CHAPTER 2: EU’s GMO POLICY

2.1. General EU policy on genetically modified organisms (GMOs)

 

The main competence in the field of GMOs on the EU level lies with the Commissioner for Environment and the Commissioner for Health and Consumer Protection.

Whilst EU legislation on GMOs was originally addressed by one directive (90/220/EC), the speed at which this new technology has been brought to the market, before considering all the implications of applying GM to the agricultural system and the food chain, has led to a proliferation of legislation dealing with GMOs, either exclusively or as part of a general framework. A long list of new legislative measures is also pending.

The EU’s legal structure dealing with GMOs is a patchwork of both horizontal and vertical legislation, constantly under review, revision and expansion. It is such a volatile and constantly changing picture that even experts have difficulties following the various processes. This unworkable mess is one of the main reasons for the self-imposed de facto moratorium on approvals of releases of new GMOs.

“Guilty until proven innocent”

In general the EU has adopted a policy, which requires any new GMO to be individually approved by the Commission and the Member States. Without such specific approval, GMOs are banned within the territory of the EU; they are neither allowed to be grown, sold, nor imported without such approval. The aim of the approval is to conduct an environmental risk assessment to establish the safety of the products prior to their release into the environment.

This process of approval is lengthy and complicated, involving many steps on both the national and EU level. However, the two key principles are: “a case by case” approach and a “based on sound science” approach. The “precautionary principle”, although mentioned in the legislation, has so far played only a minor role.

Apart from the use of GMOs in 'contained use', there are two principal steps for releasing GMOs “into the environment”:

Field trials, i.e. the growing of GMOs on a small area for scientific research in order to find out whether the GMO can be considered “safe”. This is done on a purely national level, i.e. the national “competent authority” (in most Member States this is the Ministry of Environment) approves and oversees such field trials. Other Member States and the Commission need only to be informed.

Commercialisation or marketing authorisation, i.e. the putting on the market of a GMO (both seeds and food) needs to undergo authorisation on the European level. Because of the internal market, any product that can be sold in one country can also be sold in all other Member States. Therefore, a “European authorisation” is needed. A country that wants a GMO to be commercialised has to apply for a European authorisation, after it has conducted the national field trials.

All applications have to undergo the scrutiny of several scientific committees. Any EU-wide marketing approval needs to be evaluated by the Competent Authorities (and their respective Scientific Committees) of all Member States, plus those of the European Commission. This is known as the “commitology procedure”. Authorisation is given only after all other Member States and the Commission have reached a positive agreement by voting on each proposal.

These authorisation principles basically apply in all areas and are enshrined in all the respective legislation.

The EU introduced its first general legislation dealing with GMOs in 1990 (Directives 90/219/EC on "contained use" of GMOs and 90/220/EC on "deliberate release"), followed in 1997 by a special law on GM foods (“Novel Foods”, 258/97/EC). However, already in 1996, when the first GMO crops were to be granted marketing authorisation, it became clear that the laws were highly inappropriate and unworkable.

Since then, the two original directives have undergone a lengthy revision process, which – in the case of the more important 90/220/EC - is still ongoing. Apart from updating these basic directives, there is a lengthy list of upcoming changes or additions to the EU’s GMO laws pending. As GMOs move into the agricultural sector and the food chain, the EU has realised that its whole legal system needs a complete overhaul; provisions on how to deal with genetically modified seeds, trees, vines and other agricultural products need to be included in respective legislation. In general, the requirement for risk assessments to be conducted in accordance with Directive 90/220/EC is being introduced into all product-specific legislation.

The Commission’s White Paper on Food Safety, published in 1999, is a signpost on where EU legislation is headed. There, the Commission lists more than 80 action points on legislation that still need revision or need to be created in the first place, and many of them include provisions on GMOs.

In general, this includes:

  • New legal framework for food safety

  • New legal framework for animal feed

  • Legal provisions for traceability and labelling to be completed and harmonised

  • New legal framework to deal with seeds

  • The establishment of a European Food Safety Authority.

It will be many years before this major project will be completed – in most cases, the envisaged new legislation has not even been drafted or proposed. Under normal circumstances, it takes 2-4 years for a new piece of legislation to evolve from the draft to the actual law, but experience in the field of GMO policy has shown that this can sometimes be a much longer process. Currently the White Paper is heavily and controversially debated in the EP.

Even without these forthcoming legal changes, we have already seen a significant shift in EU policy over the past 5 years: Directive 90/220/EC was tightened (labelling requirements were added) by a Commission decision in 1997. And the current revision of the whole directive also moves towards stricter rules. Some highly controversial policy decisions, however, still remain to be taken, such as the question of liability, thresholds of permissible contamination by GMOs, and GMO-free zones.

