Biocidal Products Regulation: Clarification of scope for treated articles – uncertainties remain

Regulation (EU) No 528/2012 on biocidal products has already been in force since 1 September 2013. Since this time, the requirements introduced for the first time for treated articles have in particular also applied. In addition to the labelling requirements which apply in special cases and a new right of consumers to information, treated article may, for example, in accordance with to Article 58(2) of the BPR only be placed on the market if the biocidal products used for treatment or which are incorporated in the products only contain active substances which are permitted for use in the EU. This new regulation therefore confronts companies with the problem of identifying biocidal treatment at all levels of the supply chain, even outside the EU, and of reviewing the biocidal products used and the active substances incorporated in them in light of existing active substance approvals in the EU.

The term “treated articles” is very broad and in principle covers all cases in which a biocidal product has been used to treat an article in production, for transport or in retail. The revision of the guidance published by EU Commission in September 2013 is intended to clarify the limits of the scope of the provisions for treated articles. The draft (CA-Sept14-Doc.6.1a) was discussed at a meeting of the Member State authorities responsible for enforcement of the BPR on 18 September 2014 and certainly means risks for the companies affected.

The European Commission now only wants the regime for treated articles in accordance with the BPR to apply for articles on or in which the intended biocidal treatment which was carried out still has an effect. The interpretation of the European Commission can hardly be reconciled with the wording of the definition of treated articles because the term expressly refers to all substances, mixtures or products which have been treated with one or more biocidal products or to which one or more biocidal products have been intentionally added. The “intentional addition” of a biocidal product, which alone was addressed by the Commission, clearly only refers to the second alternative contained in the definition, the first alternative of which specifically – without any restriction – considers any treatment with a biocidal product to be sufficient. The Regulation expressly states, for example, that the fumigation of a transport container (only) then does not make the product it contains a treated article if no residues are expected to remain (cf. sentence 2 of Article 58(1) of the BPR). With this provision, the legislator is, however, specifically making it clear that if residues are to be expected, the fumigation of a container solely for transport purposes already makes the product it contains a treated article in the meaning of the BPR; the wording of the Regulation does not, however, refer to any continued effect, if any, of the biocidal treatment.

Companies which rely on the differentiation now contained in the draft of the European Commission therefore run the very real risk that NGOs or consumer protection organisations will, for example, with reference to the wording of the BPR, claim and denounce competition law infringements of the restriction of the movement of goods pursuant to Article 58(2) of the BPR. The practical business challenges are therefore not eliminated either by the revision of the guidance of the European Commission and companies which are affected are still well advised to proceed with the required implementation despite many uncertainties.