The European
Union (EU) has a common policy towards genetically modified
food, and legislation was produced at EU level. The different
national laws reflect this common policy, with minor adaptations.
Find out about the
following issues.
Is it legal to produce and sell genetically
modified foods?
Is it legal to import genetically modified foods?
Who decides, what is legal?
Must genetically modified foods be labelled?
Are legal ethics considered?
Click on an issue to find out more.
Click here
to view by country.
Is it legal to produce and
sell genetically modified foods?
United Kingdom
This is governed by EU law.
Denmark
This is governed by EU law.
Finland
This is governed by EU law.
France
This is governed by EU law.
Germany
This is governed by EU law.
Italy
According to the law 1096/71 article 12,
every seed, conventional or obtained with biotechnology techniques,
can be marketed or sold only if it belongs to varieties recorded
in national registers.
Furthermore, the decree-law 212/2001, article 1, paragraph
2, requires that genetically modified varieties obtain the
proper authorization to be cultivated.
To the present, no genetically modified varieties (GMOs) of
corn and soy are recorded in the national italian register
or in the common european catalog. Therefore, waiting for
a EU law and according to the "precaution principle"
(law 1096/71, article 19, paragraph 14), it is forbidden to
sow GMO varities if not recorded in the national register.
Besides, the presence of genetically modified seeds in batches
of conventional seeds must be avoided. However, it is possible
to obtain the authorization to grow experimental GMO cultures.
In particular, the circular MIPAF on the "sowing campaign
2003" governs the control tests for corn, soy, and other
GMOs. These tests are qualitative, and no indulgence is given.
Some regional laws explicitly forbid to grow and breed GMOs
on public lands (Basilicata, Campania, Umbria, Toscana, and
Abruzzo), in some circumstances also for research purposes.
Some regions provide for sanctions to industries that use
GMOs, among which the exclusion from public funding and the
denial of quality marks to their products.
To the present, rules governing the marketing of genetically
modified food are missing. Some regions and provinces forbid
to use GMOs in food destined to public use (Campania and Toscana).
Portugal
This is governed by EU law.
Spain
This is governed by EU law.
European Union
A genetically modified food is generally
produced using genetically modified plants.
If a scientist in the EU wishes to work with
genetically modified plants his work must be approved in three
different stages. Each stage is to be approved independently.
- Approval of the laboratories and incubators
where the first trial is to be performed.
- Permission to carry out trial runs in the
field under various safety precautions
- Permission for the seeds to be sold to the
farmer and grown in the fields
Finally, companies have to have permission
to market and sell a food that is produced using a genetically
modified plant.
[Return to list of Issues]
Is it legal to import genetically
modified foods?
United Kingdom
This is governed by EU law.
In the United Kingdom, no genetically
modified foods have been approved other than the ones allowed
by the EU.
Denmark
This is governed by EU law.
In Denmark, no genetically modified foods
have been approved other than the ones allowed by the EU.
Finland
This is governed by EU law.
In Finland, no genetically modified foods
have been approved other than the ones allowed by the EU.
France
This is governed by EU law.
In France, no genetically modified foods
have been approved other than the ones allowed by the EU.
Germany
This is governed by EU law.
In the Germany, no genetically modified
foods have been approved other than the ones allowed by the
EU.
Italy
A deree-law banned the marketing of four
kinds of transgenic corn (strains MON810, MON809, T25, Bt11),
while it allows to sell the strain Bt176 on the national market.
This kind of corn is not produced in Italy because it did
not receive the proper authorization. Therefore, it is presently
imported.
Portugal
This is governed by EU law.
In Portugal, apart from soy
and corn ingredients, all imports and trade of GM food is
currently suspended (Decree-Law 12/2002, February). This suspension
period is due to the uncertainties of GM impact on public
health and the environment and it is aimed at allowing more
time for reflection and study.
Spain
This is governed by EU law.
In Spain, no genetically modified foods
have been approved other than the ones allowed by the EU.
European Union
At the moment, only certain forms of genetically
modified Soya beans, rape and sweet corn may be imported into
the EU.
If a genetically modified food or ingredient
is not approved for sale in the EU it may not be imported.
Certain foods however, identical to their
non-genetically modified equivalent, may be imported provided
that the EU is notified and the conformity documented. One
example is genetically modified sugar - which is identical
to non-genetically modified sugar. Rape seed oil is another.
