ‘The Labelling Handbook’.

(b) Annex 2 is a ‘bullet point’ guide for applicants on drafting new professional

Product Labels with an explanation of when each section of the Handbook should be used.

(c) Annex 3 is a ‘bullet point’ guide for applicants on drafting new amateur Product

Labels with an explanation of when each section of the Handbook should be used.

2. Scope of the guidance 2.1 The Product Label is as defined in Introduction/paragraph 2. 2.2 All references to pesticides in this guidance refer to:

(a) ‘pesticides’ as approved under the Control of Pesticides Regulations (COPR) 1986 and ‘plant protection products’ as approved under the Plant Protection Product Regulations (PPPR)1995; and,

07/06/2005 Part A: How To Use The Labelling Handbook 1


(b) which are the responsibilities of Pesticides Safety Directorate (PSD) by virtue of falling within the following fields of use:

• agriculture • food storage • horticulture • in or near water • forestry • vertebrate control (for plant protection purposes) • industrial herbicides • home garden (including house plants)

2.3 Biocides and Pesticides Assessment Unit (BPAU) of the Health and Safety Executive

(HSE) is responsible for non-plant protection products within the following fields of use: • wood preservation, • surface biocide treatment (in and around buildings), • public hygiene/nuisance insecticides in domestic & other buildings, • anti-fouling products, • vertebrate control (for non-plant protection purposes) • home kitchen and larder • animal husbandry • food storage

For information on the labelling of these product types please contact:

Biocides and Pesticides Assessment Unit Health and Safety Executive Magdalen House Stanley Precinct Bootle Merseyside L20 3QZ

Tel: 0151 951 3535 (International: (+44) 151 951 3535) Fax: 0151 951 3317 (International fax: (+44) 151 951 3317) e-mail: [email protected]

2.4 This guidance refers to labelling of pesticide products only. These are not requirements

for the labelling of adjuvant products. Whilst PSD exercise control over the use of Officially Listed adjuvants with pesticides, labels are not approved as for pesticides (see The Applicant Guide for advice on the adjuvant applicant’s obligations with respect to the label).

2.5 Further advice on the contents of the Labelling Handbook may be obtained from:

Information Section, Pesticides Safety Directorate Mallard House Kings Pool 3 Peasholme Green YORK YO1 7PX

Tel: 01904 640500 (International: (+44) 1904 640500) Fax: 01904 455733 (International fax: (+44) 1904 455733) e-mail: [email protected]

07/06/2005 Part A: How To Use The Labelling Handbook 2


http://www.pesticides.gov.uk/applicant_guide.asp



Part A/Annex 1

Summary of Handbook contents

Part Title Content When to use the guidance A HOW TO USE THE

LABELLING HANDBOOK • Guide on how and when each section of the Handbook

should be used. • When preparing a draft label for submission to PSD or

making changes to an existing label, applicants should use this section (and the Annexes in particular) to identify which parts of the Handbook must be read and followed.

B SUMMARY OF LABELLING

REQUIREMENTS • Definitions of the information that maybe supplied on, or

with, the Product Label. • Summary of how an applicant should draft and submit

labels with applications for approval. • How PSD regulate different parts of the information

supplied with pesticides.

• When familiarising with the general principles of UK labelling.

• To understand the applicant’s obligations in presenting draft labels to PSD and in printing the final label.

• The specific requirements for content and formatting of draft and final labels are set out in Parts C to K.

C PROFESSIONAL PRODUCT LABEL: ‘APPROVED TEXT’

• Minimum requirements and guidance on format and content for the 4 major sections of the professional Product Label, i.e. Product Identity, Statutory Area, Safety Information and Directions For Use.

• Annexes A-D provide full guidance on how to present the required information in each of these sections.

• When drafting a professional Product Label for submission to PSD, all the information for each of the 4 sections must be presented using the standard text described.

• When producing the final printed label after approval has been issued, all formatting requirements must be followed.

D AMATEUR PRODUCT LABEL: ‘APPROVED TEXT’

• Minimum requirements and guidance on format and content for the 3 main sections of the amateur product label i.e. product identity, safety information and Instructions for use.

• When drafting an amateur product label for submission to PSD, all the required information for each of the 3 sections must be presented using the standard text described.

• When producing the final printed label after approval has been issued, all formatting requirements must be followed.

E ACCEPTABLE CHANGES TO

‘APPROVED TEXT’ • Criteria within which changes may be made to the

‘Approved Text’ on the Product Label at the discretion of the applicant after approval has been issued without recourse to an application for changes to the existing approval.

• Whenever the applicant wants to make changes to the label text without submitting an application for a new approval, the criteria listed in this guidance must be complied with.

F AVOIDANCE OF FALSE AND MISLEADING STATEMENTS

• General guidance on label text which is considered unacceptable in that it may mislead the user by making inaccurate or false claims and recommendations.

• When drafting the label for submission to PSD or making any changes in line with Part E after approval has been issued.

07/06/2005 Part A/Annex 1: Summary of Handbook contents 3


G STRUCTURE AND LAYOUT OF PRODUCT LABEL ON THE CONTAINER

• Minimum requirements and guidance for presenting information on different parts of the container, other packaging and separate leaflets. This includes advice for small container types where space is a premium (e.g. sachets, water soluble packs) and products consisting of more than one component packaged together (e.g. twin-packs).

• When drafting the label for submission to PSD, appropriate label text should be presented for different parts of the product packaging if they differ in the information required.

• When producing the final printed label(s) for different parts of the packaging, this guidance must be followed.

H LEGIBILITY OF TEXT • Minimum requirements for final printed label legibility (e.g. colours, fonts etc).

• When producing the final printed label, this guidance must be followed.

I USE OF ARTWORK • Criteria to be followed in including artwork and graphics on the final printed label.

• When producing the final printed label, this guidance must be followed.

J COMPANY ADVISORY INFORMATION

• Guidance on the acceptable content of Company Advisory Information that may be supplied as a discrete part of the Product Label at the discretion of the applicant using the guidelines set by PSD.

• When drafting or making changes to the Company Advisory Section, this guidance must be followed.

• Where specified in this guidance, the Company Advisory Section must also be submitted to PSD for consideration (the first time an existing label is amended to remove ‘advisory’ information from the Directions For Use to this separate part of the label).

K SAFETY DATA SHEETS • Advice on the supply of safety Data Sheets separately to

the Product Label (as a requirement under separate UK legislation).

• Safety Data Sheets are not required as part of the ‘Approved Text’. This guidance clarifies the situation for the applicant.

07/06/2005 Part A/Annex 1: Summary of Handbook contents 4


Part A/Annex 2

How to draft a professional Product Label

(a)

Obtain understanding of ‘Approved’ and ‘Other’ text from Part B.

(b) Refer to The Applicant Guide on guidance for when a label must be submitted with an application for approval

(c) Draft ‘Approved Text’ for proposed label to reflect the text 4 label sections as detailed in the following (see also Part C): Part C/Annex 1 - Product Identity Part C/Annex 2 - Statutory Area Part C/Annex 3 - Safety Precautions Part C/Annex 4 - Directions For Use The guidance in Part F (Avoidance of false and misleading statements) must be considered in drafting this text. The specific text that must be included is dependent on the nature of the active substance and formulation, the claims and recommendations required, the available supporting safety and efficacy data and/or regulatory precedents set by previous approvals.

1. Drafting theproposed ‘Approved Text’ for a professional Product Label for submission to PSD (either a new label for a previously unapproved product or a new label for a previously approved product where the changes require a new application for approval).

(d) The proposed draft label need not be submitted in exactly the format that it will appear on the final pack (see 3. below for guidance on printing the final label). However, where different parts of the packaging are to carry different labels (e.g. water soluble packs or other types of sachet where reduced labelling requirements may be applicable; multi-packs) drafts of the text that will appear on each type of label must be submitted. Requirements on labelling different parts of the label is given in Part G.

(a) • Company Advisory Information: When drafting or making changes to the Company Advisory Section, the guidance in Part J must be followed.

• The intention is that applicants will have scope to draft and subsequently amend this section without recourse to a new application for approval. However, in the first instance of an existing label ‘Approved Text’ being amended to move information to a new Company Advisory Section, the label be submitted to PSD for consideration (the first time an existing label is amended to remove ‘advisory’ information to this separate part of the label).

2. Drafting and printing ‘Other Text’ section(s)

(b) • Safety Data Sheets: Refer to Part K.

07/06/2005 Part A/Annex 2: How to draft a professional Product Label 5



(a) The ‘Approved Text’ content on the final printed label must reflect the text on the draft label and the amendments (both as specified on the final Notice of Approval). Changes can be made to the text at this stage in line with the requirements set out in Part E and Part F.

(b) The formatting of the text in each label section (e.g. bold highlighting, font size, use of upper and lower case) must be in line with: • any requirements set out in Part C and associated Annexes; and, • the legibility requirements set out in Part I.

(c) Any artwork used on the label must be in line with the requirements as set out in Part H.

3.

Printing final label after issue of approval (including making changes to text/format of a printed label where a new application for approval is not required).

(d) Different parts of the product packaging must be labelled in line with the requirements set out in Part G.

07/06/2005 Part A/Annex 2: How to draft a professional Product Label 6


Part A/Annex 3

How to draft an amateur Product Label

(a)

Obtain understanding of ‘Approved’ text from Part B.

(b) Refer to The Applicant Guide on guidance for when a label must be submitted with an application for approval

(c) Draft ‘Approved Text’ for proposed label to reflect the text 4 label sections as detailed in the following (see also Part D): Part D/Annex 1 - Product Identity Part D/Annex 2 - Safety Information Part D/Annex 3 - Instructions For Use The guidance in Part F (Avoidance of false and misleading statements) must be considered in drafting this text. The specific text that must be included is dependent on the nature of the active substance and formulation, the claims and recommendations required, the available supporting safety and efficacy data and/or regulatory precedents set by previous approvals.

1. Drafting theproposed ‘Approved Text’ for an amateur Product Label for submission to PSD (either a new label for a previously unapproved product or a new label for a previously approved product where the changes require a new application for approval). (d) The proposed draft label need not be submitted in exactly the format that it will appear on the final pack (see 3. below for

guidance on printing the final label). However, where different parts of the packaging are to carry different labels (e.g. sachets where reduced labelling requirements may be applicable; multi-packs) drafts of the text that will appear on each type of label must be submitted. Requirements on labelling different parts of the label is given in Part G.

(a) The ‘Approved Text’ content on the final printed label must reflect the text on the draft label and the amendments (both as specified on the final Notice of Approval). Changes can be made to the text at this stage in line with the requirements set out in Part E and Part F. #

(b) The formatting of the text in each label section (e.g. bold highlighting, font size, use of upper and lower case) must be in line with:

• any requirements set out in Part D and associated Annexes; and, • Legibility of text must be in line with criteria set out in Part I. #

(c) Any artwork used on the label must be in line with the requirements as set out in Part H. #

2. Printing final label after issue of approval (including making changes to text/format of a printed label where a new application for approval is not required).

(d) Different parts of the product packaging must be labelled in line with the requirements set out in Part G. #

07/06/2005 Part A/Annex 3: How to draft an amateur Product Label 7


m147896

Part D):

m147896

G.


# However, please note that where these sections refer to Part C, this advice may not be applicable to amateur Product Labels.

07/06/2005 Part A/Annex 3: How to draft an amateur Product Label 8


Part B

Summary of labelling requirements 1. Content of text on the Product Label 1.1 Information on the use of pesticide products must be supplied with the product container

in the form of the Product Label. This is defined as: The written, printed or graphic matter which is printed on, attached to, or otherwise accompanies the pesticide container(s) or other packaging, and by which the user is informed of the requirements for the safe, humane and efficacious use of the product.

1.2 It comprises of two types of information as follows:

(a) ‘Approved Text’ which includes text controlled under the UK Pesticide Regulations and ‘approved’ by PSD (see paragraph 2 below). This is applicable to both professional and amateur Product Labels (although the requirements for each will be different); and,

(b) ‘Other Text’ which includes other advice and information which is not required

under the Pesticide Regulations, but may be included at the discretion of the applicant (using the guidelines as set out in this Handbook) or be required under separate UK legislation (see paragraph 3 below). This is applicable to professional products only.

2. ‘Approved Text’ on the Product Label

2.1 Definition of ‘Approved Text’

‘Approved Text’ is information on the safe, efficacious and humane use of the product, the text of which falls within the remit of the Pesticide Regulations and must therefore be supported by safety and efficacy data. This text is ‘approved’ by PSD, i.e. the applicant must submit a draft text to be considered as part of the application (see paragraph 2.3 below) and the resulting Notice of Approval will require as a ‘condition of sale and supply’ that: • The product is supplied with the draft text submitted by an applicant subject to any

amendments required by PSD. • It may only be amended by submission of an application for change in approval or,

in certain cases, at the discretion of the applicant in compliance with the criteria in this Handbook.

• The format of the final printed label is subject to compliance with the criteria in this

Handbook (although there is scope for the applicant to design the final label at their discretion).

07/06/2005 Part B: Summary of Labelling Requirements 1

The Labelling Handbook 2.2 ‘Approved Text’ for professional and amateur products

(a) ‘Professional’ Product Label

Full guidance on ‘Approved Text’ requirements for professional products is given in Part C. These are products for which users must be either certificated or, if the product does not require certification but is used as part of a business or employment, must receive training in its use. As such, users should be aware of their obligations in using pesticides. The label is therefore divided into different sections, some of which must always be complied with and others which may be deviated from, subject to the user carrying out a suitable safety assessment (e.g. as specified in COSHH and the ‘Code of Practice for the Safe Use of Pesticides on Farms and Holdings‘).

(b) ‘Amateur’ Product Label

Full guidance on ‘Approved Text’ requirements for amateur products is given in Part D. These are products which are on retail sale to the public and are generally used around the home and in the home garden. Amateur users are not required to be trained in the use of pesticides. There are also fewer options for a user to deviate from label instructions than available to a trained ‘professional’ (e.g. who can use COSHH and the ‘Code of Practice for the Safe Use of Pesticides on Farms and Holdings when considering how the product may be applied). As such, the approach taken for amateur product labelling is different to that required for professional products.

2.3 Submission of draft ‘Approved Text’ to PSD

The applicant must submit 2 copies of a draft text for ‘Approved Text’ to be used in the evaluation of approval as follows: (a) The draft must include the proposed text set out in the form of the appropriate

label sections detailed in Part C (professional products) or Part D (amateur products). All standard text required in this guidance must appear. The applicant should ensure that all the proposed text can be justified by the supporting data package(s) (other than information which falls within the guidelines for inclusion in the Company Advisory Information (see Part J) but which the applicant wishes to include in the main body of the label instead).

(b) However, it is not necessary for the draft to reflect all the formatting requirements

(e.g. legibility, fonts, final artwork and colours) which is an obligation that must be met when the final label is printed for supply onto the market. Full details of this final formatting are also given in Part C (professional products) and Part D (amateur products) plus Parts F to H of this guidance.



(c) Where applications for approval are made which do not affect a previously approved label, it is acceptable for the applicant to reference that label and not submit a new one (see The Applicant Guide, e.g. reference a label already approved for the product itself or, where an application is being made for a product identical to another one, reference a label text as already approved for that other product).

2.4 Content of ‘Approved Text’ on the final printed Product Label

It is an approval condition of ‘sale and supply’ that the applicant supplies the product with a final printed label which meets the following requirements for the ‘Approved Text’ content:

(a) The text on the final printed label must comply with the text in the draft label

subject to the amendments (if any) specified in the Notice of Approval. Any new text or changes to existing text which do not fall within the criteria set out in Part E require an application for approval to be submitted with the appropriate supporting information/data.

(b) Changes to the ‘Approved Text’ may be made by the applicant at any time

providing such changes comply with the criteria set out in Part E. 2.5 Format of ‘Approved Text’ on the final printed Product Label

It is an approval condition of ‘sale and supply’ that the applicant supplies the product onto the market with a final printed label which meets the following format requirements.

The format and structure of the label must comply with the criteria as follows: (a) Part C for all Professional products. (b) Part D for all Amateur products (guidance still to be published). (c) Parts G, H and I for all products.

3. ‘Other Text’ on the Product Label 3.1 Definition of ‘Other Text’

‘Other Text’ is additional advice that may be supplied on, or with, with the Product Label and which is not within the remit of the Regulations or required to be supported by safety and efficacy data. It gives additional useful advice on the handling and use of the product (see paragraph 3.2 below), is required by other legislation (see paragraph 3.3 below) or relates to non-pesticidal uses (see paragraph 3.4 below). It is not part of the ‘Approved Text’ of the Product Label but may be included at the discretion of the applicant. Guidelines are given in Part J and Part K.



The Labelling Handbook 3.2 Company Advisory Information 3.2.1 This is additional health and safety, use and agronomic information which the applicant

may wish to present to the user but which does not need to appear as part of the ‘Approved Text’ on the Product Label. The approval ‘condition of sale and supply’ will allow an applicant to include a Company Advisory Information section using the guidelines in Part J.

3.2.2 If a Company Advisory Information section is included as a discrete and separate part of

the Product Label, any changes or additions will not require an application for approval if the applicant uses the guidelines in Part J.

3.2.3 This section is considered to be ‘Other Text’ as it will not usually be checked as a matter

of course during evaluation of the label and specific amendments will not be requested on the Notice of Approval. However, it should be drafted using the guidelines in Part J and presentation of inappropriate information may lead to regulatory action being taken.

3.2.4 There are no specific formatting requirements for this section. 3.2.5 Alternatively, such information may continue to appear within the ‘Approved Text’ of the

Product Label but it will not be highlighted as ‘advisory’. However, PSD retain discretion to remove any information from the ‘Approved Text’ if necessary.

3.3 Safety Data Sheets

Full guidance is given in Part K. This is not required by the Regulations. However, supply of Safety Data Sheets with a product is governed by separate legislation which covers the content and format.

3.4 Non-pesticidal recommendations

Pesticides may also have other non-pesticidal uses which are not controlled under the Regulations, e.g. uses as a fertiliser/crop nutrient; general disinfectant uses. It is acceptable for a Product Label to carry recommendations for such uses subject to the following: (a) Recommendations must be clearly separated from those for pesticide uses; (b) A statement must appear explaining that these uses are not part of the text as

controlled under the relevant Regulations (i.e. COPR or PPPR as relevant).



Part C

Professional Product Label: ‘Approved Text’ 1. Introduction

The following guidance sets out how the ‘approved’ text on a ‘professional’ Product Label must be presented in 4 sections.

(a) The 4 sections are Product Identity, Statutory Area, Safety Information and

Directions For Use (see paragraphs 2 to 5 below and Part C/Annexes 1, 2, 3 and 4).

(b) The draft label text submitted to PSD must be presented in line with the

requirements for each section as specified in Part C/Annexes 1 to 4. It must include the relevant standard headings and phrases specified in Annexes 1 to 4. However, it need not at this stage reflect other formatting requirements (e.g. size of text, fonts, bold highlighting). These requirements will be set as a ‘condition of sale and supply’ on the final Notice of Approval (see (c) below). However, Part G does give advice on labelling different parts of the product packaging

(c) The final printed label is subject to any text amendments as specified on the

Notice of Approval, and formatting requirements as set out in Part C/Annexes 1 to 4 and Parts G to I.

2. Product Identity

This sets out the core product information so that the users, regulatory authorities and any other interested parties may easily identify the product and its intended purpose: (a) Product tradename. (b) The product registration number. (c) Name and address of the approval holder and marketing company. (d) The formulation type. (e) Name and amount of the active substance. (f) Identity of ‘dangerous’ coformulants. (g) Net quantity of product. (h) Product batch number. (i) Biological use phrase. (j) The COSHH phrase. Annex 1 to this section details the specific content and formatting requirements for Product Identity information.

3. Statutory Area This lists certain restrictions on use as given in the approval. The user must not deviate from these (other than where the product can be used on another crop/situation by virtue of a Specific Off-Label Approval or the Long Term Arrangements for Extension of Use).

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It consists of a separate boxed area of the label containing: (a) Statutory conditions of use as relating to the application of the pesticide to the

target crop/situation but not repetition of those statutory conditions which also which will also appear in the Safety Precautions section (see (b) below).

(b) A statement that the user must comply with the conditions in (a) above and specific

precautionary phrases in the Safety Precautions section which may also be statutory conditions.

(c) A statement that the user must read all other Safety Precautions and the Directions

For Use. Annex 2 to this section details the specific content and formatting requirements for the Statutory Area.

4. Safety Information These comprise the following (as appropriate to the product): (a) Hazard symbol and associated risk phrases. (b) Safety (precautionary) phrases to ensure safety of the operator and other parties,

the environment/non-target organisms and storage and disposal. (c) Medical advice/First aid (subject to the classification/type of product).

Annex 3 to this section details the specific content and formatting requirements for the Risk and Safety Phrases.

5. Directions For Use

This contains detailed claims, recommendations and instructions for the use of the product for its intended purpose (certain of the information will, by necessity, reflect that given in the Statutory Area). All text must be supported by safety and efficacy data. Compliance with the instructions in this section should ensure that the product is used safely and efficaciously. However, deviation from the instructions (such as use of different water volumes, application equipment, or a different application regime) is acceptable if the user does not exceed the statutory conditions of use and takes ‘reasonable precautions’, e.g. uses the guidance in the ‘Code of Practice for the Safe Use of Pesticide on Farms and Holdings’ (‘The Green Code’) and makes appropriate COSHH assessments. Enforcement action may however still be taken on resulting incidents where ‘reasonable precautions’ have not been taken. The following type of information should appear in this section: (a) crops/situations; (b) pests/weeds controlled; (c) dose rates; (d) number of treatments per crop/year/situation; (e) recommended application timing, intervals between applications and harvest

interval; (f) specific agricultural, plant health and environmental conditions pertaining to use; (g) following crop recommendations; (h) soil type, variety and climatic restrictions; (i) warnings relating to phytotoxicity, resistance, adjacent crops etc;



(j) ‘positive’ and ‘convenience’ tank-mix recommendations; (k) methods of application; (l) water volumes; (m) mixing instructions; (n) all other information on product application which is required for safe and

efficacious use. Annex 4 to this section details the specific content and formatting requirements for the Directions For Use.


