LABELLING Mariana Mihalcea Udrea NATIONAL ENVIRONMEMTAL PROTECTION AGENCY BUCHAREST, SPLAIUL...

LABELLING

Mariana Mihalcea UdreaNATIONAL ENVIRONMEMTAL PROTECTION AGENCYBUCHAREST, SPLAIUL INDEPENDENTEI, 294, ROMANIA+4021 202 47 91+40 746 248 [email protected]

1

19/04/23 1

• to ensure a high level of protection of human health and the environment by:

the rules on labelling and packaging for hazardous substances and mixtures

• providing an obligation for suppliers Suppliers must label a substance or mixture contained in

packaging according to CLP before placing it on the market either when:

A substance is classified as hazardous. A mixture contains one or more substances classified as

hazardous above a certain threshold.• For manufacturers and importers of substances to notify the

ECHA of such classifications and label elements if these have not been submitted as part of a registration dossier under Regulation (EC) No 1907/2006;

19/04/23NATIONAL ENVIRONMEMTAL

PROTECTION AGENCY 2

The supplier shall ensure that a hazardous substance or mixture is labelled in accordance with Title III of the CLP Regulation before placing it on the market.The contact details of one / several suppliers must be included on the label. There can be more than one supplier of the same substance or mixture in the supply chain, e.g. in case a mixture has been supplied bythe formulator to a distributor who would supply it to third parties as well. CLP Article 17 does not specify whether the contact details of both suppliers are needed in such cases. Nor does it specify whether the

contact details of one particular supplier have precedence.


PROTECTION AGENCY 3

Substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:

Name, address and telephone number of the supplier(s);The nominal quantity of the substance or mixture in the package where this is being made available to the general public, unless this quantity is specified elsewhere on the package;Product identifiers, (Art.18);Hazard pictograms, (Art.19);The relevant signal word, (Art.20);Hazard statements, (Art.21);Appropriate precautionary statements, (Art.22);A section for supplemental information, (Art.25).


PROTECTION AGENCY 4

For substances shall consist of at least the following:

name and an identification number of substance included in Part 3 of Annex VI, or

name and an identification number as given C&L Inventory, or

number provided by the CAS together with the name set out in the nomenclature provided by the IUPAC, or the CAS number together with another international chemical name

19/04/23

NATIONAL ENVIRONMEMTAL PROTECTION AGENCY 5

For mixture shall consist of both of the following: the trade name or the designation of the mixture; the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. (unless more than four names are needed to reflect the nature and the severity of the hazards; the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements)

19/04/23


The label is updated, without undue delay, following any change to the classification and labelling of substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required under Article 25, taking into account the nature of the change as regards the protection of human health and the environment.

Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay.

Where labelling changes are required other than those referred to before, the supplier shall ensure that the label is updated within 18 months.

The supplier of a substance or a mixture within the scope of Regulation 1107/2009 or Regulation 528/2012 shall update the label in accordance with those Regulations


PROTECTION AGENCY 7

A mixture that is already placed on the market before 1 June 2015 does not need to be relabelled before 1 June 2017.

Once a product is in a warehouse, labelled and ready to use by final user, it is placed on the market .

This applies not only to a distributor, but any supplier up the supply chain.

In the case of a manufacturer’s warehouse, a sales contract should be available to claim that the product has already been made available to the customer before 1 June 2015.


PROTECTION AGENCY 8

Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally.

The colour and presentation of any label shall be such that the hazard pictogram stands out clearly.

The label elements shall be clearly and indelibly marked. They shall stand out clearly from the background and be of such size and spacing as to be easily read.

A physical label is not required when the label elements are shown clearly on the packaging itself

General rules for the application of labels (Art.31)General rules for the application of labels (Art.31)


PROTECTION AGENCY 9

In selecting the precautionary statements in accordance with Articles 22 and 28(3), suppliers may combine the Precautionary Statements, having regard to clarity and comprehensibility of the precautionary advice.Annex IV - Part 1: Criteria for the selection of precautionary statements

General rules for selection of “P”General rules for selection of “P”


PROTECTION AGENCY 10

CLP requirement (Article 32) Decision left to the discretion

of the supplier

The hazard pictograms, signal word, hazard statements and precautionary statements shall be kept together on the label..

The supplier is free to choose the arrangement of the pictograms.

Hazard statements shall be grouped together on the label while the order of the hazard statements can be chosen freely..