[Return to list of Issues]
Who decides, what is legal?
United Kingdom
This is governed by EU law but partly regulated
at national level.
In the UK, the Secretary of State for the Environment is responsible
for licensing all experimental and commercial uses of GMOs.
He or she is advised by a committee of experts called the
Advisory Committee on Releases to the Environment (ACRE).
An independent body appointed by the Food Standards Agency
carries out the assessment of novel foods. Members of the
'Advisory Committee on Novel Foods and Processes' are chosen
to represent a wide range of relevant scientific expertise
and knowledge.
Denmark
This is governed by EU law but partly regulated
at a national level. In Denmark, it is the Minister of the
Environment and the Minister of Food, Agriculture and Fisheries
who evaluate applications concerning genetic engineering.
Who makes the evaluation depends on what the application is
about.
The Minister for the Environment decides whether a genetically
modified plant can be released into the environment and marketed
for cultivation.
The Minister of Food, Agriculture and Fisheries decides whether
a genetically modified food can be approved for sale and marketing
to the consumers.
The same procedure is followed when Denmark receives an application
from a company as well as when Denmark has to evaluate an
application from another country in the EU.
Before any decisions can be made, the application needs to
go through a hearing. For instance, it is stated in the Danish
law on Environment and Gene Technology (2002), that the Minister
of the Environment must hear relevant authorities, organisations
and citizens on approvals of GMOs for release into the environment.
In practise, it is the Danish Forest and Nature Agency who
carries out the hearing for the Ministry of the Environment.
The Danish Forest and Nature Agency submits the application
to experts, research institutions, authorities and interest
groups for consideration.
In the same way, practice is that the Danish Directorate for
Food, Fisheries and Agro Business handles the applications
on genetically modified foods for the Ministry of Food, Agriculture
and Fisheries.
Finland
This is governed by EU law but partly regulated
at a national level.
In Finland, The Gene Technology Decree (1995)
covers the legal aspects of genetically modified organisms.
The Board for Gene Technology supervises the research and
the National Food Agency the commercialisation of GMOs, as
well as with novel food applications. The Novel Food Board
gives permission to use GMOs as foods and the Ministry of
the Environment participates in the environmental impact assessment.
France
This is governed by EU law but partly regulated
at a national level.
In France, a large-scale operation to supervise
GMO research and marketing has been introduced. All planting
applications must be examined by the Biomolecular Engineering
Commission (CGB). This body is made up of scientific experts
and representatives of consumer and environmental protection
organisations.
The CGB is responsible for assessing GMO-related
risks to public health and the environment (not usefulness
to the economy or agriculture). The Commission's approval
is needed before the ministries responsible for Agriculture
and the Environment will grant a permit. Fields must comply
with precise constraints (safety perimeters, etc.) and are
supervised and inspected by Regional Agriculture and Forests
Authorities.
Germany
The authority that deals with any application
concerning field trials with GM plants in Germany is the "Robert-Koch-Institut"
in Berlin, which is associated with the German Federal Ministry
for Health. Additional authorities 'The Federal Biological
Research Centre for Agriculture and Forestry' (BBA) and The
Federal Environmental Agency (UBA) are involved in the admission
procedure while the Zentrale Kommission für biologische
Sicherheit ('Commission for Biological Safety') is asked for
written comment.
Approval for GM food to be sold on the
German market will be given either by the Robert-Koch-Institute
or by the Federal Institute for Health Protection of Consumers
and Veterinary Medicine (BgVV), depending on the kind of product.
Italy
The recommendation 618/97/CE Sep 16th 1997
entitles the Ministry of Health, Department of Food, Nutrition
and Public Veterinary Health to judge documents related to
genetically modified food.
Inside the Department, a specific inter-ministerial commission
has been established, in order to catch up with services of
decree aimed at marketing new products and ingredients.
In particular, the decree-law 92/93 gives power to the Ministry
of Health, Department for the Prevention, as the competent
authority to evaluate possible risks that GMOs might have
in impairing human or animal health and environmental safety.
This Department collaborates with the inter-ministerial commission
of the Council of Biotechnology (CIGB), composed of experts
designated by the Ministries of the Environment, Agricultural
Policies, Industry, Commerce and Arts and Crafts, University
Scientific and Techonological Research, Civil Protection,
National Health Institutes, and Prevention and Work Safety.