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Part C/Annex 1

Product Identity - Professional Product Label Refer to Part C/paragraph 2 1. What is Product Identity?

The range of information that falls under the general term Product Identity consists of core product information which will ensure that the users, regulatory authorities and any other interested parties may easily identify the product and its intended purpose.

2. Compulsory Formatting Requirements 2.1 The information in paragraph 3 below must appear on the Container Label and on any

separate Leaflet supplied with the product (full guidance on definition and presentation of Container Labels and Leaflet is given in Part G).

2.2 It must be formatted in line with any requirements detailed in paragraph 3 below and

those set out in Parts G to I. 3. Content The applicant for approval must suggest the text to be used for a product on the draft label. The actual final text required will be set by PSD following evaluation of the application and any changes to the draft label will be specified on the Notice of Approval. 3.1 Product tradename

3.1.1 The product name as specified on the Notice of Approval. It must be formatted such that

it is clear to the user what the full tradename is. Whilst use of different sized fonts and colours for different parts of the tradename is acceptable, applicants should ensure that this would not confuse a user.

3.1.2 PSD will not consider trademark or copyright issues with respect to tradenames. This is

the responsibility of the applicant. However, PSD reserves the right to request a different tradename where: • It is likely to cause confusion with another product or with non-pesticide products; • It misrepresents the composition or intended use of the product; • It makes claims that are not supported by data.

3.2 Product registration number

The unique 5 digit identifying registration number given in the approval (prefixed with ‘MAFF’ or ‘MAPP’) must appear in close proximity to the product tradename.

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The Labelling Handbook 3.3 Approval holder and/or marketing company details

The requirements differ depending on whether the product holds approval under COPR or PPPR. (a) COPR-approved products

Name, address and telephone number of the marketing company must appear. If different, the name, address and telephone number of the approval holder may appear (this is at the discretion of the applicant).

(b) PPPR-approved products Name, address and telephone number of the approval holder, and if different, the name, address and telephone number of the marketing company must appear.

3.4 Formulation type

The formulation type based on standard GCPC (formerly GIFAP) definitions (usually included in a ‘contents statement’ with 3.5 and 3.6 below). The formulation type should preferably be given in full (e.g. suspension concentrate) rather than the abbreviation (e.g. SC).

3.5 Amount and name of the active substance(s)

3.5.1 The target content of each named active substance, as specified on the Notice of

Approval expressed as follows (usually included in a single ‘contents statement’ with 3.4 and 3.6).

(a) for formulations which are solids, aerosols, volatile liquids (boiling point max 50°C)

or viscous liquids (lower limit 1 Pas at 20°C): as a percentage by weight; (b) for other liquids: as a percentage by weight and in grams per litre at 20°C; (c) for gases: as a percentage by volume.

3.5.2 The active substance name must be as given in the list contained in Annex I to Directive 67/548/EEC or, if not included therein, its International Organisation for Standardisation common name. If the latter is not available, the active substance shall be designated by its chemical designation according to the rules of the International Union of Pure and Applied Chemistry contained in the Nomenclature of Organic Chemistry.

3.6 Identity of any ‘dangerous’ coformulants

The following must be specified (usually in the ‘contents statement’ with the information on active substance in 3.4 and 3.5 above):

The name of each very toxic, toxic, harmful or corrosive substance contained in the formulation, excluding active substances, in concentrations exceeding those specified in Directive 78/631/EEC.'


The Labelling Handbook 3.7 Net quantity of product

The net quantity of the preparation in the container (in accordance with the Weights and Measures Act). This applies to any small containers/packs supplied within an outer container. Where a number of smaller containers are packaged within a single outer, the latter should state how many, and what size, of the former are being supplied.

3.8 Product batch number

The formulation batch number or some means of identifying it (this may be printed on the container itself rather than on the label area).

3.9 Biological use phrase

Brief statement on biological use (e.g. ‘For the control of aphids and red spider mites on top fruit’).

3.10 The ‘COSHH phrase’ 3.10.1 Pesticides for which the Control of Substances Hazardous to Health Regulations

(COSHH) are applicable must carry the following phrase on the Container Label:

‘The (COSHH) Control of Substances Hazardous to Health Regulations may apply to the use of this product at work’

3.10.2 COSHH may be applicable if the formulation:

(a) is classified Very Toxic, Toxic, Harmful, Irritant or Corrosive; (b) includes a substance which has been given a Maximum Exposure Limit, (MEL) or

Occupational Exposure Standard (OES) under the COSHH Regulations (details of substances with an MEL or OES are in the latest edition of HSE Guidance Note EH40);

(c) includes a micro-organism which may create a hazard to health; (d) includes dust which may be present in substantial concentrate of air when the

pesticide is used (‘substantial concentration is explained the General Approved Code of Practice on the COSHH Regulations, document COP 29 available from HMSO);

(e) includes any substance not mentioned in (a) or (d) which creates a hazard to

health which is comparable with the hazards created by substances in (a) to (d).



Part C/Annex 2

Statutory Area - Professional Product Label Refer to Part C/paragraph 3 1. What is The Statutory Area?

The Statutory Area is a boxed area on the main part of the label used to clearly communicate to the user the specific restrictions relating to application of the product to the approved crop/situation and other Safety Precautions with which the user must comply (i.e. the statutory conditions of use and storage).

2. Compulsory Formatting Requirements 2.1 The Statutory Area must appear on the Container Label and on any separate Leaflet

supplied with the product (full guidance on the definition of and presentation of Container Labels and Leaflet is given in Part G).

2.2 The contents of the Statutory Area must be set within at least a 2 point outlined box in

print no smaller than the remainder of the label text. 12.3 The Statutory Area heading must read as follows in bold capitals:

COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE AND ALL SAFETY PRECAUTIONS MARKED * IS A LEGAL REQUIREMENT [If the Notice of Approval for a product does not specify any ‘Statutory conditions of use or storage’ that require specifying in the Safety Precautions section as phrases (i.e. under ‘Operator protection’, ‘Environmental protection’ and ‘Other specific restrictions’), then the above phrase should be amended to read:

COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE IS A LEGAL REQUIREMENT]

2.4 The subheadings used in paragraphs 3.2 to 3.6 below must appear where appropriate. 2.5 All or some of the information in paragraphs 2.2 to 2.6 may be tabulated if required. See

Working Document 2/Example 3. 2.6 The following phrase must appear in bold capitals as the final item in the Statutory Area:

READ ALL OTHER SAFETY PRECAUTIONS AND DIRECTIONS FOR USE BEFORE USE

12.7 Where due to space constraints it is not possible to include all the information in the

container label Statutory Area itself, the items in paragraphs 3.3 to 3.6 only may be included in the Statutory Area that is included on a separate leaflet and referenced to

1 Paragraphs 2.3 and 2.7 are the only two acceptable types of ‘signposting’ from the Statutory Area to other parts of the label. 2.3 is compulsory whilst 2.7 is optional where space constraints are a problem.

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that leaflet from the container label Statutory Area. Working Document 2/Example 4 sets out the requirements for this format. 1

2.8 It must be formatted in line with any requirements set out in this Annex and those set out

in Parts G and I. 3. Content

The following information on the statutory conditions of use (and as specified in the Notice of Approval) must appear in the order stated (with the appropriate sub-heading). On the draft label the applicant must propose appropriate statutory conditions of use. The actual final conditions required will be set by PSD following evaluation of the application and any changes to the draft label will be specified on the Notice of Approval. The items in paragraphs 3.1 and 3.2 will always be set for a product. The items in paragraphs 3.3 to 3.6 will be set if appropriate to a particular product. 3.1 Field of use

The appropriate ‘Field of use’ as taken from Working Document 1 to this Annex. The sub-heading ‘Field of use’ is not required.

3.2 Crops/situations

3.2.1 The crop(s) or situation(s) upon which the product may be used must always appear in

the Statutory Area, even where the ‘signposting’ option is used for other information in this area (see Working Document 2/Example 4).

3.2.2 A sub-heading for this section of ‘Crops:’ and/or ‘Situations:’ (where the use is not

directed to a crop, e.g. natural surfaces not intended to bear vegetation, processed consumable products, etc) should be used. Alternatively, the phrase ‘For use on:’ may be used. No specific formatting for the sub-heading is required.

3.2.3 Applicants should refer to the ‘Crop Hierarchy’ guidance on PSD’s website for advice on

the appropriate way of expressing crops and situations in the Statutory Area. 3.3 Maximum individual dose

3.3.1 This is the highest dose at which the product may be applied at any one treatment

to a specific crop/situation. Depending on the product type, it will be stated as:

(a) A maximum quantity of product to be used for a given area of land, a given volume of soil/other growing medium or a given volume or weight of seed/produce; or

(b) A maximum concentration of product applied in water (e.g. if product is

applied to ‘run-off’).

3.3.2 The units of quantity used must be appropriate to the formulation type. 3.3.3 A sub-heading of ‘Maximum individual dose’ is required (no specific formatting for the

sub-heading is necessary).


The Labelling Handbook 3.4 Maximum number of treatments or Maximum total dose

3.4.1 This condition restricts the total amount of product that may be applied to a specific

crop/situation per crop/year in terms of either: (a) Maximum number of treatments: The maximum number of applications that may

be made within a given period (i.e. per crop or per year as appropriate) each application being at a dose up to the ‘maximum individual dose’. It should be stated in terms of number of treatments/crop or year (e.g. per crop for annual crops; per year for perennial crops).

(b) Maximum total dose: The maximum amount of product that may be applied

within a given period (i.e. per crop or per year as appropriate), irrespective of the number of treatments made, as long as none of the treatments exceeds the ‘maximum individual dose’. It should be stated in terms of the appropriate quantity of product/crop or year depending on the specific crop/situation (e.g. ‘per crop’ for annual crops; ‘per year’ for perennial crops).

3.4.2 A sub-heading reading ‘Maximum number of treatments’ or Maximum total dose’ as

appropriate is required (no specific formatting for the sub-heading is necessary).

3.5 Latest time of application

3.5.1 This is the latest timing at which a product may be applied to a specific crop/situation. It may be specified as: (a) a date (usually specified as ‘in the year of treatment’ ‘or ‘in the year of harvest’), (b) crop growth stage (but not just as a numerical key and usually as a latest timing

specified in terms of ‘before’ a particular stage), (c) as a number of days or weeks before harvest, or other as appropriate.

3.5.2 A sub-heading reading ‘Latest time of application’ is required (no specific formatting for the sub-heading is necessary).

3.6 Other specific restrictions

3.6.1 Any other necessary restriction on the application of the product to a specific crop/situation, e.g. minimum interval between applications; minimum concentration of product in the spray.

3.6.2 A sub-heading reading ‘Other specific restrictions’ is required (no specific formatting for

the sub-heading is necessary). 4. Examples of Statutory Area format

4.1 Working Document 2 to this Annex presents four examples for the Statutory Area

showing the different formats that may be used depending on the complexity of information to be conveyed.

4.2 These examples are hypothetical situations and are intended only to demonstrate the format of this information.



Part C/Annex 2/Working Document 1

Field Of Use Phrases - Professional Product Label Refer to Part C/Annex 2/paragraph 3.1 1. Construction of Phrase

The ‘field of use’ in the Statutory Area must read ‘FOR USE ONLY AS A[N]’ followed by the appropriate entries from the choices below as follows: (a) At least one from columns A and/or C appropriate to the product uses; and (b) At least one from column B depending on the action of the product.

A. B. C.

AGRICULTURAL # HORTICULTURAL # FORESTRY # INDUSTRIAL # AQUATIC #

INSECTICIDE FUNGICIDE HERBICIDE PLANT GROWTH REGULATOR ACARICIDE NEMATICIDE ALGICIDE DESICCANT MOLLUSCICIDE SEED TREATMENT SOIL STERILANT RODENTICIDE BACTERICIDE [ANIMAL]/[BIRD] REPELLENT TURF TREATMENT WORM CONTROL AGENT SPROUT GROWTH INHIBITOR RODENTICIDE [MOLE]/[RABBIT]/[SQUIRREL] CONTROL

IN OR NEAR WATER # IN INTERIOR LANDSCAPES# IN FOOD STORAGE PRACTICE BY COMPETENT PERSONS*

# These uses require certification of the operator (excluding products containing methyl bromide). * This phrase is required with any products which are used as a RODENTICIDE or for MOLE,

RABBIT or SQUIRREL CONTROL as specified in column B. 2. Examples of Phrases

• FOR USE ONLY AS AN AGRICULTURAL/HORTICULTURAL FUNGICIDE (e.g. disease control in wheat, oilseed rape and strawberry).

• FOR USE ONLY AS AN INDUSTRIAL HERBICIDE (e.g. weed control in on land not intended to bear vegetation).

• FOR USE ONLY AS A HORTICULTURAL FUNGICIDE/WORM CONTROL AGENT (e.g. product used on amenity turf with both fungicidal and worm control action).

• FOR USE ONLY AS AN INSECTICIDE IN FOOD STORAGE PRACTICE (e.g. insect control in stored grain).

• FOR USE ONLY AS AN AGRICULTURAL SEED TREATMENT (e.g. product applied to wheat seed for disease control).

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Statutory Area Examples - Professional Product Label Example 1 This is the simplest format where the same restrictions apply to one or more crops and there is no need to differentiate between different restrictions for different crops. COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE AND ALL SAFETY PRECAUTIONS MARKED * IS A LEGAL REQUIREMENT FOR USE ONLY AS AN AGRICULTURAL HERBICIDE Crop: Winter wheat and winter barley Maximum individual dose: 2 litres product/ha Maximum number of treatments: 2 per crop Latest time of application: Before second node detectable stage Other specific restrictions: This product must not be used on durum wheat READ ALL OTHER SAFETY PRECAUTIONS AND DIRECTIONS FOR USE BEFORE USE [REFER TO Part C/Annex 2/paragraphs 2 and 3 for explanation of the structure of this area of the label].

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C/Annex 2/paragraphs 2 and 3

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Part

The Labelling Handbook Example 2 This format may be used where different restrictions apply to different crops/situations and where there is a need to differentiate. Alternatively, the tabulated format in Example 3 may be used. COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE AND ALL SAFETY PRECAUTIONS MARKED * IS A LEGAL REQUIREMENT FOR USE ONLY AS AN AGRICULTURAL HERBICIDE Crops: Winter wheat, winter barley and oilseed rape Maximum individual dose: Winter wheat and barley: 2 litres product/ha

Oilseed rape: 1 litre product/ha Maximum number of treatments: Winter wheat and barley: 2 per crop

Maximum total dose: Oilseed rape: 3 litres product/ha/crop Latest time of application: Winter wheat and barley: Before second node detectable

stage Oilseed rape: 14 days before harvest Other specific restrictions: This product must not be used on durum wheat READ ALL OTHER SAFETY PRECAUTIONS AND DIRECTIONS FOR USE BEFORE USE [REFER TO Part C/Annex 2/paragraphs 2 and 3 for explanation of the structure of this area of the label].


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C/Annex 2/paragraphs 2 and 3

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The Labelling Handbook Example 3 As in Example 2 this format may be used where different restrictions apply to different crops/situations and where there is a need to differentiate. The use of the table presents the information in an easier to follow format than Example 2 and should be the standard where use on a number of crops/situations is approved. Note that the ‘Other specific restriction’ could appear in a column with such a heading. However, in this case, due to space availability it has been included as a separate section below the table. COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE AND ALL SAFETY PRECAUTIONS MARKED * IS A LEGAL REQUIREMENT FOR USE ONLY AS AN AGRICULTURAL/HORTICULTURAL/INDUSTRIAL HERBICIDE

Crops: Maximum individual dose

Maximum number of treatments

Maximum total dose

Latest time of application

Winter wheat and winter barley

2 litres product/ha

2 per crop - Before 2nd node detectable stage

Oilseed rape 1 litre product/ha

- 3 litres product/ha/crop

Before stem extension

Strawberry 1 litre product/ha

3 per year - 14 days before harvest

Other specific restrictions: A minimum interval of 7 days must be observed between

applications to strawberry READ ALL OTHER SAFETY PRECAUTIONS AND DIRECTIONS FOR USE BEFORE USE [REFER TO Part C/Annex 2/paragraphs 2 and 3 for explanation of the structure of this area of the label].


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Part C/Annex 2/paragraphs 2 and 3

The Labelling Handbook Example 4 PSD would prefer use of the Statutory Area formats in Examples 1 to 3 such that all required information appears on the Container Label. However the following format may be used to direct the user to any separate Leaflet is supplied with the product (see guidance in Part G/ paragraphs 2 and 3) and in which the Statutory Area must appear in any case. Note that ‘Crops/situations’ must appear on the Container Label and may not be ‘signposted’. COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE AND ALL SAFETY PRECAUTIONS MARKED * IS A LEGAL REQUIREMENT FOR USE ONLY AS AN AGRICULTURAL/HORTICULTURAL/INDUSTRIAL HERBICIDE Crops: Winter wheat, winter barley, oilseed rape, strawberry and

land not intended to bear vegetation Maximum individual dose: } Maximum number of treatments: } Maximum total dose: } Full details are given in Statutory Area on attached leaflet Latest time of application: } Other specific restrictions: } READ ALL OTHER SAFETY PRECAUTIONS AND DIRECTIONS FOR USE BEFORE USE The Leaflet must include the complete Statutory Area, (which is a requirement in any case) e.g. COMPLIANCE WITH THE FOLLOWING CONDITIONS OF USE AND ALL SAFETY PRECAUTIONS MARKED * IS A LEGAL REQUIREMENT FOR USE ONLY AS AN AGRICULTURAL/HORTICULTURAL/INDUSTRIAL HERBICIDE

Crops/ situations

Maximum individual dose

Maximum number of treatments

Maximum total dose

Latest time of application

Other specific restrictions

Winter wheat, winter barley

2 litres product/ha

2 per crop - Before 2nd node detectable

This product must not be used on durum wheat

Oilseed rape 1 litres product/ha

- 3 litres product/ha/ crop

Before stem extension

-

Strawberry 1 litre product/ha

3 per year - 14 days before harvest

Minimum interval between applications: 7 days

Land not intended to bear vegetation

4 litres product/ha

1 per situation

- - -

READ ALL OTHER SAFETY PRECAUTIONS AND DIRECTIONS FOR USE BEFORE USE [REFER TO Part C/Annex 2/paragraphs 2 and 3 for explanation of the structure of this area of the label].

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Part C/Annex 3

Safety Information - Professional Product Label 1. What is Safety Information?

Safety Information relates to: • The classification of the product with respect to physico-chemical properties and

health effects (Hazard Symbol and associated Risk Phrases, see paragraph 3 below and Working Documents 1 and 2 to this Annex).

• Safety Precautions that must be followed by the user to ensure safe storage and

use (see paragraph 4 below and Working Documents 3 to 7 to this Annex). • Medical Advice for treating poisoning incidents (see paragraph 5 below and

Working Document 8 to this Annex). 2. Format and Content 2.1 The Safety Information must appear on the Container Label and on any separate Leaflet

supplied with the product (full guidance on the definition and presentation of Container Labels and Leaflet is given in Part G).

2.2 See Part G/paragraphs 2 and 3 for advice on positioning. To summarise:

(a) The Hazard Symbol must appear on the on the Container Label; (b) The Risk Phrase should appear with the Hazard Symbol although it is acceptable if it

appears above the Safety Precautions; (c) As far as is practicable, both (a) and (b) should be in close proximity to the Safety

Precautions. (d) Medical Advice must appear as appropriate in the Safety Precautions (if a

precautionary phrase) or as separate section on the Container Label and any separate Leaflet).

2.3 The information required in each section must be formatted in line with any requirements

set out in this Annex and those in Parts G to I. 2.4 Only the relevant symbols and phrases as shown in the Appendices to this Annex and

which are appropriate to the product must be used. Others must not be used unless PSD has given prior agreement.

2.5 The applicant must suggest the symbols and phrases to be used for a product on the

draft label. The actual symbols and phrases required will be set by PSD following evaluation of the application and any changes to the draft label will be specified on the Notice of Approval.

3. Classification The supporting data package for a pesticide must include sufficient data to classify the product with respect to physico-chemical properties and health effects.

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The Labelling Handbook Depending on the classification, certain Hazard Symbols (i.e. very toxic, toxic, harmful, explosive, highly/extremely flammable, flammable, oxidising, corrosive or irritant) and associated Risk Phrases (e.g. TOXIC IF SWALLOWED; IRRITATING TO EYES; HARMFUL IN CONTACT WITH SKIN) must appear on the Product Label. Under Directive 78/631/EEC (repealed by virtue of S.I. 2002/1689 (CHIP 3) implementing Directive 99/45/EC) pesticide preparations need only be classified for the hazards listed above. The criteria to classify pesticide preparations as harmful, toxic or very toxic are set out in the paper copy of the Registration Handbook/Working Document 8/1/paragraphs 2.1 and 2.2 which gives guidance on appropriate classifications (note that this guidance will shortly be incorporated in the on-line ‘Data Requirements Handbook’). Other relevant classification criteria are given in the ‘Approved Classification and Labelling Guide (Fifth edition) (2002) (HSE Books, £10.50, ISBN 0-7176-2369-6). Full details of the implications of CHIP 3 will be included in this Handbook in due course. 3.1 Hazard Symbol(s) 3.1.1 If appropriate, the label must depict one or more of the symbols shown in

Working Document 1 to this Annex (see paragraph 2 above for positioning), chosen in accordance with the classification of the product, with the following provisos:

• an Irritant symbol is not required if the Corrosive, Harmful, Toxic or Very Toxic symbol

is used; • no symbol is required for a ‘FLAMMABLE’ classification.

3.1.2 The appropriate warning word must appear below the symbol. It may be in bold or non-bold and upper or lower case.

3.1.3 The Hazard Symbol must stand out clearly from the background colour and text. On the

Container Label it must be black on an orange-yellow background with the symbol being one tenth of the following minimum label sizes for given pack sizes:

Container capacity Dimensions of label

Minimum hazard symbol size

* 3 litres or less

* not less than 52 x 74 mm

* 20 x 20 mm

exceeding 3 litres but less than 50 litres

not less than 74 x 104 mm

28 x 28 mm



40 x 40 mm

exceeding 500 litres not less than 148 x 210 mm

56 x 56 mm

* If it is impracticable to comply with the dimensions for this pack size then the label should be as large as possible but In any case, the symbol (with background) must not be less than 10 mm x 10 mm.


