EC Proposes Rules to Improve Safety of Biocides
June 13, 2009 // Published as a news service by IHS
On June 12, the European Commission (EC) presented draft legislation aimed at significantly increasing the safety of biocide products in the European Union (EU).
The proposal phases out the most hazardous substances, particularly those that may cause cancer, and introduces new rules for articles treated with biocides, such as furniture and textiles, which are not covered by existing legislation.
It introduces simplified legislation, while providing new incentives for companies to develop safer products against harmful pests and germs.
The European Chemicals Agency (ECHA) will be involved in the authorization of some of these products through a centralized approach. ECHA is already responsible for managing the regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in the EU.
The proposal should enter into force in 2013.
Günter Verheugen, EC vice president responsible for Enterprise and Industry, and Stavros Dimas, EC environment commissioner, 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, authorized 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 (including moulds and bacteria), that are harmful to human or animal health. They include insect repellents, disinfectants and industrial chemicals, such as anti-fouling paints for ships and material preservatives.
The new proposal revises directive 98/8/EC, 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 extends the scope of the legislation to devices that produce biocides and to biocides in materials that might come in contact with food.
The EC's 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; such articles may only be treated with authorized biocides. Treated articles will be labeled with warnings so that consumer can make an informed choice to protect children and allergy sufferers, where there is a risk.
Some Biocides to be Authorized at the EU Level
To promote the use of low-risk biocides and newly discovered substances, the EC is proposing their authorization at the EU level. This centralized authorization should ensure that such products are more easily available throughout the entire EU market.
ECHA will carry out scientific and technical tasks related to this type of authorization. ECHA will also coordinate the activities for the scientific risk assessment of active substances. The task was until now carried out by the EC's Joint Research Centre in Ispra, Italy.
Most biocidal products will continue to be authorized by EU member states. Rules on the mutual recognition of existing authorizations will be simplified to speed up decision-making, facilitate access to the market of other member states and 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 be conducted only once. As is already the case with REACH, companies requesting authorization 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.
Further Information
For more information, see the EC's web site on Biocidal Products and the web site for the European Chemicals Agency.
Source: European Commission (EC).