In vitro meat cultivation and the CRISPR biotechnology
Regulating a modern PrometheusTo what extent do the EU restrictions on novel foods and GMOs undermine the
EU’s environmental policy?
Kristiaan Koop kristiaankoop@live.nl 12379077
European Union Law LLM Dhr. dr. L.J. Ankersmit 19 – 07 - 2019
1 Abstract
This thesis analyses Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Regulation 2015/2283 on novel foods, in light of the environmental efforts of the European Union. Both of these legal acts set out authorization processes which new biotechnologies need to go through in order for them to be applied in the EU.
Two recently emerged biotechnologies which have received a fair amount of attention due to their possibly environmentally conscious way of creating food and which fall within the scope of Directive 2001/18/EC and Regulation 2015/2283, the in vitro meat cultivation technology, where meat is created in a laboratory, and the CRISPR technology, which can cut and replace genes within the DNA of an organism, are addressed in this thesis in order to assess how the EU deals with bio-innovations in light of its own environmental policies.
These policies are set out in this thesis as well. Furthermore, the precautionary principle and the overarching system of risk analysis are also addressed. A special focus is put on the timeframe of both elements of the assessment; the length of the authorization processes and the ‘deadlines’ within the EU environmental obligations, such as the 40% reduction of greenhouse gas emissions by 2030.
The thesis concludes that the legal regimes can be brought more in line with the EU’s environmental objectives, and makes certain recommendations to achieve this, such as the inclusion of a simplified, substantial equivalence procedure in Regulation 2015/2283, a more process-based approach in Directive 2001/18/EC and an application of the precautionary principle which is more in line with the Commission Communication on the precautionary principle and Regulation 178/2002 on the general principles of food law.
2 Table of contents
List of abbreviations ... 3
1 Introduction ... 4
1.1 Preface and structure ... 4
1.2 Methodology and outline ... 6
2 Techniques and climate impact ... 7
2.1 In vitro meat ... 7 2.1.1 Technique ... 7 2.1.2 Climate impact ... 7 2.2 CRISPR ... 9 2.2.1 Technique ... 9 2.2.2 Climate impact ... 10
3 EU environmental obligations and policies ... 13
3.1 Framework and International agreements ... 13
3.2 Common Agricultural Policy ... 15
4 EU Regulation ... 16
4.1 In vitro meat ... 16
4.2 CRISPR ... 17
4.3 Precautionary principle ... 19
4.4 Risk analysis within EU food law ... 21
5 Challenges and discrepancies... 23
5.1 In vitro meat ... 23
5.2 CRISPR ... 24
5.3 Precautionary principle ... 27
6 Recommendations and possible solutions ... 30
6.1 In vitro meat ... 30
6.2 CRISPR ... 32
6.3 Precautionary principle ... 33
7 Conclusion ... 34
3 List of abbreviations
CAP Common Agricultural Policy
CJEU Court of Justice of the European Union
EFSA European Food and Safety Authority
EU European Union
GMO Genetically modified organism
GMO Directive Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
ibid source previously cited
Novel Foods Regulation Regulation 2015/2283 on novel foods
OJ Official journal of the European Union
TFEU Treaty on the Functioning of the European Union
4 1 Introduction
1.1 Preface and structure
‘Chinese scientist who gene-edited babies fired by university’
‘A Chinese scientist who created what he said were the world’s first “gene-edited” babies evaded oversight and broke ethical boundaries in a quest for fame and fortune, state media said on Monday, as his former university said he had been fired. He Jiankui said in November that he used a gene-editing technology known as CRISPR-Cas9 to alter the embryonic genes of twin girls born that month, sparking an international outcry about the ethics and safety of such research. Hundreds of Chinese and international scientists condemned He and said any application of gene editing on human embryos for reproductive purposes was unethical.’1
As can be seen in the news article above, biologic engineering is a sensitive topic, which might scrape past commonly held conceptions of ethics and morality.2 The vast amount of possibilities that, for example, gene editing has, might be conceived of as eerie. And maybe that is not entirely unjustified, as emerging biotechnologies can pose unknown risks to humans and/or the environment. At the same time, with severe environmental problems looming, one might ask himself how to employ emerging biotechnologies in combatting the causes as well as the consequences of man-made climate change.
In this thesis, two emerging technologies are addressed which have received a considerable amount of attention concerning their possibilities in reshaping the agri-food sector, a sector known for its large environmental impact; the in vitro meat cultivation technology, where, simply put, meat is created in a laboratory, and the CRISPR technology, which can be used to remove and replace genes within DNA in order to alter an organism. Both these biotechnological fields have been rather controversial, with gene-editing being strictly regulated after two health crises, and artificial meat creation having been regarded as ‘playing god’.3 This fear, of humans transcending the laws of nature and becoming creators, is the main theme of Mary Shelley’s Frankenstein, originally titled ‘Frankenstein; or, The
Modern Prometheus’.4 This inspired the subtitle of this thesis. Prometheus was a Titan who
1 Christian Shepherd, ‘Chinese scientist who gene-edited babies fired by university’ (Reuters, 21 January 2019)
<https://www.reuters.com/article/us-china-health-babies/chinese-scientist-who-gene-edited-babies-fired-by-university-idUSKCN1PF0RA> accessed 12 June 2019.
2 For example; Diana Caballero-Hernández, ‘Bioethics for biotechnologists: From Dolly to CRISPR’ (2017) 2
Open Agr J 160.
3 Patricia Stapleton, ‘From Mad Cows to GMOs: The Side Effects of Modernization’ (2016) 3 EJRR 517, 518;
Mrunalini Gaydhane et al, ‘Cultured meat: state of the art and future’ (2018) 3 Biomanufacturing Reviews 1, 6.
5 created mankind, and after Zeus took fire from mankind after receiving poor offerings, Prometheus gave fire back to man.5 It has been argued that this move caused Shelley to consider Prometheus as somewhat of a devil, for a reason in vitro meat might prove the solution to; fire seduced man to cook, and so fire seduced man to eat other animals’ meat.6
In vitro meat is mentioned in Article 3(2)(a)(vi) of Regulation 2015/2283, the so-called ‘Novel Foods Regulation’.7 Under this regime, a food which was not on the European market before 15 May 1997 has to go through an authorization procedure before it is allowed to be marketed on the European Market. The CRISPR technology is handled similarly. In case C-528/16 Confédération paysanne and Others the Court of Justice ruled that the mutagenesis exception under Annex 1B of the Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (‘the GMO Directive’), only can be applied to mutagenesis techniques which were developed after the Directive came into force.8 The CRISPR technique is a mutagenesis technique which was developed afterwards, so the exception does not apply. Hence the GMO authorization procedure must be followed in order to put food which was created through the CRISPR technology on the market.
