What is a technical specification?
Each source of each active substance has a specification which details:
- The minimum content (g/l or %w/w) of the pure active substance; and,
- The nature and maximum levels (g/l or %w/w) of all the impurities present at or greater than 0.1% of the total content of the active substance. There may also be a specific requirement to set a maximum level for certain toxicologically significant impurities that are present at less than 0.1% w/w (see Part A of Chapter 3 of The Data Requirements Handbook).
This is known as the ‘technical specification’. A ‘source’ is described as an individual technical specification and its supporting data package. A number of sources may be approved for an individual active substance based on different supporting data packages. In addition a number of sources of an active substance may be approved in a product.
What else is in the formulation of a product?
The formulation details of your product consist of the technical specification and the formulation ‘recipe’. The formulation recipe consists of:
- The nominal target content for the pure active substance, with acceptable tolerance limits in line with FAO guidance, (see Section 2.2 of Part C of Chapter 3 of The Data Requirements Handbook).
- The chemical name, trade name and/or CAS number, structure and quantity of all other components (the ‘co-formulants) in the formulation (see Section 2.1 of Part C of Chapter 3 of The Data Requirements Handbook).
How is this information presented on a Notice of Approval?
The details of your product’s formulation will be specified on the Notice of Approval. These details include the formulation type, the quantity and identity of the active substance(s) in the formulation, a reference to the technical specification of the active substance(s) and a reference to the formulation ‘recipe’ for your product.
You will note that in order to ensure the confidentiality of this information, the actual formulation details are not given in the approval document. Instead we make reference to where the details of the technical specification and formulation recipe can be found. This information is presented as part of the approval document as follows:
Formulation being a [GCPF definition] formulation containing [x g/l or % w/w] of [active substance]; details of the formulation consisting of the following:
- technical specification of [active substance] as specified in [reference to actual document containing technical specification] (HSE ref: [doc ref]) and;
- formulation details as specified in application form dated [Date] (HSE ref: [doc ref]) [and any relevant subsequent letters dated [Date]] (HSE ref: [doc ref])
For parallel imports, the layout differs in that it refers to the product being sold in another Member State which you are importing into the UK.
This information may be presented slightly differently on older Notices of Approval (‘old-style’ Notices of Approval where generally details of the technical specification reference are not stated. If you have an old-style Notice of Approval the formulation details will be updated so that they are presented as above whenever we next evaluate an application for your product (except for those processed via the Admin Stream).
How should this information be submitted?
When applying for a commercial level of approval (except for parallel imports) you will need to provide details of the technical specification and formulation recipe for your product, either in full or via reference to previously submitted details. This information is also required for applications for an experimental level of approval (except Administrative Experimental Approvals) if it is available.
If there are no changes to the technical specification(s) and formulation recipe, and these details have previously been referenced in full on the Notice of Approval, then you should complete Section 3.1 of the application form APP8 (along with the associated sections on data ownership Sections 3.3 and 3.5).
However, if your current approval specifies the formulation details in the old-style then you will need to provide full details of the technical specification(s) as detailed below.
You must provide full details if you are applying for approval of a new technical specification or formulation recipe. To provide full details of the technical specification(s), you should complete Section 3.2 of application form APP8. A separate Section 3.2 must be completed for each active substance in your product. To provide full details of the formulation recipe you should complete Section 3.4 of application form APP8. Sections 3.3 and 3.5 of APP8 regarding data ownership must also be completed.
You may provide full details of the technical specification and a reference to the formulation recipe, or vice-versa. If you are providing details of the technical specification and a reference to the formulation recipe you should complete Sections 3.2 of application form APP8 with the appropriate details and Section 3.4 of application form APP8 with an appropriate reference. Sections 3.3 and 3.5 of APP8 regarding data ownership must also be completed.
If you are providing a reference to the technical specification and details of the formulation recipe you should complete Sections 3.2 of application form APP8 with an appropriate reference and Section 3.4 of application form APP8 with the appropriate details. Sections 3.3 and 3.5 of APP8 regarding data ownership must also be completed.
