Another win for Fieldfisher's EU Regulatory team before ECHA's Board of Appeal concerning data and cost-sharing under the BPR
Locations
On 17 November 2020, in Case A-006-2019, ECHA's Board of Appeal (BoA) annulled an ECHA decision rejecting an application by the Appellant, Sharda Europe B.V.B.A., to refer to studies concerning the active substance alpha-cypermethrin, owned by BASF Agro BV.
Background
In December 2014, the Appellant requested a letter of access from BASF Agro BV in order to rely on the studies for inclusion in the BPR Article 95 list of active substance suppliers. The two parties subsequently took part in data and cost-sharing negotiations for over a year, but did not come to an agreement. The Appellant then applied to ECHA for permission to refer to the studies in February 2016.
In May 2016, ECHA rejected the Appellant's application on the grounds that the Appellant had not made every effort to reach an agreement with BASF Agro BV, as required under Article 63(3) of the BPR.
On 29 May 2018, the BoA upheld a first appeal by the Appellant against ECHA's decision (Case A-007-2016), holding that ECHA had committed several errors of assessment of the facts of the case. The BoA annulled the decision and referred the case back to ECHA for re-examination.
On 11 February 2019, ECHA again rejected the Appellant's application for permission to refer, considering that BASF Agro BV's efforts to negotiate were greater than those of the Appellant, and that the Appellant had not "exhausted the possibilities" to come to an acceptable agreement. The Appellant was therefore again found to have failed to make every effort to reach an agreement.
The Appeal
The Appellant contested ECHA's second decision on seven grounds, including ECHA's breach of the Appellant's right of defence by failing to hear the Appellant before adoption of the contested decision. It argued that ECHA had failed to hear its views on the meanings and implications of the Board of Appeal's first decision.
Following the same reasoning as its recent decision in Case A-009-2009 (Solvay Solutions UK Limited), the BoA observed that ECHA should have allowed the Appellant to provide its views on the first decision prior to adopting the second decision as the latter "significantly affects" the Appellant's interests, and the first decision "constituted a new factor which was highly relevant to the assessment of the case".
Furthermore, in this instance, the BoA noted that fulfilment of the right to be heard necessitates "not only that the concerned person has the opportunity to put forward its arguments, but also that the administration take these arguments into account". Whilst it was acknowledged that the Appellant had exchanged communications with ECHA subsequent to the first BoA decision, the BoA found no indication that ECHA had taken the arguments of the Appellant into account in its re-examination of the case. In failing to do so, ECHA had therefore breached the Appellant's right to be heard. As the BoA considered that the outcome of the decision might have been different if the Appellant had been heard, following settled case-law, ECHA's decision must be annulled.
As the Appellant had concluded a data-sharing agreement with BASF Agro BV between the date on which the present appeal was filed and the date on which it was heard, no permission to refer was granted under Article 63(3) of the BPR.
Your Take-Away
The BoA's decision confirms that, when a decision is annulled by this Board and remitted back to ECHA for re-examination, the parties' right to be heard should be respected. ECHA should not only give the parties, such as the Appellant in this case, the opportunity to put forward their arguments, but it should also carefully take them into account in coming to its re-examination decision.
It is therefore expected that, after the decision in this case and in Case A-009-2009 (Solvay Solutions UK Limited), ECHA re-assesses its internal procedure for the re-examination of decisions following a successful appeal before the BoA; and ensures that the parties' right of defence is respected.
The Appellant was represented by Claudio Mereu, Peter Sellar and Sandra Sáez Moreno of Fieldfisher's EU Regulatory team.
For further information or guidance, please contact Claudio Mereu, Peter Sellar & Sandra Sáez Moreno