Following the consensus reached by the REACH Committee on a series of restrictions on CMR substances, on February 10, 2012, the European Union published Commission Regulation (EU) No 109/2012 on its official website, amending paragraphs 28-30 of Annex XVII to REACH Regulation (EC) No 1907/2006. This regulation came into effect on June 1, 2012.
Annex XVII of the REACH Regulation, paragraphs 28-30, respectively added substances in Annex VI of the EU Regulation (EC) No 1272/2008-CLP, which are classified as carcinogenic in categories 1a and 1b, to Annex XVII of the REACH Regulation.
Annexes 1-6 of Annex XVII of the REACH Regulation
| appendix | describe |
| 1 | Article 28—List of Category 1A/1 Carcinogens |
| 2 | Article 28—List of Group 1B/2 Carcinogens |
| 3 | Article 29—List of Teratogenic Substances in Category 1A/1 |
| 4 | Article 29—List of Teratogenic Substances in Category 1B/2 |
| 5 | Article 30—List of Category 1A/1 Reproductive Toxic Substances |
| 6 | Article 30—List of Category 1B/2 Reproductive Toxic Substances |
This revision primarily targets clauses 28-30 of Annex XVII to the REACH Regulation, concerning restrictions on CMR substances. Key revisions include:
(1) A new Appendix 11 is added, concerning exemptions for special substances in items 28-30 of Annex XVII; if a date is specified in Appendix 11, the exemption applies to those prior to that date.
(2) In the preface of Appendix 1-6, add note B to note A and note C: Some substances (acids, bases, etc.) are presented in the form of aqueous solutions of different concentrations. Since their hazard varies with the concentration, these solutions need to be classified and labeled differently.
(3) Appendices 1, 2, 4, 5 and 6 of Annex XVII have been revised, and some substances have been updated, added and deleted.
Sources: European Union (2012-02-09) (Compiled by PIDC)