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Regulatory Updates regarding EC Directive 91/414 Annex I inclusion/ Non-inclusion decisions and Regulation (EC) 1107/ 2009 Approvals

Inclusion Decisions

Regulatory Updates are periodically sent out to alert approval holders and interested parties to the most recent Annex I inclusion decisions:

2012

Regulatory Update 12/2012

Active substance approvals and re-registration requirements: March 2012

This Regulatory Update announces the re-registration requirements following further Active Substance approval decisions under (EC) 1107/2009

Issued: 3 April 2012

Regulatory Update 03/2012

Active substance approvals and re-registration requirements : February 2012

This Regulatory Update announces the re-registration requirements following further Active Substance approval decisions under (EC) 1107/2009.

Issued: 17 February 2012

Regulatory Update 02/2012

Products to be withdrawn from the market following the non-approval of chloropicrin

This Regulatory Update gives information about the non-approval of chloropicrin under (EC) No 1107/2009 and the withdrawal of UK authorised products containing this active substance

Issued: 09 February 2012

Regulatory Update 01/2012

Active substance approvals and re-registration requirements: December 2011

This Regulatory Update announces the re-registration requirements following further Active Substance approval decisions under (EC) 1107/2009.

Issued: 12 January 2012

2011

Regulatory Update 36/2011

Regulatory Update - Products to be withdrawn from the market following the non approval of asulam

This Regulatory Update provides information about the non approval of asulam and the products to be withdrawn from the market in the UK.

Issued: 11 October 2011

Regulatory Update 35/2011

Active substance approvals and re-registration requirements: September 2011

This Regulatory Update announces the re-registration requirements following further Annex I inclusion decisions.

Issued: 06 October 2011

Regulatory Update 28/2011

Re-registration Requirements Following Further Annex I Inclusion Decisions: August 2011

This Regulatory Update announces the re-registration requirements following further Annex I inclusion decisions

Issued: 11 August 2011

Regulatory Update 26/2011

Annex I Approvals and re-registration requirements: July 2011

This Regulatory Update announces the Re-registration requirements following further Annex I Decisions (now known as Approvals) and gives details of various documents relating to other active substances which are now available.

Issued: 14 July 2011

Regulatory Update 14/2011

AIR 2 Project: Renewal of the Inclusion of Active Substances in Annex I to Council Directive 91/414/EEC

This Regulatory Update covers Commission Directive 2010/77/EU amending Council Directive 91/414/EEC regarding expiry dates for the inclusion in Annex I of 31 active substances whose inclusions originally expired in 2011 or 2012; and Commission Regulation (EU) No 1141/2010 laying down the procedure for renewal of the inclusion of these active substances in Annex I to 91/414/EEC.

Issued: 07 April 2011

Regulatory Update 12/2011

Annex I inclusions and re-registration requirements: April 2011

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 05 April 2011

Regulatory Update 11/2011

Arrangements for products containing voluntarily withdrawn active substances following a positive opinion for Annex I inclusion

This Regulatory Update concerns products containing active substances that were voluntarily withdrawn in accordance with Commission Regulation (EC) 1095/2007. It gives advice on which application types CRD will consider following a positive opinion for Annex I inclusion and before entry into force of the inclusion of the voluntary withdrawn active(s).

Issued: 22 March 2011

Regulatory Update 04/2011

Re-registration Requirements Following Further Annex I Inclusion Decisions: February 2011

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 15 February 2011

2010

Regulatory Update 30/2010

Re-registration Requirements Following Further Annex I Inclusion Decisions: December 2010

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 23 December 2010

Regulatory Update 23/2010

Re-registration Requirements Following Further Annex I Inclusion Decisions: November 2010:

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 9 November 2010

Regulatory Update 20/2010

Annex II Data Matching

This Regulatory Update announces that CRD are no longer in a position to accept and comment on Annex II data matching proposals in advance of the official publication of the list data and before the date of entry into force of the active.

Issued: 7 October 2010

Regulatory Update 19/2010

Re-submission of applications for review active substances following voluntary withdrawal and non-inclusion in Annex I of Directive 91/414/EEC - extension of expiry dates for authorisation

This Regulatory Update gives information about an extension of expiry dates for authorisations of products containing active ingredients re-submitted following voluntary withdrawal and non-inclusion in Annex I of Directive 91/414/EEC.

