Brussels, 30/08/2013 (Agence Europe) - The new European regulation on marketing authorisation for biocidal products in the European Union takes effect as of 1 September. It was adopted in May 2012 in order to increase the safety of insecticides, disinfectants and insect repellents (but not agricultural pesticides and medicines) and to simplify the marketing authorisation procedure (see EUROPE 10657).
“This regulation is another step towards ensuring that only safe, authorised products are made available throughout the EU. The simplification of authorisation procedures will bring significant economic benefits to companies while ensuring a high level of environmental protection for citizens”, said Janez Potocnik, European Environment Commissioner, in a press release published on Friday 30 August.
Companies will now have two possibilities. On one hand, they may submit a request for authorisation to the European Chemicals Agency (ECHA) which, if the product is deemed safe, will allow them to obtain authorisation and to sell the product in question throughout EU territory (large companies are most likely to resort to this procedure). On the other hand, they may submit a request to the relevant national authority with a view to selling a product in their country of origin and, if authorisation is given, they may then market the product in other member states in accordance with the principle of mutual recognition of authorisation (a procedure that will no doubt be preferred by small and medium-sized enterprises as it will reduce the burden of red tape). The regulation covers not only biocides but also goods and materials treated with biocidal products, such as furniture and food packaging. The new provisions should also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A specialised IT platform (the “Register for Biocidal Products”) will be used for submitting applications and recording decisions, and also for disseminating information to the public. The European Commission considers that ultimately the new regulation should allow the sector to save €2.7 billion over ten years. The regulation is the first piece of EU legislation to integrate the new definition of nano-materials established by the European Commission. (AN/transl.jl)