REACH – Consequences of CLP

Lars S. Rasmussen, lsr@dhigroup.com

The Wercs 2009 Global User Group10-11 June 2009The Desmond Hotel, Albany, NY (WATER ● ENVIRONMENT ● HEALTH)

REACH and CLP

REACH

RegistrationEvaluation

AuthorisationRestrictions

Safety Data SheetsCommunication

RolesManufacturer

Importer

Formulator Distributor…etc.

CLPClassificationLabellingPackagingNotification

Note:CLP contains changesto the REACH regulation!…some January 20 2009…some December 1 2010…some June 1 2015

REACH (registration)

≈100.000

EINECS≈ 4.400

ELINCS

”Non problematicsubstances”

<1 ton/year

≈ 30.000

≈ 5.000≈1.400-2,000

≈ 4.400

ELINCS+EINECS

Authorisation

Evaluation /CSR

Registration

Before REACH After REACH (estimate)

(NLP ≈700)

REACH (classification)

EINECS≈ 1,700

ELINCS

Self-classification

Annex 1

Before REACH and CLP

≈2,700≈ 6,000

Not classified

REACH (classification)

EINECS ELINCS+

C&L Inventory

Harmonized list

After REACH and CLP

Not classified

Registration

C&L notification Dec 1 2010!

CLPstyle

Harmonized list of classifications

67/548/EEC

Annex 1

”Old”style

CLP Annex VI

Table 3.1 Table 3.2

Repealed

on

1/20 09

Annex 1 vs. CLP Annex VI

Annex 1 to 67/548/EEC:• All evaluated substances were added• Only competent authorities could apply• Most classifications were mandatory• Some partial classifications (oil/coal derived)• Specific concentration limits

Annex VI to CLP:• Generally only CMR and inhalation sensitizers will be added• Both competent authorities and industry can apply• Only the listed hazard classes are mandatory• = All classifications are partial !• Specific concentration limits

- but only for evaluated hazard classes

Example: Specific concentration limits

Hydrazine (Annex 1)R10 C≥25%: R45-23/24/25-34-43-50/53Carc.Cat.2;R45 10-25%: R45-20/21/22-34-43-51/53T;R23/24/25 3-10%: R45-20/21/22-36/38-43-51/53C;R34 2.5-3%: R45-43-51/53R43 1-2.5%: R45-43-52/53N;R50-53 0.25-1%: R45-52/53

0.1-0.25%: R45

Hydrazine (CLP Annex VI Table 3.2)R10 C≥10%: R34Carc.Cat.2;R45 3-10%: R36/38T;R23/24/25C;R34 R43 N;R50-53

M-factor must be assigned by classifier

(= M-factor 1)

The curious case of 30th and 31st ATP

67/548/EEC

Annex 1

30th ATP

31st ATP

CLPstyle

”Old”style

CLP Annex VI

Table 3.1 Table 3.2

In force oct 08

In force jan 09

Repealed

on

1/20 09

Directive =National implementation

Regulation =Immediately in force

? 1st ATP 1st ATPImplementationBy June 2009

Classification and Labelling Inventory

C&LInventory

ECHA

Old REACH Article 112 / CLP Article 39:(a) substances subject to registration;(b) Dangerous substances placed on

the market on their own or indangerous mixtures

Information required (CLP Article 40):a) Identity of manufacturer / importerb) Identity of substance(s)c) Classification of substance(s)d) If lack of classification in other hazard

classes is due to lack of datae) Specific concentration limits / M factorf) Pictograms, signal word, hazard

statements, other ”EUH” hazards

Classification and Labelling Inventory

Notclassified

Important!

EU manufacturer / importer isresponsible for classification ofsubstances – and notification to ECHA.

You cannot assume that a substanceis ”Not hazardous” / ”Not classified”just because the substance is not on the Harmonized List or in the C&L Inventory

When using the Conversion Table!

Old EU:Not

Classified

CLP:Not

Classified

REACH – Current topics

Lars S. Rasmussen, lsr@dhigroup.com

The Wercs 2009 Global User Group10-11 June 2009The Desmond Hotel, Albany, NY (WATER ● ENVIRONMENT ● HEALTH)

Current REACH topics – pre-registration & SIEF’s

0

10 000

20 000

30 000

40 000

01-Jun 01-Jul 01-Aug 01-Sep 01-Oct 01-Nov 01-Dec

Date

Ma

nu

al p

re-r

eg

istr

ati

on

s p

er

da

y

Current REACH topics – pre-registration & SIEF’s

Pre-Registrants

pre-SIEF / SIEF

Data and cost sharingAgreement on classification

Submission of Dossiers

Current REACH topics – pre-registration & SIEF’s

Roles in the SIEF:

1. Leader

2. Involved

3. Passive

4. Dormant

Current REACH topics – pre-registration & SIEF’s

1734

10360

28381326 2037

1120

289139

2

4922

3186350068 39540

1

10

100

1000

10000

100000

number of participants in a pre-SIEF

num

ber

of p

re-S

IEFs

Current REACH topics – Articles and SVHC’s

Substances of Very High Concern

Notification of SVHC substances in articles

free of charge, within 45 days

SVHC

≥0.1%

NOTE:If also >1 ton per year:Notification to ECHAbefore June 1 2011

Current REACH topics – The Safety Data Sheet

When is a Safety Data Sheet required:

REACH Article 31 up to 1 June 2015:a. Dangerous substances / mixturesb. PBT /vPvB substancesc. SVHC’s (if not covered by a or b)d. > 1% dangerous substance (Health or Envir.)e. > 1% substance with EU exposure limitf. > 0.1% PBT, vPvB or SVHC’s

REACH Article 31 after 1 June 2015:f. > 0.1% PBT, vPvB, SVHC, Carcinogenic cateogry 2, Reproduction toxic categories 1A, 1B and 2, skin sensitizers, inhalation sensitizers

Current REACH topics – The Safety Data Sheet

Special labelling phrase in 1999/45/EC: “Safety data sheet available for professional user on request”

Special labelling phrase in CLP: “Safety data sheet available on request”

Note! both phrase and criteria are different

Current REACH topics – The Safety Data Sheet

Concerns from industry on disclosure:

Section 3:

Name: CAS: EC-no.: REACH-reg.no.:Formaldehyde 50-00-0200-001-8 ??????-xxxx

Last 4 digits of the REACH registration numberidentifies the registratant.

= you cannot keep ‘origin’ confidential !

ECHA, Member States and Industry are workingtowards solution – expected September 2009.

Thank you for listening!

Lars S. Rasmussen, lsr@dhigroup.comVist www.reach.dhigroup.com

(WATER ● ENVIRONMENT ● HEALTH)

The Wercs 2009 Global User Group10-11 June 2009The Desmond Hotel, Albany, NY