How to apply for authorisation to market a new pesticide product

New pesticide product supported by a data package

You may apply for authorisation of a product which is a unique formulation, or which is similar in formulation to an existing commercially authorised product. In most cases, you will need to provide formulation specific data. You may also be able to support elements of the risk assessment for the new formulation by extrapolating from, or providing ‘bridging’ data to, other authorised products. Where the changes are minor, reasoned cases may suffice.

Note: these applications can only be processed after renewal of approval of the active substance in either Great Britain or Northern Ireland under Regulation (EC) No 1107/2009 where the submission complies with the renewal end points.

Application contents

The application must include:

• A full explanation of your request in the covering letter.
• A completed application application form CRD 1.
• Any letters of access to third party data that are required.
• Any previous relevant correspondence of a previous/similar assessment (include product name, COP number).
• One copy of the draft product label and, if necessary, a Compatibility Assurance Statement (for further information go to The Labelling Handbook and the guidance on tank-mixes).
• A reasoned case or data addressing all areas of the risk assessment. It is recommended that this information is provided in the format of an Application Overview.
• A draft Registration Report (dRR).
• Safety Data Sheets for all co-formulants in your product. A reference should be provided for any SDS that have been previously submitted (including COP number and date submitted). When making applications for a new formulation, you must be aware of the restrictions on the use of unacceptable co-formulants (For further information go to Physical and Chemical Properties).
• Submit a full justification for the Classification, Labelling and Packaging of Substances and Mixtures (CLP) for your product. For further information go to CLP regulation.
• If the product contains a ‘candidate for substitution, you are required to submit information to support the process of comparative assessment.

New pesticide product citing data for which data protection has expired

You may apply for authorisation of a product which you believe is comparable to an authorised product. Article 34 of Regulation (EC) No 1107/2009 exempts you from the need to supply supporting data where the competent authority has already assessed relevant, supporting studies to support authorisation and where the data protection period for all relevant supporting active substance and reference product studies has expired at the time of application (for further information see Data Protection)

Note: these applications cannot be processed during the period after renewal of approval of the active substance in either Great Britain or Northern Ireland under Regulation (EC) No 1107/2009 and before the reference product authorisation has been renewed (known as ‘the frozen period’). Data are typically protected at product renewal.

Limitations when making an application under Article 34 of Regulation (EC) No 1107/2009 (citing data for which data protection has expired)

• Only one reference product can be considered per application.
• Only one new source of active substance, to be considered via GB technical equivalence, will be considered per application.
• If applicable, data access (for example letters of access) must be in place at the time of application.

The application must include:

• A full explanation of your request in the covering letter, including why you believe the data supporting the source of the active substance and/or reference product to which you are claiming comparability are no longer protected.
• A completed application application form CRD 1.
• Any letters of access to third party data that are required.
• Any previous relevant correspondence, for example of a previous assessment (including product name, COP number).
• One copy of the draft product label and, if required, a Compatibility Assurance Statement (go to The Labelling Handbook and the guidance on tank-mixes for further information).
• The product name and MAPP number of a single reference product to which you are claiming comparability. We do not accept general references to "any product containing <named active substance>" you must state one single reference product.
• Demonstration of comparability between your product and the reference product. This information may be provided in the form of an Application Overview.
• A draft Registration Report (dRR) (at a minimum Part A and C).
• Safety Data Sheets for all the co-formulants. When making applications for a new formulation you must be aware of the restrictions on the use of unacceptable co-formulants (for further information go to Physical and Chemical Properties).
• Submit a full justification for the Classification, Labelling and Packaging of Substances and Mixtures (CLP) for your product. For further information go to CLP regulation.
• If relevant - draft technical equivalence report and supporting data for a new GB source as detailed on the technical equivalence page. This same page also includes information on applying for a new source in Northern Ireland, which must be submitted under a separate application.

Note: you may apply for authorisation of a product which is comparable to an authorised product where the data protection period for all relevant supporting active substance and product studies has not expired. In this case, you must demonstrate access to the supporting studies. This may be via a letter of access from the data owner (go to guidance on Letters of Access).

Acceptance of application

HSE will not check data access or the data protection status at the sift stage of the application.

