Biocides: Manual of Decisions repealed – check regulatory status
With effect as of 1 October 2015, the European Commission acting together with the Member States Competent Authorities has repealed the "Manual of decisions for implementation of Directive 98/8/EC concerning the placing on the market of biocidal products" ("MoD"). Companies that have, in reliance of the MoD, considered their products to be exempted from the scope of the biocidal products regulation are recommended to check with the national authorities whether the status of their product has changed.
If, subsequent to the repeal of the MoD, a product previously exempted now falls under Regulation 528/2012 ("BPR"), the company concerned should declare an interest to notify an active substance/product-type combination for inclusion in the Review Programme by 1 October 2016.
Background to the repeal of MoD
Biocidal products function to control unwanted organisms that are harmful to human or animal health or cause damage to natural or manufactured materials. On broad terms, such harmful organisms include pests (such as insects and rodents) and microorganisms (such as moulds and bacteria).
The MoD is a compilation of issues discussed, and views agreed, by the European Commission and the Member States on specific cases. The manual has been a "living document" in the sense that decisions were added to it as and when agreed by the European Commission and the Member States.
The decision to repeal the MoD follows a judgment delivered by the European Court of Justice ("Court of Justice") already in March 2012 in Case C-420/10 Söll GmbH v Tetra GmbH. In that judgment, which was a reference for a preliminary ruling from a German court, the Court of Justice has interpreted the concept of "biocidal products" for the purposes of Article 2(1)(a) of Directive 98/8/EC (the predecessor of the BPR, which remained in force until 1 September 2013) .
According to the Court of Justice, the concept of "biocidal products" within the meaning of Article 2(1)(a) of Directive 98/8/EC include "(…) 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."
The Court of Justice reasoned that as the legislation was premised on the high level of protection for humans, animals and the environment, such level of protection could be seriously jeopardised if products containing one or several active substances but exerting only an indirect chemical or biological effect on harmful organisms were excluded from the scope of biocidal products.
According to the Court of Justice, it is the "very presence of the active substance as such, in a product (…), which is liable to present a risk for the environment, irrespective of whether that substance acts directly or indirectly on the target organisms." It continued that the gradation of the purposes of biocidal products in Article 2(1)(a) of Directive 98/8/EC from the destruction of the harmful organisms to their prevention and, importantly, also "otherwise exerting a controlling effect" established that "the possibility of [a] product having the effect, even limited, of exerting greater control over the target harmful organisms or of facilitating their elimination is sufficient".
According to the European Commission, the regulator's position has previously been that products acting only by indirect means on the target harmful organisms were not considered as biocidal products for the purposes of the applicable legislation.
What action is required from biocidal product manufacturers?
Following the decision of the European Commission's expert group for biocidal products to consider the MoD obsolete, the European Commission issued a new authoritative guidance informing the stakeholders accordingly. By the same guidance, the European Commission has informed that companies having considered their products exempt from the scope of the biocidal products regulation can submit a declaration of interest to notify a substance/product-type combination by 1 October 2016. Such declarations shall be submitted through the Register for Biocidal Products to the European Commission.
The European Commission will assess the received declarations of interest, and provide the European Chemicals Agency (ECHA) with a list of notifiable active substances/product-type combinations. The list will be published by ECHA, following which companies will have six months to notify their intention to submit an application for the inclusion of their active substance/product-type combination on the Review Programme. The full application for approval shall be submitted within two years.
Finally, transitional measures will apply to biocidal products comprising active substance/product-type combination affected by the Court of Justice's judgment. Such biocidal products can be made available on the market, and used, in accordance with national laws, pending decision of the European Commission on the application for approval of the active substance/product-type combination.