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Product Authorisations: The transition from COPR and Directive 91/414/EEC to Regulation (EC) 1107/2009

Background

From 14 June 2011 Regulation (EC) No 1107/2009 replaced previous plant protection product regulations in the UK. Article 80 of this Regulation provided measures to implement the transition from Directive 91/414/EEC to the new Regulation.

A key factor in establishing these arrangements relates to Article 80(5). This indicates that the following applications should be processed in accordance with national law in force before 14 June 2011.

This guidance explains how we will implement these transitional measures with respect to UK product authorisations and in particular Article 80(5).

Changes in terminology

We previously used the term approval to refer the legal documentation which allows: advertisement, sale, supply, storage and/or use of a plant protection product. A UK product approval could be granted under The Control of Pesticides Regulations (COPR) or The Plant Protection Product Regulations 2005 (PPPR 2005).

Under Regulation (EC) 1107/2009 the term approval refers to active substances (a.s.) that have met the criteria detailed in Article 4 (including at least one safe use of a plant protection product). The term 'approval' in effect replaces the term 'Annex I inclusion' used under Directive 91/414/EEC. All a.s.included in Annex I by March 2011 are deemed to have been approved under Regulation (EC) 1107/2009 (via a Regulation in accordance with Article 78(3)).

From 14th June 2011 onwards the UK have authorised (as opposed to approved) plant protection products and the term authorisation has been used to refer the legal documentation relating to products.

Transfer of 'Product Approvals' to 'Product Authorisations'.

On 14 June 2011, new UK legislation (the Plant Protection Products Regulations 2011 or PPPR 2011 [see Consultation on Plant Protection Products Legislation 2011 for further details]) was introduced. This deemed all extant national 'approvals' (under The Control of Pesticides Regulations' (COPR) or The Plant Protections Products Regulations 2005 (PPPR 2005)) as 'authorisations' under Regulation (EC) 1107/2009. There was no change to the individual approval documentation at this stage.

On 14 June 2011 COPR ceased to exist for plant protection products (with the exception of commodity substances). Any "pending" COPR applications or applications made under the transitional arrangements issued from this date were issued as Regulation (EC) 1107/2009 authorisations (noting that the products/uses still needed to be re-registered – see Category 2. below).

On 14 June 2011 PPPR (2005) only existed for applications "pending" or those due to be amended or withdrawn in accordance with Article 80(5). Applications issued from this date which fall into these categories were issued under PPPR 2005 and by virtue of PPPR 2011 were automatically and immediately deemed authorised under Regulation (EC) 1107/2009.

How can I make changes to an existing product authorisation?

Products which are 'deemed authorised' on 14 June 2011 (ie held extant approvals in the UK on 13 June 2011) will fall into the 4 broad categories listed below.

1. Products containing only active substances which were previously included onto Annex I of Directive 91/414/EEC and for which all re-registration work is complete (before 14 June 2011 these will have held PPPR standard approval).

Pending applications: Applications for new products or changes to an existing product which were accepted before 14th June 2011 will be considered "pending", in accordance with Article 80(5) (a), and processed in accordance with CRD's current procedures.

Changes to authorisations received after 14 June 2011 will be processed in accordance with Regulation (EC) 1107/2009 procedures and timelines and two Guidance Documents are currently in preparation ('Zonal and mutual recognition under 1107/2009' and 'Renewal, amendment and withdrawal of authorisation') and will be available on the Commission website once noted by Member States.

2. Products containing at least one active substance which was previously included into Annex I of Directive 91/414/EEC but for which re-registration is not yet complete (before 14 June 2011 these will have held either COPR national approvals or PPPR national provisional authorisations).

Pending applications: Applications for new products or changes to an existing product which were accepted before 14th June 2011 will be considered "pending", in accordance with Article 80(5) (a), and processed in accordance with CRD's current procedures.

Re-registration applications for these products are covered by Article 80(5) (b) and will be processed in accordance with CRD's current procedures.

Changes/Amendments to existing authorisations (including parallel permits and extensions of use) are not covered by Article 80(5) and will be considered under Regulation (EC) 1107/2009 timelines and procedures. The restrictions on the types of amendments to existing authorisations that can be considered ahead of the full Annex III assessment will remain in line with the current transitional arrangements (detailed in the applicant guide and Regulatory Updates 38/2007 and 32/2008).