Portugal
This is governed by EU law but partly regulated
at a national level.
In Portugal, the Ministry
of Environment (Environment Institute) is responsible for
the application of GM-related EU legislation. The Environment
Institute is also responsible for the assessment of GMO-related
risks to the environment.
Although all applications are suspended at the
moment in Portugal, the official entity responsible for the
certification, quality, and monitoring of GM planting is the
Directorate-General for the Protection of Cultivars (DGPC),
which is part of the Ministry of Agriculture, Rural Development
and Fishing. The DGPC also conducts experimental research
(not suspended).
The official entity responsible for the
release of all food products in the Portuguese market is the
Directorate-General for the Monitoring and Quality Food Control
(DGFCQA). It is integrated in the Ministry of Agriculture,
Rural Development and Fishing.
Spain
This is governed by EU law but partly regulated
at national level.
In Spain, laws are always made by the
legislature while authorisations are granted by the Administration.
Spanish standards are very strict about regulating genetically
modified organisms, which is why the principle of precaution
in the approval of new varieties always applies. For the commercialisation
of the new varieties derived from genetic modification, an
Order providing for their registration in the Commercial Varieties
Register, published in the Official State Journal by the Ministry
of Science and Technology, is required. As opposed to what
happens with other varieties improved by other procedures,
an obligatory Monitoring Plan is established to test on a
commercial scale both the usefulness of the genetic modification
and the impact on animal and plant species alien to the crop.
When the new varieties require a new application of herbicide,
prior authorisation for use through a Public Resolution from
the Agriculture Department at the Ministry of Agriculture,
Fisheries and Food is required, according to Royal Decree
2163/1994 which introduces the harmonised community system
of authorisation for commercialising and using phytosanitary
products. In the authorisation procedure the doses and conditions
of use are determined to guarantee that when the phytosanitary
products are authorised, they are sufficiently effective.
There is also a test to ensure that they have no unacceptable
effects on plants or plant products, including the possible
presence of waste; nor unacceptable effects on the environment
in general or in particular any harmful effect on human or
animal health or on underground water.
European Union
In Europe, the EU is mainly responsible
for deciding what is legal with regard to genetically modified
foods. Member countries must follow two sets of instructions
from the EU.
- A Directive on release into the environment
of genetically modified organisms (no. 2001/18/EC)
- The Regulation concerning novel foods and
novel food ingredients (no. 258/97)
If authorities consider there to be a risk to
people's health or to the environment, such genetically modified
plants or foods will not be approved. The decision of the
authorities is based on a risk assessment of the relevant
plant or food.
Who handles the application depends on what
it is about:
- Field trials: approval from the country where
trial exposure is to be performed is sufficient.
- Sales to farmers: the marketing application
must be approved for the whole of the EU.
- Sales to consumers: two main guidelines must
be followed depending on the characteristics of the product.
If a food is identical with the non-genetically modified
equivalent, it is sufficient to inform the European authorities
that the food will be sold to consumers. The similarities
however are to be documented. If a genetically modified
food is different from the equivalent non-genetically modified
food it has to be approved throughout the EU before it can
be released on supermarket shelves.
The approval required by the EU involves
three steps:
- The company sends their application to one
of the EU member countries. The relevant authority in the
country comes to a decision over the application.
- If the authorities in the country approve
the application, it is sent for hearing in all other EU
countries.
- If the other EU countries have nothing
to add, the application receives approval from the EU-commission.
If the member countries have objections - the decision is
put to a vote.
[Return
to list of Issues]
Must genetically modified
foods be labelled?
United Kingdom
This is governed by EU law but regulated
at national level.
Restaurants are outside the scope of general
EU food labelling requirements, but GM labelling laws in the
UK were extended to cover such premises. Therefore information
covering GM foods has to be provided on the menu, at the counter
or verbally by staff. This requirement came into effect on
19 September 1999.
Denmark
This is governed by EU law but regulated
at a national level.
In Denmark, restaurants and the like are
required to inform consumers about the use of genetically
modified ingredients at the consumer's request. The restaurant
can also choose to display the information on its menu. This
is stated in the national Danish announcement on labelling
etc. of foods.
Finland
This is governed by EU law but regulated
at a national level.
There are no additional laws on labelling
in Finland.
France
This is governed by EU law but regulated
at a national level.