The EU is prolific in terms of developing environmental goals. The EU is a party to the Paris Climate Agreement and has adopted corresponding legislation.9 The Paris Agreement sets out goals in both preventing climate change effects, by for example aiming at keeping the global increase of temperature under 2°C, as well as dealing with the consequences, by for example stipulating that ensuring food security is a fundamental priority within the agreement.10 The Common Agricultural Policy, which deals with the agri-food sector which accounts for more than 10% of the total greenhouse gas emissions in the EU, has incorporated throughout the years more and more environmental goals. The 2021-2027 CAP strategic plan consisted of nine objectives, two of which involve environmental efforts.11
In this research, it is assessed whether the EU system of regulating GMOs and novel foods undermines the environmental efforts of the EU. The term ‘a modern Prometheus’ was,
5 Greek Mythology, ‘Creation of Man by Prometheus’
<https://www.greekmythology.com/Myths/The_Myths/Creation_of_Man_by_Prometheus/creation_of_man_by _prometheus.html> accessed 12 June 2019.
6 Carol Adams, The Sexual politics of meat (20th Anniversary edn), Continuum New York, 154. 7 Regulation 2015/2283 of 25 November 2015 on novel foods [2015] OJL 327/1, art 3(2)(a). 8 Case C‑528/16 Confédération paysanne EU:C:2018:583 [2018] para 51.
9 Regulation 2018/1999 of 11 December 2018 on the Governance of the Energy Union and Climate Action
[2018] OJL 328/1; Commission, ‘2030 climate & energy framework’
<https://ec.europa.eu/clima/policies/strategies/2030_en> accessed 29 April 2019.
10 Paris Agreement (adopted 12 December 2015, entered into force 4 November 2016), art 2(1)(a) & preamble. 11 Commission, ‘Regulation establishing rules on support for strategic plans to be drawn up by Member States
6 by the way, not coined by Mary Shelley. Immanuel Kant came up with it for Benjamin Franklin, a political theorist known for being a Founding Father of the United States and for his experiments with electricity.12 I hope this intertwinement of legal theory and science can be seen throughout this thesis as well.
1.2 Methodology and outline
This research aims to assess to what extent the EU restrictions on the in vitro meat cultivation technology and the CRISPR technology, through the Novel Foods Regulation and GMO Directive are in line with the EU’s environmental policies.
What these technologies are and how they can positively affect the environment is set out in a descriptive analysis. Attention is given to multiple aspects of preventing climate consequences and problem mitigation, such as land and water use, greenhouse gas emissions and yield increase. After this, the European Union’s laws and policies on climate change are analysed, again through a descriptive analysis. This is done by addressing the environmental obligations of the EU, such as the Paris Agreement, to which it is party, as well as checking other EU policies, such as the agricultural framework it has set out for the coming years.
The legal regimes, which stipulate how the in vitro meat cultivation and CRISPR technologies are authorized within the EU, are assessed, with a specific focus on the timeframe of the authorization processes as time is a key element in preventing negative environmental effects as well as reaching the specific climate goals the EU has set for itself. The precautionary principle and the EU risk analysis system are also set out in this part. These topics are assessed descriptively as well.
After addressing these topics, the EU legal regimes are assessed in terms of how they correspond with the EU environmental goals and laws, and the possible problems that exist at this crossroad. If necessary, recommendations in terms of possible alterations to the EU legal approach that might improve these EU regimes regarding the EU environmental efforts are out. These assessments are normative with an external, legal realism perspective, as I will try to assess the law as to how it can serve a certain social, public policy objective, namely the environment. I have chosen this perspective as I believe European Union law is capable of serving, and ought to serve, environmental efforts. This research ends with a conclusion where the thesis is summarized and the research question is answered and the analysis is reflected upon.
7 2 Techniques and climate impact
2.1 In vitro meat 2.1.1 Technique
Inspired by the technique used in medicine for tissue regeneration of deteriorated muscle tissue with patients’ own cells, in vitro meat cultivation uses stem cells to create the meat tissue which forms the eventual end product.13 Stem cells from another animal are taken, which multiply and differentiate into muscle cells, which fuse and turn into muscle fibres.14 Once these fibres are mature they can be harvested and eaten just like regular animal meat.15 Currently, fetal bovine serum, which is taken from the blood of the heart of unborn cows, is mostly used to create to grow the tissue, although there are developments going on regarding plant-based alternatives for fetal bovine serum.16 A shift away from fetal bovine serum is considered to be needed in order to create in vitro meat on a commercial scale.17
2.1.2 Climate impact
It is said that the cow is ‘evolved to be a cow and make more cows, and not to be eaten by humans’ and that ‘it’s not very good at making meat’.18 About 30% of the world’s ice-free land surface is used for keeping animals and growing crops for their consumption.19 The livestock supply chain accounts for 14.5% of the global human-induced greenhouse gasses.20 In a 2012 study, it was estimated that livestock emissions account up to 12.8% of the total EU greenhouse gas emissions.21
Livestock production takes up a large share of water use and it is the main cause of loss of biodiversity.22 Unless the majority of people adopt a non-meat diet, new approaches to meat production are needed in order to achieve substantial improvements.23 Although meat
13 Jean-François Hocquette, ‘Is in vitro meat the solution for the future?’ (2016) 120 Meat Sci 167, 169. 14 ibid.
15 ibid.
16 Dirk Martens, Dutch House of Representatives, ‘Kweekvlees en vleesvervangers – Rondetafelgesprek’
(Youtube, 26 September 2018) <https://www.youtube.com/watch?v=PVEu6TSKhD0> accessed 21 April 2019.
17 ibid.
18 Patrick O. Brown, ‘The Future of Meat (Ep. 367)’ (Freakonomics podcast, 13 February 2019)
<http://freakonomics.com/podcast/meat/> accessed 21 April 2019.
19 European Parliament, ‘What if all our meat were grown in a lab?’ January 2018, PE 614.538.
20 Food and Agriculture Organization of the United Nations, ‘Tackling Climate Change through Livestock’
(2013) 15.
21 Hanna Tuomisto, Avijit Roy, ‘Could cultured meat reduce environmental impact of agriculture in Europe?’
(8th International Conference on LCA in the Agri-Food Sector, Rennes, October 2012) 1.
22 ibid. 23 ibid.
8 consumption in the EU rose over the last years, current estimates show a 0.87% decrease in the period 2018-2030.24
There are different ways to ‘feed’ the in vitro meat, which will all have different ecological footprints. Hence, it is hard to give one specific statistic that gives a specific, cut-and-clear outcome of the ecological improvement of a shift towards in vitro meat. It is generally, however, accepted as a possible significant environmental improvement.25 For example, if EU livestock meat production were to be replaced by in vitro meat using cyanobacteria hydrolysate, an alga, as main nutrition, EU greenhouse gas emissions would be reduced by 98.8%, land use by 99.7% and water use by 94%.26 Energy use for this type of in vitro meat was 38% higher than when producing poultry but lower for beef, sheep or pork.27 These numbers, however, only relate to producing meat; co-products such as leather and wool are not taken into account and may need a separate way of production.28
Figure 1. Comparison of environmental impacts of in vitro meat (using algae as nutrients) with European livestock meat29
24 Commission, ‘EU Agricultural Outlook for markets and income 2018-2030’ (2018) 60.
25 Neil Stephens et al, ‘Bringing cultured meat to market: Technical, socio-political, and regulatory challenges in
cellular agriculture’ (2018) 78 Trends Food Sci Technol 155, 164.
26 Tuomisto (n 21). 27 ibid.
28 ibid 4.
