Council Directive 91/414/EEC concerns the placing of plant protection products on the market within the European Community. The Directive has a derogation allowing Member States to continue granting authorisations (approvals in the UK) for products containing existing active substances under national legislation (The Control of Pesticides Regulations (as amended) 1986 (COPR) in Great Britain), prior to their inclusion in Annex I, after which Community legislation, which is implemented in Great Britain by The Plant Protection Products Regulations 2003 (PPPR), applies.
Your application will therefore be processed under one of two different legislative regimes, COPR or PPPR. Increasingly as more active substances have been reviewed at Community level and a positive decision taken, more products are becoming subject to PPPR.
Measures are prescribed to govern the transition between national and Community legislation. We refer to these measures as the transitional arrangements.
Products Approved Under COPR
Unless your application is one of the exceptions detailed below, we will only accept an application under COPR if the processing target time for your application is before the date of entry into force date:
- Administrative applications for approval for changes in an existing product's name, approval holder or marketing company.
- Applications for approval of an identical product (a 'back-to-back') or a parallel import where the parent or master product is still approved under COPR. The conditions of approval will need to be identical or within those of the currently approved product. It is not possible to allow any variation outside the conditions of approval of the parent or master product (e.g. new packaging).
- Applications to meet data submission deadlines to upgrade provisional COPR approvals to full COPR approvals. These applications need to be supported by the requested data.
- Applications for Specific Off-Label Approvals where the product is still approved under COPR.
- Applications for a change in formulation for an approved product, from a formulation containing nonylphenol, octylphenol and their ethoxylates to a formulation without these co-formulants. These applications need to be supported by reasoned scientific cases or appropriate data.
- Applications for a change in the source of active substance, providing the proposed source complies with the relevant Annex I conditions and is supported by appropriate data.
- Addition of use on undersown cereals to the label.
- Changes to the label to include a reduced water volume.
Can I request changes to my COPR approval once the active substance in the product is included in Annex I?
Under the transitional arrangements, apart from some exceptions, we cannot issue new COPR approvals for products containing active substances included in Annex I after the appropriate Inclusion Directive has entered into force. This is because the derogation to national legislation only applies until an active substance has been included in Annex I, after which PPPR applies.
What do I need to do if the change I want is not one of the above exceptions?
If you wish to make any other changes relating to the development of an existing product that would alter the form in which it is placed on the market (such as a change to its formulation; additional packaging or uses) or approval of a new product/formulation, you would need to request these changes as part of an application for standard approval under PPPR, supported by acceptable Annex II and Annex III (product related) dossiers, satisfying the Uniform Principles.
What if my product contains more than one existing active substance?
If your product contains more than one existing active substance that is not yet included on Annex I, you can continue to make applications for your product under COPR until the Annex I inclusion for the last active substance to be included enters into force, after which the transitional arrangements detailed above will apply.
Products Approved Under PPPR
What is a provisional approval under PPPR?
Council Directive 91/414/EEC has a derogation allowing Member States to grant authorisations (approvals in the UK) for products containing new active substances for a provisional period, prior to a decision being taken on whether the active may be included in Annex I.
Once a new active substance has been included in Annex I, within an agreed timeframe Member States must re-evaluate products under the terms of the Directive. In Great Britain, products meeting appropriate criteria are then issued with a standard approval under PPPR.
Products containing only AIR 1 active substances after the annex I renewal/approval has entered into force for all active substances within the product
The same transitional arrangements described above for COPR products apply.
Can I apply for provisional approval after the active substance is included in Annex I?
Once an Annex I inclusion for a new active substance has entered into force, we cannot accept applications for provisional approval for products containing that active substance (either alone or in combination with other active substances already included in Annex I) under PPPR where the target time for processing would result in the approval being issued after the date that the including Directive enters into force. This is with the exception of the following:
- Applications for approval for changes in an existing products name, its approval holder or marketing company.
- Applications for Parallel Imports, where the master product still holds a provisional approval.
- Applications for approval of identical ('back-to-back') products, where the parent product still has a provisional approval.
