Union Authorisation Process under EU Biocides Regulations 528/2012(EU BPR)
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This page provides information on the process for apply for Union Authorisations for placing biocidal product/biocidal product family on the market under the EU Biocides Regulation 528/2012 (EU BPR), where HSE is the evaluating Competent Authority.
This page does not provide information on apply for National Authorisations, Mutual Recognition in Sequence, Mutual Recognition in Parallel, Simplified Authorisation, Same Product Authorisations, Changes to Authorisations or Parallel Trade Permits under EU BPR.
A Union Authorisation allows access to the EU market through a single authorisation, so there is no need for Mutual Recognition of a National Authorisation.
Union Authorisations are for biocidal product/biocidal product family with similar conditions of use across the Union, 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
- from 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.
Union Authorisations are not possible.
- biocidal products/biocidal product families containing active substances meeting the exclusion criteria
- biocidal products/biocidal product families’ product types in product types 14, 15, 17, 20 and 21.
Making the application
Before making a formal application for Union Authorisation, an applicant should first contact the Member State they have chosen to confirm that they are able to evaluate the application.
If you have chosen the UK as the evaluating Member State, to make an application for Union Authorisation you must submit the following information using the European Chemicals Agency’s (ECHA) R4BP system.
- R4BP application form
- Dossier (in IUCLID format) that satisfies the requirements of Annex II and Annex III of EU BPR, or Letter of Access to a dossier
- A copy of the proposed label and Safety Data Sheet for the biocidal product/biocidal product family as it will be placed on the UK market.
- Safety Data Sheet for all active and non active substances in the biocidal product/biocidal product family
- A draft Summary of Product Characteristics (SPC) for the biocidal product/biocidal product family.
- The UK Competent Authority (CA) details and written confirmation that UK CA agrees to evaluate your application. Please note if choose another EU Member State to evaluate the application please contact them for details of their application process.
The application must be submitted via R4BP. There is no need to send the application to HSE directly.
For Union Authorisation there is a separate fee payable to ECHA.
Sifting the application
If HSE is the evaluation Competent Authority, we will receive an alert when the application is submitted via R4BP.
HSE will then conduct an initial assessment of the information to determine that it meets the requirements for the application type applied for and whether any additional data is needed. We will also estimate how much it may cost, to process the application.
The Applicant will then be invoiced the estimated fee.
Please note on completion of the evaluation of an application the actual costs will be calculated and, if the cost has gone beyond the initial estimated fee, then a top-up fee will be requested, if the cost is less than originally estimated, a refund will be made. This two-stage fee approach is required as our evaluation costs need to be fully cost recovered.
Paying the Estimated UK Fee
Applicants should pay the estimated fee within 30 days of the invoice date. If an applicant anticipates a delay in payment HSE should be informed as soon as possible.
Applications will not be processed until the requested fee has been received in full.
HSE accepts payments by either cheque or bank transfer. The full payment details/methods will be outlined in your invoice
Validation and Evaluation of application and dossier
Following payment of the estimated fee, HSE will validate the application and begin work on evaluating the application within the time frame specified in EU BPR.
The submitted application and dossier will be evaluated in accordance with the requirements of EU BPR to assess the risks to health and the environment, intended use and efficacy. This will involve risk assessment for human health and the environment in the context of the intended use and users (e.g. non-professional, professional or industrial), and to establish any necessary conditions and/or restrictions on the use. In addition, the efficacy in relation to the label claims will be evaluated to ensure that the biocidal product/biocidal product family has the claimed biocidal activity. In short, the evaluation is intended to ensure that the biocidal product/biocidal product family may be used safely for the intended use and that the product works.
The application and dossier should include all the information required to perform this assessment but HSE may, where necessary, request additional information from the applicant.
If the biocidal product/biocidal product family is in the form of a bait station or other physical device then HSE may request a sample to inform the risk assessment.
Outcome of the evaluation
On completion of the evaluation of an application for Union Authorisation HSE will provide a copy of its draft Product Assessment Report (PAR) to the applicant, who has 30 days to provide written comments. HSE will take due account of the applicant comments when finalising our evaluation.
HSE evaluation report will be sent to ECHA. Within 180 days of receiving HSE’s evaluation report ECHA will submit to the European Commission an opinion on the authorisation of the biocidal product/biocidal product family.
As HSE evaluation costs need to be fully cost recovered we will also at this stage calculate the actual cost for evaluating the application and if the cost has gone beyond the initial estimated fee, then a top-up fee will be requested. If the cost is less than the initial estimate, a refund will be made. Please note if a top if fee is required it must be paid prior to HSE providing its evaluation report to ECHA.
If it is recommended that the biocidal product/biocidal product family should be authorised the European Commission will adopt an implementing regulation granting the Union Authorisation.
Once the authorisation is granted the biocidal product/biocidal product family may be placed on the market in a manner consistent with the conditions and restrictions associated with the authorisation.
Where an application does not meet the required standards and it is recommended that the biocidal product/biocidal product family should not be authorised the European Commission will adopt an implementing decision stating that Union Authorisation has not been granted.
The applicant may have the opportunity to modify/update their application in order to make it acceptable.
Where the biocidal product/biocidal product family is placed on the UK market in accordance with the transitional provisions and a decision is taken not to grant an authorisation, the following periods of grace may apply
- the biocidal product/biocidal product family must be removed from the market days after the date of the decision not to grant the authorisation
- disposal and use of existing stocks of the biocidal product/biocidal product family may continue until 365 days after the date of the decision not to grant the authorisation.
Calculating the actual UK costs
We will calculate the actual cost for evaluating the application based on the total time spent. If the cost has gone beyond the initial estimated fee, then a top-up fee will be requested. Alternatively, if the cost is less than the initial estimated fee, an appropriate refund will be given. This two stage fee approach is required as HSE’s evaluation costs need to be fully cost recovered.
Notification of unexpected or adverse effects
Article 47 of EU BPR places a duties on all Authorisation holders to make known to ECHA and the EU Commission any new information of which they are aware, or may reasonably be expected to be aware, concerning the Union Authorised 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.