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28 January 2004
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MEMO/04/16
Question
and Answers on the regulation of GMOs in the EU
What are
GMOs and GMMs?
Genetically
modified organisms (GMOs) and genetically modified
micro-organisms (GMMs) can be defined as organisms (and
micro-organisms) in which the genetic material (DNA) has been
altered in a way that does not occur naturally by mating or
natural recombination. The technology is often called "modern
biotechnology" or "gene technology", sometimes also "recombinant
DNA technology" or "genetic engineering". It allows selected
individual genes to be transferred from one organism into
another, also between non-related species.
What is
the current legislation in the EU on GMOs?
EU
legislation on GMOs has been in place since the early 1990s and
throughout the decade, this regulatory framework has been
further extended and refined. The EU introduced specific
legislation designed to protect its citizens' health and the
environment while simultaneously creating a unified market for
biotechnology.
The main
legislation under which experimental releases and placing on the
market of genetically modified organisms (GMOs) have been
authorised in the EU was, up until 17 October 2002, Directive
90/220/EEC. On this date, the Directive was repealed by the new,
updated Directive 2001/18/EC of the European Parliament and
Council on the deliberate release of genetically modified
organisms(1)
(footnote moved from p. 7).
Directive
2001/18/EC, as for Directive 90/220/EEC, puts in place a
step-by-step approval process on a case by case assessment of
the risks to human health and the environment before any GMO or
product consisting of or containing GMOs, such as maize,
tomatoes, or microorganisms can be released into the environment
or placed on the market.
Products
derived from GMOs, such as food products and ingredients
(for instance paste or ketchup from a GMO tomato) are not
covered by this horizontal Directive but by the Regulation on
Novel Foods and Novel Food Ingredients of 27 January 1997
(Regulation 258/97). This will be replaced by a new Regulation
on GM Food and Feed to be applicable from 18 April 2004.
Directive
90/219/EEC, as amended by Council Directive 98/81/EC on the
contained use of GMMs, regulates the contained use of GMMs for
research and industrial purposes.
This
existing legal framework will shortly be completed by two new
Regulations, which will become applicable on 18 April 2004:
·
a Regulation on GM food and feed (Regulation 1829/2003)
·
a Regulation on traceability and labelling of GMOs and the
traceability of food and feed products produced from GMOs
(Regulation 1830/2003)
What has
changed under the new Directive for the deliberate release of
GMOs?
The revised
Directive 2001/18/EC strengthens the old rules on the release of
GMOs into the environment. In particular, it introduces:
·
principles for the environmental risk assessment (see below);
·
mandatory post-market monitoring requirements, including on
long-term effects associated with the interaction with other
GMOs and the environment;
·
mandatory information to the public;
·
a requirement for Member States to ensure labelling and
traceability at all stages of the placing on the market;
·
first approvals for the release of GMOs to be limited to a
maximum of ten years;
·
the consultation of the Scientific Committee(s) to be
obligatory;
·
an obligation to consult the European Parliament on decisions to
authorise the release of GMOs and
·
the possibility for Council of Ministers to adopt or reject a
Commission proposal for authorisation of a GMO by qualified
majority.
How does
the environmental risk assessment procedure work?
The safety
of GMOs depends on the characteristics of the inserted genetic
material, the final organism that is produced, the receiving
environment and the interaction between the GMO and the
environment. The objective of the environmental risk assessment
is to identify and evaluate potential adverse effects of the
GMO(s). These include direct or indirect, immediate or delayed,
effects taking into account any cumulative and long term effects
on human health and the environment which may arise from the
deliberate release or placing on the market of that GMO(s). The
environmental risk assessment also requires evaluation in terms
of how the GMO was developed and examines the potential risks
associated with the new gene products produced by the GMO (for
example toxic or allergenic proteins), and the possibility of
gene-transfer (for example of antibiotic resistance genes).
The
methodology of the risk assessment is as follows:
·
Identification of any characteristics of the GMO(s) which may
cause adverse effects
·
Evaluation of the potential consequences of each adverse effect
·
Evaluation of the likelihood of the occurrence of each
identified potential adverse effect
·
Estimation of the risk posed by each identified characteristic
of the GMO(s)
·
Application of management strategies for risks from the
deliberate release or placing on the market of GMO(s)
·
Determination of the overall risk of the GMO(s).
What is
the procedure for approval of the release of GMOs into the
environment?
Under
Directive 2001/18/EC, a company intending to market a GMO must
first submit an application to the competent national authority
of the Member State where the product is to be first placed on
the market.
