Since the first products of GMO technology have been placed on the market -in particular in the food sector- major opposition has developed through environmental and consumer groups, bio-farming associations and super-market chains. As a consequence, the general public has little confidence in the industry and is suspicious of the technology. This situation has been exacerbated by the BSE crisis in the UK and more recently by the dioxin scare in Belgium and public trust has gradually been eroded.
There are now numerous factions involved in the debate on GMOs and opposition has arisen from considerably different backgrounds. Certainly, the concerns regarding potential adverse effects on human health or the environment are the main driving force for consumer and environmental groups. Experiments involving genetically modified crops have been destroyed by pressure groups and other interest groups have used the fear of the public to promote their own competitiveness, particularly in the fields of trade and marketing of processed food products. Organic produce has been promoted in the wake of the adverse publicity concerning genetically modified foodstuffs although it is notable that potential risks from untreated foodstuffs, mycotoxins for example, have received little attention.
In addition, the potentially high monetary value of genetically modified organisms (GMOs) and the impact on trade, the agricultural and environmental sector, on competitiveness as well as on product streams and production systems have caused complex, very controversial and often emotional national and international discussions. All manner of arguments, promises and concerns have been used to justify position and interest but often do not arise from a scientific or legal base. It has, however, become clear that Community legislation must visibly provide the necessary safeguards for human health and the environment if the biotechnology sector is to restore public confidence, move forward and contribute to the economic and social well-being of European citizens. More importantly perhaps, the manufacturers must be able promote the beneficial aspects of GMOs in food against a background of safety.
The issue of food safety encompasses the entire food production process and consequently, the regulatory framework must cover not only the final product but also the production and processing of raw material products used as ingredients. The back-bone of the Community regulatory framework is Directive 90/220/EEC on the deliberate release of GMOs into the environment and includes provisions for the initial placing on the market of GMO products and addresses their safety for human health and the environment. Such products, particularly those derived from genetically modified plants, may subsequently be authorised for use as ingredients in or as foodstuffs. Importantly, the authorisation procedure under Directive 90/220/EEC is based upon a comprehensive scientific assessment of risk and labelling rules which can be carried forward to the next stage of the food production process.
Directive 90/220/EEC came into force in October 1991 and until the introduction of the Novel Foods Regulation, covered products containing or comprising GMOs for food use. Genetically modified soybeans and maize were authorised for placing on the market and for use in food under Directive 90/220/EEC on 3 April 1996 and 23 January 1997 respectively but from May 1997, new products have required authorisation under the Novel Foods Regulation for use in foodstuffs. Authorisations for a further eight genetically modified crop plant species, including oilseed rape and other maize varieties, have since been granted under Directive 90/220/EEC but these products now cannot be used in foodstuffs until approval is granted under the Novel Foods Regulation. This also applies to the thirteen products that are currently within the authorisation procedure and pending approval under the Directive.
In light of the above, it is now not uncommon for simultaneous applications to be submitted under Directive 90/220/EEC and the Novel Foods Regulation to cover both the placing on the market of GMO products and their use as or in foodstuffs. Whilst the importation and processing of GMO products for food use is covered exclusively by the Novel Foods Regulation, authorisation under Directive 90/220/EEC is still required for cultivation and harvesting.
Genetically modified crop plants that have received approval to date have, in the main, been modified for tolerance to herbicides and resistance to insects. These crops have been promoted by the manufacturers as beneficial to the environment through use of safer herbicides and fewer pesticides. It has been much more difficult, however, for them to convince the public of the benefits from consuming such products (if, of course, the benefits do exist). The nutritional value of foodstuffs is often promoted as a marketing ploy and genetic modification of starch composition in potatoes and wheat and fatty acid content of oilseed rape has been carried out with the aim of increasing nutritional value of the end commodities. Such GMO products are not as yet commercially available although a number are awaiting submission or pending approval within the authorisation process. The retail price of foodstuffs is possibly a factor that greatly influences consumer choice and genetically modified tomato paste has accounted for some 50% of the market in the UK. This product was clearly labelled as genetically modified but importantly, was cheaper than paste made from conventional tomatoes.
The introduction of genetically modified food products in the United States has met with considerably less resistance from a general public who appear to have accepted the technology much more readily than the Europeans. Large areas of genetically modified maize, soybean and sugar beet crops are currently grown in the United States and it is notable that GMO products are approved much more rapidly under their authorisation procedure. Moreover, the authorisation system in the European Community under Directive 90/220/EEC has been heavily criticised by the United States on the basis that approvals are delayed by the exhaustive, drawn-out administrative procedures and an over-elaborate risk assessment. This has clearly restricted trade between the two nations in terms of importation of GMOs into Europe.
The approval process is set out in Part C of Directive 90/220/EEC which stipulates that products may not be placed on the market without a prior assessment of any risks to human health or the environment and without explicit authorisation from the authorities. Notifications for the marketing of genetically modified crop plants must importantly include an assessment of any risks to human health and the environment and also take account of the use of the product and results obtained from research and development releases under Part B of the Directive. Data with respect to the genetic modification, the biology of the genetically modified plant and the receiving environment have also to be included along with specific conditions for handling of the product and a proposal for packaging and labelling.
The Directive foresees an authorisation system that requires input from all Member States of the European Community. The authorisation procedure can be summarised as follows.
(a) The manufacturer or importer to the European Community must submit a product notification dossier to the competent authority of the Member State where the product is to be placed on the market in the first instance.
(b) The competent authority evaluates the product notification dossier within a set period of 90 days, which excludes any period where new information is sought from the applicant.