Evaluation

HSE will check that (where appropriate):

• the data cited were unprotected at the time of application. HSE will inform you of the outcome prior to the assessment of the formulation comparison. HSE will refuse authorisation if some or all of the data being relied upon were protected at the time of application, even if the data protection expires prior to the completion of the assessment.
• any new source of active substance is technically equivalent to the reference source, in accordance with SANCO Guidance Doc 10597/2003.
• the proposed new product’s formulation is sufficiently comparable to that of the reference product, in accordance with SANCO Guidance Doc 12638/2011.
• the reference product assessment is still valid.

Refusal outcome

HSE will refuse authorisation if some or all of the data being relied upon were protected at the time of application, even if the data protection expires prior to the completion of the assessment. HSE will complete the assessment including the registration report, concluding on the formulation comparability. If no authorisation is recommended, we will not undertake a check of the draft label. You may cite the conclusions of a previous application in any new application submitted once the data protection period for the reference product expires. In this situation, there must have been no intervening changes in assessment standards and the conclusions should remain valid.

New pesticide product which is identical to an existing authorised product (a 'back-to-back')

You can make an admin application for authorisation of a product which is identical to an existing commercially authorised product.

The new ('child') product must be identical to the existing ('parent') product in terms of:

• technical specification of the active substance(s)
• formulation recipe
• label recommendations
• ownership of the supporting data

We do not check labels for this type of application and labels are based on that of the 'parent'

You can request authorisation for an identical product:

• when the parent is already authorised (provide product name, MAPP number, notice of authorisation number)
• when the parent is undergoing evaluation but not yet authorised (provide product name and COP number)
• at the same time as requesting authorisation for the parent (grouping applications for ease of processing)

Where the authorisation of the 'child' is dependent on the outcome of the evaluation for the 'parent', we will consider the 'child' application once the parent is authorised.

Provide the following with your admin application:

• a covering letter fully explaining your request and detailing the requirements below
• completed application form CRD2
• letters of access to third party data
• any previous relevant correspondence for example a copy of the parent product authorisation, previous authorisation/trials permit/EAMU as appropriate or any written advice previously provided by HSE

This application can be processed during the transition after renewal of approval of the active substance under Regulation 1107/2009 but before the product authorisation has been renewed.

If you wish to apply for an extension of authorisation for minor use (EAMU), as already authorised for an identical product, read our guidance on extensions of authorisation for minor use.

New pesticide product to be assessed alongside the new active substance (NAS) approval process

Representative product

In Great Britain (GB), an application for authorisation of the representative pesticide product containing a new active substance can be processed alongside the approval consideration for that new active substance.

The representative product application can be submitted as early as the submission of the active substance dossier, to enable the product evaluation, as far as possible, to be conducted in parallel with the active substance evaluation. However, the target completion date for the representative product application is 6 months from the date of approval of the active substance.

For commercial reasons, an applicant may not plan to market the representative product but may wish to bring to market a product with very minor modifications (for example, to the formulation or GAP details). These modifications can be considered but only when agreed with HSE in advance of submission (and may incur additional fees).

For a mixed-active representative product, the pesticide product application accompanying a NAS will only be acceptable if the other component active substance(s) is/are already approved in GB.

Application requirements for authorisation of the representative product

The application for authorisation of the representative product should be submitted to [email protected] and will be charged for in line with new product applications.

The submission must include relevant draft Registration Report (dRR) sections unless the assessment is already fully addressed in the Draft Assessment Report (DAR) for the active substance.

Please note that the application must be accompanied by a full Biological Assessment Dossier (BAD) and a dRR for efficacy for which a partial dossier fee will be charged, because this is not covered within the consideration of the new active substance data package. The efficacy dossier can be submitted ahead of the remainder of the product data package.

Trailing product applications and additional uses

Applications for trailing products, and products significantly not in line with the representative product and uses, can generally only be accepted once the active substance endpoints have been agreed and the DAR has been made available for public consultation. These applications will be subject to a detailed technical sift and if successful, will be accepted into the 52-week stream.

Pesticide product authorisation in Northern Ireland via Article 40

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.

Charge

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.

More on fees and charging

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.

When you can 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).