The Labelling Handbook 3.2 Risk Phrase 3.2.1 Based on relevant data, the appropriate Risk Phrase(s) as chosen from

Working Document 2 to this Annex must appear (see paragraph 2.1 above for positioning).

3.2.2 The entire phrase must appear in bold capitals and:

(a) The ‘warning words’ (i.e. (VERY) TOXIC, HARMFUL, RISK OF SERIOUS

DAMAGE, MAY CAUSE SENSITISATION etc at the start of the Risk Phrase must be not less than twice the size of the print in the surrounding text; and

(b) The remainder of the risk phrase, (e.g. ‘IN CONTACT WITH SKIN’, ‘IF

SWALLOWED’) must be half the size of the ‘warning words’ and not smaller than the remainder of the label text. If set in 6 or 8 point, double bold must be used (i.e. 6/8 or 8/10). It should be at least equal in size to the ‘biological use phrase’ (see Part C/Annex 1/paragraph 3.9).

4. Safety Precautions These set out the precautions to be followed during storage and use of the pesticide for the protection of humans, non-target organisms and the environment. Precautions must appear on the Product Label (see paragraph 4.1 below) and any label supplied with treated seed (see paragraph 4.2. below). The full list of standard safety phrases is given in Working Documents 3 to 7 to this Annex. However, certain of these phrases are also ‘statutory conditions of use or storage’ and are identified as such on the Notice of Approval. There is a legal requirement on the user to comply with these conditions and non-compliance may result in prosecution. Paragraph 4.1.6 below details how such phrases must be highlighted in this section.

4.1 Safety Precautions on Product Label 4.1.1 The Safety Precautions must appear on the Container Label and any separate Leaflet

(see Part G for advice on positioning this section on the Container Label). 4.1.2 The section must have a major heading SAFETY PRECAUTIONS in bold capitals 4.1.3 Under the heading, the subheadings indicated below (to be in bold using upper and

lower text as shown) and appropriate phrases (as specified in Working Documents 3 to 6 to this Annex) must appear. The applicant for approval must suggest which phrases are used for a product on the draft label. These will be based on the data supporting the product in question and/or precedents set for other similar products that have been previously approved. Whilst it is an obligation on the applicant to propose appropriate phrases on the draft label, the actual final phrases will be set by PSD following evaluation of the application. Any changes to the draft label will be specified on the Notice of Approval.



(a) Operator protection

Precautions to be followed to ensure the safe use of the product with respect to the user of the pesticides and any third parties that the product may come into contact with. This includes personal protective equipment and engineering controls to be used by the operator during application. The choice of standard ‘Operator Protection’ phrases is given in Working Document 3 attached to this Annex.

(b) Consumer protection Precautions to be followed to ensure the protection of persons likely to come into contact with treated material. The choice of standard ‘Consumer Protection’ phrases is given in Working Document 4 attached to this Annex.

(c) Environmental protection

Precautions to be followed to ensure the protection of the environment (i.e. water, soil and air) and non-target organisms (e.g. fish and other aquatic life, bees, livestock and game). The choice of standard ‘Environmental Protection’ phrases is given in Working Document 5 attached to this Annex.

(d) Storage and disposal

Precautions to be followed to ensure safety of product and container storage and disposal practices. The choice of standard ‘Storage and Disposal’ phrases is given in Working Document 6 attached to this Annex.

If there are no phrases required for any of (a) to (d) above, the appropriate sub-heading need not appear.

4.1.4 Phrases must be presented in either the following formats: (a) As specified in Working Documents 3 to 7 in a mixture of upper and lower case; or (b) Alternatively, the first parts of the phrases specified in upper case in this guidance

may appear in bold, but with upper/lower case as for normal text.

4.1.5 It is preferred that each phrase appears as a separate line of text. However, where space constraints dictate, they may follow on the same line as long as individual phrases are clearly differentiated from each other.

4.1.6 Where the safety phrase is specified as a ‘statutory condition of use or storage’ in the

Notice of Approval (i.e. under ‘Operator protection’, ‘Environmental protection’ and ‘Other specific restrictions’), it must be highlighted with a suitable symbol (e.g. *, #) and this must match the one used in the Statutory Area heading (see Part C/Annex 2/ paragraph 2.3).


The Labelling Handbook 4.2 Safety Precautions on treated seed sack labels 4.2.1 The handling and sowing of seed and propagules treated with pesticide are not approved

under the Control of Pesticides Regulation 1996 (COPR) and treated material is therefore not covered by the COPR labelling requirements. Voluntary labelling guidelines have therefore been agreed by the major companies in the seed potato market, the Crop Protection Association (CPA), the British Crop Protection Council (BCPC), The Health and Safety Executive (HSE), the UK Supply Trade Association (UKASTA) and the Pesticides Safety Directorate (PSD). The guidelines are not statutory but compliance enables the handlers of treated seed to meet their obligations under the Food and Environment Protection Act 1985 (FEPA), to protect the health of human beings, creatures and plants and to safeguard the environment.

4.2.2 Standard phrases used for treated seed sack labels are in Working Document 7 attached

to this Annex. 5. Medical Advice 5.1 Where toxicity of the product justifies it, statements on First Aid and Guide to Doctor or

Poisons Centre must appear. Examples of standard statements for certain active substances are given in Working Document 8 to this Annex. Other wording must not be used unless PSD has given prior agreement.

5.2 Paragraph 2 above gives advice on positioning this section on the Container Label and

separate Leaflet. 5.3 Where Medical Advice is considered necessary, the applicant should present this on the

draft label for consideration by PSD. 6. Examples of Safety Information on labels 6.1 Working Document 9 to this Annex presents four examples of Safety Information

depending on the complexity of information to be conveyed. 6.2 These examples are hypothetical situations and are intended only to demonstrate the

format of this information.




Hazard Symbols - Professional Product Label Refer to Part C/Annex 3/paragraph 3 for further information. The following relevant hazard symbol(s), or any appropriate combination thereof, must accompany the relevant risk phrases as chosen from Part C/Annex 2/Working Document 1.

Very Toxic Toxic

Harmful Irritant

Explosive Corrosive

Oxidizing Extremely Flammable or Highly Flammable

Symbols must be black on an orange yellow background. For sizes see Part C/Annex 3/paragraph 3.1.3

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Risk Phrases - Professional Product Label

Refer to Part C/Annex 3/paragraph 3 for further information. The following risk phrases, or any appropriate combination thereof, must accompany the hazard symbol(s) as chosen from Part C/Annex 3/Working Document 1. 1. VERY TOXIC/TOXIC IN CONTACT WITH SKIN/BY INHALATION/IF SWALLOWED 2. HARMFUL IN CONTACT WITH SKIN/BY INHALATION/IF SWALLOWED 3. IRRITATING TO EYES/SKIN/RESPIRATORY SYSTEM 4. CAUSES [SEVERE] BURNS 5. RISK OF SERIOUS DAMAGE TO EYES 6. MAY CAUSE SENSITISATION BY SKIN CONTACT/INHALATION 7. HARMFUL: MAY CAUSE LUNG DAMAGE IF SWALLOWED 8. EXTREMELY FLAMMABLE/HIGHLY FLAMMABLE/FLAMMABLE 9. CONTACT WITH COMBUSTIBLE MATERIAL MAY CAUSE FIRE/EXPLOSIVE WHEN

MIXED WITH COMBUSTIBLE MATERIAL

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User Protection Safety Phrases2 - Professional Product Label Refer to Part C/Annex 3/paragraph 4.1 for further information. Where a phrase is likely to be a ‘statutory condition of use or storage’ (and therefore referenced from the Statutory Area) it has been highlighted with a #. See Part C/ Annex 3/paragraph 4.1.6 1. Personal protective equipment (PPE) 1.1 General structure of PPE phrases:

The appropriate PPE must appear in the following order with the specific wording as specified in (a) to (e) below: CLOTHING → GLOVES → BOOTS → EYE/FACE PROTECTION → RESPIRATORY PROTECTIVE EQUIPMENT→ followed usually by a description of the operation for which the equipment is to be worn. Please note that in this Working Document, the PPE phrases are based on those given in Directive 78/631/EEC. The phrases in paragraphs 3.3 to 3.8 and 3.9.1 are also from Directive 78/631/EEC.

(a) Clothing

These should be specified as 'SUITABLE PROTECTIVE CLOTHING (………….)'. The parentheses should contain all necessary items from the following list: COVERALLS, APRON, HOOD, COAT, HEAD PROTECTION, IMPERMEABLE TROUSERS or any others required by PSD (as in example 1.2.1(a) below).

(b) Gloves

These should be specified as 'SUITABLE PROTECTIVE GLOVES' or 'SUITABLE PROTECTIVE GAUNTLET GLOVES' as appropriate unless otherwise specified by PSD. If it is required to specify the material of the gloves this should be included in parentheses in the body of the phrase (as in the example 1.2.1(a) below). Any additional information such as minimum glove thickness should appear outside the body of the phrase and be flagged (as in examples 1.2.1(b) and (c) below).

(c) Boots

These should be specified as 'RUBBER BOOTS' unless otherwise specified by PSD.

2 Please note that in this Working Document the PPE phrases are based on those given in Directive 78/631/EEC. The phrases in paragraphs 3.3 to 3.8 and 3.9.1 are also from Directive 78/631/EEC.

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(d) Eye or face protection

This should be specified as 'FACE PROTECTION (FACESHIELD)' or 'EYE PROTECTION (GOGGLES)' unless PSD require any other specific type to be included within the parentheses.

(e) Respiratory protective equipment

These should be specified as 'SUITABLE RESPIRATORY PROTECTIVE EQUIPMENT'. Where necessary specific items of RPE can be specified by signposting (see example 1.2.1(d) below).

1.2 Examples of PPE phrases: 1.2.1 Some general examples reflecting the above requirements are indicated below. These

phrases should be written as concisely as possible. Where necessary, additional information may be included by ‘signposting’. This information must appear immediately below the main part of the phrase and must not be separated from the phrase by any other information.

(a) # WEAR SUITABLE PROTECTIVE CLOTHING (COVERALLS, APRON),

SUITABLE PROTECTIVE GLOVES, RUBBER BOOTS, FACE PROTECTION (FACESHIELD) AND SUITABLE RESPIRATORY PROTECTIVE EQUIPMENT when handling the concentrate.

(b) # WEAR SUITABLE PROTECTIVE GLOVES (NEOPRENE OR NITRILE*) AND

EYE PROTECTION (GOGGLES) when handling the concentrate. * at least 0.5 mm thickness.

(c) # WEAR SUITABLE PROTECTIVE GAUNTLET GLOVES* when dipping.

* at least elbow length. (d) # WEAR SUITABLE RESPIRATORY PROTECTIVE EQUIPMENT* when

spraying. * disposable filtering facepiece respirator

1.2.2 When many operation/PPE combinations need to be specified then the following ‘list

format’ may be more appropriate. Only the first part of the preamble need appear in upper case and the specific PPE may appear in lower case.

. # WEAR SUITABLE PROTECTIVE CLOTHING for the operations listed as specified

below:

When handling the concentrate Suitable protective clothing (coveralls), suitable protective gloves, face protection (faceshield) and suitable respiratory protective equipment* *dust mask

During application by hand-held equipment

Suitable protective clothing (coveralls) and suitable protective gloves

During application by tractor drawn/mounted equipment

Suitable protective clothing (coveralls)


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The Labelling Handbook 2. Requirement for engineering controls during use 2.1 The following two phrases must appear with any PPE requirements in the format

specified below:

# Engineering control of operator exposure must be used where reasonably practicable in addition to the following personal protective equipment:

[appropriate PPE] # However, engineering controls may replace personal protective equipment if a COSHH assessment shows they provide an equal or higher standard of protection.

2.2 Where specific engineering controls are required for the safe use of the product

PSD will specify additional phrases that may need to appear prior to the phrases in paragraph 2.1 above and a reworded version of the phrases specified in paragraph 2.1 above, e.g. # (1) Vehicles fitted with a cab and forced air filtration unit plus a pesticide filter

complying with HSE Guidance Note PM 74, or an equivalent or higher standard, must be used when making broadcast air assisted applications.

# (2) Other engineering control of operator exposure must also be used where

reasonably practicable in addition to the following personal protective equipment: [appropriate PPE]

# (3) However, other engineering controls in additions to those specified in (1) above

may replace personal protective equipment if a COSHH assessment shows they provide an equal or higher standard of protection.

Where specific engineering controls are a requirement, amendments may also be required to the wording of the phrase in paragraph 2.1 above to clarify that they refer to other engineering controls in addition to those specified.

3. Other operator protection phrases 3.1 The following phrase is compulsory for products containing anticholinesterase

organophosphate or carbamate active substances. If required this phrase must be the first phrase in the ‘Operator protection’ section):

# This product contains an anticholinesterase organophosphate (or carbamate or

carbomoyl triazole). DO NOT USE if under medical advice not to work with such compounds.

3.2 The following phrase may be appropriate where PPE is recommended:

WASH ALL PROTECTIVE CLOTHING thoroughly after use, especially the insides of gloves.


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The Labelling Handbook 3.3 The following phrase may be appropriate for classified products: TAKE OFF IMMEDIATELY all contaminated clothing. 3.4 The following phrase is compulsory for pesticides classified as very toxic, toxic,

harmful, corrosive or irritant: WHEN USING DO NOT EAT, DRINK OR SMOKE 3.5 The following phrase is compulsory for pesticides classified as very toxic, toxic,

or corrosive: IN CASE OF ACCIDENT OR IF YOU FEEL UNWELL, seek medical advice immediately

(show the label where possible). 3.6 The following phrase is compulsory for pesticides classified as harmful only: IF YOU FEEL UNWELL, seek medical advice immediately (show the label where

possible). 3.7 The following phrase is compulsory for products which contain phosphoric acid

esters or are classified as corrosive: AFTER CONTACT WITH SKIN, WASH IMMEDIATELY with plenty of water [or other

substance deemed appropriate for the specific situation - to be agreed with PSD]. 3.8 The following phrase may be required for certain pesticides which pose a hazard

to eyes: IN CASE OF CONTACT WITH EYES, RINSE IMMEDIATELY with plenty of water and

seek medical advice. 3.9 The following phrases may also be appropriate to a product:

3.9.1 DO NOT BREATHE DUST/GAS/FUMES/VAPOUR/SPRAY 3.9.2 HANDLE WITH CARE AND MIX ONLY IN A CLOSED CONTAINER 3.9.3 WASH SPLASHES/DUST/POWDER/CONCENTRATE/ANY CONTAMINATION from

skin or eyes immediately. 3.9.4 AVOID ALL CONTACT/BY MOUTH/WITH SKIN/EYES 3.9.5 WASH HANDS/EXPOSED SKIN before eating and drinking/smoking/after work. 3.9.6 # TO BE USED ONLY BY OPERATORS INSTRUCTED OR TRAINED in the use of

chemical/product/type of produce/and familiar with the precautionary measures to be observed.


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The Labelling Handbook 3.10 The following phrases may be appropriate for storage practice products: 3.10.1 ENSURE ADEQUATE VENTILATION IN CONFINED SPACES 3.10.2 APPLY SOLUTIONS from unbreakable containers carrying a pouring tube or similar

device. 3.10.3 EXTINGUISH ALL NAKED FLAMES INCLUDING PILOT LIGHTS, WHEN APPLYING

THE FUMIGANT/DUST/LIQUID/PRODUCT 3.10.4 DO NOT BREATHE DUST/ GAS/ FUMES/ VAPOUR/ SPRAY/ FOG/ MIST/ SMOKE. or DO NOT WORK IN CONFINED SPACES OR ENTER SPACES IN WHICH HIGH

CONCENTRATIONS OF VAPOUR ARE PRESENT. Where this precaution cannot be observed distance breathing or self-contained breathing apparatus must be worn, and the work should be done by trained operators.

3.11 The following phrase is compulsory for products supplied in refillable containers: OPEN THE CONTAINER ONLY AS DIRECTED


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Consumer Protection Safety Phrases - Professional Product Label

Refer to Part C/Annex 3/paragraph 4.1 for further information. Where a phrase is likely to be a ‘statutory condition of use or storage’ (and therefore referenced from the Statutory Area) it has been highlighted with a #. See Part C/ Annex 3/paragraph 4.1.6 1. The following phrases may be appropriate to Agricultural, Horticultural and

Forestry products: 1.1 # DO NOT USE ON FOOD CROPS 1.2 # KEEP UNPROTECTED PERSONS OUT OF TREATED AREAS for at least .........

(appropriate interval to be specified). 2. The following phrases may be appropriate to food storage practice products:

2.1 DO NOT APPLY TO SURFACES on which food/feed is stored, prepared or eaten. 2.2 DO NOT APPLY TO CLOTHING 2.3 REMOVE/COVER ALL FOODSTUFFS BEFORE APPLICATION 2.4 Protect food preparing equipment and eating utensils from contamination during

application. 2.5 USE ONLY ON ...................................................... (appropriate foodstuff to be specified). 2.6 REMOVE ALL PETS/ LIVESTOCK BEFORE TREATMENT 2.7 KEEP/APPLY/SUSPEND ONLY in positions inaccessible to children and pets. 2.8 REMOVE EXCESS DUST AND AIR TREATED FABRICS THOROUGHLY BEFORE

USE 2.9 # DO NOT USE IN OCCUPIED DWELLING HOUSES 3. The following phrases may be appropriate to fumigant products: 3.1 Fumigate only under conditions which allow no leakage of gas to adjacent occupied

premises. 3.2 VENTILATE TREATED AREAS thoroughly when gas/smoke has cleared. 3.3 KEEP ANIMALS/BIRDS OUT of premises where grain is under fumigation or being aired

following fumigation.

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Environmental Protection Safety Phrases - Professional Product Label

Refer to Part C/Annex 3/paragraph 4.1 for further information. Where a phrase is likely to be a ‘statutory condition of use or storage’ (and therefore referenced from the Statutory Area) it has been highlighted with a #. See Part C/ Annex 3/paragraph 4.1.6 1. The following phrases may be appropriate to Agricultural, Horticultural and

Forestry products: 1.1 # DO NOT USE OUTDOORS 1.2 # DANGEROUS/HARMFUL TO LIVESTOCK. Keep all livestock out of treated

areas/away from treated water for at least ............... (appropriate interval required) /for at least 2 weeks and until foliage of any poisonous weeds such as ragwort has died and become unpalatable. Bury or remove spillages.

1.3 # DANGEROUS/HARMFUL TO GAME, WILD BIRDS AND ANIMALS. Bury or remove

spillages. 1.4 # HIGH RISK TO BEES. DO NOT apply to crops in flower or to those in which bees are

actively foraging/ except as directed on [crop]. Do not apply when flowering weeds are present.

1.5 # HIGH RISK TO NON-TARGET INSECTS OR OTHER ARTHROPODS. DO NOT

SPRAY [crop] within 6m of the field boundary. For advice on use on Integrated Pest Management (IPM) see Directions For Use/General Information. or

RISK TO NON-TARGET INSECTS OR OTHER ARTHROPODS. See Directions for use. For advice on risk management and use in Integrated Pest Management (IPM) see Directions For Use/General Information.* (Specific advice to be included in the Directions For Use’ will be specified by PSD on a case-by-case basis).

1.6 # HARMFUL/DANGEROUS/EXTREMELY DANGEROUS TO FISH OR OTHER

AQUATIC LIFE. Do not contaminate surface waters or ditches with chemical or used container.

or DO NOT CONTAMINATE SURFACE WATERS OR DITCHES with chemical or used

container.

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The Labelling Handbook 2. For products classified as ‘Category B’ for Local Environment Risk Assessment

For Pesticides (LERAPS): 2.1 If application is to be made by horizontal boom sprayers [and hand-held sprayers

if appropriate] only the following phrases must appear: # DO NOT ALLOW DIRECT SPRAY from horizontal boom sprayers to fall within 5 m of

the top of the bank of a static or flowing water body, unless a Local Environment Risk Assessment for Pesticides (LERAP) permits a narrower buffer zone, or within 1 m of the top of a ditch which is dry at the time of application. [DO NOT ALLOW DIRECT SPRAY from hand-held sprayers to fall within 1 m of the top of the bank of a static or flowing water body]*. Aim spray away from water. * delete if hand-held use not recommended

# This product qualifies for inclusion within the Local Environment Risk Assessment for Pesticides (LERAP) scheme. Before each spraying operation from a horizontal boom sprayer, either a LERAP must be carried out in accordance with PSD’s published guidance or the statutory buffer zone must be maintained. The results of the LERAP must be recorded and kept available for three years.

2.2 If application is to be made by horizontal boom sprayers [and hand-held sprayers

if appropriate] and broadcast air assisted sprayers the following phrases must appear:

# DO NOT ALLOW DIRECT SPRAY from broadcast air-assisted sprayers to fall within ‘X m’ of the top of the bank of a static or flowing waterbody, unless a Local Environment Risk Assessment for Pesticides (LERAP) permits a narrower buffer zone, or within 5m of the top of a ditch which is dry at the time of application. Aim spray away from water. [Where distance ‘X’ is determined through an appropriate assessment of the risks to aquatic life.] # DO NOT ALLOW DIRECT SPRAY from horizontal boom sprayers to fall within 5 m of the top of the bank of a static or flowing water body, unless a Local Environment Risk Assessment for Pesticides (LERAP) permits a narrower buffer zone, or within 1 m of the top of a ditch which is dry at the time of application. [DO NOT ALLOW DIRECT SPRAY from hand-held sprayers to fall within 1 m of the top of the bank of a static or flowing water body.]* Aim spray away from water. * delete if hand-held use not recommended # This product qualifies for inclusion within the Local Environment Risk Assessment for Pesticides (LERAP) scheme. Before each spraying operation from a horizontal boom sprayer or broadcast air-assisted sprayer, either a LERAP must be carried out in accordance with PSD’s published guidance or the statutory buffer zone must be maintained. The results of the LERAP must be recorded and kept available for three years.


