Biocides ("bios" = Greek "life", "caedere" = Latin "kill") are literally substances that destroy organisms. A large number of products for combating harmful organisms now exist. Such organisms range from insects and rodents through to mussels and also include viruses, bacteria and fungi. Care should be taken when handling biocides due solely to their effect.
As early as 1989 the Council of the European Communities asked the Commission to draw up a community-wide strategy for the placing on the market and use of biocidal products, in particular, wood preservatives. This was against the background of some very varied regulations in the Member States. Furthermore, the use of biocides had repeatedly caused health and environmental problems. However in only a few cases had this resulted in measures taken and bans on their use and then only after the damage had been caused. The authorisation procedure was intended to reverse the weight of evidence. The biocidal products should only be placed on the market and used once the competent authority has determined that their use will not have unacceptable effects on human health and the environment.
The Biocidal Products Directive 98/8/EEC of the European Parliament and the Council was published on 16 February 1998 and transposed into German law through the amendment of the Chemicals Act (ChemG) in June 2002.
Responsibilities of the Authorisation Unit
The Biocidal Products Directive regulates the authorisation and placing on the market of biocidal products for use on the European market. With the change to the Chemicals Act the BAuA is designated as the Authorisation Unit and is in charge of the assessment of the occupational safety and health in the authorization procedure.
The core of the Biocidal Products Directive is formed by two application procedures:
- Application for a biocidal active substance to be included in the annexes of the Directive
- Application for authorisation and mutual recognition of biocidal products
The Authorisation Unit - Division 5 of the Federal Institute for Occupational Safety and Health (BAuA) - is responsible for implementing the procedure without discrimination or legal error. Furthermore, it coordinates the process, assesses the completeness and plausibility of the documents submitted, evaluates both the effectiveness and chemical identity as well as the physical-chemical properties. In addition, that all biocidal products that are to be marketed in Germany must be notified to the Authorisation Unit within the framework of the Biocidal Products Notification Ordinance
As the competent national authority the BAuA is represented in the relevant European committees for the harmonised implementation of the Biocidal Products Directive. This includes the meeting of the competent authorities (CA Meeting), which is responsible for the interpretation of the Directive and harmonises the overall evaluation of biocidal active substances. In addition, the Regulatory and Administrative Committee prepares decisions. A Technical Meeting was set up to serve as an additional institution. Here experts mainly discuss issues relating to the evaluation of substances and prepare recommendations on scientific and technical issues. Further working groups at the European level have been set up from the CA Meeting. For example, the Product Authorization and Mutual Recognition Facilitation Group (PA&MRFG), the aim of which is to formulate the procedure for national product authorisation and for mutual recognition.
Finally the BAuA is also involved in the OECD Task Force on Biocides, which is currently concentrating on the areas of the assessment of effectiveness and producing environmental exposure scenarios.
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
Federal Institute for Occupational Safety and Health
Unit 5.3 "Authorisation of Biocides"
Postbox 17 02 02
Fax +49 231 9071-2679