National bans

Despite the general rule that marketing approvals are always valid throughout the internal market, there are safety clauses in each piece of legislation, to allow for temporary national bans of approved products. These safety clauses go back to a principle enshrined in the Treaties which allows for such bans, if there is a perceived threat to the environment (this must be argued based on new scientific findings).

Within directive 90/220/EC this safety clause has been enshrined in Article 16. If a Member State invokes Article 16, the GMO is banned in its territory and a renewed “commitology procedure” is initiated, during which all other Member States and the Commission review the new scientific evidence brought forward by the Member State wanting to ban the GMO. According to the law, this process should be completed within 3 months. However, over the past few years five Member States have invoked Article 16 in eight cases, and none of these national bans have been overturned so far. Some of them have already been in place for years.

Within the Novel Food Regulation, which deals with GM foods, Article 12 provides for such national bans. In August 2000, Italy made use of this paragraph to ban any food product based on 4 GM maize ingredients. In October, this Italian ban was defended by other Member States against the wishes of the Commission, who wanted to overturn it. A logical consequence would be that the ban be extended to other Member States as well.

The Moratorium

By 1999 the system of approving GMOs had been proved totally inadequate and was disintegrating. Blocked approval processes, existing approvals being overturned by courts, a number of national bans of already approved products, confusion about the legal frameworks in transition and the acknowledgement that the present system was undemocratic and just didn’t work, has led to an unprecedented move by EU governments. After fierce lobbying by NGOs, in June 1999 the Environment Council in Luxembourg adopted a de facto moratorium on new releases of GMOs!

Since there are no sound legal provisions in place in the Treaty for such moratoria, the “de facto Moratorium on GMOs” is based on the fact that a sufficient number of EU countries currently do not allow application processes to go ahead, or have decided to vote against any approval, to prevent any positive vote in the commitology procedures (blocking minority). The declared time-frame is for the Moratorium to stay in place until the legal frameworks have been clarified. Efforts by the Commission to lift this de facto moratorium have so far failed due to the resistance of Member States. (See Annex A)

Liability

One of the sticking points in all debates and also concerning the moratorium, is the question of “liability”. Existing EU legislation on product liability does not cover environmental damage. Due to the highly unpredictable and irreversible consequences of releasing GMOs into the environment, there have always been strong calls for a liability regime to be in place before any more GMOs are released. Liability is a major sticking point in the review of Directive 90/220/EC, but during its first reading, the EP passed a liability clause.

The Commission has always favoured a more general (horizontal) approach and has recently issued a long-awaited White Paper on Environmental Liability, which includes a chapter on GMOs. Whichever approach will prevail, there is pressure for the moratorium to stay in place until the question of liability has been resolved.

 

2.2. Specific EU legislation on GMOs

 

This section lists only the most important pieces of EU legislation, relating to agricultural biotechnology. This list is neither comprehensive nor can it be expected to be up-to-date for long, as several laws are currently under revision and the Commission intends to propose a number of new directives and regulations before the end of the year 2000.

 

2.2.1. Existing legislation

 

Directive 90/220/EC on the deliberate release of GMOs into the environment (currently under revision)

This is the “mother-directive” of all EU laws on GMOs. It is a classic horizontal legislation, everything that is not regulated in other legislation (see below) falls under this directive. GMOs regulated under other legislation also have to undergo an environmental risk assessment in accordance with this directive.

There are essentially 2 parts to this directive: Part B deals with experimental “field trials”; Parts C lays down procedures for EU-wide commercialisation (marketing approval).

The directive has been undergoing a 5-year revision process, which is currently in its final stages. In its new form, it can be expected to become national law not before mid-2002.

Some key provisions that are likely to be adopted during the revision of Directive 90/220/EC:

  • Phase out of antibiotic marker genes
  • Extended risk assessment also looking into indirect and long-term effects, geographical indicators etc
  • Review of permits after 5-10 years
  • Post-market monitoring of effects
  • Improved “commitology procedures”
  • Public register for commercial releases and increased transparency

Regulation 258/97/EC on novel foods and novel food ingredients (“Novel Foods” Regulation)

This regulation deals specifically with GM foods. It is modelled on the approval systems contained in Directive 90/220/EC.

Although adopted in 1997, only a year later an addition had to be created: Council Regulation 1139/98, on labelling of 2 specific products (Monsanto RR soybeans and Bt 176 maize), which in turn was amended two years later by Commission Regulation 49/2000, to establish a 1% threshold of permissible GMO contamination of food, for labelling purposes. Later this year, Commission Regulation 50/2000 was introduced to close yet another important loop-hole in the Novel Food Regulation to address “the labelling of food stuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms”.

