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Unresponsive registrants of intermediates obliged to give more information
ECHA/NA/14/06
ECHA has started sending out legally binding letters to registrants who have registered their substances as intermediates, but have not responded to the Agency's requests to correct the inconsistencies found in their dossiers. Companies receiving the letter have one month to update their registration before ECHA sends the case to the Member States enforcement authorities.
Helsinki, 14 February 2014 – Following up on its IT screening on intermediate registrations and after analysing the current situation, ECHA has still identified 118 dossiers from 46 registrants who have not reacted to the Agency's earlier communication in any way. These registrations may be in breach of the REACH Regulation.
The Agency has now started regulatory action against the unresponsive companies. It will be sending out Article 36 letters requesting tonnage information for the uses that remain inconsistent with the intermediate definition or strictly controlled conditions as laid down in Articles 3, 17 and 18 of REACH. The registrants are obliged to update their dossier within one month by submitting a full registration, by reconsidering the reported uses or by providing information on the tonnage. In case a company provides the tonnage information, a compliance check will be initiated. ECHA will use the tonnage information to establish the information requirements for the non-intermediate use.
If no update is received by the deadlines set in the letters, ECHA will invite the national enforcement authorities to take follow-up actions.
As a result of the Agency's actions on intermediates, a total of 2 000 dossiers have been updated. Overall, this is a very encouraging result both for improving the safe use of chemicals and ensuring a level playing field on the European market.
To further support industry in improving the quality of their registrations, a new version of the Dossier Quality Assistant tool will be released later in February. This version contains improved checks on the use descriptor information in intermediate dossiers. The tool also incorporates new and improved checks on substance identity information, another area of the Agency's screening activities.
Summary of the actions taken and results achieved so far on intermediate registrations. The initial screening included approximately 5 500 dossiers:
|
Dossiers |
Representing number of substances |
Concerned number of registrants |
---|---|---|---|
Included uses that do not, or are very unlikely to, fulfil the definition of intermediates and/or strictly controlled conditions. Informal letters requesting updating sent. |
2 388 |
760 |
574 |
Final reminder sent |
172 |
116 |
62 |
Dossiers updated |
1 980 |
706 |
450 |
Updated to a full registration |
97 |
72 |
58 |
Updated the dossier but remained intermediate registrations |
1 883 |
680 |
432 |
Dossiers identified for further regulatory action |
118 |
77 |
46 |
Background
REACH allows intermediates manufactured and used under strictly controlled conditions to be registered with reduced information on their properties and without a chemical safety report. Workers, consumers or the environment may be adversely exposed to substances registered as intermediates that do not fulfil the definition of intermediates and/or strictly controlled conditions and for which information on their hazards and risks is missing in the registration dossiers. For this reason, ECHA is actively verifying the compliance of these type of dossiers using a combination of automated and manual evaluation processes.
Further information
- ECHA receives updates for intermediate dossiers and announces further follow-up actions, News alert 14 February 2013
- ECHA urges 574 registrants of intermediates to improve the quality of their dossiers, News alert 14 September 2012
- ECHA strengthens its compliance check strategy, News alert 17 September 2012
- Guidance on intermediates
- Guidance on information requirements and chemical safety assessment - Chapter R.12: Use descriptor system
- Dossier Quality Assistant tool (IUCLID 5 plug-in)
- National helpdesks and the ECHA Helpdesk