Biocidal Product Authorisations under the BPD (98/8/EC) and existing national legislation

Biocidal products play a vital role in controlling organisms that are harmful to man and animals and they play a key role in protecting both manmade and natural products from damage and decay.  Biocidal products are used in industry and in the home and  include disinfectants, insect repellents, drinking water disinfectants and the preservatives used to protect a wide range of finished products and raw materials (including wood, paints, textiles etc).  Many biocidal products are currently regulated under existing national systems but with the introduction of the Biocidal Products Directive (BPD) a harmonised system of control has been introduced across the EU.

The initial stages of the BPD have focused on the evaluation of active substances. This process has now been completed for a number of active substances which have been thoroughly evaluated and have been successful in achieving Annex I inclusion. The publication of the Annex I inclusion decision for an active substance triggers the next phase of the BPD which is biocidal product authorisation.

At date of writing there have been 35 Annex I inclusions and one Annex IA inclusion (for inclusion in low risk products) published (for latest list see: http://ec.europa.eu/environment/biocides/annexi_and_ia.htm ).  These first Annex I inclusions are for the groups of active substances to be evaluated first  i.e. wood preservatives (PT 8), rodenticides (PT 14), insecticides (PT 18) and one slimicide (PT 14).

A large number of other biocidal active substances are coming towards the end of the evaluation process.  Active substance draft Competent Authority Reports (dCAR’s) have been made available for 28 insecticides, 27 wood preservatives, 12 rodenticides, 7 repellents / attractants, one in-can preservative and the first PT 2 disinfectant.  As the BPD review program continues more dCAR’s will become available and more Annex I inclusions decisions will be published.

BPD product dossiers must be submitted within 2 years of the publication of the Annex I inclusion for products (in the case of biocidal products containing more than one active substance the 2 year deadline is from the Annex I inclusion of the final active substance in the formulation). If this is not done the biocidal product must be removed from the market.

While far less complex than active substance dossiers, biocidal product dossiers can still be complex and will require a thorough understanding of the chemistry, toxicology, ecotoxicology / fate and efficacy of your product. Data will need to be provided to support any efficacy claims you make and may also be needed for toxicity and ecotoxicity. Waivers of data requirements may be possible and the development of intelligent testing strategies will help to minimise costs and prevent unnecessary testing.

Letters of access to the active substance dossier will be needed and will require negotiation with active substance manufacturers. A risk assessment will always be required for applications for authorisation therefore a thorough understanding of both the use (exposure) and hazard of your individual product will be needed together with knowledge of appropriate risk assessment tools.

Other issues that need to be considered are how to apply for mutual recognition if you are intending to market in a number of member states.

Don’t forget that until Annex I inclusion of an active substance the existing national rules still apply. These national rules vary from member state to member state and will be dependent on the type of biocidal product. It is important to be aware that the situation is further complicated as certain member states have adopted certain aspects of the BPD earlier than others. These may include poison centre notification, BPD labelling requirements, advertising restrictions and declaration for national registers. In the UK an industry wide fee also applies (General Industry Charge). It is therefore vital to be aware of each country’s specific requirement before attempting to market biocidal products within the EU.

Remember that REACH will apply to any co-formulants that you use in your biocidal products and that CLP notification may also be needed.  See our web pages for advice in these areas.

JSC can help you to understand the implications of the BPD for your company and your products and to help you plan for the future as well as ensuring regulatory compliance today.

Please contact JSC International for further information on BPD biocidal product authorisation requirements or for any assistance you may need to meet your current national obligations.

JSC International Limited, Simpson House, Windsor Court, Clarence Drive, Harrogate, North Yorkshire, HG1 2PE tel: 01423 520245 enquiries@jsci.co.uk   www.jsci.co.uk