Product Authorisation under EU Biocides Regulations (EU BPR)
Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
A biocidal product/biocidal family must be authorised to be placed on the market. At what point the requirements for authorisation applies to a particular product depends on the specific active substances in the product. In general terms, the authorisation requirements of the EU Biocides Regulations (BPR) will apply to a product when:
- the active substance(s) within the product is listed in the EU BPR Article 9 Approved List of Active Substances (Union list) (see ECHA biocide active substance database), and
- the entry covers the product type appropriate for that product.
For instance, if an active substance is listed in the Union list for use as a wood preservative (product type 8), it may be authorised for use in a wood preservative product, but may not be authorised for use in an anti-fouling product (product type 21) until that product type is included in the Union list.
When a product contains more than one active substance the biocidal product/biocidal family cannot be authorised until all of the active substances in it are in the Union list. In other words, authorisation is possible only when the last of the active substances in the biocidal product/biocidal family is included in the Union list.
If your biocidal product/biocidal family was made available on the UK market prior to the active substance(s) being included in the Union list, transitional provision will apply while you apply for authorisation or to allow you to phase out existing stocks if you are not applying for authorisation.
If your biocidal product/biocidal family was not on the UK market prior to the active substance(s) being included in the Union list, you must obtain authorisation before the biocidal product/biocidal family can be made available on the UK market.
If your biocidal product/biocidal family contains an active substance(s) that is a candidate for substitution a comparative assessment will be made under Article 23 of EU BPR and you may need to provide additional information as part of this assessment.
Companies wishing to place biocidal products on the UK market can apply for product authorisation at National or Union level under the following application types.
This application route allows for the making available on the market and the use of a biocidal product/biocidal product family in the UK.
Once the National Authorisation is granted in the UK, the applicant can ask for it to be mutual recognition by other Member States.
See further information on National Authorisation.
Once a National Authorisation is granted in a first Member State (the ‘Reference Member State’) mutual recognition in sequence can be applied for in other Member State(s) (the ‘Concerned Member State(s)’). Please note for existing biocidal products only applications for Mutual Recognition in Parallel – not in Sequence - will benefit from the transitional provisions which allow the product to stay on the market whilst the authorisation is being carried out.
See further information on Mutual Recognition in Sequence.
Mutual recognition in parallel is a new process and it is applied for at the same time as the application for National Authorisation. One Member State (Reference Member State) is responsible for evaluating the application. Once they complete their evaluation a copy of their assessment report and the proposed conditions of authorisation for the product are provide the other Member State(s) (Concerned Member State(s)). The Reference Member State and Concerned Member States all authorise the product at the same time.
For existing biocidal products to benefit from the transitional arrangements in Article 89, which allow the product to stay on the market whilst the authorisation is being carried out, only mutual recognition in parallel is available following the approval of an active substance.
See further information on Mutual Recognition in Parallel.
Allows access to the EU market through a single authorisation for a biocidal product/biocidal product family, so there is no need for Mutual Recognition of a National Authorisation.
Union authorisations are for biocidal product/biocidal family with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and certain product-types (14, 15, 17, 20 and 21).
Depending upon the product types, Union authorisation will be available in three different stages:
- from 1 September 2013 for product types 1, 3, 4, 5, 18 and 19
- form 1 January 2017 for product types 2, 6 and 13
- from 1 January 2020 onwards to the remaining products types 7, 8, 9, 10, 11, 12, 16 and 22.
See further information on Union Authorisation.
The simplified authorisation procedure is based on the principle that the eligible product is authorised on the basis of a limited data package in one Member State and can then freely circulate within the Union provided no objections are raised by the other Member States.
See further information on Simplified Authorisation.
Biocidal Product Families build on ‘Frame formulation’ concept under the Biocidal Products Directive (BPD) in that it allows for:
- Reduction in % of active substance;
- Variation in % of non-active substance
However biocidal products families also allow for the replacement of non-active substance with another with same or lower risk.
Classification, hazard and precautionary statements for all products within the biocidal product family have to be the same.
Application should be submitted according to the process for National Authorisation, Mutual Recognition in Sequence, Mutual Recognition in Parallel or Union Authorisation but details of all the products with in the family must be provided.
All products within the biocidal product family are covered by the one authorisation for the family as a whole; each individual product does not have a separate authorisation. If any new products are to be included in the authorised family you need to notify the us 30 days before placing the new product on the UK market (except where the product is explicitly identified in the original family authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations in the original family authorisation. The notification shall indicate the each composition, trade name and suffix to the authorisation number. In the case of a Union Family Authorisation the notification has to be made to ECHA and the EU Commission.
The UK notification process for these types of application is will be published when it is available. If you have any questions about biocidal product families please contact us.
This type of application allows a company to import and place on the UK market a product already authorised in another Member State under the EU Biocides Regulation (EU BPR), when an identical product is already authorised under EU BPR in the UK.
The provision is internal market driven but does not reduce the level of protection of the environment or public health.
Further Information about the process in the UK
Once an authorisation has been granted Authorisation Holders can request administrative, minor and major changes to the authorisation. The EU Commission has provided guidance to assist applicants and Member State Competent Authorities. The UK application process for these types of application is will be published when it is available. If you have any questions about changes to authorisations please contact us.
The UK B-2-B and Marketing Authorisation application types under the old Biocidal Products Directive have been replaced by a new EU procedure. The EU Commission has provided guidance to assist applicants and Member State Competent Authorities. The UK application process for this type of application is will be published when it is available. If you have any questions about same product authorisations please contact us.
Biocidal products may be allowed on the market for the purposes of research and development see further information on Research.
The European Chemicals Agency (ECHA) has published the following guidance documents to support the EU Biocides Regulation 528/2012.
- Guidance on information requirements - This Guidance deals with the information requirements on active substances and on biocidal products. Applicants should use this document when preparing dossiers for product authorisation.
- Biocides Submission Manual (BSM) series - The aim of the Biocides Submission Manual (BSM) series is to provide industry users with detailed and illustrative technical assistance. The BSM series describes how to build IUCLID dossiers for the various Biocidal Product Regulation applications and how to submit and manage those applications in R4BP 3 until a successful outcome is achieved.
- Guidance and training on IUCLID is also available.
Notification of unexpected or adverse effects
Article 47 of EU BPR places a duties on all Authorisation holders to make known to Competent Authorities, the European Commission and ECHA any new information of which they are aware, or may reasonably be expected to be aware, concerning the biocidal product or the active substance(s) in that product which is relevant to, and may affect, the authorisation. For instance, any new information relating to the hazardous properties of the active substance or biocidal product, changes in composition of the product, development of resistance to the biocidal product in the harmful organisms it is intended to control or other aspects such as changes to the packaging etc.