Issued: 21 September 2010

Regulatory Update 16/2010

Re-registration Requirements Following Further Annex I Inclusion Decisions: July 2010

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 27 July 2010

Regulatory Update 08/2010

Re-Registration Requirements Following Further Annex I Inclusion Decisions: March 2010

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 23 March 2010

2009

Regulatory Update 31/2009

Guidance Concerning the Approval of Commodity Chemicals (2009)

This Regulatory Update provides revised advice about national approvals of commodity chemicals which are used as agricultural pesticides.

Issued:1 October 2009

Regulatory Update 22/2009

Re-registration requirements following further Annex I Inclusion Decisions: Aug 2009

This Regulatory Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 4 August 2009

Regulatory Update 12/2009

Re-registration requirements following further Annex I Inclusion Decisions: March 2009.

This Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 19 March 2009

Regulatory Update 03/2009

Re-registration requirements following further Annex I Inclusion Decisions: January 2009

This Update announces the Re-registration requirements following further Annex I Inclusion Decisions and gives details of various documents relating to other active substances which are now available.

Issued: 20 January 2009

2008

Regulatory Update 38/2008

Arrangements for products containing voluntarily withdrawn active substances: December 2008

This Regulatory Update expands upon the arrangements detailed in Regulatory Update 26/2008 for products containing active substances which have been voluntarily withdrawn by companies.

Issued: 11 December 2008

Regulatory Update 37/2008

Re-registration requirements following further Annex I Inclusion Decisions: October 2008

This Update announces the Re-registration requirements following further Annex I Inclusion Decisions in October 2008 and gives details of various documents relating to other active substances which are now available.

Issued: 02 December 2008

Regulatory Update 33/2008

Re-Registration Requirements Following Further Annex I Inclusion Decisions: September 2008

This Regulatory Update notes recent decisions regarding Annex I inclusion of 3 more active ingredients and also gives details of some amendments to existing dates and deadlines.

Issued: 07/10/08

Regulatory Update 31/2008

Re-Registration Requirements Following Further Annex I Inclusion Decisions

This Regulatory Update announces Re-Registration Requirements Following Further Annex I Inclusion Decisions.

Issued: 18/09/2008

Regulatory Update 26/2008

Arrangements for products containing the voluntarily withdrawn active substances

This update announces Arrangements for products containing the voluntarily withdrawn active substances.

Issued: 05/08/2008

Regulatory Update 21/2008

Re-Registration Requirements Following Recent Annex I Inclusion Decisions

This Regulatory Update notes recent decisions regarding Annex I inclusion of several active ingredients and gives details of the re-registration process which is now triggered.

Issued: 22/07/2008

Regulatory Update 17/2008

Re-registration - Important changes to PSD’s procedures

This Regulatory Update announces changes to procedures for Re-Registration relevant to all UK approval holders, including holders of approval for parallel imported products and off-label approval holders.

Date Issued: 08/07/2008

Regulatory Update 02/2008

New Regulation for re-submission of applications for review active substances following a decision on non-inclusion in Annex I of Directive 91/414/EEC

Information about the re-submission of applications for active substances, from lists 2, 3 and 4 of the EC review, where they have not been included in Annex I of Directive 91/414/EEC.

Date issued: 05/02/2008

2007

Regulatory Update 41/2007

Amended Sell-out arrangements for products containing trifluralin.

This Update details changes to the revocation periods of all products containing trifluralin.

Date issued: 20/11/2007

Regulatory Update 34/2007

New procedures for the 3rd and 4th stages of the EC review.

This Regulatory Update explains the new procedures to speed up the EC review for stages 3 and 4 of existing active substances.

Date issued: 25/09/2007

Regulatory Update 29/2007

Transitional arrangements for products which are exempt from COPR but come within scope of Directive 91/414/EEC (PPPR).

This Update advises on transitional arrangements and timescales for suppliers to register or withdraw products which are exempt from COPR but come within the scope of PPPR .

Date issued: 23/08/2007

Regulatory Update 28/2007

Renewal of the Inclusion of Active Substances in Annex I to Council Directive 91/414/EEC.

This regulatory update covers Commission Directive 2007/21/EEC amending Council Directive 91/414/EEC regarding expiry dates for the inclusion in Annex I of azoxystrobin, imazalil, kresoxim-methyl, spiroxamin, azimsulfuron, prohexadion-calcium and fluroxypyr; and Commission Regulation (EC) No 737/2007 laying down the procedure for renewal of the inclusion of these active substances in Annex I to 91/414/EEC.

Date issued: 21/08/2007

Non-Inclusion Decisions

A list of Regulatory Updates regarding non-inclusion in Annex I of 91/414/EEC and revocation of UK products can be found on the EC News page.

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