Application process under the Control of Pesticides Regulations (COPR)

You should consider the type of application you are making before completing an application form. An idea of the application type will help guide you in filling out the form. HSE will make a final decision on the application type when we receive your application.

There are two main types of application:

• Committee applications - These need to be considered by the Advisory Committee on Pesticides (ACP) – a statutory body set up to advise Ministers on matters relating to pesticides. The applications they consider are known as committee applications. The Committee applications webpage provides information on the application process.
• Non-Committee applications - These applications can be dealt with in-house by HSE using a precedent system. This means that if an application for a new approval is considered to be within the safety and efficacy precedents agreed by the ACP on a previously approved product, approval for a new product may be granted on this basis.

In general most applications are ‘Non-committee’. There are different types of non-committee applications; you should check which type of application you are making, and then read the process outlined below for making a Non-Committee application.

To make an application for approval you must submit two items:

1. A completed FEPA1 application form and guidance on how to do this is available. Applicants should pay particular attention to providing the following information:
   • Packaging details
     In addition to the pack size we require a description of the packaging material, e.g. Polypropylene Co-Polymer tub with snap on lid containing 500g of product.
   • IUPAC name, CAS number and Safety Data Sheet
     On the application, please provide the IUPAC name for each of the non-active ingredients along with their CAS number and the safety data sheet (SDS).
   • Formulation details
     Within the formulation details, it is not necessary to split the active and non-active ingredients into their component parts, e.g. taking the water out and listing it separately. It is sufficient to state: Active ingredient (supplied as 70% aqueous solution in deionised water) at 75% w/w.
   • Application/coverage/residue/discharge rate details
     It is vital that application/coverage/residue/discharge rate details are included in your application form. In the case of antifoulings, the service life should also be included, e.g. typical length of time between repainting.
2. Specific supporting information:
   • A copy of the draft label, this may be submitted at a later stage of the process but may delay your application;
   • Safety Data Sheets (SDS) for all of the non-active substances;
   • Any additional data needed to support the application. The Applicant should make a judgement as to what Data are necessary to support their application.

If the active substance(s) in the product still has data protection the following information should also be submitted:

• A letter of Access (this is to enable HSE to access data to support the product approval)
• A letter of intent to supply from the manufacturer of the active substance.

Both elements, the form and supporting information, must be submitted to HSE to form a completed application. Applications for approval can be submitted via email, post or fax.

When HSE receive the application, an initial assessment of the information will be made to determine which type of application it is, whether any additional data is needed, how long it will take to process and how much it will cost.

The Applicant will then be invoiced for the appropriate fee to undertake the work.

Applicants should pay the fee within 30 days of the invoice date. If you anticipate 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.

Once the evaluation is complete and before any final approval documents are produced, the Applicant will be sent a copy of the approval conditions HSE intends to set for the product. These are set out on a draft Schedule of Approval and include the required classification(s) and precautionary labelling phrases. The draft Schedule will be accompanied by a NS1 form. The Applicant should examine the draft Schedule and return it to HSE (annotated if necessary) along with the completed NS1 form, signed and dated, to indicate agreement with the approval conditions.

Once the draft Schedule and NS1 form have been received by HSE and the draft label agreed, an HSE Number will be assigned to the product and a Notice of Approval and Schedule drawn up. This legal document will then be signed on behalf of Government Ministers.

Minor changes can be made to the Approvals of existing products (e.g. name of approval holder, address, name of product, marketing company) through the amendment or series change route. Changes to approvals can be requested via email, letter or fax.

Approval holders must inform HSE immediately if they become aware, or may be expected to be aware, of any new information or data which may affect the conditions of approval as detailed in the Notice of Approval and Schedule.

When an active substance is included in Annex I of the Biocidal Products Directive (BPD) all conditions of approval under the COPR for products containing it as the active substance will expire. This is because COPR no longer applies to these products.

If you wish to keep your products on the UK market after the relevant Annex I Inclusion date you must comply with the requirements of the UK Biocidal Products Regulations (BPR). Guidance is available on the transitional arrangements that are in place and the actions which must be taken by Applicants/Approval Holders.