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The Applicant Guide: Technical Specifications and Formulation Details

What is a technical specification?

Each source of active substance has a specification which must be authorised in a plant protection product. Further details on technical specification are given in: Identity and physical and chemical properties of the active substance and formulation.

What else is in the formulation of a plant protection product?

The formulation details of your product consist of the technical specification and the formulation 'recipe'. Further details are given in: Identity and physical and chemical properties of the active substance and formulation.

How is this information presented on the Authorisation?

The Authorisation includes a 'confidential conditions' section relating to active substance and formulation details. This section includes details of each source of active substance (data owner, the site of manufacture (unless confidential) and the HSE document reference for each source) and where there are no issues relating to 3rd party confidentiality, the full formulation details of the authorised plant protection product.

For Northern Ireland parallel trade permits, information relating to the product authorisation in the country of origin will be specified.

Please note that the confidential section will be removed from the version of the notice published on the HSE website.

How should this information be submitted?

When applying for a commercial level of authorisation, including a permit for trial purposes (except for parallel trade permits), you will need to provide details of the technical specification and formulation recipe for your plant protection product.

Part E of the application form CRD1 must be completed, along with the sections and appendices referenced, and where relevant a draft registration report and a draft technical equivalence report must be submitted.

Data or reasoned scientific cases to address all the appropriate data requirements must also be submitted (see The Applicant Guide: What Should I Include In An Application).

If you are applying for a new source of active substance, a draft technical equivalence report must be submitted alongside supporting data and covering letter.

What constitutes a change to the technical specification?

Details are given in Identity and physical and chemical properties of the active substance and formulation.

What is a source?

Details are given in: Identity and physical and chemical properties of the active substance and formulation.

How do we assess technical equivalence?

Details are given in: Identity and physical and chemical properties of the active substance and formulation.

What if I want to make changes to my authorised technical specification?

What are the costs and timelines?

Where you are seeking authorisation for a completely new source, standard fees (see HSE Fees for Individual Application Types) will apply (usually sift fee + co-ordination fee + chemistry data module + toxicology case). The evaluation of a change to an existing source, or for a new source will usually be considered as a 52 week stream application.

It is also possible to seek authorisation for changes to the technical specification as part of another application for the same product, for example new uses, re-registration, new product. In this case standard fees will apply.

Do I need to submit an application for assessment of technical equivalence at the Initial Compliance Check of renewal of the plant protection product?

There is no need to submit a 'formal application' at this stage – unless the conditions (relevant impurities and min purity) of the renewal regulation have changed, your existing specification does not encompass the changes, and you were not a notifier. If this applies to you then you must update the technical specification for your source of technical material. You must submit this as a separate application alongside your renewal application (it cannot form part of the renewal application).

You must ensure you comply with those requirements or your authorisation may be withdrawn.

Can I make changes to the source during the transitional period, meaning before renewal of the plant protection product?

Prior to renewal it is possible to change your existing authorisations to reflect changes in source (this is one of the exceptions under the transitional period for existing active substances). You must inform us of changes as soon as possible and submit an application to support the change. We would assess this in accordance with the Sanco Guidance document.

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Updated 2020-12-31