Genetic Modification (GM) Legislation
The application of GMO technology is strictly regulated and the European Union (EU) has established an extensive legal framework on GMOs since the early 1990s. The entire body of EU GMO legislation was amended between 2000 and 2003. In 2008, the European Commission undertook to review the EU GM legislation and this review is ongoing.
EU legislation establishes the conditions for the development, use or marketing of a GMO or a food/feed product derived from GMOs. EU legislation on GMOs has two main objectives:
- To protect health and the environment: a GMO or a food product derived from a GMO can only be put on the market in the EU after is has been authorised on the basis of a detailed EU procedure based on a scientific assessment of the risks to health and the environment.
- To ensure the free movement of safe and healthy GM products in the EU: once authorised on the basis of the EU GMO authorisation procedure, GM products can be placed on the whole EU market.
GM authorisation in Europe adopts a precautionary, case-by-case approach where the scale of release is related to the level of risk. Broadly speaking the three levels of authorisation are:
- Contained use - this means GM research experiments carried out within a contained environment, for example a laboratory or glasshouse, under the terms of Directive 2009/41/EC (previously 90/219/EEC). In Scotland the Health and Safety Executive and the Scottish Government act as a joint competent authority and both organisations are responsible for signing any contained use consent. The Health and Safety Executive considers the risk to the operator and the Scottish Government considers the risk to the environment or ecosystem from any release.
- Research releases - this means deliberate releases to the environment authorised under Part B of the Deliberate Release into the Environment of GMOs Directive, 2001/18/EC. These are small scale releases carried out under tight control. Many research releases involve trials of GM crops in field plots but, increasingly, research releases can include medical trials of GM pharmaceuticals such as vaccines administered under controlled conditions in hospitals and clinics. A GMO will only be released into the environment when a competent authority is satisfied that the release will be safe for human health and the environment.
- Commercial releases - this means deliberate releases to the environment authorised under Part C of the Deliberate Release into the Environment of GMOs Directive, 2001/18/EC, or under the Genetically Modified Food and Feed Regulation, 1829/2003. This type of authorisation covers import and use of a GMO for food or feed and non-food use and it can allow EU-wide commercial scale growing of a GM crop. Commercial releases are authorised at European level following a vote in Europe. The Food Standards Agency (FSA) is responsible for food safety issues whilst Defra and the devolved agriculture departments are responsible for assessing risks to the environment. However, all new crop varieties (GM and non GM) also have to be approved as suitable for agriculture via the National List trials route.
The Traceability and Labelling Regulations (EC) 1829/2003 and (EC) 1830/2003 require that any intentional use of GM ingredients in food and feed at any level must be labelled. However, small amounts (below 0.9%) of EU approved GM ingredients that are accidentally or unavoidably present in a food do not have to be labelled GM. A GMO that has not been approved in the EU is not allowed at any level (zero tolerance) in food and feed for sale in the EU. In summary:
- GMOs, including food and feed products derived from GMOs, placed on the market must comply with labelling and traceability rules;
- if a food or feed contains or consists of GMOs, or contains ingredients produced from GMOs, this must be indicated on the label;
- however, products produced with GM technology, for example cheese produced with GM enzymes and products such as meat, milk and eggs from animals fed on GM animal feed, do not need to be labelled.
Enforcement in Scotland
In Scotland, three sets of domestic regulations implement the EU regulations, by granting powers to authorised officers for enforcement, and creating penalties for non compliance. Local authorities are responsible for the enforcement of traceability and labelling requirements and for sampling and testing food and feed for GMOs. The GM Inspectorate and Science and Advice for Scottish Agriculture (SASA) is responsible for ensuring compliance with the regulations governing the deliberate release into the environment of GMOs in Scotland.