Brussels, 17 July 2012
Environment: Safer regulation for biocidal products
New rules on biocides enter into force today. They will bring a significant boost to the protection of human health and the environment. Biocidal products are necessary for the control of organisms that are harmful to human or animal health or that cause damage to materials. But as their properties can also pose risks to humans, animals and the environment, they need careful regulation. The new regulation on biocidal products will increase the safety of these chemical products and simplify their authorisation on the EU market, improving their free movement on the internal market.
Environment Commissioner Janez Potočnik said: "This is another step to guarantee a high level of protection for citizens' health and the environment. It is designed to ensure that only safe products are made available and that the most dangerous substances are kept out of our market. By simplifying authorisation, the new regulation will bring considerable economic benefits to European companies."
Biocidal products are part of everyday life. They include disinfectants used at home or in hospitals, rat poison, insect repellents, anti-mould sprays and paints, water purification tablets and many other products. These products have been subject to EU law since 1998, and since that time almost one thousand products have been authorised under the biocidal products directive.
The European Commission has reviewed the Biocides directive and concluded that the authorisation processes for active substances and products could be simplified and streamlined. The new regulation offers more efficient provisions for the authorisation of products, the requirements and sharing of product-related data. It will save industry an estimated 2.7 billion euros over a period of 10 years.
The new provisions also reduce animal testing by making data sharing compulsory and encouraging a more flexible and integrated approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public.
Protection will also be extended as the new legislation will now include goods and materials which are treated with biocidal products, such as furniture and food packaging.
The European Chemicals Agency (ECHA) will be given a key role in the administration of this regulation. One of the main advantages lies in the scale of resources ECHA will provide. Currently, resources are extremely limited at both national and European level, leading to delays in authorisation and increased costs for industry. ECHA is being allocated 100 staff dedicated to work on biocides activities. The number of opinions it will deliver is expected to increase from 80 in 2014 to 300 in 2020.
The Regulation becomes applicable on 1st September 2013. From that date onwards, companies will have two options to request permission to place their products on the market. The first, which is likely to be used by large firms, requires companies to submit an application to ECHA and if the product is judged safe, it may be sold throughout the EU. The second may appeal more to the numerous small and medium-sized enterprises in this business, as it requires companies to submit an application to their own national authority, to sell a product in their home country. If the authorisation is granted, they can subsequently put the product on the market of other Member States, according to the mutual recognition principle.
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