The
application must include a full environmental risk assessment.
If the national authority gives a favourable opinion on the
placing on the market of the GMO concerned, this Member State
informs the other Member States via the Commission.
If there
are no objections, the competent authority that carried out the
original evaluation grants the consent for the placing on the
market of the product. The product may then be placed on the
market throughout the European Union in conformity with any
conditions required in that consent.
If
objections are raised and maintained, a decision has to be taken
at EU level. The Commission first asks for the opinion of its
Scientific Committees composed of independent scientists, highly
qualified in the fields associated with medicine, nutrition,
toxicology, biology, chemistry, or other similar disciplines.
If the
scientific opinion is favourable, the Commission then proposes a
draft Decision to the Regulatory Committee composed of
representatives of Member States for opinion. If the Regulatory
Committee gives a favourable opinion, the Commission adopts the
Decision.
If not, the
draft Decision is submitted to the Council of Ministers for
adoption by qualified majority or rejection. If the Council does
not act within 3 months, the Commission can adopt the decision.
During the
notification process, the public is also informed and has access
to the publicly available data on the internet
http://gmoinfo.jrc.it
for example
the summary notification format, the assessment reports of the
competent authorities or the opinion of the Scientific
Committees.
For
experimental releases, notifications are examined and consent is
granted as appropriate by the authorities of the Member State in
which the release is to be conducted.
How many
GMOs have been approved for release into the environment?
Since
Directive 90/220/EEC entered into force in October 1991, the
commercial release of 18 GMOs has been authorised in the EU,
mostly by a Commission Decision following a qualified majority
vote in the Regulatory Committee.
Since
October 1998, no further authorisations were granted under
Directive 90/220/EEC although there were 13 applications pending
at the time of its repeal. Some Member States also
invoked Article 16, the so-called safeguard clause, of Directive
90/220/EEC to temporarily ban the placing on the market of
genetically modified maize and oilseed rape products in their
territories. There are currently nine outstanding Article 16
cases involving Austria, Luxembourg, France, Greece, Germany and
United Kingdom. These cases have been examined by the Scientific
Committee on Plants, which in all cases deemed that the
information submitted by Member States did not justify their
bans.
National
measures notified under Article 16 of Directive 90/220/EEC have
now to be dealt with under the safeguard clause provision of
Directive 2001/18/EEC (Article 23). The Commission has informed
Member States that they should now withdraw their measures under
Directive 90/220/EEC and lift the prohibitions, as new rules to
complete the legislative framework are in place and will be
applicable shortly.
Currently
the Commission has received twenty-two (22) notifications under
Directive 2001/18/EC. Seven (7) of these are products which were
pending under Directive 90/220/EC at the time of its repeal.
What are
the current rules on the marketing of GM foods?
Until the
new Food and Feed Regulation becomes applicable, authorisation
and labelling of novel foods including food products containing,
consisting or produced from GMOs is regulated by Regulation (EC)
258/97 on Novel Foods and Novel Food Ingredients.
The first
step of an authorisation procedure is an assessment of an
application to market a GM food product by the Member State
where the food is to be first placed on the market. In case of a
favourable opinion, this Member State informs the other Member
States via the Commission. If there are no objections against
the application, this Member State can authorise the product for
marketing in the entire EU.
If there
are objections by other Member States, a decision at EU level is
required. The Commission consults the European Food Safety
Authority (EFSA) on matters relating to health and in case of a
favourable assessment by EFSA submits a draft Decision
authorising the product for adoption by the Standing Committee
on the Food Chain and Animal Health composed of Member State
representatives.
As a
derogation from the full authorisation procedure, the Novel
Foods Regulation provides for a simplified procedure for foods
derived from GMOs but no longer containing GMOs which are
"substantially equivalent" to existing foods with respect to
composition, nutritional value, metabolism, intended use and the
level of undesirable substances. In such cases, the companies
only have to notify the Commission when placing a product on the
market together with either scientific justification that the
product is substantially equivalent or an opinion to the same
effect, delivered by the competent authorities of a Member
State.
The
procedure for authorisations and marketing of GM food under the
new Regulation is explained further on in this memo.
How many
GMOs have been approved for use in food products?
Products
from 16 GMOs can legally be marketed in the EU. These are
·
One GM soy and and one GM maize approved under Directive
90/220/EEC prior to the entering into force of the Novel Food
Regulation
·
Processed foods derived from inter alia 7 GM oilseed
rape, 4 GM maize and oil from 2 GM cottonseeds. These products
have all been notified as substantially equivalent in accordance
with the Novel Food Regulation.
