Category Archives: Specific Themes

Certain issues are of particular importance to consumers, especially where they concern their health. The European Union takes action in these areas in order to prevent and curtail the risks associated, for example, with genetically modified organisms, or with certain diseases affecting animals, such as bovine spongiform encephalopathy or foot and mouth disease.

Specific themes

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Specific themes

Outline of the Community (European Union) legislation about Specific themes

Topics

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

Food safety > Specific themes

Specific themes

Certain issues are of particular importance to consumers, especially where they concern their health. The European Union takes action in these areas in order to prevent and curtail the risks associated, for example, with genetically modified organisms, or with certain diseases affecting animals, such as bovine spongiform encephalopathy or foot and mouth disease.

GENETICALLY MODIFIED ORGANISMS (GMOs)

  • Food and Feed (GMO)
  • Traceability and labelling of GMOs
  • Unique identifiers for GMOs
  • Deliberate release of genetically modified organisms (GMOs)
  • Contained use of genetically modified micro-organisms (GMMs)
  • Transboundary movement of genetically modified organisms

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES (TSEs) AND BOVINE SPONGIFORM ENCEPHALOPATHIES (BSEs)

  • Transmissible Spongiform Encephalopathies (TSEs)
  • BSE: state of play in March 2003

FOOT AND MOUTH DISEASE

  • The fight against foot-and-mouth disease

Unique identifiers for GMOs

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Unique identifiers for GMOs

Outline of the Community (European Union) legislation about Unique identifiers for GMOs

Topics

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

Food safety > Specific themes

Unique identifiers for GMOs

Document or Iniciative

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.

Summary

Scope

The Regulation applies to all genetically modified organisms that will be imported into the Community for cultivation and for human food and animal feed, except medicinal products for human and veterinary use.

Authorisation to place on the market

Since the beginning of the 1990s, the placing on the market of genetically modified organisms has been regulated by Directive 90/220/EEC. Since 1997, the regulations on GMOs, limited to Directive 90/220/EEC (covering the import, processing and cultivation of GMOs and their use in animal feed) have been strengthened by a Regulation concerning novel foods and novel food ingredients intended for human food (Regulation 97/258/EC).

The regulatory framework for GMOs was amended and updated by the adoption of Directive 2001/18/EC repealing the above-mentioned Directive 90/220/EEC, and by the adoption of two Regulations, one relating to GMOs in human food and animal feed (Regulation 1829/2003/EC) and the other to the labelling and traceability of GMOs (Regulation 1830/2003/EC).

All GMOs must be assessed before they can be sown or placed on the market. This risk assessment is carried out on a case-by-case basis and examines the expected or unexpected possible effects that the GMO is likely to have on health and on the environment. Therefore, effects linked to a GMO’s potential toxicity/allergenicity or its effects on non-target organisms for example are evaluated by national and Community scientific bodies (including the European Food Safety Authority).

Once GMO products have been authorised to be placed on the market (Directive 2001/18/EC or Regulation 1829/2003), the appropriate identifier unique to each GMO must be included on the labelling.

The identifier is made up of 9 characters, including letters and numbers, combined in a uniform way (see the Regulation’s annex). This format was approved within the framework of the Organisation for Economic Cooperation and Development (OECD). The identifier for each specific GMO is therefore listed in the OECD’s BioTrack database.

The Commission or the authority that approved the product’s marketing must inform the Biosafety Clearing-House (set up under the Cartagena Biosafety Protocol) in writing of this unique identifier.

Context

The unique identifier is a GMO identification measure that is also linked to labelling and which facilitates the traceability of these products throughout the food chain, in application of Regulation 1830/2003.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 65/2004 16/01/2004 – OJ L 10 of 16/01/2004

Related Acts

Regulation (EC) No 641/2004 of the Commission of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Official Journal L 102 of 07/04/2004).


Regulation (EC) No 1830

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 (Official Journal L 268 of 18/10/2003).

 

Transboundary movement of genetically modified organisms

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Transboundary movement of genetically modified organisms

Outline of the Community (European Union) legislation about Transboundary movement of genetically modified organisms

Topics

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

Food safety > Specific themes

Transboundary movement of genetically modified organisms

Document or Iniciative

Regulation (EC) No 1946/2003 of 15 July 2003 of the European Parliament and of the Council on transboundary movement of genetically modified organisms Official Journal L287 of 05.11.2003.

Summary

The Regulation aims to set up a common system for notifying and exchanging information on transboundary movements of GMOs to third countries. The ultimate goal is to ensure that movements of GMOs that may have adverse effects on the sustainable use of biological diversity and on human health take due account of the environment and human health.

