Select Committee on European Scrutiny Twelfth Report



Draft Regulation on genetically modified food and feed.

COM(01) 182

Draft Regulation concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.

Legal base:(a) Articles 37, 95, 152(4)(b) EC; co-decision; qualified majority voting
(b) Article 95(1); co-decision; qualified majority voting
Documents originated:25 July 2001
Forwarded to the Council: (a) 30 July 2001
(b) 21 August 2001
Deposited in Parliament: (a) 27 September 2001
(b) 2 October 2001
Department:(a) Food Standards Agency
(b) Environment, Food and Rural Affairs
Basis of consideration: (a) EM of 5 December 2001
(b) EM of 10 December 2001
Previous Committee Report: None
To be discussed in Council: No date set
Committee's assessment:Politically important
Committee's decision:(Both) For debate in European Standing Committee C


  3.1  In order to protect public health, Council Regulation (EC) No. 258/97[5] lays down the procedures which must be observed before novel food and food ingredients — including those containing or consisting of genetically modified organisms (GMOs), or produced from, but not containing, such organisms — may be placed on the Community market for the first time.

  3.2  These measures are based on the principle that the products in question must not present a danger to, or mislead, the consumer, and, although a simplified notification procedure applies in the case of those foods or ingredients held to be substantially equivalent to existing foods, in general anyone wishing to place them on the Community market is required to submit a request to the Member State concerned, providing the necessary supporting information. In the case of GMOs, this includes any written consents and environmental risk assessments given under the Community legislation governing the deliberate release of such organisms (see paragraph 3.4 below). The Member State must then produce within three months an initial assessment, and, if no further information is required, or no other Member State has raised an objection, it may authorise the applicant to place the product on the market. However, if the initial assessment indicates that additional information is required, or if another Member State raises an objection to the request, any authorisation decision has to be taken by the Commission on the basis of the opinion of the Standing Committee for Foodstuffs. The Regulation also lays down additional labelling requirements for novel foods in order to inform consumers of any significant defining characteristics regarding their composition, nutritional value and intended use, and the presence of any GMOs.

  3.3  In practice, the Commission says that no GM food has so far been authorised under this Regulation, but that eleven products, assessed to be substantially equivalent to existing conventional foods, have been notified.

  3.4  More general controls relating to the deliberate release into the environment of GMOs not covered by product-specific legislation are laid down in Directive 2001/18/EC[6], and thus include within their scope GM animal feed (which is not covered by Regulation No. 258/97). As with Regulation 258/97, the Directive permits decisions to be taken by the Member State to which the application is made, unless there has been an objection from the Commission or another Member State within a specified period. However, where an objection has been raised, or the authorising Member State itself considers that the release request should be refused, the issue has to be referred to the relevant Community scientific committee. The Directive also requires Member States to take measures to ensure traceability, but without making any specific provisions laying down how this should be done.

  3.5  The Commission says that a total of 18 authorisations have been granted under this Directive for the placing on the market of GMOs, two of which (one maize, one soya variety) cover use as food, and a further eight cover use as feedingstuffs (one for soya, four for maize, and three for rapeseed). However, no decisions to approve GM crops have been made in the Community since 1998, partly because of the refusal of six Member States to participate in the decision-making process until rules on traceability and labelling are in place.

The current proposals

  3.6  In these two documents, the Commission has proposed a number of changes foreshadowed in its White Paper on Food Safety, in order to provide what it describes as improved, harmonised, uniform and transparent procedures in this whole area, including the introduction into Regulation No. 258/97 of safeguards at least equivalent to those in Directive 2001/18/EC.

— Document (a)

  3.7  The current arrangements on genetically modified food and feed would be amended as follows:

    —  Scope

    As well as food, the measure would extend to feed (including, for the first time, that produced from GMOs), and their ingredients. It would also provide for a specific evaluation of the genetic modification relating to substances such as food or feed additives or flavourings where these had been produced from GMOs. It would thus, according to the Commission, enable an authorisation to be obtained for "all possible uses in food and/or feed". The measure would not, however, extend to products produced with a GMO, where no material derived from the GMO is present in the end product.

