On 21 April 2016, the first case under the Biocidal Products Regulation (EU) No 528/2012 (BPR) was pleaded before the Board of Appeal (BoA) of the European Chemicals Agency (ECHA). The case concerns an ECHA Decision (Contested Decision) under Article 63(3) of the BPR in the context of a data sharing dispute. The Appellant was represented by the Fieldfisher biocides team led by partner Koen Van Maldegem, with the assistance of advocate Peter Sellar.
The Contested Decision was adopted by ECHA in 2015. By this Decision and in accordance with Article 63(3) of the BPR, ECHA granted a company (Prospective Applicant) permission to refer to studies owned by the Appellant. This is in the context of a data sharing dispute further to the Prospective Applicant's application to be included on the Article 95 list of the BPR.
The Appellant submitted that ECHA infringed Article 62 of the BPR in that the right to refer to the Appellant’s data was granted while the Prospective Applicant had no intention to conduct testing as is required under Article 62 of the BPR. In addition, the Appellant argued that the Prospective Applicant did not follow the procedure laid down in Article 63(3) of the BPR as he failed to give advance notice to the Appellant before initiating the procedure and that ECHA did not respect the procedural deadlines laid down in this Article. In addition, the Appellant claimed that its right to be heard is infringed as ECHA did not take into account relevant documents relating to the data sharing negotiations with the Prospective Applicant. Finally, the Appellant claimed that ECHA erred in its assessment of the Appellant's every effort.
The BoA is expected to adopt a decision in the next couple of months. This decision will have far-reaching consequences, since as a first legal case under the BPR, it will set an important legal precedent of how ECHA manages data sharing disputes which involve complex scientific, regulatory and procedural issues under the BPR.
Brussels, 9 May 2016
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For more information or questions:
Koen Van Maldegem
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