EU - REACH Annex XVII CMRs
Restrictions On The Manufacture, Placing On The Market And Use Of Certain Dangerous Substances, Preparations And Articles - Carcinogens, Mutagens & Reproductive Toxicants
Substances restricted under REACH are divided into two lists in Pharos. REACH Entries no. 28-30 cover carcinogens, mutagens, and reproductive toxicants, and are included here. The other REACH Entries (1-27 and 31+) do not have explicit hazard endpoints and are included in another Pharos list: EU - REACH Annex XVII non-CMRs.
Entries no. 28-30have links to the relevant appendicies (described below) that list the actual chemicals that are included in this Pharos list.
The broader REACH restriction list (which is not caputerd here in full) was established as part of REACH (Regulation (EC) No 1907/2006) and replaces the 76/769/EEC.
REACH (Regulation (EC) No 1907/2006) is the chemical regulation system of the European Union. Part of what REACH does is to restrict the production, sale, and use of certain dangerous substances. Many substances had already been determined to be dangerous when REACH was created. These restricted substances are named here, in Annex XVII which also specifies the conditions for restriction and allowed uses of these substances, and certain labeling requirements. The list is periodically updated according to the regulations recorded on the website below.
The following sections of Annex XVII of REACH are referenced here in Pharos:
- Main: Substances subject to restrictions under certain conditions.
- Appendix 1: Carcinogens: Category 1A. There is sufficient evidence to establish a causal association between human exposure to a
substance and the development of cancer. These are substances which appear in Annex I to Directive 67/548/EEC classified as carcinogen category 1 and labelled at least as 'Toxic (T)' with risk phrase R45: 'May cause cancer' or risk phrase R49: 'May cause cancer by inhalation.'
- Appendix 2: Carcinogens: Category 1B. There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer, generally on the basis of:
- Appropriate long-term animal studies,
- Other relevant information. These are substances which appear in Annex I to Directive 67/548/EEC classified as carcinogen category 2 and labelled at least as 'Toxic (T)' with risk phrase R45: 'May cause cancer' or risk phrase R49: 'May cause cancer by inhalation. - Appendix 3: Mutagens: Category 1A.
There is sufficient evidence to establish a causal association between human exposure to a
substance and heritable genetic damage. These would be substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 1 and labelled with risk phrase R46: 'May cause heritable genetic damage.' (the appendix contains no substances) - Appendix 4: Mutagens: Category 1B. There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in the development of heritable genetic damage, generally on the basis of:
- Appropriate animal studies,
- Other relevant information. These are substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 2 and labelled with risk phrase R46: 'May cause heritable genetic damage.' - Appendix 5: Toxic to Reproduction: Category 1A.There is sufficient evidence to establish a causal relationship between human exposure to the substance and impaired fertility. and Substances known to cause developmental toxicity in humans. There is sufficient evidence to establish a causal relationship between human exposure to the substance and subsequent developmental toxic effects in the progeny. These are substances which appear in Annex I to Directive 67/548/EEC classified as toxic to reproduction category 1 and labelled with risk phrase R60: 'May impair fertility' and/or R61: 'May cause harm to the unborn child.'
- Appendix 6: Toxic to Reproduction: Category 1B. There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in impaired fertility on the basis of:
- Clear evidence in animal studies of impaired fertility in the absence of toxic effects, or,
evidence of impaired fertility occurring at around the same dose levels as other toxic
effects but which is not a secondary nonspecific consequence of the other toxic effects,
- Other relevant information and Substances which should be regarded as if they cause developmental toxicity to humans There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in developmental toxicity, generally on the basis of:
- Clear results in appropriate animal studies where effects have been observed in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the othertoxic effects,
- Other relevant information. These are substances which appear in Annex I to Directive 67/548/EEC classified as toxic to reproduction category 2 and labelled with risk phrase R60: 'May impair fertility' and/or R61: 'May cause harm to the unborn child.'
Note that although the text of the Annex defines Mutagen Category 3, there are no substances listed for Mutagen Category 3, in the Appendices.
Not included in Pharos:
- Azocolourants
- Items on the REACH list with no CAS number
- Many compound groups have not been populated.
old website: ec.europa.eu/enterprise/sectors/chemicals/reach/restrictions/index_en.htm