ARCHIVE: Regulatory process for genetically modified organisms
- Contained use
- The release of GMOs into the environment
- GM food and feed
- Traceability and labelling
- Other regulations
In Europe and the United Kingdom there are strict regulations controlling the deliberate release and marketing of GMOs. The principal aim of these regulations is to protect human health and the environment. The regulations apply to all GMOs, although plants have been the subject of most interest in recent years. The legislation adopts a step-by-step approach to the assessment of GMOs. This means that initial developments are carried out in containment and only released into the environment if they are assessed to be sufficiently safe. The initial releases outside containment are small, and carefully controlled and precautionary measures can be applied to prevent or minimise the spread of genetically modified DNA. The scale of the releases is increased gradually and tested at each level. The tests at each stage indicate whether the next step can be taken.
Initially, genetic modification activities are carried out in containment, for example in laboratories, industrial production plants or greenhouses. This allows specific controls to be put in place to limit any contact between the GMOs and the environment so as to provide a high level of protection. The contained use of GMOs is closely controlled by the Health and Safety Executive (HSE). Establishments undertaking the initial laboratory research into potential applications in the UK for GMOs must notify the HSE.
The release and marketing of GMOs is controlled in the European Union under Council Directive 2001/18/EC. (This replaced the earlier Directive 90/220/EEC.) It sets out the procedures for considering all applications to release GMOs for research (Part B releases) or for commercial purposes (Part C releases). The Directive sets out a framework to ensure that all GMOs are adequately tested and evaluated at each stage in their development, and most importantly, before being placed on the European market. It is based on a transparent case-by-case assessment of safety across the EU. This assessment is made according to sound scientific evidence. Once a GMO has the suitable consent it can be imported, and if the consent conditions permit, cultivated anywhere in the EU, subject to other applicable legislation on seeds, pesticides and food and animal feed.
Details of Part B (release trial) and Part C (marketing) applications are published on the Defra website.
Practical guidance on the legislation controlling the deliberate release of genetically modified organisms (GMOs) in England has also been produced.
The UK Government and Devolved Administrations have established joint arrangements for assessing applications for the release of GMOs. This involves consultation with the Advisory Committee on Releases to the Environment (ACRE), the Health and Safety Executive and the Food Standards Agency, and as appropriate, the statutory nature conservation bodies, such as English Nature.
In assessing applications every possible precaution is taken to ensure that human health and the environment are protected. Only if the risks are considered to be very low will the release be allowed to proceed. In the context of GM plants, a very low risk generally means that the GM variety is not thought to pose any greater risk than the release of its non-GM equivalent.
ACRE's role is to advise the relevant Ministers and other bodies on environmental and human health aspects of activities involving GMOs. ACRE assesses the potential implications of proposed GMO releases very carefully, including possible toxic or allergenic effects, and the possible impact on soil and fauna such as bees. If ACRE, and the other official assessors are satisfied that the release poses a very low risk then Ministers are advised that the release be approved. However, if ACRE was not in any way satisfied that the risks to human health or the environment were very low then it would advise that consent should not be issued. ACRE is committed to openness and transparency in all its work, and publishes agenda and minutes of its meetings on its website as well as its advice to Ministers.
The locations of Part B trials in the UK are published on the Defra website at: www.defra.gov.uk/environment/gm/regulation/registers.htm
Details of Part B (release trial) and Part C (marketing) applications are published on the Defra website.
Regulation (EC) No 1829/2003 on GM food and feed (which came into force on 18 April 2004) creates a harmonised procedure for the scientific assessment and authorisation of GM food and feed through the European Food Safety Authority (EFSA). Enforcement of this regulation is implemented in England by way of the Genetically Modified Food (England) Regulations 2004 and the Genetically Modified Animal Feed (England) Regulations 2004 (similar Regulations have been implemented in Northern Ireland, Scotland and Wales). Copies of these Regulations are available from Her Majesty's Stationery Office (HMSO) (www.hmso.gov.uk).
Regulation 1829/2003 requires labelling of all GM food and feed, which:
- contains or consists of GMOs, e.g. GM Soya,
- are produced from GMOs, e.g. glucose syrup from maize starch,
- contain ingredients produced from GMOs, e.g. GM tomato paste, lecithin from GM Soya for use as an emulsifier in chocolate bars.
Under the Food and Feed Regulation, labelling is required even if there is no detectable GM material in the final product. This is an extension to the previous labelling rules, which were triggered by the presence of GM material.