    —  Authorisation

    The process would in future be centred, not on individual Member States, but on the new European Food Authority, and on a single risk management process, involving the Commission and the Member States under a regulatory committee procedure. In addition, the current simplified procedure for GM food applications based upon substantial equivalence would be removed, and a "one door-one key" principle would be developed, enabling authorisation to be given at the same time both for environmental releases under Directive 2001/18/EC and for food and feed use under the proposed Regulation. However, in the latter case, authorisations would not be granted for a single use when a product is likely to be used both for food and feed processes. Subject to a post-market monitoring plan, authorisations would be renewable for a ten-year period, and authorised products would be entered on a register.

    —  Labelling

    Whilst current labelling rules for GM foods are based on the presence of novel DNA or protein resulting from genetic modification, this applies only to live GMOs, and there are no labelling requirements for food produced from a GMO, but which no longer contains it. In future, all food and feed ingredients derived from GMOs would have to be labelled, even when they are analytically identical to those derived from non-GM sources. Though the Commission recognises that this is likely to give rise to enforcement problems, it argues that the accuracy of the system can be controlled through an effective traceability system, and that the proposal responds to a need to enable consumers to exercise choice and thereby would foster increased public confidence in genetically modified foods.

    —  Thresholds

    The Commission notes that, even though some operators make every effort to avoid using genetically modified material, this may be present as a result of adventitious contamination during cultivation, harvest, transport or processing. Consequently, current labelling rules contain a 1% threshold for such contamination of non-GM sources with approved GM varieties. The proposal would maintain this tolerance, and introduce a threshold for non-Community approved varieties which have undergone a favourable safety assessment by the relevant Community scientific committee.

— Document (b)

  3.8  The second proposal deals with the traceability and labelling of food and feed products derived from GMOs, and would expand upon the provisions in Directive 2001/18/EC so as to require operators to transmit to the next operator in the production and distribution chain specified information that a product consists of, contains, or (in the case of food or feed) is produced from GMOs. Where products are pre-packaged, this obligation would extend to their labelling.

  3.9  Although the operative provisions would not come into force until the Community has established a system of unique codes[7] for GMOs to aid identification, and hence facilitate targeted withdrawals and environmental monitoring, all operators would be required to keep for five years records of GMOs, and food and feed products produced from them, which are supplied and received at each stage of the food chain. As with the proposed amendment to Council Regulation 258/97, there would be an exemption for the accidental presence of GM material in food and feed products at a threshold of 1% or lower, provided the GMOs in question had been approved in the Community or had undergone a safety assessment by a recognised Community scientific body. In addition, the Commission would develop prior to the application of the Regulation technical guidance on sampling and testing for imports, particularly those of bulk shipments of commodity crops, and for control and inspection.

The Government's view

  3.10  In an Explanatory Memorandum of 5 December 2001, the Parliamentary Under-Secretary of State at the Department of Health (Ms Hazel Blears) says that the first Commission proposal, together with the related proposal on traceability and labelling (document (b)), is intended to improve consumer confidence, and thus to contribute towards unblocking the authorisation process for GM crops and food. However, she adds that there will be important implications for food production costs and enforcement, and an impact on the Community's trade partners, such as the United States. She says that the part of the proposal relating to the safety assessment of GM food and feed is broadly supported by the Government, although clarification will be required on a number of issues, especially the precise role of the European Food Authority. She also considers that further discussion will be needed to ensure that the proposed labelling rules are practical, proportionate and enforceable, and to recognise the external impact, including that on developing countries exporting to Europe. She suggests that it may be difficult in practice to make the proposals work, and to enforce them effectively, and that consumers could face increased costs and be vulnerable to fraud. She sees the suggestion that thresholds should be allowed for GM varieties which have received a positive scientific assessment, and which have not yet gained formal approval, as a response by the Commission to the deadlock in the current authorisation process, and says that, although the Government recognises that zero presence of non-authorised GMOs may not yet be practical, it considers that other options need to be explored.

  3.11  In a separate Explanatory Memorandum of 10 December 2001, the Parliamentary Under-Secretary of State at the Department for Environment, Food and Rural Affairs (Lord Whitty) says that the Government welcomes the proposal on traceability as an opportunity to reappraise how the Community can better deliver both safety and reliable consumer choice in both GM food and crops. Nevertheless, he considers that there are significant practical and technical details requiring further consideration. In particular, he highlights the fact that:

    —  the proposal would apply to products, such as highly refined maize oil, produced from GMOs but containing no novel genetic material in the final product: since these are analytically indistinguishable from material from non-GM sources, this would give rise to opportunities for fraud and associated enforcement difficulties, which could make this part of the proposal unworkable;

    —  though the Government supports the 1% threshold for adventitious contamination by Community-approved GMOs, it feels that this figure should be kept under review: it also has strong reservations about the proposed approach for safety assessment, in as much as the type of scientific committee which might be involved is not specified;

    —  whilst the Government recognises the importance of establishing a system of unique codes for identifying GMOs, the preponderance of imports of GMOs from third countries means that the Community system should be consistent with mechanisms being developed under wider international organisations, including the Organisation for Economic Co-operation and Development (OECD), and the requirements of the Cartegena Protocol on Biosafety.

  3.12  In addition to their Explanatory Memoranda, each of the Ministers has provided a Regulatory Impact Assessment. That by the Department of Health says that, although the benefits, in terms of increased consumer confidence, are undoubtedly real, they are difficult to quantify. The main costs will, however, be felt widely among around 600,000 food businesses, of which approximately half are in catering, and will tend to be highest in the bread, cereals and highly processed foods sectors, which contain a higher than average proportion of small businesses. Those costs would be split between the need to maintain separate growing, storage, transport and processing facilities for both GM and non GM lines, and the paper-based traceability systems required to enable claims to be verified. As the following table indicating net present values (in million pounds) shows, the costs would also increase significantly as the labelling requirement became more stringent:

Existing rules
 - with GM-free labelling
Commission proposal
 - covering products produced from GMOs

  3.13  The Assessment also identifies a number of other potential costs, which have yet to be quantified. These arise from the possible dilution of the impact of existing labelling by the inclusion of additional data on GMOs; a concentration of the food manufacturing sector into fewer larger companies as smaller businesses become less competitive; and a possible fall in consumer confidence if the proposals turn out to be unenforceable. The Assessment therefore stresses the importance of compliance, and the costs this would entail.

  3.14  Not surprisingly, the Assessment provided by the Department for Environment, Food and Rural Affairs covers similar ground, though it does also identify as a potential cost any trade dispute which might arise if the proposal were found to be contrary to World Trade Organisation rules, or if, as industry has suggested, it provided an incentive to import final products rather than produce them within the Community. In addition, the DEFRA Assessment provides estimates for enforcement costs, arising from testing and inspection, which in total range from £3.4 million for the current rules plus a "GM free" labelling scheme, to £6.3 million for the Commission's proposal extended to include products produced with GMOs. It says the costs of the Commission's current proposal without such an extension would amount to £4.6 million.


  3.15  It is clear from the preceding paragraphs that these two proposals deal with a subject which is complex both technically and from a legislative point of view. It also goes without saying that they are of some political significance, given the public interest in genetically modified organisms, not least in the areas covered here. In view of this, we have no hesitation in recommending that they should be debated together, and that such a debate should be held at an early date. We also consider that, as the underlying aim of the proposals appears to be to enhance consumer safety, it would be appropriate for the debate to take place in European Standing Committee C.

  3.16  The substance of the debate touches on a range of general issues regarding genetically modified organisms, but we also think the House will wish to focus on a number of specific points which arise directly from these documents. These include enforcement (including practicality, potential costs and scope for fraud); the role envisaged for the European Food Authority; the arrangements for dealing with adventitious contamination; the likelihood that the proposals might be open to challenge from third country suppliers; and the extent to which they will in practice fulfil the Commission's aim of increasing consumer confidence in GM foods.

5   OJ No. L.43, 14.2.97, p.1. Back

6   OJ No. L.106, 17.4.01, p.1. Back

7   These would reflect the authorised "transformation event", whereby a GMO is formulated from a conventional organism. Back

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