The Applicant Guide: Mutual Recognition Procedure

What is Mutual Recognition?

Mutual Recognition (MR) is the process that allows for the harmonisation of product authorisations between Member States (MS), provided it can be shown that the agricultural, plant health and environmental (including climatic) conditions relating to the use of the product are comparable in the regions concerned.

Using this procedure, you may submit an application for approval of a product in the UK by extrapolation from an existing authorisation for the same product granted in another MS.

If you wish to submit a MR application you must be able to demonstrate that the risk assessment (all safety aspects and efficacy and crop safety) supporting the authorisation of the product in another MS is relevant to UK conditions. Minor differences may sometimes be acceptable.

Please note that other MS will have their own procedures for MR applications and should be contacted if you wish to make this type of application in another MS.

When can I submit a Mutual Recognition application?

The provisions for the MR of product approvals are set out in Article 10 of Directive 91/414 EEC and incorporated into UK legislation in Regulation 11 of The Plant Protection Product Regulations 2003 (PPPR). MR applications are only appropriate for products and/or uses that:

1. Are approved in another Member State (MS) under the terms of Council Directive 91/414/EEC. The approval must be issued on the basis of a dossier satisfying the Annex III data requirements and evaluated in line with Uniform Principles; and,
2. Only contain active substances that are included in Annex I of Directive 91/414/EEC; and,
3. Have the same formulation as that approved in the other MS.

Minor differences between the agricultural, plant health and environmental (including climatic) conditions in the UK and the other MS may be considered acceptable. However, we may make changes or impose additional restrictions to your approval to overcome these differences. Restrictions may also be imposed on your approval to account for differences in dietary patterns between the UK and the other MS.

What are the benefits of applying for a Mutual Recognition approval?

If your product has already been authorised in another Member State under the terms of the Directive, we will accept that they have carried out an assessment which meets harmonised assessment criteria (the Uniform Principles) using Annex I agreed endpoints and will not re-evaluate the supporting data again.

MR can therefore be a quicker and cheaper way of gaining an approval.

What do I need to submit in support of my application?

Your application will need to contain appropriate information so that we can determine whether the use of the product in the other MS is comparable to the proposed use of the product in the UK. Data do not need to be submitted in support of your application (and will not be evaluated if they are) as we will assess the comparability using the expert judgement of our specialists.

In support of your application you must submit the following (see The Applicant Guide for further information):

1. A covering letter; and,
2. A signed and completed application form ; and,
3. An Application Overview detailing how each area of the risk assessment is to be addressed for the approval of your product and the relevance of the approval in the other MS to the proposed rates and timings of your product.

   Your overview must include evidence that the agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product in the other MS are comparable to those in the UK; and,

4. One copy of the draft label for your product; and,
5. A copy of the authorisation issued for the product in the other MS with a translation into English; and,
6. A copy of the approved label for the product in the other MS with a translation into English; and,
7. A declaration that the technical specification and formulation recipe of your product are the same as those for which approval has been granted in the other MS; and,
8. Evidence that a Maximum Residue Level for the active substance(s) has been set, for the proposed uses for your product, in the other MS or by the EC under the appropriate Directives.

Further information is available on the particular requirements for each area of the risk assessment.

What can I do if I cannot demonstrate comparability?

Where it is not possible to demonstrate comparability in all the relevant areas of the risk assessment, we may need to consider additional validation and/or comparability data to support the proposed uses of your product. If this is the case, your application cannot be considered via the MR procedure.

For applications that require the evaluation of data, we can still take into account the authorisation in the other MS to address some areas of the risk assessment. Such an application would be processed via the ‘Data’ or ‘Data-Plus’ streams. These applications include those where the proposed formulation for your product differs to that approved in the other MS.

If you wish to make a partial MR application you may wish to contact us for advice prior to the submission of your application to ensure that all the required aspects of the application are covered.

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

General requirements

All the proposed uses, rates and timings and packaging (i.e. the conditions for sale, supply and use) for your product must be within those authorised for the product in the other MS. In the Application Overview you should detail all the proposed conditions of use for your product and those approved for the product in the other MS. You should include information on:

1. the proposed crops;
2. the maximum individual dose;
3. the maximum total dose or number of applications and application intervals;
4. the latest time of application;
5. the method of application for the product;
6. the minimum and maximum water volume;
7. the product classification and associated risk phrases;
8. the proposed packaging (including size of container aperture);
9. operator personal protective equipment (PPE) requirements; and
10. any ‘Other specific restrictions’.

Consumer exposure

To be considered comparable to UK conditions, only applications for products holding an approval in a ‘northern region’ MS, or for a use in a protected environment (such as a glasshouse), can be considered via the MR procedure.

Where a provisional EC MRL for the proposed use(s) has been set, you should provide UK dietary intake calculations based upon the Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) (Section 3 of Chapter 5 of The Data Requirements Handbook).

If, following this consideration, the proposed use exceeds the Community agreed ADI and ARfD (where appropriate) for the active substance(s), it may still be possible to grant an approval with certain restrictions placed upon the use to ensure the consumer exposure within UK dietary intake patterns is acceptable e.g. the product may be limited to pre‑emergence use on specific crops.

