Applications for Union authorisation are submitted to ECHA; the applicant has to confirm the conditions of use for the biocidal product are similar in the entire European Union. The name of the competent authority of the Member State which he or she proposes should assess the application has to be stated and a written confirmation that this competent authority has agreed to assess the application has to be provided. That competent authority then will be the evaluating competent authority. Based on the Product Assessment Report of the evaluating Member State, the Biocidal Products Committee drafts an opinion to the European Commission. The procedure is facilitated by ECHA. Following an authorisation decision of the Commission, the product can be placed on the market in all Member States. Member States can make requests to modify certain conditions in the authorisation that are specific to their country.
If you want to apply for a Union authorisation, and you want the Netherlands to be the evaluating Member State, please contact the biocidal products account manager Cindy van der Meer at the Ctgb.
For applications for changes of Union Authorisations, see Major, minor and administrative amendments on request.
The legal basis
Union authorisations are described in Chapter VIII of the Biocidal Products Regulation.
Application type criteria
Union authorisations can be applied for both for single products and for biocidal product families.
- The active substances in the product have been approved for the relevant product-type and any conditions specified for those active substances are met; (BPR (EU) 528/2012, art. 19). You can check this in the list of approved substances.
- Its active substance has not yet been approved, but a biocidal product containing a new active substance can be authorised for a period not exceeding three years. Such a provisional authorisation may be granted only if the evaluating competent authority has submitted a recommendation for approval of the new active substance (more details in Art. 55 (2) of the BPR).
- If the active substance is approved but classified as a Candidate for Substitution, a product authorisation with this active substance will be preceeded by an evaluation of available alternatives. More about comparative assessment can be read here (link pagina CA).
- The active substance must not fulfil the exclusion criteria, unless it fulfils point 2 of Article 5 of the BPR.
- The manufacturer or supplier of the relevant substance in the biocidal product, or the manufacturer or supplier of the biocidal product for the applicable product type, must be included on the Article 95 list of the Biocidal Products Regulation.
- Conditions of use must be similar across the Union
- Product contains only existing substances: the use corresponds with PT 1, 2, 3, 4, 5, 6, 13, 18 and 19, or with PT 7, 8, 9, 10, 11, 12, 16 and 22 (submission possible from 1 January 2020 onwards).
- Product contains one or more new substances: submission for all product types except PT 14, 15, 17, 20 and 21. (BPR Art. 42 (3): for these product types, latest 31 December 2017 the commission will submit a report to the European Parliament and the Council on the application containing an assessment of the exclusion of product-types 14, 15, 17, 20 and 21 from the Union authorisation.
- With the submission, the applicant must provide a confirmation that the biocidal product will have similar conditions of use across the Union and written information that the competent authority of the applicant’s choice agrees to evaluate the application (see also Instructions for submission)
The timeframe for initiating the authorisation process is different depending on whether the product contains new or existing active substances:
New active substances
A product containing new active substances, also in combination with existing active substances, is eligible for Union authorisation from 1 September 2013.
Existing active substances
For biocidal products containing only existing active substances, Union authorisation are being made available in three different stages, depending on the product-type:
- From 1 September 2013 for product-types 1, 3, 4, 5, 18 and 19
- From 1 January 2017 for product-types 2, 6 and 13
- From 1 January 2020 onwards to the remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22.
Expiry date of the product authorisation
For products approved under the BPR, the expiry date of the approval is usually set to 10 years after approval or to a period not exceeding 1 year from the date of expiry of the approval of the active substances. However, if at least one of the active substances in the product is a candidate for substitution, the authorisation can only be granted for maximum 5 years.
Data requirements for Union authorisations are identical to those for national authorisations under BPR.
The application is submitted to and coordinated by the European Chemicals Agency (ECHA). ECHA will forward it to the evaluating Competent Authority.