Exports of GMOs to third countries

This Regulation distinguishes between GMOs intended for deliberate release into the environment and GMOs intended for use as food or feed, or for processing.

Exporters of GMOs intended for deliberate release into the environment must notify, in writing, the competent national authority of the country of import prior to the transboundary movement. The notification must contain the information specified in Annex I to the Regulation. This notification gives importers the option of only accepting the products for which they have given their prior informed consent.

Where the importer does not reply within 270 days from the date of receiving the notification, the exporter must send a reminder to the competent national authority of the country of import, with a deadline for response of 60 days from receipt. The exporter must send a copy of the notification and of the acknowledgement of receipt to the competent authority of his Member State and to the Commission. Under no circumstances may transboundary movements take place without prior written consent from the importer.

Exporters must keep the notification, the acknowledgement of receipt and the importer’s decision for at least 5 years. They must also notify the transit of the GMOs to any country upon request.

The Commission or the State which took the decision must notify the Biosafety Clearing House (BCH) (set up by the Cartagena Protocol) of any decision regarding the use, including the placement on the market, of GMOs intended for food or feed, or for processing, that may be subject to transboundary movements. The notification must contain the information specified in Annex II to the Regulation. GMOs intended for food or feed, or for processing, may not be moved across boundaries if they have not been authorised within the Community and if the importer has not given his express consent (not withstanding the provisions in Regulation (EC) No 178/2002).

Exporters must ensure that the exported GMOs are clearly identified; in particular, they must state that the product contains or consists of GMOs and produce the codes assigned to those GMOs. Exporters of GMOs intended for food or feed, or for processing, must sign a declaration to the effect that the GMOs will not be deliberately released into the environment. GMOs intended for use in a confined environment must be accompanied by safety rules for their storage, transport and use.

Unintentional transboundary movement

Member States must take the necessary measures to avoid unintentional transboundary movements of GMOs. If a Member State becomes aware of an occurrence resulting in a release of GMOs that may lead to an unintentional transboundary movement that is likely to have adverse effects on the environment or human health, that Member State must:

  • inform the public;
  • notify the Commission, the other Member States, the BCH and the relevant international organisations;
  • consult the affected States to enable them to take the necessary action.

Common provisions

With a view to setting up the information exchange procedure for exports of GMOs to third countries, the Regulation specifies the information that the Member States must notify to the Commission and to the BCH, and the information that the Commission must notify to the BCH.

The Commission and the Member States must designate focal points (entities which are responsible for liaising with the Secretariat to the Protocol in their own name). Member States must also designate their competent national authorities. The Commission and each Member State, on the date the Protocol enters into force in that State, shall notify to the Secretariat to the Protocol the name and the address of their focal points and competent national authorities.

No later than 5 November 2004, Member States must lay down the rules on penalties applicable to infringements of this Regulation.

No less than every three years, Member States must submit a report to the Commission on the application of this Regulation. The Commission must then draw up a report and sent it to the meeting of the parties to the Cartagena Protocol.

Context: the Cartagena Protocol

The Member States and the Community signed the Cartagena Protocol in 2000. In June 2002, the Council published Decision 2002/628/EC concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety. The aim of the Protocol is to ensure that the transfer, handling and use of living modified organisms resulting from modern biotechnology do not have adverse effects on the environment and human health, specifically focusing on transboundary movements. In terms of Community legislation, the term living modified organisms resulting from modern biotechnology can be considered as a synonym for the term GMO. The Cartagena Protocol has been in force since September 2003.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1946/2003 25.11.2003 – OJ L 287 of 5.11.2003

Deliberate release of genetically modified organisms

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Deliberate release of genetically modified organisms

Outline of the Community (European Union) legislation about Deliberate release of genetically modified organisms

Topics

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

Food safety > Specific themes

Deliberate release of genetically modified organisms (GMOs)

Document or Iniciative

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. [See amending act(s)].

Summary

The main aim of this Directive is to make the procedure for granting consent for the deliberate release and placing on the market of genetically modified organisms (GMOs) more efficient and more transparent, to limit such consent to a period of ten years (renewable) and to introduce compulsory monitoring after GMOs have been placed on the market.

It also provides for a common methodology to assess case-by-case the risks for the environment associated with the release of GMOs (the principles applying to environmental risk assessment are set out in Annex II to the Directive), common objectives for the monitoring of GMOs after their deliberate release or placing on the market, and a mechanism allowing the release of the GMOs to be modified, suspended or terminated where new information becomes available on the risks of such release.

