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Diversified industrials e-briefing: Biocidal Products Regulation in force 1 September 2013 – are you ready?

    • Chemicals
    • Diversified industrials

    14-08-2013

    From 1 September 2013, biocidal products imported/used in the EU must be authorised under the Biocidal Products Regulation 528/2012/EU (“2012 Regulation”) which is effectively replacing the Biocidal Products Directive (“BPD”).

    The BPD established a two stage process for authorisation. First an EU-level authorisation of the active substance(s) used in the biocidal product against one of 23 product types and second Member State approval of the biocidal product itself. Some active substances which were on the market at 14 May 2000 can continue to be used, whilst the substance itself and the products in which it is used are reviewed by the EU. Whilst these substance/product types remain part of the review programme they are subject to national legislation, for example in the UK, the Control of Pesticides Regulations. Once the review of a particular substance is completed the EU will issue a decision either to authorise the active substances for a particular product type or set a deadline by which it can no longer be placed on the EU market.

    From 1 September 2013

    The general obligations established under the BPD remain eg the two stage authorisation process. Key changes under the 2012 Regulation are:

    1. A Union list of active substances, approved by the EU for use in biocidal products across the EU is established.

    a) Active substances approved under the BPD are deemed to be included on the Union list.

    b) Active substances which remain in the review programme continue to be subject to national legislation.

    c) Active substances not currently approved or included in the review programme must be approved prior to import/use in the EU. The process to obtain approval is:

    (i) submit a dossier to the European Chemicals Agency (“ECHA”) through the Register for Biocidal Products;

    (ii) ECHA checks that the dossier is valid and refers it to the appropriate Member State authority charged with evaluating the active substance;

    (iii) this authority checks the application for completeness and evaluates whether it should be approved;  

    (iv) the result of the evaluation is forwarded to ECHA’s Biocidal Products Committee which prepares an opinion, within 270 days; and  

    (v) this opinion is submitted to the European Commission which decides whether or not the active substance should be included on the Union list.

    Not all active substances will meet the criteria for approval eg active substances which are carcinogens, mutagens and endocrine disruptors will only be approved in limited circumstances such as where the active substance is needed on public health grounds.

    2. Each biocidal product then requires either Union authorisation which applies across the EU, or individual Member State authorisation. Any biocidal product already authorised under the BPD can continue to be made available until expiry of that authorisation.

    a) Union authorisation

    This is the key difference between the BPD and the 2012 Regulation. This authorisation will allow companies to place a particular biocidal product on the market in the whole of the EU without the need to obtain separate approval from each Member State. It will only be granted to biocidal products which have similar conditions of use across the EU. It does not apply to all active substances or all product types. Union authorisation is available from:

    1 September 2013 for product types 1,3,4,5,18 and 19 eg biocidal products used for human hygiene, veterinary hygiene and repellants and attractants;

    1 January 2017 for product types 2,6 and 13 eg biocidal products used in public health area disinfectants and metalworking-fluid preservatives; and

    1 January 2020 for product types 7,8,9,10,11,12,16 and 22 eg biocidal products used in film, wood and construction material preservatives and embalming and taxidermist fluids.  

    The process to obtain Union authorisation is:

    (i) submit a dossier to ECHA;

    (ii) the national competent authority chosen by the applicant then evaluates the dossier;

    (iii) the result of the evaluation is forwarded to ECHA’s Biocidal Products Committee which prepares an opinion, within 180 days; and

    (iv) this opinion is submitted to the European Commission which decides whether or not to grant Union authorisation.

    The European Commission is set to adopt a controversial regulation setting fees for applications for Union authorisation. As Union authorisation is a new and untested system, industry has recommended that incentives are created to ensure that it is used. A Commission official has stressed that the fees regulation will be reviewed in 2015 and that impact on small and medium sized enterprises will be considered. 

    b) Member State authorisation remains available.

    3. The 2012 Regulation extends the range of biocidal products by including for the first time articles treated with a biocide. However, biocidal products used for food and feedstock are excluded from the scope of the 2012 Regulation. Discussions over the exact distinction between “treated articles” and “biocidal products” continue. Transitional provisions apply in respect of treated articles.

    4. From 1 September 2013, any person placing an active substance or biocidal product on the market must submit to ECHA  a dossier, a letter of access to a dossier or a reference to a dossier for which all data protection periods have expired. From 1 September 2015, a biocidal product cannot be placed on the market if the manufacturer/importer of the active substances contained in the biocidal product or where relevant the importer of the biocidal product has not submitted a dossier to ECHA or demonstrated that they have access to information used to approve the active substance during the review programme. Existing stocks of the biocidal products can be used and disposed of until 1 September 2016. This requirement does not apply to substances listed in categories 1-5 and 7 as set out in Annex I to the BPR or to biocidal products containing only such active substances eg baculovirus, bentonite, citronellal and iron sulphate.

    The aim of the 2012 Regulation is to simplify the procedures for authorisation and reduce administration. Industry and member states have already raised concerns over the high costs involved with Union authorisation, the key change in the 2012 Regulation. It remains to be seen whether in practice it will be effective or merely provide a further burden on industry.

    As the new regime comes into force shortly, now is a good opportunity to review and verify that all biocidal products and treated articles are compliant or will be compliant. Manufacturers/importers of relevant active substance/product types which they are not supporting through the review programme need to submit a dossier to ECHA and/or confirm that they have access to the relevant data prior to the 1 September 2015 deadline. Errors and inconsistencies in the legislation are expected to be agreed and amended by the end of 2013.

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