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CRISPR-Cas9 and Food in the European Union: An Organic Solution to an Undetectable Problem for Food Business Operators

Published online by Cambridge University Press:  03 December 2021

Shane Michael Hughes Open the ORCID record for Shane Michael Hughes [Opens in a new window]
Shane Michael Hughes*
Affiliation:
University of Groningen, Groningen, The Netherlands Email: shughes151@gmail.com
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Abstract

Various methods of genetic modification have been applied to plant breeding as an integral part of agriculture. This article examines a method of targeted mutagenesis – CRISPR-Cas9 – and its dysregulation in the European Union (EU). It provides clarity for food business operators relating to the traceability and labelling of food products induced using this biotechnology. In addition, it outlines policy recommendations to improve the regulation of such food products in the EU.

Keywords

CRISPR-Cas9food lawGMOmutagenesisorganic
Type
Articles
Information
European Journal of Risk Regulation , Volume 13 , Issue 2 , June 2022 , pp. 254 - 269
Copyright
© The Author(s), 2021. Published by Cambridge University Press

I. Introduction

As a method of genetic modification, mutagenesis often occurs naturally in plants and is unique insofar as it does not involve the insertion of external genetic material in order to occur. Recently, targeted mutagenesis has been made possible through a new breeding technique (NBT) called “clustered regularly interspaced short palindromic repeats and CRISPR-associated protein 9” (CRISPR-Cas9), which is a new, targeted mutagenesis technique. First recorded as an NBT in 2012,Footnote 1 CRISPR-Cas9 is a relatively new genome editing mechanism comprising two molecules that introduce a change into the DNA. These consist of an enzyme (Cas9) and a piece of guide RNA (gRNA). In simple terms, the Cas9 enzyme acts as molecular scissors, cutting the two strands of DNA at a genomic location.Footnote 2 This bypasses the requirement to insert foreign DNA, and precise sections of DNA can thus be removed.Footnote 3 The gRNA consists of twenty RNA bases located on a longer RNA scaffold. This ensures that the Cas9 enzyme cuts at the correct point in the genome, and it is what differentiates the technology as an innovative, precise form of gene editing.Footnote 4 Though mutagenesis may occur naturally, targeted inducement is made possible using CRISPR-Cas9, which in itself signals a more sustainable and safer method of genetic modification than traditional transgenic methods.Footnote 5 It is pivotal to note that, to date, no known method exists enabling the quantitative detection of CRISPR-Cas9 mutation points.Footnote 6

In the European Union (EU), its classificationFootnote 7 under Article 2(2) of Directive 2001/18/ECFootnote 8 (the Deliberate Release Directive) as a form of genetic modificationFootnote 9 has proven problematic for food business operators (hereinafter FBOs/operators), who – due to a reliance on analytical testing for the application of genetically modified organism (GMO) labelling and traceability requirementsFootnote 10 – cannot meet their duty to control and labelFootnote 11 their food products.Footnote 12 The root of both problems derives from a misapplication of the precautionary principle,Footnote 13 as, in its quest for preserving food safety, the Court of Justice of the European Union (CJEU) has not extended an exemption of the GMO requirements to targeted mutagenesis techniques.Footnote 14

Consequently, CRISPR-Cas9 food products may enter the market undetected and uncontrolled.Footnote 15 This is because FBOs cannot meet their duty to sell products with proper labelling,Footnote 16 as they are unable to employ alternative means of testing.Footnote 17

This article aims to rectify the CJEU’s dysregulation and is written from the perspective of FBOs. Section II explains the functioning of the organic identity preservation (IP) system, how it ensures a uniform product standard and how one could be implemented for CRISPR-Cas9 food products. Section III focuses on the problematic relationship between organics and GMOs such as CRISPR-Cas9. It outlines the incongruity of labelling rules in their application to CRISPR-Cas9 food, which manifest in a liability loophole for FBOs. In addition, it explores the credibility of organic labelling schemes. Section IV proposes solutions to the liability loophole that are grounded in law and aim to work within its classification as a GMO. Section V concludes.

II. An identity preservation system for food induced by CRISPR-Cas9

Organic products – much like their CRISPR counterparts – are defined by imperceptible attributes and therefore constitute credence goods.Footnote 18 Hence, it is worth ascertaining the suitability of the organic traceability system as a blueprint for CRISPR-Cas9 food products.

In examining the organic IP system, it is important to note that Commission Regulation 889/2008Footnote 19 implements the principles laid down in the Council Regulation (EC) 834/2007 (the Organic Regulation),Footnote 20 in the form of detailed rules on organic production, labelling and traceability. This constitutes the authoritative legislation on organic traceability rules in the EU, and therefore the IP system for organic food products.

In the EU, the principles and viewpoints as to what “organic” means are stipulated in the Organic Regulation.Footnote 21 Supplementing these are production rules concerning food, feed and farming, which verify produce as organic.Footnote 22

For organic food, traceability is arranged in a twofold system: via contracting at each stage of the supply chain, in conjunction with an IP system.Footnote 23 In a strategic sense, contracts are important for cultivating positive working relationships, and the ability of FBOs to meet their obligations ultimately defines the reputation of their business.Footnote 24 However, as contractual relationships are not unique to the organic system, the main point of examination for this article concerns the organic IP system.

Downstream coordination in most IP systems takes the form of technical requirements and process certification standards. In the organic traceability system, this is the mandatory certification system stipulated in the operator requirements under the Organic Regulation and Commission Regulation 889/2008. Its structure is hierarchical and involves the European Commission, Member States, competent authorities, third countries, control bodies and FBOs. Here, FBOs are required to keep documentary accounts,Footnote 25 which are checked by accredited control bodies.Footnote 26 However, to enable effective management, they also verify their suppliers’ documentary evidence in keeping with the “one step forward, one step back” approach.Footnote 27 These are then checked by control bodies.Footnote 28

The extensive nature of the IP system and how it ensures a uniform product standard will now be examined and proposals made as to how an IP system can be implemented for CRISPR-Cas9 food.

1. Organic controls

This subsection will examine the most relevant controls for organic food products. These are the minimum control requirements, logistical controls and specific unit descriptions that depend on the type of product involved.

