Higher level of protection of health and environment on biocide products

The European Commission presented on June 12th 2009, a draft legislation to improve the safety of biocides and to simplify authorisation procedures, by 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.

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.

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. The proposal should enter into force in 2013.

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.

Simplified legislation and authorisation at EU level

This new regulation introduces simplified legislation, whilst providing new incentives for companies to develop safer products against harmful pests and germs.

To promote the use of low-risk biocides and newly discovered substances, the Commission is proposing their authorisation at EU level. The Helsinki-based European Chemicals Agency (ECHA) will be involved in the authorisation of some of these products through a centralised approach. This centralised authorisation should ensure that such products are more easily available throughout the entire EU market. ECHA, which was inaugurated in June 2008 and 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).


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 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.