The authorisation procedure aims to progressively replace the use of potentially harmful chemicals with suitable alternatives as soon as it is technically and economically feasible to do so. Those seeking to use substances on the Authorisation List must apply for authorisation to continue to do so after the 'sunset' date beyond which the substance is legally permitted on the market.
Currently, 43 substances are included on the Authorisation List, which is set out in Annex XIV of the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH). The proposed addition of 18 new substances, if followed by the European Commission, will therefore amount to a significant extension, according to environmental law expert James Nierinck of Pinsent Masons, the law firm behind Out-Law.
James Nierinck
Associate
This will, if followed by the Commission, mark a significant addition to the Authorisation List, which as it stands contains only 43 substances.
"Industry should be aware that operations may be impacted by the upcoming Commission decision on whether to include these 18 substances in the Authorisation List," he said. "Potentially impacted sectors include those manufacturing, importing and using stabilisers (e.g. in polymers and PVC), epoxy resin, solvents, printing inks, flame retardants and paints."
The ECHA has published its recommendation to the Commission (14-page / 414KB PDF) setting out its 18 proposed additions to the Authorisation List, along with proposed latest application and 'sunset' dates. They include bisphenol A (BPA), which is used in the manufacture of polycarbonate plastics and epoxy resins; Dechlorane Plus, a flame retardant; and a number of stabilisers used in the production of polymers and PVC; among other substances.
Of the listed substances, 13 are toxic for reproduction, one of which also has endocrine disrupting properties. The others are an endocrine disruptor, a carcinogen, a very persistent and very bioaccumulative substance and two respiratory sensitisers.
The ECHA has prioritised these substances for authorisation due to their widespread use which, in combination with these properties, poses potential threats to human health or the environment. Some of these substances are not currently used in the EU, but have been included as they could otherwise be used as substitutes for other substances which the ECHA is proposing for inclusion.
The ECHA published a draft recommendation for consultation between September and December 2018. All of the substances included in its final recommendation were included in the draft regulation.
The European Commission will make the final decision on which of the recommended substances to add to the Authorisation List, in consultation with the relevant committees in each EU member state (comitology procedure). It will also specify transitional arrangements and, where relevant, exemptions and review periods.