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(a) of Regulation (EU) No 1062/2014.
Article 15(a) 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 asincluding 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 for the purpose of formally informing the stakeholders on three important legal points.
Firstly, the stakeholders should be reminded that the MoD shall not be applied hereafter. The document now indicates that "the guidance provided through this Manual of Decision is obsolete since 1 October 2015".
Secondly, a new authoritative guidance within the meaning of Article 15(a) of Regulation (EU) No 1062/2014 was published by the Commission. It enters into force upon its publication on the CIRCABS (Communication and Information Resource Centre for Administrations, Businesses and Citizens) website.
Thirdly, persons placing biocidal products on the market and relying on the MoD in order to conclude that their products are out of the scope of the biocides legislation should take action under Article 16(1)(a) of Regulation (EU) No 1062/2014 in case their products now fall under the scope of the BPR. Pursuant to Article 16 (1) "A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the Register by any person with an interest to notify a substance/product-type combination".
The deadline for submitting the notifications further to Article 16(1)(a) is 1 October 2016. The declarations should be submitted through the Register for Biocidal Products (R4BP) to the Commission.
A request to the national helpdesks or the ECHA helpdesk may be submitted by the companies that seek information on whether their products fall within the scope of the BPR.
For more information or questions please contact Koen Van Maldegem