Biocides: FAQ

• What is a biocidal product?
  
  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.

• What is the BPR?
  
  The BPR, or Biocidal Products Regulation (EC) No. 258/2012, is an EU Regulation aimed at the approval and control of biocidal products in order to protect human health and the environment, whilst maintaining sustainability and minimising resistance. It replaces and repeals the previous Biocidal Products Directive which was implemented through national legislation in the different Member States. The BPR entered into force on 1 September 2013 and a series of transitional measures are in place to allow implementation of changes introduced by the Regulation.

• Does the BPR only regulate biocidal products themselves?
  
  The BPR, like the BPD before it, adopts a two-tier approval system. First the active substances to be used in biocidal products must be approved at a Union level, and then authorisations must be sought for each biocidal product in which they are contained. In addition to this, the Regulation also applies requirements to those who place treated articles on the market. Treated articles are substances, mixtures or articles which have been treated with or intentionally incorporate biocidal products in order to protect or improve the durability of the material.

If you are unsure if the BPR applies to you, contact our Helpdesk.

• What are the general obligations?
  
  Application for authorisation of a biocidal product either throughout the Union or within individual Member States prior to placing on the market.
  
  Application for approval of an active substance at a union level for each product-type in which they are incorporated, including products used outside the European Union for the biocidal treatment of substances, mixtures and articles. Approved suppliers of the active substances to be identified and used by those formulating biocidal products.
  
  Labelling of authorised products to identify authorisation holder, and of treated articles to substantiate claims of biocidal properties.

• I supply a biocidal product, what do I have to do?
  
  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 intended use and exposure; the toxicological and ecotoxicological effects; and the environmental fate. One key requirement of an authorisation being granted is the approval of the active substance(s) it contains 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 approval of the active substance(s) within it.

• The active substance in my biocidal product is not yet approved, and is still in the review programme. What should I do?
  
  Transitional arrangements under the Regulation allow biocidal products to continue to be placed on the market until such a time as a decision on approval of the active substance is made. If the active substance in your product in not yet approved, you must ensure it is supported in the review programme for your specific product type. Following a decision to approve the active substance, a date of approval will be published. Applications for the authorisation of products containing the active substance must be submitted by this date.

• If I supply my biocidal product in multiple EU countries, do I need a separate authorisation in each?
  
  For certain product-types, the Regulation allows for a Union Authorisation to be obtained, allowing the making available on the market of the biocidal product throughout the EU. For product-types for which Union Authorisation is not available, or for applicants who only want to supply into a few Member States, a series of National Authorisations will be required. A system of mutual recognition may reduce the time, efforts and expense of this though.

• Are product authorisations obtained under previous national schemes still valid?
  
  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 BPR 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.

• What is an active substance?
  
  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 the approval of the active substance(s) within them in the European Union, and that their supplier is an approved supplier of the active substance(s) for their product type.

• What is the review programme?
  
  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.

• Can anyone place an approved active substance on the market?
  
  In order to ensure all those who will benefit from the approval of an active substance have contributed to the costs involved in obtaining the approval, from 1 September 2015 biocidal products can only be placed on the market if the manufacturer or importer of the active substance(s) within it is included on a list of approved active substance suppliers. Those not on this list can continue to place an active substance on the market, but it may not be incorporated into a biocidal product.

• How does someone who did not make the original application for approval of an active substance join the list of approved active substance suppliers?
  
  To be included on the list of approved active substance suppliers, a company must submit to ECHA, via R4BP 3, either a dossier for the active substance, or a letter of access to a dossier already submitted.

• Are approved active substances still subject to REACH registration?
  
  The use of an active substance in a biocidal product is exempt from REACH registration, and therefore this tonnage can be ignored when considering registration requirements. If the active substance is manufactured or imported as part of, or for inclusion in, non-biocidal products however, this tonnage will still be subject to the registration requirements of REACH.

• What is a treated article?
  
  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.

• What is a biocidal function?
  