Public consultation and GMO labelling are made compulsory under the new Directive. The system of exchange of information contained in notifications, set up under Directive 90/220/EEC, is maintained. The Commission is obliged to consult the competent scientific committees on any question which may affect human health and/or the environment. It may also consult ethical committees. The Directive requires registers to be established for the purpose of recording information on genetic modifications in GMOs and on the location of GMOs. Rules on the operation of these registers are laid down in Decision 2004/204/EC (see related acts).

Every three years, the Commission must publish a summary of the measures taken in the Member States to implement the Directive, and a report on experience with GMOs placed on the market. This report should include a separate chapter on the socio-economic advantages and disadvantages of each type of GMO authorised to be placed on the market, taking due account of the interests of farmers and consumers (the first report was due to be published in 2003). An annual report on ethical issues will also be published. The Directive invited the Commission to present a proposal for implementing the Cartagena Protocol on biosafety, which led to the adoption of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms.

Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms will be repealed by the present Directive from 17 October 2002.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2001/18/EC

17.4.2001

17.10.2002

OJ L 106 of 17.4.2001
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1829/2003

07.11.2003

–

OJ L 268 of 18.10.2003

Regulation (EC) No 1830/2003

07.11.2003

–

OJ L 268 of 18.10.2003

Directive 2008/27/EC

21.3.2008

–

OJ L 81 of 20.3.2008

The successive amendments and corrections to Directive 2001/18/EC have been incorporated into the basic text. This consolidated version  is for information only.

Related Acts

GMOs placed on the market in accordance with Directive 2001/18/EC
Decision 2010/135/EU – potato product EH92-527-1 [Official Journal L 53 of 4.3.2010];
Decision 2009/244/EC – carnation 123.8.12 [Official Journal L 72 of 18.3.2009];
Decision 2007/364/EC – carnation 123.2.38 [Official Journal L 138 of 30.5.2007];
Decision 2007/232/EC – oilseed rape products Ms8, Rf3 and Ms8xRf3 [Official Journal L 100 of 17.4.2007];
Decision 2006/47/EC – maize product MON863 x MON810 [Official Journal L 26 of 31.1.2006];
Decision 2005/772/EC – maize product 1507 [Official Journal L 291 of 5.11.2005].
Decision 2005/635/EC – oilseed rape product GT73 [Official Journal L 228 of 3.9.2005];
Decision 2005/608/EC – maize product MON 863 [Official Journal L 207 of 10.8.2005];
Decision 2004/643/EC – maize product NK603 [Official Journal L 295 of 18.9.2004].

Information gathering and dissemination

Commission Decision 2005/463/EC of 21 June 2005 establishing a network group for the exchange and coordination of information concerning coexistence of genetically modified, conventional and organic crops [Official Journal L 164 of 24.6.2005].

Commission Decision 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council [Official Journal L 65 of 3.3.2004].
Pursuant to Directive 2001/18/EC, the Commission must establish one or more registers recording information on genetic modifications in GMOs. The Decision specifies that the registers will contain information accessible to the public, and information accessible only to the Member States, the Commission and the European Food Safety Authority. The information which must be recorded includes:

  • detailed information on the person responsible for the deliberate release or the placing on the market;
  • general information concerning the GMO(s) (the commercial and scientific names, the Member State concerned, the decision to authorise the GMO, etc.);
  • information on the DNA inserted into the GMO;
  • information on detection and identification tools;
  • information on the lodging, storage and supply of samples.

Commission Decision 2003/701/EC of 29 September 2003 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market Official Journal L 254 of 8.10.2003.

Summary notification format

Council Decision 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market Official Journal L 280 of 18.10.2002.

Council Decision 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products Official Journal L 280 of 18.10.2002.

Explanatory notes on the annexes

Council Decision 2002/811/EC of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Official Journal L 280 of 18.10.2002.

Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Official Journal L 200 of 30.7.2002.

Reports

Second report from the Commission to the Council and the European Parliament of 5 March 2007 on the experience of Member States with GMOs placed on the market under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms [COM(2007) 81 final – Not published in the Official Journal].
Between October 2002 and October 2005, 13 applications to place genetically modified plants on the market were submitted in 8 Member States and led to the authorisation of 5 products:

  • NK603 maize from Monsanto Europe S.A;
  • MON863 maize from Monsanto Europe S.A;
  • GT73 oilseed rape from Monsanto Europe S.A;
  • 1507 maize from Pioneer Hi-Bred International INC and Mycogen Seeds;
  • MON863 x MON810 maize from Monsanto Europe S.A.

