Archive: Implementation of the Biocidal Products Directive
Implementation of the EU-Biocidal Products Directive (BPD) with regard to wood conservation and antifouling products
The Directive (98/8/EC) of the European Parliament and the Council was published on the 16th of February 1998 and transposed into German law through the amendment of the Chemikaliengesetz (ChemG) in June 2002. The authorisation procedure that was established in this way is subdivided into three central areas: the active substance procedure, the product procedure and the transitional rules.
The active substance procedure (e.g. approved antifouling biocides)
A key precondition for the authorisation of biocidal products is that the biocidal active substance is included in a "list of permitted active substances" that applies throughout the EU, Annex I or IA of Directive 98/8/EC.
For the purpose of the inclusion of an active substance in these annexes the applicant elaborates a dossier which includes all of the information necessary for a comprehensive risk assessment. Inter alia, extensive studies on the effect of the substance on human health, on its influence on the environment, on the exposure situation and on measures for the protection of man and the environment are submitted.
Upon acceptance of the dossier the rapporteur, in Germany this is the Federal Institute for Occupational Safety and Health, undertakes a thorough assessment in conjunction with further federal authorities. The result of this process is published as a Competent Authority Report for the purpose of commentary by other Member States, the Commission, the participant/applicant and further interested parties. The report includes – in addition to the examination and assessment of the submitted documents as well as the risk assessment performed by the rapporteur – a recommendation on the inclusion or non-inclusion of the active substance in Annexes I or IA of Directive 98/8/EC.
If unacceptable effects are recognised on the basis of the substance assessment, within the framework of the decision at European level, the inclusion of the active substance can either be rejected or only permitted to a limited extent.
The product procedure (e.g. biocidal antifouling products)
In addition to the inclusion of individual active substances in the annexes of Directive 98/8/EC, the biocide procedure is also concerned with the authorisation of biocidal products. The product authorisation procedure is based on the previous active substance procedure. A prerequisite for the successful authorisation of a biocidal product is that the biocidal active substances contained within it are included in the annexes of Directive 98/8/EC.
In this procedure the Federal Institute for Occupational Safety and Health, as the authorisation unit and specialist authority, assesses, in cooperation with other federal authorities, the risks to man and the environment posed by a product. It then takes a decision on authorisation, non-authorisation or authorisation under certain conditions. Here, too, a dossier produced by the applicant for the individual product forms the basis of assessment.
A biocidal product that only contains biocidal active substances that are included in Annex IA of Directive 98/8/EC must not necessarily pass the complete authorisation procedure. For these products a simplified procedure has been developed: the registration procedure.
The mutual recognition of the authorisation or registration can, in each case, be applied for in order to authorise the same product in further EU memberstates.
The transitional rules
In the case of "existing" biocidal active substances, the authorisation conditions arising from the active substance and product procedures only apply after a transitional period during which a decision is taken on the inclusion of the substances in the “list of permitted active substances". This means that biocidal products containing only existing active substances may, in consideration of the transitional rules, be placed on the market in Germany without authorisation or registration. Existing biocidal active substances are those that were on the market prior to the 14th of May 2000 and that were reported for the “existing active substances programme". The transitional time for the use of notified biocides has been extended from May 13, 20010 to May 13, 2013.
The first phase of this "programme for existing active substances" that is due to last until 13.05.2010 can be characterised as an investigation phase, the second phase, by contrast as the actual test and assessment phase. In connection with the first phase, in 2000 the European Commission introduced Commission Regulation (EC) No. 1896/2000 which requires the central registration of all of the active substances. For this purpose, the manufacturers were able to choose between two routes – the simple announcement ("identification") and the expression of serious interest ("notification"). Submission of a notification brought with it the obligation to make available all of the documents required for the examination and assessment of an existing active substance. Biocidal active substances that have been neither notified nor identified lost their ability to be marketed on the 14th of December 2003.
All of the substances recorded in the first phase were published in the subsequent Commission Regulation (EC) No. 1451/2007. This regulation additionally lays down the time sequence according to which active substance dossiers must be submitted for the purpose of examination and assigns active substances to the Member States so that they can fulfil their reporting duty. The sequence of the procedure for the assessment of the existing biocidal active substances is similar to that for the active substance procedure.
(The text cited above, was taken in main parts of the official homepage of the German Federal Institute for Occupational Safety and Health to guarentee exact information about this complex process)
Wood conservation and antifouling products
In the framework of the implementation of the EU-BPD the German Federal Institute for Occupational Safety and Health organized a conference on the entry into force of the directive with focus on wood conservation and antifouling products.
Bernd Daehne, LimnoMar, presented a lecture on procedures for the testing of efficacy of antifouling systems which will be an integral part of the guidelines of the Directive.
Actually, industry has been submitted to several national authorities comprehensive dossiers on notified antifouling biocides for registration. Dossiers for the following products have been submitted: Tolylfluanid, Dichlofluanid, Copper thiocyanate, Dicopper oxide, Copper, Irgarol, Isothiazolinone, Zineb, Chlorthalonil, Pyrithione zinc.This process will be going on to 2010. The registered biocides having to be published in the annex of the BPD will be the base of antifouling products which have to be approved in the future. The approval of antifouling products cannot be expected before 2012.
The recently published presentations of the conference can be downloaded as a pdf-file at the official homepage of the BAuA in German language only: www.baua.de