Biosafety worldwide - Historical background

European Directives relating to GMOs

From the mid-1970s, as guidelines were being adopted by the NIH in the United States, several European countries (France, Germany, United Kingdom, Denmark) had already adopted measures aimed at ensuring the safety of laboratory activities involving recombinant DNA. These measures were the subject of an initial harmonisation at a European level in 1982 (Council Recommendation 82/472/EEC of 30 June 1982 concerning the registration of work involving recombinant deoxyribonucleic acid​), then in 1984 (Council of Europe Recommendation R(84)16 concerning notification of work involving recombinant deoxyribonucleic acid​) through texts inviting Member States to notify and register activities involving recombinant DNA in order to enable the potential enforcement of protective measures.

The necessity of implementing at a European level a specific legally binding regulatory framework for GMOs became more evident from 1985 due to the objective of the European Union to achieve a single market (an objective that was reached in 1993). It should be recalled that at that time (between 01/01/1986 and 31/12/1994), the European Union (which was then called the European Economic Community) comprised twelve Member States : Germany, Belgium, Denmark, Spain, France, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal and the United Kingdom. 

The lack of harmonisation of national regulations on the use of GMOs, or even the absence of regulations in certain Member States, was detrimental to the achievement of the internal market. The European Commission therefore had to push for a coherent regulatory approach within the Union with two major objectives: protecting health and the environment, while guaranteeing the free circulation within the European Union of products originating from genetic engineering. In 1986, the Commission announced, in a European Council communication, its intention to prepare proposals for biotechnology regulations (European Commission. Communication from the Commission to the Council, A Community Framework for the Regulation of Biotechnology Com 86(573) final. Brussels: CEC, 4 November 1986).

The European Directive is a juridical act that defines the objectives to be met by the Member States, to which it delegates the choice of methods. Once the Directive is adopted at a European level, it must be transposed into national law of each Member State, within fixed timeframes. The Directive is used to harmonise national legislations, particularly for a single market.​ 
The Commission thus endeavoured to establish Directives that would meet the challenges brought about by the development of recombinant DNA technologies:
- conciliate scientific and technical progress and safety;
- give basic and applied research the means for development and give industry the means to market useful products arising from this research, without hindering their efforts with paralysing bureaucratic controls.

After two years of internal work supervised by the European Commission Directorate General XI (Environment, Nuclear Safety and Civil Protection), a first proposal of text was submitted to the Member States (Proposal for a Council Directive on the contained use of genetically modified microorganisms. Proposal for a Council Directive on the deliberate release to the environment of genetically modified organisms. COM (88) 160 final - SYN 131, 4 May 1988). After long discussions, the European Union finally set up two "GMO Directives" on 23 April 1990, Directive 90/219/EEC on the contained use of genetically modified micro-organisms and Directive 90/220/EEC​ on the deliberate release of genetically modified organisms into the environment.

Straight away, one can see that the European Commission and the Member States chose to maintain the distinction that had emerged over time between the use of GMOs in a contained environment on the one hand (laboratories, greenhouses, animal houses, large-scale production facilities) and, on the other hand, their deliberate release into the environment (for the purposes of research or commercialisation). This distinction was based particularly on the differences existing between these two major categories of applications in terms of the nature of the risks and the protective measures to be implemented. It also reflected the stepwise approach of the development of GMOs. It was finally justified by the selection of a different legal approach for the two Directives.

Indeed, Directive 90/219/EEC was adopted on the basis of Article 130 S of the European Maastricht Treaty, i.e. with reference to the legal basis governing the European environmental policy. One of the features of this legal basis is that it enabled Member States who so wished to apply enhanced protective measures (as long as they were compatible with those set out in the Treaty), in accordance with Article 130 T of this same Treaty ("The protective measures adopted pursuant to Article 130 S shall not prevent any Member State from maintaining or introducing more stringent protective measures. Such measures must be compatible with this Treaty. They shall be notified to the Commission."). In the case of contained use, minimal harmonisation was therefore set at a Community level and Member States were able to apply stricter health and environmental protection regulations if they so wished.

