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Simplified Product Authorisation Process under EU Biocides Regulations 528/2012 (EU BPR)

This page provides information on the process to apply for Simplified Authorisations for placing biocidal products 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 Authorisation, Union Authorisations, Mutual Recognition in Sequence, Mutual Recognition in Parallel, Same Product Authorisations, Changes to Authorisations or Parallel Trade Permits under EU BPR.

Introduction

EU BPR establishes an Annex I containing active substances that are eligible for the simplified authorisation procedure as outline in Article 25 and 26 of EU BPR.

A biocidal product shall be eligible for the simplified authorisation procedure if all the following conditions (Article 25) are met:

The simplified authorisation procedure is based on the principle that once the eligible product is authorised in one Member State it can then be  freely circulated within the Union provided no objections are raised by the other Member States providing the other Member State is notified before you place the product on their market.

If you have received a simplified authorisation in another EU Member State you must notify HSE before you place the biocidal product on the UK market - please see the information under the heading “Notifying HSE - Making available on the UK market a biocidal product authorised in accordance with simplified procedure in another Member State” at the end of this webpage.

Making the application

To make an application for authorisation you must submit the relevant application form and supporting information via the European Chemicals Agency’s (ECHA) R4BP system

The following information is required:

The application must be submitted via R4BP. There is no longer a requirement to send the application to HSE directly.

Sifting the Application

Where HSE is the evaluating 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 determine how much it may cost.

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 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 on evaluating the application within the time frame specified in EU BPR.

The submitted application will be evaluated in accordance with the requirements of EU BPR to assess whether the biocidal product meets the conditions in Article 25. 

The application 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 is in the form of a bait station or other physical device then HSE may request a sample.

On completion of the evaluation of an application a decision will be made as to whether or not the biocidal product can be placed on the market.

Successful Applications

If the application for simplified 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.

The Applicant should examine these and return it to HSE (annotated if necessary) to indicate agreement with the simplified authorisation conditions.

Once agreement has been received by HSE an Authorisation Number will be assigned to the product and a Certificate of Simplified 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.  

Unsuccessful Applications

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.

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.

Notifying HSE - Making available on the UK market a biocidal product authorised in accordance with simplified procedure in another EU Member State

If you have received a simplified authorisation in another EU Member State and you intending to place the biocidal product on the UK market you must notify HSE in writing at least 30 days before placing the biocidal product on the UK market.

The product can be placed on the UK market in a manner consistent with the conditions and restrictions associated with the authorisation granted in the other EU Member State but the product label must be in English.  

If HSE believes that the product does not meet the criteria for simplified authorisation procedure or is not being made available on the UK market in accordance with conditions and restrictions associated with the authorisation granted, HSE may provisionally restrict or prohibit the making available and/or use of the biocidal product in the UK.

Notification of unexpected or adverse effects

Article 47 of EU BPR places a duties on all Authorisation holders to make known to EU Competent Authorities, the European Commission and ECHA 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.

Updated 2014-06-03