Moreover, in the same period, 245 applications for the release of GMOs for purposes other than for placing on the market (e.g. for research purposes) submitted to 13 Member States led to 191 authorisations (with 23 applications pending in October 2005).
Those Member States which have handled applications are generally positive about their experience with the implementation of the Directive, despite a number of technical issues which have yet to be adequately addressed. Other stakeholders have tended to be less positive in their assessment of the Directive. Some Member States have called for more guidance on specific aspects of environmental risk assessment and increased harmonisation of the process of release for research purposes. The majority of Member States has emphasised the need for a legal instrument establishing seeds’ thresholds.

Report from the Commission to the Council and the European Parliament of 31 August 2004 on the experience of Member States with GMOs placed on the market under Directive 2001/18/EC and incorporating a specific report on the operation of parts B and C of the Directive [COM(2004) 575 – not published in the Official Journal].
This report concerns only 15 Member States as the reference period for this report ended before the accession of the new Member States (1 May 2004). The vast majority of GMOs that have been developed for deliberate release are transgenic crop plants, modified for tolerance to certain herbicides or resistance to certain insect pests. Despite the fairly limited experience gained since this Directive entered into force, the report stresses that the Directive and the relevant Regulations (see below) help to increase confidence in the legislative framework and to increase the predictability of the decision-making process.

Contained use of genetically modified micro-organisms

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Contained use of genetically modified micro-organisms

Outline of the Community (European Union) legislation about Contained use of genetically modified micro-organisms

Topics

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

Food safety > Specific themes

Contained use of genetically modified micro-organisms (GMMs)

Document or Iniciative

2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms.

Summary

Member States are required to take all measures necessary in order to avoid the contained use * of genetically modified micro-organisms * (GMMs) having negative consequences on human health and the environment.

The Directive does not cover:

  • genetic modifications resulting from the use of certain techniques or methods listed in Annex II, part A;
  • contained uses involving the GMMs listed in Annex II, part C. GMMs on this list meet the criteria laid down in Annex II, part B, establishing their safety for human health and the environment;
  • the transport of GMMs by road, rail, inland waterway, sea or air;
  • the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Directive 2001/18/EC on the release of GMOs or pursuant to other Community legislation which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.

The assessment of GMM records shall result in a risk hierarchy of the contained uses consisting of four classes. The containment measures to be applied shall also be classified in a four-level hierarchy.

  • Class 1: No or negligible risk, level 1 containment;
  • Class 2: Low risk, level 2 containment;
  • Class 3: Moderate risk, level 3 containment;
  • Class 4: High risk, level 4 containment.

The contained use of GMMs requires an examination of the containment and protection measures taken, in order to avoid a release.

When contained uses are to be carried out in premises for the first time, the user shall be required, before commencing such use, to submit to the competent authorities a notification containing at least the information listed in Annex V, Part A, B or C, as appropriate. Following notification to the competent authorities of a class 1 contained use, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep a record of each assessment, which shall be made available to the competent authority on request.

If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification. However, the applicant may himself request from the competent authority a decision on the grant of a formal authorisation. The decision must be made within a maximum of 45 days from the notification.

If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification or earlier with the agreement of the competent authority.

A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority, which shall communicate its decision in writing:

  • at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;
  • at the latest 90 days after submission of the notification, in other cases.

The Annexes to the Directive detail the criteria for assessing the risks of GMMs to health and the environment, as well as the protective measures for each of the four levels of containment.

If they so wish, Member States may provide for groups or the public to be consulted on any aspect of proposed contained use.

Before a contained use commences, Member States shall ensure that:

  • an emergency plan is drawn up in order to react effectively in the case of an accident *; and
  • persons at risk of being affected by an accident are informed of all aspects related to their safety.

If an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action. The Member State shall also inform the Commission and any Member State which may be affected by the accident.

The Commission shall create a register of accidents including an analysis of the causes of the accidents, the experience gained and measures taken to avoid similar accidents.

The Commission shall be assisted by a Committee which is to rule on matters related to the application of the Directive and adapting it in light of technical progress.

Context

This Directive replaces and repeals Directive 90/219/EEC. It is a formal amendment aimed at bringing together the original Directive and its successive amendments into a single act, without any changes to the fundamental provisions nor any new transposition into national law being made.

Finally, this Directive lays down the minimal standards applicable to the contained use of genetically modified micro-organisms. Member States are permitted to take more stringent measures. They may also extend the scope of the Directive to contained uses involving genetically modified plants, animals or fish.

Key terms of the Act
  • Genetically modified micro-organism: a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination; within the terms of this definition:
    1. genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;
    2. the techniques listed in Annex I, Part B, are not considered to result in genetic modification.
  • Contained use : any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment.
  • Accident: any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2009/41/EC

10.6.2009

–

OJ L 125 of 21.5.2009