GM Regulatory Framework
GMOs are primarily regulated through EU legislation with supporting UK and Scottish legislation.
For detailed information, see the Genetic Modification (GM) Legislation page on the gov.scot website.
All work involving GMOs is regulated. Work carried out in laboratories, glass houses or which is otherwise contained, where there is no release into the environment, is considered ‘contained use’ work. The HSE is responsible for assessing risk to human health of all work involving the contained use of GMOs in the UK. The GM team at SASA and scientific experts from other Scottish-based organisations provide advice about the environmental risk of contained use GMO work to be carried out in Scotland. For more information on working with GMOs in a contained way and how to notify your work, or apply for consent see the HSE webpage.
Consents for releasing GMOs into the environment for research purposes are granted on a case by case basis by Scottish Ministers. A detailed risk assessment must be submitted to the GM team at SASA, and is considered by ACRE (Advisory Committee on Releases to the Environment). ACRE comprises independent scientific experts who advise on the risks to human health and the environment from the release of GMOs. Scottish Ministers also take advice from SASA, the Health and Safety Executive, the Food Standards Agency and Scottish Natural Heritage as appropriate. Consents set out the conditions and limitations governing releases.
Consents for releasing GMOs for commercial reasons are granted at the EU level and are effective throughout the EU. The EU legislation has recently been amended to allow member states to opt-out or ban GM cultivation on their territory. This legislation allows member states and regions to ban biotech crops for reasons other than the risks to health and the environment assessed by the European Food Safety Authority (EFSA).
Compliance with the above regulations is established by official inspection. Non-compliance with consent conditions can lead to enforcement action including forwarding cases to the Procurator Fiscal Service where necessary. SASA has taken responsibility for the inspection and enforcement of the deliberate release and marketing of GMOs (principally crops plants) in Scotland since May 2000. For England and Wales, GM inspection and enforcement services for the deliberate release of GMOs are provided for Defra by the Animal and Plant Health Agency (APHA).
Allied to the GMO regulations are traceability and labeling rules, 1830/2003/EC, which include a threshold of 0.9%, above which the adventitious (accidental) presence of material from an EU authorised GMO in a non-GM product triggers traceability and labelling of the product. Enforcement of these regulations (1829/2003 and 1830/2003) in Scotland is the responsibility of Local Authority Environmental Health (food) or Trading Standards (feed) Departments.
EU legislation on seeds (notably Directive 2002/53/EC on the Common Catalogue of varieties of agricultural plant species and 2002/55/EC on the marketing of vegetable seed) requires national authorities that have agreed to the marketing of seed of a certain variety on their territory to notify the acceptance of the variety to the European Commission. Seed legislation also requires that genetically modified varieties must be authorised in accordance with EU Directive 2001/18/EC amendment 2018/350 before they are included in the Common Catalogue and marketed in the EU.