Regulatory Update: 40/2007
Issued: 30 October 2007

Background
2. The background to Annexes I-IV of Regulation 396/2005/EC is described in the annex to this update.

Developments
3. Member States voted to approve a Commission proposal on Annexes II, III and IV to 396/2005/EC at the Standing Committee on 23 October. The Commission intends to publish these annexes shortly and a link will be provided from the Pesticides Safety Directorate (PSD) website as soon as they are available. The Commission will now formally adopt these annexes. This is likely to happen around January. The Regulation as a whole with the new annexes then comes into force six months later or around mid-2008.

Next Steps
4. We are now entering a 9-month transition period during which the MRLs system will move from the current arrangements to the new regime under 396/2005/EC. This means that the system of member states issuing temporary national MRLs (e.g. UK tMRLs) to accommodate new uses has effectively ended. This section describes the arrangements PSD intends to operate during the transition period.

The 'second tranche'
5. There are a number of proposals for changes to the versions of annexes II and III recently approved by the Standing Committee which are already under consideration within the EC system. These include:

• Proposed changes to MRLs in Annex II arising from the ongoing programme of MRLs work including those due to the EC review under directive 91/414/EEC;
• Import tolerance proposals not already considered.

6. The Commission and EFSA have indicated that they intend to process proposals which are currently with member states in time to introduce any necessary amendments to Annexes II and III before the annexes come into force around mid-2008. The Commission describes these proposals which are already in the pipeline as the 'second tranche'. Where PSD have evaluated data and proposed MRLs for inclusion in Annex III, appropriate requests have now been submitted for consideration by EFSA.

New Proposals
7. For logistical and legal reasons new proposals for MRLs (i.e. any that are not covered in the 'second tranche') cannot be made until after 396/2005/EC is in operation. However, the Commission has indicated that the work programme to consider new MRLs will continue during the transition period so that formal proposals can begin soon after that date.
8. PSD will, therefore, continue to accept and process applications for new uses and import tolerances and where these require a change to current MRLs we will continue to submit proposals to the Commission and EFSA. But, we will not grant any relevant approvals until we have the security that any necessary change(s) in the EC MRLs have been adopted under 396/2005/EC.

New commodities
9. MRLs for commodities (such as sugar beet, coffee or cocoa) not covered under the current legislation but which are covered under 396/2005/EC have been placed in Annex IIIB to the regulation. These MRLs are generally based on those currently in the legislation of certain member states.

Annex IV
10. Annex IV lists substances for which MRLs are not required. At present it contains only relevant substances which have been reviewed under Directive 91/414/EEC. However, the Commission has indicated that they aim to identify further candidates for inclusion in Annex IV before 396/2005/EC comes into operation.

Withdrawals resulting from the new Annex III
11. As previously indicated where the Annex III MRLs do not cover existing UK uses, approvals will have to be amended or withdrawn. This process will now begin and PSD will contact relevant approval holders. In most cases there will be no wind-down period for sale since action needs to be taken to ensure that residues above MRLs are not present in crops marketed after 396/2005/EC comes into operation.

New Comitology Procedures
12. Discussions are currently being held within the European Council and European Parliament (EP) on new 'comitology procedures' (the committee arrangements under which decisions are taken). This may result in proposals for MRLs under 396/2005/EC undergoing a period of scrutiny (of 2-3 months) by the EP before they can come into operation.

Conclusion
13. The vote on Annexes II-IV of 396/2005/EC triggers the final stage in what has been a very major programme of work to introduce a fully harmonised EC MRLs regime. The transition period through to full introduction of this Regulation in the middle of next year is potentially difficult. We will not be able to issue approvals for uses where an increased MRL is required. This will inevitably lead to delays in issuing the affected approvals. At this stage it is not possible to predict how long these delays will be but PSD is committed to working with companies and with the Community institutions to make the new MRL system work as effectively and efficiently as possible.

Contacts
14. If you have any general comments or questions regarding this Regulatory Update please contact
Russell Wedgbury (tel. 01904 455780, email russell.wedgbury@psd.defra.gsi.gov.uk).
For technical queries relating to MRLs or enquiries relating to import tolerance applications, please contact Donal Griffin (tel. 01904 455788, email donal.griffin@psd.defra.gsi.gov.uk).

Background - Annexes I-IV of Regulation 396/2005/EC

1. Annex I includes over 100 food products which are not specified in the existing MRL Directives. Some of these are covered by the 'others' category in the various commodity groups, whilst others, including coffee, cocoa, herbal infusions and sugar beet, are new additions to the EC's MRLs regime. Residues data are likely to be required to support appropriate definitive MRLs for these new commodities.

2. Annex II lists definitive MRLs, namely MRLs from existing Directives (86/362/EEC for cereals, 86/363/EEC for animal products and 90/643/EEC for plant products) for those active substances which have been included in Annex I of Directive 91/414/EEC. Hence, UK MRLs and import tolerances already covered by substantive MRLs in Directives have been automatically included in Annex II.

3. Annex III is split into two parts as follows:
Part IIIA: Temporary MRLs for substances awaiting an Annex I decision or where a non-inclusion decision has been taken for all commodities;
Part IIIB: Temporary MRLs for all active substances for the new commodities introduced under 396/2005/EC.

4. Annex IV lists active substances for which MRLs are not required. The Commission's current proposals cover only a small number of active substances (such as ferric phosphate and various biological control agents) which have completed their review under Directive 91/414/EEC. The Commission's intention is to expand Annex IV before 396/2005/EC comes into operation.

5. Any active substances not mentioned in Annexes II, III, or IV will be subject to the 'default' MRL of 0.01 mg/kg when 396/2005/EC comes into force.

Reference
http://www.pesticides.gov.uk/food_safety.asp?id=2272

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