The supplier may choose whether these groups are to be presented on the left, on the right or elsewhere on the label.

Precautionary statements shall be grouped together on the label while the order of the hazard statements can be chosen freely.

The supplier may choose whether these groups are to be presented on the left, on the right or elsewhere on the label.

In case more than one language is used on thelabel, the hazard and precautionary statements ofthe same language shall be grouped together onthe label.

Where the supplier may choose whether toaccomplish this using fold-out labels, tie-on tags or on an outer packaging,

Any supplemental information as referred to in Article 25 shall be included in the section forsupplemental labelling

The supplier may choose how to visibly separatethis section from the section containing the labelElements and may also decide to place this information in more than one location on the label.



Mixtures containing leadThe label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the mixture, as determined in accordance with ISO standard 6503, shall bear the following statement:EUH201 — ‘Contains lead. Should not be used on surfaces liable to be chewed or sucked by children’In the case of packages the contents of which are less than 125 ml, the statement may be as follows:EUH201A — ‘Warning! Contains lead’

Specific rules for labelling of certain mixturesSpecific rules for labelling of certain mixtures



The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than (that specified in Table 3.4.6 of Annex I) ≥0,1 % shall bear the statement:

EUH208 — ‘Contains (name of sensitising substance). May produce an allergic reaction’.

Specific labelling rulesSpecific labelling rules



Liquid mixtures containing halogenated hydrocarbonsFor liquid mixtures which show no flashpoint or a flashpoint higher than 60 ⁰ C but not more than 93 ⁰ C and contain a halogenated hydrocarbon and more than 5 % highly flammable or flammable substances, the label on the packaging shall bear one of the following statements, depending on whether the substances referred to above are highly flammable or flammable:EUH209 — ‘Can become highly flammable in use’ orEUH209A — ‘Can become flammable in use’

Specific labelling rulesSpecific labelling rules



For mixtures not classified as hazardous but which contain: ≥ 0,1 % of a substance classified as skin sensitizer category 1, 1B, respiratory sensitizer category 1, 1B, or carcinogenic category 2, or ≥ 0,01 % of a substance classified as skin sensitizer category 1A, respiratory sensitizer category 1A, or ≥ one tenth of the specific concentration limit for a substance classified as skin sensitizer or respiratory sensitizer with specific concentration limit lower than 0,1 %, or ≥ 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation; or at least one substance in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures either:

— classified with other health or environmental hazards; or

— for which there are Community workplace exposure limits

the label on the packaging shall bear the statement:

EUH210 — ‘Safety data sheet available on request’.

Mixtures not intended for the general public



If a substance or mixture is classified within several hazard classes or differentiations of a hazard class, all hazard statements resulting from the classification shall appear on the label, unless there is evident duplication or redundancy.

Principles of precedence for hazard statements (Art.27)



Where the selection of the precautionary statements results in certain precautionary statements being clearly redundant or unnecessary given the specific substance, mixture or packaging, such statements shall be omitted from the label.

Where the substance or mixture is supplied to the general public, one precautionary statement addressing the disposal of that substance or mixture as well as the disposal of packaging shall appear on the label, unless not required under Article 22.

In all other cases, a precautionary statement addressing disposal shall not be required, where it is clear that the disposal of the substance or mixture or the packaging does not present a hazard to human health or the environment.

Not more than six precautionary statements shall appear on the label, unless necessary to reflect the nature and the severity of the hazards.

Principles of precedence for precautionary statements (Art.28)



The specific provisions on labelling laid down in section 1.3 of Annex I shall apply in respect of the following: (a) transportable gas cylinders; (b) gas containers intended for propane, butane or liquefied petroleum gas; (c) aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard; (d) metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers; (e) explosives, as referred to in section 2.1 of Annex I, placed on the market with a view to obtaining an explosive or pyrotechnic effect.



shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous has: physical properties:Unstable at the room temperature,Reacts violently with water, Flammable or occurs flammabilityExplozive, etc

or health properties:Liberates toxic gas in contact with water or with acids Repeated exposure may cause skin dryness or crackingToxic by eye contactCorrosive to the respiratory Tract

Supplemental information on the labelSupplemental information on the label



shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Directive 91/414/EEC / Regulation 1107/2009.

