Pesticide product authorisation in Northern Ireland: Article 40 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:

• the same product
• the same use
• comparable agricultural practices to NI

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

• the product contains a substance that is included in candidates for substitution
• the application concerns a provisional authorisation
• the application concerns a product that contains a substance that has been approved under the derogation of Article 4(7) of (EC)1107/2009 (substances for which there are no alternatives)

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):

• a copy of the authorisation issued by the reference authority for the reference product with a translation into English
• a core Registration Report (assessment dossier) for the reference product's evaluation that has been finalised by the reference authority (a complete and summary dossier for the product and each active substance, safener and synergist)
• a declaration that the GAP, the active substance technical specification, the formulation recipe, the packaging type and classification labelling are all the same as those for which authorisation has been granted by the reference authority, and that the assessment is to Uniform Principles using EU agreed endpoints
• a cover letter and detailed application overview, including detailed evidence that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the reference authority's territory are comparable with those in NI
• a signed and completed application form (CRD1)
• a copy of the draft UK label for your product
• a draft Registration Report Part A/B0, detailing the risk management pertinent to NI, a draft Registration Report part C, and the draft Registration Report Part B UK addenda in all relevant areas detailing the risk assessment to address UK specific issues
• if the product contains a candidate for substitution, a comparative assessment is required

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:

• the proposed crops
• the maximum individual dose
• the maximum total dose or number of applications and application intervals
• the latest time of application
• the method of application for the product
• the minimum and maximum water volume
• the product classification and associated risk phrases
• the proposed packaging (including size of container aperture)
• operator personal protective equipment (PPE) requirements
• any 'Other specific restrictions'

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 the extrapolations guidance. Product authorisations that require a new MRL cannot be accepted via this procedure.

The following will need to be provided:

• evidence of the MRL required for the product authorisation and that this is within the MRL in force in NI
• evidence that a suitable analytical method is available for enforcement/monitoring
• consumer intake assessments using UK models
• consumer intake assessments using EFSA PRIMo  
• for mixed active products a combined consumer risk assessment may be required

Non-dietary human exposure

Please go to:

• Operator Exposure guidance
• Bystander Exposure guidance
• Worker Exposure guidance

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:

• details on the mode of action and properties of the active substance(s) and the intended uses of the product (the level of detail required will depend on whether the active substance is new to the UK or already approved for other uses)
• based on the above, identify those relevant factors which may affect the product's efficacy or crop safety, and provide appropriate information to demonstrate comparability with NI conditions
• information to justify comparability of the target organisms
• a statement which indicates that the control claims made on the UK label reflect the performance demonstrated in the trials work (and if relevant whether the control claims on the UK label have been modified to achieve this) or the case might include a statement which provides information to indicate the levels of performance of the product for the relevant target pests

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

• Firstly, for products where the proposed dose differs from that for other products currently or previously authorised in the UK. If the dose of the product to be recognised in NI is higher, information to justify the dose must be provided. Robust justification would also be required if a lower dose is proposed for the same claim.
• Secondly, where the authorised label in the reference authority's territory claims control of a group of pests (for example, sucking pests, aphids, caterpillars), information must be provided on which species were tested.

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:

• Climatic differences may be important to the crop, the target organism, or the active substance(s). Discussion of the location of trials with reference to EPPO standard PP 1/241 Guidance on comparable climates would be required.
• Edaphic factors are particularly important for soil-applied pesticides and information on the range of soil types tested in the trials would be appropriate. For example, blackgrass is a major UK weed because it is particularly widespread on heavy soil types not generally common elsewhere in Europe.
• An example of a relevant agricultural factor is plant varieties. In the UK, specific varieties of apple (Cox, Bramley) and pear (Conference, Comice) are the major varieties and evidence that crop safety (and efficacy) has been tested on these would be required. Another example is dose adjustment schemes in apple orchards. Alternatively, the properties of the product and mode of action may provide further information.
• An example where the plant health aspects of pest population dynamics (for example, migration) and resistance are important is control of the damson hop aphid, which in the UK occurs in greater numbers and has a longer period of migration onto hops. It is also resistant to a range of active substances.  Authorisation under Article 40 without specific NI data is, therefore, unlikely in this circumstance.
• An example showing how a statement relating to the label control claims might be worded is shown: Data for 'Product X' show high levels of control for all aphids (on apples: apple grass aphid, mean 84%, rosy apple mean 80%, green apple aphid, mean 86% and on brassicas, peach-potato aphid, mean 83% control) except for mealy cabbage aphid on brassicas and woolly aphid on apples where 72% and 65% control respectively was achieved. The label claims moderate control of these two aphids and control of all other aphids on apples and brassicas.

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:

• Evidence that when the product is applied in accordance with the proposed UK statutory conditions of use and directions for use, the stage of crop and in particular canopy development is comparable with those of the reference authority's territory. This is required to ensure that the predicted environmental concentrations (PEC) used in the available environmental risk assessment are pertinent to the NI situation.
• The agricultural and environmental conditions in the UK are particular in that a major route of exposure for aquatic life is via drainage. To ensure that the PEC used in the environmental risk assessment are pertinent to the NI situation, the applicant must provide confirmation that a risk assessment to aquatic life as a result of a drainage route of entry to surface water pertinent to the uses requested and appropriate to the UK soil hydrological situation has been carried out.

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 Toxicity Exposure Ratio (TER) endpoint values are not exceeded upon calculation of an appropriate PEC. For limited area crops (grown on less than 500 ha in Northern Ireland and excluding major crops such as spring wheat and field bean – see definition of minor use. HSE will rely on the EU member state’s core birds and mammals risk assessment, even when these use higher tier assessments not usually applicable in UK. Where use is for a crop grown on greater than 500 ha in Northern Ireland or relates to several minor crops (where the total area is greater than 500 ha) then a NI specific birds and mammals assessment is usually required.

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 whether 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.