Brussels, 12 June 2009
Environment: Commission proposes to improve the safety of biocides and to simplify authorisation procedures
The European Commission has today presented draft legislation to achieve a higher level of protection of health and environment. This proposal aims at significantly increasing the safety of biocide products used and placed on the market in the European Union. It proposes to phase out the most hazardous substances, particularly those that may cause cancer, and to introduce new rules for articles such as furniture and textiles treated with biocides, which are not covered by existing legislation. It introduces simplified legislation, whilst providing new incentives for companies to develop safer products against harmful pests and germs. . The Helsinki-based European Chemicals Agency (ECHA) will be involved in the authorisation of some of these products through a centralised approach. The proposal should enter into force in 2013.
European Commission Vice-President Günter Verheugen, responsible for Enterprise and Industry and European Environment Commissioner Stavros Dimas jointly stated: "Biocides play a crucial role in controlling the spread of harmful organisms, but they must not be allowed to jeopardise the safety of European citizens or the environment. This new proposal will ensure that only safe, authorised products are made available throughout the Union, and that the most dangerous substances are kept out of our market. I am confident that these proposals will bring considerable benefits for European citizens and industry."
Good news for environment and health
Biocides are used to suppress organisms such as pests and germs (i.e. moulds and bacteria) that are harmful to human or animal health, and include insect repellents, disinfectants and industrial chemicals such as anti-fouling paints for ships and material preservatives. This proposal revises the 1998 directive on biocides and addresses a number of weaknesses that were identified during its implementation. It aims at further reducing the risks posed by biocidal products and now extends the scope of the legislation also to devices which produce biocides and to biocides in materials that might come in contact with food.
The Commission proposal introduces new criteria to prevent the use of the most hazardous active substances, particularly if they cause cancer or fertility problems, and replaces them with safer alternatives wherever possible. Products containing identified substances of high concern will be subject to comparative assessment so that the products with the highest risk will be eliminated and only safe products remain on the market.
The new rules will also apply to articles that have been treated with biocides, for example to preserve the quality and function of furniture and clothing; they may only be treated with authorised biocides. Treated articles will be labelled with warnings so that consumer could make an informed choice and could protect children and allergy sufferers, where there is a risk.
Some biocides to be authorised at EU level
To promote the use of low-risk biocides and newly discovered substances, the Commission is proposing their authorisation at EU level. This centralised authorisation should ensure that such products are more easily available throughout the entire EU market. ECHA, which is already responsible for managing REACH, will carry out scientific and technical tasks related to this type of authorisation.
ECHA will also coordinate the activities for the scientific risk assessment of active substances. The task was until now carried out by the Commission Joint Research Centre in Ispra (Italy).
Most biocidal products will continue to be authorised by Member States. Rules on the mutual recognition of existing authorisations will be simplified to speed-up decision-making, facilitate access to the market of other EU Member States, and to avoid duplicating work.
As the proposal will turn the existing directive on biocides into a regulation, no transposition into national law will be required, as regulations are directly applicable in Member States. The new regulation will repeal and replace the current directive on biocides.
Avoiding unnecessary tests
The new proposal will further reduce tests on animals. Under the new rules, tests on animals may only be conducted once. As is already the case with REACH, the Community's chemicals legislation, companies requesting authorisation will be required to share results of animal tests in return for fair compensation. In addition tests proving the safety and efficiency of a biocidal product will only be requested in cases of actual need. Data protection rules will also be made more consistent and transparent.
The EU policy on biocides:
European Chemicals Agency (ECHA):