24 Dec 2015
Consultation Launched with a View to Banning Use in the EU of Certain Chemicals in Batteries, Detergents and Other Products
The European Chemicals Agency (ECHA) has initiated a consultation for the inclusion of 11 chemical substances on the so-called Authorisation List under the REACH Regulation. The list, far from being one of chemicals that are generally authorised for use in Europe, is actually one which bans the placing on the market or the use of those substances. The misnomer may come from the fact that companies can ask for express authorisations to continue making use of the substance, which, if granted, would enable only them to do so for a limited time.
The aim of the authorisation process under REACH is to ensure that the risks from substances of very high concern (SVHCs) are properly controlled and that these substances are progressively phased out – i.e. from being placed on the EU market, and manufactured and used in the EU – and replaced by suitable alternatives where these are economically and technically viable.
On 18 November 2015, ECHA announced that it would like to receive comments on a proposal to include the 11 new substances on the List. Comments can be submitted by 18 February 2016. The List currently has 31 substances on it, set out in Annex XIV of the REACH Regulation.
ECHA considers recommending the following substances:
- Dihexyl phthalate and 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear: used as a plasticiser in PVC.
- HHPA and MHHPA: used as a hardener for epoxy resins.
- Trixylyl phosphate: used in lubricants, hydraulic fluids and plastics production.
- Two boron compounds: sodium perborate; perboric acid, sodium salt and sodium peroxometaborate: used in detergents and bleaching products.
- Four lead compounds - orange lead (lead tetroxide); lead monoxide (lead oxide); tetralead trioxide sulphate and pentalead tetraoxide sulphate: used in batteries and rubber production, in adsorbents.
Regarding the last bullet point above, the four lead substances were included in ECHA's previous draft recommendation of 2014. Comments that were submitted during the previous public consultation on the lead substances therefore do not need to be re-submitted.
Hong Kong sellers will need to take note of the fact that substances on the Authorisation List cannot be placed on the market or used after a so-called “sunset date” (each substance in the Annex XIV list has a sunset date). Unless specific exceptions apply, these substances may be placed on the EU market only if an authorisation has been granted (to individual companies) for a specific use, or the use has been exempted from the authorisation requirement. The European Commission decides on the granting or refusing of authorisations. Applications for authorisation can be prepared by manufacturers, importers or downstream users of a substance on the Authorisation List. The Annex XIV list provides the last date that applications can be made.
An authorisation will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. If the risk is not adequately controlled, an authorisation may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.
ECHA is seeking comments on the priority of the substances to be banned, their uses, possible exemptions, and the proposed transitional arrangements. The European Commission, for its part, is calling for information on the possible socio-economic consequences of including the 11 substances on the Annex XIV List.
Hong Kong companies may know that ECHA regularly recommends substances from the REACH Candidate List (currently containing 163 substances) for inclusion on the Authorisation List, to the Commission. The draft recommendation is based on an assessment of the data in registration dossiers that have been filed with ECHA and other available information, as well as an initial consultation with ECHA’s Member State Committee.
As for next steps, the Member State Committee will prepare an opinion on the draft recommendation, taking into account the comments received during the public consultation. Thereafter, based on the opinion of the Committee and the comments from the public consultation, ECHA will provide its final recommendation to the European Commission.
This will be ECHA's seventh recommendation for inclusion of a number of substances on the Authorisation List. The Commission will decide on which of the substances to include in the Authorisation List and on the respective conditions applicable for each substance (exemptions per substance may be provided on the list itself, which would then benefit all companies wishing to benefit from them).
Please click on the following link for further details of the consultation process (including how to submit comments): Draft recommendation for inclusion in the Authorisation List and public consultation.