European
Union

Facts On GMOs In The EU

Table of contents

1. What are GMOs and GMMs?

2. What is the current legislation in the EU on GMOs and which GMOs are approved?

3. What is the exact nature of the scientific advice underpinning GMOs in the EU ?

4. What are the rules on labelling?

5. Rules on liability for GMOs

6. In what international context are GMOs discussed?

7. What are the plans for the future?

Annex 1 : GMO Products - Approved under directive 90/220/EEC as of May 2000

Annex 2: GMO Products - Pending approval under directive 90/220/EEC as of May 2000

Annex 3: Notifications Pursuant to Article 5 of Regulation (EC) N° 258/97 of the European Parliament and of the Council

1. What are GMOs and GMMs?

Genetically modified organisms (GMOs) and 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 use of "recombinant DNA technology" or "genetic engineering" allows selected individual genes to be transferred from one organism into another, sometimes between non-related species.

2. What is the current legislation in the EU on GMOs and which GMOs are approved?

Community biotechnology legislation 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 instrument for giving consent to experimental releases and for placing on the market of genetically modified organisms (GMOs) in the Community is Directive 90/220/EEC on the deliberate release of genetically modified organisms which is currently under revision. This horizontal Directive complements specialised vertical sectoral legislation for example, the Regulation on novel foods and novel food ingredients.

2.1 GENERAL LEGISLATION

2.1.1 Micro-organisms

Directive 90/219/EEC on the contained use of genetically modified micro-organisms (GMM) regulates the contained use of genetically modified micro-organisms for research and industrial purposes.

2.1.2 Release in the environment

Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms regulates deliberate releases for research and development and the placing of the market of products intended for subsequent deliberate release. It requires environmental evaluation and step-by-step approval for the dissemination of GMOs. A case by case assessment of the risks to human health, animal health and the environment is carried out prior to a release and placing on the market (see below). The scope of Directive 90/220/EEC includes the placing on the market of GMOs and products consisting of or containing a GMO such as GM tomatoes, but does not extend to products derived from GMOs, such as paste or ketchup from a GMO tomato.

Following the first reading and the “political agreement” of the Environment Council on 25 June 1999, Common Position (EC) No 12/2000 on the revised text of Directive 90/220/EEC was adopted on 9 December 1999.

The revised Directive:

• seeks to increase the efficiency and the transparency of the decision-making process whilst ensuring a high level of protection for human health and the environment
• clarifies a number of operational aspects including the scope, definitions and administrative procedures
• promotes a harmonisation of the risk assessment
• introduces mandatory consultation of the Scientific Committees and time-limited authorisations
• improves transparency of the decision-making through consultation and reporting on ethical issues and the involvement of the public in the authorisation process
• improves the control of genetically modified organisms released into the environment by requiring Member States to take measures to ensure labelling and traceability at all stages of the placing on the market and by reinforcing plans for monitoring of approved organisms.

On 12 April 2000, the European Parliament adopted 29 amendments at its Second Reading on the Council Common Position on a revised Directive 90/220/EEC.

The final shape of the Directive will therefore be determined in conciliation between the European Parliament and the Council which is scheduled to start on 19 September this year.

How is the authorisation and risk assessment done?

a) Authorisation procedure

Under Directive 90/220/EEC, a manufacturer or importer must submit a notification to the national competent authority of a Member State where the product is to be first placed on the market, before undertaking a deliberate release into the environment of a GMO, or placing it on the market.

The notification should contain a technical dossier of information including a full risk assessment. The Member State that received the notification examines the dossier and in the case of a negative evaluation the notification is rejected.

In the case of a favourable opinion, the dossier is forwarded to the European Commission and all the competent authorities of the other Member States who have the right to raise objections. 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, which may then be placed on the market throughout the European Union.

In case of objections, a decision has to be taken at Community level. The Commission seeks the opinion of its Scientific Committees before drafting a Decision which is put forward to the Regulatory Committee composed of representatives of Member States for favourable opinion. Otherwise a proposal is put forward to the Council, which decides by qualified majority. If no Council decision is taken within 3 months the Commission takes the decision. In any case, in accordance with Directive 90/220/EEC, the Commission is ultimately obliged to adopt measures to authorise a GMO, if the application fulfils current EU legislation and if it is not rejected by unanimity in the Council, or if the Council fails to act within the fixed deadline.

b) Risk assessment procedure

GMOs have to undergo a scientific assessment of risks to human health and the environment before receiving Community authorisation. Risk assessments are performed on a case by case basis.

