Question and Answers on the regulation of GMOs in the EU

Brussels, 9 October 2003

This questions and answers fact sheet is divided into two sections; Part A covers legislation in force; Part B covers the new Regulations on tracability and labelling, which will shortly enter into force.

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.

Part A: legislation in force

What is the current legislation in the EU on GMOs?

Community 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been authorised in the Community was, up until 17 October 2002, Directive 90/220/EEC On this date, the Directive was repealed by the new, updated Directive 2001/18/EC of the European Parliament and Council on the deliberate release of genetically modified organisms.

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 paste or ketchup from a GMO tomato are not covered by this horizontal Directive but by vertical, sectoral legislation, for example the Regulation on Novel Foods and Novel Food Ingredients of January 1997(Regulation (EC) 258/97).

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.

What has changed under the new Directive for the deliberate release of GMOs?

The revised Directive 2001/18/EC strengthens the existing 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 from 17 October 2002 onwards?

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)

The Scientific Committee on Plants (SCP) issued opinions on applications for the placing on the market of 17 GM plant varieties under Directive 90/220/EEC . In one application, an unfavourable opinion was given due to an insufficient risk assessment in terms of the presence of a number of uncharacterised genes within the GM plant variety, in particular the gene which confers resistance to amikacin, a clinically important antibiotic. This application was withdrawn.

The Scientific Committee on Food is responsible for opinions relating to Novel Foods. This Committee has issued 3 favourable opinions on food of plant origin (tomato and maize) and 4 on products of microbial origin.

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 Community 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. In two cases the Commission Decision has not yet been implemented by the Member State (see Annex 1).

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.

Currently the Commission has received twenty-two (22) notifications under Directive 2001/18/EC . These are listed in Annex 2. 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?

Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients sets out rules for authorisation and labelling of novel foods including food products containing, consisting or produced from GMOs.

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 Community 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.

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 (see Annex 4). 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. (see Annex 3).

What are the current rules on genetically modified feed and which ones have been authorised?

There is currently no Community 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. (See Annex 1).

What are the current rules on genetically modified seeds?

Community 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 Community 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 90/220/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 90/220 . Community rules governing the marketing of vine material in line with Directive 90/220/EEC 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.

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 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.

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.

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