The placing on the market and use of biocidal products are prescribed in Regulation (EU) No. 528/2012 , which since September 2013 replaces the Biocidal Product Directive 98/8/EC. Biocidal products are active substances and preparations containing one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmable organism by chemical or biological means. Harmable organisms can be animals, plants or microorganisms including fungi and viruses. The European Biocidal Product Regulation determines a step-wise assessment of "existing biocidal active substances" placed on the market before 14 May 2000. Only those active substances that fulfill the requirements are included in the list of accepted active substances. Low-risk active substances are included in Annex I of the BPR. Biocidal products containing exclusively active substances listed in Annex I may be subjected to a simplified authorization procedure. The work programme for the systematic examination of existing active substances is described in Regulation (EU) No 1062/2014. Successively also the biocidal products, which also means the preparations, will be assessed and subjected to an authorisation procedure.
The website of the German Federal Institute for Occupational Safety and Health (BAuA) is providing continuous information. The BAuA as competent authority supplies downloads of several guidance documents for the authorisation of biocidal products and for dossier preparation on active substances. The national register on biocidal products can be used at the website of the BAuA.
Biocidal Products are assigned to one of 22 different product types (PT), which are described in Annex V of the Biocides Regulation. These PTs are divided into four main groups:
In Germany biocidal products against fish, birds and other vertebrates that do not belong to rodents can not be authorised (§4 ChemBiozidZulV). Products that are not defined within the scope of Biocidal Product Directive are human and veterinary medicinal products, food additives, cosmetic products and plant protection products, among others.
Information about the implementation of the Biocidal Product Regulation and the Review Programme for the evaluation of existing active substances is available from the websites of the European Chemmicals Agency (ECHA).
Hydrotox GmbH has carried out several projects regarding biocides already long before the Biocidal Product Directive has been adopted. Among them, we have realized two projects for the German Federal Environment Agency (UBA) concerning Disinfectants in hospitals and cooling water conditioning agents. Since 2004 Hydrotox is participating in several projects for the Federal Institute for Occupational Safety and Health (BAuA), as competent authority, and for the German Federal Environment Agency (see projects). The German Federal Environmental Agency provides a biocide web-portal with information on alternative measures to biocidal use (up to now only in German language available). Hydrotox has been involved in several projects on behalf of the European Commission dealing with the impact of the Biocidal Product Directive and possible amendments to the Directive.
Dr. Stefan Gartiser