On 23 August 2016, the Board of Appeal of the European Chemicals
Agency (''ECHA'') ruled on the first case (
Case A-005-2015) under the Biocidal Products Regulation (EU) No
528/2012 (''BPR''). The case concerns an ECHA
Decision under Article 63(3) of the BPR (the ''Contested
Decision''), in which ECHA had considered that the data
owner had failed to make every effort to reach an agreement on
data-sharing. The Board annulled the Contested Decision. The
Appellant in the proceedings, for whom the decision is favourable,
is Thor GmbH (''Thor''), represented by the
Fieldfisher biocides team led by partner
Koen Van Maldegem, with the assistance of advocate Peter
By way of factual background, the Contested Decision granted a
company (the ''Prospective Applicant'') applying to
be included in the Article 95 list permission to refer to certain
studies owned by Thor concerning the substance reaction mass of
2-methyl-2H-isothiazol-3-one (''CIT/MIT''). The
main issue in the case was that Thor and the Prospective Applicant
had agreed to establish technical equivalence between their
respective substances, and Thor had consistently kept to this
pre-requisite for data sharing. In essence, under Article 54 of the
BPR, a technical equivalence assessment must determine the
similarity between the two, in chemical composition and hazard
profile. ECHA argued that this was not required under the BPR and
data owners ''do not have the right to demand any form of
similarity check as a pre-requisite'' for sharing their
The Board, however, found that ECHA had not considered all the
relevant facts in a balanced manner as both companies had mutually
agreed to perform a technical equivalence assessment before sharing
data, both at the beginning of negotiations, and after ECHA had
said that such an assessment was unnecessary and confirmed that
establishing technical equivalence can be in the interest of both
parties involved in data sharing negotiations. More importantly,
the Board stated that although ECHA ''might be
correct'' in considering that the technical equivalence
assessment is not a legal requirement for data sharing under the
BPR, it is part of the companies' contractual freedom to add
the assessment to their data sharing agreement.
The Board of Appeal concluded that Thor made every effort to
reach an agreement with the Prospective Applicant, and ECHA failed
to consider all the facts of the case.
By ruling in favour of contractual freedom, the Board has
acknowledged that parties can agree between themselves on how to
conduct their data sharing negotiations. Despite clarifying the
confusion over contractual freedom, the Board did not address the
four remaining pleas in law raised by the Appellant, and as such
missed a good opportunity to clarify certain procedural questions
which would have made future data sharing negotiations under the
Nevertheless, this decision has far-reaching consequences, since
as a first legal case under the BPR, it sets an important legal
precedent on how ECHA manages data sharing disputes which involve
complex scientific, regulatory and procedural issues under the BPR
such as technical equivalence.
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After studying bioengineering and completing a PhD in the San Francisco Bay Area and a two-year postdoctoral research fellowship in London, Mark has spent the past four years analysing global health policy.
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