National 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 for applicants on the process for applying for a National Authorisation for placing a biocidal product/biocidal product family on the UK market under the EU Biocides Regulation 528/2012 (EU BPR).
This page does not provide information on apply for Union Authorisations, Mutual Recognition in Sequence, Mutual Recognition in Parallel, Simplified Authorisation, Same Product Authorisations, Changes to Authorisations or Parallel Trade Permits under EU BPR.
Article 3 of EU BPR defines a National Authorisation as “an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof;”
After the approval of an active substance, companies wishing to place biocidal product/biocidal product family on the EU market have to apply for product authorisation. In the UK this can be done by submitting an application for a National Authorisation to HSE (UK Competent Authority for biocides), which we will then evaluate and take a decision on the authorisation.
Once the National Authorisation in the UK has been granted, the applicant can ask the National Authorisation to be Mutual Recognised by other Member States by applying to those Member States for the product to be authorised via the Mutual Recognition in Sequence process. If you wish to apply for the product to be authorised in other Member States at the same time it is Nationally Authorised in the UK, you should include applications for those Member States for Mutual Recognitions in Parallel at the same time you apply to the UK.
If your biocidal product/biocidal product family was on the UK market before the approval of the active substance(s) transitional provisions may also apply.
Making the application
To make an application for National Authorisation in the UK 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 application must be submitted via R4BP. There is no longer a requirement to send the application to HSE directly.
Sifting the application
HSE 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 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 evaluating it within the time frame specified in EU BPR. Competent Authorities are normally required to make a decision on product authorisation within 365 days of validating an application.
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 evaluating the 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 product efficacy will be evaluated in relation to the label claims 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 biocidal product/biocidal product family 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, a decision will be made as to whether or not the biocidal product/biocidal product family can be placed on the market.
If the application for product authorisation is successful, before any final authorisation documents are produced, the Applicant will be sent a copy of the authorisation conditions HSE intends to set for the product. These are set out in a draft Product Assessment Report (PAR) and certificate of authorisation.
The Applicant should examine these documents and return them to HSE (annotated if necessary) to indicate agreement with the authorisation conditions.
Once agreement has been received by HSE, an Authorisation Number will be assigned to the biocidal product/biocidal product family and a final Certificate of Authorisation drawn up. This legal document will then be signed on behalf of Government Ministers.
Once the authorisation is granted that product may be placed on the market in the UK, in a manner consistent with the conditions and restrictions associated with the authorisation.
Where an application does not meet the required standards we will not issue an authorisation. The applicant may have the opportunity to modify/update their application in order to make it acceptable. We have open lines of dialogue with applicants to facilitate this.
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 180 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 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.
Please note if a top if fee is require it must be paid prior to you receiving your product authorisation number and associated UK legal documents.
Notification of unexpected or adverse effects
Article 47 of EU BPR places a duties on all Authorisation holders to make known to HSE, as the UK Competent Authority granting a National Authorisation, 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.