EU Expands List of Substances Restricted Under REACH

The European Union (EU) has expanded its list of
carcinogenic, mutagenic or reprotoxic (CMR) category 1B substances in Annex

Published on December 14, 2021, Regulation (EU)
2021/2204 expands the list of CMR category 1B substances in each of the three
CMR categories falling under entries 28 to 30 of Annex XVII. The total number
of new substances is 29, which is broken down as:

  • Entry 28 Carcinogenic
    1B: 10 substances, including dibenzo[def,p]chrysene (a polycyclic aromatic
    hydrocarbon (PAH))
  • Entry 29 Mutagenic 1B:
  • Entry 30 Reprotoxic
    1B: 17, including diisooctyl phthalate (DIOP)

[if !supportLists]

Chemicals listed in entries 28 to 30 are 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, if there is no SCL, their general concentration
limit (GCL) under Regulation (EC) 1272/2008 ‘Classification, Labeling and
Packaging of Substances and Mixtures (CLP Regulation). 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.

These changes reflect newly classified CMR substances
under Regulations (EU) 2020/1182 and (EU) 2021/849, both of which amended the
CLP Regulation.

The effective dates for the new legislation are:

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

[if !supportLists]

SGS REACH Services

SGS keeps interested parties informed about
developments and changes to REACH regulations. Their expertise, combined with
consultancy services and experience in consumer product supply chains, provides
a central point of contact for global solutions. Learn more about SGS’s
REACH Services.


keep you up to date with the latest news and developments in the consumer goods
industry. Read the full EU Expands CMR Lists


here, to receive SGS SafeGuardS
direct to your inbox.

further information contact:

Dr. HingWo Tsang

Global Information and
Innovation Manager

Tel: (+852) 2774 7420





are SGS – the world’s leading testing, inspection and certification company. We
are recognized as the global benchmark for quality and integrity. Our 93,000
employees operate a network of 2,600 offices and laboratories, working together
to enable a better, safer and more interconnected world.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top