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The Biocidal Products Regulation

International Fresenius Conference informed about the effects of the legislation amendment from 18 to 19 October 2011 in Frankfurt/Germany

Dortmund, Frankfurt (Germany), 25 October 2011

The new European regulation on biocidal products will repeal and replace the current Directive 98/8/EC from the beginning of 2013 on. The handling of biocides will be readjusted all over Europe. But what particular changes will approach the industry and authorities and what do they expect for the market′s future? The changes lead to numerous questions throughout the industry about the future procedure of authorisation. Experts met on the International Fresenius Conference "The Biocidal Products Regulation" from 18 to 19 October 2011 in Frankfurt/Germany.

The member states of the European Union are allowed to remain their national practice for placing biocidal products on their markets until May 2014, for products containing active substances not yet included in Annex I to the Biocidal Products Directive (BPD).

Authorisation according to the BPD

The first authorisation in Europe for a biocidal product according to the BPD was granted in 2009. Following the inclusions of active substances, so far mainly for use in rodenticides and wood preservatives, many applications for authorisations of such products are now being processed by Sweden and the other member states, said Anna Nordberg, Swedish Chemicals Agency (KemI), Sweden.

The member states are working towards harmonisation of the principles and administrative procedures for authorisation of biocidal products according to the BPD, Nordberg referred. This would be an on-going work, and both industry and the competent authorities would have been facing a number of technical and administrative challenges during the preparation and assessment of these first applications. Some of those would be the procedures concerning mutual recognition and the establishment of frame formulations, appropriate risk mitigation measures, evaluation of third party dossiers, Nordberg explained.

Risk mitigation measures for biocidal products

Jürgen Fischer, Federal Environment Agency (UBA), Germany encouraged to distinguish between basic or general risk mitigation measures (RMM) and specific RMM included in risk assessment. In most cases specific RMM should be risk based and derived from the risk assessment. Risk mitigation measures might be described with standard phrases but some require a more detailed specification, Fischer said. He thinks that a survey of existing risk mitigation measures would be useful. Despite not all RMM proposed could be addressed in the authorisation step but would have to be tackled in other regulatory areas.

Specific RMM for consumers are already partly implemented. In most cases they should also be risk based. A valid exemption would present the exclusion criteria of the Biocide Directive. Fischer: "Risk mitigation measures should be harmonised as far as possible on a European level in order to facilitate the European market and mutual recognition of authorisations." Fischer concluded that monitoring of biocides in the environmental compartments could be a useful tool in proving the efficiency of RMM on the long term scale.

Impact of the new Regulation on the biocides market

For biocides, when evaluating the impact of specific regulatory provisions on innovation, it would be necessary to take into account some basic characteristics of the market, said Rodolphe Quérou, Dow Microbial Control (France). When compared to other biologically active products like pharmaceuticals or plant protection products, the size of the biocides market would be small, he remarked.

Quérou pointed out that the cost to bring a single pharmaceutical product on the market would be equivalent to the total size of the European biocides market. The European Union biocides market would be also very diverse, covering applications as different as disinfectants, in-can preservatives, household insecticides or antifouling paints. "For these reasons, when a new biocidal product is launched in the European Union, the size of the potential market is limited, compared to other industries," Quérou said. This would create uncertainty on the return on investment which would be highly dependent on the speed and cost to access the market, explained Quérou.

The complete Fresenius conference documentation including scripts from all the presentations can be purchased at the Akademie Fresenius for 295,00 € (plus VAT) or here.

Contact details:

Die Akademie Fresenius GmbH
Monika Stratmann

Alter Hellweg 46
44379 Dortmund

Phone  +49 231 75896-48
Fax  +49 231 75896-53

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