As a first step, FBOs submit a binding declaration expressing an agreement to perform their operations in accordance with organic production rules and controls.Footnote 29 These rules are elucidated in Article 63 (1) of Regulation 889/2008 as the minimum control arrangements that operators implement, maintain and adhere to in order to obtain the EU organic label.Footnote 30 This also applies to FBOs involved at any stage of the chain with the importing or reception of products from third countries.Footnote 31

Personal details and details of the relevant control body are included in the declaration, in addition to the nature of their intended operations and the location where they are carried out.Footnote 32 FBOs also submit a description of the production unit to the control body and implement anti-contamination procedures, which are necessary to ensure compliance with organic production rules.Footnote 33 The declaration also includes a commitment to accept enforcement measures if necessary,Footnote 34 to inform buyers of any non-compliant products and to remove indications to the organic production method on such products.Footnote 35

Separation controls are necessary for production units handling both organic and non-organic products, and their purpose is to identify critical steps along the chain. In this scenario, FBOs keep an updated register of operations and processed quantities and ensure that batches are separated.Footnote 36 Separation may be time- or location-focused and is a requirement before, during and after operations. To enable separation, FBOs implement measures that facilitate the identification of critical processing steps and production lots.Footnote 37 These are identified to ensure that organic production rules are applied to processed products.Footnote 38 Similarly, simultaneous collections of organic and non-organic products may be facilitated if it is possible to identify organic food products and measures to prevent contamination have been implemented.Footnote 39

The second logistical control concerns transport. Here, products are transported in packaging, containers and vehicles that are closed in such a way that their contents cannot be substituted or changed without manipulating or damaging the seal.Footnote 40 A label accompanies the seal stating the personal details of the operator and, if appropriate, the owner or seller of the product.Footnote 41 The label also includes the name of the product, a lot identification mark, a reference to the organic production method and the name and/or code number of the control body or authority.Footnote 42 These details may be included in accompanying documents if they are undeniably linked with the packaging, container or transport of the product.Footnote 43 Correspondingly, imports should be marked with an identification of the exporter.Footnote 44 If relevant, the accompanying certificate of control is checked by the first consignee, who records the verification in the documentary accounts.Footnote 45 However, products directly transported between FBOs who are subject to the same control system are exempt from the packaging requirements.Footnote 46

Extra logistical controls apply to imports from third countries. All transport information for such products should be made available to a control body or authority.Footnote 47 For this type of product, references to the exporter, first consignee and transport arrangements from the first consignee’s storage facilities to FBOs in the EU should also be recorded.Footnote 48 Thus, imported consignments are accompanied by records of personal details of the first consignee,Footnote 49 either in the documentary evidenceFootnote 50 or in the certificate of inspection.Footnote 51 Both documents are subject to verification by a control body.Footnote 52

Unit descriptions are pivotal to the IP system as they provide identification of FBOs and units along the chain. Here, specific controls apply depending on the type of food product and FBO involved. The most relevant of these are those laid down for plants and plant products, imports and outsourcing arrangements.Footnote 53

Unit descriptions for plants and plant products should stipulate the production or storage premises, land parcels, collection areas and the premises where processing or packaging takes place.Footnote 54 The date of the last application on the parcels should also be specified, in addition to the collection areas of non-organic products.Footnote 55 Packaging units used for labelling or relabelling and units acting on behalf of a third party are subject to the same controls.Footnote 56 For such units, the unit description stipulates the processing, packaging, labelling, storage and transport of agricultural products that have been used before and after the operations that concern them.Footnote 57 Where units have outsourced tasks to third parties, the unit description should include a binding submission of the subcontractors to the control regime, along with a list of subcontractors, their activities and the relevant control body or authority.Footnote 58 This is important for identifying FBOs who have handled the product.

For imports, the importer’s premises and activities should be included in the unit description.Footnote 59 The points of entry of products into the EU and the intended storage facility for imports awaiting delivery to the first consignee should also be included.Footnote 60 If the first consignee and importer are not the same legal person, the unit description should indicate the facilities used by the first consignee for storing and receiving products.Footnote 61 Thus, the route of the import is laid down in extensive paper trails and any relevant actor handling the product is identified.

It is thus apparent that organic controls are thorough because they are tailored depending on the type of product. Furthermore, logistical controls identify critical steps along the chain, whereas unit descriptions identify relevant FBOs and production units. The minimum control requirements not only record personal details, but also provide a clear link between FBOs and their product, which is important for clarifying liability along the chain.

However, due to jurisdictional differences in how control systems and control bodies are organised, one might imagine that ensuring uniformity and enforcing organic rules externally may prove problematic. Accordingly, how the EU achieves a uniform product standard and prevents fraudulent food products from infiltrating the market will be examined.

2. Ensuring a uniform product standard

This subsection will analyse how organic product standards are applied uniformly. The first point of examination focuses on the strict regulation of control bodies and authorities, thereby making control procedures effective. External enforcement is particularly relevant in this context, especially as third countries may implement less stringent control systems. Lastly, the standardised electronic systems that are used to enable swift communication in the IP system will be analysed.

Accreditation and equivalency processes are paramount to achieving uniformity in that, regardless of their origin, each product is “organic” as defined in the Organic Regulation. In order to ascertain their ability to apply EU standards, private control bodies in the EU are accredited by the European Commission. Public control bodies, on the other hand, are not subject to an accreditation process. During accreditation, the tasks that the competent authority intends to confer on the control body are analysed.Footnote 62 It must also be ascertained that the control body is unbiased and has the requisite expertise, equipment and infrastructure to carry out their tasks.Footnote 63 The most recent version of ISO standard 17065:2012 is used to verify their independence and technical competences. ISO standards are also used to scrutinise the proposed standard control procedure, and this involves an analysis of the measures operators would be subject to.Footnote 64 Cumulatively, these criteria outline a uniform standard for all control bodies, which is aided by international standards. This is important to ensure that there are no discrepancies between the checks Member States impose on FBOs.

As different rules may be applied in other jurisdictions, the integrity of the organic IP system is reliant on its ability to ensure that imports comply with EU rules or are produced according to rules that are equivalent to EU rules. In this context, accreditation and equivalency assessments are applied to control systems and control bodies, depending on the type of import involved. These are categorised as either: (1) imports already compliant with EU rules; or (2) imports providing equivalent guarantees.

FBOs handling imports already compliant with organic rules must be able to prove that their products comply with the EU rules on organic production and labelling.Footnote 65 They must be able to provide documentary evidence upon request, identifying the last operator to carry out operations on the product, in addition to providing verified evidence of their compliance with organic rules.Footnote 66 FBOs must also be subject to a recognised control body or authority, which is accredited subject to the most recent European Standard EN 45011 or ISO Guide 65.Footnote 67 Accreditation is determined subject to an evaluation of the risk of non-compliance by the control bodies or authorities, which is ascertained by regular evaluation, surveillance and annual reports. This determines the level of supervision they require by the European Commission.Footnote 68

