Detailed Description on New GMO Labeling Rules in EU

Detailed Description on New GMO Labeling Rules in EU

European Report
July 28, 2001


In a controversial move, the European Commission on July 25 unveiled two
Regulations on genetically-modified organisms (GMOs) call for a strict
EU-wide system to trace and label GMOs. The new legislation will require the
traceability of GMOs throughout the food chain "from farm to table" and
provide consumers with information by labelling all GM food. It will
establish a "one door one key" procedure for the authorisation of GMOs for
food and feed, including the deliberate release into the environment. The
proposals fall under the co-decision procedure with the European Parliament
and the Council and should enter into force in 2003 at the latest. However,
these strict rules imply a heavy burden on the food industry and the EU's
trade policy.

The main EU legislation in force on GMOs (Directive 90/220/EEC on the
deliberate release of genetically-modified organisms into the environment,
as amended by Directive 2001/18) does in fact already ensure the scientific
safety assessment of GMOs, regulates its authorisation and its use. The
Directive requires traceability and labelling, but does not go into any
details. The Commission's new proposals specify the details of those
requirements designed to protect the environment in case any problem
emerges. The proposals introduce for the first time specific rules on
GM-feed in Europe and existing provisions on GM-food are unified and
streamlined. The Commission is at pains to point out that the draft
legislation takes account the EU's international trade commitments and the
requirements of the Cartagena Protocol on Biosafety to the Convention on
Biological Diversity as regards importer obligations and notifications.

--The EU's legislation concerning GMOs includes: Regulation (EC) 258/97 on
novel foods and novel foods ingredients; Regulation (EC) 1139/98 concerning
the compulsory indication of the labelling of certain foodstuffs produced
from GMOs: and Regulation (EC) 49/2000 and (EC) 50/2000 on the labelling of
foodstuffs and food ingredients containing additives and flavourings.--

Traceability entails the ability to trace products through the production
and distribution chains. For some products, it has existed for many years.
However, specific traceability requirements for products that contain GMOs
or are derived from GMOs do not currently exist. The proposed Regulation
makes it possible to trace GMOs through the production and distribution
chain. Traceability facilitates monitoring of any effects on human health
and the environment, for accurate labelling and for controlling labelling
claims. It is also necessary to enable withdrawal from the market in case of
unexpected adverse effects.

In the new Regulation, traceability is ensured by putting obligations on
business operators to transmit and retain information at each stage of the
placing on the market. The industry must have systems in place that identify
to whom and from whom GM products are made available. Information concerning
the presence of GMOs must be transmitted throughout the commercial chain and
must be retained for five years.

Transmission and storage of information will reduce the need for sampling
and testing of products. To facilitate a co-ordinated approach for
inspection and control by Member State, the Commission will develop
technical guidance on sampling and testing methods prior to the application
of this proposed Regulation.

Labelling .
In comparison with the labelling system currently in place, the proposal on
GM food and feed will add the labelling of:
- all foods produced from GMOs irrespectively of whether there is DNA or
protein of GM origin in the final product
- all genetically-modified feed.

Initial reactions.
While the European biotechnology industry seems to be happy that the
Commission has tabled new proposals on GMOs, it is still "surprised, even
disappointed" about the labelling rules proposed. "These proposals worry us
because they require labelling of products that cannot be tested", said a
spokesman for Europabio, the industry pressure group. "This kind of
legislation will leave the door wide open to fraud if one of the links in
the food chain does not play by the rules", she added.

On the other hand, the European Consumers' Organisation (BEUC) feels the
Commission's proposals "are a step in the right direction and a huge leap
for consumers in that they take account of most of their demands in the area
of GMOs". The BEUC cites as an example the need to tighten up legislation on
GMO derivative products and also on marketing authorisation systems for
products containing genetically-modified products or GMO derivatives.
For its part, the environmental organisation Greenpeace has welcomed the
Commission's proposals, even though it fears they "risk opening a gap and
allowing previously unauthorised GM products onto the European market for
the first time". In particular, it criticises the fact that the Commission
proposes to establish a 1% tolerance threshold "not just for GMOs already
authorised, but also for those that have been banned".