When will I need a signed declaration for the technical specification?
You do not need to provide a copy of the technical specification for the active substance(s) in your product if it has not changed since it was previously considered. However, you may wish to provide this information in your application form rather than provide a reference to where the technical specification was last approved. In this case you will also need to submit a signed declaration as a separate document stating the following:
‘The specific technical material to which the attached specification applies, and the supporting data package, have previously been fully evaluated as part of an application for approval and considered to be acceptable for use in a UK approved product. There have been no changes to the technical material since it was last fully considered by CRD, i.e. the minimum purity of the active substance has not decreased, the maximum level of any impurity has not increased and no new impurities are present.’
We will assume that no changes have been made to the previously considered technical specification and will include the new reference for the technical specification on any approval issued for the product.
What constitutes a change to the technical specification?
Various changes can impact upon the composition of the technical specification (e.g. change of method of manufacture, moving from pilot plant to full production and improved methods of analysis). All technical specifications must be supported by batch data and validated methods of analysis, so that we can ensure the technical specification reflects the minimum level of the active substance and the maximum levels of impurities found in routine manufacturing.
What is a source?
‘Source’ refers to a technical material manufactured by a specific process in a particular location. It is defined by a technical specification which set limits for the minimum content of active substance, and maximum content of isomers, significant/relevant impurities and additives. This is derived from evaluation of data from the analysis of representative batches of technical material.
The source is dependent on many factors, including the manufacturing location, manufacturing process, and scale of manufacture. If any of these factors change, then the source is considered to have changed and it is necessary to provide data to support the new source or a reasoned case as to why data are not required. If the new source is different to that which is authorised, an assessment of equivalence to the reference source (usually that considered for Annex I inclusion) is required, and it may be necessary to amend the technical specification in line with the new source.
How do we assess technical equivalence?
In all instances (under Control of Pesticides Regulations (COPR) and PPPR) we determine technical equivalence in accordance with Sanco Guidance document 10597/2003. This approach is used both at Step 1 of re-registration (to confirm existing approved sources comply with the conditions of Annex I inclusion) and to assess the acceptability of new sources.
Where a technical equivalence check is conducted, we will complete an Equivalence Report which can be made available to Regulatory authorities in other Member States.
When do I need to apply for a new source?
For active substances included on Annex I, you must apply to CRD if you are:
- obtaining technical material from a new/different manufacturer;
- moving from pilot to full scale manufacture;
- changing the manufacturing process;
- changing/adding a manufacturing location;
Approval holders are respectfully reminded that the ‘new’ source should not be used until approval is agreed.
What data are required?
Data are required to address the requirements under points 1.1 to 1.11 of Directive 94/37/EC (identity of active substance) and 4.1 of Directive 96/46/EC(methods of analysis). However, data need not be submitted to address the methods of analysis if the impurity profile has not changed compared to that already authorised, or if the methods used have already been assessed by CRD.
These data can be assessed as the first stage of a two-staged application, or as part of a general application.
It would be helpful if you could submit a draft Technical Equivalence Report with your submission (including the information relevant to the new source), although this is not a requirement.
What if I want to make changes to my approved technical specification?
If the technical specification has changed because of changes in the methods of analysis
If your technical specification has changed because of changes/improvements in the methods used to analyse your technical material, you can notify us of these changes provided the method of manufacture, raw materials and any other aspects of the production of the active substance have not changed.
You should notify us of the changes and all of the affected products as soon as possible and provide a full comparison of the currently approved and proposed technical specifications. We will consider the submitted information and inform you if the proposed specification is considered to be acceptable. If further information is required we will contact you and request this information.
Once we have agreed to the proposed specification we will update the approval for the affected product when the next application for that product is submitted and evaluated.
All other changes to the technical specification
If you wish to apply for a new, additional or changed source of an active substance that we have not previously considered and you will need to submit an application for approval of your specification.