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The Labelling Handbook 3. For products classified ‘Category A’ for Local Environment Risk Assessment For

Pesticides (LERAPS): 3.1 If application is to be made by horizontal boom sprayers [and hand-held sprayers

if appropriate] only the following phrases must appear:

# DO NOT ALLOW DIRECT SPRAY from horizontal boom sprayers to fall within 5 m of the top of the bank of a static or flowing water body, or within 1 m of the top of a ditch which is dry at the time of application. [DO NOT ALLOW DIRECT SPRAY from hand-held sprayers to fall within 1 m of the top of the bank of a static or flowing water body.]* Aim spray away from water. THIS PRODUCT IS NOT ELIGIBLE FOR BUFFER ZONE REDUCTION UNDER THE LERAP HORIZONTAL BOOM SPRAYERS SCHEME * delete if hand-held use not recommended

3.2 If application is to be made by horizontal boom sprayers [and hand-held sprayers

if appropriate] and broadcast air assisted sprayers the following phrases must appear:

# DO NOT ALLOW DIRECT SPRAY from broadcast air-assisted sprayers to fall within ‘X m’ of the top of the bank of a static or flowing waterbody, unless a Local Environment Risk Assessment for Pesticides (LERAP) permits a narrower buffer zone, or within 5m of the top of a ditch which is dry at the time of application. Aim spray away from water. [Where distance ‘X’ is determined through an appropriate assessment of the risks to aquatic life.] # DO NOT ALLOW DIRECT SPRAY from horizontal boom sprayers to fall within 5 m of the top of the bank of a static or flowing water body, or within 1 m of the top of a ditch which is dry at the time of application. [DO NOT ALLOW DIRECT SPRAY from hand-held sprayers to fall within 1 m of the top of the bank of a static or flowing water body.]* Aim spray away from water. THIS PRODUCT IS NOT ELIGIBLE FOR BUFFER ZONE REDUCTION UNDER THE LERAP HORIZONTAL BOOM SPRAYERS SCHEME * delete if hand-held use not recommended

# This product qualifies for inclusion within the Local Environment Risk Assessment for Pesticides (LERAP) scheme for BROADCAST AIR-ASSISTED SPRAYERS ONLY. Before each spraying operation from a broadcast air-assisted sprayer, either a LERAP must be carried out in accordance with PSD’s published guidance or the statutory buffer zone must be maintained. The results of the LERAP must be recorded and kept available for three years.

4. For products that are not classified as ‘Category A’ or ‘Category B’ for Local

Environment Risk Assessment For Pesticides (LERAPS) but which may be applied via broadcast air-assisted sprayers to orchard crops (inc. bush, cane and top fruit), the following phrase will be required:

# DO NOT ALLOW DIRECT SPRAY from broadcast air-assisted sprayers to fall within ‘X m’ of the top of the bank of a static or flowing waterbody, unless a Local Environment Risk Assessment for Pesticides (LERAP) permits a narrower buffer zone, or within 5m of the top of a ditch which is dry at the time of application. Aim spray away from water.


30


[Where distance ‘X’ is determined through an appropriate assessment of the risks to aquatic life.]

# This product qualifies for inclusion within the Local Environment Risk Assessment for Pesticides (LERAP) scheme. Before each spraying operation from a broadcast air-assisted sprayer, either a LERAP must be carried out in accordance with PSD’s published guidance or the statutory buffer zone must be maintained. The results of the LERAP must be recorded and kept available for three years.

5. For products applied by aircraft, the following phrase must appear:

# DO NOT SPRAY FROM THE AIR within ‘X’ m horizontal distance of surface waters or ditches.

[The need for this phrase is determined through an appropriate assessment of the risks to aquatic life from aerial application, the distance ‘X’ is usually 250 m.]

6. The following phrases may be appropriate to products used in aquatic situations: 6.1 HARMFUL/DANGEROUS/EXTREMELY DANGEROUS TO FISH OR OTHER AQUATIC

LIFE. The maximum concentration of active ingredient in treated water must not exceed [x] ppm or such lower concentration as the appropriate water regulatory body may require.

6.2 Users must consult the appropriate water regulatory body (Environment Agency/Scottish

Environment Protection Agency) before using the product near water and must obtain their agreement before using this product to control aquatic weeds.


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Storage & Disposal Safety Phrases - Professional Product Label3

Refer to Part C/Annex 3/paragraph 4.1 for further information. Where a phrase is likely to be a ‘statutory condition of use or storage’ (and therefore referenced from the Statutory Area) it has been highlighted with a #. See Part C/ Annex 3/paragraph 4.1.6 1. The following phrases are compulsory for pesticides classified as very toxic, toxic,

harmful, corrosive or irritant: 1.1 KEEP AWAY FROM FOOD, DRINK AND ANIMAL FEEDING STUFFS 1.2 KEEP OUT OF REACH OF CHILDREN 2. For products supplied in standard containers:

KEEP IN ORIGINAL CONTAINER, tightly closed, in a safe place/under lock and key/ away from damp/sources of heat. [This phrase is a statutory condition of storage if required to be kept ‘under lock and key’]

3. For products supplied in sachets:

STORE UNUSED SACHETS in a safe place. DO NOT STORE half-used sachets.

4. For products supplied in washable containers:

WASH OUT CONTAINER THOROUGHLY [, empty washings into the spraytank*] and dispose of safely. [* insert if appropriate] or RINSE CONTAINER THOROUGHLY by using an integrated pressure rinsing device or manually rinsing three times. Add washings to sprayer at time of filling and dispose of safely/dispose of as follows [appropriate advice]: For further information please refer to PSD’s ‘All Approval Holder’s letter’: ‘Label advice relating to the rinsing of containers’ of 7 March 1996. This may be obtained from PSD’s Information Section at the address given at the end of this document.

3 Please note that in this Working Document the phrases in paragraphs 1.1 and 1.2 are taken from Directive 78/631/EEC

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The Labelling Handbook 5. For products supplied in non-washable containers:

EMPTY CONTAINER COMPLETELY and dispose of safely.

6. For products that are harmful, toxic or very toxic and have non-returnable/non-refillable containers:

# DO NOT RE-USE CONTAINER for any purpose.

7. For products that are supplied in returnable/refillable containers:

# DO NOT RE-USE CONTAINER FOR ANY OTHER PURPOSE # RETURN EMPTY CONTAINER TO THE SUPPLIER DO NOT RINSE OUT THE CONTAINER OPEN THE CONTAINER ONLY AS DIRECTED

8. For other products as appropriate: 8.1 THIS MATERIAL AND ITS CONTAINER must be disposed of in a safe way. 8.2 DISPOSE OF USED GENERATOR/PACKAGING SAFELY

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Treated Seed Sack Label Safety Phrases - Professional Products

Refer to Part C/Annex 3/paragraph 4.2 for further information. 1. The following phrase should appear if required by PSD: WEAR SUITABLE PROTECTIVE GLOVES when handling treated seed. 2. The following phrases should appear on all sack labels: 2.1 DO NOT HANDLE seed unnecessarily. 2.2 DO NOT USE TREATED SEED as food or feed. 2.3 DO NOT RE-USE SACKS OR CONTAINERS THAT HAVE BEEN USED FOR TREATED

SEED for food or feed. 2.4 KEEP TREATED SEED SECURE from people, domestic stock/pets and wildlife at all

times during storage and use. 2.5 WASH HANDS AND EXPOSED SKIN before meals and after work. 2.6 BURY OR REMOVE SPILLAGES 2.7 HARMFUL TO GAME AND WILDLIFE. Treated seed should not be left on the soil

surface. Bury spillages. 2.8 DO NOT APPLY TREATED SEED FROM THE AIR.

(applies to approved seed treatments on grains only)

3. If the TERa or TERst is less than 100 then the seed bag label should carry the

following advisory phrases:

Treated seed should not be broadcast. Seed should be drilled to a depth of 40 mm into a well prepared and firm seed bed. If seed is present on the soil surface, or if spills have occurred, then, if conditions are appropriate, the field should be harrowed then rolled to ensure good incorporation.

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Medical Advice - Professional Product Label

Refer to Part C/Annex 3/paragraph 5 for further information. 1. Introduction

The following sets out standard medical advice required for products containing certain (types of) active substances. For other products, if it is considered that medical advice is appropriate, this will be required as part of the approved text and requested as an amendment on the Notice of Approval. The following sections provide standard medical advice for the named compounds: 2. Dangerous pesticides 3. Organophosphate pesticides 4. Dinitro compounds 5. Anticoagulant rodenticides 6. Cyanides 7. Carbamates Paragraph 8 also includes a list of Poisons Information Centres that may be included on labels.

2. For ‘dangerous’ pesticides 2.1 According to CHIP3, certain phrases are compulsory dependant on the classification,

including:

(a) The following phrase is compulsory for pesticides classified as very toxic (T+), toxic (T), or corrosive (C):

S 45: In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

(b) The following phrase is compulsory for all dangerous preparations except where

S45 is required or for those preparations which are dangerous to the environment:

S 46: If swallowed, seek medical advice immediately and show this container or

label.

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The Labelling Handbook 3. For organophosphorus compounds with anticholinesterase

activity The following medical advice should appear as part of the approved text on the label:

SYMPTOMS OF POISONING

These may include excessive sweating, headache, weakness, faintness and giddiness, nausea, stomach pains, vomiting, small pupils, blurred vision, muscle twitching, tightness of the chest. Note that the onset of symptoms may be delayed by several hours after exposure.

FIRST AID

If any of the above symptoms occur, particularly if there is known contamination:

STOP WORK Remove contaminated clothing. Wash exposed skin and hair. Prevent all exertion. Call doctor AT ONCE and show this label.

GUIDE TO DOCTOR

This product contains an anticholinesterase organophosphorus compound.

Specific Treatment 1. IN CASES OF MODERATE POISONING AND SEVERE POISONING AND AS EARLY AS

POSSIBLE inject atropine sulphate 2 mg or pro rata for children and repeat (if necessary) to maintain full atropinisation

*2. IF AVAILABLE administer pralidoxime 30mg/kg body weight by intra-muscular injection. Repeat after 4-6 hours for as long as atropine is required.

[* Note for marketing company. Omit for compounds for which pralidoxime is not an effective antidote] Other measures 1. Keep airway clear. 2. Watch respiration - intubation with endotracheal tube, or tracheotomy may be necessary in

conjunction with artificial ventilation. 3. Put patient at complete rest in hospital for 24 hours at least. Confirmation of Diagnosis By estimating cholinesterase activity in plasma and red blood cells. Further advice from:

Name, address, telephone number of marketing company/approval holder or

nearest National Poisons Information Centre. (see list in paragraph 8)


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The Labelling Handbook 4. For dinitro compounds The following medical advice should appear as part of the approved text on the label:


These may include fatigue, excessive and unusual sweating and thirst, with sleeplessness and loss of weight in protracted cases. In severe cases there may be rapidly increasing anxiety and restlessness with an increase in respiration and heart rate.

FIRST AID

If any of the symptoms occur, particularly if there is known contamination (i.e. yellow staining of the skin):

STOP WORK Remove contaminated clothing. Wash exposed skin and hair thoroughly. Keep person at rest in the coolest available place. Sponge skin with cold water and give cold water to drink. Call doctor AT ONCE and show this label.

GUIDE TO DOCTOR

This product contains a DINITRO compound that can uncouple oxidative phosphorylation.

Treatment 1. Treat suspected cases of poisoning by vigorous cooling, giving abundant fluids and oxygen for

dyspnoea. 2. DO NOT GIVE morphine or barbiturates. 3. If swallowed, wash out the stomach and give activated charcoal. Diagnosis By estimating blood [active substance] concentration. Further advice from:




37

The Labelling Handbook 5. For anticoagulant rodenticides The following medical advice should appear as part of the approved text on the label:

SYMPTOMS OF POISONING Spontaneous haemorrhage from the nose, into the skin or into internal organs. Onset may be delayed.

FIRST AID If any of the above symptoms occur, particularly if there is known contamination (including on previous occasions):

Stop work. Remove contaminated clothing wash exposed skin and hair. Prevent all exertion Call doctor AT ONCE and show label

GUIDE TO DOCTOR This product contains [active substance name] an anticoagulant. Treatment 1. Vitamin K1 (phytomenadione) 10-20 mg orally (pro-rata for children). Repeat daily until prothrombin

time returns to normal. 2. In severe cases, transfusion of fresh frozen plasma or blood may be indicated together with vitamin

K . 13. In some cases, symptoms may reappear if treatment is stopped prematurely. Prothrombin time

should be monitored for 2 weeks after stopping vitamin K. Confirmation of diagnosis By estimating prothrombin time. Further advice from:




38

The Labelling Handbook 6. Cyanides The following medical advice should appear as part of the approved text on the label:

SYMPTOMS OF POISONING Anxiety, headache, nausea, confusion, rapid breathing followed by laboured breathing and turning blue. In severe cases, impaired consciousness and convulsions.

FIRST AID

Stop work and leave the contaminated area. Remove contaminated clothing. Wash clothes, exposed skin and hair. Prevent exertion. Call doctor AT ONCE and show this label. DO NOT GIVE MOUTH TO MOUTH resuscitation in cases of ingestion

GUIDE TO DOCTOR

This compound contains or can generate cyanides. Treatment 1. If antidotes (see below) are available they should be administered if poisoning is moderate or

severe. 2. If antidotes are not available administer oxygen, maintain respiration and control convulsions. 3. Supportive therapy, including 100% oxygen may be necessary to complement antidote therapy. Antidotes Regime 1 (preferred) Adult • 300 mg dicobalt edetate (20 millilitres of 1.5% solution) intravenously over one minute followed by • dextrose (50 millilitres of 5-% solution) followed by • 12.5 mg sodium thiosulphate (50 millilitres of 25% solution) intravenously over 10 minutes Children • There is no information on the use of dicobalt edetate in children. Regime 2 Adult • 300 mg sodium nitrite (10 millilitres of 3% solution) intravenously over 5-20 minutes followed by • 12.5 mg sodium thiosulphate (50 millilitres of 25% solution) intravenously over 10 minutes Children • 4 mg/kg body weight sodium nitrite (0.13 millilitres of 3% solution) intravenously over 5-20 minutes

immediately and a further dose of 2 mg/kg body weight 30 minutes after the first only if the methaemoglobin concentrations achieved are not excessive and a satisfactory clinical response has not been attained.

• 400 mg/kg body weight sodium thiosulphate (1.6 millilitres/kg of 25% solution) intravenously over 10 minutes.

Further advice from:




39

The Labelling Handbook 7. For carbamate compounds with anticholinesterase activity The following medical advice should appear as part of the approved text on the label:


These may include excessive sweating, headache, weakness, faintness and giddiness, nausea, stomach pains, vomiting, small pupils, blurred vision, muscle twitching, tightness of the chest.

FIRST AID

If any of the above symptoms occur, particularly if there is known contamination:

STOP WORK. Remove contaminated clothing. Wash exposed skin and hair. Prevent all exertion. Call doctor AT ONCE show this label.

GUIDE TO DOCTOR

This product contains an anticholinesterase carbamate compound.

Specific Treatment 1. IN CASES OF MODERATE AND SEVERE POISONING AND AS EARLY AS POSSIBLE inject

atropine sulphate 2 mg or pro rata for children and repeat if necessary to maintain full atropinisation.

2. DO NOT USE pralidoxime. Other measures 1. Keep airway clear. 2. Watch respiration - intubation with endotracheal tube or tracheotomy may be necessary in

conjunction with artificial ventilation. 3. Put patient at complete rest in hospital for 24 hours at least. Confirmation of diagnosis Estimation of cholinesterase activity may be misleading unless special procedures are used to prevent reactivation. Further advice from:




40


8. List of UK National Poisons Information Service (NPIS) Centres The following is a list of the Poisons Information Centres that may be included on labels.

NPIS BELFAST Royal Victoria Hospital Grosvenor Road Belfast BT12 6BB

NPIS BIRMINGHAM City Hospital Dudley Road Birmingham B18 7QH

NPIS CARDIFF Llandough Hospital Penarth Cardiff CF64 2XX

NPIS EDINBURGH

The Royal Infirmary 1 Lauriston Place Edinburgh EH3 9YW

NPIS LONDON

Medical Toxicology Unit Avonley Road London SE14 5ER

NPIS NEWCASTLE Wolfson Unit Claremont Place Newcastle-upon-Tyne NE2 4HH


41



Safety Information Examples - Professional Product Label Refer to Part C/Annex 3 for further information. Example 1 - Unclassified product with minimal precautionary phrases. SAFETY PRECAUTIONS Environmental Protection DO NOT CONTAMINATE SURFACE WATERS OR DITCHES with chemical or used container.

Storage and disposal KEEP IN ORIGINAL CONTAINER, tightly closed, in a safe place. EMPTY CONTAINER COMPLETELY and dispose of safely.

Example 2 - Flammable product supplied in refillable container FLAMMABLE

SAFETY PRECAUTIONS Operator Protection WHEN USING DO NOT EAT, DRINK OR SMOKE AVOID ALL CONTACT WITH SKIN AND EYES Environmental Protection DO NOT CONTAMINATE SURFACE WATERS OR DITCHES with chemical or used container.

Storage and disposal KEEP AWAY FROM FOOD, DRINK AND ANIMAL FEEDING STUFFS KEEP OUT OF REACH OF CHILDREN KEEP IN ORIGINAL CONTAINER, tightly closed, in a safe place. DO NOT RINSE OUT THE CONTAINER # RETURN EMPTY CONTAINER TO THE SUPPLIER # DO NOT RE-USE CONTAINER FOR ANY OTHER PURPOSE

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The Labelling Handbook Example 3 - Classified product with a number of precautionary phrases required.

Harmful HARMFUL IF SWALLOWED IRRITATING TO EYES

SAFETY PRECAUTIONS

Operator protection # Engineering control of operator exposure must be used where reasonably practicable in addition to the following personal protective equipment:

# WEAR SUITABLE PROTECTIVE GLOVES AND FACE PROTECTION when handling the concentrate. # WEAR SUITABLE PROTECTIVE GLOVES AND when handling contaminated surfaces.

# However, engineering controls may replace personal protective equipment if a COSHH assessment shows they provide an equal or higher standard of protection. AVOID ALL CONTACT BY MOUTH AND WITH EYES WHEN USING DO NOT EAT, DRINK OR SMOKE IF YOU FEEL UNWELL, seek medical advice immediately (show the label where possible). Environmental Protection # HIGH RISK TO BEES. DO NOT apply to crops in flower or to those in which bees are actively foraging/ except as directed on oilseed rape. Do not apply when flowering weeds are present. DO NOT CONTAMINATE SURFACE WATERS OR DITCHES with chemical or used container. Storage and disposal KEEP AWAY FROM FOOD, DRINK AND ANIMAL FEEDING STUFFS KEEP OUT OF REACH OF CHILDREN KEEP IN ORIGINAL CONTAINER, tightly closed, in a safe place/under lock and key/ away from/damp/sources of heat. EMPTY CONTAINER COMPLETELY and dispose of safely. DO NOT RE-USE CONTAINER FOR ANY PURPOSE


43

The Labelling Handbook Example 4 - Classified product with extensive precautionary phrases required.

Toxic Highly Flammable TOXIC IF SWALLOWED RISK OF SERIOUS DAMAGE TO EYES

HARMFUL IN CONTACT WITH SKIN HIGHLY FLAMMABLE

SAFETY PRECAUTIONS Operator protection # This product contains an anticholinesterase organophosphate. DO NOT USE if under medical advice not to work with such compounds. # Engineering control of operator exposure must be used where reasonably practicable in addition to the following personal protective equipment: # WEAR SUITABLE PROTECTIVE CLOTHING for the operations listed as specified below:

When handling the concentrate

Suitable protective clothing (coveralls), suitable protective gloves, face protection (faceshield) and suitable respiratory protective equipment* *dust mask

During application

Suitable protective clothing(coveralls) and suitable protective gloves

# However, engineering controls may replace personal protective equipment if a COSHH assessment shows they provide an equal or higher standard of protection. WASH ALL PROTECTIVE CLOTHING thoroughly after use/, especially the insides of gloves. TAKE OFF IMMEDIATELY all contaminated clothing. WHEN USING DO NOT EAT, DRINK OR SMOKE IN CASE OF CONTACT WITH EYES, RINSE IMMEDIATELY with plenty of water and seek medical advice. IN CASE OF ACCIDENT OR IF YOU FEEL UNWELL, seek medical advice immediately (show the label where possible). Consumer Protection # KEEP UNPROTECTED PERSONS OUT OF TREATED AREAS for at least 7 days Environmental Protection # EXTREMELY DANGEROUS TO FISH OR OTHER

AQUATIC LIFE. Do not contaminate surface waters or ditches with chemical or used container. # DO NOT ALLOW DIRECT SPRAY from horizontal boom sprayers to fall within 5 m of the top of the bank of a static or flowing water body, unless a Local Environment Risk Assessment for Pesticides (LERAP) permits a narrower buffer zone, or within 1 m of the top of a ditch which is dry at the time of application. DO NOT ALLOW DIRECT SPRAY from hand-held sprayers to fall within 1 m of the top of the bank of a static or flowing water body. Aim spray away from water. # This product qualifies for inclusion within the Local Environment Risk Assessment for Pesticides (LERAP) scheme. Before each spraying operation from a horizontal boom sprayer or broadcast air-assisted sprayer, either a LERAP must be carried out in accordance with PSD’s published guidance or the statutory buffer zone must be maintained. The results of the LERAP must be recorded and kept available for three years. Storage and disposal KEEP AWAY FROM FOOD, DRINK AND ANIMAL FEEDING STUFFS KEEP OUT OF REACH OF CHILDREN # KEEP IN ORIGINAL CONTAINER, tightly closed, in a safe place under lock and key. EMPTY CONTAINER COMPLETELY and dispose of safely. # DO NOT RE-USE CONTAINER for any purpose.


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Part C/Annex 4

Directions For Use - Professional Product Label 1. What are the Directions For Use?

