EU Genetically Modified Organisms
Bernd van der Meulen (2007)
The EU Regulatory Approach to GM Foods
Kansas Journal of Law and Public Policy 16 Kan. J. L. & Pub. Pol’y 286 (2007)
The legal systematic analysis in this article provides a general background on EU food law. It discusses the authorisation procedure; the risk analysis methodology, EFSA’s role in risk assessment; the one-door-one-key principle; traceability requirements; GM labelling; liability and enforcement.
Bernd van der Meulen and Aylin Şule Songül 2019 (Turkish)
GENETİĞİ DEĞİŞTİRİLMİŞ GIDALARA AVRUPA BİRLİĞİ’NİN HUKUKİ YAKLAŞIMI
European Institute for Food Law working paper 2019/03
Türkçe’ye çevirisi Aylin Şule Songül tarafından yapılan söz konusu çalışma Bernd van der Meulen tarafından Kansas Üniversitesi Hukuku Fakültesi’nde (ABD) sunulan Yargıç Nelson Timothy Stephens’ın AB’nin genetiği değiştirilmiş gıdalara yaklaşımı hakkındaki dersinin yazılı metnini sağlamaktadır.
Hukuksal sistematik analiz AB Gıda Hukuku’nun gerisindeki görünüm hakkında genel bilgi sağlamaktadır. Onay prosedürünü, izlenebilirlik şartlarını, genetiği değişikliğin etiketlenmesini, sorumlulukları ve uygulanması konularını tartışmaktadır.
Bernd van der Meulen and Gema Fernández Albújar
What are GMOs? Enlightening the limping legal language
New Food issue 01 February 2018, p. 36-37
New Breeding Techniques (NBTs) have given rise to new debates on the scope of the concept Genetically Modified Organism (GMO) in EU law. This article discusses the issues.
Gema Fernández Albújar and Bernd van der Meulen
The Legal GMO concept. Reassessment of the GMO definition in the light of new breeding techniques (NBTs)
European Institute for Food Law Working Paper Series 2017/03
What are GMOs in a legal sense? According to the EU definition a GMO is an organism ‘in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. Does this definition refer to the organism, to the method by which it has been obtained or to both? This question has become acute with the emergence of New Breeding Techniques (NBTs) in particular when non-traditional methods have been used to achieve results that also could occur naturally. Are such products that could have been obtained by traditional breeding techniques GMOs? The French Conseil d’état has asked a preliminary ruling from the Court of Justice of the EU (CJEU). Unfortunately, the Conseil d’état failed to clearly phrase the question that needs to be answered. The authors express the hope that the CJEU nevertheless will be able to provide a meaningful answer. They provide an introduction to NBTs and argue in favour of a product based interpretation.
Bernd van der Meulen and Neshe Yusuf
One-Door-One-Key Principle: Observations Regarding Integration of GM Authorization Procedures in the EU
Penn State Law Review Vol. 118:4 2014, p. 877-891
Under European Union (EU) law, genetically modified organisms (GMOs) for consumption require authorizations for cultivation, for use in human food, and for use in animal feed. The recast of the legislative framework in 2003 introduced the “one-door-one-key principle.” This principle links and integrates the procedures to acquire these three authorizations partly in a mandatory and partly in an optional manner. Even though the EU legislature perceives the three authorizations as intrinsically linked, in practice considerable differences can be observed in the presence of GMOs on the EU market for cultivation, for feed use, and for food use. Partly these differences are reflected in differences in authorization.
This paper traces the one-door-one-key principle in EU GMO food law; its content is an application. Based on literature and a few interviews, it attempts to explain the gap between legal theory and business practice.
Dennis Eriksson, Eugénia de Andrade, Borut Bohanec, Sevasti Chatzopolou, Roberto Defez, Nélida Leiva Eriksson, Piet van der Meer, Bernd van der Meulen, Anneli Ritala, László Sági, Joachim Schiemann, Tomasz Twardowski, Tomáš Vaněk (2018)
Why the European Union needs a national GMO opt-in mechanism
Nature Biotechnology, vol. 36 nr. 1, 2018 p. 1-2
The paper suggests that the European Commission develop a new Directive that will allow individual EU Member States to authorize cultivating a GM crop in their territories after the European Food Safety Authority (EFSA) has, pursuant to this Directive or to Regulation (EC) 1829/2003, concluded that the GM crop in question is as safe as the organism from which it is derived.
