The advent of new European legislation on genetically modified organisms - applicable as of last week - will hit all players in the food industry. In a bid to render the new rules clearer we have decided to take the step to publish an outline of the legislation as presented by the European Commission this week.
What is the EU regulatory framework for GMO authorisation?
Genetically modified organisms (GMOs) and genetically modified micro-organisms (GMMs) can be defined 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.
Three main legal texts constitute the EU framework on genetically modified organisms (GMO).
The first one contains the rules regarding the deliberate release of GMOs into the environment (Directive 2001/18/EC, which replaces Directive 90/220/EEC). This Directive is applicable since 17 October 2002. Eighteen GMOs have been approved under Directive 90/220/EEC 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.
The second is a regulation on GM Food and Feed (Regulation (EC) No 1829/2003) which is in force since 7 November 2003 and will have to be applied after a transitional period as of April 2004. It replaces the GM part of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. Already, 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. - 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.
The third is a regulation on traceability and labelling of GMOs and traceability of food and feed produced from GMOs (Regulation (EC) No 1830/2003) laying down comprehensive traceability requirements for GMOs as well as food and feed produced from GMOs. The regulation enters into force on 7 November 2003.
Approval of new GMO products for environmental release and placing on the market
Twenty one applications for the placing on the market of GMOs have been submitted into the authorisation procedure under Directive 2001/18/EC (Annex 3), e.g. maize, oil seed rape, sugar beet, soy beans, cotton, rice, fodder beet. Eleven of these applications have scopes restricted to import and processing, while the remainder also include cultivation as a requested use.
The procedure for authorisation as specified under Part C of Directive 2001/18/EC is divided into three main periods.
A 'national period' where the lead Competent Authority (CA) has up to 90 days, from the date of receipt of the application, to prepare and submit an assessment report. During this 90-day period the 'clock' can be stopped if the lead CA is awaiting additional information from the notifier to complete the notification, thus extending the deadlines.
A 'Community period', which comprises a 105-day period, which can be sub-divided into two phases. During the first 60 days, the competent authorities of Member States can raise reasoned objections to the application. The final 45 days of the 105-day period is akin to a 'conciliation-type step', where the Commission, lead and objecting competent authorities can try and reach agreement.
Consultation of the European Food Safety Authority (EFSA) if objections based on environmental or human health considerations are not withdrawn by all Member States at the end of the above 45-day period. The EFSA is required to provide an opinion within 90 days.
The most advanced of the above 21 applications in the procedure is the Monsanto NK603 GM maize, which is currently being reviewed by EFSA (step iii). This application is for import and processing. It does not include cultivation as a requested use. An EFSA opinion is expected on 4 December 2003 in line with the 90-day deadline.
Directive 2001/18/EC requires the Commission to adopt a decision following consultation of the Member States in a regulatory committee. Taking account of the above EFSA deadline and the necessary administrative procedures, the Commission intends to call a meeting of the Regulatory Committee in early February of next year.
A further application (Monsanto GT73 oilseed rape) is shortly to be formally submitted to the EFSA for evaluation and an opinion is expected early in 2004. The scope of this application is also limited to import and processing. The remaining applications are currently being appraised by national authorities under periods (i) and (ii) above. It should be noted that the 'clock' can be stopped at various stages in the procedure, where further information is requested from the applicant, effectively extending the deadlines and making it difficult to predict a time-scale for possible approval of these products.
National safeguard measures on GMOs under environmental legislation
Directive 90/220/EEC under its Article 16 (known as the safeguard 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.
Article 16 has been invoked by Member States on nine separate occasions, three times by Austria, twice by France, and once each by Germany, Luxembourg, Greece and the United Kingdom (Annex 4). The scientific evidence provided by these Member States as justification for their measures, was submitted to the Scientific Committee(s) for opinion. In all of these cases, the Committee deemed that there was no new evidence which would justify overturning the original authorisation decision.
National measures notified under Article 16 of Directive 90/220/EEC have now to be dealt with under the safeguard clause provision of Directive 2001/18/EEC (Article 23). In view of the new regulatory framework, the Commission has informed Member States that they should now withdraw their measures under Directive 90/220/EEC and lift the prohibitions.
Approval of new GMO products as food
Article 46(1) of the Regulation 1829/2003 on GM Food and Feed provides that applications for the authorisation of a GM food made under the Novel Foods Regulation which have received a final scientific assessment before the coming into application of the new regulation are still to be processed under the Novel Foods Regulation. Authorisation for a GM food will include labelling and traceability provisions as required by the new law.
There are currently eight GM products pending authorisation under the Novel Food regulation (for details see the list attached in Annex 5) e.g. maize, soybean and sugar beet.
The scientific risk assessment has been completed for two of the applications, a GM sweet maize from Syngenta (Bt11) and a GM field corn from Monsanto (GA21). An opinion with regard to the draft decision to authorise Bt11 under the conditions as specified above could be expressed as early as 10 November or at the next meeting in December by the representatives of the Member States in the Standing Committee of the Food Chain and Animal Health by qualified majority. If no qualified majority is obtained, the decision will be referred to Council. Council has three months to act and to adopt or reject the proposed decision with qualified majority. Council could also decide not to act. In this case it will be upon the Commission to take a decision.
EFSA is currently evaluating an application from Monsanto concerning a GM maize line (NK603); the ESFA opinion is expected in December. The Commission is preparing the request for advice from the EFSA on two other maize lines from Monsanto (MON 863 and MON 810 X MON863). In both cases, the Commission has to await the advice from the EFSA before proceeding with these applications.
The four remaining applications are currently in the first stage of the authorisation process and are still undergoing risk assessment by a competent authority in a Member State. It is therefore difficult to predict when these products would be ready for authorisation.
National safeguard measures on GM foods
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 recently written to the Italian government asking it to repeal the Decree of August 2000.