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Valentina R., lawyer
EN
(2023/C 296/42)
Language of the case: English
Applicant: Dakem (Courbevoie, France) (represented by: K. Van Maldegem and P. Sellar, lawyers)
Defendant: European Commission
The applicant claims that the Court should:
—annul Commission Implementing Decision (EU) 2023/686 of 24 March 2023 not granting a Union authorisation for the single biocidal product ‘Insecticide Textile Contact’; (1)
—order the defendant to pay the costs of the proceedings.
In support of the action, the applicant relies on three pleas in law.
1.First plea in law, alleging manifest error of assessment and infringement of Regulation (EU) No 528/2012. (2)
—The defendant, it is argued, has committed a manifest error of assessment and infringed Article 19(1)(b) of, in conjunction with paragraph 8(a) of Annex VI to Regulation (EU) No 528/2012 by failing to take into account relevant factors, specifically the results of a biodegradability study which impacted on the environmental risk assessment, and a revised environmental risk assessment provided by the applicant after the failure of the evaluating competent authority’s first accordance check of its assessment.
2.Second plea in law, alleging infringement of a rule of law: the principle of non-discrimination.
—In assessing the feasibility of a proposed risk mitigation measure, the defendant failed to accord to the applicant’s product the same treatment afforded to other products in comparable situations, and to do so without proffering any objective justification, which infringes the principle of non-discrimination.
3.Third plea in law, alleging infringement of a rule of law: the principle of sound administration.
—The defendant breached the principle of sound administration by failing to act diligently in fulfilling its obligations to assist the applicant, a small and medium sized enterprise, in ensuring full compliance with the requirements of Article 19 of Regulation (EU) No 528/2012. The breach of sound administration was, it is argued, fourfold:
—The applicant was not allowed to produce and submit data to refine the environmental risk assessment after the failure of the first accordance check;
—The evaluating competent authority did not accommodate the applicant’s request to have the results of the biodegradability study taken into account in the environmental risk assessment;
—The applicant was not given any genuine opportunity to respond to the change in value used for leachable fraction in the human health evaluation; and
—The applicant was not given the opportunity to provide a product-specific study on dermal absorption.
(1)
OJ 2023 L 90, p. 42.
(2)
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 2012 L 167, p. 1).