29 Hanna Tuomisto et al, ‘Environmental impacts of cultured meat: alternative production scenarios’ (9th
9 In vitro meat, although it is still in a developmental phase, can solve some of the most prominent issues that meat production carries with itself with regard to climate change. It can drastically reduce the emission of greenhouse gasses, it uses less water and land which is now used for herding livestock can be used more sustainably.
2.2 CRISPR 2.2.1 Technique
CRISPR (‘Clustered Regularly Interspaced Short Palindromic Repeats’) is a part in genomes where certain identical palindromic DNA is repeated after itself, and in between these repeats are unique DNA parts.30 So for example; ABA – 123 – ABA – 456 – ABA – 789 - ABA, where ABA is the identical palindromic DNA which is repeated, and the numbers are the unique DNA. The unique DNA corresponds to DNA of viruses which the genome is immune to, so that if one of those viruses attacks again, the genome releases a protein which carries a copy of the corresponding DNA (RNA) and then cuts the virus’ DNA.31 If there is a new virus and the genome manages to survive its attack, part of the virus’ DNA is saved in CRISPR.32 In that sense, CRISPR is a sort of database in genomes where viruses’ DNA is archived.33
In the CRISPR technology, this cutting of DNA is not used for attacking viruses, but to snip any DNA that one wants to edit. The technology allows for the reprogramming of the protein which does the cutting of the DNA (oftentimes the Cas9 protein is used, but more recently the Cpf1 protein), by implementing RNA which corresponds with the specific DNA targeted, so that that DNA is cut out.34 After the targeted DNA is cut out, two things can happen. Either the genome simply attaches the DNA back together (non-homologous end joining), or a template DNA can be added into it, which replaces the DNA that was removed (homology-directed repair).35
30 Aparna Vidyasagar, ‘What is CRISPR?’ (Livescience, 20 April 2018)
<https://www.livescience.com/58790-crispr-explained.html> accessed 25 April 2019; Rodolphe Barrangou, ‘The roles of CRISPR–Cas systems in adaptive immunity and beyond’ (2015) 32 Current Opinion in Immunology 36.
31 Barrangou (n 30).
32 US National Library of Medicine, ‘What are genome editing and CRISPR-Cas9?’
<https://ghr.nlm.nih.gov/primer/genomicresearch/genomeediting> accessed 25 April 2019; Barrangou (n 30).
33 Barrangou (n 30) 37. 34 ibid.
10 The CRISPR technology can target any region of DNA.36 Furthermore, it is more accurate, more efficient, cheaper and faster than other genome editing methods currently available.37
2.2.2 Climate impact
With regard to climate change, multiple challenges within the sphere of agriculture are of the highest importance the following decades; how to have less impact on the environment when creating food and how to tackle risks to food creation caused by climate change.38 CRISPR may be (part of) the solution for both of these problems.
Currently, CRISPR is used for the development of crops that have higher yields than originally possible. Yield and quality of crops are traits governed by multiple genes within the crops’ DNA.39 For example in rice, CRISPR has been used to edit specific genes in a manner that increases the grain size, the number of grains per panicle and the number of panicles per plant.40 A weight gain of 29,3% per rice grain has been achieved through CRISPR.41 Furthermore, the period before the rice reaches the heading stage, the period where rice can be taken from the plant, has been significantly shortened by using CRISPR.42 Similar yield increasing alterations have been successfully applied to maize, wheat, and tomatoes.43
Plants will respond to rising carbon dioxide levels by closing their stomata, tiny pores on the surface of plants, earlier, as the plants only take up the amount of CO2 as they need.44 This leads to the overheating of plants, as plants use their stomata to distribute water to cool themselves.45 Due to this overheating, plants may die or at least have less nutritional value.46
36 Vidyasagar (n 30).
37 Library of Medicine (n 32).
38 Aaron M. Shewa et al, ‘CRISPR versus GMOs: Public acceptance and valuation’ (2018) 19 Glob Food Sec
71, 71.
39 Rukmini Mishra, ‘Genome Editing in Rice: Recent Advances, Challenges, and Future Implications’ (2018) 9,
1361 Front Plant Sci 1, 6.
40 ibid. 41 ibid. 42 ibid.
43 Deepa Jaganathan et al, ‘CRISPR for Crop Improvement: An Update Review’ (2018) 9, 985 Front Plant Sci 1,
9; Zhengzhi Zhang et al, ‘Development of an Agrobacterium-delivered CRISPR/Cas9 system for wheat genome’ (2019) Plant Biotechnol J 1, 7; Daniel Rodríguez-Leal et al, ‘Engineering Quantitative Trait Variation for Crop Improvement by Genome Editing’ (2017) 171 Cell 470, 471.
44 Cawas Engineer et al, ‘CO2 sensing and CO2 regulation of stomatal conductance: advances and open
questions’ (2016) 21 Trends Plant Sci 16, 17.
45 ibid. 46 ibid.
11 CRISPR is currently used by scientists to increase the number of stomata and to regulate the behavior of the stomata to prevent overheating.47
Due to climate change, plants are increasingly susceptible to infections and diseases.48 CRISPR is currently used to modify plants’ genomes so that they can be resistant to certain diseases. In the West-African cacao sector, where about 75% of the worlds’ entire production of cacao comes from, diseases are a growing problem.49 In a 2018 study, CRISPR was used to remove the TcNPR3 gene, which suppresses the cacao plant’s disease response.50 Furthermore, CRISPR is used to make the cacao resistant to the black pod disease fungus.51 In 2016, however, CRISPR, was used not to counter fungi, but to help them prosper; Pennsylvania State University created white button mushrooms which degradation process was halted and do not go brown.52 In order to mitigate climate change effects, similar alterations were made to i.e. apples, bananas, grapes, oranges, and peaches.53
CRISPR is not only relevant with regard to plants in terms of climate change efforts. CRISPR is currently used in algae biofuel creation efforts.54 Algae create lipids, and these lipids can be used as fuel, similarly to how oil is used.55 Algae biofuel usage emits CO2, but only CO2 that has been taken from the atmosphere by the algae through photosynthesis.56 The
Nannochloropsis gaditana alga was modified so that it created twice as many lipids as it
normally does.57 Moreover, the CO2 to lipids conversion rate was increased from 20% to 40-55%.58
47 Anne Vatén, ‘Modulation of Asymmetric Division Diversity through Cytokinin and SPEECHLESS
Regulatory Interactions in the Arabidopsis Stomatal Lineage’ (2018) 47 Dev Cell 53.
48 Yegal Elad, Ilaria Pertot, ‘Climate Change Impacts on Plant Pathogens and Plant Diseases’ (2018) 28 J Crop
Improv 99, 101.
49 International Cacao Organization, ‘Quarterly Bulletin of Cocoa Statistics’ Vol. XLV, No 1; Marius Wessel,
Foluke Quist-Wessel, ‘Cocoa production in West Africa, a review and analysis of recent developments’ (2015) 74-75 NJAS 1, 2.
50 Andrew S. Fister et al, ‘Transient Expression of CRISPR/Cas9 Machinery Targeting TcNPR3 Enhances
Defense Response in Theobroma cacao’ (2018) 9, 268 Front Plant Sci 1.
51 Virginia M. G. Borrelli et al, ‘The Enhancement of Plant Disease Resistance Using CRISPR/Cas9
Technology’ (2018) 9, 1245 Front Plant Sci 1.
