"I/A" item note: Adoption of a Common Position for a Regulation on genetically modified food and feed - Consultation deadline: 13.03.03

March 5, 2003

Brussels, 04 Mar 2003

Full text of Document 6780/03

No. prev. doc.: 5237/03 + COR2 (en)
No. Cion prop.: 7505/02
Subject: Adoption of a Common Position with a view to the adoption of a Regulation of the European Parliament and of the Council on genetically modified food and feed
COMMON GUIDELINES
Consultation deadline: 13.03.03

1. On 30 July 2001, the Council received from the Commission a proposal for the above Regulation 1 based on Articles 37, 95 and 152(4)(b) TEC.

2. The Economic and Social Committee and the Committee of the Regions delivered their Opinions on 29 May 2002 2 and 16 May 2002 3, respectively.

3. Following the European Parliament's first-reading Opinion delivered on 3 July 2002 1, the Commission submitted an amended proposal on 8 October 2002 pursuant to Article 250(2) TEC 2.

4. At its meeting on 28 November 2002, the Agriculture Council reached a political agreement on a draft Regulation 3 drawn up with a view to a common position.

5. The Working Group of Legal/Linguistic Experts has meanwhile finalised the text of the common position (document 5204/03 ).

6. The Permanent Representatives Committee is therefore invited to suggest that the Council:

- adopt under Part "A" of the agenda for a forthcoming meeting the common position ( 5204/03 ), with the LUX, A and UK delegations voting against, and the statement of the Council's reasons ( 5204/03 ADD 1), with a view to forwarding them to the European Parliament;

- register the statements set out in Addendum 1 to this note in the Council minutes.

ADDENDUM TO "I/A" ITEM NOTE
Full text of Document 6780/03

No. prev. doc.: 5237/03 + COR2 (en)
No. Cion prop.: 7505/02

Statements to be entered in the Council minutes

COUNCIL AND COMMISSION STATEMENT (regarding Article 3)

"The Council and the Commission:
- agree that the status of food produced by fermentation using genetically modified micro- organisms not present in the final product, needs to be clarified, at the latest in the context of the report to be presented by the Commission as foreseen in Article 46 of the Regulation;
- note that the status of enzymes used as processing aids will be clarified in the context of the proposal which the Commission is currently elaborating to provide a regulatory framework for enzymes for food use."

COUNCIL AND COMMISSION STATEMENT (regarding Article 32)

" The Council and the Commission agree that due consideration shall be given to the specific case of biotechnology research originating in developing countries when drafting the implementing rules provided for in Article 32. "

COUNCIL STATEMENT
(regarding EP amendments 36 and 164)
"The Council invites the Member States to encourage and contribute to the drawing up of guides in particular on good segregation practice to be applied by food and feed operators in order to minimise the adventitious or technically unavoidable presence of genetically modified material in food and feed".

COMMISSION STATEMENT
"In its forthcoming proposal on control measures for food and feed, the Commission shall aim to ensure that these provisions, in particular for GMO food and feed, will be practical and enforceable. It shall also aim to ensure that the financial aspects of these control measures will not have a disproportionate effect on Member States and that they will be proportional to the intended objective."

COMMISSION STATEMENT
(regarding Article 35)
"The Commission shall establish a new Section on "Genetically modified food and feed and environmental risk" of the Standing Committee on the Food Chain and Animal Health for the purpose of Article 35 of the Regulation, and shall endeavour to facilitate the effective participation of appropriate expertise from the Member States in the work of the Section."

COMMISSION STATEMENT
(regarding Article 47)

" In the context of the review foreseen in Article 48 (1), the Commission shall examine whether the application of Article 47 has given reason for concern, or whether its expiration is likely to give reason for concern. "

STATEMENT BY THE DANISH DELEGATION
(regarding Article 3)
"The consumers must have full information on the use of GMOs in the production of food. The proposal is a first step in this direction. Labelling of feed must be followed by labelling of products derived from animals fed on genetically modified feed as soon as possible. Denmark, however, does accept the Presidency compromise as a substantial contribution towards improved rules on labelling of GMOs."

