The European Commission (ECHA) has recently added twelve new Substances of Very High Concern (SVHCs) to its REACH Authorization List, found in Annex XIV of the REACH Regulation. These latest additions take the total number of chemical substances that are subject to Authorization to 43.
The REACH Authorization process identifies chemical substances that can have serious adverse effects on human health and the environment, with the aim of substituting the most hazardous substances with less hazardous, more suitable alternatives.
Substances that are classified as:
- Carcinogenic, Mutagenic or Toxic for Reproduction category 1A or 1B according to the CLP Regulation (also known as CMRs),
- Persistent, Bioaccumulative and Toxic (PBTs),
- Very Persistent and Very Bioaccumulative (vPvB),
- Or substances considered to have an equivalent harmful effect,
Can be proposed by a Member State or ECHA (at the request of the European Commission) to be identified as SVHCs and placed on ECHA’s Candidate List.
ECHA regularly assesses substances on the Candidate List and will then submit recommendations to the European Commission on which substances should be included in the REACH Authorization List. Recommendations are primarily based on the information contained in the REACH Dossiers, therefore if you are a manufacturer or importer of chemicals which are subject to REACH registration, it is important that your dossiers are kept up to date.
12 New Substances
Following recent public consultation and review, twelve new substances have been added to the Authorization List. This means that after a given date, these substances will require authorization to be granted before they can be used or placed on the market.
The twelve substances are as follows:
- 1-Bromopropane (n-propyl bromide) [CAS No: 106-94-5]
- Diisopentylphthalate [CAS No: 605-50-5]
- 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich [CAS No: 71888-89-6]
- 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters [CAS No: 68515-42-4]
- 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear [CAS No: 84777-06-0]
- Bis(2-methoxyethyl) phthalate [CAS No: 117-82-8]
- Dipentylphthalate [CAS No: 131-18-0]
- N-pentyl-isopentylphthalate [CAS No: 776297-69-9]
- Anthracene oil [CAS No: 90640-80-5]
- Pitch, coal tar, high temp. [CAS No: 65996-93-2]
- 4-(1,1,3,3-Tetramethylbutyl) phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) [No CAS Number Available]
- 4-Nonylphenol, branched and linear, ethoxylated (substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof) [No CAS Number Available]
Under certain circumstances, substances subject to Authorisation can be placed in Annex XIV with various categories of use exempted from the authorisation process under Article 58(2) of REACH. This is the case where risks relating to the protection of human health or environment are properly controlled by specific, existing Community legislation. However, for all of the substances listed above there is no such legislation, so these twelve substances have no defined exempted uses or categories of uses.
If you are a chemical manufacturer, importer or downstream user of a substance included on the Authorisation List, you must be aware that these substances cannot be used or placed on the market after a given date – known as the Sunset Date – unless there has been an Authorisation applied for, and subsequently granted for a specific use, or if the use is exempted.
Further information on the last dates of application and sunset dates for the latest additions to Annex XIV of REACH can be found in the European Commission’s Official Journal publication.
It is imperative that companies supplying chemical substances or products containing the chemical substances included on the Authorisation List understand their legal obligations and the implications for their business.
At UL WERCS and Safeware Quasar we have a dedicated team of expert Regulatory Consultants who can offer support for organisations who would like more information relating to their legal obligations, Substances of Very High Concern (SVHCs), and complying with the REACH Regulations. Contact us to find out more.