Authorisation procedure for biocides
The information presented here refers to the old regime under the Biocidal Products Directive (EC/98/8), which was valid until September 1st 2013. Since September 1st 2013 the Biocides Regulation (EU) No 528/2012 is applicable.
Information on the legal situation and the procedures under the Biocides Regulation (EU) No 528/2012 can be found on the website of the newly established REACH-CLP-Biozid Helpdesk (www.reach-clp-biozid-helpdesk.de).
Biocides ("bios" = Greek "life", "caedere" = Latin "kill") are quite 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 to their effect alone. The area of use, the dose and, if appropriate, the necessary protective measures must be clearly and immediately recognisable to all users from the packaging. The aim of the Biocide Directive of the European Parliament and the Council was therefore to ensure the protection of consumers, workers and the environment.
As early as 1989 the Council of the European Communities asked the Commission to elaborate a community-wide strategy for placing biocidal products, in particular, wood preservatives, on the market and using them. In addition, the use of biocides had repeatedly resulted in environmental and health-related problems. Only in particular cases, and then only after damage had occurred, had they resulted in measures being taken and prohibitions of use being introduced. The introduction of an authorisation procedure was intended to ensured that the burden of proof was reversed. Only after the Competent Authority had established that unacceptable effects on man and the environment do not occur were biocidal products to be placed on the market and used.
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 complex and is subdivided into three central areas: the active substance procedure, the product procedure and the transitional rules.
The active substance procedure
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
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 first phase of this "programme for existing active substances" that is due to last until 13.05.2014 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.
|14th December 2003|
Marketing ban for all biocidal products containing active substances that have been neither notified nor identified.
|1st September 2006|
Marketing ban for all biocidal products containing
|Up to the 13th of May 2014 at the latest|
Admissibility of placing on the market biocidal products which contain only notified active substances and belong to a product type for which notification has been accepted.
(Article 4 of Commission Regulation (EC) No 1451/2007)
Marketability of biocidal products
As a consequence of Directive 98/8/EC, biocidal products may, as a matter of principle, only be sold in the EU after official authorisation. During the transitional period, the marketing of products without authorisation is only still permitted if all of the biocidal active substances contained within them are examined within the framework of the existing active substances programme. In addition, manufactures and importers must fulfil the demands of certain transitional rules: all biocidal products must be notified to the Federal Institute for Occupational Safety and Health (BAuA) in accordance with the Biocide Notification Ordinance. Products that have been notified properly receive a BAuA registration number which must be affixed to the product. However, this notification must not be confused with the authorisation of the products. It must be applied for independently.
Take a look on the topic: Biocide Notification Ordinance
Separate rules apply in the case of the advertising of biocidal products. Each advertisement must include the phrases "Biozide sicher verwenden. Vor Gebrauch stets Kennzeichnung und Produktinformationen lesen (Use biocides safely. Always read the label and the product information before use)". These phrases must stand out clearly from the rest of the advertising. Advertising for a biocidal product must definitely not include the information "low-risk biocidal product", "non-toxic", "harmless" or other such references which play down potential risks.
In addition, biocidal products must be classified, packaged and labelled properly, i.e. they must be provided, inter alia, with the relevant danger symbol, indication of danger, risk and safety phrases. Labelling must not be misleading nor convey an exaggerated impression of the product. Information such as "low-risk biocidal product", "non-toxic", "harmless" or similar is prohibited. The aim of these rules is to provide users with comprehensive, correct information in relation to the safe handling of the products.
Finally, it is also necessary to make an announcement to the poison information and treatment centres belonging to the Federal Institute for Risk Assessment.
Further statutory rules apply in the case of some biocide products. Examples of this are the Drinking Water Ordinance and the authorisations at the Deutsches Institut für Bautechnik.
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