First published in Speciality Chemicals Magazine in February 2011.
Koen van Maldegem and Julia Lietzmann look at biocidal products under a new EU draft regulation
Biocidal products contain active substances that are ‘intended to destroy … harmful organisms’: they kill and that is their declared purpose. Balancing the risks inherent in the use of biocides with their benefits is certainly not an easy task.
Last year, the European Commission (EC) tabled the long-awaited Proposal for the Biocidal Products Regulation (BPR), which will repeal the Biocidal Products Directive (BPD). The European Parliament adopted 330 amendments to the Proposal during a first reading.
Subsequently, the European Council agreed upon its first reading position. Parliament is expected to proceed with a second reading next summer, after which the BPR is scheduled to be adopted in 2012 and to apply as of 1 January 2013.
This article investigates, structured around a set of key principles from the proposed BPR, whether the Proposal, as proposed and amended respectively by the EC, Parliament and the Council, has the potential to remedy a number of weaknesses that were identified during the past years.
Centralised authorisation & mutual recognition
Under the BPD, active substances are reviewed at the EU level and the biocidal products containing them are authorised at Member State (MS) level. During the past ten years, around two thirds of active substances have disappeared from the market, due to the costs involved with the complicated EU review procedure.
The number of new product authorisations in this time has also been low, due to the lack of harmonised procedures among the MSs. Some in industry are thus concerned that the increasingly restricted availability of active substances and biocidal products will lead to growing resistance in certain damaging organisms.
Because many MSs were concerned about losing the power to control the entry of biocidal products into their markets, the Proposal foresees that in the future only two types – those based on new active substances and those deemed to be ‘low-risk’ – will have access to a centralised authorisation allowing them to be placed on the market throughout the EU. All others will still be subject to national authorisations by MSs.
New active substances are those that were not on the EU market for a biocide use on 14 May 2010. But what exactly is a low-risk substance? Why should the centralised authorisation be limited in this way? These two questions have been discussed for the past 18 months, and no agreement has been thus far reached.
The Proposal sets two cumulative criteria for low-risk biocidal products. For any given environmental compartment, the ratio of the predicted environmental concentration (PEC) to the predicted no-effect concentration (PNEC) may be derived and must not exceed 0.1. For any effect to human health, the margin of exposure (the ratio of no observed adverse effect level (NOAEL) and exposure concentration) should be higher than 1,000.
Under the Proposal, biocidal products cannot be considered as ‘low-risk’ products if the active substances qualify as persistent, bio-accumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), endocrine disruptors, carcinogenic, mutagenic, neurotoxic, immunotoxic, reprotoxic or sensitising, except where there is only negligible exposure. The Parliament added more properties to this list, such as ‘corrosive’, ‘flammable’, ‘toxic’, ‘being a persistent organic pollutant’(POP) or ‘containing a nanomaterial’, while not accepting negligible exposure as an argument for a low-risk product.
Serious doubts exist as regards the workability of the simplified procedure and of the centralised authorization. To give just one example: where nanomaterials can generally not be considered as low-risk substances, the EC has recently published an extremely broad draft recommendation for a definition of nanomaterials thereby making unlikely that many substances can qualify for these simplified procedures. Parliament additionally suggested widening the scope of the EU authorisation to all biocidal products, except those containing active substances falling under the exclusion criteria of Article 5, albeit only from 2017 onwards. The Council took a completely different approach, focusing on the 23 Product Types (PTs) in which all biocidal products are already categorised, as listed in Annex V to the BPD and also in the draft BPR.
It wants certain biocidal products falling under certain PTs to be eligible for ‘Union authorisation’ from the entry into force of the BPR. This would expand from 2020 to all but five PTs - products used for the control of vertebrates in general, rodents, birds and fish, plus anti-fouling products – provided that they have ‘similar conditions of use across the Union’. This issue had been of great concern to some MSs, which argued that the individual conditions in every country have a strong impact on the hazard profile of a biocide.
In practice, a manufacturer will file an application for Community (or Union) authorisation to the European Chemicals Agency (ECHA) naming the competent authority (CA) of the MS of his choice, which would be responsible for the evaluation of the application. The CA would evaluate but the EC would take the final decision. If this is positive, the entire EU market will be open for the product.
