Tag Archives: Gmo foodstuffs

Novel foods and food ingredients

Novel foods and food ingredients

Outline of the Community (European Union) legislation about Novel foods and food ingredients

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Environment > Protection of nature and biodiversity

Novel foods and food ingredients

Document or Iniciative

Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [See amending act(s)].

Summary

The novel foods and food ingredients concerned by this Regulation are those which are not yet currently used for human consumption.

Novel foods and food ingredients

This Regulation applies to foods and food ingredients in the following categories:

  • foods and food ingredients which present a new or modified primary molecular structure;
  • foods and food ingredients which consist of micro-organisms, fungi or algae;
  • foods and food ingredients which consist of or are isolated from plants and ingredients isolated from animals;
  • foods and food ingredients whose nutritional value, metabolism or level of undesirable substances has been significantly changed by the production process.

The Regulation is not applicable to food additives, flavourings, extraction solvents, nor to food enzymes (which are the subject of Regulation (EC) No 1332/2008).

Genetically Modified Organisms (GMOs) are no longer covered by this Regulation, but by Regulation (EC) No 1823/2003 instead.

Furthermore, foods and food ingredients covered by this Regulation must not:

  • present a danger for the consumer;
  • mislead him/her;
  • be nutritionally disadvantageous for him/her.

Evaluation procedure

The foods and foods ingredients referred to in the Regulation must undergo Community assessment before being placed on the market.

Under the assessment procedure, the competent body of the Member State which receives an application must make an initial assessment and determine whether or not an additional assessment is required. If neither the Commission nor the Member States raise an objection, and if no additional assessment is required, the Member State informs the applicant that he may place the product on the market. In other cases an authorisation decision is required. This decision is adopted in accordance with the measures proposed by the Commission within the Committee on Food Safety and Animal Health.

The decision defines the scope of the authorisation and specifies, as appropriate, the conditions of use, the designation of the food or food ingredient, its specification and the specific labelling requirements.

Any decision or provision concerning a novel food or food ingredient which is likely to have an effect on public health must be referred to the Scientific Committee for Food.

Labelling

The Regulation lays down specific requirements concerning the labelling of novel food and food ingredients which have been added to the European general requirements on food labelling.

Without prejudice to the general requirements of European legislation concerning the labelling of foodstuffs, the labelling of novel food and food ingredients must mention:

  • any characteristics such as composition, nutritional value or the intended use of the foodstuff;
  • the presence of materials which may have implications for the health of some individuals;
  • the presence of materials which give rise to ethical concerns.

Suspension procedure

Member States are authorised to suspend or restrict provisionally the marketing and use in their territory of any novel food or food ingredient if they believe that its use constitutes a health hazard or a risk to the environment. They inform the Commission, which takes steps in accordance with the procedure regarding authorisations for placing products on the market.

References

Act Entry into force Deadline for transposition into the Member States Official Journal
Regulation (EC) No 258/97

14.5.1997

15.5.1997

OJ L 43 of 14.2.1997

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1829/2003

11.7.2003

OJ L 268 of 18.10.2003

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 258/97 have been incorporated into the original text. This consolidated versionis of documentary value only.

Food and Feed

Food and Feed

Outline of the Community (European Union) legislation about Food and Feed

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Food and Feed (GMO)

Document or Iniciative

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [See amending act(s)].

Summary

This Regulation is stricter than the previous legislation. It supplements Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms (GMOs).

Products covered

The Regulation applies to three types of product:

  • genetically modified organisms for food and feed use;
  • food and feed containing GMOs;
  • food and feed produced from or containing ingredients produced from GMOs.

Authorisation procedure

The Regulation provides for a single authorisation procedure for food products containing GMOs.

The industrial operator can submit his application in accordance with this Regulation for all food products containing GMOs in compliance with the provisions provided for by Directive 2001/18/EC on the deliberate release of GMOs into the environment.

The industrial operator submits a single application for food and feed uses and for cultivation. This means that a GMO which has obtained authorisation can be used not only in food and animal feed but also for cultivation or deliberate release into the environment.

Assessment (EFSA) and risk management (Commission)

Once the application has been made by an industrial operator, the national authority concerned acknowledges receipt in writing within 14 days and informs the European Food Safety Authority (EFSA), which is responsible for risk assessment in the food sector. The latter has 6 months in which to conduct this assessment.

The Commission is responsible for risk management. On the basis of the risk assessment carried out by the EFSA, the Commission draws up a draft decision accepting or rejecting the application within 3 months. It then submits this draft to the Standing Committee on the Food Chain and Animal Health. If this committee accepts the proposal, it is finally adopted by the Commission; if it does not, the proposal is assessed by the Council of Ministers. If the latter does not reach a position within three months or if it is unable to reach a qualified majority for or against, the Commission adopts its proposal.

The marketing authorisation is renewable for ten-year periods.

Labelling

Food and feed products containing GMOs must be labelled as such. The words ‘genetically modified’ or ‘produced from genetically modified (name of the organism)’ must be clearly visible on the labelling of these products.

Food and feed products which contain a proportion of GMOs of less than 0.9 % of each ingredient are not labelled as GMO on the condition that the presence of the genetically modified organism is adventitious or technically unavoidable.

All genetically modified organisms and products thereof for food use must respect the labelling conditions provided for in this Regulation and also those laid down in Regulation (EC) No 1830/2003 concerning the traceability and labelling of GMOs.

GMO adventitious presence threshold

The presence of GMOs in traditional crops is difficult to avoid. Minute traces in food products are tolerated if their presence is accidental or the result of technically unavoidable contamination during growing, harvesting, transport or processing.

It is the responsibility of the farmer to demonstrate to the authorities the adventitious or technically unavoidable presence of a GMO in a food product.

Background

This Regulation harmonises the legislation on the labelling of GMOs by amending or repealing the legislation in force.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1829/2003

7.11.2003

18.4.2004

OJ L 268 of 18.10.2003

Amending Act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1981/2006

12.1.2007

OJ L 368 of 23.12.2006

Regulation (EC) No 298/2008

10.4.2008

OJ L 97 of 9.4.2008