Eight
applications for GM foods are currently pending at different
stages in the authorisation procedure, including products from
GM maize, sugar beat and soy bean.
What are
the current rules on genetically modified feed and which ones
have been authorised?
Until the
entry into force of the new Regulation on GM Food and Feed,
there has been no EU legislation governing the specific use of
material derived from GMOs in feed. Eight GMOs are authorised in
accordance with Directive 90/220/EEC for the purpose of use in
feed; these are four maize varieties, three rape varieties and
one soya variety.
What are
the current rules on genetically modified seeds?
EU
legislation on seeds, notably Directive 98/95/EC, specifies that
national authorities that have agreed to the use of a seed on
their territory must notify this acceptance to the Commission.
The Commission examines the information supplied by the Member
State concerned and its compliance with the provisions of EU
seeds legislation.
If such is
the case, the Commission includes the variety concerned in the
"Common Catalogue of varieties of Agricultural Plant Species"
which means the seed can be marketed throughout the EU. The seed
legislation furthermore requires that GMO seed varieties have to
be authorised in accordance with Directive 2001/18/EEC before
they are included in the Common Catalogue and marketed in the
EU. If the seed is intended for use in food, it also has to be
authorised in accordance with the Novel Foods Regulation.
Legislation
on the marketing of forestry reproductive material also requires
prior authorisation of GM material in line with the requirements
of Directive 2001/18. EU rules governing the marketing of vine
material in line with Directive 2001/18 have also been adopted.
Further
rules on growing conditions and other requirements for purity
concerning the presence of GM seeds in seed lots of traditional
varieties, as well as detailed labelling rules are to be
proposed shortly.
What are
the rules for Medicines, Protection of workers and Transport ?
Authorisation of medicinal products for human and veterinary use
(including such derived from genetically modified organisms) is
regulated under Regulation (EEC) 2309/93 laying down EU
procedures for the authorisation and supervision of medicinal
products for human and veterinary use.
Council
Directive 90/679/EEC on the protection of workers from the risks
related to exposure to biological agents at work also regulates
GMOs alongside other biological agents.
What are
the current rules on labelling?
The EU
recognises the consumers' right for information and labelling as
a tool to make an informed choice.
Since 1997
labelling to indicate the presence of GMOs as such or in a
product is mandatory. From 17 October 2002 onwards Directive
2001/18/EC foresees that Member States shall take all necessary
measures to ensure a labelling of GMOs in products at all stages
of the placing on the market.
The Novel
Foods Regulation provides for the mandatory labelling of foods
and food ingredients which contain or consist of a GMO without
prejudice to the other labelling requirements of EU law. The
labelling requirements for foods produced from GMOs, but no
longer containing GMO are based on the concept of equivalence(2).
Council
Regulation (EC) 1139/98 lays down provisions for the labelling
of foods and food ingredients derived from one maize and one
soya(3)
variety based on the presence of DNA or protein resulting from
genetic modification. This criterion serves as a model providing
the rules applicable to labelling of all foods and food
ingredients derived from GMO.
In January
2000, the Commission adopted Regulation (EC) 50/2000 ensuring
that also additives and flavourings have to be labelled if DNA
or protein of GMO origin is present in the final product.
Regulation
(EC) 49/2000 addresses the problem of adventitious presence of
GM material in conventional food. It introduces a 1% de
minimis threshold for the adventitious presence of DNA or
protein resulting from genetic modification below which
labelling is not required. Operators have to be in a position to
demonstrate that they have used appropriate steps to avoid the
presence of GM material.
New rules
on labelling will become applicable in April. They are set out
below.
Genetically
modified seed varieties must be labelled, in accordance with
Council Directive 98/95/EEC. The label has to show clearly that
it is a GM variety.
New
Regulations to apply in April 2004
In July
2003 the Council and the European Parliament adopted two new
Regulations:
·
a Regulation on GM food and feed (Regulation 1829/2003)
·
a Regulation on traceability and labelling of GMOs and the
traceability of food and feed products produced from GMOs
(Regulation 1830/2003)
The new
Regulations were published in the Official Journal in the autumn
2003 and will apply on 18 April 2004.
The new
Regulations will set up a harmonised EU system to trace GMOs,
introduce the labelling of GM feed, reinforce the current
labelling rules on GM food and establish a streamlined
authorisation procedure for GMOs in food and feed and their
deliberate release into the environment. They aim to put into
place a stringent regulatory framework, close existing legal
gaps and address the legitimate concerns of citizens, consumer
organisations and economic operators.