Third-country imports providing equivalent guarantees are produced according to rules that are equivalent to the EU production, control and labelling rules for organic produce.Footnote 69 Two subcategories are denoted for equivalent imports: (1) imports from recognised third countries; and (2) imports from third countries that are not recognised.Footnote 70 The former involve an equivalency assessment of the third country control system,Footnote 71 while the latter involve an equivalency assessment of control bodies.Footnote 72 In both scenarios, the equivalent third country or control body checks the activities of FBOs at all stages of the supply chain.Footnote 73 To determine equivalency, the control body or authority is subject to spot checks, surveillance and reassessments, which are undertaken according to Codex Alimentarius Guidelines CAC/GL 32.Footnote 74 Risk assessments of the control bodies, based on annual reports, ascertain the likelihood of an infringement and the level of supervision required by the Commission.Footnote 75 Equivalent imports are accompanied by a certificate of inspection, which is issued by the control body or authority.Footnote 76 The certificate acts as proof that the import satisfies the control requirements for imports providing equivalent guarantees to EU organic rules and grants it access to the EU market as an organic product. The most recent audit on the organic IP system undertaken by the European Court of Auditors (ECA) identified minor weaknesses,Footnote 77 all of which are rectifiable, such as infrequent labelling discrepancies or inefficient reporting by equivalent control bodies.Footnote 78 However, frequent auditing by the ECA and the European Commission – in this context external auditing – enables the system to constantly improve and for weaknesses to be rectified. Hence, it is clear that the equivalency regime and accreditation processes are constantly monitored and extensive.

The structure and nature of organic controls highlight a heavy reliance on documentation, which is alluded to in the Organic Regulation.Footnote 79 Hence, the ability to swiftly transmit information between actors along – and outside – the chain is pivotal to their efficacy. To ensure swift transmission, standardised communication systems such as the Organic Farming Information System (OFIS)Footnote 80 and the Trade and Control Expert System (TRACES) have been employed so unsafe or fraudulent products can be swiftly retrieved from the market.Footnote 81 TRACES has expedited verification procedures for imports by collecting import data and verifying digitised certificates of inspection and code numbers.Footnote 82 In respect of infringements, events are swiftly isolated and identified, meaning events of non-compliance can be rectified quickly.Footnote 83 Combined, both are central to the enforcement of product standards.

From this analysis, one may conclude that the extensive documentary controls are efficient because swift information exchanges are facilitated between actors. In addition, the equivalency regime and accreditation processes are stringent, meaning two important aspects are qualified: (1) the competency of the control body; and (2) the level of supervision required to ensure equivalency or compliance. This ensures a uniform product standard throughout the EU. As such, both points are hallmarks of an effective traceability system for controlling food products defined by imperceptible attributes.

3. Implementing an identity preservation system for CRISPR-Cas9 food products

In order to implement an IP system for CRISPR-Cas9 food products, this article proposes a solution grounded in law that works within the GMO classification.

This article proposes the designation of a new Commission implementing regulation supplementing the current GMO legislation, which applies to NBTs whose altered genome sequences are undetectable. The purpose of this solution is to create a futureproof legislative framework that accounts for a Commission that is open to the use of NBTs.Footnote 84 The framework must therefore be broad enough to account for future genetically modified (GM) products that may also be defined by imperceptible attributes.Footnote 85

The legislative basis for the proposed implementing regulation is Article 290 TFEU.Footnote 86 Considering the inapplicability of testing, an exemption to the unique identifier requirement as the sole means of identifying the altered genetic sequence would be applied for CRISPR-Cas9 products. However, in considering the regulatory classification of such NBTs, a reference to GM material would appear alongside the logo and the code of the control body.Footnote 87 This would bypass the politics involved in redefining the scope of the GM definition under the Deliberate Release Directive.

The implementing regulation should be inclusive enough to apply to food products induced by other NBTs that are similar to CRISPR-Cas9 products. The defining criterion for its scope should be products whose altered genetic sequences are undetectable or impossible to determine as resulting from spontaneous inducement, such as natural mutagenesis. In determining the scope of the regulation, the following phrase should be included:

… products induced using new plant breeding techniques, whose altered genetic sequence is untraceable and undetectable using established analytical controls, and whose altered genetic sequence is impossible to differentiate from natural or traditional forms of genetic modification as defined in Article 2 of Directive 2001/18/EC.

A list of NBTs falling under this criterion could be drawn up by way of an annex and edited as required. This is important for futureproofing the regulation and making it adaptable.

The structure of the organic IP system provides an implementable blueprint for a new implementing regulation. Food products under the new regime should have a new label, which would be subject to a documentation-based IP and certification system. Consequently, control requirements would effectively mirror the control requirements stipulated in Commission Regulation 889/2008 for organic FBOs. Imports would be subject to either a compliance or equivalency regime using ISO standards for the purpose of applying uniform product standards. Control bodies and authorities could be accredited in a similar fashion to their organic counterparts. Connecting each actor involved in the supply chain, such as FBOs and control bodies, would be the electronic communication systems TRACES and OFIS. These could be adapted to ensure swift communication, data collection and product identification. This would be especially important for identifying non-compliant products.

Accordingly, this is the legal avenue required to implement an extensive and enforceable IP system for CRISPR-Cas9 food products.

III. CRISPR-Cas9 and the organic labelling problem

As stated previously, GMO labelling requirements are unsuitable for CRISPR-Cas9 food products. This is significant for FBOs handling cereals, which are predominantly induced by mutagenesis. They are unsure how to label their products properly.Footnote 88 Even though it is more than reasonable to assume that these food products are induced by mutagenesis, FBOs cannot verify their products as being free from GMOs using analytical testing. Furthermore, the problem is exacerbated by the asynchronous approval of CRISPR-induced maize or soybean in third countries.Footnote 89 Due to an unsuitable GMO traceability and labelling regime, such products may enter the EU market undetected.

IP systems are important for clarifying liability along the supply chain.Footnote 90 Hence, an analysis of liability in the organic IP system will identify the risks that seed companies are confronted with. A risk analysis will be undertaken, which will answer the question as to whether or not FBOs should label their products as GM. Labelling requirements will also be outlined, and liability within the organic IP system will be examined in the context of the prohibition of GMOs from organic products.Footnote 91 This will form the basis of a labelling solution for FBOs.

1. Labelling requirements for organic food products

At present, FBOs may use the EU organic production logo in the labelling, presentation and advertising of their products, subject to strict requirements.Footnote 92 They must ensure that products that do not meet the extra labelling requirements do not have an indication of the organic production method.Footnote 93 Thus, such references may only be made in relation to ingredients that have been verified as organic.Footnote 94

Considering CRISPR-Cas9 is a method of genetic modification, of most relevance for this article is the prohibition of GMOs in organic food.Footnote 95 Their use in organic production is explicitly prohibited under the Organic Regulation, and FBOs are required to submit a vendor declaration confirming their products have not been produced with GMOs.Footnote 96 However, an outright prevention of GMOs in food products is a nigh-on impossible task. The legislative requirements for GMOs mean that FBOs strive to ensure the presence of GM material in their products does not exceed either the 0.9% or the 0.5% threshold, which triggers a labelling obligation.Footnote 97 Therefore, although the presence of GM material may be adventitious or technically unavoidable, a presence nonetheless remains. Hence, extra confusion exists for organic FBOs. A reliance on the lack of a GM label does not assure them that the product is free from GMOs. Due to the prohibition on GMOs in organic production, this would lead to the presumption that products induced by mutagenesis would lose the organic label and require a GMO label instead. The main question then focuses not only on whether the product should keep the organic label, but also whether the FBO handling the product should remove it, considering the liability risks involved.

