Biocides FAQ

A biocidal product is a substance or mixture which is supplied with the intention of controlling harmful organisms by means other than solely physical or mechanical. This control is exerted by one or more active substances which are either contained within the substance or mixture, or generated by it. Articles may also be biocidal products, if their primary function is the control of harmful organisms by means other than solely physical or mechanical.

Biocidal products under the Regulation are divided into four groups: disinfectants; preservatives; pest control; and other biocidal products (including anti-fouling products and embalming/taxidermist fluids). These are further divided into 'product types' into which each product will be categorised.

Top

Biocidal products must be authorised prior to being placed on the market in an EU Member State. In order to obtain this authorisation, a dossier must be submitted meeting the data requirements set by the Regulation, and including information on: the physical and technical properties of the product; the effectiveness against target organisms and impact on non-target organisms; the intented uses and exposure; the toxicological and ecotoxicological effects; and the environmental fate. There is also a significant cost involved. Authorisations, when granted, may apply to an individual Member State or Union-wide.

One key requirement of an authorisation being granted is that the active substance(s) it contains have been approved for use in the product-type into which the biocidal product falls. This approval is undertaken at Union level and a list of those substances approved and the product-type(s) in which they may be incorporated is published on the website of the European Chemicals Agency (ECHA).

At present the processing of applications for approval of active substances is following a 10-year review programme so not all active substances have been assessed. This means it may be possible to continue placing your biocidal product on the market without an authorisation until the active substance(s) within it are approved.

Top

An active substance is a substance which destroys, deters, renders harmless, prevents the action of, or otherwise exerts a controlling effect on harmful organisms. These substances may not be used solely in the control of organisms, for example ethanol, however when supplied to be used for this purpose, the substance must be approved for the product-type into which it is incorporated.

Those who place biocidal products on the market must ensure that the active substance(s) within them are approved within the European Union, and that their supplier is an approved supplier of the active substance(s) for their product type.

Top

Prior to the entry into force of the Biocidal Products Regulation on 1 September 2013, biocides were regulated under national regulation that implemented the Biocidal Products Directive (BPD). This directive identified 'existing active substances' as those on the market as active substances in a biocidal product before 14 May 2000 and these substances were to be reviewed for approval over a ten-year period. The review of the applications for a majority of these actives has not yet been undertaken, so under the BPR a new programme was implemented with the intention of completing the review by 2024.

Since 2000 many of the applicants included in the original review programme have chosen to no longer support the active substance approval, whilst the decision has been made not to approve others. To continue placing a biocidal product on the market, the active substance must be approved (and the product authorised), or still under review for the appropriate product type.

Top

Despite what the name suggests a treated article is any substance, mixture or article which has been treated with, or intentionally incorporates, a biocidal product, but which does not have a biocidal function or, in the case of an article, a primary biocidal function. If you intend to place a treated article on the market, you must ensure that the active substance within the biocidal product used to treat it has been approved for the appropriate product-type. You must also provide information on the biocidal treatment of the material within 45-days of a request for such information by a consumer.

Those who are first to place a treated article on the market may need to label the material in accordance with the BPR if claims are made regarding the biocidal properties of the material, or the approval of the active substance sets this condition.

Top

Those products which were authorised under the national schemes which implemented the Biocidal Products Directive, may continue to be placed on the market subject to the conditions of that authorisation. When the authorisation is due for renewal however, it will be reviewed under the Biocidal Products Regulation and additional information may need to be submitted at this time. New exclusion criteria and a comparative assessment undertaken for certain products may decrease the likelihood of an authorisation being renewed for some active-substance/product combinations.

Applications for the authorisation of a biocidal product submitted under national schemes, but not yet processed will now be assessed under the BPR. Again, new information may be required for this assessment.

Top