Label elements resulting from other Community actspursuant to Article 32(6):- authorisation number (REACH Reg.1907/2006)

- listing of specified constituents such as anionic surfactants, oxygen bleaching agents, enzymes, disinfectants, optical brighteners and perfumes (Detergent Reg. 648/2004)

- flammability labelling (aerosol dispenser Directive 75/234)

- content of volatile organic compound (VOC Directive 2004/42)

Supplemental information on the labelSupplemental information on the label



Statements such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not appear on the label or packaging of any substance or mixture.

information on the labelinformation on the label



Capacity of the package Dimensions of the label(in millimetres)

Dimensions of thepictogram (inmillimetres)

Maximum 3 litres: If possible at least52 × 74 Not small than 10 × 10 If possible at least, 16 × 16

> 3 litres but ≤ 50 litres At least 74 x 105 At least 23 x 23

> 50 litres but ≤ 500 litres At least 105 x 148 At least 32 x 32

> 500 litres At least 148 x 210 At least 46 x 46

19/04/23

the label size and the size of the pictograms should remain proportional to the size of the packaging


GHS01

GHS06

GHS02

GHS07 GHS03

GHS04 GHS08

GHS05 GHS09

.



The pictograms are provided free of charge for download from the website

http://www.unece.org/trans/danger/publi/ghs/pictograms.html

An example pictogram is the exclamation mark (pictogram GHS07), which is assigned to various health hazard classes and categories of lower severity GHS07

For physical hazards- For substances and mixtures classified for more than one hazard,

GHS01 mandatory GHS02 optional GHS03 optional

if the hazard pictogram ‘GHS01’ applies, the use of the hazard pictograms ‘GHS02’

and ‘GHS03’ shall be optional, except in cases where more than one of these hazard

pictograms are compulsory; namely for substances and mixtures classified as

self-reactive Type B or as organic peroxide Type B



For physical and health hazards / if the label carries the pictogram GHS02 or GHS06 then GHS04 is optional :

or

GHS02 GHS06 GHS04

mandatory mandatory optional

For health hazards, if the label carries the pictogram GHS06 then GHS07 shall not appear:

GHS06 GHS07

.



For health hazards, if the label carries the pictogram GHS05 (corrosion), then

GHS07 (exclamation mark) shall not be used for skin or eye irritation …

GHS05 GHS07

… but still has to be used for other hazards

if the label carries the pictogram GHS08 (health hazard) for respiratory sensitisation, then GHS07 shall not be used for skin sensitisation or for skin or eye irritation …

… but still has to be used for other hazards.



For health hazards,

In case a substance or mixture is assigned the supplemental hazard statement

EUH071 (“Corrosive to the respiratory tract”), a corrosivity pictogram (GHS05) may be assigned. In that case the pictogram GHS07 for STOT, single exposure, category 3 (respiratory tract irritation) can be omitted from the label, as well as the hazard statement H335 (“May cause respiratory irritation”)sensitisation or for skin or eye irritation …

GHS05 GHS07 ( STOT SE cat3 )

For substances and mixtures that have to be labelled both in accordance with the

CLP Regulation and with the rules on the transport of dangerous goods, the CLP

pictograms may be omitted from the label where a similar transport pictogram

appears,



A signal word indicates the relative level of severity of a particular hazard in accordance with the classification of the hazardous substance or mixture:more severe hazards require the signal word ‘danger’ less severe hazards require the signal word ‘warning’

Where a substance or mixture is classified for more than one hazard, the label shall only bear one single signal word. In such cases, the signal word ‘danger’ takes precedence.

the label shall include the hazard pictogram corresponding to the most severe hazard category for each relevant hazard class.



1. Physical proprieties

EUH 001 Explosive when dryEUH 006 Explosive with or without contact with air

EUH 014 Reacts violently with water

EUH 018 In use, may form flammable/ explosive vapor-air mixture

EUH 019 May form explosive peroxides

EUH 044 Risk of explosion if heated under confinement



EUH 029 Contact with water liberates toxic gasEUH 031 Contact with acids liberates toxic gas

EUH 032 Contact with acids liberates very toxic gas

EUH 066 Repeated exposure may cause skin dryness or cracking

EUH 070 Toxic by eye contact

EUH 071 Corrosive to the respiratory tract



EUH 201 Contains lead. Should not be used on surfaces liableto be chewed or sucked by children

EUH 201A Warning! Contains lead. (for packaging content lessthan 125 ml)

EUH 202 Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children.