2. The organic labelling solution for food business operators: robbing Peter to pay Paul

In proposing a solution to the labelling problem, there appear to be two options for FBOs. The first is the “honest” option, where FBOs adhere to GMO requirements on labelling, traceability and product authorisation. The “dishonest” option disregards these requirements and switches the burden of proof for the lack of a GM label away from the FBO. Hence, the first option necessitates patenting, while the second option does not. This subsection will qualify which option FBOs are likely to be more receptive towards.

The “honest” option accounts for the fact that CRISPR-Cas9 food products will be subject to authorisation applications. These entail unique identifiers for the altered genetic sequences, which is a costly venture that only wealthy companies can afford.Footnote 98 It is also problematic considering the impossibility of detection. As the potential commercial value of CRISPR-Cas9 technology is prodigious, FBOs seeking to maximise their economic gains will have an incentive to patent sequences, as they hold the key to monopolising a potentially lucrative market.Footnote 99 However, the majority of FBOs are unlikely to choose this option due to the costs involved.Footnote 100 Only those with patents would be encouraged to make this option work, and they are still liable for problems relating to the sequence.

The alternative, “dishonest” option involves tricking the system and placing the product on the market without a GM label. Doing so irrevocably removes the possibility of tracing the product back to its source. Considering the responsibility of FBOs to ensure that their products comply with the requirements of food law at all stages of the chain,Footnote 101 this option puts all operators along the chain at risk of incurring criminal and administrative penalties.Footnote 102

Consequently, liability becomes an issue because if FBOs have a suspicion that a product does not comply with organic rules, they are obligated to check along the chainFootnote 103 and withdraw the product.Footnote 104 Similarly, control bodies or authorities may force product withdrawal.Footnote 105 Here, labels are pivotal to communicating the presence of GMOs, and, as previously highlighted, conventional FBOs are obliged to find alternative means of testing where a GM label is absent. However, testing is impossible when the altered sequence is indistinguishable from spontaneous mutagenesis.Footnote 106

Applying the same example to organic food products results in a contrasting assumption. In asserting a prohibition of GM material from organic production, the Organic Regulation only refers to the GMO definition and not its exemptions.Footnote 107 Therefore, in the context of labelling, FBOs may rely on the accompanying labels or documents of a food product, providing it is an EU-approved GM label.Footnote 108 Where none exists, organic operators may assume that the product has not been produced using GMOs or products produced from GMOs.Footnote 109 A failure to label (and accordingly a failure in the IP system) would not be subject to the realisation of the FBO duty to test if the product they handle contains GMOs. The burden of proof is switched from organic FBOs; they can always rely on the product not being labelled and are therefore free of these obligations.

Hence, it is probable that the majority of FBOs would choose the dishonest option, given the lack of an IP system. In this scenario, the most important aspect for FBOs is the liability risk associated with the absence of a GM label. Here, IP systems are designed to link actors along the chain with the final consumer,Footnote 110 meaning cooperation becomes central to the effective assignment of liability in the event product integrity failures.Footnote 111 This interdependence undermines the integrity of the organic label; it is reliant on the ability to test for GMOs, yet it does not account for its inapplicability to CRISPR techniques, and as no method is implemented that enables such, a loophole exists that FBOs may utilise.

As certain cereals induced by CRISPR-Cas9 have been asynchronously approved,Footnote 112 the loophole means it is questionable how producers of organic cereals can avoid with certainty the introduction of products onto the market that contain GMOs. The organic production method does not apply at all stages of the chain, meaning it is impossible for cereals to be “organic” as defined by the Organic Regulation.Footnote 113 A product may contain traces of GM material even though it is not labelled as such, leading to the assumption that it is impossible to have products with organic cereals in the EU.

Nonetheless, the labelling solution clarifies the liability risk of organic FBOs along the chain. The proposed solution is to switch the burden of proof onto the FBO who is required to test the product. The reliance of the organic IP system on GM labels means they may sidestep the requirement to test for GMOs and rely on the IP system to ascertain their duty to label. Consequently, it is worth releasing their risks, as they are freed from liability when no GM label accompanies the product.

In conclusion, it is possible to have organic products with cereals in the EU without FBOs incurring liability risks relating to labelling. Clearly, this disproportionately misleads consumers. To that end, policies will be proposed in the following section that account for the liability loophole and product verification.

IV. Policy proposals for food induced by targeted mutagenesis techniques

The foregoing has highlighted two points from which policy recommendations will be proposed. Firstly, it has been proven that the organic IP system is an effective traceability system for credence goods. Secondly, FBOs may utilise a loophole in the organic regime exempting them from liability for the absence of a GM label.

Clearly, there is an inapposite reliance on analytical testing in its application to targeted mutagenesis techniques. This manifests itself in the liability loophole. Based on the examination of both sub-questions, it is apparent that there is an urgent need to implement an IP system for CRISPR-Cas9 food products. As will become apparent, an IP system would remove the liability loophole and protect the reputation of the EU for multiple reasons. These points will be examined in a broad context, and they strengthen the argument for creating an IP system for CRISPR-Cas9 food products.

The ultimate solution for both the traceability and labelling problem would be to amend the Annex I B provision of the Deliberate Release Directive to exempt all targeted mutagenesis techniques from its definition. This has been proposed beforeFootnote 114 and should be encouraged for the purposes of progressive policymaking. However, this option would be an unprecedented leap for the EU legislature. Until it occurs, the IP system should be implemented to verify CRISPR-Cas9 food products. The example provided by the organic IP system has been proven to preserve the imperceptible nature of credence goods, and it provides a clear structure for FBOs who are unsure on how to control their products. Implementing it would require an exemption for undetectable targeted mutagenesis techniques from GMO testing requirements. Analytical testing would not be removed for GMOs per se; rather, targeted mutagenesis techniques would be subject to documentary verification. This bypasses radical legislative change and does not entail navigating a political minefield in redefining GMOs.Footnote 115

The second point concerns reputational damage for the EU as a market that has food safety at its core. The status quo risks undoing the legislative response to the bovine spongiform encephalopathy (BSE)Footnote 116 and horsemeatFootnote 117 scandals, which strengthened the EU’s safe reputation, especially when compared to traceability systems in other jurisdictions.Footnote 118

Additionally, failure to implement an IP system risks the reputation of the EU as a business-friendly market. This is because the law has failed to update parallel with developments in biotechnology. Indeed, companies are reacting negatively to a paradigmatic misapplication of the precautionary principle in the regulation of NBTs. FBOs are increasingly likely to establish themselves in more accommodating jurisdictions that encourage innovation.Footnote 119 Creating an IP system would facilitate a regulatory environment that is incentivising for FBOs and nip this trend in the bud.

