Cases T‑122/20 and T‑123/20

(publication in extract form)

Sciessent LLC

v

European Commission

Judgment of the General Court (Seventh Chamber), 16 November 2022

(Biocidal products – Active substances – Silver zeolite and silver copper zeolite – Refusal of approval for product-types 2 and 7 – Article 4 and Article 19(1)(b) of Regulation (EU) No 528/2012 – Efficacy – Active substances for use in treated articles – Assessment of the efficacy of the treated articles themselves – Competence of the Commission – Principle of non-discrimination – Legal certainty – Legitimate expectations)

Approximation of laws – Biocidal products – Regulation No 528/2012 – Approval procedure for an active substance with a view to its use in biocidal products – Representative biocidal product intended to be incorporated into a treated article – Obligation of the applicant for approval to prove efficacy of a biocidal product – Scope

(European Parliament and Council Regulation No 528/2012, Arts 4, 6(1)(b) and 19(1)(b))

(see paragraphs 50, 51, 54-56, 60, 61, 94)

Résumé

Sciessent LLC is a producer of several silver-containing active substances, including ‘silver zeolite’ and ‘silver copper zeolite’ (‘the substances concerned’), used to treat certain polymers to achieve an antimicrobial effect.

In the context of the programme for the assessment of existing active substances established by Directive 98/8, ( 1 ) Sciessent notified the European Commission, with a view to obtaining approval, of the substances concerned in connection, inter alia, with product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals) and product-type 7 (film preservatives).

The assessment reports submitted by the evaluating competent authority were examined by the biocidal products committee of the European Chemicals Agency (ECHA). In accordance with the opinion of the committee, the Commission refused approval of each of the substances concerned as existing active substances for use in product-types 2 and 7 ( 2 ) because the sufficient efficacy of the biocidal products in those product-types containing the substances concerned had not been demonstrated. Sciessent therefore brought two actions for annulment of those Commission decisions.

The General Court dismisses the actions and rules, for the first time, on the application of the criterion of the efficacy of an existing active substance with a view to its approval, where that substance is intended to be incorporated into treated articles.

Findings of the Court

First, the Court observes that the applicant for approval of an active substance for use in one or more treated articles is not required to demonstrate the efficacy of those treated articles with the representative biocidal product containing the active substance in question. Nevertheless, the applicant must prove that at least one representative biocidal product may be expected to fulfil the efficacy criterion in the light of the claims which the applicant has him- or herself defined for that product. Where the product chosen by the applicant is intended to be incorporated into a treated article in order to impart on that article a certain kind of protection or a certain effect, it is for the applicant to support his or her claims by way of appropriate tests.

Second, in such circumstances, the applicant cannot merely submit tests carried out under conditions that do not take account of specific conditions for use of the representative biocidal product, or to provide only proof of principle of the efficacy of the active substance. The applicant must submit tests which reproduce the realistic worst case conditions under which the product may be used and which take into account the way in which the treated article may be used. Those conditions are simulated, in essence, in phase 2 tests. The Court adds that the efficacy assessment of an active substance is more limited than that of a biocidal product in the context of a marketing authorisation procedure. It is only at the authorisation stage of a biocidal product, with a view to placing it on the market, that all the intended uses of that product and its efficacy on all of the target organisms will be examined in detail and an assessment of the product’s efficacy and risks, having regard to each of those uses, will be carried out.

Third, the ECHA guidance stresses that it is necessary for the applicant to justify the selection of the use concentrations for the efficacy tests. The likely use concentration corresponds ideally to the minimum effective concentration under realistic conditions, taking into account all relevant parameters that impact efficacy. From that standpoint, there is therefore also a necessary link between the efficacy assessment of an active substance and of the representative biocidal product, on the one hand, and the realistic conditions of use of that biocidal product as reflected in phase 2 tests, on the other, which reproduce, in laboratory conditions, the practical conditions appropriate to the intended use.

Consequently, the Court considers that, in order to demonstrate the efficacy of an active substance for use in a treated article, the applicant must prove (i) the innate efficacy of that substance in the dossier relating to the substance ( 3 ) and (ii) the sufficient efficacy of the protection imparted on the articles treated by the representative biocidal product containing the active substance in the dossier relating to that product. ( 4 ) As for the representative biocidal product, the applicant is required, for each product-type and each claim, to submit tests carried out in realistic worst case conditions and taking into account the way in which the treated articles may be used. The Court adds that this does not mean that the tests must be carried out on the treated article itself, in the state in which it will be placed on the market. It is for the applicant to conduct its tests on a representative material which can, generally speaking, be used to manufacture the treated article chosen by the applicant as an example use, in relevant conditions in the light of Regulation No 528/2012, having regard to that example use.

( 1 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1).

( 2 ) Commission Implementing Decision (EU) 2019/1960 of 26 November 2019 not approving silver zeolite as an existing active substance for use in biocidal products of product-types 2 and 7 (OJ 2019 L 306, p. 42) and Commission Implementing Decision (EU) 2019/1973 of 27 November 2019 not approving silver copper zeolite as an existing active substance for use in biocidal products of product-types 2 and 7 (OJ 2019 L 307, p. 58).

( 3 ) Dossier provided for in Article 6(1)(a) of 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 2012 L 167, p. 1).

( 4 ) Dossier provided for in Article 6(1)(b) of Regulation (EU) No 528/2012.