Products newly within scope of the EU Biocides Regulation 528/2012 (EU BPR)
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
This page provides information about the transitional measures for biocidal products that are under the scope of the EU Biocides Regulations 528/2012 (EU BPR) but were not under the scope of the Biocidal Products Directive 98/8/E C (BPD).
Some types of products that were not within scope of the old Biocidal Products Directive 98/8/EC(BPD) are, from 1 September 2013, within scope of the EU Biocides Regulation 528/2012(EU BPR). Companies placing such ‘newly within scope’ products onto the market will have to take action to comply with its requirements or remove products from the market to timeline set within the Regulation.
Newly in scope products include:
- In-situ generation of a biocide where there is no supply of a precursor chemical - this could include: ozone generated by a machine that takes oxygen from the air surrounding the machine to generate the ozone; sodium hypochlorite generated from sea water;
- In-situ generation of a biocide where there is supply of a precursor chemical, but that precursor is not itself supplied for the purpose of generating a biocide - this could include sodium hypochlorite generated from tap water and table salt where neither the water or salt were supplied with the intention that they are used to create the sodium hypochlorite.
- Vermicides (to kill or control worms) and other invertebrates not originally covered by the Biocidal Products Directive. These are now included in the new description for Product Type 16.
- Working or cutting fluid preservatives. The Biocidal Products Directive included in its scope Metal Working Fluid preservatives in Product Type13. This Product Type has now been expanded to include preservatives for fluids used for working or cutting glass or other materials, as well as metal.
The EU BPR includes Transitional Measures in Article 93 for such products that are newly within scope.
Treated Articles (that are not themselves biocidal products) are also now affected by EU BPR, and specific information on those are provided on our Treated Articles webpage including Transitional Measures which are different than those for other products described on this ‘newly in scope’ page.
Newly in scope products on the market containing active substances that haven’t been supported
If the active substance in a product was already on the market on 1 September 2013 and has not already been supported in the relevant product type under the EU BPR active substance review programme, then companies will have to submit applications for approval of the active substance by 1 September 2016.
Products containing active substances that are supported by September 2016 can continue to be made available on the market until a decision on approval of the active substance has been made.
If no application or approval of the active substance is submitted, then biocidal products containing that substance can no longer be made available on the market or used after 1st September 2017
Please note existing National Legislation in each Member State will continue to apply to your biocidal product. You will need to contact each EU Member State for details of their existing National Legislation. For the UK, details can be found on the UK existing National Legislation section of this website.
Products on the market on 1 September 2013 containing an active substance that has been supported
If the product was already on the market on 1 September 2013 and contains an active substance(s) that has already been supported, in the relevant product type, under the EU BPR active substance review programme companies must comply with the transitional provisions in Article 89 of EU BPR. Therefore, once a decision is made on the Approval of the active substance, you will either need to get your product authorised under the EU BPR, or remove it from the market.
Existing National Legislation in each Member State will to apply to your biocidal product until it receives authorisation under EU BPR. You will need to contact each EU Member State for details of their existing National Legislation. For the UK, details can be found on the UK existing National Legislation section of this website.
Requirements of Article 95 of the EU BPR
The requirements of Article 95 place a duty on companies making biocidal products available on the EU market to ensure that their active substance supplier or product supplier is included on the list of active substance suppliers, which is maintained by the European Chemicals Agency (ECHA). From 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market if the substance supplier or product supplier is not included in the list for the product type to which the product belongs. Therefore, if your active substance was already supported for your product type under the existing review programme, you will need to comply with the Article 95 requirements by 1 September 2015.
If your active substance was not already supported for your product type under the existing review programme, as the deadline to support active substances used in biocidal products that are newly within the scope of the EU BPR is the 1 September 2016, it is the UK’s understanding, based on advice from the EU Commission, that requirements of Article 95 of the EU BPR will apply once the active substance dossier has been accepted as complete by the evaluating Competent Authority and the active substance supplier is included on the Article 95 list. If this Article 95 listing happens before 1 September 2016 then you will have to comply with the Article 95 requirements from the date that Article 95 listing takes place.
Further information about the requirements of Article 95, including the list of active substance suppliers can be found on the ECHA website.