11 March 2008

Key Points for the Revision of the
Biocidal Products Directive (98/8/EC)

Biocides are essential for the high health and hygiene standards of our society. They ensure and enhance the quality of products and of industrial processes. As disinfectants or pesticides they afford protection against dangerous diseases or their carriers, and they are used to protect perishable materials.

However, with the current form of the Biocidal Products Directive many active substances and biocidal products – which are needed for an efficient protection of health, environment and materials – will be no longer available. A major underlying reason is that existing requirements of the Directive are too work- and cost-intensive and overly complex.

Therefore, the following improvements are necessary for an effective modernisation and simplification of the Directive:

Harmonisation of the Single Market

·The new legislation should have the status of an EU regulation with equal applicability throughout all EU Member States. This would achieve uniform implementation across Europe and, furthermore, guarantee an equally high level of protection.

·A centralised and uniform procedure for the review of active substances and for product authorisation is called for. Product authorisations should be granted Europe-wide. The Member States can apply for exemptions in justified individual cases.

Simplified procedure in product authorisation

Existing procedures and requirements for the authorisation of biocidal products are much too work- and cost-intensive and need to be simplified considerably.

·In particular, the frame-formulation concept should be brought in a much more flexible form. Regarding authorised frame-formulations, replacement should be possible not only for pigments, dyes and perfumes but also for further ingredients.

·For authorised products that do not refer to frame-formulations, certain changes to the product should be possible without highly bureaucratic procedures. Relevant binding criteria and procedures for such changes should be laid down in a guideline.

Tiered data requirements

·Tiered data requirements in product authorisation are necessary. A minimum data set should include only absolutely essential test requirements (physical-chemical data, letter of access, and proof of efficiency).

·Generally, further items of product information needed for authorisation purposes should be derived on the basis of available data on individual substances, according to the Preparations Directive (as provided for e.g. in Annex II B to the Biocidal Products Directive).

·Data requirements should be flexible and adequate. They should be oriented to available results and to exposure.

Data protection

·Inclusion of an active substance in Annex I to the Directive should be made in a company-related approach. An effective compensation rule for subsequent notifiers is essential.

·Data protection must be granted for all data that have been submitted at national levels, since the publication of the Biocidal Products Directive.

·There should be the option to revoke letters of access to active substance data. Letters of access should be required not only for submitting applications for authorisation but for the entire duration of authorisation.

Scope

·A binding, EU-wide borderline is imperative between the scope of the Biocidal Products Directive and other pieces of regulation (e.g. for medicinal products, medical devices, or pesticides).

·Imported products, which contain biocides or are treated with biocides, must be regulated similarly to products manufactured inside the EU. For reasons of health and environmental protection and competitiveness, such imported products may contain only active substances that are included in Annex I.

This position paper was jointly developed by:

·Verband der Chemischen Industrie (VCI)

·Verband Chemiehandel (VCH)

·Deutscher Schädlingsbekämpfer Verband (DSV)

·Verband Schmierstoff-Industrie (VSI)