The Food and Feed Regulation also sets a threshold of 0.9% for the "adventitious", that is, accidental and technically unavoidable, presence of authorised GM material in non-GM food or feed, above which the product must be labelled. An additional threshold of 0.5% for GM material not yet authorised by that has a favourable assessment form an EC scientific committee is also established. This latter threshold is for a transitional period of three years until April 2007.
Applications for food or feed containing or consisting of GMOs must include the relevant information required under Directive 2001/18/EC. When an authorisation is requested that includes cultivation of GM crops for feed or food use, EFSA will consult the national competent authorities designated under Directive 2001/18/EC.
The Food Standards Agency (FSA) lead on all matters relating to the Food and Feed Regulation. Please see www.food.gov.uk/gmfoods/ for more information.
Regulation (EC) No 1830/2003 concerning traceability and labelling of genetically modified organisms also came into force in April 2004. This regulation establishes a harmonised EU system on the documentation to account for and identify products throughout the supply chain, with the objective of facilitating accurate labelling. For certain products, a system of unique identifier codes will be used to allow access to specific information on GMOs from a register.
For products consisting of or containing GMOs (e.g. Soya) written documentation will be required to be transmitted throughout all stages of the supply chain stating that the product:
- Contains or consists of GMOs
- Giving the unique identifiers for the GMOs.
For food and feed products produced from GMOs (e.g. rapeseed oil, maize gluten feed, Soya lecithin), written documentation must be transmitted to the operator receiving the product. For each transaction this documentation must:
- Indicate which of the food ingredients, feed materials or feed additives are produced from GMOs;
- Or, in the case of products for which no ingredient list exists, indicate that the product is produced from GMOs.
All operators will be required to retain documentation for a period of 5 years detailing the operator providing the product and whom the product was sold on to. Operators are required to adopt a "one step up, one step down" approach to verifying and validating documentation.
The enforcement of this regulation has been implemented in England by way of the Genetically Modified Organisms (Traceability and Labelling) (England) Regulations 2004 (similar Regulations have been implemented in Scotland, Northern Ireland and Wales). Copies of these Regulations are available from Her Majesty's Stationery Office (HMSO) (www.hmso.gov.uk).
For links to the implementation of Directive 2001/18/EC see:
- Implementing Directive 2001/18/EC: Regulatory Impact Assessment
- The Genetically Modified Organisms (Deliberate Release) Regulations 2002 (Statutory Instrument 2002/2443) are available at www.hmso.gov.uk/si/si2002/20022443.htm (on the HMSO web site)
- For EU Directive 2001/18/EC see http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber
GMO products may have to satisfy other regulatory procedures that apply to the commercial use of similar products, whether or not their production involves genetic modification. For example, for the main agricultural and vegetable species, new varieties may not be marketed unless they have been added to the UK National List or the European Common Catalogue (an amalgam of MS National Lists). This requires a series of tests and trials to demonstrate that new varieties are distinct, uniform and stable, and for agricultural varieties, that they have a value for cultivation and use in the UK. GM varieties must have the appropriate marketing consents under GM legislation before they can be added to the National List.
Any use of pesticides on GM crops has to be approved under the Control of Pesticide Regulations 1986 (as amended) and the Plant Protection Products Regulations 1995 (as amended). Inseeking any extension of approval of a pesticide to include GM crops, the necessary safety and efficacy data would have to be supplied by the applicant. The Pesticide Safety Directorate would evaluate the application against the considerations of human and environmental safety which have been established for all pesticide uses.
The Animals (Scientific Procedures) Act 1986, administered by the Home Office, regulates the production, possession and use of protected animals, living vertebrate animals and the invertebrate species octopus vulgaris, for experimental or other scientific purposes. The deliberate release of GM animals protected by the 1986 Act for an experimental or other scientific purpose will also require the express permission of the Secretary of State for the Home Department, unless the Secretary of State for the Home Department has specifically discharged them from the controls of the 1986 Act.
There are also separate regulatory procedures that any human or animal medicines containing GMOs have to pass through before being allowed to be administered to humans or animals.
For information on the contained use of GMOs: www.hse.gov.uk
Further information on the work of ACRE: www.defra.gov.uk/environment/acre/
For information on GM food and feed: www.food.gov.uk/
Page published 5 March
Page last modified 16 September, 2011