Thirdly, it is imperative that the liability loophole is rectified. Although the labelling solution solves a liability problem for organic FBOs, it poses existential questions for the organic regime in the EU. It has been proven that it is impossible to ascertain whether or not products containing organic food products – such as soybean – are completely free from GMO material, and therefore it is wrong to state that it is possible to have organic products with cereals in the EU. To do so misleads consumers because the exclusion of GMOs from organic food is a principle of organic production.Footnote 120 Accordingly, the organic label is thrown into disrepute, as consumers are likely to distrust an IP system where there is mere suspicion that incentives exist for FBOs to use negative product attributes to take advantage of a premium.Footnote 121 FBOs will continue to exploit this loophole for as long as the law remains unchanged, and food induced by CRISPR-Cas9 will continue to be improperly labelled. Benefits are thus accrued by FBOs at the expense of consumers, and Peter is robbed to pay Paul.

It follows that preventing misleading labels should be a priority for the EU. To that end, it is imperative to find a compromise between the radical change required and what is practicable. This article proposes to focus on product verification: the creation of an IP system is an implementable, compelling option. It is essential that one is created, not least for the purposes of mitigating reputational damage and resolving the liability loophole. Accordingly, focus should turn to acceptance by FBOs.

In this context, it is worth acknowledging that product verification is enabled through thorough documentary controls that are verified by stringently regulated control bodies.Footnote 122 Here, extensivity goes even further than the “one step forward, one step back” rule, which requires FBOs to be able to identify receiving and supplying operators.Footnote 123 However, extensivity necessitates costs for FBOs,Footnote 124 as knowledge technology-based methods of IP involving documentation are expensive due to their extensive, laborious nature and the rigorous methods involved.Footnote 125

Nonetheless, it is logical to assume that FBOs would be content to incur such costs, providing the predominant use of CRISPR-Cas9 in plant breeding will be to vastly improve nutritional aspects, increase fruit yields or make plants resistant to diseases that are otherwise difficult to prevent. Indeed, CRISPR techniques are not exclusive to food, and their use in COVID-19 vaccinations and potential virus variants is already being explored.Footnote 126 As such, FBOs would be receptive to an IP system that preserves the positive attributes of their product and the unique details they wish to communicate to consumers.Footnote 127 It is inconceivable that FBOs would not seek to advertise the unique selling points of their product over other, similar products. As a cross-sectoral example, it is unthinkable that pharmaceutical companies would waive patents to their COVID-19 vaccines, and at the time of writing none have done so meaningfully.Footnote 128 Thus, CRISPR-Cas9 is used to create positive, highly marketable qualities that are worth preserving and patenting.

Hence, it is possible to implement an IP system for such products. To do so should not be a matter of “if” but “when”, not least for reputational reasons, but also for the credibility of the organic label itself.

V. Conclusion

This article has proven that the organic traceability system provides a blueprint for CRISPR-Cas9 food products and that, under the current regulatory framework, FBOs should not be liable for the absence of a GM label on products with cereals. In addition, the likelihood of FBOs choosing to adequately control and label their products was ascertained. Accordingly, it was highlighted that an IP system would be attractive for FBOs as it enables them to meet their obligations and to stay ahead in the market.

Clearly, the question of how to enforce labelling requirements for CRISPR-Cas9 will have to be answered before authorisation occurs. The irony of Confédération paysanne is that the purpose of the precautionary principle is to enable food safety, but a consequence of its (mis)use in classifying modern mutagenesis as a GMO technique is that food products perceived as unsafe will continue to infiltrate the market. The creation of an IP system would prevent this through its ability to verify credence goods and enforce EU standards uniformly.

The labelling solution demonstrates that the prohibition of GMOs in the organic regime enables consumer misinformation; FBOs will continue to utilise the liability loophole for as long as analytical testing is incongruously applied to mutagenesis techniques. Consequentially, the status of the EU as a purveyor of food safety is relegated to that of a hypocritical promoter of consumer misinformation. This should be a source of ignominy for the EU.

Thus, an IP system provides a solution and should be viewed as a stepping stone towards salvaging a safe and business-friendly reputation for European food regulation. Failure to implement such a system would be a rejection of food safety, meaning the scenario of robbing Peter to pay Paul will continue.

Acknowledgements

The author sincerely thanks Justin Lindeboom and Sarah Harris for their useful comments on earlier versions of this manuscript. He is also grateful to Kai Purnhagen for introducing him to the world of CRISPR-Cas9 and food law.

Competing interests

The author declares none.

References

1 M Jinek et al, “A Programmable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity” (2012) 337 Science 816 <https://www.sciencemag.org/lookup/doi/10.1126/science.1225829> (last accessed 7 December 2020).

2 PD Hsu, ES Lander and F Zhang, “Development and Applications of CRISPR-Cas9 for Genome Engineering” (2014) 157 Cell 1262, p 7 <https://linkinghub.elsevier.com/retrieve/pii/S0092867414006047> (last accessed 20 July 2020).

3 ibid, p 4.

4 Y Demirci, B Zhang and T Unver, “CRISPR/Cas9: An RNA-Guided Highly Precise Synthetic Tool for Plant Genome Editing” (2018) 233 Journal of Cellular Physiology 1844 <http://doi.wiley.com/10.1002/jcp.25970> (last accessed 7 December 2020); WA Ansari et al, “Genome Editing in Cereals: Approaches, Applications and Challenges” (2020) 21 International Journal of Molecular Sciences 4040, p 11 <https://www.mdpi.com/1422-0067/21/11/4040> (last accessed 25 January 2021).

5 K Yin, C Gao and J-L Qiu, “Progress and Prospects in Plant Genome Editing” (2017) 3 Nature Plants 17107, p 5 <http://www.nature.com/articles/nplants2017107> (last accessed 7 December 2020).

6 European Network of GMO Laboratories (ENGL), “Detection of food and feed plant products obtained by new mutagenesis techniques”, 26 March 2019 (JRC116289) <https://gmo-crl.jrc.ec.europa.eu/doc/JRC116289-GE-report-ENGL.pdf≥ p 14 (last accessed 14 August 2020).

7 PM Poortvliet et al, “On the Legal Categorisation of New Plant Breeding Technologies: Insights from Communication Science and Ways Forward” (2019) 10 European Journal of Risk Regulation 180 <https://www.cambridge.org/core/product/identifier/S1867299X19000102/type/journal_article> (last accessed 20 July 2020).

