Abstract
This chapter undertakes a detailed analysis of the EU’s controversial policy on ‘novel foods’ to reveal the potential and limits of the WTO’s influence on the domestic decision-making process. As EU institutions were forced in 2011 to abandon a proposal for a new Novel Food Regulation (NNFR), WTO commitments were cited as a key cause for the inter-institutional failure to find legislative compromises. Two elements of this sanitary measure—the regulation of traditional exotic products from outside the EU and the treatment of food from cloned animals—proved particularly problematic, illustrating the difficulties of reconciling international trade obligations and domestic policy preferences. This chapter first recounts the development of the NNFR, and then traces the influence of SPS and other WTO disciplines in the EU’s proposed regulation of traditional and ‘cloned’ food. This account finds that SPS obligations do have a role in shaping EU food policy, but in a far more subtle and complex way than is commonly assumed.
This chapter was first published as ‘The Rise and Fall of the New EU Novel Food Regulation: The Complex Influence of the WTO SPS Agreement’ (2013) 8 Asian Journal of WTO and International Health Law and Policy 249.
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Notes
- 1.
For a discussion of the definition of novel foods, see s 5.2.1 below.
- 2.
J Dalli, ‘Statement by Commissioner Dalli on the Lack of Agreement in the Conciliation Procedure on the Novel Food Regulation’, Europa Press Releases RAPID (29 March 2011) europa.eu/rapid/press-release_MEMO-11-202_en.htm.
- 3.
See European Parliament, ‘Q&A on the Novel Foods Regulation’ (29 March 2011) www.europarl.europa.eu/en/pressroom/content/20101019BKG88150/html/QA-on-the-novel-foods-regulation.
- 4.
Statement of the Hungarian Presidency, ‘Cloned Foods Unleashed’, HunPR/22/2011 (29 March 2011) www.eu2011.hu/files/bveu/documents/HunPR_22__-_29_03_2011_-_Cloned_foods_unleashed.pdf.
- 5.
See ‘Members of the EP Refute Claims of “Trade War” If EU Regulates Clone Offspring’, AGRA FACTS (11 May 2011) and the transcript of the EP plenary debate of 11 May 2011, Statement by the President of the European Parliament’s delegation to the Conciliation Committee–Novel foods (continuation of debate), agenda point 11 (May 2011 EP debate) www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+CRE+20110511+ITEM-009+DOC+XML+V0//EN.
- 6.
The Council’s Legal Service subsequently (justifiably) dismissed Mrs Liotard’s presentation of their arguments as ‘not correct because it is neither precise nor complete’. Council of the European Union, ‘Novel Foods–Statement of the Council’s Legal Service’, 10332/11, PRESSE 140 (17 May 2011) www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/122071.pdf.
- 7.
While our primary interest is in the influence of SPS rules, the fate of this EU sanitary measure cannot be understood in isolation from GATT and TBT obligations.
- 8.
A further controversial issue, the regulation of foods produced using nanotechnology, which was prominent in institutional discussions is not discussed here, as the impact of regulating these foods is not expected to be disproportionately burdensome for imported foods and therefore less relevant to the international trade implications which are the focus of this chapter.
- 9.
D Jones, ‘Safety Evaluation of Novel Foods: A European and International Perspective’ (EUFIC Review 04/2000) www.eufic.org/article/en/expid/review-novel-foods. See also D Wilson, ‘Marketing Mycoprotein, The Quorn Foods Story’ (2001) 55 Food Technology Magazine 48–50 (discussing the development of one of the first novel foods nurtured from a species of fungi).
- 10.
For an overview, see N Binns and J Howlett, ‘Functional Foods in Europe: International Developments in Science and Health Claims’ (2009) 48 (Supp 1) European Journal of Nutrition S3.
- 11.
See generally European Food Safety Authority (EFSA), ‘Scientific Opinion of the Scientific Committee, The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety’ (2009) 958 EFSA Journal 1.
- 12.
F Macrae, ‘“Grey Goo” Food Laced with Nanoparticles Could Swamp Britain’ Daily Mail (8 January 2010) www.dailymail.co.uk/news/article-1241506/Britain-maybe-swamped-nanoparticle-grey-food.html.
- 13.
