Treated Articles Under the BPR - A Problem Solved?

Figure 1: Navin-Jones - Definition of Treated Articles has Caused Much Debate

Marcus Navin-Jones of Keller & Heckman have assessed the likely impact of the new Biocidal Products Regulation on the key issue of treated articles.

The current Biocidal Products Directive (BPD) does not define what is meant by the term treated article and the term itself does not appear in the legal text. It was initially developed in the US under the US Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) and has been further developed in the EU in Guidance and the BPD Manual of Decisions. The term treated article is now commonly used in the EU to mean an article which as been treated with a biocidal product where the biocidal product has the intention of either controlling organisms harmful to the treated article itself (internal effect) or controlling harmful organisms outside the treated articles (external effect).

In the US there is a legal provision contained within US legislation which expressly exempts registration of a treated article if the non-agricultural pesticide (i.e. biocide) has been registered and the use of the treated article is covered. By comparison, in the EU, as there is no mention of the term treated article in the BPD itself, whether treated articles fall within the scope of the BPD and therefore whether they are subject to the legal requirements under it, has always been a more contentious issue.

Almost ten years ago, the European Commission (EC) and the Member State (MS) Competent Authorities (CAs) came to the agreement that certain treated articles did, in their view, fall within the scope of the BPD. Therefore those treated articles had and still have to comply with its provisions.

Specifically, they agreed that if a treated article contained a biocidal active substance which was intentionally released from the treated article (external effect) the article would be regarded as a delivery system of the active and therefore the biocidal product must comply with the BPD provisions. Not all MSs agreed that the BPD could be interpreted in this way. Nonetheless, and despite the early conflicting views, it is now generally agreed that treated articles with actives with external effect fall within the scope of the BPD.

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Many believe that this agreement has, in practice, had a discriminatory effect putting EU treated article manufacturers at a disadvantage in comparison to non EU manufacturers. They argue that EU manufacturers of treated articles are prohibited from using active biocidal substances in the production of treated articles in the EU which are not on Annex I for the relevant Product Type (PT) or not being supported under the BPD Review Programme for the relevant PT.

Whereas, because the BPD is not regarded as regulating treated articles with actives with internal effect, the BPD has allowed non-EU manufacturers and suppliers to import and sell these products within the EU even when the active biocidal active substances contained within them were banned or prohibited in the EU.

Clearly this legal loophole has caused regulators concern and there have been a number of reports into how best to resolve this issue from a legal and practical perspective. However, it is only now, with the repeal and replacement of the BPD with the new Biocidal Products Regulation (BPR) that a legal solution at the EU level has been agreed.

New BPR: A solution?

The BPR has not yet been finally adopted by the European Council. However, following the European Parliament vote of 19 January 2012 and the deal struck on 23 November 2011 after trilogue discussions between the Parliament, the Council and the EC, the new provisions on treated articles are in substantively final form.

The BPR does not just plug the legal loophole that currently exists by ensuring that those treated articles with actives with internal effect now fall within the scope of the BPR. Instead, it changes the main provisions regarding them by three means: redefining a biocidal product, introducing for the first time a definition of the term treated article into the legal text itself and introducing a new set of requirements which apply specifically to treated articles.

There has been disagreement between the EU institutions as regards the new definition of a biocidal product under the BPR. In previous drafts of the BPR, proposals were tabled to include a reference to primary intention meaning that only those products which had a biocidal effect as their primary intention, would be regarded as biocidal products. More recently, in the compromise text of 23 November 2012, this reference was dropped.

However, the new definition of a biocidal product in the compromise text retains a statement initially proposed by the Belgian MEP Kathleen Van Brempt, stating: "A treated article that has a primary bioc