The safety assessment takes into account of the following:

• How the GM was developed – including the source of the genes to be introduced and detailed molecular analysis of the modified plant and organism. The process can be likened to that of ‘cutting’ and ‘pasting’ where pieces of DNA are cut out of the donor organism and pasted into a recipient organism. It is necessary to establish which genes are incorporated and where in the recipient genome.
• Risk associated with the gene products in the plant, mainly proteins. It is necessary to know that the gene does not encode for a protein that is toxic to humans or does not produce an allergic response. It must also be established that the inserted gene(s) does not result in unexpected effects.
• Investigation of the possibility that the inserted gene may be transferred to bacteria. This has particular relevance to the possible transfer of antibiotic resistance genes.

Approved and pending applications under 90/220/EEC

Since the entry into effect of Directive 90/220/EEC in October 1991, 18 authorisations have been approved for the commercial release of GMOs (Annex 1) in the EU. The majority of these consents have been granted following a qualified majority vote in the Regulatory Committee composed of Member States. However, no consents have been granted since October 1998 and there are currently 14 applications pending approval at various stages in the procedure, either still being evaluated by the respective scientific committee or discussed in the Regulatory Committee (Annex 2).

Some Member States have invoked Article 16 ‘safety 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 eight ongoing Article 16 cases involving Austria, Luxembourg, France, Greece and Germany. Six of these cases have been transmitted to the Scientific Committee on Plants for opinion. In all cases, the Committee deemed that the information submitted by Member States did not justify their bans.

2.2 SPECIFIC LEGISLATION

2.2.1 Novel Foods

Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients sets out rules for authorisation and labelling of GMO derived food products and other novel foods.

The authorisation procedures for GMOs are slightly different from the procedure under Directive 90/220/EEC, but the basic rule is similar: In general, the authorisation of GMOs is a one-step process if all Member States agree to the initial assessment of a Member State, and a two-step process if one or more Member States object.

The first step is an assessment by the Member State where the food is to be placed on the market first. 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, the first Member State can authorise for the whole Community and the product can circulate freely in the Single Market. This procedure can be completed within several months only.

If there are objections by Member States, the second step has to be taken, which means a Commission Decision, following consultation of the Scientific Committees on matters relating to public and the Comitology procedure. Once at Community level, the time frame for authorisation is necessarily extended.

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 product can then be marketed in the entire EU.

Approved and pending applications

Under Directive 90/220/EEC two genetically modified food plants have been authorised to be on the European market for the use in food, a variety of soy and a variety of maize prior to the entering into force of the Novel Foods Regulation. Under the Novel Foods Regulation (EC) N° 258/97 no products consisting of or containing live GMOs have so far been authorised but nine applications are pending at different stages in the procedure.

11 products have been notified to the Commission as being substantially equivalent (Annex 3). The list of notifications is published in the Official Journal of the EU once a year.

2.2.2 Feed legislation

For the moment there is no specific Community legislation on GM derived feed. However, eight GMOs are authorised in accordance with Directive 90/220/EEC for the purpose of use in feed; they are four maize varieties, three rape varieties and one soya variety.

2.2.3 Seeds legislation

The seed legislation (amongst other Directives 98/95/EC) specifies that following the notification of acceptance in a national catalogue, the Commission on the basis of the information supplied by the respective Member States, examines whether acceptance is in accordance with the provisions of the seed legislation and if confirmed, publishes the varieties in the Official Journal of the European Communities under the title "Common Catalogue of varieties of Agricultural Plant Species". This publication is an autonomous act of the Commission.

Furthermore, the legislation requires that GMO seed varieties have to be authorised in accordance with Directive 90/220/EEC before commercialisation (inclusion in the Common Catalogue) in the EU. If intended for food, it also has to be authorised in accordance with the Novel Foods Regulation. At a later stage, it is foreseen that the authorisation can be carried out under the seed legislation. The White Paper on Food Safety provides that such a Proposal be presented by June 2001.

So far only two GMO seed varieties have been included in the Common Catalogue for seed varieties which can be marketed in the EU. They had received prior authorisation through the Directive 90/220/EEC. Three new GMO varieties are pending for inclusion in the common catalogue of seeds which have been already approved under 90/220/EEC. Member States have the possibility of requesting through the Standing Committee for Seeds an authorisation to prohibit a variety. A notification has to be put forward to the Commission which will then trigger the same evaluation and decision procedure as under Directive 90/220/EEC.

The Commission has proposed similar amendments to the regimes governing vine material which are in line with Directive 90/220/EEC. One on forestry reproductive material is already adopted.

