Authorisation is potentially the most impactful part of Europe’s chemicals management. It stands out as the ultimate chemicals risk management tool at the disposal of the European Union and its partners in the European Economic Area.
The pipeline toward Authorisation, starting with the identification of the relevant Substances of Very High Concern (SVHC) to be placed on the Candidate List, may have serious consequences for the industrial and commercial fate of a substance. The policy-makers’ objective is clearly to force a phase-out of the substance as soon as feasible and to encourage industry to opt for alternatives. A solid and credible dossier proving adequate control of the substance or demonstrating that the socio-economic benefi ts of continued use outweigh the risks to society is only a means to try and gain time, i.e. until the next review.
The REACH regulation sets criteria for identifying SVHCs that are generic, creating the impression that it is enough for a substance to be a carcinogen category 1a and 1b, for example, to be ‘identified’ as an SVHC and hence be put on the Candidate List for Authorisation. This is formally true and the first public consultation will be geared around the intrinsic properties of the substance under scrutiny, but the process is overall more selective and focuses on those substances that are considered to be relevant. On top of political priorities – some Member States focus on endocrine disruptors – elements such as identified risks, dispersive uses and tonnages enter the equation very quickly and there, industry input is of the utmost importance.For individual companies, Authorisation is a particular challenge as it shifts the debate from the intrinsic properties of a substance and the way risks are addressed the justification of continued use. Substance producers, those in Industry who were the most-closely involved with REACH up to now with substance Registration, cease to be the central players. The burden will now weigh more on the substance users who will ultimately have to get clearance for the substance in a particular use while the impact will be on the final industrial user. In some cases, the end user may not use the substance in itself but parts (articles) containing the substance or parts that were manufactured in a process involving the use of the substance.
For REACH consortia, strategic choices will have to be made regarding their future role. As the process leading to Authorisation starts with an evaluation of the quality and content of the Registration dossier, the first step is to check this dossier and to make sure it is up-to-date or improved if necessary.
Seen from the regulator’s perspective, the Authorisation process follows a series of logical steps, some of them purely technical, others more political, to which Industry needs to prepare itself. Regulators are eager to obtain data that can help them in making and justifying a decision. The combination of resource pressure and political agendas make it even more critical for Industry to prepare itself to be able to provide in a timely manner data that is relevant and substantiated.
As indicated throughout the document, each company will be faced with technical and business decisions at various stages of the Authorisation process. Its role and responsibilities will vary according to its status regarding the use of the substance: manufacturer, importer, downstream user, user of the article when contains the substance or has been manufactured with the substance.Taking stock of some of the extensive exploratory work performed by NI and the learning lessons from the first listings for Authorisation, this document will
- Describe the Authorisation process by addressing its key successive milestones
- Identify the relevant stakeholders and actors at each stage of the process
- Clarify the role of stakeholders and set the frame in which they’ll have to act
- Indicate what type of decisions will have to be taken, i.e. business or technical, and when
- Provide some guidance on the DOs and DON’Ts that experts have identified up to now as political avenues must sometimes be kept separate from the technical ones.
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