52 Ismail Eş et al, ‘The application of the CRISPR-Cas9 genome editing machinery in food and agricultural
science: Current status, future perspectives, and associated challenges’ (2019) 37 Biotechnol Adv 410.
53 Chittaranjan Kol et al, ‘Application of genomics-assisted breeding for generation of climate resilient crops:
progress and prospects’ (2015) 6, 563 Front Plant Sci 1, 6.
54 Imad Ajjawi et al, ‘Lipid production in Nannochloropsis gaditana is doubled by decreasing expression of a
single transcriptional regulator’ (2017) 35 Nature Biotechnology 647.
55 Dinabandhu Sahoo et al, ‘Using algae for carbon dioxide capture and bio-fuel production to combat climate
change’ (2012) 42 Phycological Society India 32, 34.
56 ibid 33. 57 Ajjawi (n 54). 58 ibid.
12 Additionally, CRISPR can also be applied to animals. Social acceptance might differ from the usage of CRISPR with regard to plants, but the technological possibility exists. CRISPR has already been applied to animals in a non-commercial manner, for example by creating cows that have an increased resistance to tuberculosis, or pigs which are resistant to the blue-ear pig disease.59 Other changes to animal DNA have been made which are not related to diseases, such as goats having more hair and captive salmon not being able to breed with wild ones.60
CRISPR is a method that can be applied to all DNA; its universality is why it can be of importance to many aspects that need ‘patching up’ in order to meet the EU climate goals. Yields increase, nutritional value increase and disease resistance, among other CRISPR possibilities, may decrease the nutrient usage, land usage (deforestation), water usage and the herbicide or pesticide usage. CRISPR can make livestock farming more efficient, and more climate-friendly. Additionally, CRISPR may be capable of reshaping biofuels sources, so that they can be CO2-neutral.
In the next chapter, the environmental laws, obligations, and policies of the EU are set out. The Common Agricultural Policy is addressed as well, as this policy is closely related to the environment and both the biotechnologies discussed create foods which are conventionally created through agriculture.
59 Yuanpeng Gao et al, ‘Single Cas9 nickase induced generation of NRAMP1 knockin cattle with reduced
off-target effects’ (2017) 18 Genome Biol 1; Christine Burkard et al, ‘Precision engineering for PRRSV resistance in pigs: Macrophages from genome edited pigs lacking CD163 SRCR5 domain are fully resistant to both PRRSV genotypes while maintaining biological function’ (2017) 13 PLoS Pathogens 1.
60 Xiaolong Wang et al, ‘Disruption of FGF5 in Cashmere Goats Using CRISPR/Cas9 Results in More
Secondary Hair Follicles and Longer Fibers’ (2016) 11 PLoS One 1; Rolf B. Edvardsen et al, ‘Targeted Mutagenesis in Atlantic Salmon (Salmo salar L.) Using the CRISPR/Cas9 System Induces Complete Knockout Individuals in the F0 Generation’ (2014) 9 PloS One 1.
13 3 EU environmental obligations and policies
3.1 Framework and International agreements
Article 3(3) of the Treaty on European Union states that the EU is to aim for improvement of the quality of the environment in establishing the internal market.61 Article 11 TFEU stipulates that environmental protection requirements must be integrated into the EU policies and activities.62 Environment is a shared competence under Article 4(2)(e) TFEU.63 In Article 191 TFEU environmental policy is set out more substantively, where it is set out that the environment is to be preserved, protected and improved, and a special focus is to be put on human health, the utilization of natural resources and climate change.64 Article 193 TFEU establishes that the EU measures based on Article 191 TFEU are minimum harmonization rules, meaning that Member States are allowed to adopt more stringent protective measures.65
Before the Paris Agreement was made, the main international legal instruments on environmental issues were the United Nations Framework Convention on Climate Change (UNFCCC) and the Kyoto Protocol.66 In 2009 world leaders got together to create the Copenhagen Accord, which has been regarded as a failure. The 2015 Paris Agreement, however, has been received positively.67 The EU is party to the Paris Agreement and has adopted legislation to meet the targets set out in the agreement.68 The Paris Agreement aims to hold the ‘increase in the global average temperature to well below 2°C above pre-industrial levels’.69 It furthermore stresses that parties will put effort into keeping those levels below a 1.5°C increase above pre-industrial levels, ‘recognizing that this would significantly reduce the risks and impacts of climate change’.70 The need to increase the ability to deal with adverse consequences of climate change is stressed throughout the agreement, with the parties to the agreement even stating in the preamble that food security, and ‘in particular vulnerabilities of food production systems to the adverse impacts of climate change’ are a fundamental priority.71
61 European Union, Treaty on European Union (Consolidated Version), Treaty of Maastricht, Official Journal of
the European Union C 325/5; 24 December 2002, art 3(3).
62 European Union, Treaty on the Functioning of the European Union (Consolidated Version), Treaty of Lisbon,
Official Journal of the European Union C 326/1; 26 October 2012, art 11.
63 ibid art 4(2)(e). 64 ibid art 191(1). 65 ibid art 193.
66 Steinar Andresen et al, ‘The Paris Agreement: Consequences for the EU and Carbon Markets?’ (2016) 4
Politics and Governance 188, 189.
67 ibid.
68 Regulation 2018/1999 (n 9); 2030 climate & energy framework (n 9). 69 Paris Agreement (n 10).
70 ibid.
14 The accompanying Decision to the Paris Agreement calls for increased action by developed countries.72 A pledge of 100 billion US Dollars per year by 2020 by developed countries was urged for, for the mitigation of and adaptation to climate change.73 A number of actions have flowed from the Paris Agreement. For example, 23 countries and the European Commission (on behalf of the European Union) started Mission Innovation as a result of the Paris negotiations.74 Mission Innovation aims to innovate in the energy sector so that global clean energy will be widely affordable in order to meet the Paris targets.75
In May 2018, the EU adopted the Regulation on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry (LULUCF) into the 2030 climate and energy framework.76 Member States are now obliged to compensate the same amount of CO2 emissions, as is emitted from land use, land use change or forestry.77
These policies are in line with the EU goals set out in the 2030 climate and energy framework, where it was decided that the EU should have at least a 40% cut in its greenhouse gas emissions (from 1990 levels), at a minimum a 32% share for renewable energy and at least 32.5% improvement in energy efficiency.78 In its Multiannual Financial Framework 2014-2020 the EU allocated 20% of its budget (€206 billion) to climate objectives.79 This percentage is increased to 25% (€320 billion) in the Multiannual Financial Framework for 2021-2027, where on multiple occasions explicit reference is made to the Paris Agreement.80 Also here not the only the prevention of climate change is mentioned, but also the mitigation of adverse effects of climate change.81
72 ‘Decision 1/CP.21, Adoption of the Paris Agreement’ Report of the Conference of the Parties on its
twenty-first session (Paris 30 November-13 December 2015) FCCC/CP/2015/10/Add.1, para 114.
73 ibid.
74 Mission Innovation ‘About MI’ <http://mission-innovation.net/about-mi/overview/> accessed 30 April 2019. 75 ibid.
76 Commission, ‘Land use and forestry regulation for 2021-2030’
<https://ec.europa.eu/clima/policies/forests/lulucf_en> accessed 1 May 2019.