The Directions For Use section contains all other information required for the user to use the product safely and efficaciously and which does not appear in the other parts of the label. All text must be supported by safety and efficacy data and the final ‘Approved Text’ is subject to evaluation of those data by PSD.

2. Compulsory Requirements 2.1 The Directions For Use should appear on the Container Label and on any separate

Leaflet supplied with the product. However, where space constraints dictate, they may appear on the Leaflet only, providing a suitable phrase directs the user to where they may be found (full guidance on the definition and presentation of Container Labels and Leaflet is given in Part G).

2.2 The section must be headed with DIRECTIONS FOR USE in bold capitals. 2.3 The heading must be followed with the following statement to highlight the status of the

Directions For Use to make clear the user’s responsibilities.

‘IMPORTANT: This information is approved as part of the Product Label. All instructions within this section must be read carefully in order to obtain safe and successful use of this product’.

2.4 The text under the major heading DIRECTIONS FOR USE should be set normally, i.e. in

capitals and lower case as appropriate. 2.5 All subheadings must be distinct from the main DIRECTIONS FOR USE heading. 2.6 This section must be formatted in line with any requirements set out in this Annex and

those set out in: • Part G (which specifies the structure of the whole label); • Part H (use of artwork); and • Part I (legibility of text).

2.7 When drafting text for this section, and producing the final printed label, applicants must

ensure that they follow the guidance on avoidance of false and misleading statements as set out in Part F.

3. Content 3.1 Introduction 3.1.1 The aim is to ensure the clarity of instructions for the end user. It is therefore preferable

that all product Directions For Use sections follow a common format. However, PSD do not wish to be prescriptive over the structure of the Directions For Use and would prefer

07/06/2005 Part C/Annex 4: Directions For Use - Professional Product Label 45


to allow applicants some discretion in drafting this section (other than the requirements in paragraph 1 above which are compulsory).

3.1.2 It is acknowledged that not all Product Labels can be drafted to fit into a set Directions

For Use format. Some require extensive information whereas others require only brief instructions. However, by adopting a common format, labels should become easier to understand by the user. The suggested formats in paragraph 3.2 below try to take account of good labelling practice already in use prior to publication of this guidance document and combine the qualities of several styles into a common format for all. The most important aspect is that labels should be logical and consistent with clear headings and sub-headings and PSD’s preferred layout is outlined below. Simple mock Directions For Use are included in Working Document 1 to this Annex.

3.1.3 The applicant for approval must suggest the text to be used for a product on the draft

label, ideally in line with one of the three formats set out in paragraph 3.2 below. The final ‘approved’ text will be agreed by PSD following evaluation of the application and any changes to the draft label will be specified on the Notice of Approval.

3.2 Examples of possible formats

Applicants for approval are urged to present the Directions For Use section in one of the following three formats (specified headings do not need to appear if no relevant information is being presented).

3.2.1 Format 1 This is a suggested format for a product which is used for the control of similar pests for a number of crops and for which the majority of all other information is applicable to all crops. It is suggested that the required information be presented under the following sub-headings (or similar) below the major heading ‘DIRECTIONS FOR USE’ and the statement specified in paragraph 2.3 above.

(a) Restrictions or Warnings

Most products have a restrictions or warnings section. This should be the first sub-section listing the restrictions for the product so the user can immediately see these without having to search through the rest of the section. (e.g. Do not use on sandy or very light soils; Do not use on frosted crops or during frosty weather; Do not use on crops suffering under stress, from drought or from pest/disease attack). It may be necessary to note in this section that where there are varietal restrictions or certain following crop restrictions etc, that further information on these is situated elsewhere on the label in more detail.

(b) Problem/pest controlled

This section should list the pests, weeds or diseases controlled with the susceptibilities and latest weed/pest growth stage or stage of the disease for effective control. This section should provide general advice on the effective use of the product and include resistance advice/management strategy and any positive tank mixture recommendations.



(c) Crop specific information

This section should provide specific information relating to each crop, e.g. dose, timings and varieties. This may be achieved with one simple section where there is only one crop or where all the crops may be treated the same or a number of sections covering the information for the range of crops. Alternatively a simple table may be used with general information following.

As a rule, the information for each crop should follow only one format to avoid confusion.

(d) Following crops

If required a detailed following crop section should then follow. However it may be appropriate for this section to appear in the crop specific information section if the specific crop sprayed (or its timing) would influence the succeeding crop. If there are no following crop restrictions this could simply be stated in the ‘Restrictions’ section.

(e) Mixing and Spraying

A section covering mixing and spraying instructions should appear next. This section would include information on water volumes (if not specified for each crop in the crop specific information section), application methods, spray quality (BCPC) and the method for cleaning application equipment. This section must also include advice to use mechanical handling of the container if the pack size is greater than 20 litres or 25 kg.

(f) Compatibility

The compatibility section should list ‘convenience’ tank-mixes (i.e. those for which no specific recommendations and claims for use are made) and if required, positive tank-mixes (for which specific claims and recommendations are made in the Directions For Use). Full details of the requirements for listing of these tank-mixes are given in The Applicant Guide.

See Working Document 1/Example 1 of this Annex for an example of Format 1.

3.2.2 Format 2

This is a variation on Format 1 with the simple instructions for use on each crop presented in a tabular format.


3.2.3 Format 3

For some products with more complex labels, the layout described in Formats 1 and 2 above would make the label difficult to write or understand (e.g. an insecticide used on many crops, for the control of many different pests with several different crop/pest combinations each with specific recommended application regimes). In such cases, the following is suggested:


http://www.pesticides.gov.uk/applicant_guide.asp?id=1250

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(a) The Directions For Use be spilt into mini-sections for each approved crop/ situation which covers all details for problem/pest controlled, doses, timings, water volumes, application techniques, following crops and any other instructions necessary for that particular use. Ideally, suitable sub-headings should also be used for different aspects of the instructions.

(b) Where instructions relate to all uses of the product and it would be unnecessary

to repeat text for each crop/situation, the format in 3.2.1 could still be used for those particular sub-headings.

(c) For large labels an index should be included at the start of the Directions For Use

to aid clarity.



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Directions For Use Examples - Professional Product Label

1. Example of Format 1 (see Part C/Annex 4/paragraph 3.2.1)

DIRECTIONS FOR USE ‘IMPORTANT: This information is approved as part of the Product Label. All instructions within this section must be read carefully in order to obtain safe and successful use of this product’. RESTRICTIONS Weedkiller X must not be applied to any crop suffering from stress as a result of drought, waterlogging, low temperatures, pest or disease attack, nutrient or lime deficiency or other factors reducing crop growth. Do not use on under sown crops. Do not use on broadcast sown crops Do not spray if frost is expected Certain following crop restrictions apply; these are detailed under ‘Crop Specific Information’ WEEDS CONTROLLED Weedkiller X is a herbicide with foliar and root activity against a broad range of weeds. Good spray cover of the weeds is essential. Weedkiller X is most effective against small actively growing weeds. Weed species Susceptibility Growth stage Cleavers S Up to 6 whorls Chickweed MS Up to 3 true leaves Charlock MR Up to 2 true leaves Poppy, common S Up to flower bud visible Weed resistance Where resistance to Weedkiller X is known or suspected within a population of chickweed Weedkiller X should be used in sequence or tank mixture with a herbicide with a different mode of action. Recommendations for improved weed control with tank-mixtures If black-grass is present Weedkiller X may be mixed with Weedkiller Z; this mixture will also improve control of chickweed and charlock. Products should only be tank-mixed if each product can be applied within the label recommendations for its use.

(continued overleaf)

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(continued from previous page) CROP SPECIFIC INFORMATION Winter and spring wheat, winter and spring barley, winter and spring oats and rye. Apply Weedkiller X at a dose of 5 litres product/ha to healthy, actively growing crops from when the crop has two true leaves until before the flag leaf just visible stage. All varieties of wheat (except varieties of durum wheat), barley, oats and rye may be treated. Do not apply Weedkiller X more than once to any cereal crop. Apply in 100-200 litres of water per hectare. Where crop growth is thick or weed growth dense up to 400 litres per hectare may be used. Spray quality: MEDIUM (BCPC) Only cereals, field beans or grass may be sown in the same calendar year as an application of Weedkiller X is made. Carrots and Parsnips Weedkiller X may be applied once the crop has three true leaves up to and including 28 days before harvest. Apply in spray volume of 100-200 l/ha water using conventional ground vehicle mounted/drawn equipment. Use the higher volume where crop growth is thick or weed growth dense. Spray quality: MEDIUM (BCPC) All commercial varieties may be treated. Crops should be actively growing. Only cereals, field beans or grass may be sown in the same calendar year as an application of Weedkiller X is made. MIXING Before use ensure that all spraying equipment is clean. Add half the required volume of water and start agitation, add the required quantity of Weedkiller X. Fill the tank to the required volume whilst maintaining agitation. Continuous agitation must be maintained until spraying is complete. All application equipment must be thoroughly cleaned with water prior to storage or use on another crop. COMPATIBILITY Weedkiller X may be tank mixed with any of the following products. Weedkiller X should be added to the spray tank before the other product, always ensure Weedkiller X is fully dispersed before adding the second product. Maintain agitation throughout mixing and spraying. Weedkiller Z Pestkiller A Weedkiller ZX Pestkiller B

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The Labelling Handbook Example of Format 2 (see Part C/Annex 4/paragraph 3.2.2)

DIRECTIONS FOR USE ‘IMPORTANT: This information is approved as part of the Product Label. All instructions within this section must be read carefully in order to obtain safe and successful use of this product’. RESTRICTIONS Weedkiller X must not be applied to any crop suffering from stress as a result of drought, waterlogging, low temperatures, pest or disease attack, nutrient or lime deficiency or other factors reducing crop growth. Do not use on under sown crops. Do not use on broadcast sown crops Do not spray if frost is expected Certain following crop restrictions apply; these are detailed under ‘Crop Specific Information’ WEEDS CONTROLLED Weedkiller X is a herbicide with foliar and root activity against a broad range of weeds. Good spray cover of the weeds is essential. Weedkiller X is most effective against small actively growing weeds. Weed species Susceptibility Growth stage Cleavers S Up to 6 whorls Chickweed MS Up to 3 true leaves Charlock MR Up to 2 true leaves Poppy, common S Up to flower bud visible CROP-SPECIFIC INFORMATION Crop Dose Earliest timing Latest timing Winter and spring varieties of wheat*, barley, oats and rye.

5 litres product/ha

Three true leaves Before the flag leaf just visible stage

Carrots 5 litres product/ha

Three true leaves Before 30 % of the expected root diameter is reached

Parsnips 5 litres product/ha

Four true leaves Before 30 % of the expected root diameter is reached

*excluding varieties of durum wheat. (continued overleaf)



(continued from previous page) All crops should be actively growing. Do not apply Weedkiller X to any crop more than once. Apply in 100-200 litres of water per hectare using conventional ground vehicle mounted/drawn equipment. Where crop growth is thick or weed growth dense up to 400 litres per hectare may be used. Spray quality: MEDIUM (BCPC) FOLLOWING CROPS Only cereals, field beans or grass may be sown in the same calendar year as an application of Weedkiller X. is made. MIXING Before use ensure that all application equipment is clean. Add half the required volume of water and start agitation, add the required quantity of Weedkiller X. Fill the tank to the required volume whilst maintaining agitation. Continuous agitation must be maintained until spraying is complete. All application equipment must be thoroughly cleaned with water prior to storage or use on another crop. COMPATIBILITY Weedkiller X may be tank mixed with any of the following products. Weedkiller X should be added to the spray tank before the other product, always ensure Weedkiller X is fully dispersed before adding the second product. Maintain agitation throughout mixing and spraying. Weedkiller Z Weedkiller ZX Pestkiller A Pestkiller B



Example of Format 3 (see Part C/Annex 4/paragraph 3.2.3)

DIRECTIONS FOR USE ‘IMPORTANT: This information is approved as part of the Product Label. All instructions within this section must be read carefully in order to obtain safe and successful use of this product’. RESTRICTIONS X Pest must not be applied to any crop suffering from stress as a result of drought, waterlogging, low temperatures, nutrient or lime deficiency or other factors reducing crop growth. Do not spray if frost is expected. Avoid spraying crops under conditions of high temperature and sun light as this may lead to transient crop effects. FOLLOWING CROPS Any crop may be sown after a crop treated with X Pest. MIXING Apply using conventional ground vehicle mounted/drawn equipment. Before use ensure that all application equipment is clean. Add half the required volume of water and start agitation, add the required quantity of X Pest. Fill the tank to the required volume whilst maintaining agitation. Continuous agitation must be maintained until spraying is complete. All application equipment must be thoroughly cleaned with water prior to storage or use on another crop. CROP SPECIFIC INFORMATION Wheat, barley and oats For the control of cereal aphids (Barley Yellow Dwarf Virus vectors) in autumn sown crops. Apply a single application as a routine in the period mid-late October if BYDV is commonly a problem on the farm or locality. Spray immediately if aphids are found in the crop earlier. Further treatments may be required in high risk areas especially during mild winters. Winter and spring crops: Grain aphid and Rose-grain aphid applications should be made once official threshold have been reached. Dose: 1 l/ha. A maximum of three applications may be made to any one crop Latest time of application: 3 days before harvest Water volume: 200-300 l/ha Spray quality: MEDIUM (BCPC)

(continued overleaf)

07/06/2005 Part D: Amateur Product Label: Approved Textvvedved 53


(continued from previous page) Peas (All varieties) For the control of pea aphids and pea moth. Apply to flowering crops according to specialist advice or once thresholds have been reached. Repeat as necessary. Dose: 1 l/ha. A maximum of two applications may be made to any one crop Latest time of application: 5 days before harvest Water volume: 100-300 l/ha Spray quality: MEDIUM (BCPC) Winter and spring oilseed rape For the control of pollen beetle and flea beetle Pollen beetle: Apply at the green/yellow bud stage according to specialist advice or if official thresholds have been reached. Flea beetle: Apply at first signs of attack. Repeat 10-14 days later if necessary. If aphid vectors of Beet Western Yellow Virus are present at application then X Pest should be co-applied with 100ml of X Pest Z in a minimum spray volume of 300 l/ha. Dose: 1.25 l/ha. A maximum of three applications to any one crop, including only one after yellow bud stage. Latest time of application: 5 days before harvest. Water volume: 200-400 l/ha Spray quality: MEDIUM (BCPC) Brassicas: Cabbage, Brussels sprouts, Cauliflower, Broccoli and Calabrese For the control of flea beetle, caterpillars and mealy cabbage aphid. Apply at first signs of attack. Repeat if necessary. If infestations of mealy cabbage aphid are high at application then X Pest should be co-applied with Pest Control Extra at a dose of 500 ml in a spray volume of 400 l/ha. Dose: 1 l/ha. A maximum of two application per crop Latest time of application: 3 days before harvest Water volume: 200-400 l/ha Spray quality: MEDIUM or COURSE (BCPC) COMPATIBILITY X Pest may be tank mixed with any of the following products. X Pest should be added to the spray tank before the other product, always ensure X Pest is fully dispersed before adding the second product. Maintain agitation throughout mixing and spraying. Weedkiller Z X Pest Z (winter and spring oilseed rape only) Weedkiller ZX Pest Control Extra (Listed brassicas only)



Part D

Amateur Product Label: Approved Text 1. Introduction 1.1 The following guidance sets out the requirements for presentation of the Approved Text

on an ‘amateur’ Product Label:

(a) Text is divided into 3 sections: • Product Identity (see paragraph 2 below and Part D/ Annex 1) • Safety Information (see paragraph 3 below and Part D/ Annex 2) • Instructions For Use (see paragraph 4 below and Part D/ Annex 3)

(b) The draft label text submitted to PSD must be presented in line with the

requirements for each section as specified in Part D. It must include the relevant standard headings and phrases specified in Annexes 1 to 3. However, it need not at this stage reflect other formatting requirements (e.g. size of text, fonts, bold highlighting). These requirements will be set as a ‘condition of sale and supply’ on the final Notice of Approval (see (c) below). However, Part G does give advice on labelling different parts of the product packaging.

(c) The Approved Text on the final printed label must comply with:

• all amendments to the draft text as specified on the Notice of Approval; • the requirements of Parts E and F where the Applicant makes any other

amendments to the text; and, • the formatting requirements as set out in Part D and Parts G, H and I.

(d) There is no provision for the addition of Unapproved Text to amateur

Product Labels such as ‘Company Advisory Information’ which can be included on professional product labels.

1.2 Chemicals (Hazard Information and Packaging for Supply) Regulations 2002

(CHIP 3) 1.2.1 The Health and Safety Executive’s Chemicals (Hazard Information and Packaging for

Supply) Regulations 2002 (CHIP 3) implement Directive 99/45/EC, relating to the classification, packaging and labelling of dangerous preparations. All pesticide products in the supply chain must now comply with CHIP 3. The CHIP 3 Regulations are supported by various information sources, including the ‘Approved Supply List’ (ASL) and ‘Approved Classification and Labelling Guide’ (ACLG). Further useful details, including an overview and frequently asked questions, are given on the CHIP web-site at http://www.hse.gov.uk/chip

1.2.2. The classification requirements of CHIP 3 encompass physicochemical properties,

health effects and environmental effects. 1.2.3. When an amateur product is classified under CHIP 3 the following details are usually

required on the label:

• the name, address and telephone number of the supplier;

07/06/2005 Part D: Amateur Product Label: Approv ed Text 1

http://www.hse.gov.uk/chip


• the trade name;

• identification of the constituents which result in the product being classified;

• any indication of danger together with the corresponding symbol (e.g. Irritant and St Andrews Cross);

• the risk phrases (e.g. Irritating to skin);

• the safety phrases (e.g. Keep out of the reach of children);

• the nominal quantity of the product;

• the phrase ‘To avoid risks to man and the environment, comply with the instructions

for use’.

Note that some of this information is also required under Product Identity. There is no need to duplicate the information on the label.

1.2.4. The CHIP 3 information should appear on the Main Area of the label (see Part D/Annex

1). 2. Product identity

2.1 This sets out the core product information so that the users, regulatory authorities and

any other interested parties may easily identify the product and its intended purpose; namely:

(a) Product trade-name. (b) The product registration number. (c) Name and address of the approval holder and marketing company. (d) The formulation type. (e) Name and amount of the active substance. (f) Net quantity of product. (g) Product batch number. (h) Biological use phrase. (i) Statement of users’ obligation in following label instructions. Annex 1 to this section details the specific content and formatting requirements for Product Identity information.

3. Safety Information 3.1 These comprise the following (as appropriate to the product):

(a) The “CHIP 3” information (see paragraph 1.2 above) (b) Other safety (precautionary) phrases required by COPR/PPPR. These phrases

are to ensure the safety of the operator and other parties, the environment/non-target organisms and storage and disposal.

07/06/2005 Part D: Amateur Product Label: Approved Textvedved 2


(c) Medical advice/First aid (subject to the classification/type of product).

Annex 2 to this section details the specific content and formatting requirements for the safety (instruction) phrases required by COPR/PPPR.

4. Instructions For Use

4.1 This contains detailed claims, recommendations and instructions for the use of the product for its intended purpose. All text must be supported by safety and efficacy data and compliance with the instructions in this section should ensure that the product is used safely and efficaciously.

4.2 The following information should appear in this section: (a) crops/situations; (b) pests/weeds controlled; (c) dose rates; (d) number of treatments per crop/year/situation; (e) recommended application timing, intervals between applications and harvest

interval; (f) specific plant health and environmental conditions pertaining to use; (g) following crop recommendations; (h) soil type, variety and climatic restrictions; (i) warnings relating to phytotoxicity, resistance, adjacent crops etc; (j) methods of application; (k) water volumes; (l) mixing instructions; (m) all other information on product application which is required for safe and

efficacious use. Annex 3 to this section details the specific content and formatting requirements for the Instructions For Use.



Part D/ Annex 1

Product Identity – Amateur Product Label

1. What is Product Identity? 1.1 The range of information that falls under the general term Product Identity consists of

core information which will ensure that the users, regulatory authorities and any other interested parties may easily identify the product and its intended purpose. It is not a discrete part of a label under a specific heading but a collection of information that must appear prominently but not with the Safety Information or the Instructions for Use.

2. Compulsory Formatting Requirements 2.1 The information in 3 below must appear on the Main Area of the Container Label and on

any separate Leaflet supplied with the product (full guidance on definition and presentation of Container Labels and Leaflets is given in Part G). Although font point size 6 is permitted in Gill sans or Helvetica fonts, this should only be used when it is not possible to use larger text. Tiny font sizes cause significant difficulty for many users with poor eyesight.

2.2 It must be formatted in line with any requirements detailed in 3 below and those set out in

Parts G, H and I. 3. Content

The application for approval must suggest the text to be used for a product on the draft label. The actual final text required will be set by PSD following evaluation of the application, and any changes to the draft label will be specified in the Notice of Approval.

3.1. Product trade-name 3.1.1 The product name as specified in the Notice of Approval. It must be formatted such that

it is clear to the user what the full trade-name is. Whilst use of different sized fonts and colours for different parts of the trade-name is acceptable, applicants should ensure that these would not confuse a user.

3.1.2 PSD will not consider trademark or copyright issues with respect to trade-names. This is

the responsibility of the applicant. However, PSD reserves the right to request a different trade-name where: • It is likely to cause confusion with another product or with non-pesticide products; • It misrepresents the composition or intended use of the product; • It makes claims that are not supported by data.

3.2 Product registration number

The unique 5 digit identifying registration number given in the approval (prefixed with ‘MAFF’ or ‘MAPP’) must appear in close proximity to the product trade-name. Where

07/06/2005 Part D/Annex I: Product Identity – Amateur Product Label 4


appropriate, this may appear on the back packaging label above the ‘safety information’ as an alternative to stating the product registration number on the front packaging label.

3.3 Approval holder and/or marketing company details

The name, address and telephone number of the approval holder, and if different, the name, address and telephone number of the marketing company must appear for all products approved under ‘The Plant Protection Products Regulations’, whilst only the name, address and telephone number of the marketing company must appear on the labels for products approved under the ‘Control of Pesticides (as amended) regulations.