J Maryanski, ‘Special Challenges of Novel Foods (Biotechnology)’ (1990) 45 Food, Drug, Cosmetic Law Journal 545, 549 (explaining how the bulk of many novel foods meant that the hundredfold increase normally applied in animal studies would entirely disrupt the diet of the animal).
- 14.
An early definition of a novel food—those not previously eaten by a human population—was established by the United Nations Protein Advisory Committee (PAC). ‘PAG/UNU Guideline No. 6: Preclinical Testing of Novel Sources of Food’ (1983) 5 Food and Nutrition Bulletin 94, 60–63.
- 15.
World Health Organization, ‘Strategies For Assessing The Safety of Foods Produced by Biotechnology: Report of a Joint FAO/WHO Consultation’ (1991) 24.
- 16.
Jones (n 9).
- 17.
See S Waters, ‘The Regulation of Herbicide Resistant Crops in Europe’ in S Duke (ed), Herbicide Resistant Crops: Agricultural, Economic, Environmental, Regulatory, & Technological Aspects (Cleveland, CRC Press, 1995) 347, 356 (recounting the case of the Netherland’s introduction of a novel food Regulation in 1993).
- 18.
European Commission, Proposal for a Council Regulation (EEC) on Novel Foods and Novel Food Ingredients [1992] OJ C190/4.
- 19.
P Berry Ottaway, ‘New European Controls on Novel Foods and Ingredients’ Nutraceuticals International (March 1997).
- 20.
See ‘MEPs Vote to Amend Novel Foods Proposal’ Europe Environment (9 November 1993).
- 21.
C Kirkham, ‘Legislative Developments. Novel Foods and Food Ingredients’ (1997) 3 Columbia Journal of European Law 317, 318–19.
- 22.
Regulation (EC) 258/97 of the European Parliament and of the Council Concerning Novel Foods and Novel Food Ingredients [1997] OJ L43/1 (CNFR). The consumer protection element, entirely absent in the original proposal, was included in Recital 2 of the CNFR.
- 23.
Regulation (EC) 1829/2003 of the European Parliament and of the Council on Genetically Modified Food and Feed [2003] OJ L268/1.
- 24.
CNFR (n 22) Art 1.2. May 15, 1997 signifies the date of entry into force of the Regulation.
- 25.
These are the categories that remained following the removal of GM foods.
- 26.
Where the Commission envisages measures that do not have the support of the Standing Committee, it has the option of presenting the measures to Council for adoption. CNFR (n 22) Art 13.
- 27.
CNFR (n 22) Art 5.
- 28.
‘Comments on Regulation (EC) N° 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients’, Working Party on Novel Foods—Peru, ec.europa.eu/food/food/biotechnology/novelfood/peru_en.pdf.
- 29.
CNFR (n 22) Art 1(e).
- 30.
The Commission’s own evaluation of the CNFR points to ‘confusion over the intention of the legislation concerning “exotic plants”’. European Commission, ‘Evaluation Report on the Novel Food Regulation 258/97 Concerning Novel Foods and Novel Food Ingredients’ (22/1/2004) Commission CNFR Evaluation) 5, ec.europa.eu/food/food/biotechnology/novelfood/evaluation_report_en.pdf.
- 31.
For an elaboration of this view, see UK Foods Standards Agency (UK FSA), ‘Goji Berries’ (2007) 9, www.food.gov.uk/multimedia/pdfs/gojiberriesrep.pdf.
- 32.
Thus, the EU’s Impact Assessment of the NNFR confidently proclaims: ‘At present traditional food which was not on the EU market before 1997, but for which there is information on safe use outside the EU, is subject to the same rigorous safety assessment procedure as any newly developed innovative food’. European Commission, ‘Draft report on Impact Assessment for a Regulation Replacing Regulation (EC) No 258/97 on Novel Foods and Novel Food Ingredients’, COM (2007) 872 final (Commission NNFR Impact Assessment) 3.
- 33.
In 2000, Nangai nuts and Stevia rebaudiana Bertoni were both rejected due to the inadequacy of the data submitted for assessment. Commission Decision 2001/17/EC on refusing the placing on the market of ‘Nangai nuts’ as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council [2001] OJ L4/35; Commission Decision 2000/196/EC refusing the placing on the market of Stevia rebaudiana Bertoni: plants and dried leaves as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council [2000] OJ L61/14.