In France, two decrees have been added to the
Consumer Code (August 2000 and November 2001) that compel
manufacturers to mark the packaging of products whose ingredients,
additives or flavouring contain more than 1% of GMO as 'produced
using genetically-modified maize/soya'. But an investigation
conducted by the magazine '60 millions de consommateurs 'published
in January 2001 revealed that out of a sample of 103 common
foodstuffs, 36 contained traces of GMO (less than 1%) not
mentioned on the packaging.
The only foodstuffs that are guaranteed
100% GMO-free are organic products marked "AB" (Organic
Farming Label).
Germany
This is governed by EU law but regulated
at a national level.
In Germany, GM plants and foodstuffs which contain
or have been made from GM plants must be labelled according
to these EU guidelines. There are no additional specific regulations
concerning the labelling of GM foods in Germany.
However, since October 1998, foods that
don't contain any GM plants and have been made without using
any ingredients deriving from GM organisms can be labelled
as "ohne Gentechnik" ("without gene technology"),
if the producer can supply evidence of this according to very
strict rules.
Italy
This is governed by EU laws. Therefore,
every food and fodder containing more than 0.9% of genetically
modified organisms must be labelled. Before six months from
the publication on the EU Official Gazette, every company
will have to label their products. Each GMO will have its
own ID code, in order to know what kind of genetic modification
it went through. The threshold level for 13 not-authorized
GMOs is 0.5%. If this threshold is overcome, the product is
banned from the market.
Portugal
This is governed by EU law but regulated
at a national level.
In Portugal, GM plants and foodstuffs which
contain or have been made from GM plants must be labelled
according to EU guidelines. There are no additional specific
regulations concerning the labelling of GM foods in Portugal.
Spain
Yes, Community regulations are followed.
For a genetically modified seed to appear on the market, the
agreement of Community Regulation (CE) 258/97 on new foods
and food ingredients is required if the crops or by-products
may be intended for human consumption. That notification is
published in the Official Journal of the European Communities
and regulates both the authorisation and any possible labelling
of the product. For the labelling of foods containing fractions
or additives from genetically modified organisms, the terms
of Community Regulations CE nos. 49/2000 and 50/2000 will
be taken into account; they establish a threshold of 1% for
exemption from labelling due to duly documented accidental
contamination.
European Union
In the EU, products containing traces of
genetically modified substances are to be labelled as genetically
modified. In other words - foods that are different from the
corresponding non-genetically modified foods because they
contain new substances in the form of proteins and genes,
derived from gene-modification. The same rules apply to additives
and flavourings.
Food not containing traces
of genetic modification does not require labelling in the
EU, not even when produced by genetically modified plants.
For example, manufacturers need not label rape seed oil, produced
by seeds from genetically modified rape plants. The rape seed
oil contains no new substances in relation to non-genetically
modified rape seed oil. Thus the oil is not regarded as different.
If a food unintentionally
contains less than 1% genetically modified material, it is
not to be labelled as genetically modified. This limit (the
triviality limit), is fixed by the EU, because it can be difficult
to avoid a certain chance contamination of non-genetically
modified foods.
Milk and animal products,
derived from animals fed with genetically modified feed, need
not be labelled in the EU. This happens because the materials
derived from genetic modification cannot be traced in the
animal.
It may be in the future that foods, such
as rape seed oil, will have to be labelled. A new proposal
for labelling regulations is currently under consideration
in the EU. The proposal is that all food produced on the basis
of genetically modified plants will be labelled. Even if the
foods contain no trace of the genetically modified material.
The proposal does not concern labelling meat from animals
fed on genetically modified feed.
[Return to list of Issues]
Are legal ethics considered?
United Kingdom
This is governed by EU law but partly regulated
at national level.
The current legislation in Britain only
takes into account safety data from the applicant companies
and institutions. This focuses on crude health and environmental
safety issues only. At present there is no legislation that
considers ethical issues relating to GM.
Denmark
This is governed by EU law but partly regulated
at a national level.
Recently, the Danish law on Environment and
Genetic Engineering has been changed so that a consideration
of ethical values is now included in the objects clause. The
law also allows the Minister of the Environment to lay down
rules so that principal decisions require the hearing of an
independent agency representing ethical values. The changes
to the law came into force in October 2002.
Finland
This is governed by EU law but partly regulated
at a national level. | 
legislação 
