GM directive deficiencies in the European Union (original) (raw)
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The EU regulatory framework on GMOs has always been featured by a high degree of har-monisation and centralisation, resulting in a loss in its States' regulatory power. However, the EU harmonisation process has gone through several controversies over the years; as a consequence, the EU institutions have increasingly striven to support the pressing requests of Member States with a view towards granting the latter greater room to manoeuvre and decide as regards GMOs cultivation, starting from coexistence concerns. This article briefly analyses the changes recently introduced by means of Directive 2015/412/EU as regards the cultivation of GMOs, from the point of view of the evolution of the EU regulatory framework and national attitudes towards the risks and benefits linked to biotechnology derived products and their production. According to the new Directive 2015/412, amending Directive 2001/18/EC on the deliberate release into the environment of GMOs, Member States are entitled to enact measures restricting or banning the cultivation of GM crops on their territory complying with several so called " compelling grounds ". In the light of the diverse nature of such reasons, and considering the hostility expressed by Member States towards GMOs over the years, some doubts arise as to whether the exercise of the new regulatory powers by Member States will comply with the 'EU acquis'. What is certain is that today, after more than a decade since the big reform of 2001-2003, the EU GMO regime is still one of the much-contested policy sectors in the EU.
2021
2.3.3 Comitology reform: changing the rules of the game 2.3.4 Implications of regulatory strategies 3. Research question 4. Outline CHAPTER 3 GM crop authorisations: undecisiveness caused by political conflict 1. Introduction 2. Decision-making on GM crops 2. 1 A brief overview of characteristics of decision-making 2.2 Contributions and limitations of decision-making in a scientific, societal and regulatory context 2.2. 1 Science does not compel action 2.2.2 Public opinion compels various and conflicting actions 2.2.3 Regulations do not determine the outcome: law in books # law in action 3. Undecisiveness about GM crops as a political conflict 3. 1 Politics = decision-making in cases of conflict 3.2 Indicators of political conflict in biotechnology 4. Hypothesis CHAPTER 4 Ethics of dissent: a plea for restraint in the scientific debate about the safety of GM crops the regulations, such as a safety assessment (see Directive 2001/18/EC resp. Annex IA, part 1, Annex IA, part 2 and Annex IB). European regulations provide requirements which EU MS need to implement in their own legislation. There are Directives and Regulations [20] for different applications such as contained use (i.e. laboratory experiments), deliberate release into the environment (i.e. field trials with plants) and commercialisation (i.e. market authorisation of GM crops, pharmaceutical products and gene therapy). For the purpose of this thesis I will not discuss all GMO Directives and Regulations, but zoom in on the relevant regulations for market authorisations of GM crops. Market authorisation of GM crops (import as food/feed and/or cultivation) is regulated on a European level and based predominantly on an assessment of food/feed and environmental safety (Directive 2001/18/EC and Regulation (EC) No. 1829/2003) and requirements for traceability (for food safety purposes) and labelling (Regulation (EC) No 1830/2003). When applying for market approval, applicants are required to provide data substantiating the food and environmental safety of their product, including reference material and a detection method that enables tracing the product in the food chain. The food and environmental safety are assessed by the EFSA [21] and competent authorities (CA) of the EU MS. Labelling and traceability requirements are assessed and validated by the by European Union Reference Laboratories for GM food and Feed (EURL GMFF). [22] In addition, in 2015 a Directive has come into force which, in addition to and separately from the safety assessment, enables MS to ban or restrict cultivation of GM crops on their territory based on non-safety arguments, such as socioeconomic aspects or environmental policy objectives (Directive (EU) 2015/412). 20 Directives lay down results that must be achieved by MS but they are free to decide how to transpose those directives into National Laws. Regulations have binding force throughout every MS and enter into force on a set date. 21 The European Food Safety authority is a European agency funded by the European Union that operates independently of the European legislative and executive institutions (Commission, Council and Parliament) and EU Member States. EFSA provides independent scientific advice and communicates on existing and emerging risks associated with the food chain, including the commercial application of GMO's. EFSA conducts food safety and environmental risk assessments of GM crops that are applied for market authorisation in the European Union. 22 The core tasks of the EURL GMFF are the scientific assessment and validation of detection methods for GM Food and Feed as part of the EU authorisation procedure and the provision of support to the National Reference Laboratories (NRL) for GMO control in the EU Member States. The EURL GMFF is supported by the ENGL, the European Network of GMO Laboratories, and hosted by the Joint Research Centre (JRC) of the European Commission. This means the GM plant needs to be characterised geno-and phenotypically [24] and its effects on the environment are compared to a similar non-GM plant in field trials. For the food safety assessment, the molecular composition of the plant is tested for potential toxic or allergenic effects. The assessment also includes mandatory 90 day feeding studies with rodents (see Section 5). Besides food and environmental safety assessments on specific applications, EFSA also publishes (non-binding) guidance documents on specific aspects of the risk assessments to assist applicants who want to file for market authorisation. Some of these guidance documents have been translated into legally binding texts. [25] Applications for market authorisations are also sent to EU MS who get the opportunity to assess the application and send their conclusion, remarks and questions to EFSA. Eventually, this results in a scientific opinion from EFSA that is sent to the EC (European Commission 2015). 4.2 REGULATORY DECISION-MAKING: COMITOLOGY Eventually, decision-making about GM crop authorisation lies not with the EFSA but with European and national government representatives. If the EFSA concludes that the product does not pose a risk to human health or to the environment and that additional requirements (such as traceability and labelling) have been met, the EC submits a draft implementing decision of authorisation to a committee made up from representatives of the MS. Here, a voting takes place that officially has to be scheduled within three months after publication of the EFSA scientific opinion. MS representatives vote under the rule of 'qualified majority' [26] or system of weighed voting defined in the Lisbon Treaty (EPRS 2014). Comitology refers to a set of procedures that give MS a say in the implementing acts of the EU. To understand the challenges of the comitology procedures with regard to GM crop authorisations, the working mechanism and role of comitology in Europe have to be explained first. 24 Genotype is constituted by an organisms' entire DNA (its hereditary information), its phenotype are the properties that we can observe such as morphology, development and behaviour in the environment. 25 Implementing regulation (EU) No. 503/2013 in accordance with Regulation (EC) No. 1829/2003. 26 A measure will be approved if it is supported by 55% of the Member States (15 out of 27), provided they represent 65% of the EU population.
Consistent risk regulation? Differences in the European regulation of food crops
Journal of Risk Research, 2018
In the EU legal system, there is a large difference between the procedures and requirements for the introduction of crops that are classified as genetically modified (GM) and crops not so classified. In order to investigate whether this regulatory divide is compatible with real risks two cases of GM crops and two cases of non-GM crops are scrutinized. It is concluded that the regulatory divide cannot be justified from the viewpoint of risk assessment, since the GM/non-GM dichotomy is not an accurate indicator of either health risk or environmental risk. Much better such indicators are available and should form the basis of a legislation aimed at preventing the introduction of crops that are harmful for human health or the environment. If the legislator has other reasons to regulate GM crops differently than conventional crops, then those reasons should be stated in the legislation and determine the types of measures that it prescribes.