Proposed new rules for marketing biocidal products in the EU
On June 12, 2009, the European Commission published plans for a major revision of the EU regime for the authorization of biocidal products (i.e., referred to as "pesticides" in the U.S.), in the form of a draft regulation. The proposed regulation would replace the current Directive 98/8/EC concerning the placing of biocidal products on the EU market. Biocidal products contain or generate active substances and they are used against harmful organisms such as pests or bacteria. They include household products such as insecticides, rodenticides, repellents, and disinfectants, or products used in more industrial applications, such as anti-fouling paints, wood and material preservatives, and embalming products (i.e. products designed to avoid damage to natural or manufactured products).
The proposed new rules affect manufacturers, users, suppliers and distributors of biocidal products, as well as articles containing biocidal products, that are placed on the EU market. This is a critical time for the biocides industry to acquaint itself with the rules which are expected to take effect on January 1, 2013. In some cases, companies may find that more of their product line is subject to the proposed rules. For those companies that may be adversely affected by the application of the more restrictive rules proposed, there still remain opportunities to shape the content of the final text. Additionally, the new proposed procedures may make it easier to market certain products concurrently in several EU Member States, thus offering new business opportunities.
Under the proposed regulation, the two-step authorization process brought in by the current Directive would remain. This means that active substances will continue to be first tested and approved and consequently included in an EU list (known as the Annex I), followed by subsequent authorization of a product containing the active substance.
The main changes under the proposed regulation are set out below.
- Scope : the rules would be extended to cover all articles and materials treated with biocidal products, including textiles and furniture. Under the current regime, if an article is treated in the EU then only authorized biocidal products may be used; however, if the article is treated with a biocidal product outside the EU and then imported, there is no control over the substance it may incorporate. In order to close this "loophole", under the proposed regulation, articles and materials could only be marketed in the EU if they have been treated with biocidal products authorized for that purpose by an EU Member State.
- The proposed regulation would also apply to active substances generated in situ (i.e. active substances that are only produced by the addition of other substances when the product is to be used) and to biocidal products used in materials that come into contact with food. New product labeling requirements would also be introduced.
- EU wide-authorization : under the current Directive, all biocidal products are authorized at Member State level and companies marketing in more than one Member State are obliged to apply for mutual recognition of authorization from other Member States. In contrast, under the new proposal this system would change for two types of biocidal products - those deemed to be "low-risk" and those that contain one or more new active substances - which would be authorized at EU level. Under this centralized authorization, companies are therefore expected to find it simpler to place these two categories of products on the EU market.
- Mutual recognition by EU Member States : all other biocidal products would still be subject to national authorizations issued by Member States. However, there would be further changes to the rules on mutual recognition. For example, it would be possible to submit an application for mutual recognition of a biocidal product which runs in parallel to the first authorization process.
- Parallel trade provisions : a parallel trade permit would be introduced whereby authorized biocidal products that have substantially identical composition to products authorized in another Member State could be placed on the market of that other Member State via a simplified administrative procedure. A parallel trade permit would be able to respond to specific demands for imports of biocidal products, although unlike mutual recognition, it is likely to be limited to trade between two Member States, a specified quantity and a particular timeframe.
- Data requirements : under the current Directive, the same set of data must be submitted for all biocidal products, not all of which is always necessary. Under the proposed regulation, it would be possible to waive requirements if data is: not scientifically necessary, technically impossible to supply, or not relevant. Furthermore, it would no longer be possible to repeat tests that have already been carried out on vertebrate animals, and information from such tests would have to be shared by companies in exchange for fair compensation.
- Exclusion criteria for the phase out of active substances : exclusion criteria would prevent the authorization of active substances with very poor hazard profiles, including substances that are carcinogenic, mutagenic or reprotoxic ("CMRs") or are hormone disrupters. Such substances would only be authorized provided that: human exposure is negligible, the substance is necessary to control a serious danger to public health, the effects of banning the active substance would be disproportionate to the impact on human health or the environment, and no alternatives exist.
- New role for ECHA : applications for EU-wide authorization for biocidal products that are low risk or contain new active substances would be submitted to the European Chemicals Agency ("ECHA") and to a competent national authority of the applicant's choice. The competent authority would evaluate the application and send its conclusions to ECHA. ECHA would then submit its opinion to the European Commission which would decide whether the authorization should be granted, and if so under what conditions.
- Furthermore, in the event of any disputes between Member States or between Member States and applicants over mutual recognition, ECHA would provide the Commission with technical and scientific support. ECHA would also intervene in cases of disagreements about data sharing from vertebrate animal tests.
Companies should note that substances still being evaluated under the current rules (i.e. Directive 98/8/EC and, where relevant, Regulation (EC) 1451/2007) when the new regulation enters into force would complete evaluation under the older rules.
In order for the proposed regulation to become law, the European Parliament ("EP") and the Council (composed of representatives from the 27 EU Member States) have to reach an agreement on the text of the regulation. Discussions between the EP and the Council are expected to take place during the course of 2010. Thus, stakeholders interested in impacting the final text should consider the next few months as the opportune moment for making potential approaches to the appropriate EU decision-makers, in particular Council officials and Members of the EP ("MEPs").
Assuming an agreement is reached between the EP and the Council, the new regulation is scheduled to take effect from January 1, 2013.
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