Genetic Engineering, Plants, and Food The European Regulatory System

GMOs must receive authorisation before they enter the market. This applies to GMOs used in food and feed and to seeds for GM crops. In 2004, a new, fundamentally revised legal system took effect in all EU Member States. The essential foundations of the EU's policies are tight safety standards and freedom of choice for consumers and farmers.

Based on a comprehensive decision making process, the EU and the Member States are of the opinion that using genetic engineering in agriculture and food production is permissible.

Can't be marketed without authorisation: Approval is needed before GM plants (GM rapeseed) or GM foods (GM rapeseed oil) can be used commercially.

Nonetheless, each individual GMO must receive approval before it can be sold as seed or used in food and feed. Approval is granted only under certain conditions: Safety: The product must be safe and cannot pose threats to human or animal health. It also must be safe for the environment. All products from GMOs must be considered just as safe as their conventionally derived counterparts according to tests using the most advanced knowledge and technology available. If this isn’t the case, the GMO will not receive authorisation. Freedom of Choice: Even GMOs that receive authorisation are held to special requirements. Consumers, farmers, and businesses must be given the freedom to either use or to reject products made from GMOs.

This means: It must remain possible in the long term to produce foods without the use of genetic engineering. The term used for this is coexistence. Genetically modified plants must be grown and handled in such a way that prevents uncontrolled mixing with conventional products. It is up to the individual Member States to decide how to ensure coexistence. The European Commission has provided a set of guidelines to aid with this process.

• Labelling: Labelling is the most important tool for ensuring the freedom of choice, a freedom that is required by EU law: Whenever GMOs are intentionally used in a food product, it must be clearly stated on the label. Every consumer is thereby entitled to make an "informed decision".

• Traceability: Labelling is required even if GM content cannot be detected in the final product. This is why all producers, suppliers, and retailers must inform their buyers if GMOs were used in their products. To do this, stakeholders must set up systems for keeping and sharing information and documentation. The obligation to keep records and allow for traceability is declared in its own EU regulation(1830/2003).

GM plants in the environment vs. GM food on the table: Different authorisations

Safety, freedom of choice, and case-by-case evaluations – these important principles are the framework for the European laws on the commercial use of genetic engineering. Made up of several different regulations and directives, requirements differ depending on if the GM product is capable of being propagated and cultivated, or if it’s a processed product that isn’t made of living material. The differences apply to authorisation requirements and procedures.

• Directive for the deliberate release of genetically modified organisms into the environment: Authorisation based on this directive (2001/18) is needed before seed for a GM plant can be put on the market. This authorisation process demands testing to see if the large-scale cultivation of the plant could have effects on the environment. Authorisation is also needed for crops that are not grown in the EU, but that are imported in a living form that could potentially grow somewhere and spread in the environment. Products falling under this category are considered "organisms from a legal standpoint". This is why imported GM maize kernels or GM rapeseed would need authorisation under this directive. On the other hand, authorisation based on this directive is not required for the importation of processed products like cornstarch or rapeseed oil made from GM plants, because these products are not capable of growing and hence are not legally considered organisms.

• The EU regulation for genetically modified food and feed: Food and feed made from GMOs fall under their own regulation that came into effect across the EU in April 2004. This regulation covers foods that are GMOs (e.g. sweet corn) as well as processed foods derived from a GMO (e.g. cornstarch) that are no longer organisms themselves. This regulation (1829/2003) applies to food and feed and addresses health, safety, and labelling.

For example: Releasing a new GM sugar beet

If a company is planning on introducing a new GM sugar beet to the market, two approvals are required:

• Authorisation for growing the sugar beets according to the directive for deliberate release of genetically modified organisms into the environment

• Authorisation for food and feed according to the EU regulation on genetically modified food and feed

• Not all GM food authorisations are held to the directive for deliberate release of genetically modified organisms into the environment. Sugar from GM sugar beets, for instance, can forgo authorisation if the beets are grown and processed elsewhere. Especially in the cases of processed rapeseed and maize products, many food and feed authorisations have been granted without corresponding authorisations for cultivation.

In past years, applications for growing and for consuming GMOs were submitted separately, and the respective authorisation processes were carried out in parallel. Now it is possible to submit both applications to the European Food Safety Authority (EFSA) for an integrated authorsation process resulting in a single final decision. This does not lessen or compromise any safety requirements.

See also on GMO-Compass:

• GMO Database
• Two Laws Governing Genetically Modified Plants
• Labelling of GMO Products