The Commission's long battle to draw up effective legislation on GMOs in food has reached an important stage with the adoption of two new regulations designed to reform the GM authorisation process and to tighten up the rules on the labelling of GM products. A key objective of the new legislation is to ensure full traceability of GMOs throughout the chain from farm to table.

Regulation number 1829/2003 on genetically modified food and feed requires that all GMOs for food use, foods which contain or consist of GMOs and foods produced from or containing ingredients produced from GMOs meet the following basic criteria:

• they must not have adverse effects on human health, animal health or the environment;
• they must not mislead the consumer; and
• they must not differ from the foods which they are intended to replace to such an extent that normal consumption would be nutritionally disadvantageous for the consumer.

Only authorised GMOs will be allowed on the market and GM products must be clearly labelled as such to protect the consumer.

AUTHORISATION PROCEDURE

Under the new process applications for authorisation will be sent to the national competent authorities for onward transmission to the European Food Safety Authority. The EFSA will then make the applications available to the member states and will publish a summary of the technical dossiers accompanying them. It will have six months to make its opinion on the applications known, though this may be extended whenever it needs supplementary information from the applicant.

As well as checking the documentation, the EFSA may ask the appropriate food assessment body of a member state to conduct a safety assessment of the food. It can also ask the appropriate authority designated under directive 2001/18/EC (on the deliberate release of GMOs) to conduct an environmental risk assessment.

All applicants will have to propose methods of GM detection and identification. These will then be validated and tested by the EU's Community Reference Laboratory.

If the EFSA issues a favourable opinion on the application, it will include in that opinion certain information. This will include the details of the applicant, the food designation and its specification, any restrictions which should be imposed on marketing or use thereof, and the validated methods of detection and identification, with an indication of where appropriate reference material can be accessed.

It will also include any environmental monitoring plan drawn up for the GMO in question under directive 2001/18/EC. EFSA opinions will be published and will carry a 30-day deadline for comment. Authorisations will be issued by the Commission via the Standing Committee on the Food Chain and Animal Health and will be entered into a Community register of genetically modified food and feed. Existing GM products will be allowed to continue subject to certain notification procedures. In due course all authorisations, both previous and new ones, will be renewed. Thereafter, renewals will occur every ten years.

Where post market monitoring takes place, eg for environmental purposes, authorisation holders must make reports available to the Commission and to the public, after removal of any confidential information. Authorisation holders must also inform the Commission of any new scientific or technical information, which might influence their food safety evaluation. The Commission has the power to modify, suspend or revoke authorisations.

LABELLING

The basic principles for the labelling of foods which are delivered as such to the final consumer or to mass caterers and which contain or consist of GMOs, or which are produced from or contain ingredients produced from GMOs are set out in the regulation. They will not apply where the GMOs in question are of a proportion no higher than 0.9 per cent of the ingredients considered individually or of a food consisting of a single ingredient, provided this presence is adventitious or technically unavoidable. To prove the latter, operators must be able to show the steps they have taken to avoid it. The basic rules are as follows:

• Where the food consists of more than one ingredient, the words "genetically modified" or "produced from genetically modified (name of the ingredient)" must appear in parentheses immediately following the ingredient concerned.
• Where the ingredient is designated by the name of a category, the words "contains genetically modified (name of organism)" or "contains (name of ingredient) produced from genetically modified (name of organism)" must appear in the ingredients list.
• Where there is no list of ingredients, the words "genetically modified" or "produced from genetically modified (name of organism)" must appear clearly on the labelling.
• The indications referred to in (a) and (b) may appear in a footnote to the ingredients list, printed in a font of at least the same size as the ingredients list. Where there is no ingredients list, they must appear clearly on the labelling.
• Where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information required under this paragraph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.

New foods which are different from their conventional counterparts in certain respects, eg in nutritional value or composition, or in terms of giving rise to ethical or religious concerns, must provide this information on the label.

GM FEED

The rules on authorisation and labelling for GM feed are broadly similar. GM feeds must not have adverse effects on human health, animal health or the environment and must not harm or mislead the consumer by impairing the distinctive features of the animal products. Where a product is likely to be used as both food and feed, a single application for authorisation must be submitted and will give rise to a single opinion and authorisation decision.

Under the existing directive on the deliberate release of GMOs, member states must already take certain measures to ensure the traceability and labelling of all authorised GMOs placed on the market. However, national provisions can lead to unfair competition. A second GM regulation, number 1830/2003 on the traceability and labelling of GM organisms and the traceability of food and feed products produced from GM organisms, aims to alleviate this by providing harmonisation at EU level for GMOs, which are released as products or within products of a food or feed nature.

Under the regulation the Commission must establish a system for the development and assignment of unique identifiers to GMOs. When placing on the market products consisting of or containing GMOs above the thresholds set out in the deliberate release directive, including bulk quantities, operators must ensure that information giving the relevant identifier and the fact that they contain or consist of GMOs is transmitted in writing to the operator receiving the product.

In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, this information may be replaced by a declaration of use by the operator. This must be accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture.

Operators must have in place systems and standardised procedures for holding the above information, along with the identities of the originating and the receiving operators, for a period of five years from each transaction.

In the case of products for food and feed produced from GMOs, the information to be transmitted must include an indication of each of the ingredients produced from GMOs, an indication of each of the feed materials or additives produced from GMOs and, in the case of products for which no list of ingredients exists, an indication that the product is produced from GMOs.

Where Community legislation provides for specific identification systems such as lot numbering for pre-packaged products, some of the above may be waived.

All pre-packaged products consisting of, or containing GMOs must bear the words, "this product contains genetically modified organisms" or "this product contains genetically modified (name of organism(s))" on a label.

All non-pre-packaged products offered to the final consumer must bear the words, "this product contains genetically modified organisms" or "this product contains genetically modified (name of organism(s))" on, or in connection with, the display of the product.

Member states must conduct inspections and other control measures, including sample checks and testing (qualitative and quantitative) to ensure compliance with the regulation. Technical guidance on sampling and testing will be issued by the Commission to assist food control authorities. In addition, it will establish a central register containing all available sequencing information and reference material for authorised GMOs. Where available, the register will also contain information on GMOs not authorised in the EU.

Both regulations will apply from April next year. The Food Standards Agency and the Department for the Environment Food and Rural Affairs hope to issue a joint consultation on UK implementing legislation at the end of 2003, along with guidance on the new regulations.

Regulation (EC) no 1829/2003... of 22 September 2003 on genetically modified food and feed, visit: http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf

Regulation (EC) no 1830/2003... 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, visit: http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00240028.pdf