- 34.
In the absence of extensive available data, the ‘[c]hances of EU market authorization for the majority of exotic food species are currently nil’. M Hermann, ‘The Impact of the European Novel Food Regulation on Trade and Food Innovation Based on Traditional Plant Foods from Developing Countries’ (2009) 34 Food Policy 499, 505.
- 35.
A procedure for defining criteria for clarifying the concept was foreseen in the Commission’s proposal. See European Commission, Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EU) No XXX/XXXX COM(2007) 872 final (NNFR), Art 3.2(a).i. The EU’s understanding of significant use must currently be inferred from its categorisation of foods in its Novel Foods Catalogue, available at ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/index.cfm.
- 36.
See N Craddock, ‘The EU Novel Food Regulation, Impact on the Potential Export of Exotic Traditional Foods to the EU: Suggestions for revision’ (Discussion paper prepared for UNCTAD and CBI, in cooperation with GTZ, GFU and IPGRI, November 2005) 6, www.underutilized-species.org/Documents/PUBlICATIONS/cbi_unctad_paper_on_eu_nfr.pdf; EM Cumming Smith, The European Novel Foods Regulation: The Case of Exotic Foods (Wageningen University, June 2009) 66–67, www.underutilized-species.org/documents/publications/ecsmith_nfr_thesis_09.pdf.
- 37.
For instance, the case (accepted by the UK authorities) for the significant use of Goji berries relied on a mixture of information ranging from signed statements by Chinese food outlets to recipes in health magazines appearing before 1997. See UK FSA (n 31) 4–8.
- 38.
See Cumming Smith (n 36) 52.
- 39.
The export value of paprika to the European market in 2005 was reported to be US$ 42 million. WTO Document, G/SPS/GEN/713 (12 July 2006) para 8.
- 40.
A report undertaken by the Central Bank of Ecuador identified the market value of novel foods in their country to be between 67 and 68 million US$. G/SPS/GEN/714 (12 July 2006) para 2.
- 41.
In one of its submissions to the SPS Committee, Colombia produces a list of around 50 products deemed to be novel foods (although some of those listed would probably not be considered novel by the EU). G/SPS/GEN/735 (18 October 2006) Annex.
- 42.
Ecuador estimates that exporting only five primary products—manila hemp, Quito orange, tree tomato, Andean lupin and cocoyam—could potentially have a social impact on 154,000 people. G/SPS/GEN/714 (n 40) para 5.
- 43.
For example, Phytotrade, a well-organised consortium of interests, is reported to have invested £ 150,000 in its successful NF application. Hermann (n 34) 505.
- 44.
The UN Conference on Trade and Development (UNCTAD) that runs the BioTrade Facilitation Programme (BFTP) aimed at supporting minor crops, views the CNFR to indiscriminately hinder imports of natural products, for some of which market interest is growing steadily. See O Mück, ‘Trade Barrier NFR? Underutilised Species under the European Union’s Novel Food Regulation’ (Paper commissioned by Deutsche Gesellschaft für Technische Zusammenarbeit, 2003) 7, www.underutilized-species.org/Documents/PUBlICATIONS/trade_ barrier_nfr.pdf. For the Dutch governmental partner involved in the BTFP, the contradiction became particularly painful when the Maca root it had been promoting was confiscated by Dutch authorities on import due to its novel-food status. See Cumming Smith (n 36) 49.
- 45.
The EU has funded the growth of exotic foods to this end in Bolivia and Colombia, but does not allow the resulting novel foods to enter the EU. G/SPS/R/42 (25 September 2006) para 36.
- 46.
See ns 118 and 119 below and related text on the discussion within the WTO SPS Committee.
- 47.
Agreement on Technical Barriers to Trade, 15 April 1994, 1868 UNTS 120 (1 January 1995) (TBT Agreement). A rationale for this position was first expounded in G/SPS/GEN/699 (8 June 2006) para 6. When challenged, the EU has declined to elaborate its standpoint, preferring to reference the initial explanation. See, e.g. the EU’s responses to the WTO Trade Policy Review, WTO Document, WT/TPR/M/214/Add.1 (2 July 2009) 219, 407.