2.2.4 Medicines, Protection of workers & 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 Community 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.

Several pieces of legislation regulate transport of GMOs, in particular the Council Directives on the approximation of laws of Member States with regard to transport of dangerous goods carried by road, rail and inland seaways, the Council Directives on the appointment and vocational qualification of safety advisers for the transport of dangerous goods in the same sectors, as well as a Council Directive on uniform procedures for checks on the transport of dangerous goods by road.

3. What is the exact nature of the scientific advice underpinning GMOs in the EU ?

Like all organisms, GMOs are neither inherently risky or safe. Their degree of riskiness or safety depends on the characteristics of the inserted gene(s), the final organism that is produced and the application to which it is put. There is no scientific evidence that the use of the technology is itself inherently unsafe.

In Europe, the use of the technology in all organisms is strictly regulated, at all stages from research to production; in contained use and in deliberate release to the environment, or placing on the market. The safety record world-wide over some 30 years has been very good with no recorded accident or unanticipated event. Genetic engineering is now routinely used in many thousands of research laboratories world-wide and has resulted in many novel products and processes such as industrial enzymes and medicines such as insulin and vaccines. Its application in agriculture and the food industry in Europe has been much slower because of public concerns.

EC research into the safety of GM crops and GM foods was initiated in 1986 and has not shown any safety concerns for human health or the environment for the materials studied. However, there are some widely publicised reports that have suggested that there might be some harmful effects of specific GMOs on animals. These studies have been contested and the consensus view recently published by the OECD is that safety assessment of possible risks presented by GMO foods does not pose problems different in nature from those associated with conventional foods.

3.1 SCIENTIFIC ADVICE

Scientific advice on the safety of GMOs is provided to the competent authorities in each of the Member States. At the Community level, applications for the use of GMOs are thoroughly scrutinised by the independent scientists who advise the European Commission in its policy making task. The scientific committees work on the basis of the principles of excellence, independence and transparency. All developments in international fora are closely followed so that the best available science is taken into account.

The basis for safety assessment is the scientific principles developed through international consultation in agencies, such as, the World Health Organisation (WHO), and the Food and Agriculture Organisation (FAO) and the Organisation for Economic Co-operation and Development (OECD). The safety assessment takes into account how the GM plant was developed and examines the risk associated with the gene products in the plant, mainly proteins, including the possible transfer of antibiotic resistance genes. The concept of substantial equivalence (see above) allows for comparison of the novel food that is being assessed with one that has a long history of safety. Parameters compared include levels of sugars, proteins, minerals and possible toxins.

The Scientific Committees are also involved in updating Community guidance documents which underpin Community legislation.

The Scientific Committee on Plants (SCP) has issued opinions on 14 GM plants in the context of Directive 90/220/EEC on the deliberate release of genetically modified organisms. The opinions cover the requirements of Directive 90/220/EEC (impact on the environment and on the safety of the products if consumed on an occasional basis) and in the absence of Community legislation on novel feedstuffs also cover the risk when used as an animal feedingstuff. In one case an unfavourable opinion has been given due to the presence of a number of uncharacterised genes and particularly the gene which confers resistance to amikacin, a clinically important antibiotic. Therefore, this product was not allowed onto the market.

The Scientific Committee on Food is responsible for opinions relating to Novel Foods. This Committee has issue one favourable opinion on food of plant origin (processed tomato) and 4 on products of microbial origin.

Scientific Opinions on Genetically Modified Plants

The Scientific Committee on Plants

1. Bt - Resistance monitoring (4 March 1999)

2. Chicory derived from genetically modified male sterile, Glufosinate tolerant parental lines (18 December 1998)

3. Placing on the market of genetically modified high amylopectin potato cultivars apriori and apropos (2 October 1998)

4. Placing on the market under directive 90/220/EEC of genetically modified processing tomato line (23 June 1998)

5. Genetically modified cotton line, insect-tolerant (14 July 1998)

6. Genetically modified cotton, tolerant to glyphosate herbicide (14 July 1998)

7. Placing on the market of fodder beet tolerant to glyphosate (23 June 1998)

8. Placing on the market of Glufosinate tolerant swede rape transformation event (14 July 1998)

9. Glufosinate tolerant, hybrid rape derived from genetically modified parental lines (19 May 1998)

10. Placing on the market of genetically modified, insect-resistant maize lines (19 May 1998)

11. Genetically Modified Maize Lines

12. Placing on the Market of Glufosinate Tolerant Corns

13. Genetically Modified Glufosinate-Tolerant Rape

14. Genetically Modified, Insect Resistant Maize Lines. (full texts available at http://europa.eu.int/comm/food/fs/sc/scp/index_en.html)

