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Editor-in-chief:
Johanna Salomaa-Valkamo
Johanna Salomaa-Valkamo
Editor:
Päivi Jokiniemi
What to know about...REACH authorisation
The three-phase authorisation process begins when an EU Member State or ECHA proposes that a chemical be identified as a substance of very high concern (SVHC). This proposal is made public in 'the registry of intentions' to give advanced notice to industry and other stakeholders.
The proposal is published online and anyone can comment on it or add further information within 45 days. The proposal and the comments are then forwarded to ECHA's Member State Committee (MSC) to try to reach an agreement on whether it merits identification as an SVHC.
If the committee does not reach a unanimous agreement, the European Commission takes the decision. If no comments are made during the public consultation, the substance is automatically identified as an SVHC.
All SVHCs are included in the Candidate List. Being on the Candidate List brings legal obligations for companies manufacturing, importing or using the substance on their own, in mixtures or in articles. For example, suppliers of Candidate List substances have to provide their customers with a safety data sheet and suppliers of articles containing Candidate List substances have to provide safe use information to their customers and, upon request, to consumers.
Prioritising substances
ECHA then selects substances from the Candidate List and recommends that they be included in the Authorisation List. Priority is normally given to substances with persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties, wide dispersive use or high production volumes.
ECHA usually prepares a draft recommendation, which can include several substances, once a year. It is published online and can be commented on within 90 days of its publication.
After the public consultation ends, ECHA considers the comments and updates its draft recommendation. This updated draft recommendation will then go to the Member State Committee for its opinion. Based on the opinion of the MSC, ECHA finalises its recommendation and submits it to the European Commission. They take the final decision on which substances to include in the Authorisation List.
Applying for authorisation to continue using an SVHC
A substance included in the Authorisation List cannot be manufactured or used in the EU after the ‘sunset date' unless an authorisation is granted. Manufacturers, importers or downstream users can apply for authorisation to continue using an SVHC.
When an application is submitted, ECHA publishes information on uses applied for on its website and welcomes information on possible alternative substances or techniques for the specific uses. The consultation lasts for eight weeks.
ECHA publishes all the comments received and gives the applicants the possibility to respond publicly to the comments.
ECHA's Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) have 10 months to prepare their draft opinions. RAC assesses the risks arising from the use of the substance. This includes an assessment of the risk management measures described in the application, and if relevant, of the risks of possible alternatives.
SEAC assesses the socio-economic factors (impact on businesses, consumers and society) and the availability, suitability and technical feasibility of the alternatives included in the application.
Within three months of receiving the Committees' opinions, the European Commission prepares a draft decision on the application.
The final decision for granting (or refusing) the authorisation is published in the EU's Official Journal. The decision is subject to a time-limited review period. If authorisation is granted, companies have to comply with the obligations in the Commission's decision, such as implementing conditions or notifying ECHA of their use of the substance.
Inspiring substitution
The authorisation process encourages companies to search for safer alternatives to SVHCs. Substitution requires a thorough assessment of the entire production chain and an analysis of viable alternatives as well as research into the already available resources and tools. The actual decision to start using alternative substances or techniques can only be taken by the companies directly involved in the supply chain.
Companies seem to be replacing SVHCs with safer alternatives. For example, there are several SVHCs for which the latest application date has passed but no applications for authorisation have been submitted. This means that after the sunset date their unauthorised uses are no longer allowed within the EU.
Further information:
- Authorisation
- Registry of intentions
- Candidate List
- Authorisation List (Annex XIV of REACH)
- ECHA's web pages on substitution
 | Did you know? Substances of very high concern SVHCs are, for example:
The Candidate List currently has 163 substances. The Authorisation List has 31 substances. Authorisation applications so far ECHA has delivered 50 opinions on applications for authorisation to the European Commission. The Commission has issued 10 decisions:
Currently, 40 authorisation decisions are pending with the Commission. There are seven substances (musk xylene, MDA, DIBP, BBP, diarsenic pentoxide, TCEP and 2,4-DNT) for which the latest application date has passed and no applications for authorisation have been submitted. |
Text by Nedyu Yasenov
Top image: Three phases of REACH authorisation
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