Retailers throughout the EU already have to label a food consisting of or
containing GMOs. This also includes food produced from GMOs if traces of DNA
or protein from the genetic modification is detectable in the final product
(such as flour produced from genetically-modified maize. However, the
labelling provisions do not cover some foods or food ingredients, such as
highly refined soya or maize oil. The effect of the new proposal is to
extend the current labelling requirements to also cover such food and food
ingredients produced from GMOs and to allow consumers to exercise their
freedom of choice. The accidental presence of GM-material in food up to 1%
will continue to be exempted from the labelling obligation.

The proposal also introduces for the first time strict labelling
requirements of GM-feed along the same principle as for GM food. Currently
no labelling requirements are in place for feed produced from GMOs. The
proposal will require labelling of, for example, GM-soy meal and any
compound feed that includes in its composition the GM-soya meal. It will
also require labelling of corn gluten feed produced from GM maize. The
accidental presence of GM-material in feed up to 1% will be exempted from
the labelling obligation.

Adventitious presence.
An issue which arises from the cultivation of GMOs is the possibility of the
presence of minute traces of unauthorised GMOs in food and feed. These
traces may be technically unavoidable during cultivation, harvest, transport
and processing. Whether we like it or not this has become a reality. This is
not a problem which is particular to GMOs. In the production of food, feed
and seed, it is practically impossible to achieve products which are 100%
pure. The Commission's July 25 proposal acknowledges this fact and sets up
specific conditions under which technically unavoidable presence of
unauthorised GMOs could be permitted. In the EU, a number of GMOs have
already been assessed by the Scientific Committees as not posing a danger to
environment and health. However, these GMOs are still pending final
approval. The proposal allows for these GMOs which have received a positive
opinion from a EU Scientific Committee to be present in a food or feed up to
a maximum of 1%.

Authorisation procedure.
Clear rules are set out in the EU for the assessment and authorisation of
GMOs and GM-food but responsibilities are divided between Member States and
the Community. It is therefore proposed to establish a "one door one
key"-procedure for the scientific assessment and authorisation of GMOs and
GM food and feed resulting in a centralised, clear and transparent Community
procedure where an operator only has to file a single application. Learning
from the US experience with StarLink, the proposal provides that GMOs likely
to be used as food and feed can only be authorised for both uses or not at

The scientific risk assessment will be carried out by the European Food
Authority covering both the environmental risk and human and animal health
safety assessment. Its opinion will be made available to the public and the
public will have the possibility to make comments. On the basis of the
opinion of the European Food Authority, the Commission will draft a proposal
for granting or refusing authorisation. The proposal will as it is currently
the case be approved through qualified majority of the Member States within
a Regulatory Committee. Products authorised shall be entered into a public
register of GM-food and feed. The authorisation should be granted for a
period of 10 years, subject where appropriate to a post-market monitoring
plan. Authorisations are renewable for 10-year periods.
The simplified procedure for putting on the market GM-foods which are
considered to be substantially equivalent to existing foods will be

Current GM-products will remain eligible for marketing. Traders will however
be obliged to provide methods for sampling and detection to the European
Food Authority within six months of entry into force of the new Regulation.
The proposal also establishes the Joint Research Centre (JRC) of the
Commission as new Community Reference Laboratory which will have the main
task of validating sampling and detection methods. The JRC will continue to
work with the European Network of GMO laboratories. Existing GM-products
shall also be entered into the public register and the time limit of 10
years from the day when the concerned product was first placed on the market
equally applies to them.

--Commenting on the proposals, Environment Commissioner Margot Wallstr'm
said: "The provisions for traceability ensure a high level of environmental
and health protection and pave the way for a proper labelling system.
Certainly, there is a cost for the producers and for trade, but what is at
stake is our ability to build public confidence. European companies will
only be able to seize the opportunities provided by biotechnology if this
confidence is established".

Health and Consumer Protection Commissioner David Byrne said the new laws
"will ensure that the regulatory framework in the EU is up to the high
standard consumers expect. After that it is for consumers to decide if they
want to buy food produced from a GMO. The proposed labelling regime will
allow consumers to make that choice. Consumers can be assured that any GMOs
in their food have been assessed strictly for their safety. Equally
important to me is that for the first time ever we will have clear rules on
GM-feed in place in Europe which is a major contribution to provide
trustworthy information to farmers on the feed they buy".--

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