EUH 203 Contains chromium (VI). May produce an allergic reaction

EUH 204 Contains isocyanates. May produce an allergic reaction

EUH 205 Contains epoxy constituents. May producean allergic reaction (M <700)

EUH 206 Warning! Do not use together with other products. May release dangerous gases (chlorine) (public use)



EUH 207 Warning! Contains cadmium. Dangerous fumesare formed during use. See information supplied by themanufacturer. Comply with the safety instructions.

EUH 208 Contains (name of sensitizing substance). Mayproduce an allergic reaction

EUH 209/209A Can become highly flammable in use / Can become flammable in use

EUH 210 Safety Data Sheet available on request (not for public use)

EUH 401 To avoid risks to human health and the environment, comply with the instructions for use



`

EUH 059 Hazardous to the ozone layer



The suppliers have to select precautionary statements according to CLP Art.21 provisions and considering Parts. 2-5 of Annex I, as well

H2xx – physical hazardH3xx - health hazardH4xx – environmental hazard

19/04/23


The suppliers have to select precautionary statements according to CLP Art.22 and 28 provisions and considering Part.1 of Annex IV, as well.

Suppliers: manufacturers or importers of substances, importers of mixtures; downstream users of substances or mixtures (including formulators), distributors (including retailers) of substances or mixtures, and producers or importers of explosive articles as defined in Part 2.1 of

Annex I to CLPP1xx – general

P2xx - prevention

P3xx – response

P4xx – storage

P5xx – disposal

19/04/23


derogations for packaging which is so small or in such a shapeor form or that it is impossible to meet the requirements of Art. 31:label elements may be provided either on: fold-out labels, / tie-on tags - shall meet the same performance

standards as a normal label outer packaging

19/04/23


CLP labelling is normally required on every inner and intermediate layer of the packaging of a substance or mixture; it may also appear on an outer packaging.

Transport labelling will have to appear on the outer packaging of hazardous substances and mixtures if these are “dangerous goods” according to the rules on the transport of dangerous goods.

Single packages need to carry both the CLP label elements and the transport labelling, except for the CLP hazard pictograms where these are already covered by equivalent transport pictogram reflecting the same hazard.



Transportable gas cylinders, with a water capacity of less than or equal to 150 litres:

format and dimensions following the prescriptions of the current edition of Standard ISO 7225 relating to ‘Gas cylinders — Precautionary labels’

Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard

Metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers

Explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect



The hazard statements and the precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:the contents of the package do not exceed 125 ml; andthe substance or mixture is classified in one or more of the following hazard categories:

1) Oxidising gases of category 1;2) Gases under pressure;3) Flammable liquids of category 2 or 3;4) Flammable solids of category 1 or 2;5) Self-reactive substances or mixtures Types C to F;6) Self-heating substances or mixtures of category 2;7) Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3;



8) Oxidising liquids of category 2 or 3;

9) Oxidising solids of category 2 or 3;

10) Organic peroxides Types C to F;

11) Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public;

12) Skin irritation of category 2;

13) Eye irritation of category 2;

14) Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public;

15) Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public;

16) Hazardous to the aquatic environment — Acute of category 1;

17) Hazardous to the aquatic environment — Chronic of category 1 or 2.



The precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:

(a) the contents of the package do not exceed 125 ml; and(b) the substance or mixture is classified in one or more of the following hazard categories:

1) Flammable gases of category 2;

2) Reproductive toxicity: effects on or via lactation;

3) Hazardous to the aquatic environment — Chronic of category 3 or 4.



The pictogram, the signal word, the hazard statement, and the precautionary statement linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:

(a) the contents of the package do not exceed 125 ml; and(b) the substance or mixture is classified in one or more of the following hazard categories:1) Corrosive to metals.



Labelling of soluble packaging for single useThe label elements required by Article 17 may be omitted where:

a) The content of each soluble packaging does not exceed a volume of 25 ml; (b) The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories presented previous 4 slides and (c) The soluble packaging is contained within outer packaging that fully meets the requirements of Article 17

The before provisions shall not apply to substances or mixtures within the scope of Regulation 1107/2009 or Regulation 528/2012.



Thank you for attention !



LABELLING Mariana Mihalcea Udrea NATIONAL ENVIRONMEMTAL PROTECTION AGENCY BUCHAREST, SPLAIUL...

Documents

Transcript of LABELLING Mariana Mihalcea Udrea NATIONAL ENVIRONMEMTAL PROTECTION AGENCY BUCHAREST, SPLAIUL...