3.4 Formulation type

The formulation type must be given in full (e.g. suspension concentrate) rather than the abbreviation (e.g. SC).

3.5 Amount and name of the active substance(s) 3.5.1 Each active substance name must be as given in the list contained in Annex I to

Directive 67/548/EEC or, if not included therein, its International Organisation for Standardisation common name. If the latter is not available, the active substance shall be designated by its chemical designation according to the rules of the International Union of Pure and Applied Chemistry contained in the Nomenclature of Organic Chemistry. This will be as specified on the Notice of Approval.

3.5.2 The target content of each named active substance, as specified on the Notice of

Approval must be specified on any product

The target content must be expressed as follows (usually included in a single ‘contents statement’ with 3.4 above).

(a) for formulations which are solids, aerosols, volatile liquids (boiling point max 50°

C) or viscous liquids (lower limit 1 Pas at 20°C): as a percentage by weight; (b) for other liquids: as a percentage by weight and in grams per litre at 20°C where

these are non-classified non-volatile liquids, this can be expressed as grams per litre only;

(c) for gases: as a percentage by volume.

3.6 Net quantity of product

The net quantity of the preparation in the container (in accordance with the Weights and Measures Act). This applies to any small containers/packs supplied within an outer container. Where a number of smaller containers are packaged within a single outer, the latter should state how many, and what size, of the former are being supplied.

3.7 Product batch number

The formulation batch number or some means of identifying it (this may be printed on the container itself rather than on the label area).


The Labelling Handbook 3.8 Biological use phrase

Brief statement on biological use (e.g. ‘For the control of aphids and red spider mites on apples and pears’). This statement may use descriptive terms such as kills, controls, repels and eradicates, but these terms must be supported by appropriate data.

3.9 Field of use phrase

A statement specifying that this is a home-garden product and its action (e.g. weedkiller, insecticide lawn treatment etc). For example: FOR USE ONLY AS A HOME GARDEN WEEDKILLER (e.g. outdoor herbicide in edible crop situations).

3.10 Statement of users obligation in following label instructions The following phrase must appear in bold capitals on all amateur product labels: “To avoid risk to man and the environment, comply with the instructions for use.” You will note that this is the same as the phrase required under CHIP, however there is no need to duplicate this statement on the label.



Part D/ Annex 2

Safety Information- Amateur Product Label 1. What is Safety Information?

Safety Information relates to:

The CHIP 3 area (see Part D paragraph 1.2) • • Safety (Instruction) phrases required under COPR/PPPR that must be followed

by the user to ensure safe storage and use (see paragraph 3 below and Working Documents 1 to 4 to this Annex).

• Medical Advice for treating poisoning incidents (see paragraph 5 below).

IMPORTANT NOTE: A requirement for an amateur product to be classified does not automatically preclude issue of approval. However, it must be noted that approval for such products will not be given if the product would be classified as Very Toxic, Toxic or Corrosive or where a risk assessment demonstrates that protective clothing is required for safe use of the product. However products that fall outside these criteria but require standard recommendations in respect of protective clothing under CHIP 3 will continue to be approved where appropriate. For further details see All Approval 31 of 2003 (available on our website).

2. Format and Content 2.1 The Safety Information must appear on the Container Label and on any separate Leaflet

supplied with the product (full guidance on the definition and presentation of Container Labels and Leaflet is given in Part G). A heading or title of ‘Safety Information’ is not required but the information on Classification and the COPR/PPPR Safety Instructions should as far as practicable appear in close proximity to each other.

2.2 See Part G/paragraphs 2 and 3 for advice on positioning. To summarise:

(a) For classified products, a CHIP 3 Area must appear on the Container Label. (b) It is preferable that the COPR/PPPR Safety Instructions are in close proximity to

the to the CHIP 3 Area. (c) Medical Advice must appear as appropriate in the Safety Instructions (if a

precautionary phrase) or as separate section on the Container Label and any separate Leaflet).

2.3 The information required in each section must be formatted in line with any requirements

set out in this Annex and those in Parts G, H and I. 2.4 Only the relevant phrases as required under COPR/PPPR must be used. Others must

not be used unless PSD has given prior agreement.

07/06/2005 Part D/Annex 2: Safety Information – Amateur Product Label 7

The Labelling Handbook 2.5 Based on the supporting data/information, the applicant for approval must suggest the

phrases to be used for a product on the draft label. The actual phrases required will be set by PSD following evaluation of the application, and any changes to the draft label will be specified on the Notice of Approval.

3. The Safety Instructions These are COPR/PPPR instructions to be followed during use and storage of the pesticide to ensure the protection of humans, non-target organisms and the environment. Some of these phrases are also ‘statutory conditions of use or storage’ and are identified as such in the Notice of Approval. There is a legal requirement on the user to comply with these conditions.

3.1 Safety Instructions on Product Label 3.1.1 The Safety Instructions must appear on the Container Label and any separate Leaflet-

see Part G for advice on positioning this section on the Container Label. 3.1.2 The section must have a major heading SAFETY INSTRUCTIONS in bold capitals. 3.1.3 Under the heading, the following subheadings (to be in bold using upper and lower text

as shown) and appropriate phrases (as specified in Working Documents 1 to 4 this Annex) may appear. The applicant for approval must suggest which phrases are used for a product on the draft label. These will be based on the data supporting the product in question and/or precedents set for other similar products that have been previously approved. Whilst it is an obligation on the applicant to propose appropriate phrases on the draft label, the actual final phrases will be set by PSD following evaluation of the application. Any changes required to the draft label will be specified on the Notice of Approval.

(a) Protection during/in use

Instructions to be followed to ensure the safe use of the product with respect to the user of the pesticides and any third parties that the product may come into contact with. See Working Document 1

(b) Other General protection

Instructions to be followed to ensure the protection of persons likely to come into contact with treated material. The choice of standard ‘general protection’ phrases is given in Working Document 2 attached to this Annex.

(c) Environmental protection

Instructions to be followed to ensure the protection of the environment (i.e., water, soil and air) and non-target organisms (e.g. fish and other aquatic life, bees, livestock and game and other wildlife).



The choice of standard ‘Environmental Protection’ phrases is given in Working Document 3 attached to this Annex.

(d) Storage and disposal

Instructions to be followed to ensure safety of product and container storage and disposal practices. The choice of standard ‘Storage and Disposal’ phrases is given in Working Document 4 attached to this Annex. If there are no phrases required for any of (a) to (d) above, the sub-heading need not appear.

3.2 Phrases must be presented in either the following formats.

(a) As specified in Working Documents 1 to 4 in a mixture of upper and lower case;

or (b) Alternatively, the first parts of the phrases specified in upper case in this guidance

may appear in bold, but with upper/lower case as for normal text.

3.2.1 It is preferred that each phrase appears as a separate line of text. However, where space constraints dictate, instructions and sub headings may follow on the same line as long as individual phrases are clearly differentiated from each other.

4. Medical Advice 4.1 Where toxicity of the product justifies it, statements on First Aid and Guide to Doctor or

Poisons Centre must appear. Examples of standard statements for certain active substances are given at Part C/Working Document 8 to this Annex. Other wording must not be used unless PSD has given prior agreement.

4.2 Paragraph 2 above gives advice on positioning this section on the Container Label and

separate Leaflet. 4.3 Where Medical Advice is considered necessary for other active substances/ products the

applicant should present this on the draft label for consideration by PSD. 5. Examples of Safety Information on labels 5.1 Part C/Annex 3/Working Document 9 presents examples of Safety Information

depending on the complexity of information to be conveyed. 5.2 These examples are hypothetical situations and are intended only to demonstrate the

format of this information.



Part D/Annex 2/Working Document 1

Protection During/ in Use Phrases - Amateur Product Label

1. The following phrase is compulsory for all products containing an

anticholinesterase organophosphate or carbamate active substance:

This product contains an anticholinesterase [organophosphate/ carbamate] compound. DO NOT USE if under medical advice NOT to work with such compounds.

For further information please refer to PSD’s ‘All Approval Holder’s letter’: ‘Labelling of Amateur Products Containing Organophosphorous (or Carbamate) Anticholinesterase Compounds’ of 21 June 1999. This may be obtained from the PSD website.

2. The following phrases are examples of phrases that may be appropriate for any product:

2.1 AVOID ALL CONTACT BY MOUTH 2.2 KEEP OFF SKIN/AWAY FROM EYES 2.3 WASH OFF SPLASHES (IMMEDIATELY) 2.4 DO NOT BREATHE SPRAY/MIST/VAPOUR/DUST/FUMES 2.5 WASH HANDS/AND EXPOSED SKIN/AFTER USE/HANDLING Note: Some of these phrases are identical to S phrases required under CHIP 3. Even if

the phrase is not a specific requirement of CHIP 3, we may require the phrase to appear on the label to ensure safe use.

07/06/2005 Part D/Annex 2/Working Document 1: Protection During/in Use Phrases – Amateur Product Label

10


Part D/Annex 2/Working Document 2

Other General Protection Phrases - Amateur Product Label

1. The following phrases may be appropriate: 1.1 DO NOT SPRAY/APPLY DIRECTLY ON FOOD/FOOD CROPS 2. The following phrases may be appropriate for products used on food crops: 2.1 DO NOT PICK/GATHER FOOD CROPS WITHIN ............. hours/days of treatment

07/06/2005 Part D/Annex 2/Working Document 2: Other General Protection Phrases – Amateur Product Label

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Part D/ Annex 2/ Working Document 3

Environment Protection Safety Phrases - Amateur Product Label

1. The following environmental precaution phrases may be appropriate: 1.1 APPLY AWAY FROM BIRDS/BEES/PETS/FISH 1.2 HARMFUL/DANGEROUS TO BIRDS/BEES/PETS 1.3 Do not contaminate ponds or streams.

or Remove/cover fish bowls/fish tanks/caged birds/pets before spraying/dusting.

1.4 Do not contaminate water with product or its container (this Annex V phrase is a

requirement for all amateur products following Annex I inclusion) 1.5 DO NOT USE OUTDOORS

1.1. DO NOT USE OUTDOORS 2. The following phrases must appear on all products:

2.1. Do not empty into drains; 2.2. Do not contaminate water with the product or its container.

Note: These phrases may need to be revised in light of CHIP phrases and any

additional phrases required in respect of disposal

The product may also require environmental classification in accordance with CHIP3. You will note that the S29 phrase ‘Do not empty into drains’ should be applied to environmentally classified products used by the general public.

07/06/2005 Part D/Annex 2/Working Document 3: Environment Protection Safety Phrases – Amateur Product Label

12



Storage and Disposal Safety Phrases - Amateur Product Label

1. The following phrases may be appropriate

1.1. KEEP PRODUCT AWAY FROM CHILDREN/AND PETS.

1.2. KEEP AWAY FROM FOOD AND DRINK 2. The following phrase must appear on all products supplied in ‘single-dose’

sachets:

2.1. STORE UNUSED SACHETS in a safe place. DO NOT STORE half-used sachets. 3. The following phrase must appear on all products:

3.1. KEEP PRODUCT IN ORIGINAL CONTAINER, tightly closed, in a safe place 4. The following phrase must appear on products with non-washable containers:

4.1. EMPTY CONTAINER COMPLETELY and dispose of safely

Note: There may be phrases required in accordance with CHIP 3 which relate to

storage and disposal of the product. 5. The following phrases must appear on all products except those containing

ferrous sulphate alone or ferrous sulphate + fertiliser.

5.1. Dispose of unused product in its container at a household waste site (civic amenity site). Contact your local council (local authority) for details.

5.2. Dispose of empty container in the dustbin.

6. The following phrase must appear on all products containing ferrous sulphate

alone or ferrous sulphate + fertilizer.

6.1. Unused product in its container may be disposed of in the dustbin.

07/06/2005 Part D/Annex 3: Instructions For Use – Amateur Product Label 13


Part D/ Annex 3

Instructions For Use - Amateur Product Label 1. What are the Instructions For Use?

The Instructions For Use section contains all information required for the user to use the product safely and effectively. All text must be supported by safety and efficacy data and the final Approved Text is subject to evaluation of those data by PSD.

2. Compulsory Requirements 2.1 The Instructions For Use should appear on the Container Label and on any

separate Leaflet supplied with the product. However, where space constraints dictate, they may appear on the Leaflet only, providing a suitable phrase directs the user to where they may be found (full guidance on the definition and presentation of Container Labels and Leaflet is given in Part G).

2.2 The section must be headed with INSTRUCTIONS FOR USE in bold capitals. 2.3 The text under the major heading INSTRUCTIONS FOR USE should be set

normally, i.e. in capitals and lower case as appropriate. 2.4 All subheadings must be distinct from the main INSTRUCTIONS FOR USE

heading. 2.5 This section must be formatted in line with any requirements set out in this Annex

and those set out in • Part G (structure of the whole label); • Part H (use of artwork); and • Part I (legibility of text).

2.6 When drafting text for this section, and producing the final printed label, applicants

must ensure that they follow the guidance on avoidance of false and misleading statements as set out in Part F.

3. Content 3.1 Introduction 3.1.1 The aim is to ensure the clarity of instructions for the end user. It is therefore

preferable that all product Instructions For Use sections follow a common format. However, (other than the requirements in paragraph 1 above which are compulsory, PSD does not wish to be prescriptive over the structure of the Instructions For Use and prefers to allow applicants some discretion in drafting this section.


The Labelling Handbook 3.1.2 Instructions and guidance for amateurs should be written in a way which may be

understood by a lay person. They may need to be simpler than that appearing on similar professional product labels. However the guidance given on professional labelling may be used as a starting point as it may provide useful guidance relevant to the amateur situation. For amateur products, guidance on doses/application rates may need to be very carefully worded, especially for products such as slug pellets. The user must be able to determine the dose without resorting to sophisticated weighing equipment.

3.1.3 It is acknowledged that not all Product Labels can be drafted to fit into a set

Instructions For Use format. Some require extensive information whereas others require only brief instructions. However, by adopting a common format, labels should become easier to understand by the user. The suggested formats in paragraph 3.2 below try to take account of good labelling practice already in use prior to publication of this guidance document, and combine the qualities of several styles into a common format for all. The most important aspect is that labels should be logical and consistent with clear headings and sub-headings and PSD’s preferred layout is outlined below. Simple mock Instructions For Use are included as Working Document 1 to this Annex.

3.1.4 The applicant for approval must suggest the text to be used for a product on the

draft label, ideally in line with one of the two formats set out in paragraph 3.2 below. The final ‘approved’ text will be agreed by PSD following evaluation of the application, and any changes to the draft label will be specified on the Notice of Approval.

3.2 Examples of possible formats

Applicants for approval are encouraged to present the Instructions For Use section in one of the following two formats (specified headings do not need to appear if no relevant information is being presented).

3.2.1 Format 1

This is a suggested format for an amateur product which is used to control a pest or group of pests in one crop or a group of crops where the majority of the information is the same. It is suggested that the required information be presented under the following subject headings (or similar) below the main heading ‘INSTRUCTIONS FOR USE.

(a) When to use

Details of when to use a product should appear first on an amateur label to enable users to easily locate the appropriate product for their needs. There should be a clear statement of the weeds, pests or diseases controlled and this should be followed by brief general advice on the optimum time to use the product (e.g. time of year or plant growth stage).

On an amateur product guidance on any restrictions should appear immediately after the statement of the weed, pest or disease controlled. It should enable the user to easily establish when use of the product would not be appropriate (e.g. Do not use on lawns; Do not use on desired plants. Do not spray open flowers. Do not use on African violets.)



(b) Where to use

This section should provide specific information relating to each crop, e.g. dose, timings and varieties. This may be achieved with one simple section (where there is only one crop or where all the crops may be treated the same), or a number of sections covering the information (for a range of crops). Alternatively a simple table may be used with general information appearing afterwards. As a rule this section should follow only one format to avoid confusion.

(c) How to use

A section covering mixing and application instructions should appear next. This section would include information on doses and water volumes (if not specified for each crop in the crop specific information section), application methods (e.g. watering can, sprayer or a particular type of lawn spreader) and any specific information such as the need to not let the mixture stand, spray quality (fine, coarse) and advice to clean the applicator after use. It may be appropriate to include guidance on how to measure or mark out areas to ensure accurate application. Where additional action on the part of the user is required, this should be detailed. In the case of a mosskiller for example this could include advice on scarifying and improving drainage. In the case of certain herbicides it could include the need to wait for a specified period before digging-in weeds or planting the following crop.

See Working Document 1/ Example 1 ….for an example of Format 1 3.2.2 Format 2 Relatively few amateur products need to have complex labels (i.e. there are not normally large numbers of uses and instructions). However where the layouts described in Format 1 above would make the label difficult to write or understand a tabular format is suggested. An example of where this might be appropriate is a label for an insecticide used on many crops for the control of a number of different pests with several crop/pest combinations, each with specific recommended application regimes), See Working Document 1/ Example 2 ….for an example of Format 2.




Instructions For Use Examples- Amateur Product Label

1. Example of Format 1 (see Part D/Annex 3/paragraph 3.2.1)

INSTRUCTIONS FOR USE WHEN TO USE Weedkiller Y is applied to control a range of weeds in lawns including moss, dandelion, daisy, plantain and creeping buttercup. It is most effective when applied to actively growing weeds in the spring. WHERE TO USE For use on lawns Do not apply to lawns sown or turfed less than six months ago. Do not apply within three days before or after mowing. Do not apply under drought conditions, if frost is expected or if the lawn is waterlogged. Do not apply in mixture with other weedkillers. Do not exceed the recommended dose. HOW TO USE Mix 25 ml of Weedkiller Y in 20 litres of water and apply to 15 m2 of lawn using a sprayer or watering can fitted with a fine rose or dribble bar. Ensure complete and even coverage but avoid overdosing. If rain does not fall within three days, water the lawn lightly. A repeat application can be made after six weeks if required but do not apply more than twice in any three month period. When moss has turned black, affected areas should be raked to remove dead moss. Re-occurrence of moss can be minimised by improving drainage. Grass clippings must be composted for at least six months before being used as a mulch.

07/06/2005 Part E – Instructions for Use Examples - Amateur Product Label 1 1

The Labelling Handbook 2. Example of Format 2 (see Part D/Annex 3/paragraph 3.2.2)

INSTRUCTIONS FOR USE WHEN TO USE Insecticide Y controls aphids on vegetable plants, bedding plants and shrubs (including roses), aphids, capsid and caterpillars on apple, and carrot fly on carrots and parsnips. WHERE AND HOW TO USE Crop Pest Maximum

dose per litre of water

Timing

Bedding plants 5 ml Spray when aphid colonies seen Shrubs and roses 10 ml Treat roses as soon as aphids are

seen. Treat other shrubs when aphid numbers increase

Peas and beans 10 ml Treat once if aphids are present before the end of flowering.

Cabbage, Brussels sprouts

15 ml Treat up to three times at 14 day intervals. Latest time of application 5 days before harvest

Apple

Aphids (greenfly and blackfly)

10 ml Treat once before flowering and once after petal fall.

Apple Capsid 15 ml Treat once if capsids are seen pre-flowering.

Apple Caterpillars 10 ml Treat once in June/July if caterpillars are seen on developing fruitlets

Strawberry Vine weevil 50 ml Using a watering can, apply as a drench to the crown of the plants at a dose of 1 litre per 3 metres of row as soon as adult weevils are seen or leaf notching is seen on most leaves. Latest time of application 5days before harvest

Carrot and parsnip

For all the above crops except strawberry, apply as a fine spray to thoroughly wet foliage but not so that the leaves are dripping. Wash equipment thoroughly after use. Do not apply to Fuchsia or Clematis. Do not apply directly to open blossoms as spotting may result.

07/06/2005 Part E – Instructions for Use Examples - Amateur Product Label 2


Part E

Acceptable changes to ‘Approved Text’ 1. Is it possible to make changes to ‘Approved Text’?

As described in Part B/paragraph 2.4, the text that appears on the Product Label is that which is given on the draft label subject to any amendments set out in the Notice of Approval. However, PSD appreciate that applicants may wish to make changes to this text at subsequent printing or re-printing which do not require a change to the approval, i.e. changes which do not alter the meaning of the text but which present the required information in a different way.

2. Changes that may not be made to text without a new application

(a) Hazard Symbols and associated Risk Phrases as specified in Part C/Annex 3/ Working Documents 1 and 2.

(b) Safety Precaution phrases as specified in Part C/Annex 3/Working Document 3. (c) Standard headings, sub-headings and other phrases required in the Statutory

Area (as specified in Part C/Annex 2), Safety Precautions (as specified in Part C/Annex 3) and Directions For Use (as specified in Part C/Annex 4).

(d) Any information on the Product Identity which is specified on the Notice of

Approval and where such a change requires an amendment to the approval (e.g. tradename, approval holder/marketing company, MAFF or MAPP no, formulation type, active substance and content, ‘dangerous’ coformulants etc).

(e) Any other change to any part of the label which:

• changes the meaning of the text; • adds any text which was not considered by PSD during evaluation of

application(s) for approval, and for which assessment of supporting safety and/or efficacy data is required;

• deletes any text which PSD consider to be supported by safety and/or efficacy data/information and is required for the safe and efficacious use of the product

But also refer to paragraph 3 below.

3. Changes that may be made to text without an application 3.1 Examples of the types of text changes in the Product Identity or Directions For Use that

may be made without submitting an application for approval to PSD are given in Annex 1. A representative range of label statements have been used (e.g. biological use phrases, pest control claims, application), but the list is not intended to be exhaustive. In each case, an example of ‘Approved Text’ is followed by examples of changes that could

07/06/2005 Part E – Acceptable Changes to Approved Text 1


be made without affecting the overall meaning. 3.2 Further to paragraph 2 (e) above, it is acceptable to

(a) Delete all claims and recommendations for a particular use of a product (i.e. crop/situation) where the deleted text is specific only to that use. However, PSD urge applicants to consider commercial withdrawal of such uses so that the approval is amended (see The Applicant Guide);

(b) Delete ‘convenience’ tank-mix recommendations.

