Proposed EU Biocidal Products Regulation

Date: Sep 29, 2010

In June 2009 the European Commission adopted a proposal for a regulation concerning the placing on the market and use of biocidal products ("Proposed Biocidal Products Regulation" or "Proposed BPR"). On 22 September 2010, MEPs voted to adopt the majority of the amendments proposed by the European Parliament rapporteur Christa Klass (EPP) and, following its first hearing in plenary, the Proposed BPR was approved. It will now be considered by the Council of Ministers under the Belgian Presidency. The core provisions of the final text may therefore be agreed upon before the end of this year. The Proposed BPR will repeal and replace current Directive 98/8/EC ("Current BPD") and is expected to enter into force on 1 January 2013. Differences between the Current BPD and the Proposed BPR In October 2008 the Commission published a report on the implementation of the Current BPD as statutorily required, and the report identified a number of weaknesses. The Proposed BPR aims to addresses these weaknesses and to take into account the comments made in the consultation procedure. Therefore, generally speaking, the Proposed BPR broadly retains the same two-tier authorization process as established under the BPD and the underlying legal framework regarding the regulation of biocidal products will remain the same. However, and pending the outcome of the EU legislative process, the Proposed BPR is likely to make some significant changes to, amongst other things, the following: 1. Scope The Proposed BPR will widen the scope of the Current BPD. Significantly, the Proposed BPR shall be extended to include articles and materials treated with biocidal active substances such as textiles and furniture (Article 47). This amendment is most likely to impact importers of treated articles. Under the Current BPD, articles treated with unauthorised active substances outside the EU may lawfully be imported into the EU and placed on the EU market (i.e. the EU treated articles exemption - which is not the same as the US "treated articles exemption"). However, under the Proposed BPR, this will no longer be possible. Articles treated with unauthorised active substances outside the EU could not be placed on the EU market. The Proposed BPR also provides for specific labelling requirements as regards treated articles (Article 47(2)). Although, in the Commission Proposal, it was proposed that the BPR/BPD also be extended to regulate the use of surface biocides in food contact materials, the EU Parliament rejected this proposal on grounds that "Food contact materials are already regulated by the Food Contact Materials Framework Regulation (EC) No 1935/2004. Should any changes be made to the rules governing food contact materials, they should be addressed through a revision of the food contact legislation, not by extending the scope of the BPR". 2. Amendments aimed at improving the functioning of the EU single market Generally speaking, the Proposed BPR will retain the two-tier authorization procedure established under the Current BPD (i.e. approval of the active for Annex I inclusion re PTs and approval of the product). However, the Proposed BPR sets out a number of changes with the aim of improving the functioning of the EU single market as regards biocidal products. Firstly, the Proposed BPR establishes a new EU centralised system of authorization whereby the Commission/ECHA, rather than the Member State authorities, shall approve certain biocidal products. Those biocidal products include: (i) products containing one or more new active substances; and (ii) low-risk (as defined in Article 17) biocidal products (Article 33). At present, it is envisaged that most biocidal products will continue to be authorised at the Member State level in the short term. However, following the incorporation of Parliamentary amendments to the Proposed BPR to broaden the definition of ‘low-risk' biocidal products, as from 2017 most biocidal products are likely to be approved at the EU (i.e. Commission/ECHA) level. In any event, MSs shall retain the right to impose extra controls of the use/placement on the market of biocidal products approved. Secondly, the Proposed BPR alters the rules on mutual recognition (i.e. the process whereby one Member State recognises the product authorisation of another Member State). The Proposed BPR sets out a ‘mutual recognition procedure' whereby an applicant can either (i) apply for mutual recognition of a product authorization already granted in another MS (Article 25); and/or (ii) apply for mutual recognition of a product authorization being granted at the same time and in parallel to product authorization in another MS (Article 28). Lastly, the Proposed BPR strengthens and brings into line labelling provisions relating to biocidal products with the CLP and the DPD (Article 58). 3. ‘Exclusion criteria' and substitution The Proposed BPR also introduces new requirements regarding the inclusion of substances on Annex I BPD. Most significantly, the Proposed BPR is designed to phase out the use of substances classified as CMRs 1A or 1B under the CLP or considered as endocrine disruptors. It does this by way of the so-called ‘exclusion criteria' (Article 5). The ‘exclusion criteria' provides that active substances classified as CMRs 1A/1B or considered as endocrine disruptors can only be included on Annex I BPR if: (i) there is negligible exposure to humans under normal conditions of use; or (ii) the active substance is necessary to control a serious danger to public health, animal health or to the environment, etc and that there are no effective alternative substances or technologies available. In addition, even where an active is included on Annex I BPR, the BPR provides that the substance may be identified and considered as a ‘candidate for substitution' (Article 9). If/when a substance is considered as a ‘candidate for substitution', products containing that substance may only be authorized/re-authorized after ‘comparative assessment' with products containing substances of lower risk (Article 21). If the product containing a candidate for substitution substance presents significantly higher risk than alternatives, their authorisation will be refused or cancelled (Article 21(3)). 4. Other issues Given the enormous impact the BPD has already had on the EU biocides industry and the weaknesses identified in the October 2008 Commission report on problems associated with data protection of information submitted under the BPD review programme, free riding, etc, the Proposed BPR seeks to improve data protection provisions to prevent "free-rider and cashing in effects". Specifically, the Proposed BPR sets out provisions on letters of access (and the specific content of a letter of access) necessary to obtain data access for the evaluation of an active or product authorization etc, after 2015 (Articles 50, 83, etc). In order to prevent unnecessary testing on vertebrate animals, the Proposed BPR also contains data sharing provisions. Significantly, following the adoption of the amendments by the EU Parliament, the Proposed BPR now also contains a number of provisions relating to nanomaterials. The Proposed BPR sets out new requirements that the risks posed by nanomaterials used in biocidal products be assessed separately at the product authorization stage (Article 16), it disqualifies products containing nanomaterials from being considered ‘low risk' (Article 17) and the Proposed BPR sets out labelling requirements regarding nanomaterials contained in biocidal products (Article 47).

For more information, please contact Herb Estreicher at estreicher@khlaw.com or Marcus Navin-Jones at navinjones@khlaw.com.