The regulation of genetically modified food

Genetically modified food is regulated by Regulation (EC) No. 1829/2003 on genetically modified food and feed, the Genetically Modified Food (England) Regulations 2004 and the Genetically Modified Food (Wales) Regulations 2004.

Authorisations for sell genetically modified food

In order to sell genetically modified organisms for food use, food containing or consisting of genetically modified organisms and food produced from or containing ingredients produced from genetically modified organisms it is necessary to obtain an authorisation.

There is a set procedure for applying for an authorisation which is set out in the Regulations. In England and Wales an application should be made to Food Standards Agency.

Once an application has been made the Food Standards Agency is required to give notice of the application to the European Food Safety Authority who in turn is obliged to give notice of the application to the other Member States and the Commission.

The European Food Safety Authority will then give an opinion as to whether the food should be authorised for sale and the Commission will decide whether to give authorisation. The Commission may also obtain the opinion of the European Group on Ethics in Science and New Technologies before making a decision.

An authorisation will not be granted if the food:

  • has adverse effects on human health, animal health or the environment; or
  • misleads the consumer; or
  • has a lower nutritional value than the food which it is intended to replace.

Any authorisation given may be subject to conditions or restrictions and may be subject to monitoring.

The Commission’s decision will be published in the Official Journal of the European Union.

Any authorisation given will be valid throughout the European Community for 10 years unless it is revoked by the Commission. It will also be entered into the register of genetically modified food and feed, which is maintained by the Commission and can be publicly inspected.

Authorisations can be suspended where it is evident that a product is likely to constitute a serious risk to human health, animal health or the environment.

Authorisations can be renewed for 10 years at a time by making an application to the Commission at least 1 year before the expiry date of the authorisation.

Labelling of genetically modified food

Foods which contain or consist of genetically modified organisms or which are produced from or contain ingredients produced from genetically modified organisms and which are to be delivered to a final consumer or a mass caterer in the European Community must, subject to certain exceptions, comply with certain labelling requirements.

If the food consists of more than one ingredient the list of ingredients must include the words “genetically modified” or “produced from genetically modified [name of the ingredient]”.

If an ingredient is designated by the name of a category the list of ingredients must include the words “contains genetically modified [name of the organism]” or “contains [name of the ingredient] produced from genetically modified [name of the organism]”.

If there is no list of ingredients the words “genetically modified” or “produced from genetically modified [name of the organism] must be clearly stated on the label.

In the case of non-pre-packaged food or pre-packaged food in small containers (where the largest surface area is less than 10cm2) the required wording must be permanently and visibly displayed at the point of sale or on the packaging.

There are additional labelling requirements in relation to certain characteristics and/ or properties specified in an authorisation.

Liability for genetically modified food

Notwithstanding the fact that an authorisation has been granted a food operator will still be liable if the food in question breaches any civil or criminal laws.

Failure to comply with the Regulations

Contravention of the Regulations is a criminal offence punishable by way of a fine and/ or imprisonment. Any food that contravenes the Regulations may also be seized.