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PRODUCT LABELLING AND PACKAGING >
PROTECTION OF NATURE AND BIODIVERSITY >
SPECIFIC THEMES >
AGRICULTURE AND FOOD >

Traceability and labelling of genetically modified organisms (GMOs)

The European Union guarantees the traceability and labelling of genetically modified organisms and products produced from GMOs 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 GMOs which are potentially dangerous for human or animal health.

ACT

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.

SUMMARY

The Regulation concerning the traceability and labelling of GMOs and products produced from GMOs stipulates that traceability will be required throughout the food chain. This measure has two main objectives:

• to inform consumers through the compulsory labelling of this type of products,
• to create a "safety net" based on the traceability of these products at all stages of production and placing on the market.

This "safety net" will facilitate the monitoring and checking of the nutritional claims made on labels, the surveillance of the potential effects on human health or the environment and the withdrawal of products if an unforeseen risk to human health or the environment is identified.

The Regulation concerns the traceability of GMOs as products or product components, including seeds, and of food or feed products produced from GMOs. It does not preclude the application of existing stricter legislation concerning the traceability and labelling of products.

The traceability rules apply to all GMOs; consequently, applications for GMOs for use in food or feed ( Regulation (EC) No 1829/2003 ) must comply with them, as must applications for GMOs for crops ( Directive 2001/18/EC , part C).

Labelling

The Regulation covers all foodstuffs produced from GMOs.

It also covers all genetically modified feedingstuffs, with the same protection as for foodstuffs.

All products approved in accordance with this Regulation are subject to compulsory labelling; consumers will therefore be better informed about GM products, whether for human or animal consumption. The consumer's safety is guaranteed as a result of the traceability of products consisting of or containing GMOs.

Food or feed produced from or containing GMOs must also meet the specific labelling requirements of Regulation (EC) No 1829/2003 . In addition, genetically modified foods and feedingstuffs are subject to the general legislation on this subject, Directive 2000/13/EC on labelling and Directive 96/25/EC on the circulation of feed materials.

Products consisting of or containing GMOs

In order to facilitate the traceability of GMOs and also to protect the environment, the Regulation requires operators to transmit the following information in writing:

• an indication that the products consist of or contain GMOs;
• the unique alphanumerical identifiers assigned to the GMOs contained in the products.

Through this system of unique identifiers of GMOs, it is possible to know these products' features and characteristics for the purposes of surveillance of traceability.

In the case of products which are or contain mixtures 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.

Moreover, the Regulation stipulates that 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 affixed to 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.

Food products produced from GMOs

When placing a product on the market, the industrial 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 nevertheless bear an indication that it is produced from GMOs.

GMO adventitious presence threshold

For food or feed products, including those intended directly for processing, traces of GMOs will continue to be exempt from the labelling obligation if they do not exceed the threshold of 0.9% and if their presence is adventitious and technically unavoidable.

The adventitious presence of GMOs is an important point of the Regulation.

For more information regarding the adventitious or technically unavoidable presence of GMOs , see the SCADPlus sheet.

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 detain a product that does not meet the conditions laid down in this Regulation.

Background

On 25 July 2001 the European Commission put forward a package of integrated measures in two proposals for regulations to monitor the presence of genetically modified organisms in food and feed, with the aim of protecting human and animal health.
The first Regulation concerns the traceability and labelling of products containing or produced from GMOs, while the other one relates to foodstuffs and animal feed . The traceability of GMOs will thus be required throughout the food chain.

This Regulation harmonises the traceability measures laid down in the legislation, particularly Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of GMOs and repealing Council Directive 90/220/EEC.

It also harmonises the disparate legislation on the labelling of GMOs by amending Regulation (EC) No 258/97 concerning novel foods and novel food ingredients . Lastly, it repeals Regulation (EC) No 1139/98 (concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified maize and soya ) and Regulation (EC) No 50/2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified.

Other legislation on GMOs

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms .

Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms .

Key terms used in the act
Traceability: the capacity to keep track of GMOs and products produced from GMOs, at all stages of their marketing, throughout the production and distribution chain.

REFERENCES

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1830/2003 [adoption: co-decision COD/2001/0180]	07.11.2003	16.01.2004	OJ L 268 of 18.10.2003

RELATED ACTS

Report from the Commission to the Council and the European Parliament of 10 May 2006 on the implementation of Regulation (EC) No 1830/2003 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 [COM(2006) 0197 final].

The report notes that the European Union (EU) has ratified the Cartagena Protocol (13-17 March 2006, Curitiba, Brazil) under which the signatories undertake to comply with a series of requirements concerning international trade in GMOs intended for food, feed or processing.
The documentation accompanying international shipments of such GMOs must specify the precise identity of the GMO(s) concerned. If the precise identity is not known, the documentation must include the words "may contain GMOs".
The report also includes the opinions of most of the Member States, trading partners, certain non-governmental organisations (NGOs) and food production and distribution chains on the implementation of the Regulation.

Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms [Official Journal L 10 of 16.1.2004].
This Regulation establishes a system for the development and assignment of unique identifiers for genetically modified organisms.

Recommendation 2004/787/EC from the Commission of 4 October 2004 on technical guidance for sampling and detection of genetically modified organisms as or in products in the context of Regulation (EC) No 1830/2003 [Official Journal L 348 of 24.11.2004].

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [Official Journal L 268 of 18.10.2003].

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [Official Journal L 268 of 18.10.2003].

Last updated: 1.2.2007

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