European Union and UK regulation of genetic modification and GM-derived food products.
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.
Just over thirty years 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 (the 'Asilomar' conference', initiated by US biologist Paul Berg). 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, later replaced by Directive 98/81/EC ) and 'deliberate release' (Directive 90/220/EEC) of genetically-modified organisms (GMOs) into the envirconment. 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.
N.B. To date, no live genetically-modified organisms have been approved for food use in the European Union. Any GM products must be processed to ensure that their DNA is broken down (although fragments of genes remain, which can be used to verify whether a product is derived from a GM source).
Deliberate releases AND FIELD TRIALS
'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 now the Department for the Environment, Food and Rural Affairs (DEFRA). The DEFRA 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 DEFRA also consults the Food Standards Agency and other relevant government departments and advisory bodies (such as the Department of Health).
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 DEFRA 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 discussion. 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 (EC 1139/98) 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 Food Standards Agency) in the country where the product is to be marketed for the first time. In the UK, the FSA will consult with the Advisory Committee on Novel Foods and Processes (ACNFP), an independent group of specialists that advises the Government on novel foods. The FSA will also consult with the DEFRA, the Department of Health and other relevant departments.
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. If 1% or more of a product consists of GM-derived material labelling is mandatory. In theory, modern methods allow even a single DNA molecule to be detected, so it is quite possible to detect GM material in fresh and processed foods. [In comparison, it is virtually impossible to differentiate between 'organic' and conventionally-produced foods, and the labelling requirements for them are also far less stringent -- up to 5% of the material in an 'organic' food may be from 'non-organic' sources.]
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 chose to label tomato purée from genetically-modified tomatoes, even though there was no statutory requirement for them to do so.
Most UK retailers and manufacturers have stated that they obtain all of their supplies from non-modified sources, particularly for their own-brand products over which they have the greatest control.
Additional regulations for the labelling of GM foods were introduced in the UK in March 1999. They extended the range of products in which labelling must be applied, including food in restaurants and from 'fast food' outlets.
UNOFFICIAL EU BAN
In 1998, six EU member states imposed an unofficial moratorium on the approval of new varieties of GM crops. This eventually prompted the USA to complain to the World Trade Organisation, which was asked to judge whether the ban breached international free trade agreements. Before the WTO responded however, the European Parliament approved some new regulations that could break the deadlock.
REVISED EU REGULATIONS, JULY 2003
In July 2003 the European Parliament approved a new set of regulations that impose additional labelling requirements on those wishing to sell any foods derived from GM sources. These regulations came into force in October 2003.
Under the regulations the presence of novel DNA or protein is no longer be the trigger for labelling, but the use of the process of genetic modification in producing the food is instead. This means that, for example, oil from GM rape has to be labelled as do other products such as glucose syrup produced using starch from GM maize, even though they contain no trace of GM material and are identical to the non-GM product. The amount of GM material permitted before labelling is required is now 0.9%, slightly lower than at present, but only 0.5% contamination by non-approved GM crops is permitted, and only then if the inclusion of this material is "technically unavoidable". Also, for the first time, animal feed derived from GM sources has to be labelled as such.
Because the presence of material from GM will, in many cases, not be detectable, each food ingredient has to be accompanied by paperwork confirming its provenance. The UK's Food Standards Agency and both Conservative and Labour MEPs from Britain have argued that this approach could lead to fraud and effectively amounts to a trade barrier.
Even if the new regulations end the unofficial moratorium imposed by some EU member sates (which seems probable) it is unlikely that many European food manufacturers or retailers will wish to use GM materials, given the opposition to them from vocal anti-GM campaigners and ordinary consumers.
UK Advisory Committees
Advisory Committee on Animal Feedingstuffs
Advisory Committee on Genetic Modification
Advisory Committee on Novel Foods and Processes
Advisory Committee on Releases to the Environment
European Union GMO site