- Applications for a change in technical specification of the active substance e.g. where the specification considered for Annex I Inclusion and /or initial approval in the UK was based on pilot scale production and changes are necessary following a move to full scale production.
- Applications for Specific Off-Label Approvals where the product still holds a provisional approval under PPPR.
- Applications for a change in formulation for an approved product, from a formulation containing nonylphenol, octylphenol and their ethoxylates to a formulation without these co-formulants. These applications need to be supported by reasoned scientific cases or appropriate data.
- Addition of use on undersown cereals to the label.
- Changes to the label to include a reduced water volume.
Conditions of approval for on-label uses must be identical to or within those for the existing product.
The period of approval granted will be in line with that permitted for the master product.
What do I need to do if the change I want is not one of the above exceptions?
If you wish to make any other changes relating to the development of an existing product that would alter the form in which it is placed on the market (such as a change to its formulation; additional packaging or uses) or approval of a new product/formulation, you would need to request these changes as part of an application for standard approval under PPPR, supported by acceptable Annex II and Annex III (product related) dossiers, satisfying the Uniform Principles.
How can I determine under what legislation my application will be processed?
The questions below will help you work out the governing legislation for your products and requirements that will need to be met.
For products containing a single active substance
Does your product contain an existing active substance and has it been included in Annex I of Council Directive 91/414/EEC?
If NO, your application will be evaluated under COPR
If YES, and the date of entry into force of Annex I has passed:
- If the product is not currently on the market (nor is it a permitted exception during the transition phase), your application will be evaluated under PPPR.
- If the product is already approved, it will continue to be regulated under COPR until the final Commission deadline (unless a decision is taken on whether it can be re-registered under PPPR in advance of this deadline). The continuing approval of your product will be subject to it complying with the conditions of inclusion in Annex I and being supported by an Annex II (active substance related) data package by the Commission compliance deadline. Only certain types of applications may be submitted for the product and considered under COPR (e.g. change in product name).
Does your product contain a new active substance?
- If your product contains a 'new' active substance it will be evaluated under PPPR
Prior to a decision being taken on whether the active substance can be included in Annex I, a provisional approval may be issued for your product under PPPR for a period of three years (unless a further prescribed extension is granted).
Once the active substance has been included in Annex I, you will need to apply for a standard approval of your product if your application is for a new product that is currently on the market.
For products containing more than one active substance
Does your product contain at least one 'existing' active substance not yet included in Annex I?
Your application will be processed under COPR until all the active substances in the product have been included in Annex I. When an active substance in your product is included in Annex I, you will need to demonstrate compliance with Annex I conditions and access to an Annex II data package by the appropriate deadline.
Does your product contain at least one existing active substance already included in Annex I?
If YES, and the date of entry into force of Annex I has passed:
- If the product is not currently on the market (nor is it a permitted exception during the transition phase), your application will be evaluated under PPPR
- If the product is already approved, it will continue to be regulated under COPR until all the active substances have been included in Annex I, with deadlines for re-registration as specified in the last published Inclusion Directive. Continuing approval of your product will be subject to the product complying with the conditions of Annex I inclusion and being supported by Annex II (active substance-related) data packages by each of the appropriate Commission compliance deadlines for the component active substances. A PPPR Standard Approval may be issued any time after the date of entry into force of the last Inclusion Directive.
If your product only contains 'new' active substances your application will be evaluated under PPPR
Prior to a decision being taken on whether all the active substances in your product can be included in Annex I, a provisional approval may be issued under PPPR for a period of three years, unless a further prescribed extension is granted. Continuing approval of your product will be subject to the product complying with the conditions of Annex I inclusion and being supported by an Annex II (active substance-related) data package by each of the appropriate Commission compliance deadlines for the component active substances.
Once the active substances have been included in Annex I, you will need to submit an application for a standard approval if your application is for a new product that is not currently on the market. A standard approval may be issued any time after the date of entry into force of Annex I inclusion for the final active substance to receive Annex I inclusion.
