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2021-05-21
ProductIP
Intermediate

CMR Substances

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

What are CMR Substances?

CMR substances are chemical substances (or mixtures) of specific concern due to the long term and serious effects that they may have on human health. 

  • Carcinogenic stands for chemical substances having the potential to cause cancer.
  • Mutagenic stands for chemical substances causing a mutation (a change in the DNA of a cell). DNA changes caused by mutagens may harm cells and may result in serious diseases
  • Reprotoxic stands for chemical substances which may affect sexual function and fertility of adults, as well as causing developmental toxicity in the offspring. 

There is classification of CMR substances according to the International Agency for Research on Cancer (IARC) criteria on which European legislation regarding CRM substances is based.

The IARC categorising criteria for CMR substances are as follows:

 Category  Criteria
 1

 carcinogenic, mutagenic or reprotoxic to humans

 2A

 probably carcinogenic, mutagenic or reprotoxic to humans

 2B

 possibly, carcinogenic, mutagenic or reprotoxic to humans

 3

 not classifiable as to its carcinogenicity, mutagenicity or reproductive toxicity to humans

 4

 probably not carcinogenic, mutagenic or reprotoxic to humans

 

CMR substances in non food consumer products

CMR substances can be listed on the so called candidate list for authorisation of substances of very high concern (SVHC), however there is a large number of CMR substances which are not yet listed in the candidate list. Initiatives for listing a CMR substance as SVHC may come from the European Commission or one of the EU member states.

For non-food consumer products consisting of a container (packaging) with a chemical substance (such as glue, paint, detergents, etc.) all details regarding these chemical substances must be available. If the substance itself or one of the substances in the mixture is dangerous then the product must be classified, labelled and packaged according to the CLP Regulation. This European legislation is globally harmonised.

In the Classification and Labelling inventory database from REACH you can find all dangerous substances including CMR substances for which CLP legislation is applicable.

Category 1A and 1B

EU legislation subdivides CMR Category 1 into 1A and 1B. 

  • 1A stands for chemical substances for which there is scientific evidence based on humans that the substance is carcinogenic, mutagenic or reprotoxic; 
  • 1B stands for chemical substances for which there is scientific evidence based on animals that the substance is carcinogenic, mutagenic or reprotoxic. 

Not all CMR substances are restricted by REACH. Only CMR category 1A/1B substances listed in the table 3.1 of annex VI to CLP regulation.

REACH Annex XVII (the restriction list) entries 28, 29 and 30 restricts the use of CMR category 1A and 1B substances in products supplied to the general public (such as detergents, paints) and requires additional labeling for products intended for professional users.

CMR substances in articles that are not intended to be released (meaning that there is no direct exposure) are excluded from the restriction under REACH Annex XVII entries 28, 29 and 30.

REACH annex XVII entry 72 restricts the presence of CMR 1A and 1B substances in clothing or related accessoires, other textiles which come into contact with the human skin under foreseeable conditions and footwear.

The European Toy Safety Directive 2009/48/EC prohibits the presence of CMR substances from category 1A, 1B and 2 in toys.

CMR substances that are frequently used in solvents or as monomers of plastics may also be found in residual amounts if the materials or components processed in consumer products contain paint coatings, plastics, rubbers, adhesives, fibreboards, synthetic textiles, etc.  Consumers may be exposed to CMR substances present in all kind of consumer products through contact with skin or inhalation. A non-exhaustive list of examples of consumer products which might contain residual amounts of CMR substances are clothing & fashion articles, sportswear and (sport)bags, footwear, toys, automotive parts, DIY materials and tools.

Next to restrictions which apply to all CRM substances falling in categories 1A, 1B and 2 you have also several restrictions for specific CMR substances listed in other entries of REACH annex XVII.


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