Brussels, 28 January 2004

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 . On this date, the Directive was repealed by the new, updated Directive of the European Parliament and Council on the deliberate release of genetically modified organisms (1) (footnote moved from p. 7).

Directive , as for Directive , 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.

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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 January 1997 (Regulation ). This will be replaced by a new Regulation on GM Food and Feed to be applicable from 18 April 2004.

Directive , as amended by Council Directive on the contained use of GMMs, regulates the contained use of GMMs for research and industrial purposes.

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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 )

• a Regulation on traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs (Regulation )

The revised Directive 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.

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).

Under Directive , 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.  

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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

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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 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 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 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 have now to be dealt with under the safeguard clause provision of Directive (Article 23). The Commission has informed Member States that they should now withdraw their measures under Directive 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 . Seven (7) of these are products which were pending under Directive 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.

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How many GMOs have been approved for use in food products?

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DN: Date: 28/01/2004