Under what legislation will applications be considered?
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
Since 11 June 2011 the majority of products are considered under Regulation (EC) 1107/2009. Transitional arrangements are in place for products previously approved in accordance with Council Directive 91/414/EEC (implemented in Great Britain by The Plant Protection Products Regulations 2003 (PPPR))and the UK national legislation (The Control of Pesticides Regulations (as amended) 1986 (COPR).
On 11 June 2011 products approved under either COPR or in accordance with Council Directive 91/414/EEC were deemed to be authorised under 'Regulation (EC) 1107/2009. However, adjuvants and a few 'out of scope' products continue to be considered under the national legislation COPR.
'Measures are prescribed to govern the transition between national and Community legislation which we refer to as the transitional arrangement.
Your application will be processed under 'Regulation (EC) 1107/2009 in accordance to Uniform Principles or under national rules under the transitional arrangements until product reregistration/renewal has been completed.
Products Approved Under national legislation (COPR) and deemed authorised under Regulation (EC) 1107/2009
Under the transitional arrangements, apart from some exceptions, we cannot issue new COPR authorisations for products containing approved a.s. after the appropriate Inclusion Directive/Approval Regulation has entered into force. The derogation to national legislation only applies until an a.s has been Annex I included/ approved after which EU legislation applies.
Unless your application is one of the exceptions detailed below, we will only accept an application under national legislation if the processing target time for your application is before the date of entry into force of the a.s. Inclusion/approval.:
- Administrative applications for authorisation for changes in an existing product's name, approval holder or marketing company.
- Applications for authorisation of an identical product (a 'back-to-back') or a parallel import where the parent or master product is still authorised under COPR. The conditions of authorisation will need to be identical or within those of the currently authorised product. It is not possible to allow any variation (eg new packaging).
- Applications to meet data submission deadlines to upgrade provisional COPR authorisations to full authorisations.
- Applications for Extensions of Authorisations for Minor Use (EAMU).
- Applications for a change in formulation from a formulation containing nonylphenol, octylphenol and their ethoxylates to a formulation without these co-formulants..
- Applications for a change in the source of active substance, providing the proposed source complies with the relevant a.s. inclusion/approval conditions.
- Addition of use on undersown cereals to the label.
- Changes to the label to include a reduced water volume.
What do I need to do if the authorisation 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 authorisation under Regulation 1107/2009, supported by full a.s./ product dossiers, satisfying the Uniform Principles.
What if my product contains more than one existing active substance?
If your product contains more than one existing a.s.not yet included on Annex I/ approved, you can continue to make applications under national legislation until the approval for the last a.s.enters into force, after which the transitional arrangements detailed above will apply.
Products authorised under PPPR using the principles of Council Directive 91/414/EEC prior to the introduction of Regulation (EC) 1107/2009
Products containing only AIR 1 active substances after the Annex I renewal/approval has entered into force for all a.s. within the product
The same transitional arrangements described above for COPR products apply.
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 authorisation of a new product/formulation, you would need to request these changes as part of an application for standard authorisation, supported by acceptable a.s.. and product related dossiers, satisfying the Uniform Principles.