77 ibid.
78 Commission, ‘A policy framework for climate and energy in the period from 2020 to 2030’ (Communication)
COM(2014) 15 final; Commission, ‘2018 assessment of the progress made by Member States as required by Article 24(3) of the Energy Efficiency Directive 2012/27/EU’ (Report) COM(2019) 224 final.
79 Commission, ‘Supporting climate action through the EU budget’
<https://ec.europa.eu/clima/policies/budget/mainstreaming_en> accessed 30 April 2019.
80 Commission, ‘Multiannual Financial Framework for 2021-2027’ (Communication) COM(2018) 321 final, 22. 81 ibid 95.
15 3.2 Common Agricultural Policy
The agri-food sector accounts for more than 10% of the total greenhouse gas emissions in the EU, it is one of the main actors which cause soil and water depletion.82 The objectives set for the Common Agricultural Policy (CAP) have evolved toward society’s needs, including environmental protection.83 Since the CAP was introduced in 1962, multiple developments have taken place which have attempted to pursue environmental efforts within the CAP. In the 1992 MacSharry reform, direct payments were introduced to encourage environmentally-friendly farming.84 In the 2003 Fischler reform the ‘cross-compliance’ concept was introduced, where environmental protection, health, and animal welfare were introduced as payment requirements.85 In the 2013 Ciolon reform, the direct payment system was increased so that it preferred food producers which took an effort in terms of climate action and sustainable resource management.86
In the 2021-2027 strategic plan, nine objectives are proposed for the future of the CAP. Among these nine are the climate change action objective and the environmental care objective.87 These objectives attempt to coordinate the CAP with international environmental efforts.88 Sustainable agriculture is part of the UN Sustainable Development Goals.89 The CAP environmental efforts, however, have been said to be too one-dimensional, and that multi-faceted approaches with non-CAP subjects are needed.90
In the following chapter, the Novel Foods Regulation and the GMO Directive are set out, as well as the precautionary principle and the risk analysis system within the EU, which overarches these legal regimes.
82 Francesca Recanati et al, ‘Assessing the role of CAP for more sustainable and healthier food systems in
Europe: A literature review’ (2019) 653 Sci Total Environ 908, 909.
83 ibid. 84 ibid.
85 Commission, ‘Cross-compliance’ <https://ec.europa.eu/agriculture/direct-support/cross-compliance_en>
accessed 1 May 2019.
86 Recanati (n 82).
87 Strategic plans Common agricultural policy (n 11). 88 Commission, ‘FOOD 2030
Future-Proofing our Food systems through Research and Innovation’ (2017)
89 UNDP, ‘Goal 2: Zero Hunger’
<http://www.undp.org/content/undp/en/home/sustainable-development-goals/goal-2-zero-hunger.html> accessed 1 May 2019.
90 Recanati (n 82) 912; Tuomas Kuhmonen, ‘Systems view of future of wicked problems to be addressed by the
16 4 EU Regulation
4.1 In vitro meat
Regulation 2015/2283 on novel foods, which went into effect January 1st, 2018, stipulates that new foods have to get permission from the Commission before they are allowed on the market.91 Article 3 sets out that ‘any food that was not used for human consumption to a significant degree within the Union before 15 May 1997’ is a ‘novel food’.92 If a novel food is authorized to be placed on the European market, it will be placed on the so-called ‘Union list’.93
Article 3(2)(a)(vi) seems to indicate in vitro meat is a novel food by setting out that ‘food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae’ fall within the scope of the regulation.94 On October 8th, 2018, European Commissioner Vytenis Andriukaitis explained to the European Parliament that in vitro meat ‘may fall in this category’.95 Currently, the Dutch government interprets the Novel Foods Regulation as to include in vitro meat.96
In order to get permission to put a certain food on the European market, the applicant must submit an application to the European Commission.97 The Commission may request the European Food and Safety Authority (‘EFSA’) to assess whether the product is liable to have an effect on human health.98 After the EFSA’s opinion is released or in case the opinion is not requested, the Commission creates a draft implementing act which it presents to the comitology committee, namely the Standing Committee on Plants, Animals, Food and Feed.99 If this committee gives its approval, the Commission will adopt the draft implementing act.100 The novel food will be placed on the Union list and will be allowed to be put on the European market. Before the new regulation came into force, the authorization process was not centralized and the average time between the receipt of the application by the national body and the Commission approving the application is around 40 months, with a range between 267
91 Regulation 2015/2283 (n 7). 92 ibid art 3(2)(a).
93 ibid art 6(1). 94 ibid art 3(2)(a)(vi).
95 Parliamentary questions of 8 October 2018, Answer given by Mr Andriukaitis on behalf of the European
Commission, E-004200/2018.
96 Han Ceelen, ‘De kweekvleeskwestie’ (Tegenlicht, 23 May 2018)
<https://www.vpro.nl/programmas/tegenlicht/lees/bijlagen/2017-2018/Vleeskwekers/De-kweekvleeskwestie.html> accessed 5 May 2019.
97 Commission, ‘Authorisations’ <https://ec.europa.eu/food/safety/novel_food/authorisations_en> accessed 6
May 2019.
98 Regulation 2015/2283 (n 7) art 10(3). 99 ibid art 12, 30(1).
100 ibid art 30(3); Regulation 182/2011 of 16 February 2011 concerning mechanisms for control by Member
17 and 3,523 days.101 There was a large divergence in application costs in Member States. In Belgium, the costs are €3,718.50, where in The Netherlands, where currently the most developments are regarding in vitro meat cultivation, the costs are around €25,838,00.102 With the new centralized procedure, the authorization period is aimed to take up a maximum total of twenty-four months.103
4.2 CRISPR
Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms restricts the use of GMOs, which do not have the approval of the Commission.104 Article 2 of the GMO Directive defines a GMO as ‘an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination’.105 In Annex 1B of the Directive, certain techniques for genetic modification are exempted from the sphere of the directive, as these techniques have been used in a number of applications and have a long safety record.106 The excluded techniques mentioned in Annex 1B are mutagenesis and cell fusion.107 Mutagenesis is the manipulation of an organism’s genomes without the insertion of foreign genes.108 The Directive itself prohibits transgenesis, which is a technique where foreign DNA is inserted into a living organism.109
In Case C-528/16, the Court of Justice decided that the mutagenesis exemption in Annex 1B only applies to techniques that existed by the time the GMO Directive was adopted.110 The Court reasons that development and the use of GMOs are to be followed closely, as set out in recital 55 of the GMO Directive, and that the use of the new mutagenesis techniques ‘might prove to be similar to those which result from the production and release of a GMO through transgenesis’.111 The Court points to the lack of long safety records of new technologies as a reason to exclude them from the scope of Annex 1B.112 The Court explains
101 Richard Hyde et al, ‘Drawing lessons for future Novel Food Governance through a retrospective examination
of Regulation 258/97’ (2017) 72 Food Drug Law J 488.
102 ibid.
103 International Platform of Insects for Food and Feed, ‘Regulation (EU) 2015/2283 on novel foods’, 25. 104 Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically
modified organisms [2001] OJL 106/1.
105 ibid art 2.