8 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [2001] OJ 2 106/1 (Deliberate Release Directive).

9 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt [2018] EU:C:2018:583 [54].

10 Regulation (EC) No 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed [2003] OJ 2 268/1, Arts 5(3)(i) and 17(3)(i); Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 [2013] OJ 2 157/1, Annex III; Regulation (EC) No 641/2004 Annex I.

11 General Food Law, Arts 19(1) and (3).

12 feednavigator.com, “ECJ Ruling on Gene Editing: ‘A Missed Opportunity for Agricultural Innovation in the EU’” (feednavigator.com) <https://www.feednavigator.com/Article/2018/07/26/ECJ-ruling-on-gene-editing-A-missed-opportunity-for-agricultural-innovation-in-the-EU> (last accessed 8 February 2021); K Purnhagen and J Wesseler, “EU Regulation of New Plant Breeding Technologies and Their Possible Economic Implications for the EU and Beyond” (2020) Applied Economic Perspectives and Policy aepp.13084, p 9 <https://onlinelibrary.wiley.com/doi/10.1002/aepp.13084> (last accessed 2 December 2020).

13 See further: H Bremmers and K Purnhagen (eds), Regulating and Managing Food Safety in the EU: A Legal-Economic Perspective (1st edn, New York, Springer International Publishing 2018) pp 69, 217–45, 308, 361–72; G Steier and KK Patel (eds), International Food Law and Policy (1st edn, New York, Springer International Publishing 2016) pp 451–60, 1334–35; I Härtel (ed.), Handbook of Agri-Food Law in China, Germany, European Union: Food Security, Food Safety, Sustainable Use of Resources in Agriculture (1st edn, New York, Springer International Publishing 2018) pp 80–81, 525–33; R Norer (ed.), Genetic Technology and Food Safety (1st edn, New York, Springer International Publishing 2016) pp 20–28, 34–37; JD Graham and S Hsia, “Europe’s Precautionary Principle: Promise and Pitfalls” (2002) 5 Journal of Risk Research 371 <http://www.tandfonline.com/doi/abs/10.1080/1366987021058580> (last accessed 8 July 2020); SO Hansson, “How Extreme Is the Precautionary Principle?” (2020) 14 NanoEthics 245 <http://link.springer.com/10.1007/s11569-020-00373-5> (last accessed 31 March 2021); A de Boer, “Scientific Assessments in European Food Law: Making It Future-Proof” (2019) 108 Regulatory Toxicology and Pharmacology 104437, p 2 <https://linkinghub.elsevier.com/retrieve/pii/S0273230019302016> (last accessed 9 July 2020); J Leinen, “Risk Governance and the Precautionary Principle: Recent Cases in the Environment, Public Health and Food Safety (ENVI) Committee” (2012) 3 European Journal of Risk Regulation 169 <https://www.cambridge.org/core/product/identifier/S1867299X00002014/type/journal_article> (last accessed 17 June 2021); L Petetin, “The Precautionary Principle and Non-Scientific Factors in the Regulation of Biotech Foods” (2017) 8 European Journal of Risk Regulation 106 <https://www.cambridge.org/core/product/identifier/S1867299X16000180/type/journal_article> (last accessed 23 July 2020); R von Schomberg, “The Precautionary Principle: Its Use Within Hard and Soft Law” (2012) 3 European Journal of Risk Regulation 147 <https://www.cambridge.org/core/product/identifier/S1867299X00001987/type/journal_article> (last accessed 17 June 2021); MD Adams, “The Precautionary Principle and the Rhetoric behind It” (2002) 5 Journal of Risk Research 301 <http://www.tandfonline.com/doi/abs/10.1080/13669870210139798> (last accessed 8 July 2020); S Vezzani, “The International Regulatory Framework for the Use of GMOs and Products Thereof as Food Aid” (2018) 9 European Journal of Risk Regulation 120, pp 124–26 <https://www.cambridge.org/core/product/identifier/S1867299X17000587/type/journal_article> (last accessed 17 June 2021); J Davison and K Ammann, “New GMO Regulations for Old: Determining a New Future for EU Crop Biotechnology” (2017) 8 GM Crops & Food 13 <https://www.tandfonline.com/doi/full/10.1080/21645698.2017.1289305> (last accessed 17 June 2021); GC Leonelli, “GMO Authorisations and the Aarhus Regulation: Paving the Way for Precautionary GMO Governance?” (2019) 26 Maastricht Journal of European and Comparative Law 505 <http://journals.sagepub.com/doi/10.1177/1023263X19855081> (last accessed 17 June 2021); C MacMaoláin, Irish Food Law: European, Domestic and International Frameworks (Oxford, Hart Publishing 2019) pp 146–61.

14 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, supra, note 9, para 47.

15 B Voigt and A Münichsdorfer, “Regulation of Genome Editing in Plant Biotechnology: European Union” in H-G Dederer and D Hamburger (eds), Regulation of Genome Editing in Plant Biotechnology (New York, Springer International Publishing 2019) p 183 <http://link.springer.com/10.1007/978-3-030-17119-3_5> (last accessed 1 December 2020).

16 General Food Law, Arts 18(3) and (4).

17 JRC116289, supra, note 6, p 15.

18 Purnhagen and Wesseler, supra, note 12, p 9; Voigt and Münichsdorfer, supra, note 15, p 137.

19 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control [2008] OJ 2 250/1.

20 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [2007] OJ 2 189/1 (Organic Regulation).

21 Organic Regulation, Arts 3 and 4.

22 Organic Regulation, Arts 5–7.

23 Purnhagen and Wesseler, supra, note 12, p 9.

24 In the EU, the controversy regarding the AstraZeneca vaccine rollout is the most recent manifestation of a company suffering severe reputational damage as a result of contractual discrepancies. The domino effect of a party in a supply chain reneging on their contractual obligations can be detrimental to multiple actors; “Martin Welcomes EU Decision to Withdraw Article 16 in Row over AstraZeneca Vaccine in Northern Ireland” (Irish Independent) <https://www.independent.ie/irish-news/martin-welcomes-eu-decision-to-withdraw-article-16-in-row-over-astrazeneca-vaccine-in-northern-ireland-40030300.html> (last accessed 14 February 2021); “Prospects for Game-Changing AstraZeneca Vaccine Become Increasingly Clouded” (Irish Times) <https://www.irishtimes.com/business/health-pharma/prospects-for-game-changing-astrazeneca-vaccine-become-increasingly-clouded-1.4470349> (last accessed 14 February 2021).

25 Reg 889/2008, Art 66(1).

26 A list of control bodies has been collated by the Directorate General of the European Commission for Agriculture and Rural Development: <https://ec.europa.eu/agriculture/ofis_public/actor_cbeu/ctrl.cfm?targetUrl=home> (last accessed 10 December 2020).

