The Consortium currently has an extensive workplan relating to Authorisation. Four lead compounds – lead oxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate – were included in ECHA’s draft 7th priority list for Authorisation. The Consortium responded to the ensuing public consultation and debates by Member States, addressing four key concerns: prioritisation, scope of authorisation, transitional arrangements, and uses exempted from Authorisation.
The Swedish Chemicals Agency is expected to propose the identification of lead metal as a substance of very high concern (SVHC). The Consortium will actively defend against Candidate Listing in light of the existing framework of lead-specific EU legislation designed to manage risk.
The Consortium is assessing the most effective organisational structure for Applications for Authorisation (AfA), and will develop a specific AfA workplan, in the event that lead substances are included in Annex XIV to REACH. Subject to approval from the General Assembly, an AfA template would be prepared by the Consortium for use by all members that have paid relevant fees.
During 2018, the Consortium will also continue its advocacy work in partnership with relevant downstream user organisations for lead and lead compounds. The Consortium is also an active participant in the activities of the Eurometaux Authorisation and Restriction platform.
What is Authorisation?
Authorisation is one of two key REACH mechanisms designed to address chemicals of concern. It aims to identify and manage the risks from “substances of very high concern (SVHCs)”, substances which:
- meet the criteria for classification as carcinogens, mutagens, reproductive toxicants, or
- are persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with the criteria of Annex XIII to REACH, or
- pose an equivalent level of concern to human health or the environment.
Authorisation seeks to ensure that SVHCs are progressively replaced with safer alternatives. Once a substance is added to Annex XIV a sunset date will apply, after which it cannot be used or placed on the EU market without Authorisation unless an exemption applies.
Companies wishing to continue to use, import or supply the substance will need to make an Application for Authorisation (AfA), demonstrating either that the risks are adequately controlled or that the socio-economic benefits of continued use outweigh the risk. Applicants must also analyse whether there are safer suitable alternative substances or technologies and prepare substitution plans, or provide information on appropriate activities to research and develop such alternatives.
An Application for Authorisation can be made individually or collectively by a group of applicants. An AfA is much more comprehensive than a REACH Registration dossier, but some aspects will again require companies to have legitimate access to Consortium data. The AfA dossier will normally contain:
- Application summary
- Substance identity
- Applicant information
- Uses for which the AfA is made
- Chemical Safety Report
- Socio-economic analysis (optional, but recommended)
- Analysis of alternatives (optional, but recommended)
- Substitution plan (optional, but recommended where alternatives exist)
Subject to a review period, authorisation is granted by the European Commission, with input from Member States and ECHA. The Commission may amend or withdraw any authorisation on review if suitable substitutes become available.
Find out more about Authorisation.