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Wednesday, 18 September 2019
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Raw materials & technologies, Raw materials, Coatings additives

Experts discuss novel Biocidal Products Regulation

Thursday, 8 November 2012

Starting on 1 September 2013, the New Biocidal Products Regulation (BPR) will be applied. The central novelties were presented and debated at an international conference.

From 1 September 2013 on, the New Biocidal Products Regulation (BPR) will be applied

Source: Paolo Toscani/Fotolia

From 1 September 2013 on, the New Biocidal Products Regulation (BPR) will be applied

Source: Paolo Toscani/Fotolia

From 1 September 2013 on, the new Biocidal Products Regulation (BPR) will be applied. This will bring important novelties to the current Directive, as the regulatory powers and the requirements for official authorisation as well as the courses of procedures will change. At the recent International Fresenius Conference "The New Biocidal Products Regulation", experts from all over Europe discussed the upcoming alterations.

The most important novelties
The central novelties of the BPR were presented by Pierre Choraine (European Commission). The new BPR introduces the common authorisation of similar biocidal products, new requirements for treated articles as well as exclusion and substitution criteria and comments on topics like mandatory data sharing, cost-sharing by alternative substance suppliers and the new managing role of the European Chemicals Agency (ECHA). Similarly, the regulation will approach the detailed procedure for a mutual recognition of substances. Choraine pointed to Article 95 of the new regulation which deals with transitional measures concerning access to the active substance dossier and its implications for all companies involved in the biocidal products sector. Thus from 1September 2015 on, manufacturers and importers who have not made a submission and will therefore not be listed at ECHA are no longer allowed to place biocidal products containing active substances on the market. Choraine also drew the participants’ attention to the possibility to submit all relevant data for product registration through the IUCLID 5-software from 1September 2013 on.

Exclusion criteria for active substances
One of the most significant amendments by the BPR will be the new exclusion criteria for active substances. According to the regulation, substances that are carcinogen, mutagen, toxic to reproduction or do show endocrine disrupting properties, as well as substances that are persistent, bioaccumulative and toxic cannot be approved. Nevertheless, there is one exemption: as long as the exposure of the relevant substance is negligible, its presence essential to control a serious danger to human or animal health or the environment or a non-approval could cause a disproportionate negative impact for society, a substance can be approved all the same. However, Dr Joachim Rumbolz (GAB Consulting GmbH) criticised the set criteria as too non-specific. According to Rumbolz, the BPR would raise too much questions at that point and at many others, too, to work smoothly with it. On top of that, the exclusion criteria would reduce the number of applicable active substances considerably.
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