3.3 The form in which the text is presented may be changed (e.g. amendment from prose to

tabulated information). 3.4 Where appropriate clearance has been obtained from the PCS, you may include

• the PCS number as well as the MAFF/MAPP number (for both the product and any tank mixes recommended on the label),

• contact details for the Republic of Ireland marketing company/authorisation holder.

If more significant changes are required to bring the Irish and UK labels in line, you should contact PSD since an application may be required.

3.5 Certain information may appear within the body of the ‘Approved Text’ which are not

subject to the Regulations and changes may be made to these without a change in approval, e.g.: • Company disclaimer statements • Trademark information

3.6 Any changes to the text must also follow the criteria for the ‘avoidance of false and misleading information’ as set out in Part F.

3.7 There is scope for amending information that is not supported by data and not covered

by the Regulations. Such text which is considered to be ‘advisory’ may be removed from the ‘Approved Text’ sections to be included in a separate Company Advisory Information section. Full details are given in Part J of this guidance.

IF IN DOUBT AS TO WHETHER THE PROPOSED CHANGE FALLS

WITHIN THE ACCEPTABLE CRITERIA, CONTACT PSD FOR ADVICE.

07/06/2005 Part E – Acceptable Changes to Approved Text 2



Part E/Annex 1

Examples of acceptable alternatives to ‘Approved Text’ 1. Contents statement ‘Approved Text’ Acceptable alternatives

An emulsifiable concentrate formulation containing 100g/l [active 1] and 50 g/l [active 2] in xylene

• [active 1] (100g/l) and [active 2] (50 g/l) formulated as emulsifiable concentrate (also contains xylene)

• Formulation type: emulsifiable concentrate

Active substances: 100g/l [active 1] and 50 g/l [active 2] Contains xylene

2. Biological use phrases ‘Approved Text’ Acceptable alternatives

For the control of annual grasses and a wide range of broad leaved weeds in winter wheat and winter barley, and certain varieties of winter rye and triticale

• A contact and residual herbicide for control of annual grasses and broad leaved weeds in listed cereals

• For control of a range of weeds in listed cereals

A fast acting aphicide for use in a range of crops • An insecticide for control of aphids in sugar beet, potatoes, cereals, peas, beans, brassicas and other crops

• An aphicide for use in listed crops

A broad-spectrum insecticide controlling many pests of agricultural, horticultural and forestry crops

• An insecticide for use against a number of pests in a range of crops, including leather jackets in pasture

• A broad-spectrum insecticide for the control of

a number of insect pests in cereals, pasture and various fruit and vegetable crops

A protectant fungicide for the control of potato blight, downy mildew in winter oilseed rape and cereal diseases

• A fungicide for use against certain diseases in potato, oilseed rape and cereals

• A protectant fungicide for the control of potato

blight, downy mildew in winter oilseed rape and leaf spot, brown rust, yellow rust, sooty mould, leaf blotch and net blotch in listed cereals

Note: Where the biological use phrase is expanded (as shown above), this is acceptable only where the claims made are as detailed elsewhere in the Directions For Use.

07/06/2005 Part E/Annex 1: Examples of acceptable alternatives to ‘Approved Text’

3

The Labelling Handbook 3. Pest control claims, application doses and timings ‘Approved Text’ Acceptable alternatives

Pest controlled: cutworms. Dose per hectare: 2.0 litres

•

•

Cutworms will be controlled by the application of 2.0 litres of product per hectare

For control of cutworm, apply 2.0 l/ha product

For the reduction of downy mildew (Peronospora parasitica) [product] should be applied at 1.7 kg in 200 – 1000 litres of water per hectare

•

•

Disease: downy mildew (reduction of). Application rate: 1.7 kg product in 200 – 1000 l/ha water

Apply 1.7 kg product in 200 – 1000 litres of water per hectare for the reduction of downy mildew (Peronospora parasitica

Annual weeds will be controlled if spraying is done while the majority of weeds are seedlings

•

•

For control of annual weeds, apply [Product] when the majority of weeds are seedlings

Control of annual weeds will only be achieved if application takes place when the majority of weeds are at the seedling stage

Apply post-crop emergence, when susceptible weeds have not passed the stage shown in the following tables and before the crop reaches the second node detectable stage (Zadoks 32)

•

•

Apply [product] before the susceptible weeds have passed their recommended growth stage (see table, below). Applications may be made from crop emergence up to second node detectable stage (Zadoks 32)

Application timing: After crop emergence until the second node detectable stage (Zadoks 32). Susceptible weeds will only be controlled up to the growth stages described in the table below

Leaf blotch: spray when disease is seen, before the second node detectable stage of the crop

•

•

For the control of leaf blotch (Rhynchosporium secalis), apply [product] at the first sign of disease. The latest timing of application is the second node detectable stage of the crop (Zadoks 32)

Apply [product] at the onset of disease symptoms for the control of leaf blotch. Application must be made prior to the second node detectable stage of the crop


4

The Labelling Handbook 4. Application method, water volume and spray quality ‘Approved Text’ Acceptable alternatives

Apply [product] in 200-450 litres of water per hectare.

•

•

•

Use an application volume in the range 200 – 450 l/ha

Apply in 200 – 450 litres of water per hectare

Water volume: 200 – 450 litres of water per hectare

Apply as a medium quality spray (as defined by BCPC). A spray pressure of 2 – 3 bar is recommended.

•

•

•

Spray quality: medium spray (BCPC classification), using 2 – 3 bars

A spray pressure of 2 – 3 bars is recommended to give a medium quality spray, as defined by BCPC

Spray quality: BCPC medium spray

Thoroughly mix the pellets with the seed when filling the drill hopper, ensuring that they are evenly distributed throughout the seed

•

•

Mix pellets with the seed when filling the drill. Ensure an even distribution through the seed by mixing thoroughly

It is important to achieve an even distribution with the seed when applying [product] by admixture at drilling. Thoroughly mix the pellets and seed when filling the hopper

Mixing – Half fill the spray tank with water, add the required amount of [product] and agitate during completion of filling

•

•

Spray tank mixing instructions: Half fill the tank with water. Add the recommended amount of [product] and commence agitation. Top up tank to required level and continue agitation

Mixing instructions: Half fill the spray tank before adding the required quantity of product. Commence agitation before completion of filling.


5

The Labelling Handbook 5. Tank cleaning instructions ‘Approved Text’ Acceptable alternatives

Wash equipment thoroughly with water and liquid detergent immediately after use. Finally wash out twice with water and drain

•

•

Following use of the product, immediately wash out the spray tank with water and liquid detergent. Then wash twice more with water, and drain the tank

The spray tank should be washed as soon as possible after use. Thoroughly wash the tank with a mixture of liquid detergent and water. Carry out a further two washes with water and drain.

Wash out the sprayer thoroughly after use of [product], using a wetting agent or proprietary tank cleaner

•

•

Use a wetting agent or proprietary tank cleaner to thoroughly clean the sprayer after use

The spray equipment must be properly cleaned after application of the product. Use a wetting agent or a recommended proprietary tank cleaner (e.g. [product]).

6. Restrictions and warnings ‘Approved Text’ Acceptable alternatives

Do not treat broadcast crops as uncovered seed may be damaged

•

•

To avoid damage to uncovered seed, DO NOT treat broadcast crops

This product is not suitable for use on broadcast crops, due to the risk of damage to uncovered seed

Do not treat on crops grown for seed •

•

Not for use on seed crops

Do not use on crops being grown for seed

In common with many soil-applied pesticides the activity of [product] may be reduced in organic soils

•

•

Activity may be reduced in organic soils

The activity of this product may be reduced in soils containing more than 10% organic matter

Do not apply when the crop is wet or rain is imminent

•

•

Do not apply to crops with wet foliage, or if rain is expected

Do not apply is rain is expected or if the crop is already wet

Do not roll or harrow within a week of spraying •

•

Do not roll or harrow for seven days before or after spraying

Do not carry out cultivations (rolling, harrowing) +/- 7 days of spraying


6

The Labelling Handbook 7. Agronomic advice/general recommendations for use ‘Approved Text’ Acceptable alternatives

The purpose of spraying is to delay the 75% foliage blight development stage until after the full weight of tubers has been formed. With main crop varieties, bulking comes to an end in late September, so there is no point in preserving the haulm after this stage

• Treatment is carried out to delay the development of foliar blight until the end of bulking. With main crop varieties the full weight of tubers will have been formed by late-September; there is no point in continuing treatment after this stage

• For main crop varieties, bulking will be

complete by late-September and there is no point in preserving the haulm after this stage

Phoma leaf spot is spread by rainsplash and can be found from October onwards

• Phoma can be found from October onwards, and is spread by rainsplash

• Rainsplash is the principal mechanism by

which Phoma leaf spot is spread through the crop, and it is usually found from October onwards

8. Positive and convenience tank mixtures ‘Approved Text’ Acceptable alternatives

For improved control of [x] and residual activity, [product 2] may be added to [product] applications in a low dose post-emergence programme

•

•

Low dose post-emergence programme: Tank-mix with [product] 2 for improved control of [x] and residual activity

When using [product] in a post-emergence low dose programme, addition of [product 2] will enhance control of [x] and give residual activity

Compatibility: The following mixtures for use on cereals only are compatible provided they are sprayed at the dose and timing for each component

•

•

The following products are compatible with [product] when used in cereals. Note that each product must be applied within the recommended doses and timings.

Compatibility, cereals. The table below gives compatibility recommendations for [product]. All products must be applied within their approved recommendation for use


7


Part F

Avoidance of false and misleading statements 1. Obligations on applicants

In submitting the draft label text to PSD, and printing the final Product Label in line with any required amendments and the other requirements of this guidance, applicants must ensure that no false or misleading claims are included. This also applies to any ‘Other Text’ supplied with the product.

2. Examples of false and misleading statements

The following are examples of claims considered to be false or misleading and which must not be used. These are only examples for guidance and the range of such potential statements is not limited to those detailed below. If the applicant is in doubt as to whether a claim or statement is false or misleading, they should consult PSD

2.1 A false or misleading statement concerning the composition of the product. 2.2 A false or misleading statement concerning the effectiveness of the product as a

pesticide. 2.3 A false or misleading statement about the use of the product for purposes other than as

a pesticide. 2.4 A false or misleading comparison with other pesticides. 2.5 Any statement directly or indirectly implying that the pesticide is recommended or

endorsed by PSD, DEFRA or any other Government Department. However, the Product Label may carry either of the following phrases as appropriate: ‘This product is approved under The Control of Pesticides Regulation 1986’: or, ‘This product is approved under The Plant Protection Product Regulations 1995’.

2.6 A false or misleading statement that the product is endorsed by another organisation. 2.7 A true statement worded in such a way as to give a false or misleading impression to the

purchaser. 2.8 General claims as to the safety of the pesticide or its ingredients. This includes

statements such as ‘safe,’ ‘non-poisonous’, ‘harmless’ or ‘non-toxic to humans and pets’ (irrespective of whether a qualifying phrase such as ‘when used as directed’ also appears).

2.9 Comparative statements on the safety of the product, e.g.: ‘Contains all natural ingredients’ ‘Among the least toxic chemicals known’ ‘Safer than chemical pesticides’

07/06/2005 Part F: Avoidance of false and misleading statements 1

The Labelling Handbook 3. However, specific claims which do not fall within the above categories and which are

demonstrably true (i.e. supported by PSD’s safety and efficacy assessment) may be acceptable e.g.: ‘Children and pets may play on treated turf once dry.’

IF IN DOUBT AS TO WHETHER THE PROPOSED CHANGE FALLS WITHIN THE ACCEPTABLE CRITERIA, CONTACT PSD FOR ADVICE.

07/06/2005 Part F: Avoidance of false and misleading statements 2


Part G

Structure and layout of Product Label on the Container

1. Introduction 1.1 The Product Label is defined as the written, printed or graphic matter on, or attached to,

or accompanying the pesticide or any of its containers or wrappers. It can comprise information presented on the container itself (see paragraph 2 below), a separate or detachable leaflet (see paragraph 3 below) and any additional outer packaging or separate inner packs (see paragraph 4 below),

1.2 The following guidance sets out how the required label information (as set out in Part C)

must be attached to, or accompany, the container in which the product is sold and supplied. All final Product Labels must comply with this guidance unless specific cases have been agreed with PSD.

2. Text on Container Label 2.1 This is defined as any information printed directly onto the container or completely

and securely affixed to the container and must meet the requirements detailed below: 2.2 It must carry all the essential information for the user on safe handling of the product,

i.e. items specified in Part C/Annexes 1 to 3. 2.3 It should carry the Directions For Use (see Part C/Annex 4). However, where necessary

(e.g. due to space constraints), the Container Label may refer to Directions For Use supplied on a separate ‘Leaflet’ (see paragraph 3 below) e.g. ‘READ DIRECTIONS FOR USE ON ATTACHED LEAFLET’.

2.4 If necessary, the Container Label text may be arranged into two or more distinct areas of

the label, a Main Area and a Subsidiary Area. (e.g. a ‘Front’ panel and ‘back’ panel respectively). The following information should preferably appear in each Area. However, if space constraints dictate, other options are acceptable providing that all the information is visible to a user upon first handling the pack.

(a) Main Area

This should contain at least the following items relating to Product Identity and Safety Information (see Part C/Annex 1): • Product tradename; • Product registration number; • Formulation type; • Amount and name of the active substance; • Identity of any ‘dangerous’ co-formulants; • Biological use phrase; • Hazard symbol (see Part C/Annex 2/2.1).

07/06/2005 Part G: Structure and layout of Product Label on the Container 1


(b) Subsidiary Area

This should contain all other information required on the Container Label in Part C not conveyed on the Main Area.

2.5 The Container Label must be strong, durable and attached securely. These qualities

should be sufficient to meet all conditions under which the container is likely to be transported, stored and used. It should be resistant to both the contents of the container and of other substances with which it might be expected to come into contact. Refer also to paragraph 4.6.2 below for additional requirements for refillable container labels.

2.6 It must be in a prominent position and for ‘dangerous’ products, it must be so placed that

it can be read horizontally when the container is set down normally. 2.7 It must be the largest allowed by design of the pack and at least of the following

minimum sizes:

Container capacity Dimensions of label

* 3 litres or less

* not less than 52 x 74 mm





exceeding 500 litres


* If it is impracticable to comply with the dimensions for this pack size, the label should be as large as possible.

3. Text on separate Leaflet 3.1 This is defined as:

Any separate leaflet or booklet designed to accompany the container and which may be attached to the container (e.g. ‘fold-out’ leaflet) or be loose within the outer packaging of the container (e.g. separate booklet). It is part of the Product Label. It may be used where the Container Label has insufficient space to carry the DIRECTIONS FOR USE and must comply with the requirements detailed below:

3.2 A following phrase must appear on the leaflet:

‘This leaflet/booklet is part of the approved Product Label’. 3.3 All the information on safe handling for the user as detailed in paragraph 2 above must

be repeated in the leaflet (except that the Hazard Symbol may be printed in black on white) plus the Directions For Use.

3.4 The leaflet must be of a suitable quality and durability for the purpose.


The Labelling Handbook 4. Labelling different parts of the packaging 4.1 What other types of packaging have specific labelling requirements?

Where the product is not supplied in a single container (e.g. a liquid or solid formulation in a plastic container with no additional outer packaging) the requirements in paragraph 1 above apply. However, additional requirements will apply where the product packaging is more complex e.g.:

• The container includes a potentially removable inner liner. • Product is supplied in single or multiple packs within an outer container. • Product is packaged within sachets or water soluble sachets. • Product is supplied as a ‘twin-pack’ of two pesticides or a pesticide plus non-

pesticide. • Any other situation where a combination of packaging is used to deliver the product

to the end-user. 4.2 Labelling of outer packs 4.2.1 Any outer pack offered for sale or supply to the user must comply with the full label

requirements for the Container Label as set out in paragraph 2 above. 4.2.2 Labelling required under separate legislation related to the transport of product is not

covered by the Regulations. Applicants must ensure that any outer cartons used purely for transport comply with such legislation. However, any product offered for supply to users must comply with these labelling requirements for pesticides.

4.3 Labelling of inner containers 4.3.1 Where an outer pack contains one or more inner containers (e.g. sachets; water soluble

bags) intended to be removed from the outer pack during use, the inner(s) must also be labelled with the essential information for the user on safe handling as detailed in paragraphs 2.1 and 2.2 above.

4.3.2 Advice on the labelling of certain types of inner containers such as sachets and water

soluble packs where space is limited is given at Annex 1 to this section. applicants wishing to label such containers in any other way should discuss the issue with PSD.

4.4 Labelling of inner liners not intended to be removed

4.4.1 Inner liners should not be removable from a container (e.g. a polyethylene liner in a

cardboard outer for solid formulations), These differ to the ‘inners’ described in paragraph 4.3 above which are specifically intended to be removed during use. If an inner liner is potentially removable, a statement warning against removal from the container must appear on the Container Label (not in the Statutory Area or under Safety Precautions), e.g.:

DO NOT REMOVE INNER LINER

4.4.2 As a further precaution, such inner liners may in addition be labelled with essential information on safe handling i.e. items specified in Part C/Annexes 1 to 3.


The Labelling Handbook 4.5 Labelling of product containing two or more separate components (e.g.

‘twin-packs) Detailed guidance is presented in Annex 2 to this section on the labelling of a product consisting of two or more separate components to be applied as a tank-mix.

4.6 Labelling of refillable containers 4.6.1 The requirements for refillable container labels are identical to those for standard pack

types other than:

• Additional precautionary statements are required (see Part C/Annex 3/ Working Document 6).

• Specific advice for using refillable containers must be included on the label where appropriate.

4.6.2 In addition, applicants must check the condition and legibility of labels for refillable

containers each time the packs are re-filled. Where necessary new labels must be attached to the container.

IF IN DOUBT AS TO ACCEPTABLE FORMATTING, CONTACT PSD FOR

ADVICE.



Part G/Annex 1

Labelling of products supplied in Water Soluble Bags 1. Introduction 1.1 A water soluble bag or sachets should carry all the information required for the safe

handling of the product (items specified in Part C/Annexes 1 to 3). However, due to the potential size of such packs and impracticality of printing large amounts of information on PVA a reduced level of labelling may be acceptable.

1.2 The vital consideration in dealing with such packs is reducing the likelihood of a user

removing unlabelled packets from labelled containers long before use and then forgetting what they are. It is not permissible to package a quantity of unlabelled soluble packets in an outer container where they could be separated from the accompanying labelling. Each packet must bear identifying labelling on the PVA itself. If this is not feasible, the applicant should contact PSD to discuss the issue.

2. Labelling of Water Soluble Bags 2.1 The following minimum information has been considered acceptable for the water soluble

bag itself. Any application for such labelling will be considered on a case-by-case basis.

(a) Product tradename (b) Product registration number (c) The formulation type. (d) Name and amount of the active substance (e) Identity of any ‘dangerous’ coformulants (f) Phrases such as :

DO NOT TOUCH [WITH WET HANDS OR GLOVES] 1 DO NOT STORE USE IMMEDIATELY ENSURE ALL OTHER LABEL INSTRUCTIONS ARE FOLLOWED

2.2 Additional Safety Precautions are also required on any outer container in which the water

soluble bag is supplied to alert the operator to the hazards of touching the bag. DO NOT TOUCH WATER SOLUBLE BAG [WITH WET HANDS OR GLOVES] 1 PLACE WHOLE BAG DIRECTLY INTO THE SPRAY TANK

1 inclusion of the reference to ‘wet hands or gloves’ depends on whether the packaging is such that the actual bag does not need to be handled at all in order to be placed into the spray tank.

07/06/2005 Part G/Annex 1: Labelling of products supplied in Water Soluble Bags 5

The Labelling Handbook 3. Labelling of outer packaging

Outer packaging should carry all the information required for the safe and efficacious use of the product (see Part C and Part G). If the applicant wishes to label outer packs in any other way, it is essential that draft text is submitted to PSD for consideration. Any novel packaging type will be dealt with on a case-by-case basis. Possible scenarios include: • Single bag in protective outer - e.g. tear-open foil envelope containing each soluble

packet. The foil will require labelling but reduced labelling may be acceptable depending on the size of the foil pack and whether it is itself packaged in an outer container. (This foil envelope method has the added benefit of protecting the soluble packet from moisture which could cause shelf-life problems).

• Multiple bags in protective outer - e.g. ‘egg-box’ type of package where each packet

is enclosed in a depression with a tear-off top that seals each depression. The tear-off top may possibly carry required labelling.

Applicants should contact PSD for specific advice in such cases.

07/06/2005 Part G/Annex 1: Labelling of products supplied in Water Soluble Bags 6


Part G/Annex 2

Labelling of Multi-Packs 1. Introduction 1.1 Where two or more pesticide formulations in individual containers are packaged and sold

together for use as a tank-mix, this constitutes a new single product and requires an application for approval supported by all the relevant data requirements. Such products may be supplied as two or more separate packs within a single outer container, as a single container with two or more separate compartments, or any other acceptable system of packaging. A single MAPP number will be allocated to the whole product.

1.2 The use of the two or more components together must be fully considered for safety (risks

to consumers, operators, wildlife and the environment) and efficacy (effectiveness and crop safety), as well as the safety of handling each individual component prior to use and their individual physical/chemical properties.

1.3 The Product Label must fully explain the nature of the product and its separate

components and give full Safety Information and Directions For Use on handling and using both the individual components and the mixture. The labelling requirements in paragraphs 2 and 3 below apply (note that ‘Product’ refers to the combination of individual components marketed together).

2. Labelling requirements for two or more pesticides packaged

together 2.1 Tradename

The Product must have a single tradename and each of the individual component packs must be identified by separate names or codes (e.g. ‘Twin-Pack Insecticide’ containing ‘Component A’ and ‘Component B’).

2.2 Requirements for each component container

Each component container must:

(a) Carry both the tradename and MAFF/MAPP number of the Product and, less prominently, the name of the individual components (note: if an individual component is approved separately as a product in its own right, that MAFF/MAPP number must not appear as well).

(b) Be clearly labelled with the appropriate formulation type, active substance content,

other dangerous coformulants, hazard symbol and associated risk phrase, pack size and batch number (if appropriate) for that specific component.