Scientific Committee for Food

1. Opinion on a request for consent to place on the market a tomato fruit genetically modified to down-regulate the production of polygalacturonase (PG), & solely intended for processing (23/09/99)

2. Opinion concerning the scientific basis for determining whether food products, derived from genetically modified soya and from genetically modified maize, could be included in a list of food products which do not require labelling because they do not contain (detectable) traces of DNA or protein (17 June 1999)

Full texts of these opinions are available at http://europa.eu.int/comm/food/fs/sc/scf/index_en.html

3.2 COMMUNITY FUNDED SCIENTIFIC RESEARCH

The Commission is actively involved in funding research under the 5th Framework Program that addresses remaining uncertainties and gaps in knowledge with respect to safety. In particular, the specific programme on “Quality of Life and Management of Living Resources (€ 2.4 billion, 1999-2002) includes in its Key Action on “Food, Nutrition and Health” research projects addressing various aspects of food safety and the detection and tracing of GMOs (more information: http://europa.eu.int/comm/research/quality-of-life-html).

The Joint Research Centre (JRC), has been active in the validation of analytical methods for the detection and quantification of GMOs in raw materials and in processed food and has been asked by Member States to co-ordinate a network of national enforcement laboratories, relating to detection of GMOs. The JRC has also developed and produced GMO based certified reference materials, which are an essential contribution for the establishment of appropriate protocols for GMO detection.

Complementing these activities is the JRC database on "Deliberate Release" of GMOs into the environment for experimental small scale field trials (1600 dossiers) and the ongoing development of a register of molecular data of authorised GMOs. The JRC is also carrying out a number of relevant studies including a study on "Quantitative Environmental Risk Assessment".

The Commission also promotes research on tools for assessing the potential impact of GMOs on the environment and in particular, on biodiversity.

4. What are the rules on labelling?

In general, the EU is in favour of labelling and is in the process of the developing a comprehensive labelling framework. Currently the following rules apply:

4.1 Environment

For GM plants authorised since the implementation of the second amendment of 90/220/EEC labelling indicating the presence of GMOs is mandatory. Genetically modified plant material authorised before 1997 under Directive 90/220/EEC (one soya, one maize and two rapeseed) is not subject to labelling requirements. The revised Directive 90/220/EEC provides for more stringent labelling provisions, requiring labelling at all stages of the placing on the market of GMOs

4.2 Food

The Novel Foods Regulation specifies that GMO food products which consist of or contain GMOs must be labelled as such. Furthermore, in Regulation (EC) N° 1139/98 that currently serves as a model for labelling in the EU, the presence of DNA or protein resulting from genetic modification is used as the criterion triggering labelling of food or food ingredients derived from GMOs. Earlier this year these labelling provisions were amended by Commission Regulation 49/2000 to provide a 1-%-labelling threshold for "adventitious" or accidental presence of material of GMO origin (during cultivation, harvest, transport or processing). Products containing less than 1% of GM material do not have to be labelled. In addition, Commission Regulation 50/2000 lays down specific labelling requirements for foodstuffs and food ingredients containing additives and flavourings derived from GMOs.

4.3 Seed

Genetically modified seed varieties must be labelled, in accordance with Council Directive 98/95/EEC. The label has to show clearly that is a GM variety.

4.4 Feed

Currently, there is no specific Community legislation on the labelling of GMO feed. The general labelling rules under Directive 90/220/EEC apply.

5. Rules on liability for GMOs

The question on liability in terms of damage to health or property is already addressed under Directive 85/374/EEC, as modified by Directive 99/34/EC, which concerns liability for defective products. This directive imposes strict liability on the producer (or importer) of a defective product, and joint liability in cases where more than one person is liable for the same damage. The Directive does not extend to cover environmental damage and does not address the issue of insurance.

The Commission intends to submit a proposal on general environmental liability rules as a follow-up to the White Paper on Environmental Liability before the end of 2001, as requested by the European Parliament. This will deal specifically with damage caused to the environment by GMOs. Today, national liability regimes apply.

6. In what international context are GMOs discussed?

6.1. Biosafety Protocol

The UN Biosafety Protocol, also known as the Cartagena Protocol, integrates environmental, trade and development aspects of GMOs. The Protocol was adopted in Montreal in January this year.

