Over the recent years, the metals industry has gradually built its understanding of, and experience with, the process that leads to Authorisation. Because the legal criteria qualifying a substance for possible identification as an SVHC are so broad, NI took the decision to get prepared for any eventuality. The steps toward Authorisation were explored and analysed. NI developed its understanding and expertise in accompanying and organising the process (consultations and data gathering along value chains, input in Member State risk management option analyses) as well as in prioritisation scoring methodologies, the preparation of an analysis of alternatives and a socio-economic analysis. Test cases led to the publication of various guidance documents.
This document summarises some of the key points of these guidance documents, enriches them with some lessons from the first Authorisation cases and focuses on the role and challenges for each stakeholder. For example, metal producers are now confronted not only with the theoretical prospect of some of their products will be considered in the future for identification as an SVHC but also with the possibility of being users of substances that are on the candidate list, are being considered for prioritisation or are put on the Authorisation list.
It was at a late stage in the process that the metals industry fully realised the possible implications of the prioritisation of Refractory Ceramic Fibres. An intensive effort had to be deployed to raise the alarm, explain the issues and encourage participation in the Public Consultation on Prioritisation. But it was too late to collect data substantiating claims that scoring was too high and prioritisation was not necessary.
One of the primary objectives of REACH is to improve the knowledge of hazards of chemicals and risks associated with their use in order to ensure better risk management. As the acronym REACH indicates, there are three major steps to achieve that objective: Registration, Evaluation and Authorisation.
European countries concerned by REACH:
- The 28 EU Member States
- Iceland, Liechtenstein, Norway, as part of the Agreement on the European Economic Area.
Registration required from Industry (manufacturers and importers) to collect and collate specified data on the properties of those substances they manufacture or supply. This information is then used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled.
Evaluation describes the various checks and analyses that will be performed on the Registration dossiers. There are two main checks on top of the automated completeness check:
- Dossier Evaluation:
- Compliance checking: The quality of the information submitted by Industry is checked. This will be undertaken by ECHA and will be done on a sample (at least 5%) of dossiers submitted at each tonnage level.
- Testing proposal: For substances registered at the highest tonnage levels (≥1000 tonnes/annum) a proposal is made by the registrant detailing any animal tests they consider are required. ECHA will evaluate these testing proposals to prevent unnecessary animal testing.
- Substance evaluation: National Competent
Authorities perform an evaluation on substances that have been selected for potential regulatory action because of concerns about their hazardous properties, i.e. identified as Substances of Very High Concern. A key regulatory outcome of evaluation could be the imposition of restrictions on the manufacture, supply or use of a substance. Substance evaluation may also lead to a substance being added to the Priority List for Authorisation or a proposal to change the classification and labelling.
Substances identified as relevant SVHC will be considered for prioritisation, i.e. Authorisation.
A Member State may suggest a Restriction in order to put pressure on its peers and force the consideration of Authorisation or to address additional concerns such as imports of articles.
The REACH Authorisation process, starting with the identification of a relevant SVHC, requires an unprecedented mobilisation of all the actors in the substance’s supply chain and beyond. It is indeed the entire value chain linked to the use of the substance that may be affected and that needs to consider action.
There are existing structures that may help to get the process organised and running:
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