A major problem of the Novel Food legislation is that it allows for fast-track approval (without risk assessment) for GM foods which are deemed to be “substantially equivalent” to non-GM food. In October 2000, this principle has been effectively challenged by EU Member States, when they defended a national ban imposed by Italy under Article 12 against the Commission’s proposal to lift this ban. The Regulation as it now stands will probably have to be revised very soon. The Commission has already indicated that there will be no more novel food approvals under the "fast-track" system at least until a report has been undertaken, which is unlikely before mid-2001.

Directive 98/95/EC on the marketing of seeds

This is an update of directives that govern the marketing of seeds. The marketing of seeds within the EU is only possible if a seed receives the status of a “variety” and is being registered in a national catalogue. This is also true for GM seeds. However, this directive now establishes that GM seeds will have to undergo a risk assessment, also in accordance to 90/220/EC.

It states clearly that the public must be informed about the use of GM seeds. Directive 98/95/EC, Article 18 reads: “The published note shall clearly indicate those [seed] varieties which have been genetically modified.”

Despite this inclusion of GM seeds into the general seeds directive, a special “Novel Seed” Regulation for GM seeds will be proposed by the Commission soon.

Council Directive 1999/105/EC on the marketing of forest reproductive material

This too is an update of older directives (66/404/EEC and 71/161/EEC), which now includes the requirement for GM trees to undergo risk assessment according to directive 90/220/EC. A forthcoming Regulation on “Novel Trees” is envisaged.

 

Directive 98/81/EC on contained use of GM Micro-organisms (GMMOs)

This is the revised Directive 90/219/EC, the original sister-directive of 90/220/EC. It deals only with the use of GM micro-organisms in “contained” circumstances, i.e. laboratories and commercial use of GMMOs in the production of pharmaceuticals and other biochemicals.

Biosafety Protocol

The EU (as well as its Member States) has signed the Biosafety Protocol to the Convention on Biodiversity, the so-called “Cartagena Protocol”. This international law establishes rules on the transboundary trade of GMOs, especially the need for prior informed consent, i.e. the need for explicit permission from an importing country before any imports can actually take place. It also gives importing governments the possibility to ban the import of specific GMOs on the basis of health and environmental risks, even in the absence of scientific certainty. In this way, the Protocol enables importers to invoke the precautionary principle. Once the Protocol comes into force (expected in 2001) these rules will apply for any imports or exports to and from the EU.

Århus Convention

In June 1998, the EU and member states, as well as all the governments of Accession countries signed the Århus Convention on public participation. The 'access to information' pillar of this Convention guarantees citizens the right to information about "releases of GMOs into the environment". So far, the Convention has been ratified by 11 countries, and is expected to come into force in 2001. A Taskforce, that includes NGOs, is currently examining some of the ambiguities and shortcomings of the Convention, although it is not clear how these will be addressed (through amendments to the Convention or a separate protocol on GMOs). NGOs are calling for the Convention to ensure requirements for labelling of GM foods and the right of the public to participate in decision-making on GMOs. The GMO provisions in this Convention are important in CEE, especially in non-accession countries, where this Convention will provide the only rights for the public to have information on GMOs.

 

2.2.2. Proposed Legislation

Legislation currently being formulated includes:

  • Novel Feed Regulation on GM animal feed, has been proposed by Commission in July 2000 (SANCO/748rev 11/2000) and is about to start its long and slow march through the institutional law making process

  • The Commission’s proposal for a directive amending directive 68/193/EC on the marketing of material for vegetative propagation of the GM vines is currently heavily debated in the EP (368L0193-Proposed Amendment)

 

2.2.3. Possible New Legislation

This section reviews new legislation that the Commission has stated is necessary, but about which no concrete proposals have yet been published. It is an incomplete list of some of the laws that the Commission believes need to be amended, updated or created. The dates given are timelines by which the Commission envisages the legislative process will be completed. It must be noted, however, that the deadlines are always very optimistic and are rarely achieved. Experience has shown that creating new legislation, especially in the highly controversial field of GMOs, always takes longer than estimated – and first delays have already occurred, as the Commission did not publish a number of proposals it wanted to put forward in September 2000.

  • Establishment of Food Safety Authority (enabling legislation unlikely to be in place before December 2001)
  • New legal framework for food safety, general Food Law Directive (not before December 2001)
  • New legal framework for animal feed, overhaul of existing legislation
  • Revision of Novel Food: tighten and streamline
  • Completion and harmonisation of labelling provisions: amend or create at least 5 laws
  • Amendments to 4 directives on food additives, sweeteners, colours and purity (89/107, 95/31, 95/45, 96/77) to include provisions for GMOs
  • Framework for novel seeds: amend or create at least 4 directives on GM plant varieties, the marketing of seeds
  • Amendments to Directive 91/414/EC on maximum residue limits of pesticides in food, to include GMOs (not before 2003)
  • Directive on GMO-free labels for food

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