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.
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
Number of Substances Added
|28||Carcinogenic 1B||2||10, including dibenzo[def,p]chrysene - a polycyclic aromatic hydrocarbon (PAH)|
|30||Reprotoxic 1B||6||17, including diisooctyl phthalate (DIOP)|
SGS keeps interested parties informed about the latest developments relating to the REACH regulation. Our expertise, combined with consultancy services and experience in consumer product supply chains, provides a central point of contact for global solutions. In the end, it’s only trusted because it’s tested. Discover more on our website, read our brochure and contact us if you would like to learn more about how SGS can support your REACH compliance activities.
For inquiries, please contact:
Dr. Hingwo Tsang
Global Information and Innovation Manager
t: (+852) 2774 7420
© SGS Group Management SA - 2021 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.