Chapter 3 Regulatory Regime for Genetically Modified Organisms in the European
3.4 The Regulation on GM Food and Feed
3.4.6 The main changes between pre-2003 and post-2003 legislative framework
The year of 2003 could be seen as milestone in the development of EU’s legislation on GM food and feed. There are great changes and improvement contributed by the two regulations enacted in 2003. To start with, the GM food and feed were regulated in a single and specialized regulatory framework. Before 2003 the GM food was regulated as novel food, the feed which consist of or contains GMOs was generally regulated under the Deliberate Release Directive while the feed directly produced from GMOs was not covered by the legislation for GMOs.191 Secondly, EU completed the centralized authorization procedure for GM food and feed which under the former system the EU was only partly involved in the procedure. If the result of the assessment which was carried out by one competent authority of one Member State granted the GM food and feed to be placed on the market, and within certain period of time there was no comments received from the European Commission or other Member States, the application would be approved. However, based on the centralized authorization procedure, the European Commission is involved in the whole process of every single case.192 Moreover, the role of the EFSA in the assessment and evaluation was greatly enhanced. Before 2003, the competent authority of one Member State was in charge of processing the scientific evaluation. In case the
189 Regulation (EC) No 1829/2003, Art 12(2) and Art 24(2). In case of a GMO that has not yet been authorized, a presence of
5% maximum is considered not to constitute an infringement provided that this GMO has benefited from a favourable opinion from the Community Scientific Committee or the European Food Safety Authority before the date of application of Regulation (EC) 1829/2003, Art 47.
190 Regulation (EC) No 1829/2003, Art 12(3).
191 European Commission Evaluation of the EU legislative framework in the field of GM food and feed (2010) DG SANCO
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Member States objected, the scientific evaluation would have to be carried out by the Scientific Committee for Food of the European Union. After 2003 the EFSA was designed to independently complete all the scientific assessments.193
Furthermore, the labelling requirements of GM food product was used to be provided by the Regulation (EC) No 1139/98194 and Regulation (EC) No 49/2000195 while labelling
requirement for GM feed or for food and feed produced from GMOs was absent.196 The fourth
main development after 2003 is that the labelling requirements have been systematized and applicable to all food and feed consisting, containing of or produced from GMOs. and a tolerance threshold was introduced into the system allowing unintended and technically unavoidable presence of GMOs. and finally, before the year of 2003 there was no requirement for the submission and validation of detection method included in the legal regulation at the EU level. After the Regulation No 641/2004197 and Regulation No 1981/2006198 came into force, applications for authorization should include the detection methods and identification of transformation event and control samples of the food and animal feed which must be validated by the Community Reference Laboratory before the authorization.199
3.5 Multi-Level Governance of GMOs in the EU
It is increasingly difficult to identify clear lines dividing national from European Union competences.200 The EU has always been characterized by its multi-level governance, in which
193 Ibid.
194 Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain
foodstuffs produces from genetically modified organism of particulars other than those provided for in Directive 79/112/EEC.
195 Commission Regulation (EC) No 49/2000 of 10 January 2000 amending Council Regulation (EC) No 1139/98 concerning
the compulsory indication on the labelling of certain foodstuffs produced form genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC.
196 European Commission Evaluation of the EU legislative framework in the field of GM food and feed (2010) DG SANCO
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197 Commission Regulation (EC) No 641/2004 of 4 April 2004 on detailed rules for the implementation of Regulation (EC) No
1829/2003 of the European Parliament and of the Council as regards the application for the authorization of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presense of genetically modified material which has benefited from a favourable risk evaluation.
198 Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32
of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms.
199 European Commission Evaluation of the EU legislative framework in the field of GM food and feed (2010) DG SANCO
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authority is not allocated in a straightforward way to either the EU or the Member States. Instead, authority is dispersed along a spectrum of more or less national-centralized control. Multi-level governance calls on institutions that enable collaboration, learning, and discussion in order to escape the limited solutions or deadlocks that occur when using harder-edged techniques of law and government.201 Multi-level governance is not straightforward in respect
of GMOs, however, the classic mechanisms of multi-level governance are present in the regulatory framework for GMOs. The regulation of GMOs provides plenty of opportunities for different levels of governance to intervene in decision-making, and the legislative framework generally avoids recourse to single levels of authority, as well as building in opportunities for early discussion. For example, the centralization implies by the role of the European Food Safety Authority (EFSA) in assessing risk is mediated by obligations of networking and consultation with national authorities, and special obligations of transparency in respect of disagreement.
