ECJ Söll Judgment Makes Biocides Manual Of Decisions Obsolete - Possibility To Notify Products With Indirect Effect In The Review Programme

In September 2015, during the 61st meeting of representatives of Member State competent authorities, an important document regarding Article 15 of Regulation (EU) No 1062/2014 (the so-called "review programme Regulation") was discussed. As a result of the discussion, the CA Meeting representatives endorsed a new authoritative guidance within the meaning of Article 15 of Regulation (EU) No 1062/2014.

Article 15 of Regulation (EU) No 1062/2014 outlines the notification process for an active substance that is eligible for inclusion in the biocides active substance review programme. This process only applies to active substances that were not included in the review programme, under specific conditions, and notably where previous guidance from the Commission or a competent authority is reviewed or replaced by new authoritative guidance published by the Commission.

Concept of 'biocidal product'

On 1 March 2012, the European Court of Justice delivered in Case C-420/10 an interpretation of the definition of the concept of 'biocidal products' under article 2(1)(a) of Directive 98/8/EC (BPD). According to the Court, the concept "must be interpreted as including even products which act only by indirect means on the target harmful organisms, so long as they contain one or more active substances provoking a chemical or biological action which forms an integral part of a causal chain, the objective of which is to produce an inhibiting effect in relation to those organisms".

Repeal of earlier guidance provided by the Commission

The clarification provided by the Court of the concept of 'biocidal product' implied the reconsideration of the application of the guidance given in the Manual of Decisions (MoD). Indeed, the MoD states that products acting only by indirect means on the harmful target organisms should not be regarded as biocidal products.

Due to the above mentioned contradiction, along with the replacement of the BPD by Regulation (EU) No 528/2012 (BPR), on the occasion of the 58th CA Meeting, in November 2014, the Competent Authorities agreed to no longer consider the MoD applicable.

Alert to the stakeholders

As a result of the discussion during the September 2015 CA meeting, the Competent Authorities published a note...