106 ibid Annex 1B; recital 17. 107 ibid Annex 1B.
108 CJEU Press Release No 111/18. 109 ibid.
110 Confédération paysanne (n 8) para 51. 111 ibid paras 48, 50(1).
18 that the GMO Directive should not be interpreted using a literal reading, but that additional attention has to be given to the precautionary principle and the protection of human health and the environment.113 The Court furthermore argues that Directive 2002/53/EC of 13 June 2002 and Regulation 1829/2003 on genetically modified food and feed are to be interpreted in light of the GMO Directive.114
CRISPR is a mutagenesis technique that was created after the GMO Directive came into effect. Hence, it falls within the scope of the GMO Directive and outside the scope of Annex 1B. If the CRISPR technique is not directly meant for the creation of food, for example, if it is used for the creation of biofuels, the authorization procedure of the GMO Directive is to be followed. First, an application is again to be made to the national authorities of a Member State.115 This assessment is sent to the European Commission which will forward it to all Member States for their input on the risk assessment.116 If the Member States do not have objections or have objections but they can be resolved, it is up to the Member States to decide whether the mutagenesis technique is to be authorized to be used or not.117 If the objections cannot be resolved, the EFSA will deliver an opinion. Based on this opinion, the Member States shall decide on whether they will grant the applicant’s request for authorization or not by qualified majority voting.118 Under normal circumstances, this procedure may take up to a maximum of around 225 days.119
If the CRISPR technology is directly meant for the creation of food, the authorization procedure of Regulation 1829/2003 is to be followed.120 First, an application is sent to the national authorities of a Member State which sends it to the EFSA for a risk assessment.121 After the EFSA has published its assessment, there will be a 30 day public consultation period.122 After this period the Commission sends a proposal to the Member States for the authorization of the proposed technology.123 Through comitology, the Member States will
113 ibid paras 42, 49. 114 ibid paras 64-68.
115 Directive 2001/18/EC (n 104) art 6(1). 116 ibid arts 7(1) & 7(2)(a).
117 ibid art 7(3). 118 ibid art 18.
119 Belgian Biosafety Server, ‘Notification procedures for the commercial use of GMOs in the environment
and/or as food/feed’ <https://www.biosafety.be/content/notification-procedures-commercial-use-gmos-environment-andor-foodfeed> accessed 6 May 2019.
120 Regulation 1829/2003 of 22 September 2003 on genetically modified food and feed [2003] OJL 268/1,
recital 16.
121 ibid art 5(2)(ii). 122 ibid art 6(7). 123 ibid art 7(1).
19 decide by qualified majority voting.124 If the Member States can still not make a decision, the Commission eventually decides.125
This authorization process itself may take up around nine to twelve months.126 In the application, however, a ‘systematic review of studies published in the scientific literature and studies performed by the applicant within the period of ten years prior to the date of submission’ has to be submitted along, in order to assess the potential effects on human and animal health.127
Recently it has been made possible for Member States to opt-out of the approval of a GMO. Directive 2015/412 grants Member States the possibility to restrict or prohibit the cultivation of GMOs in their territory.128 The European Parliament and the Council wanted more flexibility for Member States in cultivation, as it is an issue with strong national, regional and local dimensions, as it is intrinsically linked to land use, local agricultural structures and the protection of maintenance of habitats, ecosystems, and landscapes.129 Through this directive, Article 26b is added to the GMO Directive, which stipulates that Member States can alter the geographical scope of the authorization of a GMO to the effect that all or part of the territory of a Member State is to be excluded from where the GMO is permitted for cultivation.130 This restriction must comply with certain conditions; they must comply with EU law, they must be reasoned, proportional, non-discriminatory, and they must be based on compelling grounds such as environmental policy objectives, town and country planning, land use, socio-economic impacts, avoidance of GMO presence in other products, agricultural policy objectives, and public policy.131
4.3 Precautionary principle
As mentioned, Article 191 paragraph 1 sets out that the EU shall pursue the preservation, protection, and improvement of the environment and human health.132 Paragraph 2 of the same Article stipulates that the EU is to aim at a high level of protection with regard to the environment, on the basis of the precautionary principle.133 In the Commission Communication
124 ibid jo 35(2) jo Council Decision 1994/468/EC of 28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission [1999] OJL 184/23, art 6(6).
125 ibid.
126 Regulation 1829/2003 (n 120) arts 6(1), 7(1), 18(4).
127 Implementing Regulation 503/2013 of 3 April 2013 on applications for authorization [2013] OJL 157/1, art
6(1).
128 Directive 2015/412 of 11 March 2015 amending Directive 2001/18/EC [2015] OJL 68/1. 129 ibid recital 6.
130 ibid art 1(2).
131 ibid art 26(b)(3) in 1(2). 132 TFEU (n 62) art 191(1). 133 ibid art 192(2).
20 on the precautionary principle, it is stated that action based on the precautionary principle is justified where ‘scientific evidence is insufficient, inconclusive or uncertain and there are indications through preliminary objective scientific evaluation that there are “reasonable grounds” for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the chosen level of protection’.134 Article 7 of Regulation 178/2002 on laying down the general principles and requirements of food law sets out the following regarding the precautionary principle: ‘In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment’.135 In light of environmental efforts, the precautionary principle means that the EU does not give economic interests precedence over potential environmental risks.136
The precautionary principle was introduced in the Maastricht Treaty of 1992.137 Additionally, the EU is party to, and played a key role in creating, the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, where the precautionary principle is reaffirmed for emerging new biotechnologies.138
The precautionary principle is set out in Article 1 of the GMO Directive and Article 12 of the Novel Foods Regulation.139 These regimes are in line with the precautionary principle, as the burden of proof on safety lies with the applicant, as they need to demonstrate safety, as opposed to the Commission or the EFSA being required to prove a possible risk.140
In the Solvay ruling, the CJEU stated that the precautionary principle requires the competent authorities to take appropriate measures to prevent specific potential risks to health, safety, and the environment.141 In Artegodan, the CJEU confirmed that the precautionary principle is a general principle of EU law.142 Before this, the CJEU had already stressed that,
134 Commission, Communication on the precautionary principle’ (Communication) COM(2000) 1 final, 1. 135 Regulation 178/2002 on laying down the general principles and requirements of food law [2002] OJL 31, art
7(1).
136 T-141/00 Artegodan EU:T:2006:286 [2002], para 184.
137 Peter-Tobias Stoll et al, ‘CETA, TTIP and the EU precautionary principle’, June 2016, Foodwatch, 9. 138 Tom Delreux (2012) The EU in Negotiations on the Cartagena Protocol on Biosafety. In: The European
Union and Multilateral Governance. Palgrave Macmillan, London, 214; Cartagena Protocol on Biosafety to the Convention on Biological Diversity (adopted on 29 January 2000, entry into force 11 September 2003) UNTS 2226.
139 Directive 2001/18/EC (n 104) art 1; Regulation 2015/2283 (n 7) art 12.
140 Commission, ‘The precautionary principle: decision-making under uncertainty’ (Future Brief 18), 14. 141 T-392/02 Solvay EU:T:2003:277 [2003], para 121.