- 48.
See generally respectively WTO Documents: G/TBT/N/EEC/188 (14 March 2008); G/TBT/Notif.97.151 (21 April 1997). The one inconsistency in the EU’s practice in this respect was its communication of a pubic consultation on the EU CNFR which was transmitted to the SPS rather than TBT Committee. See G/SPS/GEN/700 (8 June 2006).
- 49.
The labelling requirements (Art 8) originally provided a basis for identifying GM foods. However, following the introduction of specific GM legislation and at the time of the EU’s comments with regard to the TBT Agreement, the significance of labelling provisions was much reduced.
- 50.
See, e.g. Commission Decision 2003/867/EC authorising the placing on the market of salatrims as novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council [2003] OJ L326/32, Art 2 (requiring labelling indicating potential risk of gastrointestinal disturbance).
- 51.
The EU’s argument is all the more peculiar, as elsewhere in the same communication, the EU emphasises that ‘one of the essential pillars in this [novel food] application is the provision of a safety assessment’. G/SPS/GEN/699 (n 47) para 13.
- 52.
ibid para 7 (emphasis in original).
- 53.
See SPS Agreement Art 8 and Annex C.
- 54.
Recital 2 of the CNFR explains that ‘in order to protect public health, it is necessary to ensure that novel foods and novel food ingredients are subject to a single safety assessment through a Community procedure before they are placed on the market within the Community’. See CNFR (n 22).
- 55.
The elaborate, if rather unconvincing, efforts on the part of the EU to circumvent the SPS regime are all the more striking if, as Bronckers and Soopramanien claim, the TBT Agreement imposes equally strict disciplines as the SPS Agreement. M Bronckers and R Soopramanien,‘The Impact of WTO Law and European Food Regulation’ (2008) 3 European Food and Feed Law Review 361, 366–67. Their account differs, however, from the predominant view that the SPS Agreement places a higher burden on health as opposed to other types of risk. See, e.g. A Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO (London, Cameron May, 2007) 312.
- 56.
G/SPS/GEN/681 (5 April 2006) para 8. In its contributions to the SPS Committee, Colombia has emphasised Arts 2.2 and 5.6.
- 57.
See CE Foster, ‘Prior Approval Systems and the Substance–Procedure Dichotomy under the WTO SPS Agreement’ (2008) 42 JWT 1203, 1205 (drawing this distinction between substantive and procedural measures in her analysis of the EC—Biotech case).
- 58.
It cannot be excluded that third countries would contest the EU’s use of risk assessment in rejecting a particular authorisation. However, given the limited number of traditional products considered, it is clear that the thrust of third-country discontent is the need for authorisation in the first place.
- 59.
See Foster (n 57) 1213. See also T Epps, ‘Pre-market Approval Systems and the SPS Agreement’ in G Van Calster and D Prévost (eds), Research Handbook on Environment, Health and the WTO (Cheltenham, Edward Elgar, 2013) (discussing the applicability of both substantive and procedural SPS disciplines to pre-market approval systems).
- 60.
Foster alternatively suggests that approval procedures should only be considered a measure where they have inhibited international trade. ibid 1215. This appears to be an unduly narrow interpretation of the scope of the SPS Agreement Art 1, which includes ‘measures which may, directly or indirectly, affect international trade’ (emphasis added).
- 61.
WTO, Sanitary and Phytosanitary Measures, European Communities Regulation 258/97 Concerning Novel Foods, Statement by Peru at the Meeting of the Committee Held on 8 and 9 October 2008, G/SPS/GEN/884 (21 October 2008) para 5.
- 62.
SPS Agreement Art 5.7 provides that ‘Members, where implementing provisional measures, shall seek to obtain the additional information necessary for a more objective assessment of risk and review… within a reasonable period of time’.
- 63.
SPS Agreement Annex C, 1(i).
- 64.
Japan—Measures Affecting Agricultural Products, Appellate Body Report (adopted 22 February, 1999) WT/DS76/AB/R, para 84.
- 65.
The difficulty for a complainant in this context is that it would have to demonstrate that the CNFR is irrational in its demand for evidence. However, this would require establishing the eminent safety of a product, and presumably precisely the type of detailed risk assessment the complainant views to be unnecessary.