Some critics of Union authorisation, as discussed in the Council, have voiced concern that this would be hardly more than an upgraded mutual recognition procedure involving ECHA performing mere organisational tasks and collecting fees. It would not, however, shorten the procedure; this would still take around two years.
Even if the Proposal only considers centralised authorisation for products containing new and low-risk substances, it at least tries to strengthen mutual recognition among the MSs by providing in much greater detail than in the BPD the procedures for granting MS authorisations and mutual recognition of those authorisations.
In particular, the acceptable grounds for opposing mutual recognition are made clear and procedural steps are provided for the resolution of disputes between MSs. Pursuant to the draft BPR, it would be possible to launch the process of the mutual recognition together with the application for the first authorisation in order to save time.
Furthermore, the existing simplified procedures involving the current Annex IA and IB will be repealed under the BPR, as little or no use has been made of them. The simplified procedure involving frame formulations - which has not been put into practice – will be modified to allow, within a group of products belonging to the same frame formulation, the replacement of any non-active ingredient by other non-active ingredients where such permitted variations do not adversely affect the level of risk or the efficacy of these products.
Another novelty concerns the exclusion criteria that will prevent a biocidal product containing a certain active substance from being authorised. The Proposal provides that an active substance cannot be included in Annex I – and therefore cannot be used in a biocidal product – if it is carcinogenic, mutagenic or reprotoxic (CMR) or having endocrine disrupting properties, unless at least one of the following is applicable:
- Human exposure to the active substance in the biocidal product is negligible.
- The active substance is necessary to control a serious danger to public health, such as an epidemic of particular insects.
- The negative effects of banning the active substance would be disproportionate to the impacts on human health or the environment and no alternatives are available.
The Council and Parliament added PBT and vPvB to the black list in their respective texts. In addition to this, they - especially Parliament - changed the list of derogations proposed by the EC. The most significant change lies in the fact that both versions leave the inclusion of a substance in Annex I within the discretion of the authorities in case a derogation (e.g. negligible human exposure) applies.
The Proposal also introduces a new concept of comparative assessment of substances. A problematic active substance should be phased out if it can be replaced by a substance that meets all of the following criteria:
- better hazard profilesame efficacy,
- available in sufficient variety to avoid the development of resistances amongst harmful organisms, and
- no significant adverse economic or practical impacts
Not surprisingly, the criteria for flagging a substance as a candidate for substitution are under dispute.
Why should any marine toxicity studies be performed if a product is reserved for use on dry land? This question paraphrases the newly introduced approach by which not the same set of data has to be submitted anymore for all biocidal products but the data set depends on the exposure to the respective substance. The proposed grounds for data waivers are based on those provided for in REACH.
One of the big issues in chemicals legislation during the past few years is the reduction of animal testing in the name of product safety. The BPD did not provide for mandatory data sharing. Instead, it merely encouraged applicants to undertake ‘best efforts’ to cooperate in the sharing of vertebrate animal data and allowed MS to introduce mandatory data systems nationally (which only very few have done).
In line with REACH and the Plant Protection Products Regulation 1107/2009/EC, the BPR will make the sharing of vertebrate animal studies in exchange for equitable compensation mandatory. It will transform the fifteen year (for new active substances) and ten-year (for existing active substances) data protection or exclusive use right of the BPD into a fifteen or ten-year period during which vertebrate animal data is ‘compensable’, i.e. the data owner has no exclusive use rights on its data but is allowed to receive compensation for reliance on this by third parties. The mandatory data sharing would not apply for non-vertebrate animal studies.
As under REACH, data owners and non-data owners will be required to undertake best efforts to reach an agreement on the sharing of data. Such an agreement may be replaced by arbitration and a commitment of both parties that they will accept the arbitration order.
If no agreement is reached two months after a request is made, the non-data owner must inform the data owner and ECHA, within which a new Biocidal Product Committee will be created. ECHA will then give the applicant the right to refer to the vertebrate animal data and it will be up to national courts to decide on the amount of data compensation.
As is the case under the BPD, data protection ends when the relevant time limits expire. From that point onwards, subsequent applicants will no longer need the approval of the former data owner.
In particular for non-EU based manufacturers of ‘treated articles’, i.e. products treated with a biocide for their own protection, the draft BPR may be the beginning of a new era that will make them familiar with the nature of EU bureaucracy.
