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Diversified industrials e-briefing: Biocides – new EU obligations on manufacturers and importers of active substances and biocidal products

  • United Kingdom
  • Diversified industrials - Chemicals

14-08-2013

From 1 September 2013, new obligations will affect you if you manufacture or import an active substance in the EU and you have not previously been involved in its authorisation or review (with some limited exceptions). From that date you have to demonstrate to the European Chemicals Agency (“ECHA”) that you have access to the information contained in the application for authorisation of the active substance. The same obligation applies where you import a biocidal product containing an active substance into the EU, where the manufacturer of that active substance is located outside of the EU.

Previously the burden of producing the data required for an application for authorisation rested with the party applying for it/supporting it through the review programme (the review programme applies to all active substances which were already on the market on 14 May 2000 and the person placing them on the market had notified the European Commission that it intended to continue to place them on the market and support them through the review programme after that date). From 1 September 2013 anyone benefitting from an active substance’s authorisation or inclusion in the EU’s review programme must contribute. This is a new requirement under the Biocidal Products Regulation (the “2012 Regulation”) which comes into force on 1 September 2013 and effectively replaces the Biocidal Products Directive.

You can meet this requirement through submitting to ECHA  a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier. ECHA will publish a list of persons who have submitted the required evidence. This list will first be published on 1 September 2013. From 1 September 2015 if the manufacturer or importer of the active substance in your biocidal product is not included in the list, or you are not included, then you cannot make it available on the market. However, use and disposal of existing stocks which were already in the supply chain can continue until 1 September 2016.

If you are submitting a dossier by way of required evidence, be aware that it must comply with the specific requirements of the 2012 Regulation.

More obligations take effect from 1 September 2013. In addition EU manufacturers of biocidal products should verify that whoever supplies the active substance(s) they use  is included on the list to prevent future supply chain issues.

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