REACH – Authorization: ECHA calls for consultation

A substance included in the Authorisation List (Annex XIV of REACH), can be placed on the market or used, after a given date, if and only if an authorisation is granted for a specific use. Companies can apply for authorisations should they need to place on the market and/or use a substance for which an authorization has been granted..

ECHA regularly recommends substances for inclusion in the Authorisation List to the Commission. These substances are selected among those belonging to the Candidate List of Substances of Very High Concern (SVHC). The draft recommendation is based on the assessment of the data in registration dossiers, any other available relevant information and an initial consultation with the Member State Committee. The draft recommendation specifies the conditions proposed for the authorisation requirement for every substance, including the sunset date. Registrations will be then checked again at the end of the public consultation to find out if any update has occurred.

On November 18th, ECHA launched a public consultation on 11 substances to be proposed for authorization, and invites comments on the priority of the substances, their uses, possible exemptions from the authorisation requirement and on the proposed transitional arrangements. Comments can be given by 18 February 2016 (three months consultation, as stated by the REACH regulation).

In the same three months, the European Commission calls for information on the socio-economic consequences, if any, of including these 11 substances in the Authorisation List.  Any information received on the socio-economic impact is passed on directly to the Commission and ECHA does not consider them in the recommendation process.

Once the public consultation goes to an end, the Member State Committee prepares an opinion on the draft recommendation taking into account, besides the other matters, the comments received during the public consultation. Based on the opinion of the Committee and the public consultation, ECHA will formulate its final recommendation, which will be the seventh, to the European Commission, which will then decide on which of the substances to include in the Authorisation List and on the respective conditions applicable for each substance. The authorization process is usually a long time process: from the public consultation to the EU Commision’s decision it takes at least 18 months.

The following substances are those ECHA considers recommending for the Authorisation List (examples of uses in brackets):

• Dihexyl phthalate EINECS 271-093-5 (plasticiser in PVC);
• 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear EINECS 201-559-5 (plasticiser in PVC);
• HHPA: Cyclohexane-1,2-dicarboxylic anhydrid [1] EINECS 201-604-9 cis-cyclohexane-1,2-dicarboxylic anhydride [2] EINECS 236-086-3, trans-cyclohexane-1,2-dicarboxylic anhydride [3] EINECS 238-009-9 [The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered by this entry] (hardener for epoxy resins);
• MHHPA: Hexahydromethylphthalic anhydride  [1] EINECS 247-094-1 Hexahydro-4-methylphthalic anhydride  [2] EINECS 243-072-0 Hexahydro-1-methylphthalic anhydride  [3] EINECS 256-356-4, Hexahydro-3-methylphthalic anhydride [4] EINECS 260-566-1. [The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry]. (hardener for epoxy resins);
• Trixylyl phosphate EINECS 246-677-8 (in lubricants, hydraulic fluids and plastics production);
• sodium perborate EINECS 239-172-9; perboric acid, sodium saltEINECS 234-390-0 (in detergents and bleaching products);
• sodium peroxometaborate EINECS 231-556-4 0 (in detergents and bleaching products). Nota: alla data del 01/06/2015l a sostanza non risulta ancora registrata secondo REACH;
• Orange Lead (lead tetroxide) EINECS 215-235-6 (batteries and rubber production, in adsorbents);
• lead monoxide(lead oxide) EINECS 215-267-0 (batteries and rubber production, in adsorbents));
• tetralead trioxide sulphate EINECS 235-380-9 (batteries and rubber production, in adsorbents));
• pentalead tetraoxide sulphate EINECS 235-067-7 (batteries and rubber production, in adsorbents).

It has to be noted that the last four substances were already object, among the other, of a public consultation in 2014 because of their inclusion in the 6th draft recommendation. It was concluded they were of high priority for being included in the final 6th recommandation, but at the end they weren’t because of “workload considerations” (sic).

Their unchanged priority makes them to be now listed within the 7th draft recommendation: this is why they are undergoing a new public consultation. Since all the information provided in the previous consultation were taken into account for assessing the substances in the new context, there is no need to submit the comments/information already given in 2014.

Source: ECHA