How to apply

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:

• A copy of the authorisation issued for the reference product in the reference authority with a translation into English.
• A finalised core Registration Report for the reference product's evaluation in the reference member state (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 in the reference member state, and that the assessment is to Uniform Principles using EU agreed endpoints.
• The declaration must state that the finalised core Registration Report is available.
• 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 member state are comparable with those in Northern Ireland.
• 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 the UK, 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 Northern Ireland specific issues.
• If the product contains a candidate for substitution, a comparative assessment is required.

Aspects that need to be addressed for each area of the risk assessment

Details of the UK specific requirements which need to be addressed are 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

Go to the guidance on:

• operator Exposure
• bystander Exposure
• worker Exposure

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 2 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.

Zonal pesticide product authorisation in Northern Ireland

What you need to submit for a Following Zonal application

• 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 zonal Member State are comparable with those in Northern Ireland (NI).
• A signed and completed application form CRD1.
• A copy of the draft NI 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 NI addenda in all relevant areas detailing the risk assessment to address NI specific issues.
• A complete and summary dossier for the product and each active substance, safener and synergist.
• A declaration that the active substance technical specification, the formulation recipe of your product and classification labelling are all the same as those assessed and accepted by the zRMS, and that the assessment is to Uniform Principles using EU agreed endpoints.
• A declaration that the GAP and packaging type is within that assessed and accepted by the zRMS.
• If the product contains a candidate for substitution, a comparative assessment is required.

Your application will need to contain appropriate information so that we can determine whether the use of the product in the reference Member State is comparable with the proposed use of the product in NI. These applications should not involve data evaluation (except where data are required to address the national specific requirements or demonstrate comparability of environmental / agricultural conditions).

NI procedures for sifting and processing of following zonal applications in accordance with Articles 33–39 of Regulation (EC) No 1107/2009

All following zonal applications will be processed in line with the normal procedures for consideration of applications for authorisation of new Plant Protection Products, or applications for changes to the authorisations of Plant Protection Products. The exceptions to this are detailed below.

Application sift

HSE will continue operating the existing procedures for sifting following zonal applications and commenting on the core assessment. The procedures are summarised in brief as follows:

• Commenting upon a zonal Rapporteur Member State draft assessment will be conducted in tandem with the detailed sifting of a following zonal application (for which comments are requested where NI are a concerned Member State).
• Once a draft assessment is circulated for commenting by the zonal Rapporteur Member State, a following zonal application is considered for the first time since submission. This process is carried out over the 4-week sift period, after which the result of the detailed sift is finalised. Once the content of both the NI commenting table and the detailed sift feedback have been finalised, the comments are then sent to the zonal Rapporteur Member State.
• The non-confidential comments and the detailed sift feedback will be sent to the applicant.
• No charging or invoicing is carried out at this point. This is the first contact an applicant will receive to confirm that HSE is considering their following zonal application.
• A sift fee will be charged for consideration of the application. Should the initial sift result in a rejection and subsequent re-submission, two sift fees will be charged. For more information on fees and charging, please see the fees page.

Application processing

Once the final Registration Report is received from the zonal Rapporteur Member State, with any provisions made following consideration of Member State comments, the following zonal application will be accepted, charged, and the 120-day statutory processing time will begin. Under exceptional circumstances, NI may allow an applicant additional time to address any detailed sift feedback requirements before beginning processing of the following zonal under 120-day timelines, even if this information is received after the zonal Rapporteur Member State's final report. This is granted because an application is not 'complete' until the dossier fully addresses NI requirements and is amended in accordance with the results of a zonal Rapporteur Member State assessment.

Where additional time is allowed, the sifter for the following zonal application will be available to negotiate a suitable submission date for the revised following zonal dossier if necessary.

Please note, no requests for further information can be issued once the 120-day processing time has commenced, in line with procedures for Mutual Recognitions.

Technical equivalence of an active substance

In order to include a new source of active substance in a product to be marketed in the UK you will need to submit separate technical equivalence applications for Great Britain and Northern Ireland.

You can also submit an application for consideration in Great Britain only of a new source without inclusion in an existing product.

More about applying for technical equivalence

Two-stage application procedure

The two-stage procedure is used where one aspect of the assessment can be concluded before progressing on to the remainder of the application.

Find out more about two-stage application