(c) In case of a negative evaluation the notification is rejected. In the case of a favourable opinion, the dossier is forwarded to the Commission and all the competent authorities of the other Member States who have the right to raise objections within a given time of 60 days.
(d) If there are no objections, the competent authority that carried out the original evaluation grants the consent for the placing on the market of the product which may then be placed on the market throughout the European Union.
(e) Where at least one objection is made, the Commission proposes to the Regulatory Committee, established under Article 21 of the Directive, the measures that need to be taken. Currently the Commission seeks the opinion of its Scientific Committee for Plants before drafting its Decision.
(f) In the case where the Regulatory Committee approves this Decision, the Commission adopts the proposed measures and the Member State that received the application is obliged to issue or refuse the consent accordingly.
(g) If the Regulatory Committee does not deliver an Opinion, the issue is transmitted to the Council for a Decision within 3 months.
(h) In the absence of the Council giving an opinion, the Commission is required under the Directive to adopt the proposed measure.
To date, eighteen GMO products in total have been authorised under the above system, including genetically modified vaccines and flowers in addition to crop plant species. It has, however, been accepted that these administrative procedures are somewhat cumbersome and have led to delays in the approval of some products. Moreover, a review of the Directive in 1996 suggested that the objectives for risk assessment were not clearly defined and this has hindered full harmonisation between Member States and led to disagreements during the approval procedure. The flexibility of the Directive was also questioned in that it did not provide for easy adaptation to technical progress.
Criticisms have also arisen regarding the lack of transparency in the decision-making process, including a lack of public access to the notification dossiers and participation in the review process. The public has also expressed the need for users of genetically modified material to be fully aware of the methodology by which these products have been produced so that they are able to make a more informed choice.
The issue of labelling has again been a subject of controversy and some Member States have objected to the marketing of products where the labelling does not indicate that they are genetically modified. Specific provisions for labelling are certainly foreseen in product legislation and the issue has been at least partially addressed by the amendment to Directive 90/220/EEC in June 1997. It is, however, essential to take continued account of the need to inform consumers and to comply with the international obligations of the Community.
There is clearly a need for regular updating and adaptation of this Directive in order to keep pace with scientific and technological progress in such a rapidly developing sector. In February 1998, in line with the above shortcomings, the Commission adopted a Proposal amending Directive 90/220/EEC. This modification focused on the need for increased transparency of the decision making process, common principles for the risk assessment, mandatory monitoring and a science based approach for the decisions regarding consents for placing products on the market.
Further input from the European Parliament has introduced additional amendments that focus on the precautionary principle, antibiotic resistance marker genes, strengthening of control measures and socio-economic aspects such as the consideration of agricultural practice as part of the risk assessment. Clarification of the text and inclusion of new elements has led to more transparent and stringent provisions and on this basis, the Commission has agreed to the revisions.
A political agreement to take the revised Directive forward was reached at the Environmental Council meeting of 24/25 June 1999 following clarification of a number of operational aspects of the Directive including the scope, definitions and administrative procedures.
The revised Directive introduces the following changes to the standard procedure for authorisation of products as a means to strengthen and speed up the evaluation process and to increase transparency.
In addition, the revised Directive introduces an additional, streamlined procedure for the renewal of consents or for cases where new information with regard to the risks of the GMOs to human health or the environment becomes available. It also includes a possibility for establishing a differentiated standard procedure in terms of lighter information requirements for specified GMOs on the basis of safety and familiarity.
The revised Directive also provides that consent shall be granted for a maximum period of 10 years when GMOs are placed on the market for the first time allowing for new information to be considered prior to the granting of subsequent consents. In the case of renewal of consent, the time limitation is optional and may be limited as appropriate.
The status of Directive 90/220/EEC as the primary legislation within the Community regulatory framework for biotechnology has been strengthened and exemption for products authorised under other Community legislation will only apply under certain conditions. These conditions specify that other Community legislation has to be at least equivalent with regard to risk assessment, risk management, monitoring as appropriate, labelling, information to the public and the safeguard clause.
Mandatory labelling and traceability of GMOs at all stages of the placing on the market has been suggested and it must be clearly stated on the label that the product contains genetically modified organisms. In certain cases, thresholds may be established for products where adventitious or technically unavoidable traces of GMOs cannot be excluded and products contaminated with GMOs below these thresholds will not have to be labelled as genetically modified. Precise threshold values are currently being discussed in line with the introduction of a similar threshold scheme under the Novel Foods Regulation to maintain consistency. This labelling scheme must be practical to implement and should ensure the identity of such products when used as ingredients in novel foods with a confirmation that their safety has been comprehensively assessed.
The political agreement on the revision of Directive 90/220/EEC clearly reflects the need for a more transparent, efficient and effective system to alleviate public concern but the importance of retaining the strict scientific and risk-based approach of the existing Directive has not been overlooked. Whilst a certain degree of fine-tuning will be required before these new provisions are adopted, notifiers have already confirmed a voluntary commitment to take the more stringent criteria into account when submitting new applications for approval. This should ensure a smooth transition between the existing system and forseeable structure of the amended Directive.
The recent developments in the field of biotechnology and the current public concern demand that the industry is well regulated and that any potential risks to human health and the environment from GMO products must be comprehensively assessed at an early stage, particularly when their use is for food. To gain public confidence in the technology will clearly require assurances of lack of risk and this can only be achieved through a stringent and transparent regulatory framework with public involvement. The Commission is satisfied that the revised Directive will provide for an effective and efficient regulatory framework and will ensure that both public concerns and the interests of industry are taken into account. A more stringent and transparent approach may convince the public of the safety of GMO products. Provision of an informed choice is paramount but ultimately the continued production and consumption of such products are likely to be decided by other issues including cost benefits, personal preference and political decisions.