6-Regulation: Speech of David Byrne on GM food and feed
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TITLE: Speech of David Byrne on GM food and feed
SOURCE: European Commission, SPEECH/02/314
DATE: July 2, 2002
------------------ archive: http://www.gene.ch/genet.html ------------------
European Commissioner for Health and Consumer Protection
GM Food and Feed Plenary Session - European Parliament
Strasbourg, 2 July 2002
European Commissioner for Health and Consumer Protection
GM Food and Feed
Plenary Session - European Parliament
Strasbourg, 2 July 2002
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
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
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 Wallstršm 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
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 nˇ 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
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.
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 Wallstršm has spoken at length on the issue of thresholds. I
believe, nevertheless, that the importance of this issue cannot be
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.
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
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.
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