21 since environmental efforts are to be included in other EU policies due to Article 11 TFEU, the precautionary principle should also be a factor in other EU policies.143 The role of the CJEU in dealing with the precautionary principle is not unlimited; it has stated that its scope of review is limited to checking whether the EU institutions exercised their discretion correctly, by not exceeding it or making a manifest error.144 A procedural guarantee with regard to this discretion is that the scientific assessment made by the EU institutions is to be in line with the principles of excellence, independence, and transparency, so that the absence of arbitrariness is guaranteed.145 This does, however, not mean that scientific certainty is required.146
4.4 Risk analysis within EU food law
The GMO Directive, the Novel Foods Regulation, and the precautionary principle are part of a larger system: that of risk analysis.147 Risk analysis consists of three different elements; risk assessment, risk management, and risk communication.148 Risk assessment is composed of four components; hazard identification, hazard characterization, appraisal of exposure, and risk characterization. Risk management means, according to Regulation 178/2002, ‘the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options’.149 Risk communication is the ‘interactive exchange of information and opinions throughout the risk analysis process’.150
These risk policies came to being in the 1990s, after two health and food scandals took place in Europe.151 One involved HIV-infected blood and the other was the BSE (mad cow) crisis.152 In the aftermath of these events, it was revealed that safety regulation had been toned down in favor of economic concerns.153 The scandals lead to decreased levels of trust in food safety and the ability of governments to protect public health.154
143 T-13/99 Pfizer EU:T:2002:209 [2002], para 114. 144 ibid paras 164-172.
145 ibid.
146 ibid para 393.
147 Ghisleri et al, ‘Risk Analysis and GM Foods: Scientific Risk Assessment’ (2009) 4 EFFL 235, 241;
Communication on the precautionary principle (n 134).
148 Communication on the precautionary principle (n 134). 149 Regulation 178/2002 (n 135) art 3(12).
150 ibid art 3(13). 151 Stapleton (n 3).
152 ibid; Alie de Boer, Aalt Bast, ‘Demanding safe foods – Safety testing under the novel food regulation’ (2018)
72 Trends Food Sci Techno 125, 126.
153 Stapleton (n 3). 154 ibid.
22 The overall emergence of risk as a regulatory matter for governments is closely connected to technological development, as demand grew for governmental intervention to deal with negative side effects of modernization.155 The role of governments to assess and manage risks has increased over the years, especially in technology-driven knowledge societies.156 Some have argued that as a form of governments ‘welfare states’ have evolved into ‘regulatory states’ and now into ‘risk states’.157 Within the current EU risk regulatory system, a factual, scientific basis is established after which political decisions are made, based on those facts.158 The EFSA currently uses a ‘weight of evidence’ approach towards its scientific assessments. In this method, all the relevant scientific evidence considered relevant is evaluated and weighed, as well as the hypotheses used in the research.159
In the next chapter, the problems and challenges, in light of the EU’s environmental efforts, of the Novel Foods Regulation, the GMO Directive and the precautionary principle are addressed.
155 Maria Weimer, Risk Regulation in the Internal Market (OUP 2019) 24. 156 ibid.
157 ibid. 158 ibid 71.
159 EFSA ‘Guidance on the use of the weight of evidence approach in scientific assessments’ (Opinion, 12 July
23 5 Challenges and discrepancies
5.1 In vitro meat
Concerning the role in vitro meat can play in tackling climate change, some problems arise with regard to the relevant EU law. First and foremost; with the aims of reducing the greenhouse gas emissions by 40% by 2030, environmental friendlier farming within the CAP and mitigating the consequences of climate change, whilst livestock emission account for about 12.8% of the EU greenhouse gas emissions, it being a major cause of water depletion and the projected meat consumption barely decreasing in the next decades, an authorization period that takes up to two years might cause the Novel Foods Regulation to harm the EU’s environmental efforts.
Secondly, why would in vitro meat fall within the scope of the Novel Foods Regulation? Meat has been on the market since before 15 May 1997. In fact, one could argue that in vitro meat can be more ‘the same product’ than how meat is currently created, as you can use the same tissue to get meat from as it regenerates, instead of constantly making new animals which need to be slaughtered. Recital 9 of the Novel Foods Regulation states that foods resulting from new technologies are to fall within the scope of the regulation, but only if they significantly differ from conventional foods in composition or structure, affecting its nutritional value, metabolism or level of undesirable substances.160 This is not the case here, as the in vitro meat cultivation technology is specifically created to make the same product as one can get in the store. Recital 29 even states that new food production technologies and innovations should be encouraged as ‘they could reduce the environmental impact of food production’ and ‘enhance food security’.161 As set out earlier, in vitro meat needs fewer resources than regular meat production, which can reduce the environmental impact of food production as well as enhance food security, which falls in line with the EU’s plans on preventing climate change and mitigating the harmful effects of climate change.
The Novel Foods Regulation has been criticized before, namely for being too ‘cultural’ instead of scientific.162 Cultural perceptions of safety are of course normal aspects of the human perception of risk, but one can wonder what influence this should have on a legal food safety regime as, for example, much of the foods that fall within the scope of the Novel Foods regulation has been consumed in non-EU parts of the world without causing injury, such as
160 Regulation 2015/2283 (n 8) recital 9. 161 ibid.
162 Sarah Hartley et al, ‘European Novel Foods Policy at a Critical Juncture: Drawing Lessons for Future Novel
Food Governance through a Retrospective Examination of Regulation 258/97’ (2017) 72 Food & Drug L.J. 472, 485.
24 certain edible insects that were not on the European market before 15 May 1997.163 The timing of the introduction of the new Novel Foods Regulation has also been criticized, for simply being too late to deal with the products it is supposed to regulate.164 Part of the regulation is the marketing of edible insects on the internal market, and before the regulation came to power, certain Member States approved the introduction of edible insects on their market.165 These products will need to be authorized again, but can still be marketed in those Member States during a transitional period of 24 months.166
As mentioned earlier, there are different ways to feed the cells of the in vitro meat. Will these different methods all require different authorizations? Within the current in vitro meat production developments, some methods are already starting to get outdated. With the replacement of fetal bovine serum with plant-based alternatives the next coming years, a new authorization for every new method would mean that authorization procedures that have already been started now will be irrelevant in a couple of years.
5.2 CRISPR
Similar to the Novel Foods Regulation, the GMO Directive has an authorization period which might impede with time-bound EU environmental goals. Especially the possibility of having to provide studies which may have taken up to ten years to be concluded may interfere with reaching the 2030 goals. And just like with in vitro meat cultivation, the question is whether all possible techniques relating to the CRISPR technology require separate authorizations. As mentioned earlier, different proteins can be used for applying the technology (e.g. Cas9 and Cpf1) and the technology can be used to create a wide variety of foods. The CRISPR technology is relatively new and has a very broad application, so if new authorizations are required, further development of the technology might get hampered.
The EU political stance in these GMO authorization processes has been marked by divergence.167 Both the comitology committee and the Council of Ministers have not been able to create a common stance in forming the EU’s opinion towards GMOs.168 If during the GMO authorization procedure in comitology a qualified majority is not reached, the matter is sent to
163 ibid.
164 Nicole Grmelová; Anu Lähteenmäki-Uutela, ‘European Law on Insects in Food and Feed’ (2016) 11 EFFL
2, 6.