Authorisations/permits/extensions of use will be issued under Regulation (EC) 1107/2009 (noting that these are amendments to COPR standard assessments and products/uses will still need to be re-registered in accordance with Directive 91/414/EEC requirements and the uniform principles).

The amendments that can be considered ahead of a full uniform principles assessment are:

3. Products containing existing active substance for which a completeness decision in accordance with Article 6 (3) of Directive 91/414/EEC was made before 14 June 2011, but for which a decision (either inclusion or non-inclusion) following that completeness decision has not yet entered into force. (This will include products containing: the 7 actives substances included in the AIR1 project (Regulatory Update 28/2007), active substances for which a resubmission application was made but no decision on Annex 1 inclusion is in force by 14 June 2011).

Pending applications: Applications for new products or changes to an existing product which were accepted before 14th June 2011 will be considered "pending", in accordance with Article 80(5) (a), and processed in accordance with CRD's current procedures.

Re-registration applications for these products are covered by Article 80(5) (b) and will be processed in accordance with CRD's current procedures.

Changes/Amendments: The restrictions on the types of amendments that can be considered following approval of all active substances within a product but ahead of the full Annex III assessment will remain as current (see details under category 2. above).

Notes on expiry dates: The current expiry dates for product authorisations falling in this category vary, with the majority due to expire on 31 December 2011. It is anticipated that a decision on Annex I inclusion/approval will be made and have entered into force before that date. CRD will then either extend the product authorisations until the Step 2 deadline specified in the relevant inclusion directive, or take action to revoke the products (where the decision is not to approve). Continuing approval until the Step 2 deadline will however be dependent on the approval holder fulfilling all the Step 1 requirements at the appropriate deadline (in accordance with the inclusion Directive and Directive 91/414/EEC).

4. Products containing a new active substance for which a completeness decision in accordance with Article 6 (3) of Directive 91/414/EEC was made before 14 June 2011, but for which a decision (either inclusion or non-inclusion) following that completeness decision has not yet entered into force.

Pending applications: It will still be possible for CRD to grant changes to National Provisional Authorisations in response to applications submitted before 14 June 2011 (as these will be considered "pending").

Changes/Amendments: It will be possible to make changes to National Provisional Authorisations received after 14 June 2011providing the completeness decision on the new active substance dossier was made before 14 June 2011.

Re-registration applications for these products will be considered "pending" in accordance with Article 80(5) and will be processed using CRD's current procedures/timelines.

New authorisations issued after 14 June 2011 for products falling into the above categories, will be issued under PPPR 2005 and by virtue of PPPR 2011 will automatically be deemed authorised under Regulation (EC) 1107/2009.

Applying for New products

In this context 'New products' excludes 'back to back' applications for the same product using a different trade name or marketing company and a different registration number, where no evaluation (other than checking access to protected data) is required. These are considered as amendments in line with Article 45 of Regulation (EC) 1107/2009. A Guidance Document on renewal, withdrawal and amendment of authorisation under the Regulation is in preparation and will be available on the Commission website once noted by Member States.

The process and timelines for all new product applications received after 14 June 2011 will be as described under Regulation (EC) 1107/2009. A Guidance Document on zonal evaluation and mutual recognition under the Regulation is in preparation and will be available on the Commission website once noted by Member States. Further guidance is also available in the Applicant Guide.

As described under changes to existing products, New National Provisional Authorisations can be granted for applications received after 14 June 2011 (providing the completeness decision on the new active substance dossier was made before 14 June 2011).

Mixed active products

For products containing active substances for which the most recent Annex I inclusion/approval was in accordance with Directive 91/414/EEC, the re-registration work will be conducted in accordance with that Directive's procedures.

The re-registration process will change when active substances are approved in accordance with Regulation (EC) 1107/2009 procedures.

It is anticipated that for some mixed active substance products there may be an overlap in the product re-registration (following 'Annex I inclusion' of all active substances in the product) and the renewal of the authorisation following 'approval' of active substances in accordance with Regulation (EC) 1107/2009. It is anticipated that, if this does occur, it will be limited to mixed active products containing active substances in the AIR2 programme. If necessary, guidance will be developed at a later date.

Updated 2016-11-07