Question and Answers on the regulation of GMOs in the EU (link)

Brussels, 15 April 2004

What are GMOs and GMMs?

Genetic modification, genetic engineering or recombinant-DNA technology, first applied in the 1970s is one of the newest methods to introduce novel traits to micro-organisms, plants and animals. Unlike other genetic improvement methods, the application of this technology is strictly regulated. Before any genetically modified organism (GMO) or product can be put on the market in the EU, it has to pass an approval system in which the safety for humans, animals and the environment is thoroughly assessed.

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.

The most common types of GMOs are genetically modified crop plant species and include genetically modified maize, soybean, oil-seed rape and cotton varieties. Such varieties have, in the main, been genetically modified to provide resistance to certain insect pests and tolerance to specific herbicides.

The development of insect resistant plants reduces the use of pesticides needed to control certain insect pests in the crop. Use of plants tolerant to a specific broad-spectrum herbicide allows this herbicide to be used to remove a range of weed species in the crop without destroying the genetically modified plants themselves. This type of herbicide reduces the need for a greater number of spray treatments with herbicides that only destroy a single or a few weed species.

Overview of EU legislation on GMOs

EU legislation on GMOs has been in place since the early 1990s. The EU introduced specific legislation on GMOs to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology.

• Directive 2001/18 on the deliberate release into the environment of genetically modified organisms is a 'horizontal' Directive, which regulates experimental releases and the placing on the market of genetically modified organisms.

• Regulation 1829/2003 on GM food and feed regulates the placing on the market of food and feed products containing or consisting of GMOs and also provides for the labelling of such products to the final consumer.

• Regulation 1830/2003 on traceability and labelling of GMOs and the traceability of food and feed products from GMOs introduces a harmonised EU system to trace and label GMOs and to trace food and feed products produced from GMOs.

• Regulation 641/2004 on the detailed rules for the implementation of Regulation 1829/2003

• Directive 90/219/EEC , as amended by Directive 98/81/EC , on the contained use of genetically modified micro-organisms (GMMs) , regulates research and industrial work activities involving GMMs under conditions of containment. This includes work activities in laboratories.

Release into the environment

What are the main features of Directive 2001/18 ?

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, a Community system for which is provided for by Regulation 1830/2003 on traceability (see below);

• Information to allow the identification and detection of GMOs to facilitate post-market inspection and control;

• 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.

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 European Commission.

If there are no objections by other Member States or the European Commission, 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 Panels composed of independent scientists, highly qualified in the fields associated with medicine, nutrition, toxicology, biology, chemistry, or other similar disciplines. The European Food Safety Authority provides the relevant panels for this purpose.

If the scientific opinion is favourable, the Commission then proposes a draft legislative Decision to the Regulatory Committee composed of representatives of Member States for an 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 or rejection by qualified majority. If the Council does not act within 3 months, the Commission shall adopt the decision.

During the notification process, the public is also informed and has access to the publicly available data on the internet: at

http://gmoinfo.jrc.it

for example the summary notification format, the assessment reports of the competent authorities or the opinion of the Scientific Panels.

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 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).

How many GMOs have been approved for release into the environment?

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DN: MEMO/04/85 Date: 16/04/2004