On 22 March 2011, the Agency adopted the Contested Decision and notified it to
the Appellant. Hereinafter, ‘Contested Decision’ refers to that part of the
Contested Decision which is the subject of the appeal, namely section II part 2) of
Decision CCH-D-0000001396-72-03/F of 22 March 2011 adopted by the European
Chemicals Agency, to the extent that the Agency required the Appellant to
conduct a 90-day repeated dose toxicity study in the rabbit by inhalation (Test
Method B.29 of Regulation (EC) No 440/2008 or OECD Test Guideline 413) as
modified by the additional clinical pathology and histopathalogical evaluations
specified in the Contested Decision with reference to OECD Test Guideline 416.
PROCEDURE BEFORE THE BOARD OF APPEAL
On 21 June 2011, the Appellant lodged a notice of appeal at the Registry of the
Board of Appeal seeking the annulment of the Contested Decision to the extent
that the Agency required the Appellant to conduct the Study. The Appellant also
requested the refund of the appeal fee.
The notice of appeal also contained a request to treat certain information as
confidential. More specifically, the Appellant requested that the identity of the
Substance (including the IUPAC name, the chemical and trade names, the EC and
CAS numbers, as well as the REACH registration and dossier submission numbers)
be treated as confidential, as well as information on the uses of the Substance,
the precise tonnage data, the identity of and comment by a MSCA, the names of
three contract research organisations that provided expert statements on the
Appellant’s behalf, and details of certain studies submitted to the Agency.
On 29 July 2011, and further to two requests by the Registry of the Board of
Appeal for clarifications, the Chairman adopted a decision on the Appellant’s
request for confidential treatment. By that decision, the Chairman rejected the
Appellant’s request insofar as it pertained to the identity of the Substance and its
uses, and the names of the contract research organisations (hereinafter ‘CROs’).
The Chairman also rejected the Appellant’s request with respect to information on
the precise tonnage data and information on certain studies that had been
submitted to the Agency. Finally, the Chairman granted the Appellant’s request to
treat as confidential certain personal data.
On 22 September 2011, and further to a request of 29 July 2011 for an extension
of the time limit, which was accepted by the Board of Appeal, the Agency
submitted the defence. The Agency’s defence also contained a request to treat
certain personal data as confidential which was granted by the Chairman.
By letters received on 28 September 2011, DuPont de Nemours (Nederland) B.V.
(hereinafter ‘DuPont’) and the European Coalition to End Animal Experiments
(hereinafter ‘ECEAE’) applied to intervene in the proceedings before the Board of
Appeal. On 14 October 2011, the Agency submitted observations on the
applications to intervene in which it supported the intervention by DuPont but
contested the application lodged by ECEAE. On 20 October 2011, the Appellant
submitted its observations on the applications to intervene in which it expressed
its support for both applications. By separate decisions of 8 November 2011, the
Board of Appeal granted both applications to intervene.
On 23 November 2011, the Agency lodged a request for rectification of the
Decision of the Board of Appeal granting ECEAE’s application to intervene. By
Decision of 15 December 2011, the Board of Appeal rejected the Agency’s request
On 22 December 2011, the Appellant lodged observations on the defence. The
Appellant’s observations contained a request for confidential treatment with
respect to DuPont and ECEAE (hereinafter ‘the interveners’).