27 General Food Law, Arts 18(2) and (3); Organic Regulation, Art 29(2).

28 Reg 889/2008, Art 66(2).

29 Reg 889/2008, Art 63(2)(a).

30 Reg 889/2008, Art 63(1).

31 Reg 889/2008, Art 81.

32 Reg 889/2008, Art 63(3)(a)(b)(c)(f).

33 Reg 889/2008, Art 63(1)(a)(b)(c).

34 Reg 889/2008, Art 63(1)(b).

35 Reg 889/2008, Art 63(2)(c).

36 Reg 889/2008, Art 26(5)(a)(b)(c).

37 Reg 889/2008, Arts 26(5)(d) and (2).

38 Reg 889/2008, Art 26(3).

39 Reg 889/2008, Arts 30 and 34.

40 Reg 889/2008, Art 31(1).

41 Reg 889/2008, Art 31(1)(a).

42 Reg 889/2008, Art 31(1)(b)(c)(d).

43 Reg 889/2008, Art 31(1).

44 Reg 889/2008, Art 34.

45 Reg 889/2008, Art 34.

46 Reg 889/2008, Art 31(2)(a)(b)(c).

47 Reg 889/2008, Art 83.

48 Reg 889/2008, Art 83.

49 Reg 889/2008, Art 84(a).

50 Reg 889/2008, Art 84(b)(i).

51 Reg 889/2008, Art 84(b)(ii).

52 Reg 889/2008, Art 85.

53 Reg 889/2008, Arts 70–89.

54 Reg 889/2008, Art 70(1)(b).

55 Reg 889/2008, Art 70(1)(c).

56 Reg 889/2008, Art 80.

57 Reg 889/2008, Art 80.

58 Reg 889/2008, Art 86(a)(b).

59 Reg 889/2008, Art 82(1).

60 Reg 889/2008, Art 82(1).

61 Reg 889/2008, Arts 82(2) and 83.

62 Organic Regulation, Art 27(5)(a).

63 Organic Regulation, Art 27(5)(b)(i)(ii)(iii).

64 Organic Regulation, Art 27(6)(a).

65 Organic Regulation, Art 32(1)(a)(b).

66 Organic Regulation, Art 32(1)(c); Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries [2008] OJ 2 334, Art 6.

67 Organic Regulation, Art 32(2).

68 Organic Regulation, Art 32(2).

69 Organic Regulation, Art 33(1)(a)(b).

70 Organic Regulation, Arts 33(2) and (3).

71 Reg 1235/2008, Art 7.

72 Reg 1235/2008, Art 10.

73 Organic Regulation, Art 33(1)(c).

74 Organic Regulation, Arts 33(2) and (3); Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (GL 32 – 1999, Rev. 1 – 2001) <http://www.fao.org/docs/eims/upload/230124/cxg_032e.pdf> (last accessed 18 October 2020); Organic Regulation, Art 33(3).

75 Organic Regulation, Art 33(2).

76 Organic Regulation, Art 33(1)(d).

77 European Court of Auditors, The Control System for Organic Products Has Improved, but Some Challenges Remain. Special Report No 04, 2019. (Publications Office 2019) p 37 <https://data.europa.eu/doi/10.2865/217286> (last accessed 17 December 2020).

78 ibid, p 30.

79 Organic Regulation, Art 27(5)(e).

80 Regulation (EC) No 889/2008, Art. 92(a)(1); Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries [2008] OJ 2 334, Art 15.

81 foodnavigator.com, “EU Launches Electronic Tracking System for Organic Imports” (foodnavigator.com) <https://www.foodnavigator.com/Article/2017/04/19/EU-launches-electronic-tracking-system-for-organic-imports> (last accessed 14 February 2021).

82 H Willer et al, The World of Organic Agriculture Statistics and Emerging Trends 2020 (2020) p 145 <http://www.fibl.org/fileadmin/documents/shop/5011-organic-world-2020.pdf> (last accessed 3 February 2021).

83 European Court of Auditors, supra, note 77, p 37.

84 “EC Study on New Genomic Techniques” <https://ec.europa.eu/food/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en> (last accessed 6 September 2021); “Gmo_mod-Bio_ngt_eu-Study.Pdf” <https://ec.europa.eu/food/system/files/2021-04/gmo_mod-bio_ngt_eu-study.pdf> (last accessed 6 September 2021); G Fortuna and N Foote, “Commission Reopens Gene Editing’s Box amid Sustainability Claims” ( www.euractiv.com , 29 April 2021) <https://www.euractiv.com/section/agriculture-food/news/commission-reopens-gene-editings-box-amid-sustainability-claims/> (last accessed 6 September 2021).

85 New GM methods are constantly trialled in the EU. See further: European Medicines Agency “Genome Editing EU-IN Horizon Scanning Report.Pdf” p 4 <https://www.ema.europa.eu/en/documents/report/genome-editing-eu-horizon-scanning-report_en.pdf> (last accessed 6 September 2021).

86 Consolidated version of the Treaty on the Functioning of the European Union [2012] OJ 1 326/47, Art 290.

87 Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ 2 268/24, Art 4(4).

88 General Food Law, Arts 18(3) and (4).

89 E Waltz, “With a Free Pass, CRISPR-Edited Plants Reach Market in Record Time” (2018) 36 Nature Biotechnology 6 <http://www.nature.com/articles/nbt0118-6b> (last accessed 17 December 2020).

90 E Castellari et al, “Food Processor and Retailer Non-GMO Standards in the US and EU and the Driving Role of Regulations” (2018) 78 Food Policy 26, p 35 <https://linkinghub.elsevier.com/retrieve/pii/S0306919218301088> (last accessed 29 November 2020).

91 Organic Regulation, Art 23(3).

92 Organic Regulation, Arts 23(1), (6), 23(4) and 25(1).

93 Reg 889/2008, Art 26(4)(c).

94 Organic Regulation, Art 23(4).

95 Organic Regulation, Art 23(3).

96 Organic Regulation, Recitals 9 and 10, Arts 9 (1), 25(3) and 69.

97 Organic Regulation, Recital 10; Deliberate Release Directive, Arts 21(1) and (3); Reg 1829/2003, Recital 29, Arts 12(1) and 24.

98 R Ferreira, F David and J Nielsen, “Advancing Biotechnology with CRISPR/Cas9: Recent Applications and Patent Landscape” (2018) 45 Journal of Industrial Microbiology & Biotechnology 467, p 475 <https://academic.oup.com/jimb/article/45/7/467-480/5996688> (last accessed 25 February 2021).

99 A Churi and S Taylor, “Continuing CRISPR Patent Disputes May Be Usurped by Its Potential Role in Fighting Global Pandemics” (2020) 39 Biotechnology Law Report 184, p 188 <https://www.liebertpub.com/doi/10.1089/blr.2020.29180.ac> (last accessed 25 February 2021).