The above sections introduced the comprehensive legal framework in the EU regarding to the authorization, traceability and labelling of GMOs. The Food and Feed Regulation provided legal basis for regulating the food, food ingredients, and containing, consisting of or produced from GMOs and it also regulates GMOs used as source material for food and feed production, for example the cultivation. The Deliberate Release Directive regulates all kinds of GMOs, in comparing to the GM food and feed, the Directive focus more on the cultivation of GM plants. The aim of the authorization procedure set out by both pieces of acts is to the products in questions placed on the market would not have adverse effect on human and animal health as well as the environment. From this perspective, the center of the authorization is the risk assessment based on the scientific evidence that every authorization should be justified on the ground of scientific assessment.202 The EFSA plays a crucial role as it is designated by the
in Luc Bodiguel and Michael Cardwell (eds), The Regulation of Genetically Modified Organisms: Comparative Approaches (OUP 2010), p101
201 Governance also generally implies the involvement of civil society beyond ‘government’ although the focus here is
particularly on the legal arrangement of EU and national contributions to decisions. Multi‐level governance should also encourage consideration of the role and influence of sub‐national regions and international bodies such as the World Trade Organization (WTO).
202 Article 7 and Article 19 of the 2003 Regulation that the Commission may, take into account ‘other legitimate factors
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legislation to cooperate with competent authorities of Member States to process the scientific risk assessment.
According to the examination procedure provided in EU Regulation No 182/2011203, the decision making on authorization of GMOs shall follow the form of implanting acts adopted by the Commission. Therefore, the authorization process is very much centralized to the European Union level while the Member State also plays a crucial role in the process. There are two stages the Member States involved in which could influence the decision making: the Member States could vote on the draft decisions provided by the Commission in the Standing Committee and in case the decision is unable to be reached at the Standing Committee level, the Member States could vote in the Appeal Committee. The decision can be made either based on the qualified majority in favour of or against to. The qualified majority in defined in the as “…votes representing at least 55 percent of the 28 Member States, and at least 65 percent of the EU population. Where there is no qualified majority in favour of or against the draft decision in the Appeal Committee, the result is “no opinion”.204
The rules governing this procedure205 provide that where “no opinion” is issued by the Appeal
Committee, “the Commission may adopt the draft implementing act.”206 This wording in
certain extent gives the Commission the discretion. While regarding to the decision making of GMOs cases, the Deliberate Release Directive, the Food and Feed Regulation together with the Traceability and Labelling Regulation reduced the “margin for manoeuvre” of the Commission significantly.207
The process for authorizing GMOs broke down at the end of the 1990s, in the face of
203 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules
and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers.
204 European Commission, Communication From the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions—Reviewing the decision‐making process on genetically modified organisms (GMOs), COM(2015) 176 final, Brussels, 22.4.2015. 205 Regulation (EU) No 182/2011 206 Article 6(3) of Regulation (EU) No 182/2011. 207 European Commission Evaluation of the EU legislative framework in the field of GM food and feed (2010) DG SANCO Evaluation Framework Contract Lot3 (Food Chain)
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widespread public rejection of GM food and agriculture, and there were no authorizations between 1998 and 2004. The EU institutions and Member States ceased to apply the old legislation, and instead negotiated a new regulatory framework, composed of two key pieces of legislation, the Deliberate Release Directive and the Food and Feed Regulation. Since the entry into force of the Food and Feed Regulation in 2003, the Member States have not obtained a qualified majority in favour of or against a draft decision made by Commission on authorizing GMOs, including GMOs for cultivation or for GM food and feed. The result has always been “no opinion”. This situation has consistently happened at all stages of the authorization procedure both in the Standing Committee and in the Appeal Committee, under the current rules, and in the Council in the past.208
The authorization process is complicated, varying according to the level of agreement or disagreement between the Member States, and according to the uses for which the GMO is to be authorized, in particular, according to whether the GMO (including a seed or other plant propagating material) is ultimately for food or feed use or not. The key steps are a risk assessment by the EFSA, on the basis of information submitted by the applicant, and a decision on authorization by the Commission and Member States through the examination procedure set out by the Regulation (EU) 182/2011.209