Authorisation under Article 40 of Regulation (EC)1107/2009

The procedure for recognition in Northern Ireland of an authorisation issued by another competent authority is described in Articles 40-42 of Regulation (EC)1107/2009. Article 40 can be applied to authorisations from any other authority.

These applications will be subjected to the validation check to ensure UK specific requirements have been submitted. Further details are given in Criteria for Validation Check in Appendix 3 of Overview of the process and procedures for the authorisation of PPP in the UK.

When can I apply for recognition under Article 40?

Authorisation holders can apply for recognition of an authorisation already granted by another authority provided the application relates to:

There are a number of cases for which recognition is optional (Article 41(2)):

Recognition of authorisations according to articles 40-42 is also applicable to minor uses (Article 51(7) of (EC)1107/2009).

What information do I need to submit?

Your application will need to contain appropriate information so that HSE can determine whether the use of the product in the reference authority's territory and conditions is comparable with the proposed use of the product in NI.

These applications should not involve significant data evaluation (except where data are required to address the UK's national specific requirements or demonstrate comparability of environmental/agricultural conditions). If additional data are required to support any aspect of the core assessment, an application under Article 33 of (EC)1107/2009 is required instead.

In support of your application you must submit the following (go to The Applicant Guide what should i include in an application for further information):

What aspects need to be addressed for each area of the risk assessment?

Details of the UK specific requirements which need to be addressed are provided in the Applicant Guide and summarised below.

General requirements

All the proposed uses, rates and timings and packaging (that is, the conditions for sale, supply and use) for your product must be the same as those authorised for the product in the reference authority's territory. In the Application Overview you should detail all the proposed conditions of use for your product and those approved for the product by the reference authority.

You should include information on:

Consumer exposure

Only applications for products based on residue trials data that are relevant to agricultural practices in NI can be accepted for authorisations under article 40. The trials must correspond to the critical GAP and the production conditions (such as cultural practices, climatic conditions) must be comparable to NI.

Differences in agricultural production methods (for example, outdoor versus indoor uses), seasons of production and types of formulation shall be taken into account. The number of trials must reflect the requirements in NI and the data must cover the residue definitions (for enforcement and risk assessment) in force in NI.

Furthermore, the trials must reflect the crop extrapolations permitted in NI. Information on the number of trials and crop extrapolations are outlined in SANCO 7525/VI/95, REV 10.3, 13/06/2017.Product authorisations that require a new MRL cannot be accepted via this procedure.

The following will need to be provided:

Non-dietary human exposure

Please go to:

Efficacy

In demonstrating the comparability with the NI of agricultural, environmental and plant health conditions, you should consider those factors relevant to the product which may affect performance or crop safety. You should also consider any differences in the biology and pathogenicity of the target organism.

Where differences have been identified, an application under Article 40 may still be possible. For example, it may be possible to demonstrate that the supporting data were generated under conditions relevant to, or more challenging than, NI.

You should also ensure that the label claims made on the UK product label reflect the performance demonstrated in the trials work supporting the authorisation of the product.

The case should include:

There are two other areas where further information supporting an application for recognition under Article 40 may be necessary:

As a general guide, the factors that may be important are detailed in Efficacy Data Requirements (Overseas Evidence) (available from the UK Government Web Archive section of 'The National Archives' website). This guidance discusses the relevant climatic, edaphic, agricultural and plant health factors that may need to be considered.

However, you only need to relate these factors to the product under consideration. To illustrate these areas, some working examples are given below:

Further information relating to UK product labelling and UK national issues is available in the document '(EC) 1107 Efficacy Assessments: UK product labelling and National Issues/Addenda'.

Environmental considerations (Fate and Behaviour and Ecotoxicology)

Information relating to the comparability of climate and agricultural conditions is also relevant when demonstrating that the environmental risk assessments carried out by the reference authority are appropriate to NI conditions. The following information must be provided:

Alternatively, the application must include a risk assessment that addresses this route of entry into the environment. Go to the current guidance on calculating the surface water PECs required to complete such an assessment.

Further guidance is included in the data requirements for Environmental Fate.

Evidence must be provided that the assessment of groundwater exposure upon which the environmental risk assessment is based, is comparable with the geoclimatic conditions in NI. This should include details of the situations considered within the risk assessment and how they are considered to be comparable with UK conditions.

If this groundwater exposure assessment was completed using the FOCUS groundwater modelling and standard scenarios, the scenarios considered pertinent to UK conditions are Chateaudun, Hamburg, Kremsmunster and Okehampton. If this evidence is not available, the applicant must submit appropriate PEC groundwater calculations with the application for the UK geoclimatic situation. Further guidance is included in the data requirements for Environmental Fate.

You must demonstrate that the Ecotoxicological risk assessment carried out is appropriate to NI conditions. You must provide evidence that the fate endpoints used in deriving the PEC are relevant to NI conditions (see above) and the TER endpoint values are not exceeded upon calculation of an appropriate PEC.

If the authorisation in the reference authority includes risk management or risk mitigation measures, you should demonstrate how the proposed UK statutory conditions of use afford the level of risk mitigation provided in that authority's territory (for example, buffer zones for the protection of aquatic life). HSE will assess if the risk management proposed is compatible with NI regulatory requirements and agricultural practice.

Details of the UK specific requirements which need to be addressed are provided in the Applicant Guide.

How much will I be charged?

You will be charged using the standard modular system which will normally reflect the level of complexity in each area of the risk assessment. If additional environmental fate modelling, non-dietary human exposure modelling or higher tier ecotoxicology assessment pertinent to the NI evaluation is required then you will be charged a data fee in the relevant areas.

Further guidance on our fee structure is given in the Applicant Guide.

What are the UK timelines?

Under Article 40 HSE, as competent authority, has 120 days to decide on the application. It is not generally possible to 'stop-the-clock' for these applications. Therefore, no requests for additional information can be issued once the 120-day processing time has commenced.

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Updated 2021-08-09