STATEMENT BY THE GERMAN DELEGATION
(regarding Article 32)
"The German delegation considers that the applicant's financial contribution to the costs of the Community reference laboratory and the European Network of GMO laboratories, provided for in Article 32, may be determined only on the basis of the actual demonstrable expenditure on control samples. This arrangement should be included in the review provided for in Article 45 of Regulation No 178/2002 ."

STATEMENT BY THE SPANISH DELEGATION
(regarding Articles 4 and 16)
"The term "unacceptable risk" is not defined in Regulation 178/2002 laying down general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures of food safety. The term "unacceptable" is undetermined and could occasion different interpretations, which would make difficult the appropriate food risk management."

STATEMENT BY THE SWEDISH DELEGATION
(regarding the term "unacceptable risk" in Articles 4 and 16) "Sweden considers that the wording proposed in the Commission's original proposal, to the effect that "food falling within the scope of this Section must not present a risk for human health or the environment", would be preferable. Risk is defined in Regulation No 178/2002 as a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard. The term "unacceptable risk" is not defined. Risk management is to be carried out in accordance with the principles laid down in Article 6 of Regulation No 178/2002 , and the results of risk assessment are to be taken into account. The term "unacceptable" may give rise to different interpretations."

STATEMENT BY THE SWEDISH DELEGATION
(regarding Article 30)
"The Commission has proposed amending Regulation No 178/2002 in such a way that Regulation No 1049/2001 /EC will apply to documents held by EFSA. Sweden presumes that Article 30 will be structured in such a way as to reflect that proposed amendment."

STATEMENT BY THE SWEDISH DELEGATION
(regarding Article 47)
"With regard to the present legislation on genetically modified food and feed, Sweden considers that legislation should permit, for a transitional period, exemptions from official authorisation for certain GMO products which have been risk-evaluated within the Community. However, Sweden would emphasise that, as things stand at present, it regards that time-limited legislative solution as an exception and not as a precedent to be applied in other areas."

STATEMENT BY THE U.K. DELEGATION
(regarding derived products)
"The UK maintains that the labelling rules for derived products that do not contain GM material are unenforceable and will mislead the consumer. The UK recognises that the importance of the proposed review (Article 48) in addressing these concerns. The UK therefore calls on the Commission to ensure that mechanisms are in place to collect the necessary information for the review from the date of application of the regulation and that the review includes:

* Details of products on the market labelled as GM in accordance with the provisions of the regulation;
* Details of enforcement action taken by Member States to ensure compliance with the regulation;
* An assessment of the impact on developing countries; and
* A detailed assessment of the economic impact of the regulation following implementation, including enforcement costs.

The UK further calls on the Commission to ensure that a proposal to amend the regulation accompanies the report referred to in Article 48. The proposal should address any difficulties over enforceability and practicality identified by the review. "

STATEMENT BY THE U.K. DELEGATION
(regarding the vote)
"This is not a safety issue ­ we already have procedures in place to ensure products are rigorously assessed for safety, rather it is about informed consumer choice. Consumers need to have confidence in product labels. The UK supports genuine consumer choice, but has consistently argued for a policy based on sound science and which is practicable and enforceable. The compromise text failed to meet these objectives.

The requirement to label products derived from GMOs but which do not contain any GM material potentially opens the door to fraud on a significant scale. This will only serve to undermine consumer confidence. The proposals will also present significant practical problems for developing countries, indeed meeting the requirements will probably be impossible for the least developed countries.

On thresholds the UK maintains that, currently, 1% is the lowest level that can reliably be enforced. The UK recognises that zero presence of non-authorised GMOs having a favourable risk assessment but awaiting EU authorisation is not practical given extent to which GM crops are grown world- wide.

On the authorisation procedure, we have doubts about the omission of Article 308 of the Treaty from the legal base of the regulation. The procedure adopted is very similar to the Commission's `centralised' procedure on which the Council Legal Service advised that a legal base of Article 308 was necessary. The UK reserves the right to take such further action as it may consider appropriate. For these reasons the UK voted against the compromise."

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