Should EU legislation be updated? Scientific developments throw new light on the process and product approaches

The EU legislation on genetically modified organisms (GMOs) is no longer in step with scientific  developments in plant biotechnology. As a result it is no longer clear what should be considered to be GMOs and this has led to an uneven playing field for the European plant breeding industry compared with their colleagues in North America. It also undermines consumer choice and strains the government’s credibility. This situation calls for a rethink of the European legislation.

In Europe a decision was made to introduce a specific regulation for GMOs in order to guarantee human and environmental safety. The reasoning behind this was that genetic modification can be used to create organisms with new characteristics that have never before existed in the environment, and would therefore involve inherent risks. The principles underlying the EU legislation are set out in Directive 2001/18.
 The EU legislation is referred to as a process-based legislation because the reason for passing it in the first place is the method of production – the process. The United States, Canada and some other countries have chosen to place GMOs under the general legislation. In these cases the characteristics of an organism – the product – are the subject of the legislation. These characteristics are the reason for implementing the legislation (product-based legislation), regardless of the techniques used and the way in which the organism is produced. ‘Process’ therefore stands for the technique used to make the crop, in this case genetic modification. ‘Product’ stands for the crop and its characteristics.

Although from the start the difference between the principles underlying the legislation in the United States and the EU has been the subject of considerable debate, the actual consequences were limited. Until recently the use of genetic modification always resulted in a plant with a newly acquired character. In addition, the different legislative bases of the regulatory systems do not influence the method of assessing the implications for human and environmental safety. Safety assessment is always based on the characteristics of the product, regardless of the reason for carrying out the assessment in the first place.

However, new techniques in plant biotechnology have made it possible to use genetic modification in the development process without the final products (crops) having any new combinations of genetic material, making them indistinguishable from, or the same as, conventional plant breeding products. In principle, these crops fall under the EU GMO legislation. In other parts of the world, such as the US, these crops are considered to be conventional plant breeding products. This has consequences for the position of trade and industry, and also for consumer choice and government credibility.

In Europe these new crops are subject to an exacting and costly assessment regime, but not in the US, which creates an ‘uneven playing field’ for companies. Foreign companies can use these techniques and market the products outside Europe without having to invest heavily in GMO authorisation procedures; European companies do have to incur these costs. Moreover, this undermines consumer choice. If these products are imported into the EU they are not identifiable as GM products because they cannot be distinguished from conventional plant breeding products. Although under EU regulations these products have to be labelled as GMOs, there is little chance of this actually happening when they are imported because in the producing country they are not classified or registered as GMOs, and therefore cannot be identified as such. The EU has made consumer choice the cornerstone of its policy and so failure to label these products can damage the credibility of the government. This problem raises questions about the basis of the European GMO legislation.

In response to the earlier COGEM report on this topic, ‘New Techniques in Biotechnology’ (CGM/061024-02), a European working group was established at the instigation of the Dutch government with the task of investigating a number of new techniques and determining whether the products of these techniques should fall under the GMO legislation. We point out that an approach in which decisions on whether a technique or product falls under the GMO legislation are made on an ad hoc basis is probably inadequate. New techniques are continually being developed and in each case new appraisals will have to be made and fresh decisions taken. Such decisions will be contingent on the prevailing scientific insights and the political and social climate, which erodes the core values of consistency and continuity of policy. Neither do EU decisions on whether a specific technique does or does not lead to the production of GMOs under EU legislation resolve the problems arising from the different regulatory approach in countries like the US and Canada.

A radical recasting of the EU GMO legislation from a process-based to a product-based system would seem to offer prospects for overcoming the problems of new techniques and their applications, as well as the trade-related issues. There would then be no need to appraise each new technique separately because the production method would no longer be relevant. In addition, the main trading blocks in the world would be working with a similar sets of regulations. However, a change to a product-based GMO legislation in the EU would run up against two complications.

First, it would be more difficult to guarantee consumer choice because labelling of GMOs is closely linked to the process approach. Under a product-based approach GMOs are not considered to be a separate category and are thus not registered as such. Under a process-based regulatory approach GMOs are considered to be a separate category, are registered as such and can therefore be labelled appropriately.
 Consumer choice is the cornerstone of both Dutch and EU policies. This means that some form of registration is required to meet the demands of those consumers who wish to avoid GMOs altogether. This in turn raises the question of definitions: what is a GMO? A possible solution is to label ‘GMO-free products’. The question is whether reversing the labelling requirements will be an acceptable solution for those who wish to avoid being exposed to GMO products.
 Second, the process-based approach is firmly established in Europe and the regulations can only be changed with the approval of a qualified majority of EU countries. It is doubtful whether majority support can be found in Europe for such a change in the legislation.

A possible alternative solution to the dilemma thrown up the workings of the legislation and the emergence of new scientific applications may be found in the Cartagena Protocol on Biosafety. The Cartagena Protocol has been in force since 2003 and has been signed by 153 countries, including the EU member states. In the protocol a GMO, or ‘living modified organism’ in the words of the protocol, is defined as ‘any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology’. 

In the EU the Cartagena Protocol is implemented by EU Regulation 1946/2003. This regulation states that the definition of a GMO in the Cartagena Protocol means a genetically modified organism as defined in Directive 2001/18, despite the fact that Directive 2001/18 states that a GMO is an organism ‘in which the genetic material has been altered’. Regulation 1946/2003 therefore equates ‘altered’ with ‘a novel combination’. This means that there is room to interpret EU Regulation 2001/18 differently from the way it is currently interpreted, and in a way which makes the ‘new combination’ of genetic material the key issue. Plants developed using new biotechnological techniques but which do not contain a new combination of genetic material, such as ‘reverse breeding’ products, would then not fall within the scope of the EU GMO legislation. This has a number of advantages. Only plants or crops with new characteristics, and which are therefore identifiable and traceable, would then fall under the GMO legislation. Human and environmental safety would still be safeguarded, but it would be easier to verify the labelling of products. On the other hand, it would mean that consumers that reject the use of techniques involving genetic modification would be obliged to turn to ‘organic products’. Only products with an ‘organic’ label would then be guaranteed not to contain any material derived from biotechnological breeding techniques.
 Another advantage is that the EU legislation would not have to be amended, just interpreted differently. In addition, the greater emphasis on the fact that the plants or crops must possess new characteristics would make the EU regulations more compatible with ‘product-based’ legislation, helping to create a level playing field for European companies and avoid trade conflicts.

COGEM concludes that it would be worth raising the potential opportunities for bridging the differences outlined above within the EU.