Questions and answers on the new biocides regulation
European Commission - MEMO/09/275 12/06/2009
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Brussels, 12 June 2009
Questions and answers on the new biocides regulation
The new regulation on the use and placing on the market of biocidal products will repeal and replace the current directive on biocides (98/8/EC). It will enter into force on 1 January 2013.
What are biocidal products?
Biocidal products contain or generate active substances and are used against harmful organisms such as pests and bacteria. They are used both to protect human and animal health. They include household products such as disinfectants, rodenticides, repellents, and insecticides. Others are used in more industrial applications as wood and material preservatives, anti-fouling paints, and embalming products to avoid damage to natural or manufactured products.
Due to their intrinsic properties and uses, biocidal products may themselves pose health risks and be harmful to the environment. It is vital therefore to ensure that only biocidal products safe for use are placed on the market.
What are the main differences between the current directive and the new regulation?
The new regulation increases the protection of health and environment, while being more efficient at the same time, notably through the active involvement of ECHA. It will retain the two-step authorisation process brought in by the current directive, whereby active substances are first tested and approved and included in a Community list (known as the Annex I), with subsequent authorisation of a product containing the active substance.
The scope has been extended to cover articles and materials treated with biocidal products, including furniture and textiles. The regulation will also apply to active substances generated in situ, and to biocidal products used in materials that come into contact with food. But other products that are sufficiently covered by existing legislation (including food and feed, food and feed additives and processing aids) are excluded from the scope of the new regulation. Biocidal products approved under the International Convention for the Control and Management of Ships' Ballast Water and Sediments are considered as authorised.
Product authorisation and mutual recognition
Under the current Directive, all biocidal products are authorised at Member State level. This will change for two types of biocidal products – biocidal products based on new active substances and low-risk biocidal products – which will have access to a Community authorisation allowing them to be placed on the market throughout the Community. All other biocidal products will still be subject to national authorisations issued by Member States.
There will also be further changes to the rules on mutual recognition, the process whereby an authorisation in one Member State may be recognised by another Member State. Under the regulation, it will be possible to apply either for a mutual recognition of an existing authorisation, or for a mutual recognition which runs in parallel to the first authorisation process. The new regulation will also clarify the conditions for obtaining a parallel trade permit.
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, data requirements will be more aligned with the actual needs of the evaluating authorities. It will become possible to waive requirements if data is not scientifically necessary, if it is technically impossible to supply, or if it is not relevant (there is no need for marine toxicity studies, for example, if a product is reserved for use on dry land). It will no longer be possible to repeat tests that have already been carried out on vertebrate animals, and information gained from such tests must be shared, in exchange for fair compensation.
What active substances will be phased out?
The proposed regulation sets out 'exclusion criteria' to prevent authorisation of active substances with very poor hazard profiles, including substances that can cause cancer, mutations, reproductive problems and hormonal imbalances.
In future, such substances will only be allowed for use provided that:
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.
Biocidal products with problematic active substances will also be compared to ensure that only the products with the lower risk remain on the market.
How will the rules on the inclusion of active substances change?
There is a need to ensure equality of treatment for active substances evaluated before and after the entry into force the new regulation. It is therefore proposed that substances still being evaluated under the old rules on 1 January 2013 should continue to be evaluated under the same rules.
The changes introduced by the new regulation, including the data requirements, data waiving, obligatory sharing of vertebrate animal data and so forth will only apply to active substances whose evaluation starts after 1 January 2013.
The new proposal will not affect the rules on the examination of existing active substance (those on the market on 14 May 2000) laid down under Regulation (EC) No 1451/2007.
How will the rules on Community-wide authorisation work?
Community authorisation will be available for two types of biocidal products: those based on new active substances, and low-risk biocidal products. Such authorisations will be granted by the European Commission, and will allow products to be placed on the market across the EU without any need to apply for separate national authorisations or the mutual recognition process.
Applications for a Community authorisation will be submitted to the European Chemicals Agency (ECHA) and to a competent authority of the applicant's choice. The competent authority will evaluate the application and send its conclusions to ECHA for an opinion. The Commission will then decide whether a Community authorisation can be granted, and if so under which conditions.
Community-wide authorisations should stimulate innovation and the development of new and improved products.
What will be the impacts on animal?
The proposal strives to minimise animal testing as far as possible Vertebrate tests may not be repeated, and a new obligation to share data involving vertebrate animal tests will come into force. This means that data owners will be obliged to share their data, in exchange for fair compensation.
The regulation will also encourage the sharing of data from other types of animal tests, with a view to reducing the overall costs and avoiding the duplication of tests..
What will be the tasks of ECHA under the new Regulation?
The European Chemicals Agency (ECHA) will coordinate the active substance evaluation for new and existing active substances, the re-assessments of the already approved active substances in light of available new information, and some related evaluation work.
The agency will also play a key role in the centralised authorisation of products. ECHA will be in charge of coordinating the technical and scientific work of this new centralised authorisation process. In the event of any disputes between over mutual recognition between the Member States or the Member States and applicants, ECHA will provide the Commission with technical and scientific support.
ECHA will intervene in cases of disagreements about data sharing from vertebrate animal tests. ECHA will also be responsible for maintaining the relevant databases and other administrative and scientific tasks, such as coordinating the meeting of experts reviewing the draft risk assessments reports prepared by the Member States in the context of the review programme of the biocidal active substances.
What are the costs and benefits of this proposal?
Compared with the existing rules, the only change involving additional costs to the industry concerns the extension of the scope to treated articles and materials. These costs will mainly result from the inclusion of further active substances in Annex I and the compliance with the labelling obligations. But it should be noted that according to the impact assessment carried out to evaluate the proposal, the environmental and human health benefits of extending the scope to treated articles and materials will easily outweigh the costs.
The other measures introduced by the proposal, such as improved authorisation procedures, including the Community authorisation, obligatory data sharing for vertebrate animal data and streamlining the data requirements, will result in significant cost savings. The reduction of financial and administrative burden was also one of the main objectives of this proposal. However, this proposal shows that these savings can be achieved without compromising the high level of environmental and human health protection.