  Where the biocidal treatment of a substance or mixture confers a biocidal function, or in the case of an article a primary biocidal function, the material will be a biocidal product rather than a treated article. A biocidal function is an intended purpose of controlling harmful organisms by means other than solely physical or mechanical, and will usually be conferred when a substance, mixture or article has been treated with a disinfectant, algaecide, insecticide, rodenticide or repellent/attractant. In the case of a disinfectant the general reason behind the incorporation will be to give the treated article a disinfecting property, and thus a biocidal function. In the case of an insecticide or rodenticide however, the treatment may be to protect the article and extend its durability (i.e. a wood treatment to protect the wood against termites) or to provide a biocidal function (i.e. a treated bait aimed at killing rodents).

• What is a primary biocidal function?
  
  A material which meets the definition of an article under the REACH Regulation will only be a biocidal product if it has a biocidal function which is primary. Whether a biocidal function is primary will be judged on a case-by-case basis, taking into account the intended use of the material. For example, a bed net which is impregnated with an insecticide will be a biocidal product, as the primary function is to repel or destroy a harmful organism. A door handle which has been given an anti-microbial treatment to prevent cross-contamination when used in a hospital would be a treated article however, as its primary function is to allow one to open and close a door. For a material meeting the definition of a substance or mixture, whether a biocidal function is primary or not bears no relevance, as all substances and mixtures with biocidal functions are biocidal products. Therefore, for example, an anti-mould paint will be a biocidal product even if its primary function could be claimed to be decorative.

• What is the requirement for the biocidal products used to treat treated articles?
  
  The requirement under Article 58 is that all active substances included in the biocidal product are approved in the European Union for the product-type used to treat the material. Whilst for materials treated in the EU, this should be achieved easily, as the products used for the treatment would have to be authorised and a condition of the authorisation is the approval of the active substance, for imported substances, mixtures and articles it will be a lot more difficult to establish or ensure.

• Where can I find details of approved active substance-product type combinations?
  
  A list of the active substances so far approved under the BPR can be found on the ECHA website.

• What if the active substance(s) used in the treatment of my material are not on the list of approved actives?
  
  Until 2024, a programme aimed towards the review of all active substances identified as existing prior to 14 May 2000 is being undertaken. If the active substance used in the treatment of a treated article is included in the review programme, then import and supply of that treated article may continue until such a time as a decision not to approve the substance is made. If such a decision is made, the treated article may no longer be placed on the market from 180 days after the decision or 1 September 2016, whichever is later. If the active substance is not in the review programme, transitional arrangements allow you to apply for the approval of the active substance up until 1 September 2016. If not approved or in the review programme when this date is reached, the treated article cannot be placed on the EU market.

• Does the active substance still need to be approved if it does not remain in the treated article?
  
  Yes, the Regulation sets no conditions around the level of active substance in the product used for the treatment, or the level that remains in the treated article, therefore all active substance in the biocidal product used for the treatment must be approved. The only exemption from this requirement is where goods have been stored or transported in premises or containers which were fumigated or disinfected, and where no residues can be expected to remain from this treatment. This may be relevant where fumigation is required as part of an international agreement when goods are imported from third countries.

• When does a treated article have to be labelled under the BPR?
  
  Treated articles must be labelled where claims relating to a biocidal property are made. For example, a paint containing an in-can preservative which makes a claim that it ‘Contains a preservative to control microbial deterioration’ would have to be labelled in order to substantiate these claims. In other cases, the approval of an active substance may set the condition that treated articles containing the substance are labelled. This may be, for example, because the active substance can cause skin sensitisation.

• Do the treated article requirements apply to complex articles?
  
  The Regulation does not distinguish between whether the treatment described must be to an article as a whole, or one of its component parts. The requirements therefore apply regardless of whether the treatment occurred to only a part of a treated article. An importer of a treated plank of wood would have exactly the same requirements as an importer of a sofa containing a wooden frame which has been subject to treatment.