(c) Carry all other information on Product Identity, the Statutory Area, Precautions and

Directions For Use for the product (rather than information specific to the individual components), i.e.:

07/06/2005 Part G/Annex 2: Labelling of Multi-Packs 7


(i) The other Product Identity information not detailed in (a) and (b) above which are appropriate to the product as a whole.

(ii) The Statutory Area will include the rates required for each of ‘A’ and ‘B’ plus

any other requirements for each individual component (clearly there will only be a single maximum number of treatments, latest timing etc for the use of the mixture on any one crop/situation).

(iii) The Safety Precautions must include all the relevant phrases for each

component without any identification of which component any specific phrase relates to. Where each component would separately be labelled with a different Safety Precautions phrase addressing the same area of risk (e.g. ‘harmful to fish…’ and dangerous to fish’), the ‘worst-case’ must be specified.

(iv) The Directions For Use must give the appropriate information for handling

the components and using them in mixture. Note that the same option for use of a separate Leaflet applies (as set out in Part G/paragraph 3).

(d) Where the individual components are supplied in a multi-compartment container, it

must be clear in which compartment each named component is in and the Container Label must clearly identify which information applies to which component.

2.3 Requirements for outer pack

Any outer pack within which the individual containers are packed must: (a) Explain that the product is composed of a number of named components. (b) Explain, specifically for each of the components, the appropriate formulation type,

active substance content, other dangerous coformulants, hazard symbol and associated risk phrase and pack size.

(c) Carry all the other information as listed in paragraph 2.2 above

3. Labelling requirements for pesticide(s) packaged with non-

pesticide(s)

Where a product compromises of one (or more) pesticides and is sold with a separately packaged non-pesticide (e.g. an adjuvant, dye, carrier) to be mixed prior to application of the product, the same labelling guidelines apply as set out in paragraph 2 above. The labelling required will depend on the nature of the non-pesticide product (e.g. adjuvant, solvent, dye). Applicants should contact PSD for specific advice in such cases.

07/06/2005 Part G/Annex 2: Labelling of Multi-Packs 8


Part H

Use of Artwork 1. Introduction It is acceptable to include artwork or graphics on the final printed label which did not

appear on the draft label considered by PSD. It is anticipated that such artwork may appear for various reasons especially in association with the Directions For Use section (e.g. to clarify the text) or as a marketing tool (e.g. product logos). PSD would encourage their use especially if they afford greater comprehension of the label text.

2. Acceptable graphics & symbols 2.1 Graphics and symbols are acceptable as long as:

(a) They do not obscure or crowd required label text or misrepresent the product. (b) They are not used instead of required text.

2.2 Subject to paragraph 2.1 above, examples of acceptable graphics and symbols include:

(a) Information on use presented in tabular form. (b) Diagrams of how to open product containers. (c) Graphics which display spray patterns of nozzles and/or application patterns and are

supported by the label text. (d) Pictures depicting appropriate personal protective equipment. (e) Pictures illustrating proper use. (f) Company and product logos.

3. Unacceptable graphics & symbols 3.1 Examples of unacceptable graphics and symbols include:

(a) Those which are unrelated to the use on the label, e.g.:

• A food/crop/situation pictured on a label which is not approved. • Pictures of people using a product without the required personal protective

equipment. • Pictures of a pest or weed not claimed to be controlled by the product.

07/06/2005 Part H: Use of Artwork 1


(b) Graphics and symbols which are misleading to the user, e.g.

• Pictures of children playing, • Symbols implying safety or non-toxicity, such as a red cross or a medical seal of

approval. • Pictures of use sites in a residence when the Product Label is limited to use in

commercial or industrial sites.

(c) Graphics or symbols which obscure or crowd required label text. (d) Graphics or symbols which are used instead of required label text.

3.2 Refer also to Part I/paragraph 2.3 which advises on the effects of label artwork on the

legibility of the text.

IF IN DOUBT AS TO WHETHER THE PROPOSED ARTWORK FALLS WITHIN THE ACCEPTABLE CRITERIA, CONTACT PSD FOR ADVICE.

07/06/2005 Part H: Use of Artwork 2


Part I

Legibility of Text 1. Introduction

The Product Label contains vital information on safety and efficacy aspects of the product and its use. It therefore essential that label text is legible and clearly laid out. The following sets out the minimum legibility requirements for the Product Label.

2. Legibility Requirements 2.1 Label size

The Container Label must be the largest allowed by design of the pack and preferable at least of a minimum size as specified in Part G/paragraph 2.7.

2.2 Text and background colours

Colours of Product Label background and text are at the discretion of the applicant. However, to ensure maximum impact, there must be adequate colour contrast of the print to the background, e.g. black print on white background. Other combinations which would make the text difficult to read should not be used (e.g. red on black).

2.3 Graphics

2.3.1 Use of graphics as part of the Product Label is at the discretion of the user (see Part H). 2.3.2 If graphics are used as part of the label background upon which text is superimposed, it

should not be of a colour or of such complexity to render illegible the overlying text. 2.3.3 Use of graphics should not take up excessive space so as to make the label text illegible

or difficult to read. 2.4 Font and font size 2.4.1 The largest possible typeface should be used in relations to the label size. PSD suggest

that:

• The minimum recommended type size is 6 point with 1 point bold – this should only be used if the pack size precludes any larger point.

• The typeface should be devoid of oddities and the lower case ‘o’ must meet the minimum standard size.

• Roman face should be used for all body of text with Gill sans or Helvetica being examples of a face with clarity when set in 6 point.

The applicant may choose other minimum standards providing the label remains legible to a user.

07/06/2005 Part I: Legibility of Text 1

The Labelling Handbook 2.4.2 Any other guidance on where certain text must appear larger than the surrounding text is

given in the guidance (e.g. for Risk Phrases in Part C/Annex 3/2.2).

2.5 Hazard symbol size

Minimum sizes of Hazard Symbols are set out in Part C/Annex 3/3.1.3. 2.6 Legibility of Product Label for refillable containers

Applicants must check the condition and legibility of labels for refillable containers each time the packs are re-filled. Where necessary new labels must be attached to the container.

2.7 Other requirements

Where appropriate, other sections in this guidance set further requirements for the printing of certain text with respect to size, bold-highlighting and capitalisation such that it stands out on the label. This must be complied with as appropriate.

IF IN DOUBT AS TO WHETHER THE LEGIBILITY FALLS WITHIN THE

ACCEPTABLE CRITERIA, CONTACT PSD FOR ADVICE.

07/06/2005 Part I: Legibility of Text 2


Part J

Company Advisory Information - Professional Product Label

1. What is Company Advisory Information? 1.1 A Company Advisory Information section may be supplied with professional

pesticide products only to provide additional information that the applicant wishes to appear on the Product Label but which is not required as part of the approval process and does need not appear on the Product Label. A full definition is provided in paragraph 1.2 below.

1.2 The term Company Advisory Information relates to information that:

(a) Is not required under Schedule 2 of the Plant Protection Products Regulations 1995;

(b) Is not required to appear on the Product Label as a condition of its sale and

supply; (c) Does not need to be supported by safety and efficacy data; (d) Does not contradict the ‘Approved Text’ or ‘Conditions of Approval’; (e) Is not required under any separate UK legislation.

1.3 Subject to the provisos laid down in paragraph 1.2 above, specific types of

information that may appear are:

(a) Additional Health and Safety information (see paragraph 4.1 below); (b) Additional phrases relating to the use of the product (see paragraph 4.2 below); (c) Other information not directly related to the approval, e.g. company disclaimers

(see paragraph 4.3 below). 1.4 The aim of providing the option of including Company Advisory Information is:

(a) To give applicants more scope in making changes to the label which may not actually be subject to regulatory control, and to make changes to certain information supplied with their products without the requirement for an application for approval (and the associated costs). By making this distinction between ‘approved’ and ‘advisory’ text, applicants would also be in a better position to simplify their Product Labels. The ‘Approved Text’ can be kept to a minimum, and the applicant would be free to decide on the appropriate amount and type of advisory information; and

(b) To improve clarity and user understanding of the label text without compromising

the safety and efficacy of the end use.

07/06/2005 Part J: Company Advisory Information - Professional Product Label 1

The Labelling Handbook 2. Location of Company Advisory Information 2.1 The Company Advisory Information may be supplied for professional products only as

follows:

(a) As a separate section to the ‘Approved Text’ on the Product Label (either Container Label or Leaflet); or,

(b) As a completely separate Leaflet, which would be referenced from the ‘Approved

Text’. (This could make it even easier for applicants to amend and update the information therein without the need to reprint the ‘Approved Text’).

In either case, this information still forms part of the Product Label, but its status as ‘Other Text’ must be made clear (see paragraphs 3.1 and 3.2 below).

2.2 The inclusion of Company Advisory Information is not compulsory. Applicants are

under no obligation to change the content and format of existing approved labels in line with this section.

3. Format of Company Advisory Information 3.1 The Company Advisory Information section should be clearly separated from the other

label information as specified in Part C. 3.2 The Company Advisory Information section must carry:

(a) A clear heading reading Company Advisory Information. (b) A clear statement that this section is not part of the Product Label under the

Control of Pesticides Regulations 1986 or the Plant Protection Products Regulations 1995 (as appropriate) and that it provides additional advice on product use at the discretion of the applicant.

3.3 There are no other specific formatting requirements although PSD suggest that the

section be structured for ease of use by the reader. 4. Content 4.1 Additional Health and Safety Information

Part C/Annex 3/Working Documents 3 to 7 detail the standard risk and safety phrases which must be placed in the Safety Precautions section of the Product Label. The phrases to be used depend on the classification of the product, the type of product, the container type and other aspects of the risk assessment. The Company Advisory Information section could be used to provide the following types of additional Health and Safety information where they are not specifically required by other Government Departments or other legislation.



(a) Disposal of product/container and spray washings Further advice on product/container disposal, beyond that specified in Part C/ Annex 3/Working Document 6 (e.g. standard phrases require that all washable containers should be labelled ‘WASH OUT CONTAINER THOROUGHLY/empty washings into spray tank, /and dispose of safely/dispose of safely as follows:’). Applicants should ensure that any additional advice on disposal which is not required on the Product Label is acceptable under any other UK legislation (e.g. Environment Agency may be able to advise).

(b) Fire precautions

Advice on fire precautions beyond the standard phrases specified in Part C/ Annex 3/Working Documents 1 and 2. (Working Document 2 requires that flammable substances must be identified as ‘EXTREMELY FLAMMABLE/ HIGHLY FLAMMABLE/FLAMMABLE/ EXTREMELY FLAMMABLE LIQUIFIED GAS’, as appropriate).

(c) First aid/medical treatment

Part C/Annex 3/Working Document 8 details the medical advice that must be given on labels depending on the type of product and its classification. Other advice may also be required by PSD depending on the specific product. Any additional advice would be considered to be Company Advisory Information.

4.2 Guidance relating to the use of the product

The Directions For Use section is an integral part of the Product Label (see guidance in Part C/Annex 4). The content of the Directions For Use must provide sufficient information for the end user to be able to apply the product safely and effectively, taking into account the requirements of Schedule 2 of the Plant Protection Products Regulations 1995. The Company Advisory Information should consist of additional advice that is not required as part of the ‘Approved Text’, and need not be supported by safety/efficacy data on, e.g. application equipment and on factors relating to general crop agronomy. It should consist of specific information relating to good practice, which applicants would want to highlight to ensure that the product is used efficaciously.

(a) Machinery calibration

Advice on calibrating specific types of equipment for pesticide application could be placed in the Company Advisory Information section. This would include conversion tables (e.g. for metric to imperial), and calibration charts (e.g. for relating nozzle output to forward speed, and for showing what areas will be treated by different amounts of product).

(b) Nozzle selection

The BCPC classification of spray quality (fine, medium, coarse) must appear in the ‘Directions for use’, where relevant (e.g. this would not be necessary for a pre-emergence herbicide). However, additional advice on nozzle type and nozzle selection could be provided in the Company Advisory Information section (See Section 1.2. ‘Definition’).



(c) Factors relating to product/crop agronomy

This component of the Company Advisory Information section should consist of advice on additional factors relating to the use of the product, e.g. general crop agronomy. This could include the following types of information:

• General agronomic advice

Advice on pest or crop biology, pest threshold levels, pesticidal mode of action and symptoms of pesticidal effect, where no specific claims are made. Examples would include ‘Phoma leaf spot is spread by rainsplash and can be found from October onwards’ and ‘[Product] contains [active substance], a broad spectrum fungicide’.

• ‘Good Agricultural Practice’ (GAP)

This could include standard GAP advice on cultural operations (such as rolling and harrowing) and general application advice (such as ‘Do not spray when frost is imminent’, ‘Do not allow spray swaths to overlap’ and ‘Do not apply to soils with more than 10% organic matter), where these phrases were not part of the ‘Approved Text’.

• Resistance Issues

General advice on resistance issues not specifically required under the conditions of sale and supply (See Section 1.2. ‘Definition’). An example of this would be ‘In order to reduce the risk of resistance developing, consider using products of different mode of action when carrying out repeat treatments’.

It would be impossible to provide a fully comprehensive list of the information that may be used on a label without supporting data. This is because the acceptability of a phrase will depend on the context in which it is to be used (i.e. the type of product/active substance, target pest and target crop). Additionally, a particular phrase may be used on the label without supporting data but might still be a condition of the approval, in which case the phrase would belong in the Directions For Use.

This consideration of label phrases in context rather than isolation forms the basis for decision making in PSD and is the reason why devising a set of standard label phrases could be unnecessarily restrictive. In drawing up labels applicants are encouraged to adopt a similar approach by first considering the basis for each label phrase used (e.g. it may be based on general knowledge for spray applications or based on data previously submitted for the active substance).

Part J/Annex 1 provides further examples of the types of phrases relating to the use of the product which would generally be considered to be Company Advisory Information.

4.3 Other information not directly related to use

This includes information such as company disclaimers and trademark agreements.


The Labelling Handbook 5. Checking and changing the content of Company Advisory

Information 5.1 Converting existing labels to include a Company Advisory Information

section

5.1.1 In the transitional period between use of the previous labelling guidance and this new Handbook, applicants may wish to amend their existing labels to move such ‘advisory’ information from the approved Directions For Use section to a new Company Advisory Information section. Whilst this option is intended to be at the applicants discretion (within the guidelines set out in Part J), it is considered that it may be difficult for the approval holder to differentiate between existing ‘Approved’ and ‘advisory’ text. It may not be clear from the approval which parts of the text were or were not considered to be supported by data at evaluation. Therefore, text that could be treated as ‘advisory’ for one product will not necessarily be so for another, e.g.

The advice ‘Avoid spray drift onto neighbouring crops’ would, for some active substances, be good practice and would be considered ‘advisory’. However, the same advice could be a fundamental condition of approval for certain herbicides which are active at particularly low concentrations.

5.1.2 Approval holders can amend their labels to include a ‘Company Advisory Information’ section in line with Part J without recourse to PSD. However, if required, and subject to an appropriate fee, PSD can be asked to check the content of a ‘Company Advisory Information’ section for compliance with Part J, either as part of an application or via a specific application. If applicants require a check of the ‘Company Advisory Information’ section, then they should request this clearly in their covering letter. Full details of the procedures by which this be actioned will be published shortly.

5.2 Subsequent changes to the Company Advisory Information section

5.2.1 Subject to the guidelines set out in this Handbook, applicants may make amendments to the Company Advisory Information components of a Product Label at any time, and without consulting PSD. Applicants must ensure that such changes do not conflict with the Conditions of Approval and do not go beyond the recommendations supported in the ‘Approved Text’.



Part J/Annex 1

Company Advisory Information - Examples The acceptability of a phrase (without data) will depend upon the context in which it is to be used (i.e. the type of product/active substance, target pest and target crop). This list is not designed to be exhaustive. There may be certain circumstances where some of the phrases listed below would need to be accompanied by supporting data and so would belong in the Directions For Use (See Section 1.2. ‘Definition’). Some of the phrases listed below are only relevant to certain products therefore would not be permitted if they were irrelevant to the product in question (e.g. instructions to ‘Mix well’ would not be applicable to products applied as granules, except those applied by admixture). 1. General agronomic advice (advice on pest and crop biology,

threshold levels, mode of action and pesticidal effect. (a) [Product] is a useful input for high yield wheat and winter barley growing systems. The

influence of [product] on growth will vary according to the crop and its stage of growth at the time of application.

(b) For severe infestations use a recommended pesticide (c) [Product] is a foliar acting herbicide. Leaf symptoms, being a reddening then yellowing

of foliage, are first seen on grass weeds but take longer to appear on broad-leaved weeds.

(d) In common with all protectant fungicides it is necessary to spray [product] before blight

appears in the crop. For this reason a regular spraying programme should be carried out (e) Root development and tiller production for autumn sown barley is largely determined in

the autumn of sowing (f) For information on threshold levels for treatment contact [your adviser] (g) Frit fly: Winter wheat crops following grass and late sown spring oats may be attacked.

Larvae damage the shoots causing the centre leaf to become yellow and die resulting in plant death or very weak growth

(h) Leatherjackets: Roots and stems are attacked at or below ground level and plants die-off

rapidly. Damage usually occurs between March and May but earlier attacks can be seen in some seasons

(i) Wheat bulb fly: Crops are usually attacked from mid-January to March. Centre leaves of

damaged plants turn yellow and die. (j) Eyespot is associated with second or subsequent winter cereal crops, but can be a

problem even after a one year break. Susceptible varieties, wet autumns, mild winters and early drilling all increase the risk of infection

(k) Diseases of oilseed rape can develop and spread very rapidly. It is therefore important

07/06/2005 Part J/Annex 1: Company Advisory Information - Examples 6


that crops are regularly inspected so as to detect sudden increases in disease levels. (l) Alternaria brassicae mainly develops through the spring and summer, especially

following hot humid weather (m) Phoma leaf spot is spread by rain and can be found from October onwards. (n) The spread of Sclerotinia is favoured by wet weather during flowering. (o) The purpose of spraying is to delay the 75% foliage blight development stage until after

the full weight of tubers has been formed. With main crop varieties, bulking comes to an end in late September, so there is no point in preserving the haulm after this stage

(p) [Product] is a protectant fungicide and will not control established disease 2. Application equipment (use and calibration of equipment, nozzle

selection, etc). (a) Application should be carried out with [application machinery] operating according to the

manufacturer’s instructions (b) The table below gives the amount of [product] required per 50 kg of seed to obtain the

correct dosage per hectare at differing seeding rates. (c) When the seed treatment machine throughput capacity has been determined, select the

appropriate vibrator and rheostat settings from the graphs below to admix the recommended proportion of [product]

(d) It is essential that safety guards are fixed to all potentially dangerous moving parts and

exposed chains (e) Unless otherwise specified, recommended nozzles are for use at 0.5m nozzle spacing.

For other nozzle spacings check manufacturer’s output charts for suitability (f) Use high clearance tractors with narrow wheels and crop dividers (g) Ensure that the sprayer is in good working order by paying particular attention to the

condition of the pump, hoses, nozzles or disc assemblies and pressure gauge. Replace damaged, worn or malfunctioning parts. Calibrate sprayer accurately.

(h) Adjust the boom height to give the correct height above target; alternate spray fans or

cones should meet just above the top of the crop. Even cover with a well mixed spray is essential for good results


The Labelling Handbook 3. ‘Good Agricultural Practice’ (a) Maximum benefit will be obtained where crop development is not restricted by

inadequate nutrition or by attack from pests and diseases (b) Clean application machinery before use (c) Ensure that the boom height is correctly adjusted (d) Do not apply to crops suffering from stress (e) Spray cones should overlap just above the top of the crop (f) Water volume should be maintained to ensure good coverage and contact with the pest (g) Good spray cover is essential to achieve optimum control. (h) Good spray coverage of soil and weeds is essential (i) The soil type should be accurately diagnosed as this determines the recommended rate (j) Allow foliage to dry before applying [product] after rainfall or irrigation (k) Avoid spraying during periods of drought/extreme temperatures/freezing conditions/rain

or if rain is imminent/low relative humidity (l) Ensure good coverage and penetration of the crop (m) Ensure that spray swaths do not overlap (n) Ears not emerged at the time of treatment will not be protected (o) [Product] should be applied to crops during good growing conditions at the correct timing (p) Where the soil is cloddy it is advisable to increase the volume of water (q) Weeds become less susceptible to [product] when their growth is restricted by natural

senescence or by drought, frost, high temperature, a covering of dust or flooding. Reduced control will occur if such conditions occur at, or immediately after, spraying

4. Resistance issues (a) ‘In order to reduce the risk of resistance developing, consider using products of different

mode of action when carrying out repeat treatments’

IF IN DOUBT AS TO WHETHER THE PROPOSED ADVISORY INFORMATION FALLS WITHIN THE ACCEPTABLE CRITERIA,

CONTACT PSD FOR ADVICE.



Part K

Safety Data Sheets 1. Safety Data Sheets (SDS) are provided with professional products under Section 6 of the

Health and Safety at Work Act. In the future, one of the consequences of the new Dangerous Preparations Directive 1999/45/EC will be the requirement for SDS to be supplied for pesticides under the Safety Data Sheets Directive (91/155/EEC). SDS will have to follow the 16 headings given in Article 3 of 91/155/EEC.

2. However, the supply of SDS is not required under the Regulations that govern

pesticides. They are therefore not checked by PSD and are not considered to form part of the Product Label.

3. The Product Label will include all relevant safety information to address the risk of the

product to operators and the environment during its use as a pesticide as directed. The SDS contains general hazard information on the active substance(s)/formulation which is not specific to use as a pesticide and therefore may appear to contradict information on the label (e.g. personal protective equipment on the SDS may be significantly different to that on the Product Label as the latter has been assessed specifically for use of the pesticide as intended).

4. The following phrase or similar should appear on the SDS (or the Product Label) to

clarify this fact:

[This Safety Data Sheet/ The attached Safety Data Sheet] * does not form part of the label approved under the [Control of Pesticides Regulations 1986/ Plant Protection Product Regulations 1995]*. Following the instructions on the pesticide Product Label for the specified uses should ensure that the product is used safely and efficaciously for those uses. * as appropriate

07/06/2005 Part K: Safety Data Sheets 1

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