- 66.
The second explanation remains difficult to reconcile with the presumption emerging from jurisprudence that a measure is not consistent with Art 2.2 where not based on risk assessment. For a detailed analysis of the relationship between Art 2.2 and Art 5.1, see J Scott, The WTO Agreement on Sanitary and Phytosanitary Measures: A Commentary (Oxford, OUP, 2007) 82–84.
- 67.
Foster suggests that a challenge on prior approvals ‘would potentially expose the SPS Agreement and the WTO itself to ridicule’. Foster (n 57) 1213. This may particularly be the case for novel foods, given the existence of comparable novel-food pre-market approval systems in place in Canada, Australia and New Zealand. For a summary of these measures, see Mück (n 44) 9–10. However, some commentators do anticipate a WTO challenge of the EU’s prior authorisation scheme. See A Szajkowska, Regulating Food Law Risk Analysis and the Precautionary Principle As General Principles of EU Food Law (Wageningen, Wageningen Academic Publishers, 2012) 79.
- 68.
Peru presents this argument with regard to the disparate treatment of Nangai and other varieties of nuts. G/SPS/GEN/884 (n 61) para 7.
- 69.
US National Research Council Lost Crops of the Incas: Little-Known Plants of the Andes with Promise for Worldwide Cultivation (Washington, D. C, National Academy Press, 1989) 263.
- 70.
ibid 115.
- 71.
See EU Novel Foods Catalogue (n 35) reference ‘lucuma obovata’; No Rojas, ‘La Lúcuma Dejó de ser Novelfood en Francia y ya Tiene Ingreso Libre a Europa’, Agro Negocios Perú [Agricultural Business Peru] (27 April 2009) www.agronegociosperu.org/noticias/270409_n2.htm.
- 72.
See EU Novel Foods Catalogue (n 35) reference ‘smallanthus sonchifolius’.
- 73.
See European Rapid Alert System for Food and Feed (RASFF), Alert 2009/20 reporting the finding of unauthorised yacon syrup from Peru, ec.europa.eu/food/food/rapidalert/reports/week20-2009_en.pdf.
- 74.
This is particularly so if one accepts the view of the Panel in US-Poultry that the justification for this different treatment needs to be a demonstration of differing risk using scientific evidience. United States Certain Measures Affecting Imports of Poultry from China, Panel Report (adopted 29 September 2010) WT/DS392/R, para 7.263.
- 75.
The cumulative nature of the three elements was established in Hormones. European Communities—EC Measures Concerning Meat and Meat Products (Hormones) Appellate Body Report, (adopted 16 January 1998) WT/DS26/AB/R and WT/DS48/AB/R, para 214.
- 76.
ibid para 217 (arguing that situations cannot be compared ‘unless they present some common elements or elements sufficient to render them comparable’).
- 77.
ibid para 215.
- 78.
Hermann (n 34) 506.
- 79.
Australia—Measures Affecting Importation of Salmon (Australia—Salmon), Appellate Body Report (adopted 20 October 1998) WT/DS18/AB/R, para 194.
- 80.
See G/SPS/GEN/681 (n 56) points 11(a) and (b) respectively.
- 81.
Such inference is deemed to be permissible in cases where a Member insufficiently clarifies the level of protection sought. See Australia—Salmon, Appellate Body Report, para 207.
- 82.
See European Commission, Commission Recommendation 97/618/EC concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council [1997] OJ L253/1 (Commission NF Application Recommendations) 4 (stating that ‘[w]henever changes are made to the way in which a food is put on the market… the implications for consumer safety and nutritional value will require consideration’).
- 83.
Before the SPS Committee, the EU has reiterated its view that traditional foods cannot be deemed to be safe per se, as ‘products marketed as “products of biodiversity” had in the past turned out to be unsafe and harmed the users’. G/SPS/R/40 (26 May 2006) para 29. The risk emanates either from the plant constituents which can be toxic or the lack of knowledge among the population of the importing country as how they must be used. See I Knudsen et al., ‘Risk Management and Risk Assessment of Novel Plant Foods: Concepts and Principles’ (2008) 46 Food and Chemical Toxicology 1681, 1682.
- 84.
