The European Chemicals Agency (ECHA) has recently launched a public consultation on proposals to identify nine new Substances of Very High Concern (SVHCs). If the proposals are accepted, these substances will be included in ECHA’s Candidate List, which may result in additional legal obligations for manufacturers and importers who supply these chemicals.
Substances of Very High Concern (SVHCs)
If a chemical substance has or may have serious and often irreversible effects on human health and the environment, either a Member State or ECHA (at the request of the European Commission) can make a proposal for it to be identified as an SVHC.
This proposal is prepared in accordance with Annex XV of REACH, and once published, will be open for public comment. The proposal and any comments are then passed on to ECHA’s Member State Committee who decide whether the substance should be identified as an SVHC. If the committee does not reach a unanimous agreement, the matter will be referred to the European Commission for a final decision. If a substance is identified as an SVHC it will be added to ECHA’s Candidate List.
When a substance is placed on the Candidate List, companies who supply the substance – on its own, in a mixture or when contained in articles – may have IMMEDIATE legal obligations, such as providing their customers with a Safety Data Sheet (SDS) or submitting a notification to ECHA.
More detailed information on the specific legal obligations for manufacturers and importers supplying substances which are included in the Candidate List can be found in a previous article we wrote on this issue.
What are the 9 potential SVHCs?
The substances, along with some examples of their uses, are as follows:
- 4,4′-isopropylidenediphenol (Bisphenol-A) (EC 201-245-8). Used in the manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing PVC and in the production of thermal paper. Bisphenol A is already included in the Candidate List due to its toxic for reproduction properties and its endocrine disrupting properties with effects on human health.
- Chrysene (EC 205-923-4). Not registered under REACH. Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.
- Benz[a]anthracene (EC 200-280-6). Not registered under REACH. Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.
- Cadmium nitrate (EC 233-710-6). Used in laboratory chemicals and for the manufacture of glass, porcelain and ceramic products.
- Cadmium hydroxide (EC 244-168-5). Used in laboratory chemicals and for the manufacture of electrical, electronic and optical equipment.
- Cadmium carbonate (EC 208-168-9). Used as a pH regulator and in water treatment products, laboratory chemicals, cosmetics and personal care products.
- Tricobalt tetraoxide containing ≥ 0.1% w/w nickel oxides (EC 215-157-2). Used in laboratory chemicals, pH regulators and in water treatment products, semiconductors, polymers and coating products.
- Dechlorane plus (including any of its individual anti- and syn-isomers or any combination thereof) (CAS 13560-89-9; 135821-74-8; 135821-03-3). Used as a non-plasticising flame retardant, used in adhesives and sealants and in binding agents.
- Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear] (No EC Number). Used as a lubricant additive in lubricants and greases.
ECHA has invited the public to comment on these proposals. The deadline for comments is 20th October 2017, and if you wish to submit a comment, you can do so here.
If the proposals are accepted, these substances will be added to the Candidate List, where they will eventually be considered for inclusion in the Authorisation List contained in Annex XIV of REACH.
ECHA regularly assesses substances on the Candidate List for inclusion in the REACH Authorisation List. Substances which are ultimately added to the Authorisation List cannot be placed on the market or used after a given date unless they meet specific authorisation requirements.
If you are a manufacturer or importer of potentially hazardous substances, you should be aware of the SVHC identification process and the potential legal implications for your business. At UL Safeware Quasar we have a dedicated team of expert Regulatory Consultants who have a comprehensive understanding of chemical regulations across the globe, and are constantly monitoring the regulations to help hundreds of companies sustain chemical compliance.
If you need any help understanding the chemical regulations impacting your business, contact us.
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