A strict
safety assessment of GMOs will continue to assure a high level
of health and environmental protection. The labelling of all GM
food and feed products will allow consumers and farmers to
decide if they want to buy food or feed produced from a GMO, or
not.
Why did
the Commission propose specific rules on traceability of GMOs?
Traceability provides the means to trace products containing or
produced from GMOs through the production and distribution
chains. The general objectives are to facilitate:
·
control and verification of labelling claims
·
targeted monitoring of potential effects on the environment,
where appropriate.
·
withdrawal of products that contain or consist of GMOs should an
unforeseen risk to human health or the environment be
established;
Directive
2001/18 includes general provisions on which a traceability
system for GMOs could be based but neither contains a definition
of traceability for GMOs,or includes the objectives of
traceability or a complete approach for its implementation.
Differences
and overlap between national laws, regulations and
administrative provisions concerning traceability of GMOs and
food and feed products produced from GMOs may hinder the free
movement of products and create conditions of unfair
competition. Therefore, a EU Regulation based on the
requirements of Directive 2001/18/EC and laying down a
harmonised framework for traceability of such products was
foreseen to provide legal certainty and a coherent approach, and
thus contribute to the effective functioning of the internal
market.
Does
traceability apply to GMOs and GM products only, or also to
other food products?
Traceability for certain products has existed for many years.
The new regulation sets specific traceability requirements for
GM products. Traceability specifically for GMOs was introduced
in general terms into EU legislation with Directive 2001/18/EC
which requires that Member States ensure traceability at all
stages of the placing on the market for GMOs. General
traceability provisions have already been laid down in EU
legislation concerning food, feed and seed.
What are
the new rules on traceability of GMOs?
Under the
rules of the new Regulation on traceability, business operators
must transmit and retain information about products that contain
or are produced from GMOs at each stage of the placing on the
market.
In
particular, the requirements are that:
·
operators shall have systems and procedures in place to identify
to whom and from whom products are made available;
·
for GMOs intended for deliberate release into the
environment, operators must transmit specified information
on the identity of the individual GMO(s) a product contains;
·
for GMOs intended for food, feed or for processing,
business operators may either transmit the specified information
mentioned above or transmit a declaration that the product shall
only be used as food or feed or for processing, together with
the identity of the GMO(s) that 'have been used' to constitute
the original mixture from which the product arose;
·
for food and feed produced from GMO(s) operators shall
inform the next operator in the chain that the product is
produced from GMO(s);
·
operators shall retain the information for a period of 5 years
and make it available to competent authorities on demand.
Transmission and keeping records of this information will reduce
the need for sampling and testing of products.
How does
traceability work in practice?
Traceability can be defined as the ability to trace products
through the production and distribution line. For example, where
production starts with a genetically modified seed, the company
selling the seed would have to inform any purchaser that it is
genetically modified, together with more specified information
allowing the specific GMO to be precisely identified. The
company is also obliged to keep a register of business operators
who have bought the seed.
Equally the
farmer would have to inform any purchaser of the harvest that it
is genetically modified and keep a register of operators to whom
he has made the harvest available.
The new
Regulation covers all GMOs that have received EU authorisation
for the placing on the market, that is all products, including
food and feed, containing or consisting of GMOs. Examples are
seeds, which have been genetically modified and bulk quantities
or shipments of whole GM grain eg. soybean and maize.
The new
Regulation also covers food and feed that are derived from a
GMO. This includes tomato paste and ketchup produced from a GM
tomato or starch, oil or flour produced from a GM maize.
What are
the cost implications for operators of the traceability
Regulation?
It is
difficult to estimate the exact costs of introducing
traceability specifically for GMOs and products derived from
GMOs.
Information
with respect to the supplier, customer, price and transaction
date as well as the nature, source, contents and amount of the
product already accompanies the majority of transactions.
This
information has also to be retained by operators under national
administrative systems, for example for filling in VAT returns.
Transmission and retention of the information specified in the
new Regulation could largely be incorporated into existing
systems for transactions and as such, should not imply
significant extra costs for operators.
What are
the new labelling rules and what is the difference with the
existing rules?
The new
Regulation extends the current labelling provisions to all
genetically modified food or feed, irrespective of the
detectability of genetically modified DNA or protein. All food
and feed which consist of, contain or are produced from GMOs
would have to be labelled as such. The purpose is to inform
consumers and farmers about the exact nature and characteristics
of the food or feed, so that they can make informed choices.
