SAFEGUARDS | Consumer ProductsNO. 161/21
In the European Union (EU), entries 28 to 30 of Annex XVII of Regulation (EC) 1907/2006 ‘Registration, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH, consolidated version to October 2021) regulate carcinogenic, mutagenic and reprotoxic category 1A or 1B substances (CMR category 1A or 1B substances). These CMR substances are prohibited to be placed on the market, or used, as substances, as constituents of other substances or in mixtures for the general public when their individual concentration in the substance or mixture is equal to or greater than their specific concentration limit (SCL), or in the absence of an SCL, their generic concentration limit (GCL), under Regulation (EC) 1272/2008 ‘Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to October 2021).
In Switzerland, Annex 1.10 to the Chemical Risk Reduction Ordinance (ORRChem, SR 814.81, in French, German or Italian) regulates CMR category 1A or 1B substances with provisions similar to those falling under entries 28 to 30 of Annex XVII of REACH. In the event of amendments to Appendixes 1 to 6 under entries 28 to 30 of Annex XVII of REACH, Switzerland’s Federal Office of Public Health (FOPH), in agreement with the Federal Office for the Environment (FOEN) and State Secretariate for Economic Affairs (SECO), adapts those amendments to its national law.
In October 2021, Switzerland’s FOPH announced its intention to add 26 CMR substances to Annex 1.10 of its ORRChem – 18 substances are adopted from Regulation (EU) 2020/1182 (ATP-15 to the CLP Regulation, SafeGuardS 122/20) and 8 substances are adopted from Regulation (EU) 2021/849 (ATP-17 to the CLP Regulation, SafeGuardS 76/21). These 26 CMR substances consist of:
- 8 carcinogenic category 1B substances, including dibenzo[def,p]chrysene (CAS 191-30-0) - a polycyclic aromatic hydrocarbon (PAH)
- 2 substances that are both carcinogenic category 1B and mutagenic category1B
- 16 reprotoxic category 1B substances, including diisooctyl phthalate (CAS 27554-26-3) – a phthalate
There are two effective dates:
- March 1, 2022 for substances adopted from ATP-15 to the CLP Regulation
- December 17, 2022 for substances adopted from ATP-17 to the CLP Regulation
Both of the aforementioned effective dates are consistent with those in ATPs-15 and 17 to the CLP Regulation.
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