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Diversified industrials e-briefing: New biocides obligations for those manufacturing, importing or supplying articles in the EU treated with or containing biocidal products such as antifungals, preservatives, insecticides or pesticides

    • Chemicals
    • Diversified industrials

    14-08-2013

    From 1 September 2013, there are new EU requirements on articles treated with or incorporating a biocidal product (“treated articles”) under the Biocidal Products Regulation 528/2012/EU (“BPR”) which effectively replaces the Biocidal Products Directive (“BPD”). The European Commission and Member State Competent Authorities (the Health and Safety Executive in the UK) are developing specific guidance. A draft Frequently Asked Questions on Treated Articles (“draft FAQs”), dated July 2013 has already been produced and is being discussed.

    What challenges does this present?

    A distinction is made between treated articles and treated articles with a primary biocidal function. The EU and Member State Competent Authorities continue to discuss the exact distinction. The distinction is important because different provisions apply to treated articles and treated articles with a primary biocidal function, including timescales for compliance and labelling requirements. Whether a treated article’s primary function is biocidal will be decided on a case-by-base basis taking into account all individual properties and functions of the article as well as its intended use. Criteria to be taken into account include:

    • the concentration of the active substance in the treated article and its mode of action;
    • the intended use of the treated article; and
    • any claim regarding the function of the treated article and whether a biocidal claim is given greater prominence than other described properties or functions or whether the biocidal claim has public health relevance. A claim with public health relevance is a claim that the treated article is expected to provide certain benefits against pathogenic organisms such as bacteria, viruses, fungi or other organisms. eg E-coli and salmonella. 

    Manufacturers and importers of treated articles need to be aware of and consider the impact of any claims made to market their products. Claims such as “fights germs”, “kills 99% bacteria” and “controls fungus” are public health claims and may mean that the article has a primary biocidal function.

    In general terms treated articles with a primary biocidal function are subject to more onerous obligations. (For further information on these obligations please see our article “Biocidal Products Regulation in force 1 September 2013 – Are you ready?”) However, treated articles not having a primary biocidal function are still subject to their own specific obligations.

    Key EU obligations for treated articles not having a primary biocidal function:

    Approved active substances

    Articles can only be treated with or incorporate biocidal products containing approved active substances. Treated articles that were available on the market on 1 September 2013 which contain biocidal products with un-approved active substances can remain on the market:

    • until 1 September 2016; or
    • provided that an application for the approval of the active substance is submitted by 1 September 2016 until the date of that approval or 180 days after the date the application is rejected. 

    Labelling requirements

    Where a claim regarding the biocidal properties of an article is made or where the approval of the active substances requires it, the label of a treated article must include:

    • a statement that the treated article incorporates biocidal products;
    • where substantiated, the biocidal property attributed to the treated article;
    • the name of all active substances contained in the biocidal products;
    • the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets; and
    • any relevant instructions for use.

    The draft FAQs explain that a claim regarding the biocidal properties of an article is any statement indicating or implying that the treated article has a certain efficacy or action against unwanted organisms or that the treated article has a certain degree of protection against unwanted organisms eg contains a preservative to control microbial deterioration or contains an insecticide.

    This is a complex area and further advice may be required. Manufacturers, importers and suppliers of treated articles should also be aware of the obligations imposed on suppliers of the biocidal products they use and the potential supply chain impacts this may have.

    For more information contact

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