A product must be authorised to be placed on the market. At what point the requirements for authorisation applies to a particular product depends on the specific active substances in the product. In general terms, the requirements of the Biocidal Products Regulations (BPR) will apply to a product when:
For instance, if an active substance is listed in Annex I of the Biocidal Products Directive (BPD) for use as a wood preservative (product type 8), it may be authorised for use in a wood preservative product, but may not be authorised for use in an anti-fouling product (product type 21) until that product type is included in the Annex I entry.
The BPD transitional provisions will apply for products that contain an existing active substance(s) (i.e. a substance which was on the market before 14 May 2000) that are still being reviewed under the BPD.
Products containing a new active substance(s) (i.e. a substance which was not on the market before 14 May 2000) must be authorised before they can be placed on the market. You can find out how to do that by reading about the active substance process.
When a product contains more than one active substance the product cannot be authorised until all of the active substances in it are in Annex I of the BPD. Or in other words, authorisation is possible only when the last of the active substances in the product is entered into Annex I of the BPD.
Guidance is available on the transitional arrangements that are in place and the actions which must be taken by for product currently on the UK market when the active substance(s) it contains is included into Annex I of the BPD.
"Low-risk" biocidal products, which only contain active substances listed in Annex IA of BPD, may be registered for placing on the market. The process for seeking product registration is essentially the same as for seeking product authorisation.
In addition, biocidal products may also be allowed on the market for the purposes of research and development the application process for these types of application is outlined on our biocides research page.
The BPR product authorisation process is outlined below. You can also view a flow chart of this process.
To make an application for authorisation you must submit the relevant application form and supporting information to HSE. The information required for each application route varies so you should determine which type of application you are making and then submit the required information as outlined in our information to be submitted page.
Please note that as of 1st December 2012 HSE will be unable to accept applications for products which are not intended to be marketed in the UK. Such applications should instead be made to a Member State where the product will be marketed.
When HSE receive the application, an initial assessment of the information will be made 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 long it will take to process and how much it may cost.
The Applicant will then be invoiced for the initial minimum 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 minimum fee, then a top-up fee will be requested. This two-stage fee approach is required as our evaluation costs need to be fully cost recovered and, at this early stage in the authorisation/process process, it is difficult to predict exactly how much product evaluations will cost to process.
Applicants should pay the request within 30 days of the invoice date. If an applicant anticipates a delay in payment please inform us 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
Following payment of the fee, HSE will begin work on evaluating the application and will process the application as quickly as possible.
The submitted application and dossier will be evaluated according to the determinations referred to in Schedule 3 of the BPR in relation to 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 product has the claimed biocidal activity. In short, the evaluation is intended to ensure that the product may be used safely for the intended use and that the product works.
The dossier provided 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 to inform the risk assessment.
On completion of the evaluation of an application a decision will be made as to whether or not the product can be placed on the UK.
As our 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 minimum fee, then a top-up fee will be requested. 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.
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 Certificate and Product Assessment Report (PAR).
The Applicant should examine the draft Certificate and PAR and return it to HSE (annotated if necessary) to indicate agreement with the authorisation conditions.
Once agreement has been received by HSE and the draft label agreed, a BPR Number will be assigned to the product and a Certificate of Authorisation/Registration 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/registration.
If a Certificate of Exemption (CoE) has been granted to allow the product to be placed on the UK market while we carry out our evaluation, the CoE will revoked and an appropriate phase out period will be granted to remove existing stock of the product that does not comply with the conditions and restrictions associated with the authorisation/registration.
Where an application does not meet the required standards we will not issue an authorisation/registration. 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.
When an authorisation/registration is not granted the product may not be placed on the market in the UK. If the application relates to an existing product (e.g. one containing existing active substances already on the market) then it will need to be removed from the market as soon as possible. HSE may issue a Certificate of Exemption to provide a reasonable amount of time for this to occur.
Authorisation/Registration holders can request changes to the authorisation/registration. Changes to the authorisation/registration can be requested via email, letter or fax and must state the required change and the reason.
Regulation 21 of BPR places a duties on all Authorisation/Registration holders to make known to HSE 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/registration. 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.
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