In support of your application you will need to submit:
- A covering letter explaining the reasons for the application; and,
- A fully completed application form (see The Applicant Guide); and,
- Any letters of access that are required (see the guidance document on letters of access); and,
- Data or reasoned scientific cases to address all the appropriate data requirements (see The Applicant Guide).
This application would be considered in either the No-Data, Data or ‘Data Plus’ streams, depending on the type and nature of any data submitted to support the change. Applications for other (trailing) products containing the new technical specification may be considered via the Admin. Stream.
If the ownership of the supporting data package has changed
If the ownership of the data package supporting your approved technical specification changes you should notify us as soon as possible including details of all the affected products. We need confirmation of the change from both the previous and the new data owners. We also need confirmation from the new data owners that the technical specification has not changed (see the guidance document on letters of access and above).
If the inclusion of a new (or additional) source has an impact on a product's formulation details
The inclusion of a new (or additional) source of an active substance may have an impact on the formulation details of your product e.g. changes may be required to the approved formulation to achieve the target content of the pure active substance. If this is the case then you will need to submit an application so that we can consider the new formulation. In support of your application you will need to submit:
- A covering letter explaining the reasons for the application; and,
- A fully completed application form (see The Applicant Guide); and,
- Any letters of access that are required (see the guidance document on letters of access); and,
- Data or reasoned scientific cases to address all the areas of the risk assessment affected by the formulation change.
Can I still notify CRD of changes under COPR?
Where the active substance is not yet included on Annex I, it is still possible to use the notification process, as long as you provide the updated technical specification and a declaration that the technical material has not changed since it was last considered by CRD (minimum purity of active substance has not decreased, maximum level of any impurity has not increased and no new impurities are present). Where you cannot provide such a declaration, you must apply for a change in source under COPR, which will be considered in accordance with the Sanco Guidance document.
What are the costs and timelines?
Where you are seeking approval for a completely new source, standard fees 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 data stream application (18 week target).
It is also possible to seek approval for changes to the technical specification as part of another application e.g. new uses, re-registration, new product. In this case standard fees will apply.
If the source has already been considered technically equivalent in another member state a copy of the technical specification must be submitted in support of an application. CRD will obtain the equivalence report from the evaluating member state to ensure that it supports the submitted specification. These applications will be charged a reduced fee (i.e. sift fee, admin. fee, and a chemistry case fee. This will be considered as a no data data stream application (9 week target).
If the only issue to be considered is a change to the existing source (i.e. the technical specification is similar to that previously approved - minimum purity of active substance has not decreased, maximum level of any impurity has not increased and no new impurities are present) a reduced fee and stream allocation will be applied as outlined in the paragraph above.
It should be noted that if, during evaluation, we find that the technical specification is not supported by the batch data, or it is not similar to that previously approved, then we will apply additional charges to cover the costs of addressing the additional issues.
Where you are submitting a notification for a non-included active substance, no charge is applied.
Do I need to submit an application for assessment of technical equivalence at Step 1 of re-registration?
There is no need to submit a ‘formal application’ at this stage – details of requirements at Step 1 are outlined in our ‘Post Inclusion Guidance’. You must ensure you comply with those requirements or approval may be revoked.
Can I make changes to the source during the transitional period?
During the transition from COPR to PPPR (after Annex I Inclusion of all actives) it is possible to change your COPR approval to reflect changes in source (this is one of the exceptions under the transitional period for both new and 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.
What if the source had been considered as technically equivalent in another Member State?
If another Member State (MS) has conducted a technical equivalence check in accordance with the Sanco Guidance document, the UK will accept their decision, but will need to check the proposed UK specification against that considered in that MS (via reference to the technical equivalence report produced by the MS which we will request from the MS for confirmation). This type of application will be charged a reduced fee as described above.
How will the source(s) be referenced on the notice of approval?
Our new approval documents (see Regulatory Update 6/2008) will detail a ‘document’ reference to the technical specification, as well as brief information on the manufacturing site and data owners in the confidential section.