The current
GM labelling system is based on the detectability of genetically
modified DNA or protein in the final food product. In practice
this means that highly processed foodstuffs produced from GM
material, such as highly refined oils, do not need to be
labelled. The new labelling rules extend the labelling
requirements to all food and ingredients produced from GMOs to
allow consumers to exercise their freedom of choice.
Genetically
modified feed will need to be labelled along the same principles
to give livestock farmers accurate information on the
composition and properties of feed. This will mean that a large
number of feedstuffs currently not subject to GM labelling
requirements, such as GM soy meal in feed or compound feedstuffs
and the four genetically modified feed plants authorised under
Directive 90/220/EEC will in future need to be labelled.
Will the
meat or milk of an animal fed with GM feed also be labelled as
GM?
In line
with the general EU rules on labelling, the Regulation does not
require labelling of products that are not food ingredients such
as processing aids.
It does not
require labelling of products such as meat, milk or eggs
obtained from animals fed with genetically modified feed or
treated with genetically modified medicinal products.
How will
GM food and feed in future be authorised?
Clear rules
are already set out in the EU for the assessment and
authorisation of GMOs and GM-food, but the responsibilities are
currently divided between the Member States and the EU. The
Regulation replaces this with a "one door one key" procedure for
the scientific assessment and authorisation of GMOs and GM food
and feed.
It puts in
place a streamlined, uniform and transparent EU procedure for
all marketing applications, whether they concern the GMO itself
or the food and feed products derived thereof.
This means
that business operators need not request separate authorisations
for use of the GMO, and for its use in feed or in food, but that
a single risk assessment and a single authorisation are given
for a GMO and its possible uses. The Regulation also ensures
that experiences such as with Starlink maize in the US are
avoided because GMOs likely to be used as food and feed can only
be authorised for both uses, or not at all.
The
European Food Safety Authority will be responsible for the
scientific risk assessment 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. Authorisations will 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 abandoned.
Why do
the new Regulations allow the presence of traces of GM material
which have received a favourable scientific assessment, but
which are not yet formally approved?
The
adventitious or unintended presence of GM material in products
placed on the market in the European Union is largely
unavoidable and can occur during cultivation, handling, storage
and transport. This situation already exists and affects
products originating both in the EU and third countries.
This is not
a problem which is not unique to GMOs. In the production of
food, feed and seed, it is practically impossible to achieve
products that are 100% pure.
The
Regulation acknowledges this fact and defines the specific
conditions under which a technically unavoidable presence of
GMOs not yet formally authorised could be permitted.
A number of
GMOs have already been assessed by the Scientific Committees
advising the European Commission as not posing a danger to
environment and health, but their final approval is still
pending. The Regulations allow the presence of these GMOs in a
food or feed up to a maximum of 0.5% below which labelling and
traceability will not be enforced.
This is on
the basis that the presence of such material is adventitious or
technically unavoidable and has been subject to a scientific
risk assessment by the relevant Scientific Committees or
European Food Authority, which has concluded that the material
does not present a risk for human health and the environment.
The Regulation limits the application of this threshold to three
years and provides that a detection method must be publicly
available.
This
exemption aims to solve the problem faced by operators who have
tried to avoid GMOs, but find that their products contain a low
percentage of GM material due to accidental or technically
unavoidable contamination. Current legislation on GM foods
already sets a threshold of 1% for the labelling of approved GM
material.
What do
we mean by co-existence?
Co-existence refers to the ability of the farmer to make a
practical choice between conventional, organic and GM-crop
production in compliance with the legal obligations for
labelling and purity. As such, co-existence is essentially an
economic issue. What is at stake are the economic consequences
that conventional and/or organic farmers could incur if they
have to sell their crops at a lower price because of
adventitious presence of GMOs above the authorised threshold
level and that result from measures to avoid such presence. Only
authorised GMOs can be cultivated in the EU, the environment and
health aspects are covered by Directive 2001/18/EC.
At its
meeting of 5 March 2003 the Commission decided that it should be
left to the Member States to develop national approaches and
strategies for co-existence. The position of the European
Parliament confirmed this orientation on 2 July 2003 when it
adopted the Regulation on GM food and feed. This regulation
amends Directive 2001/18/EC and inserts a new article which
stipulates that "Member States may take appropriate measures to
avoid the unintended presence of GMOs in other products"
(Article 26a) and invites the Commission to elaborate
guidelines.
