EU Regulatory Bulletin contents
- BPR amendments have been published in the EU Official Journal
- REACH authorisation & legal remedies
- EU Commission to propose rules on REACH data sharing
- ECHA's Board of Appeal decides on substance ID case
On 2 April 2014 ECHA's Board of Appeal (BoA) issued a decision on one of its most complicated cases to date. In particular, the appeal concerned a registration dossier submitted by the Polish firm Przedsiębiorstwo Produkcyjno - Handlowe UTEX for a product of the semi-dry absorption (SDA) method of flue gas desulphurisation.
First, the decision highlights important points relating to the general rules of registration and compliance check. The BoA makes it clear that it is the responsibility of the registrant to decide which substance it is required to register (registration strategy) and to act accordingly (e.g. by submitting compliant registrations). ECHA is responsible under the compliance check procedure for verifying whether the information provided by the registrant meets the requirements of the REACH Regulation. The Member State enforcement authorities are responsible for taking action if they consider that a manufacturer or importer has failed to register a substance in accordance with the REACH Regulation.
Second, in the context of this particular case, the decision clarifies the interpretation of the notions of ''substance'' and ''mixture'' with regard to the registration requirements under REACH.
Third, the BoA emphasises the key role ECHA plays in providing advice to registrants on their registration strategy and the information required to make a compliant registration.
In the appealed decision, the Agency had found that the Appellant's registration dossier contained information on more than one substance. The BoA decision confirmed that registration dossiers should contain information on only one substance. Nevertheless, the appeal was upheld as the Board considered that the ECHA decision appeared to direct the registrant as to the substance that should be included in the registration dossier, while this decision is the sole responsibility of the registrant.
This case illustrates the risks of ECHA directing a registrant in this way. According to the BoA, information made available during the appeal proceedings showed that ECHA's assumptions on the substance that the registrant needed to register may have been based on a false premise.
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