See G Brookes, ‘Economic Impact Assessment of the way in which the EU Novel Foods Regulatory Approval Procedures Affect the EU Food Sector’ (July 2007) 4, www.pgeconomics.co.uk/pdf/novelfoods.pdf.
- 85.
Hermann reports that the average time for the adoption of traditional foods is 39 months. Hermann (n 34) 505.
- 86.
This argument is among those raised by third countries. See, e.g. G/SPS/GEN/713 (n 39) para 5.
- 87.
In its 2008 overview, the Commission reported only one case in which a novel food authorisation had been finalised and approved at the Member-State level. Commission NNFR Impact Assessment (n 32) Annex 1.
- 88.
See, e.g. UK FSA, ‘Letter to the European Commission Concerning Tahitian Noni Juice (Morinda citrifolia)’ (NFU 146, 10 December 2001) 1, www.food.gov.uk/multimedia/pdfs/uknoniopin.pdf; Health Council of the Netherlands, ‘Noni Juice: Second Opinion Regarding Consumer Safety, in Accordance with European Regulation 258/97 Concerning Novel Foods and Novel Food Ingredients’ (No. 2001/03VNV, 13 December 2001) www.cbg-meb.nl/NR/rdonlyres/96B16752-9CA3-43F8-AF79-5592E200C693/0/nonisap.pdf.
- 89.
SPS Agreement Annex C, para 1(b).
- 90.
Craddock (n 36) 7–8; Cumming Smith (n 36); WTO, Committee on Sanitary and Phytosanitary Measures, G/SPS/GEN/713 (n 39) para 5.
- 91.
For example, traditional products such as noni juice, baobab pulp and chia seed have met with success.
- 92.
SPS Agreement Annex C(c) (emphasis added).
- 93.
Commission NF Application Recommendations (n 82).
- 94.
See, e.g. the UK FSA’s assessment of baobab pulp. The determinant opinion found that ‘the absence of extensive toxicological analyses did not give cause for concern because baobab fruit was a staple part of the diet throughout Africa and a retrospective toxicological assessment would have limited value’. UK FSA, ‘Initial Opinion: Baobab Dried Fruit Pulp’ (12 July 2007) 9, www.food.gov.uk/multimedia/pdfs/baobabinitialopinion.pdf.
- 95.
G/SPS/GEN/884para 10.
- 96.
See (n 35).
- 97.
The Commission’s definition of traditional food established four criteria. Firstly, the food cannot merely have been used at one point in time, but must ‘continue… to be part of the diet’. Secondly, it must be ‘part of the normal diet’ and not say a plant that has been used say for medicinal or cosmetic purposes. Thirdly, experience of the use of the product must be extensive, equivalent to that of ‘at least one generation’. Finally, use of the product cannot simply be local, but have been consumed by ‘a large part of the population of the country’. NNFR (n 35) Art 3.2(b).
- 98.
NNFR (n 35) Art 8.
- 99.
ibid.
- 100.
European Commission, ‘Evaluation Report on the Novel Food Regulation 258/97 Concerning Novel Foods and Novel Food Ingredients’ (2004 22/1/2004, Annex 1) ec.europa.eu/food/food/biotechnology/novelfood/summary_report_annex1_en.pdf.
- 101.
See Servicio Nacional de Sanidad Agraria del Peru (SENASA)–‘Peru, Novel Foods–Responses to the Online Consultation on the revision of Regulation EC 258/97’ (Discussion Paper responses) ec.europa.eu/food/food/biotechnology/novelfood/resp_consult_258_97_en.htm. The original discussion paper is European Commission, Implementation of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 Concerning Novel Foods and Novel Foods Ingredients (2002) ec.europa.eu/food/food/biotechnology/novelfood/discussion _en.pdf.
- 102.
BEUC European Consumers Organisation–EU, Discussion Paper responses (ibid) 3 (warning that ‘we reject any notification procedure’).
- 103.
ibid.
- 104.
In 2004, the Commission had noted the need to ‘clarify their intentions as regards plants and products produced naturally in countries outside of the Community’. Commission CNFR Evaluation (n 30) 8.
- 105.
See (n 32).
- 106.
Ireland, Discussion Paper responses (n 101) 1.
- 107.
