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The defendant, relying upon the Biocidal Products Committee (BPC) opinions on the approval of the active substance silver zeolite for product-types 2 and 7, reached the conclusions that the substance could not be approved on the grounds that sufficient efficacy had not been demonstrated. However, in the applicant’s view, the efficacy assessment was wrongly undertaken by reference to the article in which silver zeolite is used. The efficacy of the substance, silver zeolite, has been demonstrated by the applicant in accordance with the applicable law. The defendant, in its evaluation of, and conclusion on, the efficacy of the substance, has misinterpreted and misapplied the relevant law.

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The reason for the non-approval of silver zeolite under the contested act is the alleged insufficient efficacy of the treated article in which it is used. However, the applicant maintains that the only criteria that the defendant could lawfully take into account are limited to those listed in Articles 4 and 19 of Regulation (EU) No 528/2012. Those criteria do not include the efficacy of the treated article whose assessment is otherwise left to the secondary, subsequent stage of biocidal product authorisation at the Member State level. In light of the fact that precisely that assessment has been undertaken by the defendant to justify the non-approval of silver zeolite, meaning that the defendant has gone far beyond what it is delegated to do under Regulation (EU) No 528/2012, the defendant breached Article 290 of the Treaties and Articles 4 and 19 of that Regulation.

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The applicant’s substance has been treated differently from other substances used for the same product-types 2 and 7, without the defendant justifying objectively why silver zeolite should be treated any differently from the other substances, which were all subject to the same rules of assessment under Regulation (EU) No 528/2012 (and Directive 98/8/EC (3)) for the same product-types.

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The defendant issued an open letter to the Chair of the BPC, which was designed to set straight how the law on efficacy assessment and treated articles under Regulation (EU) No 528/2012 was to be interpreted and applied. Whilst the law was clear, that letter reconfirmed that requiring the demonstration of the benefits of the treated articles does not fall within the scope of Regulation (EU) No 528/2012. The applicant relied upon the content of that letter, which confirmed the clarity of the law, and had legitimate expectations regarding the approval of the substance. As a result, the contested act appears to have infringed the principles of legitimate expectation and legal certainty