The Cartagena Protocol is based on the Precautionary Principle and aims to ensure the safe transfer, handling and use of living modified organisms (LMOs) that may have an adverse effect on biodiversity. It focuses on transboundary movements of LMOs, and takes into account risks to human health. It establishes an Advance Informed Agreement (AIA) procedure for imports of LMOs intended for introduction into the environment, and an alternative procedure for mass movements of LMOs intended for food, feed and for processing (commodities). It sets out a detailed basis for decision making on imports, incorporating the precautionary principle and includes specifies documentation requirements for the movement of all LMOs. The Protocol also contains provisions on confidential information, information-sharing, capacity-building and financial resources, with a special view to the situation of developing countries. These most often lack adequate domestic regulatory systems. In Montreal it was established that the Protocol and the WTO agreements are mutually supportive.

The European Community confirmed its commitment to the Protocol by signing it in Nairobi in May this year during the fifth Conference of the Parties of the Convention on Biological Diversity (CBD) together with 67 parties to the CBD.

6.2 G8/OECD

In June 1999, the G8 requested OECD to carry out an analysis on Food Safety and Biotechnology and report back to the G8 before the summer 2000. The work began in September 1999 and the OECD identified the following three working groups to prepare the analysis:

• Ad hoc group on Food Safety

The ad hoc group consisted of high level representatives from OECD Member States and the Commission. The main tasks were to supervise the work on a compendium of international food safety systems and activities and a compendium on current and planned food safety systems and activities in OECD Member States.

• Task Force for the Safety of Novel Foods and Feeds

The task force primarily dealt with the safety aspects of Novel Foods, including current approaches and experiences in Food Safety assessment of Novel Foods.

• The Working Group for the Harmonisation of Regulatory Oversight in Biotechnology

This working group dealt with inter alia environmental applications of biotechnology, current approaches and experiences in environmental safety assessment, monitoring and interaction between food safety and environmental safety.

The reports of the three working groups can be found on the web-side of OECD. G8 is expected to address the OECD work on food safety and biotechnology during the Okinawa Summit on 21-23 July 2000.

6.3. Codex Alimentarius

Codex has established a Task Force on Foods Derived from Biotechnology with the objective to develop standards, guidelines or recommendations for GMO foods. Japan hosts the task force which met for the first time in March 2000. It is envisaged that the work will take three years and that the full report will be finalised in 2003.

The Codex Committee on Food Labelling is currently working on a standard for the labelling of GMO food.

7. What are the plans for the future?

• Directive 90/220/EEC is currently under revision (see above)

A series of measures relevant to GMO's in sector legislation have been announced in the Commission's White Paper on Food safety. They include:

• proposal for a Regulation on the labelling of GM free foodstuffs (Autumn 2000)
• a proposal for a regulation harmonising and completing the labelling rules concerning food containing or derived from genetically modified organisms (Autumn 2000)
• a Regulation clarifying the authorisation procedure for novel foods (Autumn 2000)
• a Regulation on novel feed (Autumn 2000)
• a Commission Directive detailing the labelling requirements for seeds of GM plant varieties and other requirements for purity concerning the presence of GM seeds in seeds of traditional plant varieties (Autumn 2000)
• a proposal for a Regulation specifying the conditions for the environmental risk assessment for GM plant varieties (March 2001 )

Pia Ahrenkilde : 02/299.12.23

Beate Gminder : 02/296.56.94

Andrea Dahmen : 02/296.04.86

Catherine Bunyan : 02/299.65.12

Lone Mikkelsen : 02/296.05.67

Annex 1

GMO PRODUCTS – APPROVED UNDER DIRECTIVE 90/220/EEC as of May 2000

1 where objections were raised by Member State authorities

2 in the absence of objections by Member State authorities

3 linked to item 1 (same product, further uses)

4 linked to item 5 (same product, further uses)

5 this product is the result of a different transformation event to that of No. 9

Annex 2

GMO PRODUCTS - PENDING APPROVAL UNDER DIRECTIVE 90/220/EEC as of May 2000

6 This is the same product as No. 7 on the list of approved GMOs, which was restricted to breeding activities.

7 This is the same product as No. 16 on the list of approved GMOs, which was restricted to import and processing

8 This product is obtained from conventionally derived crosses between Nos. 14 and 15 on the list of approved GMOs

9 This is the same as product 13 on the list, but for restricted use (not cultivation)

Annex 3

Notifications Pursuant to Article 5 of Regulation (EC) N° 258/97 of the European Parliament and of the Council

i* ACNFP Advisory Committee on Novel Foods and Processes (UK)

s ** BgVV Bundesamt für gesundheitlichen Verbraucherschutz und Veterinärmedizin (D)