The lists of CMR substances under Annex XVII of REACH have been expanded. The provisions will be implemented in two phases, starting March 1, 2022.

SAFEGUARDS | Consumer ProductsNO. 165/21

 SG 16521 Chemical

Under entries 28 to 30 of Annex XVII of REACH, the use of carcinogenic, mutagenic or reprotoxic category 1A or 1B substances (CMR category 1A or 1B substances) is prohibited as substances, constituents of other substances or in mixtures, for the general public if their concentrations are equal to or greater than their specific concentration limits (SCL), or in the absence of an SCL, their generic concentration limits (GCL), under Regulation (EC) 1272/2008 ‘Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version to October 2021). The GCL is 0.1% for a carcinogenic category 1A or 1B substance, 0.1% for mutagenic category 1A or 1B and 0.3% for reprotoxic category 1A or 1B.

On December 14, 2021, the European Union (EU) published Regulation (EU) 2021/2204 to expand the list of CMR category 1B substances in each of the three CMR categories falling under entries 28 to 30 of Annex XVII of REACH. This latest addition reflects the new classification of CMR substances under Regulations (EU) 2020/1182 and (EU) 2021/849, both of which amended the CLP Regulation (SafeGuardS 122/20 and 76/21). This latest amendment incorporates a total of 39 new entries to entries 28 to 30 of Annex XVII of REACH.

There are two effective dates in the new legislation:

  • March 1, 2022 to reflect CMR substances adopted from Regulation (EU) 2020/1182
  • December 17, 2022 to reflect CMR substances adopted from Regulation (EU) 2021/849 

Highlights of Regulation (EU) 2021/2204 are summarized in Table 1

Entry number to 
Annex XVII of REACH

CMR Classification

Appendix 

Number of Substances Added 

 28  Carcinogenic 1B  2  10, including dibenzo[def,p]chrysene - a polycyclic aromatic hydrocarbon (PAH) 
 29  Mutagenic 1B  4  2
 30  Reprotoxic 1B  6  17, including diisooctyl phthalate (DIOP)

Table 1

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