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
The linked table referred to as the ‘table of recent deadlines’ lists all active substances with an Annex I inclusion date/approval under (EC) 1107/2009 of 1 January 2009 or later.
Table of recent deadlines – active substances listed by date of Standing Committee vote – latest decisions at bottom of list.
Table of recent deadlines – active substances listed alphabetically.
The table sets out the deadlines that Authorisation holders are required to meet and provides supporting documentation namely the:
- European Food Safety Authority (EFSA) conclusion and supporting documents
- 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).
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 in PSD’s (now CRD's) post-inclusion document. This explains the deadlines and obligations you are required to meet. This document should be read in conjunction with our guidance notes which provide additional information in meeting the requirements for Step 1 of the re-registration process.
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 PSD’s (now CRD's) post-inclusion document for parallel importers.
For holders of Authorisations for Extension of Use the implications and any action that you are required to take is explained fully in PSD’s (now CRD's) post-inclusion document for off-label approval holders.
The following supporting documents and links are provided to provide Authorisation holders with additional information on the decision making and re-registration process that may be relevant to their re-registration applications.
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.
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]'. (pdf document)
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.
