Genetically Modified Organisms

Genetically Modified Food and Feed – What are GMOs?

Genetic modification, also known as “genetic engineering” or “recombinant-DNA technology” was first applied in the 1970’s. It is one of the newest methods to introduce novel traits to micro-organisms, plants and animals.

Food and Feed generally come from plants and animals which have been grown and bred by humans for several thousand years. Over time, these plants and animals have undergone substantial genetic changes as those with the most desirable characteristics for food and feed were chosen for breeding the next generation of food feed. The desirable characteristics were caused by naturally occurring variations in the genetic make-up of those plants and animals. In recent times, it has become possible to modify the genetic material of living cells and organisms using techniques of modern biotechnology called gene technology. The genetic characteristics are being modified artificially in order to give them a new property (a plant’s resistance to a disease or insect, a plant’s tolerance of a herbicide, improvement of a food’s quality or nutritional value, increased crop productivity, etc.).

Genetically modified organisms (GMOs) are organisms, such as plants and animals, whose genetic characteristics are being modified artificially in order to give them a new property. Food and feed which contain or consist of such GMOs, or are produced from GMOs, are called genetically modified (GM) food or feed.
– European Commission

Rules on GMOs in the EU

In order to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in complete safety, the European Union has established a legal framework. Regulation (EC) 1829/2003 on genetically modified food and feed provides general framework for regulating genetically modified (GM) food and feed in the EU. This framework pursues the global objective of ensuring a high level of protection of human life and health and welfare, environment and consumer interests, whilst ensuring that the internal market works effectively. The Regulation is supplemented by Regulation (EC) 1830/2003 which ensures traceability and labelling of GMOs placed on the market.

Directive 2001/18/EC on the deliberate release of GMOs into the environment outlines the principles for, and regulates, experimental releases and the placing on the market of GMOs in the EU. To help prevent contamination of conventional crops by GM crops, the European Commission has drawn up guidelines on the co-existence of genetically modified, conventional and organic crops.Member States can adopt measures to avoid such contamination. However, the main responsibility for avoiding contamination ultimately lies with operators, such as farmers.

The main objectives of the Regulation on genetically modified food and feed are:

  • To protect human and animal health by introducing a safety assessment of the highest possible standards at EU level before any GM food and feed is placed on the market.
  • To have in place harmonised procedures for risk assessment and authorisation of GM food and feed that are efficient, time-limited and transparent.
  • To ensure clear labelling of GM food and feed in order to respond to consumers’ concerns and enable them to make an informed choice; and to avoid misleading consumers.
  • To set labelling requirements for GM feed which provide farmers with accurate information on the composition and properties of feed, thereby enabling them to make an informed choice.

Authorisation

The Regulation on genetically modified food and feed introduces a centralised procedure of authorisation by the European Commission based on an independent risk assessment carried out by the European Food Safety Authority (EFSA). It also introduces rules for the labelling of GM food and feed and a threshold for the presence of GM material that is adventitious or technically unavoidable.

The authorisation procedure is as follows:

  • The submission of an application for an authorisation for the placing on the market of a GM food or feed.
    The application has to be sent to the competent authority at national level which has to acknowledge the receipt of the application and inform EFSA without delay.
  • The preparation and the delivery of an opinion by EFSA.
    EFSA publishes summaries of the applications on the EFSA website. Applications are sent to the European Commission and to the Member States, who are consulted on the application over a 3 month period. If a GMO is to be used as seeds EFSA has to ask the appropriate authority at national level to carry out the appropriate environmental risk assessment (Art. 6 and 18 of Reg. (EC) 1829/2003).EFSA must give its opinion within 6 months of receiving the application. However, if additional data is requested during the scientific assessment the time limit is extended.
    A favourable opinion by EFSA, is issued with supplementary information from its GMO Panel such as a proposal for labelling, appropriate conditions or restrictions for the placing on the market of the GM product. This supplementary information contributes to the overall EFSA opinion. It is therefore important to make a clear distinction between the scientific opinions of the GMO Panel and the overall EFSA opinions that are required by the Regulation.
    The verification of the detection method of GM food and feed is part of the centralised authorisation procedure which is conducted by the European Commission’s Joint Research Centre (JRC) in its capacity of Community Reference Laboratory for GM Food and Feed, and assisted by the European Network of GMO Laboratories (ENGL). These verifications are published on the JRC website.
  • The preparation and adoption of a Decision.
    The European Commission submits a draft Decision to the Standing Committee of Food Chain and Animal Health (SCoFCAH) within 3 months of receiving the overall EFSA opinion.

Labeling

Food and feed must carry a label which refers to the presence of GMOs. However, these labelling requirements do not apply to food/feed which contains, consists of, or is produced from GMOs in a proportion no higher than 0.9 % of the food/feed ingredients considered individually and if this presence is adventitious or technically unavoidable.

Labelling provides information for consumers and allows them to make an informed choice. In the case of pre-packaged products consisting of, or containing, GMOs, the list of ingredients must indicate “genetically modified” or “produced from genetically modified [name of the organism]”. In the case of products without packaging these words must still be clearly displayed in close proximity to the product (such as a note on the supermarket shelf).

Harmonisation of controls

On 24 June 2011 the Commission adopted Regulation EC 619/2011, harmonising the implementation of the zero-tolerance policy on non-authorised genetically modified (GM) material in feed. This Regulation enters into force on 15 July 2011 and will address EU business operator’s legal uncertainty when marketing feed imported from non-EU countries.

Prior to this Regulation, GM food and feed legislation did not provide rules for controlling the presence in feed of material which contains, consists of or is produced from GMOs undergoing EU authorisation or for GMOs with an expired authorisation. Consequently, EU countries’ official controls applied different approaches for these GMOs.

Key points of the new Regulation

  • Sets a technical zero at a level of 0.1 % – the lowest level of GM material considered by the EU Reference Laboratory for the validation of quantitative methods;
  • Harmonises sampling and testing controls in all EU countries;
  • Limited to GM feed material;
  • GM material must comply with the following criteria:
    • be authorised for commercialisation in a non-EU country;
    • have a valid EFSA application under Article 17 of Regulation EC 1829/2003 or have an expired authorisation under Regulation EC 1829/2003;
    • authorisation pending for more than 3 months
      • have not been identified by EFSA as susceptible to have adverse effects on health or the environment when present under 0.1%;
      • quantitative method of analysis published by the EU reference laboratory;
      • certified reference material must be available to EU-countries and third parties

Source: European Commission  | Health and Consumers

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