Mutual Recognition in Parallel under EU Biocides Regulations 528/2012 (EU BPR)
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
This page provides information on the process to apply for Mutual Recognition in Parallel for placing a biocidal product/biocidal product family on the UK market under the EU Biocides Regulation 528/2012 (EU BPR), where HSE is the Reference Member State or Concerned Member State.
This page does not provide information on apply for National Authorisation, Union Authorisations, Mutual Recognition in Sequence, Simplified Authorisation, Same Product Authorisations, 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 the process for mutual recognition in parallel.
Mutual recognition in parallel is a new process, which is outlined in Article 34 of EU BPR.
Mutual recognition in parallel is applied for at the same time as the application for National Authorisation. One Member State (the ‘Reference Member State’ - RMS) 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) (the ‘Concerned Member State(s)’ - CMS). The RMS and CMS authorise the product at the same time.
For an existing biocidal product 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.
Making the application
Before making a formal application for Mutual Recognition in Parallel, an applicant should first contact the Member State they have chosen to confirm that they are able to evaluate the application as the RMS.
To make an application for mutual recognition in parallel you must submit the relevant application form and supporting information via the European Chemicals Agency’s (ECHA) R4BP system.
Applications for mutual recognition in parallel must be submitted at the same time as the application for National Authorisation. For existing biocidal product to benefit from the transitional arrangements in Article 89 only mutual recognition in parallel is available following the approval of an active substance.
The following information is required:
- 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 EU 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.
- Name of the Competent Authority(s) (CA) you want to authorise the biocidal product/biocidal product family including the name of the RMS CA you propose should evaluate the application. Please note written confirmation that the RMS CA agrees to evaluate must be included.
The application must be submitted via R4BP. There is no need to send the application to HSE directly.
Sifting the Application
When HSE is the RMS or a CMS, 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 determine how much it may cost to grant the UK authorisation. If HSE is the RMS, 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 Reference Member State (RMS) 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 biocidal product/biocidal product family works.
The application and dossier should include all the information required to perform this assessment but the RMS 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 the RMS may request a sample to inform the risk assessment.
Outcome of the evaluation
On completion of the evaluation of an application the RMS will provide a copy of its draft assessment report to the applicant, who has 30 days to provide written comments. The RMS will take due account of the applicant comments when finalising their evaluation.
The RMS evaluation report will be sent to the CMS, who have 90 days to agree with the RMS assessment.
If it is recommended that the biocidal product/biocidal product family should be authorised the RMS and CMS will record their agreement in R4BP and the RMS and CMS shall grant the authorisation within 30 days of that agreement.
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
Where an application does not meet the required standards the RMS and CMS will not issue an authorisation for the biocidal product/biocidal product family. The applicant may have the opportunity to modify/update their application in order to make it acceptable.
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 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.
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 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 may continue until 365 days after the date of the decision not to grant the authorisation.
Derogations from mutual recognition
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 HSE is the RMS and a top if fee is require it must be paid prior to HSE providing its evaluation report to CMS.
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.