Directive 90/220/EEC was adopted on the basis of Article 100 A of the Maastricht Treaty. This legal basis is specifically aimed at harmonising legislative, regulatory and administrative measures of the Member States (among which are product standards). On this basis, the European regulatory provisions strictly apply and national governments cannot amend the contents of these provisions. Legislation related to the environmental release of GMOs therefore has the primary objective of avoiding differences between the various national measures potentially generating competition. Harmonisation measures were aimed at establishing and ensuring successful running of the internal market, while ensuring a high level of environmental protection.

Another major feature distinguishes the two Directives: their scope. Whereas Directive 90/220/EEC applies to all GMOs (micro-organisms, plants and animals), Directive 90/219/EEC only covers genetically modified micro-organisms (i.e. bacteria, fungi, parasites and viruses). This limitation of scope of the "contained use" Directive (which did not appear in the initial proposal from the Commission) was contested by several Member States (including Belgium) during negotiations. It was nevertheless finally kept by the Commission to allow the adoption of the Directive, knowing that the Member States who so wished could, taking account of the flexible legal basis mentioned above, extend the scope to GMOs within the framework of the transposition into national law (which is what most of the Member States chose to do). It was also expected that the Commission would make an additional legislative proposal covering the contained use of GMOs but this proposal never came.

The two Directives provided a notification and authorisation system for activities involving GMMs or GMOs. They were procedural Directives. Their main objective was the preventive management of risks (aimed at the protection of human health and the environment). The Directives were based on the general principle that risks from any contained use or deliberate release of GMOs should be assessed on a case-by-case basis before an activity could be authorised. Furthermore, considering that European environmental regulation is based on the precautionary principle in the case of scientific uncertainties, it was considered necessary to adopt preventive measures against damage by taking into account the worst case scenario and therefore the highest risk. One can note that the Directives were qualitative in scope. Indeed, no limit value or quantitative threshold is mentioned.
The Directives also foresee the designation of competent authorities by the Member States specifically to implement their provisions and to communicate with the public. It is also worth mentioning that these Directives did not apply to the transport of GMMs or GMOs.

Revision of Directive 90/219/EEC

Within a short time of Directive 90/219/EEC entering into force, it was recognised by many within the EU that it was being rapidly overtaken by developments in gene technology and that the administrative procedures and notification requirements were not appropriately related to the risk of the contained uses. Furthemore, as a result of the extensive use of the techniques of genetic modification in many research laboratories and industrial facilities, there has been scientific evidence pointing to the safety of many types of contained use activities involving GMMs provided they are carried out by applying the principles of good microbiological practices and good occupational safety and hygiene.

Last but not least, the Commission's White Paper on Growth, Competitiveness and Employment, published in 1993, concluded that the Community should be open to reviewing its biotechnology regulatory framework, in order that the full potential of modern biotechnology for jobs, investment and growth could be realized.

Following this commitment, the Commission, in consultation with national Competent Authorities for implementation of the Directive, undertook such a review in 1993. Its objective was to ensure that the safety requirements and administrative procedures are appropriate to the risks for human health and the environment and reflect acquired experience, advances in scientific knowledge and established international practices. It also took account of the existing regulatory frameworks on modern biotechnology used by its main competitors, in particular the United States.

Discussions led to the publication by the Commission in December 1995 of a proposal for revision of the Directive. After hard negotiations, Member States reached in December 1996 unanimous political agreement on a modified version of the original Commission proposal.
According to the Treaty, that proposal had to go through several procedural steps:
- First opinion of the European Parliament on the proposal, delivered in March 1997 (OJ C 115, 14.4.1997, p. 59);
- Adoption by the Council of Ministers in December 1997 of a "common position" adapting its political agreement of December 1996 in the light of the Parliament's first opinion (OJ C 62, 26.2.1998, p. 1);
- Second opinion of the European Parliament in June 1998 based on the "common position" text (OJ C 210, 6.7.1998).

Directive 98/81/EC amending Directive 90/219/EEC was finally adopted by the Council on the 26th of October 1998.

