Non-committee application types
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This page outlines the type of Non-committee applications which can be dealt with in-house by HSE. The application types covered are:
- Series changes
- Rodenticide – Administrative fast stream
- Rodenticide – Fast stream
An appropriate fee is charged depending on the type of application.
A new product application follows the "Departmental" route when the active ingredient is used in currently approved products within the same product type, but falls outside existing efficacy and safety precedents. Therefore, a new assessment needs to be performed to ensure use of the product is safe and efficacious.
Examples of when the "Departmental" route is appropriate for an application include an increase in active ingredient concentration above that previously used i.e. above the precedent level, or if a product previously used indoors is now to be used outdoors.
It should be noted that on occasion, Departmental applications may be subject to consultation with the Advisory Committee on Pesticides (ACP).
An application follows the "Secretariat" route when the formulation and use profile of a new product are similar to that of previously approved products i.e. within the safety and efficacy precedents.
An application follows the "Back-to-back" route if an applicant wishes:
- to register a number of identical product applications at the same time (the formulation, application rate, user group and pest and usage area etc must be identical); or
- to register an identical product to one that is already approved, with the only difference being the product name and/or the approval holder and/or the marketing company.
Applicants should send a letter to HSE detailing:
- the name of the product they wish to gain approval for;
- the proposed approval holder;
- the proposed marketing company;
- the name and HSE number of the currently approved product they wish to copy; and
- if necessary, a letter of authorisation from the approval holder of the currently approved product.
Administrative changes to a product approval, not resulting in changes to the efficacy or safety of the product, may be made by the amendment route.
In general, an amendment is made by submission of a letter on company headed paper or an email from the approval holder to HSE outlining the proposed changes along with any necessary letters of authorisation or declaration.
When a change in product name is proposed, while retaining the current HSE number, the approval holder must be able to declare that existing stocks under the old name are small. If the product has not been marketed the approval holder must provide an assurance that the product will not be marketed under the old name.
When a change in approval holder is proposed, the original approval holder must send a signed and dated declaration from a senior member or director of the original approval holding company:
- stating that they have transferred responsibility to the new company;
- stating that they will not place the transferred product on the market;
- giving an assurance that all relevant documentation and correspondence from HSE relating to the approval are in possession of the newly named approval holder; and
- declaring that existing stocks under the old name are small and the old approval holder must provide an assurance that they will no longer market the product.
An application for a "Series change" is made when the same change applies to more than one product. The change is usually one of the following:
- there is a single approval holder which is changed for another
- there is a single marketing company that is changed for another
- both of the above occur
Applicants should submit a letter or email to HSE, detailing the desired changes along with any necessary letters of authorisation or declaration.
In the case of a merger between two companies, a statement on letter headed paper from each company stating the details of the merger and the name of the new company. On occasion, confirmation letters from solicitors are requested.
This is equivalent to a "Back-to-back" application but for rodenticides. A different fee structure applies for rodenticides applications.
An application follows the "Rodenticide – Fast stream" route, if the product is within existing precedent for the active substance but read-across of storage stability / efficacy / palatability data cannot be considered as the formulation, packaging etc is not identical to an existing product (or HSE do not consider it sufficiently similar to allow read-across).
Typically, the application will be for approval of a product that contains an existing rodenticide active substance in an accepted formulation type but that formulation type will either be novel to that company (so never supported by their own data) or they are making changes to the bait base / carbohydrate content that require supporting data to show that it is both efficacious and palatable after long term storage. Data (covering efficacy / palatability / storage stability) needs to be submitted and assessed to support the application.