165 ibid. 166 ibid.
167 Christoph Klika, ‘Why Science Cannot Tame Politics’ (2013) 3 EJRR 327, 327. 168 ibid.
25 the Commission, who thus far has always followed the EFSA opinion.169 A qualified majority has never been reached, as the Member States’ representatives have clear instructions from their national ministries and act out their mandate as such instead of using the comitology procedure as a deliberation mechanism.170 Hence, all GMO applications which have received a positive opinion from the EFSA have been authorized, despite political division.171 There is a double lack of political influence in this process. Firstly, the deadlock in the comitology committees leads to a lack of Member State-specific input. Secondly, the Commission, who is at least voted in indirectly, always follows the EFSA, an unelected regulatory body.
The ESFA’s role in the GMO authorization procedure is to assess whether a GMO should be allowed on the European market with regard to the risks it poses to food and health safety, based on scientific research.172 Other, more political factors are left out if its role. So social, economic, moral and other reasons for (not) allowing a GMO on the market that would normally be part of the Council’s decision will not find their way in the final authorization decision.
This may work in the environment’s favor, as environmental peril is backed by scientific proof and economic factors are oftentimes the cause of the lack of climate action.173 The 2015 amendment to the GMO Directive, however, might run counter to the environmental cause, as Member States can decide to not allow the cultivation of a GMO which has been approved under Union law. This can lead to an overall demise of the common approach of the EU in tackling climate change in the agri-food sector. Furthermore, the opt-out clause only works in one way; opting out of authorization. A Member State cannot unilaterally decide to ‘opt-in’ while the EU itself does not want to authorize a GMO.
As set out earlier, in Case C-528/16 the CJEU ruled that mutagenesis technologies that are developed after the adoption of the GMO Directive are considered GMOs. The legal certainty of the GMO Directive might be at stake here, as Annex 1B of the directive explicitly excludes mutagenesis from the directive. The Court reasons that the mutagenesis technologies from before the adoption ‘have conventionally been used in a number of applications and have a long safety record’.174 One can also use this focus on safety differently by pointing at the
169 ibid 330. 170 ibid. 171 ibid.
172 EFSA, ‘Panel on Genetically Modified Organisms’ <https://www.efsa.europa.eu/en/panels/gmo> accessed 3
June 2019.
173 IPCC, ‘Climate Change 2014 Synthesis Report Summary for Policymakers’ 2. 174 Confédération paysanne (n 8) para 54.
26 benefits scientists see in CRISPR, namely its accuracy in comparison to older technologies.175 Another often used form of mutagenesis is irradiation. Through this method, plants are exposed to radiation in the hope of triggering random mutations that might be useful.176 As irradiation is allowed under the GMO Directive, can the CRISPR technology be exempted as well, if it proves that it is as safe as irradiation?
Even if one is rather skeptical about the safety of the CRISPR technology, one has to wonder if the GMO Directive and the CJEU ruling are giving sufficient protection against the possible unknown risks of the CRISPR technology. The CJEU ruling renders the process and not the product to fall under the scope of the GMO Directive; ‘organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive’.177 It seems logical that the worrisome aspect of the technology is not so much the production method of products created through CRISPR but rather about the outcomes of this method, such as possible mutations, biodiversity concerns or general food safety, the end products should be assessed individually instead of assessing the technology used. Currently, once (a variant of) the CRISPR technique is authorized through a number of successful applications, all organisms that are created through this method fall outside of the scope of the GMO Directive. Hence, the GMO Directive seems unfit for the assessment of the CRISPR technology.
Lastly, one can wonder whether the CJEU made the right call by going against the Advocate-General in this case. Advocate-General Bobek came to the conclusion that mutagenesis is exempted from the scope of the GMO Directive as long as it does not involve recombinant nucleic acid (simply put, DNA that could otherwise not be found in the organism) or other GMOs that are not exempted from the GMO Directive.178 This reasoning is a literal interpretation of Annex 1B. Furthermore, the fact is that mutagenesis is not the same as transgenesis; transgenesis involves foreign DNA being put into the host genes, while mutagenesis is the creation of a genetic mutation, which might only be the switching off of genes, or replacing DNA with DNA from its own type of organism.179 The results of this are often indistinguishable from traditional methods such as crossing, irradiation or natural
175 Science Media Centre ‘Expert reaction to Court of Justice of the European Union ruling that GMO rules
should cover plant genome editing techniques’ (25 July 2018) <https://www.sciencemediacentre.org/expert- reaction-to-court-of-justice-of-the-european-union-ruling-that-gmo-rules-should-cover-plant-genome-editing-techniques/> accessed 21 July 2019.
176 Helen Albert, ‘Why the GMO Regulations in Europe Are ‘Not Fit for Purpose’’ (Labiotech, 26 February
2019) <https://labiotech.eu/features/gmo-regulations-europe/> accessed 21 July 2019.
177 Confédération paysanne (n 8) para 54.
178 Confédération paysanne (n 8) AG Bobek, para 168.
27 mutation.180 To quote Nick Talbot, deputy vice chancellor and professor of molecular genetics at the University of Exeter: ‘To classify gene-edited crops as GMOs and equivalent to transgenic crops is completely incorrect by any scientific definition’.181
5.3 Precautionary principle
One of the issues regarding the precautionary principle is the lack of a clear definition of it.182 This is inherent to the precautionary principle; it is a legal principle, not a specific procedure or application scheme.183 Aside from the lack of a clear definition, the precautionary principle has been criticized for being arbitrary and ‘extra-scientific’; decisions in the risk assessment process, where information on whether a technology poses a possible risk is gathered, are not based on science but on the precautionary principle, and that by doing so the line with risk management, where decisions are made based on this information as well as societal values, is blurred.184 This tension between evidence and uncertainty has created noticeable volatility in how the principle is perceived; some argue that the principle is focused on worst-case scenarios and ignores benefits of specific technologies, while others argue that the precautionary principle does not get due credit for all the harm it prevents.185
The precautionary principle has furthermore been criticized for possibly halting innovation.186 Certain critics believe that innovation relies on trial and error and technological development needs to be applied before certain problems can be resolved after the fact.187 Within this line of reasoning, the CRISPR and in vitro meat technologies can be adapted to societal demands, so that harmful effects are minimized or even resolved.188
The European regimes on GMOs and novel foods do have step-by-step approaches where the technologies are assessed individually, on a scientific basis.189 This has been dubbed a ‘sophisticated version of trial and error’.190 In theory, all technologies can be allowed within
180 ibid.
181 Science Media Centre (n 175).
182 Oliver Todt; Jose Luis Luján, ‘Analyzing Precautionary Regulation: Do Precaution, Science, and Innovation
Go Together?’ (2014) 34 Risk Analysis 2163, 2165.
183 ibid. 184 ibid 2166.
185 Kenisha Garnett; David J. Parsons, ‘Multi-Case Review of the Application of the Precautionary Principle in
European Union Law and Case Law’ (2017) 37 Risk Analysis 502, 504.
186 Caroline Orset, ‘Innovation and the precautionary principle’ (2014) Econ. Innovation New Tech. 780, 797. 187 Todt (n 182) 2166.
188 ibid. 189 ibid 2167. 190 ibid 2169.