UK, Discussion Paper responses (n 101) 2.
- 108.
Denmark, Discussion Paper responses (n 101) 3.
- 109.
The Council shared concerns expressed by the EP in first reading and agreed to replace the criterion ‘one generation’ with ‘at least 25 years’. Position (EU) No 6/2010 of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001, [2010] OJ C122/3, Art 3.2(d) (NNFR Common Position).
- 110.
To respond to these concerns, the Council toyed with the idea of limiting the scope of traditional foods to cover only fruits and vegetables. See Council of the European Union, ‘Employment, Social Policy, Health and Consumer Affairs Council Meeting of 9 and 10 June 2008’ (9689/08) II.B.1.
- 111.
See comments by EFSA official J Kleiner, EP workshop on novel foods in Brussels, European Parliament Report IP/A/EMVI/WS/2008–15 (2008) 25, www.europarl.europa.eu/RegData/etudes/divers/join/2008/408556/IPOL-ENVI_DV(2008)408556_EN.pdf.
- 112.
Art 8 of the NNFR providing for the procedural requirements for traditional foods was reported to have been rewritten around ten times. ‘Nano, Cloning, Third Countries Threaten Novel Foods Deal’ EU Food Law (13 February 2009).
- 113.
The advantage that this procedure offers to third countries is a reduced risk management period (3 months rather than 9 months) permitted to the Commission to submit a proposal to the Standing Committee. NNFR Common Position (n 109) Art 11.
- 114.
A solution addressing the identified inefficiencies of the risk-assessment process for novel foods was already foreseen in Art 7 of the NNFR (n 35). Likewise, the informational shortcomings identified above could have been overcome through the amendment of the Commission’s Recommendations.
- 115.
Scott (n 66) 75.
- 116.
The obligation to notify under SPS Agreement, Annex B, para 5 is limited to proposed regulations.
- 117.
See n 48.
- 118.
These debates took place in March 2006 (G/SPS/R/40, paras 21–29); June 2006 (G/SPS/R/42, paras 35–37); October 2006 (G/SPS/R/43, paras 140–43); February 2007 (G/SPS/R/44, para 64); April 2008 (G/SPS/R/49, paras 48–52); October 2008 (G/SPS/R/53, paras 19–23); October 2009 (G/SPS/R/56, paras 53–55).
- 119.
Concerns were raised by Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, El Salvador, Honduras, India, Mexico, Paraguay, Philippines, Uruguay and Venezuela.
- 120.
A compromise was agreed with the EP in conciliation which did not make substantial changes to the Council Common Position. See NNFR Common Position (n 109).
- 121.
J Suk et al., ‘Dolly for Dinner? Assessing Commercial Land Regulatory Trends in Cloned Livestock’ (2007) 25 Nature Biotechnology 47, 48.
- 122.
See L Rudenko et al., ‘Animal Cloning and the FDA–The Risk Assessment Paradigms under Public Scrutiny’ (2007) 25 Nature Biotechnology 39, 40 (explaining how the US FDA ‘considers cloning to fall on the continuum of [assisted reproductive technologies] currently in use in agriculture’).
- 123.
S Poulter, ‘Cloning Opens Door to “Farmyard Freaks”’ Daily Mail (11 January 2007) www.dailymail.co.uk/news/article-427963/Cloning-opens-door-farmyard-freaks.html.
- 124.
EFSA, ‘Food Safety, Animal Health and Welfare and Environmental Impact of Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their Offspring and Products Obtained from those Animals’ (2008) 767 EFSA Journal 1, 19–20 (EFSA Cloning Opinion).
- 125.
ibid 25.
- 126.
The European Group on Ethics in Science and New Technologies to the European Commission, ‘Ethical aspects of animal cloning for food supply’ Opinion No 23, Abstract,16 January 2008) (EGE Cloning Opinion) ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf.
- 127.
ibid. The discussion of long-term applications of cloning can be found at 15.
- 128.
GS Becker and T Cowan, ‘Biotechnology in Animal Agriculture: Status and Current Issues’ 2009) 32 Congressional Research Service Reports 1, 11, digitalcommons.unl.edu/crsdocs/32.
- 129.
For discussion of this dilemma, see generally DA Kysar, ‘Preferences for Processes: The Process/Product Distinction and the Regulation of Consumer Choice’ (2004) 118 Harvard Law Review 525.
