REACH Authorization List Expanded with the Addition of 5 New Substances of Very High Concern
The addition of five substances of very high concern (SVHCs) to the REACH Authorization List was recently announced by the European Chemicals Agency (ECHA). This addition brings the total number of substances on the list to 59.
Substances of Very High Concern
According to the ECHA, SVHCs must exhibit the following properties:
- “Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.”
- “Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII.”
- “Substances on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.”
Following its identification as an SVHC, a chemical may be added to the REACH Candidate List. Substances on the Candidate List are candidates for eventual inclusion on the Authorization List (REACH Annex XIV).
Authorization List and Process
The REACH Authorization List (REACH Annex XIV) includes chemicals that are subject to authorization under the REACH regulation. Authorization is intended to help control risks of high concern substances during their lifecycle.
The authorization process for chemicals, as noted by the ECHA, includes three key phases:
- Phase 1: Substances of Very High Concern (SVHCs)
- Phase 2: Recommendation for Authorization List Inclusion
- Phase 3: Authorization Application
Phase 1 – General Steps
- Member States indicate their intention to classify a substance as an SVHC.
- Corresponding SVHC dossier is prepared.
- Relevant interested parties may provide additional information and comments on the proposal.
- Provided no comments debate its suitability for identification as an SVHC, the chemical substance is added to the REACH Candidate List.
Phase 2 – General Steps
- Candidate List substances are reviewed to determine prioritized potential inclusion in the Authorization List.
- Substances are proposed for inclusion via draft recommendation.
- Draft recommendation is submitted for consultation and comments.
- Corresponding opinion on the recommendation is issued by the Member State Committee.
- ECHA sends recommendation to the European Commission.
Phase 3 – General Steps
- Application for authorization is prepared and submitted to the ECHA.
- Consultation is initiated on possible alternative substances, and parties may provide additional information and comments.
- Committee for Risk Assessment (RAC) and Committee for Socio-economic Assessment (SEAC) issue opinion(s).
- Decision is prepared by the European Commission and adopted by REACH Committee.
- If authorization is issued, the authorization holders must adhere to decision requirements. Authorization may be subject to further review.
- If use of the chemical substance is deemed necessary following the period of review, review report is submitted by the authorization holder.
Several reasons have been cited for recommended inclusion of the new chemicals on the Authorization List:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate – Considered to be reprotoxic.
- 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler's ketone or Michler's base – Regarded as carcinogenic.
- Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate – Considered to be reprotoxic.
- 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 – Regarded as endocrine disrupting.
- Tetraethyllead – Considered to be reprotoxic.
|Substance Name||EC Number||CAS Number|
|4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol [with ≥ 0.1% w/w of Michler's ketone or Michler's base||209-218-2||561-41-1|
|Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate||-||-|
|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||-||-|
Source: European Chemicals Agency
Additional Information on Authorization List Substances and More
A complete list of all Authorization List substances may be found on the European Chemicals Agency website.