1. REACH – Consequences of CLP Lars S. Rasmussen, lsr@dhigroup.com The Wercs 2009 Global User Group 10-11 June 2009 The Desmond Hotel, Albany, NY (WATER ● ENVIRONMENT ● HEALTH)

2. REACH and CLP REACH Registration Evaluation Authorisation Restrictions Safety Data Sheets Communication Roles Manufacturer Importer Formulator Distributor …etc. CLP Classification Labelling Packaging Notification Note: CLP contains changes to the REACH regulation! …some January 20 2009 …some December 1 2010 …some June 1 2015

3. REACH (registration) ≈100.000 EINECS ≈ 4.400 ELINCS ”Non problematic substances” <1 ton/year ≈ 30.000 ≈ 5.000 ≈ 1.400-2,000 ≈ 4.400 ELINCS+EINECS Authorisation Evaluation /CSR Registration Before REACHAfter REACH (estimate) (NLP ≈700)

4. REACH (classification) EINECS ≈ 1,700 ELINCS Self-classification Annex 1 Before REACH and CLP ≈2,700 ≈ 6,000 Not classified

5. REACH (classification) EINECSELINCS+ C&L Inventory Harmonized list After REACH and CLP Not classified Registration C&L notification Dec 1 2010!

6. CLP style Harmonized list of classifications 67/548/EEC Annex 1 ”Old” style CLP Annex VI Table 3.1Table 3.2 Repealed on 1/20 09

7. 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

8. Example: Specific concentration limits Hydrazine (Annex 1) R10 C≥25%: R45-23/24/25-34-43-50/53 Carc.Cat.2;R4510-25%: R45-20/21/22-34-43-51/53 T;R23/24/253-10%: R45-20/21/22-36/38-43-51/53 C;R34 2.5-3%: R45-43-51/53 R43 1-2.5%: R45-43-52/53 N;R50-530.25-1%: R45-52/53 0.1-0.25%:R45 Hydrazine (CLP Annex VI Table 3.2) R10 C≥10%: R34 Carc.Cat.2;R453-10%: R36/38 T;R23/24/25 C;R34 R43 N;R50-53 M-factor must be assigned by classifier (= M-factor 1)

9. The curious case of 30th and 31st ATP 67/548/EEC Annex 1 30th ATP 31st ATP CLP style ”Old” style CLP Annex VI Table 3.1Table 3.2 In force oct 08 In force jan 09 Repealed on 1/20 09 Directive = National implementation Regulation = Immediately in force ? 1st ATP Implementation By June 2009

10. Classification and Labelling Inventory C&L Inventory ECHA Old REACH Article 112 / CLP Article 39: (a)substances subject to registration; (b)Dangerous substances placed on the market on their own or in dangerous mixtures Information required (CLP Article 40): a)Identity of manufacturer / importer b)Identity of substance(s) c)Classification of substance(s) d)If lack of classification in other hazard classes is due to lack of data e) Specific concentration limits / M factor f)Pictograms, signal word, hazard statements, other ”EUH” hazards

11. Classification and Labelling Inventory Not classified Important! EU manufacturer / importer is responsible for classification of substances – and notification to ECHA. You cannot assume that a substance is ”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

12. REACH – Current topics Lars S. Rasmussen, lsr@dhigroup.com The Wercs 2009 Global User Group 10-11 June 2009 The Desmond Hotel, Albany, NY (WATER ● ENVIRONMENT ● HEALTH)

13. Current REACH topics – pre-registration & SIEF’s

14. Pre-Registrants pre-SIEF / SIEF Data and cost sharing Agreement on classification Submission of Dossiers

15. Current REACH topics – pre-registration & SIEF’s Roles in the SIEF: 1.Leader 2.Involved 3.Passive 4.Dormant

16. Current REACH topics – pre-registration & SIEF’s

17. 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 ECHA before June 1 2011

18. 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 / mixtures b. PBT /vPvB substances c. SVHC’s (if not covered by a or b) d. > 1% dangerous substance (Health or Envir.) e. > 1% substance with EU exposure limit f. > 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

19. 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

20. Current REACH topics – The Safety Data Sheet Concerns from industry on disclosure: Section 3: Name:CAS:EC-no.:REACH-reg.no.: Formaldehyde50-00-0200-001-8??????-xxxx Last 4 digits of the REACH registration number identifies the registratant. = you cannot keep ‘origin’ confidential ! ECHA, Member States and Industry are working towards solution – expected September 2009.

21. Thank you for listening! Lars S. Rasmussen, lsr@dhigroup.com Vist www.reach.dhigroup.com (WATER ● ENVIRONMENT ● HEALTH) The Wercs 2009 Global User Group 10-11 June 2009 The Desmond Hotel, Albany, NY