The
Commission Recommendation on guidelines for the development of
national strategies and best practices to ensure the
co-existence of genetically modified crops with conventional and
organic farming was adopted on 23 July 2003.
What is
the content of the guidelines?
The
guidelines state that approaches to co-existence need to be
developed in a transparent way, based on scientific evidence and
in co-operation with all stakeholders concerned. The guidelines
are based on experiences with existing segregation practices
(e.g. in certified seed production); at the same time they
ensure an equitable balance between the interests of farmers of
all production types.
Further,
they state that management measures to ensure co-existence
should be efficient and cost-effective, without going beyond
what is necessary to comply with EU threshold levels for GMO
labelling. They should be specific to different types of crop,
since the probability of admixture varies greatly from one crop
to another; while for some crops the probability is high (e.g.
oil seed rape) for others the probability is fairly low (e.g.
potatoes). In addition, local and regional aspects should be
fully taken into account.
Farmers
should be able to choose the production type they prefer,
without imposing the necessity to change already-established
patterns in the neighbourhood. As a general principle, during
the phase of introduction of a new production type in a region,
farmers who introduce the new production type should bare the
responsibility of implementing the actions necessary to limit
admixture.
Continuous
monitoring and evaluation and the timely sharing of best
practices are indicated as imperatives for improving measures
over time.
Priority
should be given to farm-level management measures and to
measures aimed at co-ordination between neighbouring farms. If
it can be demonstrated that these measures can not ensure
co-existence, regional measures could be considered (e.g.
restriction on the cultivation of a certain type of GMO in a
region).
Such
measures should apply only to specific crops whose cultivation
would be incompatible with ensuring co-existence in the region,
and their geographical scale should be limited as possible.
Region-wide measures should be justified for each crop and type
(e.g. seed and crop production separately).
Are the
new labelling rules in line with the international trade rules?
The new
Regulations take account of the EU's international trade
commitments and of the requirements of the Cartagena Protocol on
Biosafety with respect to obligations of importers.
How is
the issue of exchange of GMOs regulated with Countries outside
of the EU?
The UNEP
Cartagena Protocol on Biosafety to the Convention on Biological
Diversity was adopted on 29 January 2000. The overall purpose of
this United Nations agreement is to establish common rules to be
followed in transboundary movements of GMOs in order to ensure,
on a global scale, the protection of biodiversity and of human
health.
The
European Union ratified the Cartagena Protocol on Biosafety on
27 August 2002 In order to fulfil its international obligations;
the EU must transpose the provisions of the Biosafety Protocol
into its own legal order.
The
implementation of the Cartagena Protocol on Biosafety into EU
legislation relies on a wide range of biotechnology legislation
applying to the use of GMOs within the European Union, including
imports. The centre part of this legal framework is the
Directive 2001/18/EC on the deliberate release into the
environment of genetically modified organisms.
·
Regarding exports from the European Union of GMOs, the Biosafety
Protocol "Advanced Informed Agreement" is implemented through
the Regulation on the transboundary movements of GMOs, which was
adopted on 13 June 2003. The main elements of the Regulation
are: The obligation to notify exports of GMOs intended for
deliberate release into the environment and secure express
consent prior to a first transboundary movement;
·
The obligation to provide information to the public and to our
international partners on EU practices, legislation and
decisions on GMOs, as well as on accidental releases of GMOs;
·
A set of rules for the export of GMOs intended to be used as
food, feed or for processing;
·
Provisions for identifying GMOs for export.
The current
Regulation does not foresee new specific EU provisions for
imports or for movements of GMOs between Member States. These
operations will continue to be covered by existing EU
legislation.
The final
adoption of the Regulation on the transboundary movements of
GMOs, on 13 June 2003, completes the EU legal framework
necessary to the full implementation of the Cartagena Protocol
on Biosafety, in time for its entry into force.
The
required number of 50 instruments of ratification was reached on
13 June 2003. In accordance with the provisions of its Article
37, the Protocol entered into force on 11 September 2003.
(1) OJ L 106,
17.4.2001
(2)This means that
if a characteristic or property (composition, nutritional value
or nutritional effects, intended use) renders a food or food
ingredient no longer equivalent to an existing counterpart, it
has to be labelled indicating the method (i.e. genetic
modification) by which the characteristic or property was
obtained.
(3)These varieties
were approved before the entering into force of the Novel Foods
Regulation under Directive 90/220/EEC
on the deliberate release into the environment of genetically
modified organisms
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