EU and UK regulation of GMOs
Genetic modification has been regulated from the start
New safety regulations often follow in the wake of a problem that was not anticipated e.g. the restrictions on the processing and sale of beef once the nature of BSE was appreciated. However, the regulations covering genetic modification are an exception, as they were developed in advance of the occurrence of any hazards to health or the environment.
A quarter of a century ago, when the possibility of combining genetic information from different organisms was first proposed, the international scientific community voluntarily imposed a world-wide moratorium on the use of this technology. Later these restrictions were eased, as safe working practices and regulatory frameworks to control their use were developed.
In 1978, the United Kingdom was the first country in the world to pass legislation controlling genetic modification. Similar regulations were also introduced in the USA and elsewhere in Europe (the most stringent in Germany and Denmark).
In October 1990 all European Union (EU) nations adopted two European Council Directives governing the 'contained use' (Directive 90/219/EEC) and 'deliberate release' (Directive 90/220/EEC) of genetically-modified organisms (GMOs) into the environment. In essence, these Directives harmonised existing laws in the different member states.
The two Directives cover genetically-modified organisms used in 'containment' e.g. in a laboratory or an enclosed factory or brewery and 'deliberately released' into the environment through field trials or crops, commercial production (which has not yet happened in the UK) and (potentially) the marketing a living GMO (e.g. a whole fruit) which may have been grown outside the EU and imported.
'Deliberate releases' of genetically-modified organisms (GMOs) into the environment include field trials of plants and the use of microbes for bioremediation (environmental clean-ups). Under EC Directive 90/220/EEC all the member states have agreed to put into place laws and regulations to ensure that common policies on GMOs are adopted throughout the Union. The regulations do not apply to organisms obtained by 'conventional' breeding techniques that have been applied over very many decades.
The Directive requires that proposed field trials should be considered individually. People intending to test new varieties must first seek permission from the appropriate national authority. In the UK the responsible authority is the Department of the Environment, Transport and the Regions (DETR). The DETR provides the secretariat for the Advisory Committee on Releases to the Environment (ACRE). ACRE is the independent body which reviews applications for field trials of organisms. Any application to ACRE must contain a technical dossier including information about the personnel concerned and their training, and a full environmental risk assessment.
The DETR also consults the Ministry of Agriculture, Fisheries and Food (MAFF) and other relevant government departments and advisory bodies (such as the Department of Health).
The membership of ACRE (August 1998) is as follows:
Chairman - Professor John Beringer - University of Bristol
This group includes government-funded scientists, a representative from an environmental group, and a representative from industry. It has recently (February 1999) been announced that the membership of ACRE is to be widened. This change has been in the pipeline for several months, and for a while ACRE meetings have included assessors from other government departments such as the Health and Safety Executive and English Nature.
In certain cases interest groups or the public may be consulted about a proposed release. It is up to individual member states to decide whether and how this should be done. Action has been taken in the several countries (including the UK) to ensure that there is 'public interest' representation on ACRE and that the public should have access to information about proposed tests (all ACRE's deliberations and advice to Ministers are available from the ACRE Web site). Companies or others may ask for some information to be kept confidential on grounds of commercial competitiveness, but in such cases they must give verifiable justification.
The review process generally takes up to 90 days, but the DETR has implemented 'fast track' procedures in certain cases. These include proposals which are low hazard, low risk or repeat trials for particular organisms that have previously been approved. In these cases the application is processed in 30 days and not reviewed by ACRE.
A general principle is that tests of new crops should be conducted a step at a time and that the scale of use should be increased gradually only as it becomes apparent that it is safe to do this. Once a field test has been carried out a report on it must be sent to the appropriate authorities. The EC Directive makes provisions for the exchange of information on releases between member states, and for the widespread publication of details.
The Novel Foods Regulation
In 1997, a third European regulation was approved after several years of argument. The Regulation for Novel Foods and Novel Food Ingredients (EC 258/97) superseded the marketing consent for food GMOs previously covered by the Deliberate Release Directive, and also introduced requirements for safety assessment, environmental risk assessment (for GMOs); and labelling of products.
The Novel Foods Regulation applies not only to foods and ingredients derived from genetic modification, but to modified or new molecules, to any products that have not previously been eaten by humans (in the EU) to a significant degree, and to novel processing methods.
The Novel Foods Regulation was followed by a Labelling Regulation (EC 1831/97) which referred specifically to GM soya and maize as well as other GM foods. However, this Regulation was somewhat vague, and did not spell out the wording to be used on food packages. Under the UK presidency of the EU, an amended Labelling Regulation (EC1139/98) was adopted, which defined the exact wording to be used. This came into force throughout the European Union on September 1st 1998.
Before it can be placed on the market, the Novel Foods Regulation demands that a novel food or ingredient:
Under the Regulation, when a company wishes to place a novel food or ingredient on the market, it must first apply to the responsible authority (e.g. the Ministry of Agriculture, Fisheries and Food - MAFF) in the country where the product is to be marketed for the first time. In the UK, MAFF will consult with the Advisory Committee on Novel Foods and Processes (ACNFP), an independent group of specialists that advises the Government on novel foods. MAFF will also consult with the DETR, the Department of Health and other relevant departments.
The composition of ACNFP (as at August 1998) was as follows:
Chairman - Professor Janet Bainbridge - Director of Science and Technology, University of Teesside
Notice that the group includes an ordained minister, a consumer representative, scientists and medical experts.
An application to ACNFP must demonstrate that the three criteria listed above have been complied with. Within 90 days, the authority will either accept or reject the application. This period may be extended if the regulatory authority requests additional information from the applicant.
The UK advice will then be forwarded to other EU states who need to agree before approval can be given.
In short, the Novel Foods Regulation requires that labelling should be applied if:
If the GM food is not substantially equivalent to an existing food, the labelling must indicate the properties of the food that have been altered and the method by which the new characteristic was obtained.
Where the inserted gene is the subject of health, ethical or religious concerns, the origin of the new material must be given.
The Labelling Regulation introduced additional labelling requirements specifically for GM soya and maize derivatives, which would not necessarily have been caught under the Novel Foods Regulation. It spells out the precise form of wording, typesize, etc. to be used on food packaging. For labelling to be required, however, novel DNA and/or protein must be present in the food. As the ability to detect trace amounts of DNA or protein keeps improving, the concept of having a threshold below which labelling would not be required is currently being discussed. A limit of 1% has been suggested, above which labelling would be mandatory.
Individual food producers and retailers may implement their own voluntary labelling policies in addition to those required by law. For example, in the United Kingdom, both Sainsbury's and Safeway stores have chosen to label tomato purée from genetically-modified tomatoes, even though there is no statutory requirement for them to do so (because the processed purée contains neither novel DNA or novel protein arising from the expression of introduced genes - it is identical to the conventional product)..
Other retailers and manufacturers have stated that they will obtain all their supplies from non-modified sources e.g. Iceland in the UK claims that it will use non-GM materials for its own-brand products.
Regulatory and Advisory Bodies in the UK