Mutual Recognition in Sequence under EU Biocides Regulations 528/2012 (EU BPR)
This page provides information on the process for apply for Mutual Recognition in Sequence for placing biocidal product/biocidal product family on the UK market under the EU Biocides Regulation 528/2012 (EU BPR), where HSE is the Concerned Member State.
This page does not provide information on apply for Mutual Recognition in Parallel, National Authorisations, Union Authorisations, Simplified Authorisation, Same Product Authorisations and Changes to Authorisations or Parallel Trade Permits under EU BPR.
There are two processes for mutual recognition. These are mutual recognition in sequence and mutual recognition in parallel. This page outlines for the process for Mutual recognition in sequence
Once a National Authorisation has been granted in one Member State (the ‘Reference Member State’), mutual recognition in sequence can be applied for in other Member State(s) (the ‘Concerned Member State(s)’).
For an existing biocidal product /biocidal product family to benefit from the transitional arrangements in Article 89 and be allowed to remain on the market whilst it is assessed for authorisation, only mutual recognition in parallel is available following the approval of an active substance. If you apply for mutual recognition in sequence, you cannot place the biocidal product/biocidal product family on the market until authorisation via the mutual recognition process if granted, and would therefore need to remove the product from the market until that authorisation has taken place.
Making the application
To make an application for mutual recognition in sequence you must submit the relevant application form and supporting information via the European Chemicals Agency’s (ECHA) R4BP system.
Applications for mutual recognition in sequence can be submitted anytime after a National Authorisation has been granted.
The following information is required:
- A copy of the official authorisation granted by the Reference Member State or statement that this is available via R4BP. We require this as evidence that the authorisation has been granted. We will not require a version in English as all relevant information will be in the Product Assessment Report;
- A copy of the Product Assessment Report produced by the Reference Member State which should include a summery of the product characteristics;
- Summary 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 market in the UK.
The application must be submitted via R4BP. There is no longer a requirement to send the application to HSE directly.
Sifting the Application
HSE as a Concerned Member Stated (CMS) 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 determine how much it may cost to grant the UK authorisation. If HSE is the reference Member State the fee will also include HSE costs to evaluate the data as the RMS.
The Applicant will then be invoiced for the estimated fee to undertake the work.
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 les 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
Evaluation of application and dossier
Following payment of the fee, the HSE as a CMS 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 check the risks to health and the environment, intended use and efficacy have been evaluated by the Reference Member State. 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 the HSE as a CMS may, where necessary, request additional information from the applicant.
Outcome of the evaluation
On completion of the evaluation of an application, the CMS will either agree or disagree with the RMS evaluation.
If the CMS agrees with the RMS evaluation they must record their agreement in R4BP and shall grant the authorisation in the CMS within 30 days.
Once the authorisation is granted the product may be placed on the market in a manner consistent with the conditions and restrictions associated with the authorisation.
Unsuccessful Applications/Disagreements regarding Mutual Recognition
If the Member States have any disagreements regarding mutual recognition these will be referred to a Coordination Group, which has 60 days to seek agreement. ECHA will provide the secretariat for this group. If the Coordination group agrees with the CMS, the biocidal product/biocidal product family will not be authorised in the CMS. The applicant may have the opportunity to modify/update their application in order to make it acceptable. If an agreement cannot be reached, the matter is referred to the Commission, which may ask ECHA for an opinion on the scientific or technical aspects of the case.
The Commission will publish its decision and all Member States (RMS and CMS) have 30 days to comply with it by either granting, refusing modifying or cancelling the authorisation.
Derogations from mutual recognition
A member state (CMS) may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted if they can justify that such measures can be justified on grounds of:
- the protection of the environment;
- public policy or public security;
- the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants;
- the protection of national treasures possessing artistic, historic or archaeological value; or
- the target organisms not being present in harmful quantities.
The CMS will seek the applicant agreement on the proposed derogation. If agreement can’t be reached the CMS shall ask the European Commission to adopt a decision.
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.
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 and other EU MS CA any new information of which they are aware, or may reasonably be expected to be aware, concerning the 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.