Please note that for mixed active products a combined human health assessment may be required (see CRD and ACP approach to assessing the mammalian toxicity (and consumer/ operator risk assessment) of two or more compounds in a pesticide product formulation Regulatory update: 05/2005)

Operator exposure

Operator exposure

A quantitative estimate of exposure should be provided using the appropriate models as outlined in the guidance document on completing an Application Overview and compared to the Community agreed Acceptable Operator Exposure Level (AOEL) for the active substance(s). The assumptions used to derive these estimates should be clearly stated and appropriate to UK conditions (e.g. work rates, container sizes, application equipment). Systemic exposure should be derived using the agreed dermal absorption value for the formulation and assume an operator bodyweight of 60kg.

Where the product authorisation in the other MS is supported by measured levels of exposure from an appropriately conducted and validated field exposure study and/or biological monitoring study, confirmation is required that the studies were conducted under the same conditions of use and are in line with current working practices in the UK. Where this is not the case, you will need to provide a scientific reasoned case to support any differences.

Bystander exposure

An estimation of bystander exposure appropriate to each method of application is required and should be based on the assumption that there is no reduction in exposure from clothing.

Worker exposure

An estimation of worker exposure should be provided for each crop and task carried out. The estimate should be based on working practices appropriate to the UK (e.g. crop inspection, manual planting or harvesting operations) and should assume that the worker is not wearing any personal protective equipment. Details of any exclusion periods and the basis upon which these are derived should also be provided.

Please note that for mixed active products a combined human health assessment may be required (see CRD and ACP approach to assessing the mammalian toxicity (and consumer/ operator risk assessment) of two or more compounds in a pesticide product formulation Regulatory update: 05/2005)

Efficacy

In demonstrating the comparability 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, you should not be deterred from submitting a MR application. For example it may be possible to demonstrate that the supporting data were generated under conditions relevant to, or more challenging than, the UK. 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:

1. 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).
2. 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 UK conditions.
3. Information to justify comparability of the target organisms.
4. 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). Alternatively 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 the mutual recognition application may be necessary:

1. Firstly, for products where the proposed dose differs from that approved in other products currently or previously approved in the UK. If the dose of the product to be recognised in the UK is higher, information to justify the dose should be provided, and if lower but for the same claim, there would need to be a good case to justify an approval.
2. Secondly, where the authorised label in the other member state claims control of a group of pests (for example, aphids, caterpillars), information should be provided on which species were tested.

As a general guide, the factors that may be important are detailed in Section 3.4 of Chapter 8 of The Data Requirements Handbook (Overseas Evidence). 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. Not all of the factors will be relevant and additionally there may be other factors that you are aware of that are important. Section 3.3 of Chapter 8 of The Data Requirements Handbook and Regulatory Update 17/2006 provide information relating to control claims and performance levels.

To illustrate these areas, a few working examples are given below:

1. Climatic differences may be important to the crop, the target organism, or the active substance(s). Generally, the closer the locality to the UK, the less extensive a justification is required. Typically, the Republic of Ireland, Belgium, the Netherlands, Luxembourg, Northern France, Northern Germany and Southern Scandinavia are considered similar. Where the use is in protected situations or for stored produce, climate variation is less relevant and extrapolation from e.g. Southern Europe may be acceptable. Please see All Approval Holders Letter 11/2003 containing the Climate Justification document.
2. Edaphic factors are particularly important for soil-applied pesticides and information on the range of soil types tested in the trials would be appropriate e.g. blackgrass is a major UK weed because it is particularly widespread on heavy soil types not generally common elsewhere in Europe.
3. 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, Regulatory Update 18/2006 provides further guidance. Alternatively the properties of the product and mode of action may provide further information.
4. An example where the plant health aspects of pest population dynamics (e.g. 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. MR without specific UK data is therefore unlikely.
5. 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 (i.e. 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.

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 other MS are appropriate to UK conditions.

The following information should be provided:

1. 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 to the other MS. This is required to ensure that the predicted environmental concentrations (PEC) used in the available environmental risk assessment were pertinent to the UK situation.
2. 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 UK situation, the applicant should 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. Current guidance on calculating the surface water PECs required to complete such an assessment is included in Section 5 of Chapter 6 of The Data Requirements Handbook.

3. Evidence that the assessment of groundwater exposure upon which the environmental risk assessment is based, is comparable to the geoclimatic conditions in the UK. This should include details of the situations considered within the risk assessment and how they are considered to be comparable to 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 Chapter 6 of The Data Requirements Handbook.

4. You should demonstrate that the Ecotoxicological risk assessment carried out is appropriate to UK conditions. You should provide evidence that the fate endpoints used in deriving the PEC are relevant to UK conditions (see (a) to (c) above) and the TER endpoint values are not exceeded upon calculation of an appropriate PEC.
5. If the authorisation in the issuing MS 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 Member State e.g. buffer zones for the protection of aquatic life. We will assess if the risk management proposed is compatible with UK regulatory requirements and agricultural practice.

Division of European States into Northern and Southern regions for residues trials.

Northern and Central Europe

Southern Sweden, southern Norway, southern Finland, Denmark, United Kingdom, Ireland, northern France, Belgium, The Netherlands, Luxembourg, Germany, Poland, Czech Republic, Slovakia, Austria, Hungary, Switzerland.

Southern Europe and the Mediterranean

Spain, Portugal, southern France, Italy, Greece, Croatia, Serbia, Bosnia and Herzegovina, Slovenia, FYROM (Former Yugoslav Republic of Macedonia), Turkey, Bulgaria, Romania, Cyprus.