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Regulatory
Posted By:
Trace One
Importance of Restrictions
Restrictions are a tool to protect human health and the environment from unacceptable risks posed by some chemicals. Restrictions, described in Annex XVII of Regulation 1907/2006 (REACH), may limit or ban the manufacture, placing on the market or use of a substance. Restrictions to which substances are potentially subjected have to be reported in Section 15 of the SDS.
What do these new Regulations bring to the table?
Regulation 2021/1297 reintroduces Restriction 68, previously removed with Regulation 2020/2096, related to “Linear and branched perfluorocarboxylic acids of the formula CnF2n+1-C(= O)OH where n = 8, 9, 10, 11, 12, or 13 (C9-C14 PFCAs), including their salts, and any combinations thereof”. From February 25th 2023, these substances:
- Shall not be manufactured, or placed on the market as substances on their own.
- Shall not be used in, or placed on the market in another substance, as a constituent, a mixture or an article, except if the concentration is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances.
Regulation 2021/2030 introduces Restriction 76 related to N,N-dimethylformamide (CAS No 68-12-2, EC. No 200-679-5). From December 12th 2023, this substance shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures in a concentration ≥ 0,3 % unless:
- Manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, Derived No-Effect Levels (DNELs) relating to exposure of workers of 6 mg/m3 for exposure by inhalation and 1,1 mg/kg/day for dermal exposure.
- Manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified above.
Finally, Regulation 2021/2204 brings significant changes to Annex XVII, with the addition of some substances in Appendices 2, 4 and 6 with application date December 17th 2022 for some substances and March 1st 2022 for some others:
- 10 substances have been added to Appendix 2, Carcinogens: Category 1B
- 2 substances have been added to Appendix 4, Germ cell mutagens: Category 1B
- 17 substances have been added to Appendix 6, Reproductive toxicants: Category 1B
Trace One is already working on implementing and providing the update related to these new regulations.
For more information about the aforementioned Regulations amending the Restrictions of Annex XVII, follow the following links:
