Tag Archives: Genetically modified organisms

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.

Traceability and labelling of GMOs

Traceability and labelling of GMOs

Outline of the Community (European Union) legislation about Traceability and labelling of GMOs

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

Traceability and labelling of GMOs

Document or Iniciative

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)].

Summary

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).

Objectives

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.

GMOS

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.

Context

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.

References

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

Regulation (EC) No 1830/2003

07.11.2003

16.01.2004

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

11.12.2008

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 versionis of documentary value only.

Life sciences and biotechnology

Life sciences and biotechnology

Outline of the Community (European Union) legislation about Life sciences and biotechnology

Topics

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

Employment and social policy > European Strategy for Growth > Growth and jobs

Life sciences and biotechnology

Helping the European Union to harness the life sciences and biotechnology in many areas such as health care, agriculture, food, industrial uses and the environment in order to create a sustainable, knowledge-based economy. This is the aim of the various acts in this field adopted by the European Commission over the last few years. For Europe, life sciences and biotechnology represent both a challenge and a major potential to be harnessed. A potential which the Commission aims to develop by means of a European strategy. This document summarises the main aspects of that strategy (the basic idea, the challenges, the action planned, ethical aspects, etc).

Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions of 23 January 2002: “Life sciences and biotechnology – A Strategy for Europe” [COM(2002) 27 final – Official Journal C 55 of 2.3.2002].

Summary

Biotechnology is a technique which, by means of genetic manipulation, produces biological molecules or transgenic organisms for industrial, agricultural, pharmaceutical or chemical applications, etc.

The life sciences raise important policy and social issues and have prompted wide public debate. A revolution is taking place in the biotechnology knowledge-base, opening the way to new applications in the areas of health care, agriculture, food production and environmental protection.

Major scientific and technological advances have been made in life sciences and biotechnology over the last few years. In response, in January 2002 the European Commission adopted a strategy for Europe to devise sustainable and responsible policies to deal with the following three major issues:

  • life sciences and biotechnology offer opportunities to address many of the world’s needs as regards health, ageing, food, the environment and sustainable development;
  • broad public support is essential, and ethical and social implications and concerns must be addressed;
  • the scientific and technological revolution is a global reality which creates new opportunities and challenges for all countries of the world.

The strategy is divided into two sections:

  • general policy outlines;
  • a thirty-point plan to flesh out these outlines and measures.

It reflects the importance which the European Council attaches to the life sciences. It proposes a comprehensive roadmap up to 2010 and puts the sector at the forefront of those frontier technologies which are helping the European Union to meet the Lisbon objectives.

The potential of life sciences and biotechnology

Life sciences and biotechnology are widely regarded as being among the most promising frontier technologies for the coming decades.

In the health care sector, biotechnology already permits safer and more ethical production of an increasing number of drugs and medical services. Stem cell research offers the prospect of replacement tissues and organs to treat degenerative diseases, Alzheimer’s disease and Parkinson’s disease, etc. It also opens up prospects for quality-of-life improvement through innovative medical applications.

In the agri-food sector, biotechnology has the potential to improve the quality of foodstuffs and animal feed to help prevent disease and reduce health risks. Plant genome research is a key area. In this context, the size of the world’s area under genetically modified crops (GMOs) has nearly doubled.

In the case of non-food uses for crops, biotechnology helps to improve the use of industrial raw materials for the energy transformation industry and the pharmaceutical industry. The modifications under development include alterations to carbohydrates, oils, fats, proteins and fibres. Similarly, biomass could provide alternative sources of energy, with both liquid and solid biofuels such as biodiesel and bioethanol.

From an environmental point of view, biotechnology offers new ways to protect and improve the environment, especially air, soil, water and waste. Research focuses on the development of cleaner industrial products and processes and on more sustainable agricultural practices.

In the context of the revised Lisbon strategy, the life sciences and biotechnology sector should have a role to play. As the latest progress report points out, over the coming decades it should:

  • strengthen Europe’s position on the world high-technology market;
  • become a leading area of science, industry and employment;
  • increase prosperity by creating higher-quality jobs;
  • contribute to the modernisation of European industry.

Harnessing the potential

The European strategy for the life sciences and biotechnology identifies the following strategic priorities:

  • launching a knowledge-based economy by means of greater investment in research and development and education and training;
  • translating that knowledge into concrete scientific and technological applications (new products, processes and services);
  • strengthening governance in terms of drafting and implementing policies and actions;
  • widening Europe’s international dimension;
  • promoting dialogue, coherence and cooperation as regards the implementation of current and future action.

Europe’s competitiveness should be enhanced through three main pillars for action:

  • Strengthening the resource base
    The objective is to place the emphasis on life science education (lifelong learning for scientists, general awareness of the public, etc.). The key to advances in biotechnology is access to detailed and up-to-date bioinformatics databases.
  • Networking Europe’s biotechnology communities
    There is a need to facilitate open access to knowledge, skills and best practice and to create a close community of the people and institutions involved in biotechnology.
  • A proactive role for public authorities
    The aim is to anticipate emerging issues and proactively adapt policies.