A ‘treated article’ could, for example, be a rug made outside the EU and treated with a biocidal product as a preservative. ‘Treated articles’ are currently not covered under the BPD in the sense that neither the article, nor the active substances or biocidal products it contains must be authorized when the article is placed on the market. The EC previously referred to this in its Manual of Decisions as an “internal effect”, a term which is also not used in the legislation itself.
This exclusion of ‘treated articles’ was seen as unfair by the EC and its new Proposal introduces for the first time a definition of the concept in the scope of the draft BPR. The term ‘treated article’ includes ‘any substance, mixture, material or article which was treated with or incorporates one or more biocidal products’ and where the intention is to protect the article itself from harmful organisms.’ ‘Article’ is defined according to REACH as an object.
Qualification as a ‘treated article’ incorporating an active substance or biocidal product with an ‘internal effect’ triggers a limited number of obligations on the party responsible for placing the ‘treated article’ on the market. It must ensure that the biocidal products used are authorised for this use, in the EU or in at least one MS, and that they are labelled accordingly.
Both the Council and Parliament adopted the concept of ‘treated articles’ introduced by the EC Proposal, but with some deviations. One important difference in the Council text is the extension of the ‘regime to ‘treated articles’ that no longer contain any active substances by the time they are placed on the market.
According to the Council, products treated with a biocidal product - even if solely during the production process - can only be released onto the market if the active substance is approved in the EU. This could have significant repercussions, in particular, with regards to ‘treated articles’ imported from non-EU manufacturers.
The Proposal requires the following information to be listed on the label of treated article:
- The active substance(s) name(s).
- The biocidal property.
- The authorisation number of the biocidal product(s) used for the treatment of or incorporated in the article.
- Any hazard or precautionary statements set out in the authorization of the biocidal product(s).
The labelling requirements suggested by Council and Parliament differ in some aspects, the latter introducing, for example, a requirement to add the phrase ‘treated with biocidal products’, or ‘nano’ where nanomaterials are used. Last but not least, Parliament introduced an additional requirement in the form of a letter of certification, which must be obtained from the authorisation holder of the biocidal products used.
External effect biocides
In the Manual of Decisions a product treated with a biocide can also have an ‘external effect’, namely when it releases the active substances, or it can control organisms that are not harmful to the treated article itself. Although ‘articles’ are not mentioned in the definition of biocidal products in the BPD, the Manual (which is not legally binding) establishes a requirement for them to be authorised.
Examples would be mosquito nets containing insect repellents, impregnated tissues with ‘antibacterial’ properties or socks treated with a biocidal active substance intended to have a biocidal action on the foot against odour. The Proposal remains silent over these kinds of ‘treated articles’ but one has to assume the policy adopted in the Manual of Decisions is valid and that they have to be authorised as such.
The Council takes a slightly different approach by introducing into the definition of ‘biocidal products’ an explicit inclusion of treated articles where they have a primary biocidal intention.
The example of socks that release active substances to the feet in order to control odour shows the difference between the approaches of the EC and the Council. The EC would presumably not consider socks as ‘treated articles’ because in the given example the active substance does not protect the socks themselves against harmful organisms.
However, the EC would presumably apply the approach expressed in its Manual and would require an authorisation of the socks because of their ‘external effect’. The Council, on the other hand, would presumably argue that the ‘primary intention’of the socks is to cover the foot and not to kill bacteria.
In other words, the Council takes the more pragmatic approach by limiting the scope of ‘biocidal products’ to those with a primary biocidal intention, but it also leaves much room for interpretation on what the ‘primary intention’ of a product actually is.
The draft BPR has the potential to remedy a number of weaknesses of the current BPD. However, if the centralised authorisation procedure for all biocidal products will enter into force only in 2017, as suggested by the Parliament, this improvement might come too late for some products which will already have entered the conventional authorisation procedure by then.
In terms of timelines, the Council’s approach seems, at first glance, more pragmatic: immediate applicability of the ‘Union authorisation’ for biocidal products of seven PTs. The exclusion of five PTs from the opening of the centralised authorisation to all other biocidal products from 2020, on the other hand, seems to be motivated by political, not objective, reasons. As so often with the workings of the EU, it is hard to tell.
In light of the various issues still being under dispute between Parliament and Council even regarding the most fundamental elements like definitions, the outcome of the Second Reading is impossible to predict. Very diligent work is needed to achieve both goals: the functioning of the internal market as regards biocidal products and the protection of human health and the environment.
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