100 Directorate General Internal Market, Industry, Entrepreneurship and SMEs, “Final Report of the Expert Group on the Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering” (2016) 114, 124 <https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjylZXSsfryAhWOQEEAHZp5AigQFnoECB8QAQ&url=https%3A%2F%2Fec.europa.eu%2Fdocsroom%2Fdocuments%2F18604%2Fattachments%2F1%2Ftranslations%2Fen%2Frenditions%2Fnative&usg=AOvVaw3mIaad8erOMRToQaBPqSpm> (last accessed 12 September 2021); European Commission, “COMMISSION STAFF WORKING DOCUMENT Study on the Status of New Genomic Techniques under Union Law and in Light of the Court of Justice Ruling in Case C-528/16” (2021) 42, 43 <https://ec.europa.eu/food/system/files/2021-04/gmo_mod-bio_ngt_eu-study.pdf> (last accessed 12 September 2021).

101 General Food Law, Art 17(1); Reg 1830/2003, Art 3(3).

102 Deliberate Release Directive, Art 33; Reg 1829/2003, Arts 45(1) and (2); Reg 1830/2003, Arts 11(1) and (2).

103 General Food Law, Arts 17 and 19.

104 Reg 889/2008, Art 91(1).

105 Reg 889/2008, Art 91(2).

106 JRC116289, supra, note 6, p 9.

107 Organic Regulation, Recital 10, Art 9(1).

108 Organic Regulation, Art 9(2).

109 Organic Regulation, Art 9(2).

110 A Varacca and C Soregaroli, “Identity Preservation in International Feed Supply Chains” (2016) 15 EuroChoices 38, p 38 <http://doi.wiley.com/10.1111/1746-692X.12118> (last accessed 27 August 2020).

111 ibid.

112 Waltz, supra, note 91.

113 Organic Regulation, Art 2(a).

114 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt [2018] EU:C:2018:583, Opinion of AG Bobek, para 62; D Eriksson et al, “A Welcome Proposal to Amend the GMO Legislation of the EU” (2018) 36 Trends in Biotechnology 1100 <https://linkinghub.elsevier.com/retrieve/pii/S0167779918301367> (last accessed 3 March 2021).

115 G Tagliabue, “The EU Legislation on ‘GMOs’ between Nonsense and Protectionism: An Ongoing Schumpeterian Chain of Public Choices” (2017) 8 GM Crops & Food 57, pp 58, 60, 63 <https://www.tandfonline.com/doi/full/10.1080/21645698.2016.1270488> (last accessed 22 April 2021).

116 “BSE Crisis in 1990s Caused Havoc in Industry” (Irish Independent) <https://www.independent.ie/business/farming/bse-crisis-in-1990s-caused-havoc-in-industry-31296502.html> (last accessed 22 April 2021).

117 “Horsemeat Scandal: The Essential Guide” (The Guardian, 15 February 2013) <http://www.theguardian.com/uk/2013/feb/15/horsemeat-scandal-the-essential-guide> (last accessed 22 April 2021).

118 S Charlebois et al, “Comparison of Global Food Traceability Regulations and Requirements: Global Food Traceability Regulations…” (2014) 13 Comprehensive Reviews in Food Science and Food Safety 1104, p 1111 <http://doi.wiley.com/10.1111/1541-4337.12101> (last accessed 16 February 2021).

119 Reuters Staff, “Bayer, BASF to Pursue Plant Gene Editing Elsewhere after EU Ruling” (Reuters, 27 July 2018) <https://www.reuters.com/article/us-eu-court-gmo-companies-idUSKBN1KH1NF> (last accessed 7 April 2021); PAC Hundleby and WA Harwood, “Impacts of the EU GMO Regulatory Framework for Plant Genome Editing” (2019) 8 Food and Energy Security e00161, p 3 <https://onlinelibrary.wiley.com/doi/abs/10.1002/fes3.161> (last accessed 20 July 2020).

120 Organic Regulation, Art 23(3).

121 JE Hobbs, WA Kerr and PWB Phillips, “Identity Preservation and International Trade: Signaling Quality across National Boundaries” (2001) 49 Canadian Journal of Agricultural Economics/Revue canadienne d’agroeconomie 567, p 576 <http://doi.wiley.com/10.1111/j.1744-7976.2001.tb00327.x> (last accessed 15 February 2021).

122 Reg 889/2008, Art 66(1).

123 General Food Law, Arts 18(2) and (3).

124 E Nuijten, M Messmer and EL van Bueren, “Concepts and Strategies of Organic Plant Breeding in Light of Novel Breeding Techniques” (2016) 9 Sustainability 18, p 4 <http://www.mdpi.com/2071-1050/9/1/18> (last accessed 23 July 2020).

125 T Ruttink et al, “Knowledge-Technology-Based Discovery of Unauthorized Genetically Modified Organisms” (2010) 396 Analytical and Bioanalytical Chemistry 1951, p 1956 <http://link.springer.com/10.1007/s00216-009-3218-6> (last accessed 17 December 2020); N Kalaitzandonakes, R Maltsbarger and J Barnes, “Global Identity Preservation Costs in Agricultural Supply Chains” (2001) 49 Canadian Journal of Agricultural Economics/Revue canadienne d’agroeconomie 605, p 607 <http://doi.wiley.com/10.1111/j.1744-7976.2001.tb00330.x> (last accessed 11 November 2020); Varacca and Soregaroli, supra, note 112, p 40; J Bovay and JM Alston, “GMO Food Labels in the United States: Economic Implications of the New Law” (2018) 78 Food Policy 14, pp 14, 23 <https://linkinghub.elsevier.com/retrieve/pii/S0306919218301295> (last accessed 25 February 2021).

126 TR Abbott et al, “Development of CRISPR as a Prophylactic Strategy to Combat Novel Coronavirus and Influenza” (Bioengineering 2020) preprint <http://biorxiv.org/lookup/doi/10.1101/2020.03.13.991307> (last accessed 23 April 2021); “How MRNA Technology Could Upend the Drug Industry” (Time) <https://time.com/5927342/mrna-covid-vaccine/> (last accessed 23 April 2021).

127 Hobbs et al, supra, note 123, p 575.

128 “Big Pharma Lobby’s Self-Serving Claims Block Global Access to Vaccines” (Corporate Europe Observatory) <https://corporateeurope.org/en/2021/04/big-pharma-lobbys-self-serving-claims-block-global-access-vaccines> (last accessed 23 April 2021); “Could Waiving Covid-19 Vaccine Patents Save the World?” (France 24, 16 April 2021) <https://www.france24.com/en/europe/20210416-could-waived-covid-19-patents-save-the-world> (last accessed 23 April 2021).