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Traceability and labelling of GMOs
The European Union guarantees the traceability and labelling of genetically modified organisms (GMOs) and products produced from these organisms throughout the food chain. Traceability of GMOs allows the monitoring and checking of information given on labels, the monitoring of effects on the environment and the withdrawal of products from the market in cases where new scientific data demonstrate that the GMOs used in the product present an environmental or health risk.
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [See amending act(s)].
The European Union sets out a framework for guaranteeing the traceability of GMOs throughout the food chain, including in processed foods in which the production methods have destroyed or altered the genetically modified DNA (e.g. in oils). These rules apply not only to GMOs to be used in food, but also those intended to be used in crops (e.g. seeds).
The European Union has two main objectives:
- to inform consumers through the compulsory labelling, giving them the freedom to choose;
- to create a "safety net" based on the traceability of GMOs at all stages of production and placing on the market. This "safety net" will facilitate the monitoring of labelling, the surveillance of the potential effects on human health or the environment and the withdrawal of products in cases of risk to human health or the environment.
This Regulation covers:
- all products which consist of GMOs or which contain them (this includes fields as diverse as the products, which are intended for entry into the human or animal food chain, products destined for industrial processing for uses other than consumption (e.g. in the production of biofuel) or even products destined to be used ornamentally (e.g. in the production of cut flowers));
- foodstuffs and animal feed products made from GMOs.
Labelling and traceability
All the products covered by this Regulation are subject to compulsory labelling, which shall enable consumers to be better informed and will offer them the freedom to choose to buy products consisting of, containing or made from GMOs.
The specific requirements of this Regulation related to labelling shall not apply in isolation as these rules are in addition to the following rules which also concern labelling:
- the general labelling rules applicable to foodstuffs generally intended for human consumption (Directive 2000/13/EC);
- the general labelling rules provided for the marketing of feed (Regulation (EC) No 767/2009);
- the specific labelling rules applicable to GMO food and feed (Regulation (EC) No 1829/2003).
Traceability enables GMOs and their products to be traced throughout the production chain. This system is based on the transmission and holding of information by each operator.
GMOs or products containing GMOS
Operators must transmit the following information in writing:
- an indication that the products consist of or contain GMOs;
- the unique identifiers assigned to the GMOs.
If the product is a mixture of GMOs, the industrial operator may submit a declaration of use of these products, together with a list of the unique identifiers assigned to all the GMOs used to constitute the mixture.
This information must also be held for five years.
The operators who place on the market a pre-packaged product consisting of or containing GMOs must, at all stages of the production and distribution chain, ensure that the words "This product contains genetically modified organisms" or "Product produced from GM (name of organism)" appear on a label of the product. In the case of products, including in large quantities, which are not packaged and if the use of a label is impossible, the operator must ensure that this information is transmitted with the product. It may take the form of accompanying documents, for example.
Products produced from GMOs
When placing a product on the market, the operator must transmit the following information in writing to the operator receiving the product:
- an indication of each food ingredient produced from GMOs;
- an indication of each raw material or additive for feedingstuffs produced from GMOs;
- if there is no list of ingredients, the product must bear an indication that it is produced from GMOs.
This information must also be held for five years.
GMO adventitious presence threshold
All food or feed products, including those intended directly for processing are subject to the labelling obligation when they consist, contain or are made from GMOs. Only traces of GMOs may be exempt from this obligation if they do not exceed the threshold of 0.9 % and if their presence is adventitious and technically unavoidable.
The Member States carry out measures for the inspection and monitoring of products, including sampling and quantitative and qualitative analyses of food and feed. These measures entail the Member States being able to withdraw from the market a product that does not meet the conditions laid down in this Regulation.
This Regulation harmonises the traceability measures laid down in the legislation, particularly Directive 2001/18/EC on the deliberate release of GMOs in the environment.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 1830/2003
OJ L 268, 18.10.2003
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 1137/2008
OJ L 311, 21.11.2008
The successive amendments and corrections to Regulation (EC) No 1830/2003 have been incorporated into the original text. This consolidated version is of documentary value only.