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The Applicant Guide: Do I Need To Submit An Application?

You will need to submit an application for an approval if you wish to market a pesticide, carry out research and development work with a pesticide, import a pesticide into the UK or require an ‘extension of use’ of a pesticide. If you wish to market an adjuvant then you will need to submit an application for the inclusion of your product on the ‘Official List’ of adjuvants.

Your approval will be issued under one of two different legislative regimes, The Control of Pesticides Regulations (as amended) 1986 (COPR) or The Plant Protection Product Regulations 2003 (PPPR). Further information on legislation governing pesticides.

How do I obtain an approval?

For a commercial level of approval

If you wish to market a pesticide (including biological and novel pesticides) in the UK, you must apply for a commercial level of approval. The amount of information you will need to submit will vary depending on the nature of your request but in each case we will assess the safety and effectiveness of the product and its uses. If they are, we will issue an approval which specifies the conditions under which the product can be marketed, stored and used.

Further information is available on the data and/or information that will need to be provided. Your application will be processed under one of two procedures depending on the type of application, as detailed below:

Procedures for the evaluation of applications

  • Applications for products containing an active substance that is either new to the UK or European Union (EU) are processed by the Registration Branch. We will determine whether the products can be provisionally approved in the UK prior to Annex I inclusion (if the active substance is new to the EU). The UK can also act as Rapporteur Member State for the assessment of whether an active substance can be included in Annex I of Council Directive 91/414/EEC. The evaluation process will include consideration by the Advisory Committee on Pesticides (ACP). For active substances new to the EU, Annex I inclusion is assessed at the EU level.
  • Applications for products containing an active substance already approved in the UK or included in Annex I are also processed by the Registration Branch. These applications include:
    • Those where the type of use is very different to those previously considered for the active substance and/or product. Technical evaluations are carried out by our specialists and then considered by other government departments responsible for the approval of pesticides and sometimes by the ACP (departmental applications).
    • Those where the type of use is similar to those previously considered for the product.
    • Those that do not require technical consideration (administrative applications)

For research and development work

If you wish to carry out research and development work on an approved or unapproved active substance and/or pesticide you must apply for an experimental approval. We will assess your application, which, depending on your request, may contain data and/or information or may simply be a declaration that you will comply with certain restrictions. We will issue an approval that specifies how the pesticide should be stored and used. An approval may not be necessary if the active substance and/or pesticide is not going to be released into the environment.

See the guidance document on experimental approvals for further information on this type of application. Further information is available on the data and/or information that will need to be provided in support of this type of application.

For importing pesticides into the UK

If you wish to import a pesticide into the UK and market it on the basis that it is identical to a product already approved in the UK, you must apply for a commercial level of approval. This type of product is called a ‘parallel import’ and procedures for these applications are different to those for other commercial approvals. If you want to use an imported product but do not wish to market it in the UK, you may apply for an ‘own use parallel import’.

See the guidance document on parallel imports for further information on this type of application. Further information is available on the data and/or information that will need to be provided in support of this type of application.

For an extension of use of a product by a grower

The Long Term Arrangements for the Extension of Use (LTAEU) allow the extrapolation of use(s) of approved pesticides, from an approved crop on the product label to certain other listed crops, without the need for an approval. See the guidance document on off-label approvals for further information on these extrapolations.

However, where an extrapolation is not possible under these arrangements, you may apply for an Specific Off-Label Approval (SOLA) or an ‘extension of use approval’ for the product. We will assess whether the proposed use is safe. If so, an approval will be issued that specifies how the pesticide should be used on that particular crop/situation in order to ensure that risks are acceptable. The use is not assessed for effectiveness or crop safety and if you use a SOLA you do so at your own commercial risk.

The LTAEU also allows for the extrapolation of use(s) of approval pesticides from crops approved under SOLA. See the guidance document on off-label approvals for further information on this type of application. Further information is available on the data and/or information that will need to be provided in support of this type of application.

For an adjuvant

A company wishing to market an adjuvant for use with a pesticide in the UK must apply for its inclusion on the ‘Official List’ of adjuvants. Your documentation will take the form of a ‘List Entry’ and will specify the identity of the adjuvant and the conditions that a user will need to comply with.

See the guidance document on adjuvants for specific information on this type of application.

For commodity substances

Commodity substances are chemicals which have a variety of non-pesticidal uses and also have uses as pesticides. If such a substance is to be used as a pesticide it will require approval. Details of existing commodity substance approvals are available. If you wish to gain approval for a new commodity substance see the guidance document on commodity substances.

What if I want to import treated produce into the UK?

A Maximum Residue Level (MRL) is the maximum amount of residues likely to be found in a particular foodstuff based on the approved use of a pesticide either in the UK or elsewhere in the EU. MRLs are not safety limits but are fundamental in assisting international trade as they demonstrate whether pesticides have been applied in accordance with their approved conditions of use. However, MRLs do not account for legitimate agricultural practices outside the EU. Where an EC MRL (a MRL set at the European level by the European Commission) is exceeded, or no MRL has been specified for particular pesticide/crop combination, this may act as a barrier to the importation of produce from outside the EU (for further information see the guidance document on import tolerances and MRLs and general MRLs information available on this website.

If you wish to import produce into the EU that may contain levels of pesticide residues exceeding EC MRLs, you will need to establish an ‘import tolerance’ for that pesticide/crop combination. See the guidance document on import tolerances and MRLs for information on submitting this type of application.

What if I want to export a pesticide outside the EU?

If you want to export an active substance or pesticide approved in the UK to a country outside the EU, the authorities in the importing country may ask you to provide evidence of the approval status of the active substance, the pesticide product or the adjuvant. Upon request we will issue certificates of free-sale which provide details of the approval status of the active substance, pesticide or adjuvant and confirm that they are registered for use in England, Scotland and Wales. Information on obtaining certificates of free-sale can be found on this website.

What if I want to conduct efficacy trials?

If you wish to carry out efficacy testing and analysis for yourself or on behalf of a third party, your testing facilities must be ‘Officially Recognised’. We will only accept data from efficacy trials started after 1 January 1998 where the tests were carried out by Officially Recognised organisations. Further information on Official Recognition and applying for your organisation to be Officially Recognised is available. Official recognition also applies to efficacy testing of beneficials and semiochemicals (Regulatory Update 11/2006)

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