The face of the biocides industry is undergoing a dramatic transformation with the implementation of the new Biocidal Products Directive in Europe.

The Directive has taken several years of debate to formulate and has far-reaching effects on those who make, distribute and use biocides. The new regulations are tougher than any existing legislation either within Europe or in the rest of the world.

The new Directive aims to plug the gaps that exist in current legislation. Until now there has not been an EU-wide standard for disinfectant products for example.

The new Directive was enforced as national legislation in all EU member countries by May 14th 2000.

The new Directive describes biocides as chemical preparations containing one or more active substances that are intended to control harmful organisms be either chemical or biological, but by implication, not physical means although providing purely physical control has been difficult. The classification of biocides is broken down into four main groups – disinfectants and general biocides, preservatives, pest control and other biocides and these are further broken down into 23 separate categories.

The three main goals of the legislation are to simplify and harmonise Europe’s regulatory framework for biocides, to remove trade barriers within the EU, and to improve the protection of both human health and the environment.

The Main Features Are:

• Establishment of a positive list of biocide active substances
• National authorisation of biocidal products containing active substances on the positive list
• Mutual recognition by Member States of biocidal product authorisations
• Ten-year review programme to evaluate existing active substances

Under the Directive, each product must have a ‘dossier’ that contains information on its biocidal efficacy, physical, chemical and analytical properties, toxicological and ecotoxicological properties, environmental effects and, where appropriate, any effects it has if brought into contact with food. The aim is to establish that the biocide is sufficiently efficacious without having unacceptable effects. Data must be submitted in accordance with the data requirements in Annexes II and III of the Directive.

All new active substances are required to follow this approval process from May 14th 2000. Existing biocidal products can continue to be marketed if they were identified or notified by 28th March 2002 while their active substances are reviewed under the EU program. The European Chemicals Bureau (ECB) has produced an indicative non-exhaustive list of existing active substances. This list contains 1506 possible entries. It is available at the ECB website. Note the list has no legal status and is for guidance only. Any active substances not marketed by May 14th, 2000, together with any products containing them, are considered as ‘new’ and have to meet the various provisions of the Directive before they can be marketed in the EU.

All new active substances will need extra data which satisfy the requirements in Annexes II and III of the Directive. Assessing data for existing products brings it’s own problems. Although the ‘core data’ requirements have been defined (in Annex II of the Directive), some information may not be necessary either because of the nature of the substance, it’s use pattern, or because testing is scientifically unnecessary or technically impossible. These data waivers have to be justified on a case-by-case basis. Specific additional data requirements will apply to the 23 biocidal categories, and criteria for selection of these extra tests have been developed as Technical Notes for Guidance.

Let us help you with our ‘turn-key’ complete service:

• Literature searching for public domain date on the active substance
• Evaluation of available studies and any literature data for existing actives
• Advising on the use of surrogate data
• Designing testing programs to minimise cost
• Full testing service – Analytical and Physical Chemistry, Toxicology, Ecotoxicology, Metabolism and Environmental Fate
• Preparing dossiers in electronic format
• Liaison with regulatory authorities

SafePharm Laboratories can conduct or arrange any necessary additional studies for you. Our Project Management Department ensures the testing programme meets your target completion date, and liaises closely with the Registration staff assigned to your project. Quotations for the Registration services and testing are available on request.

We firmly believe that the use of our considerable expertise will enable companies to save time and money in complying with the Biocidal Products Directive.

The Key Elements that SafePharm can bring to this process are:

• Minimising testing costs
  We offer discounts on our standard prices for testing packages involving multiple compounds
• Effective project management
  To ensure testing programmes are completed on time and within budget
• Reducing workload of our sponsor companies