Before any genetically modified organism (GMO) or product can be put on the market in the EU, it has to pass an approval system in which the safety of humans, animals and the environment is thoroughly assessed.
GMOs are defined by Brussels as ‘organisms (and micro-organisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination.
The most common types of GMOs are genetically modified crop plant species and include genetically modified maize, soybean, oil-seed rape and cotton varieties. Such varieties have, in the main, been genetically modified to provide resistance to certain insect pests and tolerance to specific herbicides.
Overview of EU legislation on GMOs EU legislation on GMOs has been in place since the early 1990s. The EU introduced specific legislation on GMOs to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology.
Directive 2001/18 on the deliberate release into the environment of genetically modified organisms is a 'horizontal' Directive, which regulates experimental releases and the placing on the market of genetically modified organisms.
Regulation 1829/2003 on GM food and feed, enforced this week, regulates the placing on the market of food and feed products containing or consisting of GMOs and also provides for the labelling of such products to the final consumer.
Regulation 1830/2003 on traceability and labelling of GMOs and the traceability of food and feed products from GMOs, also introduced this week, is a harmonised EU system to trace and label GMOs and to trace food and feed products produced from GMOs.
Under the rules on the deliberate release of GMOs into the environment (Directive 2001/18/EC and previously Directive 90/220/EC) so far 18 GMOs have been approved for different uses, some for cultivation, some for import and processing, some as feed, some as food. In terms of crops species, these GMOs include maize, oil seed rape, soybean and chicory. Clearance includes soybeans tolerant to glyphosate for import and processing from Monsanto and a Bt-maize tolerant to glufosinate ammonium (Bt-176) supplied by Ciba-Geigy.
Twenty four applications for the placing on the market of GMOs have been submitted into the authorisation procedure under Directive 2001/18/EC and include maize, oil seed rape, sugar beet, soy beans, cotton, rice, fodder beet. Eleven of these applications have a scope which is restricted to import and processing, while the remaining ones also include cultivation as a requested use.
A number of Member States have invoked the so-called 'safeguard clause' of the previous Directive 90/220/EEC. This clause provided that where a Member State has justifiable reasons to consider that a GMO, which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory.
The safeguard clause has been invoked on nine separate occasions, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the UK. The scientific evidence provided by these Member States as justification for their measures, was submitted to the Scientific Committee(s) of the EU for opinion. In all of these cases, the Committees deemed that there was no new evidence which would justify overturning the original authorisation decision.
In spite of the repeal of Directive 90/220/EEC, the bans remain in place and have now to be considered under safeguard provision (Article 23) of Directive 2001/18/EC. In view of the new regulatory framework, the Commission informed Member States that they should withdraw their measures under Directive 90/220/EEC and lift the prohibitions.
The Commission is currently in the process of finalising decisions to lift the bans taking account of the information provided by the above Member States.
Only one Member State has invoked the safeguard clause (Article 12) under the Novel Food Regulation. This took place in August 2000, when Italy suspended the trade in and use of products derived from four GM maize varieties (MON 810 from Monsanto; T25 from Bayer Crop Science; Bt11 from Syngenta and MON 809 from Pioneer) which had been notified under the simplified procedure for products considered as "substantially equivalent".
The Commission immediately sought an opinion from the Scientific Committee for Food (SCF) which concluded, in September 2000, that the information provided by the Italian Authorities did not provide detailed scientific grounds for considering that the use of the GM foods in question endangered human health. The Commission has written to the Italian Government asking it to repeal the Decree of August 2000.
Regulation 1829/2003 on genetically modified food and feed covers GMOs for food/feed use and includes all rules concerning food/feed containing or consisting of GMOs; food/feed produced from GMOs and food containing ingredients produced from GMOs referred to as GM food/feed. The regulation stipulates that GM food/feed must not: have adverse effects on human health, animal health, or the environment; mislead the consumer; differ from the food/feed it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer/animals.
According to the Commission, the new rules establish a ‘streamlined, uniform and transparent’ EU procedure for all marketing applications, whether they concern the GMO itself or the food and feed products GMO derivatives.
This means that business operators need not request separate authorisations for use of the GMO, and for its use in feed or in food, but that a single risk assessment and a single authorisation are given for a GMO and its possible uses.
"The regulation also ensures that experiences such as with Starlink maize in the US (a GM maize which was only authorised for feed but turned up in food) are avoided because GMOs likely to be used as food and feed can only be authorised for both uses, or not at all," said the Commission.
The regulation is based on the 'one door-one key' principle. As such, it is possible to file a single application for obtaining both the authorisation for the deliberate release of a GMO into the environment, under the criteria laid down in Directive 2001/18/EC and the authorisation for use of this GMO in food and/or feed under the criteria laid down in Regulation 1829/2003.
This authorisation, valid throughout the Community, is granted subject to a single risk assessment process under the responsibility of the European Food Safety Authority and a single risk management process involving the Commission and the Member States through a regulatory committee procedure.