Bernd van der Meulen (2007)
The EU Regulatory Approach to GM Foods
Kansas Journal of Law and Public Policy 16 Kan. J. L. & Pub. Pol’y 286 (2007)
The legal systematic analysis in this article provides a general background on EU food law. It discusses the authorisation procedure; the risk analysis methodology, EFSA’s role in risk assessment; the one-door-one-key principle; traceability requirements; GM labelling; liability and enforcement.
Bernd van der Meulen and Aylin Şule Songül 2019 (Turkish)
GENETİĞİ DEĞİŞTİRİLMİŞ GIDALARA AVRUPA BİRLİĞİ’NİN HUKUKİ YAKLAŞIMI
European Institute for Food Law working paper 2019/03
Türkçe’ye çevirisi Aylin Şule Songül tarafından yapılan söz konusu çalışma Bernd van der Meulen tarafından Kansas Üniversitesi Hukuku Fakültesi’nde (ABD) sunulan Yargıç Nelson Timothy Stephens’ın AB’nin genetiği değiştirilmiş gıdalara yaklaşımı hakkındaki dersinin yazılı metnini sağlamaktadır.
Hukuksal sistematik analiz AB Gıda Hukuku’nun gerisindeki görünüm hakkında genel bilgi sağlamaktadır. Onay prosedürünü, izlenebilirlik şartlarını, genetiği değişikliğin etiketlenmesini, sorumlulukları ve uygulanması konularını tartışmaktadır.
Bernd van der Meulen and Gema Fernández Albújar
What are GMOs? Enlightening the limping legal language
New Food issue 01 February 2018, p. 36-37
New Breeding Techniques (NBTs) have given rise to new debates on the scope of the concept Genetically Modified Organism (GMO) in EU law. This article discusses the issues.
Gema Fernández Albújar and Bernd van der Meulen
The Legal GMO concept. Reassessment of the GMO definition in the light of new breeding techniques (NBTs)
European Institute for Food Law Working Paper Series 2017/03
What are GMOs in a legal sense? According to the EU definition a GMO is an organism ‘in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’. Does this definition refer to the organism, to the method by which it has been obtained or to both? This question has become acute with the emergence of New Breeding Techniques (NBTs) in particular when non-traditional methods have been used to achieve results that also could occur naturally. Are such products that could have been obtained by traditional breeding techniques GMOs? The French Conseil d’état has asked a preliminary ruling from the Court of Justice of the EU (CJEU). Unfortunately, the Conseil d’état failed to clearly phrase the question that needs to be answered. The authors express the hope that the CJEU nevertheless will be able to provide a meaningful answer. They provide an introduction to NBTs and argue in favour of a product based interpretation.
Bernd van der Meulen and Neshe Yusuf
One-Door-One-Key Principle: Observations Regarding Integration of GM Authorization Procedures in the EU
Penn State Law Review Vol. 118:4 2014, p. 877-891
Under European Union (EU) law, genetically modified organisms (GMOs) for consumption require authorizations for cultivation, for use in human food, and for use in animal feed. The recast of the legislative framework in 2003 introduced the “one-door-one-key principle.” This principle links and integrates the procedures to acquire these three authorizations partly in a mandatory and partly in an optional manner. Even though the EU legislature perceives the three authorizations as intrinsically linked, in practice considerable differences can be observed in the presence of GMOs on the EU market for cultivation, for feed use, and for food use. Partly these differences are reflected in differences in authorization.
This paper traces the one-door-one-key principle in EU GMO food law; its content is an application. Based on literature and a few interviews, it attempts to explain the gap between legal theory and business practice.
Dennis Eriksson, Eugénia de Andrade, Borut Bohanec, Sevasti Chatzopolou, Roberto Defez, Nélida Leiva Eriksson, Piet van der Meer, Bernd van der Meulen, Anneli Ritala, László Sági, Joachim Schiemann, Tomasz Twardowski, Tomáš Vaněk (2018)
Why the European Union needs a national GMO opt-in mechanism
Nature Biotechnology, vol. 36 nr. 1, 2018 p. 1-2
The paper suggests that the European Commission develop a new Directive that will allow individual EU Member States to authorize cultivating a GM crop in their territories after the European Food Safety Authority (EFSA) has, pursuant to this Directive or to Regulation (EC) 1829/2003, concluded that the GM crop in question is as safe as the organism from which it is derived.