Biotechnology focuses on solving specific problems. The strategy pays special attention to building up the competitiveness of European industry by improving the potential to create small and medium-sized enterprises (SMEs) whose activity is based on research and the spirit of enterprise. These new industries, founded on scientific knowledge, are a source of industrial competitiveness, technological innovation, investment opportunities and job creation.

Ethical and social implications

The development and application of life sciences and biotechnology raise fundamental ethical questions such as the definition and the nature of human beings and the use and supervision of genetic information.

In addition, the life sciences and biotechnology have attracted much attention from the general public and prompted serious debate. The dialogue should be open, in-depth, well-informed and structured in order to provide better information and promote mutual understanding. It is therefore of key importance to promote information and dialogue to help the public and stakeholders to better understand and appreciate these complex issues and to develop methods and criteria for weighing the benefits against disadvantages or risks.

The public authorities, economic operators and the scientific community should strive to communicate the relevant facts and facilitate an understanding of the key questions in a context of international cooperation.

Steps to be taken: action plan

The objective of the action plan is to set up a coherent policy framework aimed at promoting the creation of conditions favourable to the development of biotechnology in Europe and to collaboration between the Member States and private individuals or organisations. There are four types of action:

  • action intended to support research, to establish a European intellectual property system, etc.;
  • action aimed at establishing dialogue on the ethical, legal and social implications;
  • action in the area of international cooperation, particularly with the developing countries;
  • action to pursue the development of a European biotechnology policy.

Progress reports and outlook

To take stock of the progress being made under this strategy at regular intervals, the Commission has adopted three progress reports since 2002. In these, the Commission reviews not just the progress made but also the hold-ups encountered in some areas. The three reports set out the results achieved in terms of policy development and implementation on the ground, and address new emerging issues. Where possible, they also look into the areas covered by the roadmap.

For the mid-term review of current strategy (at the European Council meeting in spring 2007), the European Commission has made an in-depth evaluation of the progress achieved since 2002 and looked at the overall role of life sciences and biotechnology in European society. These two initiatives are based in particular on:

  • public consultation;
  • an independent study carried out by the Joint Research Centre (JRC);
  • a report on the competitiveness of European industry and research in the field of biotechnology.

Background

The EU has a substantial research potential in the area of biotechnology. Society needs to reap the expected benefits in terms of growth and job creation. The Fifth (1998-2002) and Sixth (2002-2006) Framework Programmes provided researchers, businessmen, industrialists and financiers with the means. Life sciences and biotechnology are also a global reality and are vital for generating knowledge-based dynamic and innovative economies. The success of any knowledge-based economy also rests upon the generation, dissemination and application of new knowledge. However, European investment in research and development is lagging behind that of the United States. The Commission aims to restore European leadership in the life sciences and biotechnology. The Sixth Framework Programme for research (2002-2006) makes this area a priority, providing a solid platform for constructing a European research area in collaboration with the Member States.

Related Acts

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the mid-term review of the Strategy on Life Sciences and Biotechnology [COM(2007) 175 final – Not published in the Official Journal].

In this document the Commission underlines the effectiveness of the life science and biotechnology strategy, which it intends to complete as scheduled (2011).

The main results highlighted for the period ended (2002-2006) are:

  • the regional integration of clusters;
  • inspiring national action plans;
  • the adoption of a new legal framework on GMOs.

By contrast, the results as regards promotion and development of innovation in biotechnology are less striking. In this sector, small and medium-sized enterprises (SMEs) are still suffering from the lack of a Community framework (patents), low investment levels and poor cooperation between the academic world and finance.

The Commission identifies five priority areas of action for the strategy:

  • promoting research and market development for life science and biotechnology applications;
  • fostering competitiveness, knowledge transfer and innovation from the science base to industry;
  • encouraging debate on the benefits and risks of life sciences and biotechnology;
  • improving implementation of the legislation and optimising its impact on competitiveness;
  • ensuring a sustainable contribution of modern biotechnology to agriculture.

The document also describes a number of modern life science and biotechnology applications, with information on their impact in areas such as industry, the economy, the environment and healthcare.

Report from the Commission to the European Parliament, the Council, the Committee of the Regions and the European Economic and Social Committee of 29 June 2005 “Life sciences and biotechnology – A strategy for Europe” Third progress report and future orientations [COM(2005) 286 final – Not published in the Official Journal].

Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee of 7 April 2004 “Life sciences and biotechnology – A strategy for Europe” Second progress report and future orientations [COM(2004) 250 final – Not published in the Official Journal].

Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee of 5 March 2003 “Life sciences and biotechnology – A strategy for Europe” Progress report and future orientations [COM(2003) 96 final – Not published in the Official Journal].

Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions of 4 December 2001 “Science and Society – Action Plan” [COM(2001) 714 final – Not published in the Official Journal].

Communication from the Commission of 4 September 2001 “Towards a strategic vision of life sciences and biotechnology – Consultation document” [COM(2001) 454 final – Not published in the Official Journal].

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