Food Law News - EU - 2001

Commission Memo (MEMO/01/42), 16 February 2001

GMOs - Commission welcomes the adoption of new rules for GMOs

Environment Commissioner Margot Wallström and Commissioner for Consumer Protection and Health David Byrne welcomed today's adoption by the European Parliament and Council of Ministers of the revised Directive 90/220/EEC on the deliberate release of genetically modified organisms into the environment. The revised Directive strengthens the existing regulation, in particular by introducing mandatory consultation of the public, mandatory labelling and traceability at all stages of the placing on the market, as well as mandatory monitoring of long term effects. The Commission believes that this Directive will provide the foundation for a coherent, transparent and efficient regulatory framework to govern the handling of genetically modified organisms (GMOs). The Commission will soon complement this framework by proposing regulatory initiatives on traceability and labelling of GMOs through the entire chain as well as on GM feed.

Margot Wallström said: “The adoption of this Directive represents an important first milestone towards the restoration of public and market confidence. The public is concerned about the use of these new technologies in the sector of Health and Environment. It is our responsibility as policy makers to take up those concerns and address them in a coherent and transparent way. We must show strong political leadership and explain that we have a strict efficient and transparent system in place to deal with production and processing of GMOs. But I believe also that it will be necessary for all stakeholders, including the European institutions, Member States, industry and research as well as NGOs and the media to reflect upon their responsibilities and provide a strong and balanced response to the questions and concerns raised by the general public.”

David Byrne added: “The regulatory framework must provide for a high level of protection for human health and the environment based on sound science and at the same time should also allow society to profit from the benefits of these new technologies. The adoption of the new legislation today is an important point of departure for further legislation on the use of GMOs in food, feed and seed. I am particularly committed to provide consumers with clear and precise information through labelling. I believe informed consumers should be able to make an informed choice and will ensure this rationale to the proposals in each sector.”

The Commission will work closely with Member States and the European Parliament to put together a legislative 'package' to complement the revised Directive. The 'package' aims at further addressing reliability and safety for consumers and the environment and allow citizens an informed choice with respect to the purchase and consumption of GMOs. It should also provide legal certainty for all stakeholders with regard to the authorisation of such products.

The next step will be a proposal for a horizontal Council and Parliament Regulation on traceability with specific and distinct requirements for GMOs including provisions on the labelling of GMOs.

Background

On 23 February 1998, the Commission adopted a Proposal for a Directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (GMOs).

The Proposal seeks to increase the transparency and efficiency of the decision-making process, to promote a harmonisation of the risk assessment and to introduce clear labelling requirements for all GMOs which are placed on the market. It clarifies the scope and definitions of the Directive and includes all direct and indirect ecological aspects. In addition, it introduces mandatory monitoring for GMO-products and a mandatory time limitation of maximum ten years for first-time consent.

On 11 February 1999, the EP adopted its first reading, with 78 amendments. The Council adopted its Common Position on 9 December 1999.

On 12 April 2000, the EP adopted a total of 29 amendments at second reading. On 15 September 2000 the Council formally notified Parliament that it could not accept these amendments. This made it necessary to convene a Conciliation Committee, which agreed on a joint text on 20 December 2000.

The agreement reached in conciliation covers in particular the following issues:

• Marker genes A timetable for the gradual elimination of antibiotic resistance makers in GMOs, namely end of 2004 for commercial releases (part C) and end 2008 for research purposes (part B) have been introduced
• Environmental liability The Commission undertook to bring forward a legislative proposal on environmental liability before the end of 2001, covering also damage resulting from GMOs
• Cumulative long term effects Potential cumulative long-term effects associated with the interaction with other GMOs and the environment are taken into account in the context of the risk assessment carried out prior to authorisation
• Pharmaceuticals The compromise reached provides for an exemption for pharmaceuticals for human use for research purposes (part B of the directive) provided that the sectoral Community legislation that governs their authorisation fulfils certain criteria (e.g. an equivalent risk assessment, explicit consent)
• Public registers It was finally agreed that GMOs released in the trial period (part B of the Directive) should be registered and details made available to the public. As regards the release of GMOs for the placing on the market (part C of the Directive), their locations will have to be notified to the competent authorities and made known to the public in a manner deemed appropriate by the authorities
• Time-limited consent The first-time consent for a release of GMOs is limited to a maximum of ten years. It was agreed that also the renewal of an initial authorisation will be limited in time. As a general rule, the renewed consent will be valid for an additional ten-year period. This period may be limited or extended for specific reasons
• Labelling and traceability of GMOs The Directive contains general rules on traceability and labelling concerning GMOs. In addition, the Commission announced to bring forward appropriate legislative proposals on traceability and labelling for GMOs and products derived from GMOs

In addition, the new Directive includes

• Mandatory monitoring requirements after the placing on the market of GMOs
• Mandatory consultation of the Scientific Committee(s)
• Mandatory consultation of the public for both experimental and commercial releases
• The application of the precautionary principle, when implementing the Directive
• The opportunity for consulting Ethics Committee(s) on issues of general nature

A new inter-institutional procedure (comitology) in accordance with Council Decision 1999/468/EC of 28 June 1999, which includes consultation of the European Parliament and the possibility for Council to adopt or reject a Commission Proposal by qualified majority

The European Parliament has adopted the joint text as agreed by the Conciliation Committee by large majority of votes cast on 14 February 2001. The Council adopted the joint text by written procedure by 15 February 2001.