by Dr. Martina Schneider
Commission Regulation (EU) 2020/171 was published on February 6 and updates Regulation (EC) No 1907/2006 (REACH) by adding 11 substances to the Authorisation list (REACH Annex XIV).
The newly added substances cannot be used in the future without an authorisation being granted by the EU. ECHA and the Commission decide on the authorisation per use. To apply for an authorisation, the following basic steps are needed:
- Check if you are affected by the authorisation requirement. Investigate if other actors in the supply chain intend to apply for authorisation.
- Consider the scope of your application and the number of uses and then start preparing your authorisation.
- Request a Pre-submission information Session with ECHA.
- Finalize and submit your application.
Manufacturers, importers or only representatives may also group together to prepare a ‘joint application’ for the uses of their downstream users.
Plan your steps on time
The entries in Annex XIV contain two important dates: the sunset date and the latest application date. The sunset date defines the date from which on it is prohibited to use the substance in the EU unless an authorisation has been granted. If companies want to continue the use of the substance after the sunset date, the application for authorisation must be submitted before the latest application date (set at least 18 months before the sunset date). If this has been done, companies will be able to use the substance, even though a conclusion on the application has not been published yet. To guarantee that you can make use of this transition agreement, ECHA actually recommends that you submit your application 3 months before the latest application date, in case there are issues with the business rule check that require a resubmission (ECHA Q&A ID 0572).
If you submit your application after the latest application date, you will only be able to continue the use after the sunset date once the authorisation has been granted. That means you will have to stop until the authorisation is granted. According to ECHA, a decision on the authorisation will take about 2 years (ECHA Q&A ID 0584).
The earliest application date for some of the newly added substances is August 27, 2021, which gives you less than 1 ½ years from now to prepare your application.
- Check if the newly added substances are part of your EU relevant portfolio.
- If they are, check if you are affected by the authorisation requirement.
- If you are affected, act now and develop an authorisation strategy if the substance cannot be replaced by a suitable alternative.
- Submit your application for authorisation early enough (3 months before the latest application date) to take advantage of the transition arrangement.
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Commission Regulation (EU) 2020/171: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020R0171
Regulation (EC) No 1907/2006 (REACH): https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32006R1907
- European Union
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