Environment & Regulations

Treated articles under the BPR - A problem solved?

Marcus Navin-Jones of Keller & Heckman assesses 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.

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.

Navin-Jones - Definition of treated articles has caused much debate

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 biocidal function shall be considered a biocidal product". The question therefore is whether this amendment, together with the introduction of a definition of 'treated article' in the legal text, moves the dividing line between biocidal products and products currently regarded as treated articles under the BPD.

Generally speaking, from a legal perspective, there has always been a distinction under the BPD between the two concepts and they have always been regarded as mutually exclusively. This meant that a product could not be both a biocidal product and a treated article at the same time; it was either one or the other.

A 'trilogue' of discussions at EU level has partially resolved the definition issue

Often treated articles which fall within the scope of the BPD are, themselves, mistakenly regarded as biocidal products. This is not legally accurate. Under the BPD, treated articles with actives with external effect fall within the scope of the BPD because they are regarded as a delivery system of a biocidal product, and therefore the biocidal product which is intentionally released is caught within the scope.

The BPR maintains and reinforces the notion that a biocidal product and a treated article are mutually exclusive concepts. Under the BPR, therefore, a product can only be regarded as either a biocidal product or a treated article or neither. It cannot be both. In this respect, the BPR maintains the status quo.

At the same time, the dividing line between treated articles and biocidal products will - arguably - move slightly under the BPR because the legal criteria used to determine which of them a product is, will change. For example, the question of whether an active biocidal substance has internal or external effect is no longer likely to be of such significance as to whether a treated article comes within the scope of and is subject to, the BPR provisions.

As the legal criteria changes, this will inevitably throw into question whether a particular product, which may have been regarded as a biocidal product, treated article or neither under the BPD, will continue to retain the same status under the BPR. Clearly this question will form the starting point for determining compliance under the BPR.

The concerns

One of the major concerns regarding the new provisions on treated articles under the BPR is the new definition of a treated article itself. The concern is that, as currently defined, there is no cut off limit, concentration limit or other threshold to trigger the treated article requirements. In other words, even if extremely small quantities of a biocidal product were contained in a particular product, that may be sufficient for the product to be regarded as a treated article and trigger some or all of the requirements relating to treated articles.

To a large extent this issue has been successfully dealt with during the trilogue discussions, as the compromise text makes a clear distinction between different types of treated articles and those triggering labeling requirements and those not. Nonetheless, this issue is still likely to be of concern regarding complex end products made up of components that may have small amounts of biocidal products such as, for example, certain food packaging products.

Another concern is that the EC can, at the request of a MS, decide whether "a specific product or group of products" is a biocidal product, a treated article or neither (Article 3(3) BPR).

Some paints form an example of a treated article under the BPD and BPR

From industry's perspective, the first concern here is likely to be that a MS may grant the EC free rein to decide generically whether a whole class or group of products are treated articles or biocidal products, thereby allowing it to classify a particular product as biocidal product, when in fact, it is generally regarded as a treated article. Industry will therefore want to try and manage the requests referred to the EC where possible, particularly in the early days after adoption.

The second concern is that the legal procedure used to adopt these decisions, the new implementing acts procedure with examination, provides industry relatively limited ability to participate or intervene in the decision-making process. Lastly, given the infamous difficulty in proving legal standing, as and when a decision is adopted by the EC, it is likely to be particularly difficult for industry to legally challenge that decision.

Another area of concern is the requirements that apply as regards treated articles themselves. In summary, those include the obligations that: the actives contained within the biocidal products with which a treated article is treated, are on Annex I for the relevant PT/Article 9(2) list, the labelling requirements and the notification requirements. Some of these core requirements are not fleshed out in the legal text and therefore many questions remain regarding their application.

For example, Article 57(6) of the BPR gives the EC the authority to decide whether industry should be required to notify treated articles to the ECHA. However, there is no detail on whether notification would require proof of technical equivalence with actives reviewed under the BPR/BPD review programme, whether notification would require compensating notifiers under the BPD for reliance on the dossiers submitted by them in order to obtain Annex I inclusion, whether non EU entities will be able to appoint a representative to notify, fees for notification, etc.

The stated objective behind the new provisions on treated articles in the BPR, as stated in the preamble to the BPR, is to "protect human and animal health and the environment, and to avoid discrimination between treated articles originating in the Union and the treated articles imported from third countries" (Paragraph 51).

As the new provisions on treated articles are likely to regulate treated articles manufactured outside the EU and those manufactured within the EU in the same way, the current legal loophole that exists benefiting non EU treated article manufacturers is likely to be sewn up and this problem therefore resolved. The question is, whether, in resolving this one issue, the BPR will only cause more problems in the future. Given the current concerns that exist, the answer to that question is not yet certain.

 

 

From Online Issue: February 2012