As every year, the month of January 2022 brought with it an update of the Candidate List for authorization. You will find the four substances concerned, their CAS numbers, and examples of uses in the table below:
Name of the substanceEC numberCAS numberReason for inclusionExamples of use6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol204-327-1119-47-1Toxic for reproduction (Article 57 c)Rubbers, lubricants, adhesives, inks, fuelstris(2-methoxyethoxy)vinylsilane213-934-01067-53-4Toxic for reproduction (Article 57 c)Rubbers, plastics, sealants(�)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)--Endocrine disrupting properties (Article 57 f - human health)CosmeticsS-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate401-850-9255881-94-8PBT (Article 57 d)Lubricants, greases
Interestingly, 4-MBC is the first substance added to the SVHC (Substances of Very High Concern) list as an endocrine disruptor for human health that has its primary use in cosmetics. This marks a turning point in the prioritization of substances by the European Commission.
ECHA also raises the fact that the list of SVHC substances now consists of 223 entries. However, many more substances are impacted as many of these entries concern groups of substances.
The list of candidate substances for authorization and your obligations
Each year, based on proposals and study dossiers submitted by the Member States, the European Commission adds new substances to the list of substances of very high concern (SVHC), usually in January and June or July.
This list includes substances that pose significant risks to human health or the environment, including:
- CMR substances (Carcinogenic, Mutagenic or Reprotoxic) of category 1A or 1B
- PBT substances (Persistent, Bioaccumulative and Toxic) or vPvB (Very Persistent and Very Bioaccumulative),
- substances, on a case-by-case basis, presenting a level of risk similar to that of CMR or PBT/vPvB substances.
Once a substance is added to the Candidate List, it will not be removed. The next step, at regulatory level, is the potential addition of the substance to Annex XIV of REACH. This means that the substance becomes subject to authorization. Its use will become prohibited in the European Union as of the sunset date without prior authorization by the European Commission.
Other obligations arise as a result of the addition of new substances to the Candidate List. In particular, manufacturers and assemblers of articles are required to declare on the SCIP notification portal the presence at more than 0.1% w/w of SVHC substances in their articles. To learn more about the SCIP declaration, please contact our experts, read our other articles or watch the replay of our dedicated webinar!
As every year, the month of January 2022 brought with it an update of the Candidate List for authorization. You will find the four substances concerned, their CAS numbers, and examples of uses in the table below:
Name of the substanceEC numberCAS numberReason for inclusionExamples of use6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol204-327-1119-47-1Toxic for reproduction (Article 57 c)Rubbers, lubricants, adhesives, inks, fuelstris(2-methoxyethoxy)vinylsilane213-934-01067-53-4Toxic for reproduction (Article 57 c)Rubbers, plastics, sealants(�)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)--Endocrine disrupting properties (Article 57 f - human health)CosmeticsS-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate401-850-9255881-94-8PBT (Article 57 d)Lubricants, greases
Interestingly, 4-MBC is the first substance added to the SVHC (Substances of Very High Concern) list as an endocrine disruptor for human health that has its primary use in cosmetics. This marks a turning point in the prioritization of substances by the European Commission.
ECHA also raises the fact that the list of SVHC substances now consists of 223 entries. However, many more substances are impacted as many of these entries concern groups of substances.
The list of candidate substances for authorization and your obligations
Each year, based on proposals and study dossiers submitted by the Member States, the European Commission adds new substances to the list of substances of very high concern (SVHC), usually in January and June or July.
This list includes substances that pose significant risks to human health or the environment, including:
- CMR substances (Carcinogenic, Mutagenic or Reprotoxic) of category 1A or 1B
- PBT substances (Persistent, Bioaccumulative and Toxic) or vPvB (Very Persistent and Very Bioaccumulative),
- substances, on a case-by-case basis, presenting a level of risk similar to that of CMR or PBT/vPvB substances.
Once a substance is added to the Candidate List, it will not be removed. The next step, at regulatory level, is the potential addition of the substance to Annex XIV of REACH. This means that the substance becomes subject to authorization. Its use will become prohibited in the European Union as of the sunset date without prior authorization by the European Commission.
Other obligations arise as a result of the addition of new substances to the Candidate List. In particular, manufacturers and assemblers of articles are required to declare on the SCIP notification portal the presence at more than 0.1% w/w of SVHC substances in their articles. To learn more about the SCIP declaration, please contact our experts, read our other articles or watch the replay of our dedicated webinar!
