Regulatory Compliance > Legislative requirements for Biocides

The Biocidal Products Directive (98/8/EC) requires all biocidal active ingredients placed on the market to be authorised. Authorised biocides are listed in Annex I of the Directive. All applications of those actives in biocidal products must also be authorised.

In order to be added to Annex I, a full technical dossier containing information on the properties of the substance must be submitted to the appropriate Competent Authority. The core data requirements are similar to those for notification under REACH, including data on intended uses and efficacy on target organisms. Additional data may be required dependent on the characteristics of the substance or the product type in which it is used. A technical dossier must also be prepared for products containing biocidal actives.

Existing biocidal actives and products, sponsored by industry under the First Review Regulation, were subsequently published in the Second Review Regulation in November 2003. Over a period of 10 years, these existing substances will be evaluated for possible inclusion on Annex I. The third and fourth review Regulations (2005 and 2006) Evaluation involves submission of the full dossier including test reports and active substance risk assessment. Evaluation has started for wood preservatives and rodenticides. Actives and products not included in the Second Review Regulation will have to be withdrawn from the market.

Further information on the Directive and testing requirements can be obtained from the website of the European Chemicals Bureau (http://ecb.jrc.it/biocides/).

One of the key elements of the evaluation process is risk assessment, in order to ensure that a biocidal product does not pose an unacceptable threat to non-target organisms. The principles of risk assessment of biocides are similar to those used under REACH. The risk assessment is undertaken following the Technical Guidance Document (TGD) available from http://ecb.jrc.it/tgd/.

Biocidal products are categorised into 23 different product types such as wood preservatives, disinfectants or slimicides. Emission Scenario Documents, describing each use and default emissions to the environment, are being developed for each product type. These are complete for some product types and are included in the TGD and implemented in EUSES 2.0. Click here for the full list of product types, and here for Emission Scenario documents.

Peter Fisk Associates has extensive experience in the field of environmental risk assessment. Click here for details of some of the services we offer or contact us for further information.

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