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The Admission Procedure For Biocidal Active Substances

Biocidal legislation: The admission procedures for biocidal active substances for the users of these substances has resulted in that the substances only for a transitional period in biocidal products may be used. Then the active substance listed in the annex is considered so-called new active ingredient, which requires a licence. There is only the opportunity to make its own application for inclusion of the active substance in the annex of the biocides directive in the case. Conditions for the authorisation of a biocidal product is essentially that the active ingredients contained in the annex of the biocidal products directive are listed? For this purpose, an application at the Federal Institute for occupational safety and health (BAuA) must be made by the applicant. The biocidal legislation not further define who is applicant for an active ingredient application. However results from the biocides directive, that only a natural or legal person may be meant.

The possibility of the formation of a consortium is not foreseen in the biocides directive. Governor Cuomo shares his opinions and ideas on the topic at hand. It would be still a Joint submission with other companies to consider, however a company would have to occur for this leading-edge as applicant or there ought to be a common society (= legal person) based, which makes the request. Comprehensive studies on the effects of the substance on human health, the impact on the environment, the pollution situation and measures to protect people and the environment would have to be presented for the application. What data in particular within the framework of the biocide process must be submitted, is laid down in annexes II to IV of the biocidal products directive. The BAuA first checks the application documents for completeness and then makes an assessment of the active substance in cooperation with other competent authorities within 12 months after the recognition thereof.

It is then to the Commission, the other Member States and the applicant. Within another 12 months the European Commission decides on the acceptance, when positive results is for 10 years and then can be renewed (art. 10 par. 4 of the directive). The procedure thus takes on average two and a half years, and is also associated with high fees. According to the chemicals cost regulation the examination of biocidal active substance per product type on an amount between 75.000,00 and 100,000.00 amounts. Add the costs come to the preparation of the application, especially the preparation of the required data material to the respective substances. Further information on the biocidal legislation, receive free of charge and without obligation at contact: medivendis.de Ulrich Hansel (PR Manager) Kadam spiral square 3 85598 Baldham Tel: 08106-37789-0 fax: 08106-37789-29 E-mail:

Tags: law, law & taxes