FSA Consultation Letter, 30 March 2004
The two Regulations are: (EC) 1830/2003 on the Traceability and Labelling of GMOs (the 'Traceability and Labelling Regulation') and Regulation (EC) 1829/2003 on Genetically Modified (GM) Food and Feed (the 'Food and Feed Regulation'). Responses are requested by: 25 June 2004
As the regulations cut across departmental responsibilities, consultations
on their implementation in England are being conducted jointly by the Food Standards
Agency (FSA) and the Department for Environment, Food and Rural Affairs (Defra).
Stakeholders were consulted on the Regulations themselves between 2001 and 2003 before and during negotiations on them. Both Regulations are now EU law. The GM Food and Feed Regulation applies in Member States from 18 April 2004. The Traceability and Labelling Regulation is also expected to apply from April 2004, although final decisions are still needed at EU level on the detailed arrangements for its application in Member States.
Both Regulations take direct effect in the UK. The only new legal issue to consider is the setting at national level of appropriate and proportionate offences and penalties for failure to comply with the Regulations provisions.
This consultation package also aims to address points on the practical effects of national application of the Regulations. In order to inform assessment of these effects, the FSA and Defra had preliminary face-to-face consultations with groups of representative key stakeholders in October and November 2003. Questions asked and points made were subsequently raised with the European Commission, and are answered in the package. The Commission will also be sent a copy of this package to ensure our interpretation of the Regulation is consistent with that of other Member States.
The purpose of this written consultation is consequently to seek stakeholders views on the attached documents:
i) Draft National Regulations
(a) Administration and Enforcement Regulation
Drafts of national Regulations, setting out offences and penalties in relation respectively to the traceability and labelling, food, and feed aspects of the new EU Regulations. The draft Regulations are attached at annexes 1, 2 and 3.
(b) The Seeds (National Lists of Varieties) Regulations 2001
Consequential amendments are required to these Regulations to take account of amendments made by the GM Food and Feed Regulation to EC Directive 2002/53 on the common catalogue of varieties of agricultural plant species (the 'Common Catalogue Directive') and Directive 2002/55 on the marketing of vegetable seed (the 'Vegetable Seeds Directive'). The required changes are described at Annex 4.
(c) The Genetically Modified Organisms (Deliberate Release) Regulations 2002
Consequential amendments are required to these Regulations to take account of amendments made by the GM Food and Feed Regulation to EC Directive 2001/18/EEC on the deliberate release to the environment of genetically modified organisms (the Deliberate Release Regulations). The required changes are described at Annex 5.
ii) Regulatory Impact Assessment
A draft full Regulatory Impact Assessment (RIA), containing a final assessment of the likely impact of the measures in terms of the costs and benefits. This is attached at Annex 6.
Draft guidance notes, with the aim of providing informal, non-statutory guidance for operators to be read in conjunction with the appropriate legislation. This is attached at Annex 7. The European Commission and the European Food Safety Authority has still to finalise a number of documents in relation to the authorisation of new products, guidance on sampling and testing and submitting applications for authorisation. Where available, the most up to date documents have been attached to these notes.
Specific questions for consultation are:
Draft national administration and enforcement Regulations
1) Are the offences proposed appropriate in relation to the requirements of the Regulations?
2) Are the penalties created proportionate to the offences?
Draft full Regulatory Impact Assessment
3) Do you agree with the analysis of costs and benefits as presented in the RIA?
4) Are any significant areas of benefits and/or costs not covered by the RIA? Please submit any relevant supporting information.
5) Does the guidance take into account the points raised at the consultation meetings held with representative stakeholders in October and November 2003?
6) Should the guidance cover any additional points?
For copies of the documents see the FSA web site at: http://www.food.gov.uk/foodindustry/Consultations/completed_consultations/compconsulteng/gmosconsultengat: