Mr President, Honourable Members,

May I first express my thanks for all the hard work that has taken place in the different Committees in relation to the proposal for a Regulation on GM food and feed.

The issues raised under this banner are complex and sensitive and often give rise to strong emotional reactions and divided opinions.

The vote in the Committee on the Environment, Public Health and Consumer Policy frequently resulted in amendments being rejected or adopted by a very narrow margin.

This highlights the difficulty of the subject but also, in my opinion, serves to show that the Commission proposal strikes a good, sensible and balanced compromise between the differing views.

I do not intend to address each and every amendment, but instead would like to focus on four major issues, namely:

• the scope of the proposal;
• the environmental risk assessment;
• transparency; and,
• thresholds for adventitious presence.

Scope of the proposal

Amendments have been adopted:

• to extend the scope of the proposal to processing aids and animal products from animals fed on GM feed; and,
• to restrict the scope of the proposal to products derived from GMOs which contain transgenic DNA or protein.

Let me deal first with the amendments aiming to extend the scope of the proposal. These are the amendments that were voted in the Environment committee.

In drawing up the proposal, the Commission carefully considered which products should be included within its scope. We decided to only include products that are produced from a GMO.

This corresponds to the scope of the Novel Foods Regulation, which has now been in place since 1997, except that the Commission is proposing to also include additives and flavourings produced from a GMO.

Processing aids are not covered by the Novel food Regulation as these are not considered to be food ingredients. That is also the reason why processing aids in general do not have to be labelled on the final product.

The Commission does not believe it would be appropriate to require authorisation and labelling of GM processing aids, whether they are enzymes or otherwise, without having the same requirements for conventional processing aids.

The Commission proposal also covers GM feed. However, to extend its scope to products such as milk, eggs and meat from animals fed on GM feed would radically depart from existing food legislation concerning animal products.

As Commissioner Wallstrom has said, the Commission does not believe that including products from animals fed on GM feed in the scope of the regulation is either feasible or practicable. The Commission therefore firmly rejects amendments to that effect.

Allow me now to address the amendments, tabled last week, that aim to restrict the scope of the proposal, both in respect of authorisation and in respect of labelling.

I will start with labelling, because this is how the debate started.

The Commission proposes to expand the current labelling requirements, and to require the mandatory labelling of food, food ingredients and feed produced from a GMO, even when transgenic DNA or protein is not present that is, not detectable in the food, feed, or in the ingredient.

The classic example is table oil directly derived from GM maize, GM soya beans, or GM rapeseed. Through the refinement process, all transgenic material has been removed. The question therefore arises should it be labelled as GM or not?

Everyone would agree that safety is not the issue here: this is dealt with in the authorisation process.

Labelling serves the purpose of informing consumers and users and allowing them to exercise choice if this is something that matters to them.

And what is abundantly clear to me is that the GM origin of products is something that really matters to a great number of consumers.

We also know that many of Member States want the mandatory labelling of all GM derivatives, and a number of them have clearly indicated that they would not support the authorisation of new GMOs if full labelling and traceability of all GM derivatives was not required.

Those who argue against mandatory labelling of all GM derivatives, irrespective of the presence of transgenic DNA or protein, take the view that control of this obligation is unworkable and that it would lead to massive fraud.

Let me state very clearly I cannot accept this argument. I cannot accept that legal requirements are not enforceable if compliance cannot be checked through analytical methods.

The reality is that a great number of regulatory requirements and legal rights, from mandatory labelling of the geographic origin of products to intellectual property rights, are enforced without any recourse to physical checks. None of the practical difficulties predicted in connection with GM labelling, has proven
insurmountable in these contexts.

Indeed, the very requirement that we are discussing today is already in effect in many parts of the Community, albeit imposed by companies within the food chain rather than through Community legislation.

I have yet to meet a business operator who would admit that he does not know the origin of the ingredients he or she is using.

And there is a good reason for this. Admitting that you don't know whether your input is GM or not, is also admitting, by the same token, that you don't know whether or not you are perhaps using a non-authorised GM.

It is probably for this very reason that those who oppose the mandatory labelling of products not containing transgenic DNA or protein also propose to exempt these products from authorisation.

This, I am afraid, would be totally unacceptable for the Commission. It would turn the clock back more than five years, before the adoption of the Novel Food Regulation, at the very time that international consensus is emerging, in Codex Alimentarius, that all foods produced from GMOs should be subject to a pre-market approval process.

The message to our consumers would be disastrous. Currently, the message is: "Sorry, we cannot tell you whether this table oil is GM or not". If these amendments were adopted, we would have to add: "And, sorry again, if it is GM, we cannot tell you whether the GMO from which it is extracted was
authorised or not".

Finally, I would like to address the issue of "GMO-free labelling". You have already understood that the Commission cannot accept "GMO-free" or "non-GM" as an alternative to the mandatory labelling of GM-derivatives. However, I can see value in the development of guidance on the voluntary use
of expressions such as "non-GMO", if this is in addition to mandatory labelling of GM-derivatives. Under that condition, the Commission could accept amendment nr. 170.

Environmental risk assessment

A series of amendments challenge the suggestion that the European Food Safety Authority should carry out the environmental risk assessment as part of the overall assessment of a GM food or feed.

In fact, these amendments would effectively deny the proposed Regulation the status of sectoral legislation within the meaning of Directive 2001/18.

However, I must emphasise that Directive 2001/18 clearly provides for sector-based legislation to be developed. This relies on the inclusion of a number of requirements that are at least equivalent to those of Directive 2001/18.

The Commission considers that these requirements are fully provided for by the proposed GM food and feed Regulation.

Equally, it would also deny the application of the "one door, one key" principle. This would result in the need for companies to file more than one application for the same GMO even though the applications would contain much of the same information.

Furthermore, it is clearly within the remit and competence of the European Food Safety Authority to carry out the environmental risk assessment for GMOs. The Commission cannot therefore accept the amendments requiring the environmental risk assessment for GMOs covered by the Food and Feed
proposal to be carried out only under Directive 2001/18.

Transparency

A number of amendments have been put forward with the intention of strengthening the information requirements of the proposal.

I have to say, however, that I believe the Commission proposal already provides for a thoroughly transparent system.

The Commission would be prepared to accept some of the amendments to increase further the level of public availability of information, but I do not consider it appropriate or reasonable to try to amend general comitology rules through this instrument.

It is also important that we do not forget the intellectual property rights of companies. In this regard I would draw attention to Article 31 of the proposal which, in my opinion, provides the right balance between protecting such legitimate rights and the interests of transparency.

Thresholds for adventitious presence

A number of amendments suggest that very small trace amounts of unauthorised GMOs and GM material should not be accepted in food and feed.

Commissioner Wallstrom has spoken at length on the issue of thresholds. I believe, nevertheless, that the importance of this issue cannot be overstated.

It would simply not be feasible or practicable if the proposals did not provide for any tolerance under certain conditions of course for small traces in food and feed of GMOs or GM material.

Indeed, even when an operator makes every effort to avoid using GMOs or GM material, traces may be technically unavoidable during cultivation, harvest, transport and processing.

I have said it before and I will say it again. Whether we like it or not, this has become a reality. We have to live in the real world. And this is not just a problem that is exclusive to GMOs. In the production of food, feed and seed, it is practically impossible to achieve end products that are 100% pure and totally free from foreign substances.

In the EU, the Scientific Committees have already assessed a number of GMOs and concluded that they do not pose a risk to the environment or to human health. However, some of these GMOs have been awaiting final approval for quite some time.

I therefore consider it sensible that the proposal allows for these GMOs and GM material which have been "pre-authorised" in terms of a complete positive risk assessment from an EU Scientific Committee, to be present in a food or feed up to a maximum of one per cent. This is of course provided that the GM presence is adventitious or technically unavoidable.

Other amendments suggest that a maximum labelling threshold for adventitious presence of authorised GM material should be established at one half of one percent (0.5%).

I believe that we should follow the principle established in Directive 2001/18, which provides for thresholds to be fixed in comitology procedure in order to take into account technological and scientific progress.

Conclusion

Mr President, honourable members, may I repeat that the Commission considers that the two proposals together strike a good and balanced compromise between the differing views.

Furthermore, I firmly believe that they also provide the right approach to foster public confidence and social acceptance of the application of biotechnology in agri-food production.

To conclude, let me state the Commission's position on all of the tabled amendments.

The Commission can accept the following 65 amendments wholly or in part or subject to editorial amendment: 1, 3, 10, 12, 13, 15, 16, 17, 18, 19, 20, 23, 28, 30, 31, 34, 36, 37 (in part), 38, 41 (in part), 44 (in part), 45, 55, 56, 57 (in part), 64, 67 (in part), 68 (in part), 69 (in part), 70, 71, 75, 77, 78, 80, 81
(in part), 82, 86 (in part), 89, 90, 101, 102 (in part), 103 (in part), 110, 112, 114, 115, 117, 118, 119, 121, 123, 124, 134 (in part), 138, 141, 144, 145, 146, 147, 158 (in part), 165, 166, 168 and 170.

The Commission cannot accept the following 107 amendments wholly or in part: 2, 4, 5, 6, 7, 8, 9, 11, 14, 21, 22, 24, 25, 26, 27, 29, 32, 33, 35, 39, 40, 42, 43, 46, 47, 48, 49, 50, 51, 52, 53, 54,58, 59, 60, 61, 62, 63, 65, 66, 72, 73, 74, 76, 79, 83, 84, 85, 87, 88, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 104, 105, 106, 107, 108, 109, 111, 113, 116, 120, 122, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134 (in part), 135, 136, 137, 139, 140, 142, 143, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158 (in part), 159, 160, 161, 162, 163, 164, 167 and 169.

Thank you.

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