On 27 July 2015, the ECHA Board of Appeal adopted an important and a first of its kind decision (Case A-019-2013) with regards to the legal nature of the so-called statement of non-compliance (SONC) issued by ECHA under the REACH Regulation. The appellant in the proceedings before the Board of Appeal, for whom the decision is favourable, is Solutia Europe, represented by the fieldfisher team led by partner Claudio Mereu.
By way of factual background, the case concerned a substance N-(1,1-dimethylethyl) bis (2-benzothiazolesulfen) amide) previously notified under the Dangerous Substances Directive 67/548/EEC, which was considered as registered for the purposes of REACH, pursuant to Article 24(1) of REACH. In response to a request for further information from the Belgian authorities, the appellant provided a dossier update including a read across adaptation. ECHA subsequently issued a SONC to the Belgian authorities indicating that the registration was non-compliant. In its decision, the Board of Appeal annulled the SONC as it found that ECHA had in practice adopted a fresh decision on the basis of substantial new information provided by the appellant, without following the procedure and applying the procedural guarantees provided by Articles 50 and 51 of REACH.
In essence, the Solutia case sets an important precedent because the Board of Appeal made the following important conclusions having far-reaching implications for the way in which ECHA handles the decision-making process under REACH:
- Where it involves an assessment of substantial new information, a SONC is not merely a non-binding communication to the Member States enforcement authorities (as claimed by ECHA) but a formal, follow-up decision of ECHA within the meaning of Article 42(1) of REACH and in conjunction with Articles 41 and 51 of REACH. This legal interpretation is a crucial one, since REACH has not been clear on the legal status of a SONC up until now.
- As a formal decision, a SONC is challengeable on condition that, it is not a simple confirmation of the first decision adopted by the national authorities or by ECHA, but it rather: (i) provides for a new assessment of substantial new information; and (ii) has an effect on the legal situation of the applicant company.
- Finally, and most importantly, as a formal decision, Article 51 of REACH will be applicable to a SONC. This means that, from now on ECHA will have to follow the ordinary procedure for adoption of decisions under dossier evaluation in accordance with Article 51, whereby a company will be given the opportunity to comment, to be heard and be fully involved in the process, which was indeed the main procedural point in the case of Solutia.
For more information and questions please contact Claudio Mereu.
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