In 2009, the European legislation on contained use has been recasted in the interests of clarity (due to the various amendments that were made and to the need to introduce new elements concerning the committee procedures). Directive 2009/41/EC repealing Directive 90/219/EEC has been published on the 21st of May 2009.

Revision of Directive 90/220/EEC

Directive 90/220/EEC was repealed in 2001 by Directive 2001/18/EC. This new directive sought to enhance the efficiency and transparency of the decision-making process while ensuring a high level of protection for human health and the environment. It clarified a series of operational aspects of Directive 90/220/EEC.

Its principal objectives were: to clarify the scope and definitions; to lay down common principles for case-by-case risk assessment; to enhance the risk evaluation and management processes (notably by taking due account of any direct or indirect, immediate or delayed, adverse effects, and of the requirement for the Commission to consult the competent scientific committees on any question which may affect human health and/or the environment); to improve the administrative procedures and authorisation system by introducing more stringent administrative deadlines; to improve the procedures for monitoring after placing on the market and to introduce a mandatory ten-year limit on the first authorisation; to increase the transparency of the decision-making process and allow for public consultation during the authorisation procedure; to establish registers for the purpose of recording information on genetic modifications in GMOs and on the location of GMOs; to introduce clear-cut requirements on the labelling and traceability of all GMOs placed on the market in accordance with the Directive.

In parallel with the development of this horizontal directive (in the sense that it relates to all GMOs, irrespective of their fields of application), sectoral regulations have also been gradually established in the EU. These regulations relate specifically to certain types of product, in particular those for use as food or feed, and medicinal products for human or veterinary use.

Until 1997, the placing on the market of GMOs or products derived from GMOs intended for use as food or feed was regulated by Directive 90/220/EEC. From 1997, food containing or consisting of GMOs was regulated by Regulation (EC) No. 258/97 on novel foods. These provisions on GM foods and derived products were replaced in September 2003 by Regulation (EC) No. 1829/2003 (also referred to as the "GM Food/Feed Regulation"). The scope of this Regulation extends not only to GMOs for use as food but also to those for use as feed (which had, up till then, been covered by Directive 90/220/EEC). Furthermore, in contrast to Directive 2001/18/EC which related solely to living GMOs, it also covers the placing on the market of food and feed derived from, but no longer containing GMOs.

This new Regulation establishes the principle of a single "one door – one key" authorisation based on two key factors:
- For GMOs for use as food or feed that are likely to be released into the environment, it imposes an environmental risk assessment to be undertaken in accordance with the principles laid down in Directive 2001/18/EC. It therefore creates a legal link between the "GM Food/Feed Regulation" and the GMO Framework Directive, so that a single procedure can be used for managing release into the environment and use as food or feed of a GMO;
- It establishes an authorisation procedure centralised at European level. When the European Food Safety System was revised, a new independent institution was in fact created to deal with risk assessment and communication: the European Food Safety Authority (EFSA). This Authority plays a central role in the risk assessment process and in contacts with the European institutions and notifiers. The Authority closely coordinates its activities with the Member States.

In the field of medical applications, specific sectoral legislation for the placing on the market of pharmaceutical products was established in the EU in 1993 (Regulation (EEC) No. 2309/93). For medicinal products derived from biotechnology, the authorisation procedure is centralised and managed by the EMA (European Medicines Agency, formerly the EMEA, the European Medicines Evaluation Agency). This European agency was established in 1995 for the evaluation of medicines and is primarily responsible for coordinating scientific assessment of European applications for marketing authorisation of medicinal products. In 2004, the abovementioned Regulation was replaced by Regulation (EC) No. 726/2004, itself supplemented a few years later by Regulation (EC) No. 1394/2007. The latter established a Committee for Advanced Therapies, including gene therapies aimed at restoring, correcting or modifying physiological functions. In this case too, a central authorisation procedure was put in place under the aegis of the EMA.
In the same way as for food, there is a legal link between the sectoral legislation on "medicinal products" and Framework Directive 2001/18/EC. From 1993, a requirement to undertake an environmental risk assessment for medicinal products composed of or containing GMOs, as defined in the GMO Framework Directive, was imposed by law.