Applications are submitted first to the competent authority of the Member State where the product is first to be marketed. The application must clearly define the scope of the application, indicate which parts are confidential and must include a monitoring plan, a labelling proposal and a detection method for the new GM food or feed.
The national authority must acknowledge receipt in writing within 14 days and inform the European Food Safety Authority. The application and any supplementary information supplied by the applicant must be made available to EFSA which is responsible for the scientific risk assessment covering both the environmental risk and human and animal health safety assessment. Its opinion will be made available to the public and the public will have the possibility to make comments.
In general a time limit of 6 months for the EFSA opinion will be respected. This time limit can be extended if EFSA has to request further information from the applicant.
Within 3 months of receiving the opinion of EFSA and on the basis of that opinion, the Commission will draft a proposal for granting or refusing authorisation. The proposal will, be approved through qualified majority of the Member States within the Standing Committee on the Food chain and Animal Health, composed of representatives of the Member States.
If the Committee gives a favourable opinion, the Commission adopts the decision. If not, the draft Decision is submitted to the Council of Ministers for adoption or rejection by qualified majority. If the Council does not act within three months, the Commission shall adopt the decision.
Products authorised shall be entered into a public register of GM-food and feed. Authorisations will be granted for a period of 10 years, subject where appropriate to a post-market monitoring plan. Authorisations are renewable for 10-year periods.
So how many GMOs have been approved for use in food products? Products from 16 GMOs can legally be marketed in the EU These are: one GM soy and one GM maize approved under Directive 90/220/EEC prior to the entering into force of the Novel Food Regulation and processed foods derived from inter alia seven GM oilseed rape, four GM maize and oil from two GM cottonseeds.
These products have all been notified as substantially equivalent in accordance with the Novel Food Regulation. Nine GM foods are currently pending at different stages in the authorisation procedure, including products from GM maize, sugar beat and soy bean.
With regards to the new rules on the traceability of GMOs, under the rules of Regulation 1830/2003 on labelling and traceability, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market.
In particular, the requirements are that: operators shall have systems and procedures in place to identify to who and from whom products are made available. For GMOs intended for deliberate release into the environment, operators must transmit specified information on the identity of the individual GMOs a product contains.
For GMOs intended for food, feed or for processing, business operators may either transmit the specified information mentioned above or transmit a declaration that the product shall only be used as food or feed or for processing, together with the identity of the GMOs that 'have been used' to constitute the original mixture from which the product arose.
For food and feed produced from GMOs operators need to inform the next operator in the chain that the product is produced from GMOs. Operators have to retain the information for five years and make it available to competent authorities on demand.
Transmission and keeping records of this information will reduce the need for sampling and testing of products, says the Commission.
The regulation covers all GMOs that have received EU authorisation for the placing on the market, that is all products, including food and feed, containing or consisting of GMOs. Examples are seeds, which have been genetically modified and bulk quantities or shipments of whole GM grain, for example soybean and maize.
The regulation also covers food and feed that are derived from a GMO. This includes tomato paste and ketchup produced from a GM tomato or starch, oil or flour produced from a GM maize.
Regulation 1830/2003 on labelling and traceability provides for comprehensive information by labelling all food and feed containing, consisting of or produced from a GMO. All food, including soya or maize oil produced from GM soya and maize, and food ingredients, such as biscuits with maize oil produced from GM maize must be labelled.
The label has to indicate "This product contains genetically modified organisms" or "produced form genetically modified (name of organism)".
The same rules apply to animal feed including any compound feed that contains GM soya. Corn gluten feed produced form GM maize must also be labelled. This is to give livestock farmers accurate information on the composition and properties of feed.
Minute traces of GMOs in conventional food and feed could arise during cultivation, harvest, transport and processing. Whether we like it or not this has become a reality.
With this background, in order to ensure legal certainty thresholds have been established above which conventional food and feed have to be labelled as consisting of or containing or being produced from a GMO. The presence of GM material in conventional food does not have to be labelled if it is below 0.9 per cent and if it can be shown to be adventitious and technically unavoidable.
In line with the general EU rules on labelling, the regulation does not require labelling of products such as meat, milk or eggs obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products.
The new rules allow the presence of traces of GM material which have received a favourable scientific assessment, but which are not yet formally approved.
A number of GMOs have already been assessed by the Scientific Committees advising the European Commission as not posing a danger to environment and health, but their final approval is still pending. The regulations allow the presence of these GMOs in a food or feed up to a maximum of 0.5 per cent below which labelling and traceability will not be enforced. Above 0.5 per cent it is prohibited to put the product on the market.
"This exemption aims to solve the problem faced by operators who have tried to avoid GMOs, but find that their products contain a low percentage of GM material due to accidental or technically unavoidable contamination," said the Commission.
And finally. "The EU's regulatory system for GMO's authorisation is in line with WTO rules: it is clear, transparent and non-discriminatory."