Re-registration requirements for existing UK Authorisation Holders
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
This page provides important information for existing UK Authorisation holders for products containing active substances included on Annex I of Directive 91/414/EEC on 1 January 2009 or later, or approved under Regulation (EC) 1107/2009 since this came into force on 14 June 2011.
Since Regulation (EC) No 1107/2009 came into force, replacing Directive 91/414/EEC, actives substances have been approved under this Regulation rather than added to Annex I of 91/414/EEC. Regulation (EU) No 540/2011 has transferred all active substances listed in Annex I to Directive 91/414/EEC to a list of substances deemed to have been approved under the Regulation.
The information on this page is provided to ensure that existing Authorisation holders are aware of the deadlines and requirements that they are obliged to meet in order to ensure that their existing product Authorisations are supported in the re-registration process.
Key deadlines for affected UK Authorisation holders
Complete table of Annex I inclusions(now Approvals) and associated deadlines – alphabetical listing by active substance. This table includes all Annex I inclusions (now Approvals under (EC) 1107/2009), including those that entered into force before 1 January 2009 and their associated deadlines. Complete table of Annex I inclusions (now Approvals) and associated deadlines - listing in order of date of inclusion.
European Commission database on active substances considered under Regulation (EC) 1107/2009 The following are available from the above site:
- text of the Commission's Review Report;
- text of the Commission's Directive providing for the inclusion/approval; and,
- the list of tests and studies relied on for the inclusion/approval for which the main data submitter has claimed protection (in some cases you will need to request these from the Rapporteur Member State).
- European Food Safety Authority (EFSA) conclusion and supporting documents are available from the above site.
If you are an existing Authorisation holder for a product(s) containing an active substance listed in the table then you must take action if you wish to support continued Authorisation for your product(s) containing the listed substance.
Key documents for affected UK Authorisation holders [excluding Permit holders for parallel imported products and holders of Authorisations for Extension of Use ]
The action you are required to take is explained fully The Applicant Guide Contents: Re-registration.
Key documents for Permit holders for parallel imported products and holders of Authorisations for Extension of Use
For Permit holders for parallel imported products the implications and any action that you are required to take is explained fully in The Applicant Guide: Re-Registration Of Parallel Imports.
For holders of Authorisations for Extension of Use the implications and any action that you are required to take is explained in The Applicant Guide: Re-Registration For Extensions Of Use.
Supporting documents and links
The European Commission's 'Guidance document on the procedures relating to the authorisation of Plant Protection Products following inclusion of an existing active substance in Annex I of Council Directive 91/414/EEC [Sanco/10796/2003 – rev. 10.4 2 October 2009]'
The European Commission's 'Guidance document on the assessment of the equivalence of technical materials of substances regulated under Council Directive 91/414/EEC' (Sanco/10597/2003 –rev. 8.1 May 2009)'
Can be found on the EC commission site Guidelines page.