- 130.
Grahame Bulfield, former director of the Roslin Institute responsible for producing the first cloned sheep (Dolly), described the treatment of cloned food as novel to be ‘nonsense’: ‘There’s nothing novel about it, and you might as well say every new type of cereal should be treated with the same caution.’ Cited in J Meikle and R Smithers, ‘Cloning-Derived Milk Claim Prompts Food Agency Enquiry’ The Guardian (3 August 2010) www.guardian.co.uk/uk/2010/aug/02/fsa-investigating-gm-milk-claims.
- 131.
W Surman, ‘FSA Admits Meat from Cloned Cow’s Calf Entered UK Food Chain’ Farmers Guardian (4 August 2010) www.farmersguardian.com/home/livestock/fsa-admits-cloned-meat-entered-food-chain/33530.article.
- 132.
H Mahony, ‘Milk From Cloned Cow Offspring Exposes Gap In EU Food Law’ euobserver.com (3 August 2010) (citing European Commission spokesman’s confirmation of the legal position) euobserver.com/9/30578.
- 133.
‘UK Changes Stance on Food from Cloned Offspring’ EU Food Policy (10 December 2010).
- 134.
In response to the Commission Discussion Paper in 2002, cloning was already flagged up as an issue by consumer organisations. See, e.g. comments from the Danish Consumer Agency, Discussion Paper responses (n 101).
- 135.
See n 32.
- 136.
FDA News Release, ‘Agency Continues to Ask Producers and Breeders Not to Introduce Food from Clones into Food Supply’ (20 December 2006) www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108819.htm.
- 137.
See generally US Food And Drug Administration, Centre For Veterinary Medicine, Animal Cloning: A Risk Assessment (2008) www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AnimalCloning/UCM124756.pdf.
- 138.
‘Rapporteur Calls for Cloning to be Excluded from Novel Foods’ EU Food Law (20 June 2008) (reporting on the first discussions of the non-leading EP Agriculture Committee).
- 139.
In July 2008, one participant reported on the non-controversial nature of the NNFR discussions in Council, noting that ‘Member State officials have not been getting excited over cloning’. Cited in ‘Slow Council Progress on Novel Foods’ EU Food Law (25 July 2008).
- 140.
See generally European Parliament, Resolution of 3 September 2008 on the Cloning of Animals for Food Supply (P6_TA(2008)0400). 622 MEPs voted in favour with just 32 against, and 25 abstentions.
- 141.
European Parliament legislative resolution of 25 March 2009 on the proposal for a regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [2010] OJ C117 E/236.
- 142.
‘Presidency Amendments Put Cloning outside Novel Food Regulation’ EU Food Law (17 October 2008).
- 143.
Council of the European Union, Preparation for the Informal Trialogue, 6414/09 DENLEG 12 CODEC 162 (February 18, 2009).
- 144.
Council of the European Union, Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX, Political Agreement, Addendum to the A Item Note, 10754/09 (17 June 2009) (Council PA) 2.
- 145.
In accordance with: The Treaty of Amsterdam amending the Treaty on European Union, the Treaties establishing the European Communities and certain related acts—Consolidated version of the Treaty establishing the European Community, Art 251, [2002] OJ C325/33. Ultimately, unanimity was contrived through the abstention of UK and Greece, having allowed these countries to make specific statements. ibid. Addendum, 3–4.
- 146.
European Parliament, Legislative Resolution of 7 July 2010 on the Council Position at First Reading for Adopting a Regulation of the European Parliament and of the Council on Novel Foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (P7_TA(2010)0266), Art 2.c.
- 147.
These consisted of a ban on animal cloning in the EU for food production, all food from cloned animals and any supply of clones for food production. This position was confirmed in a Council of the European Union, Press Release 8308/11 (29 March 2011) 1, www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/120351.pdf (Council NNFR PR).
- 148.
ibid.
- 149.
The only previous conciliation procedure failure involved a proposal for a working time directive. See n 3.
- 150.
See ‘Cloned Foods Unleashed’ (n 4).
- 151.
Council NNFR PR (n 147).
- 152.
‘MEPs Refute Claims of “Trade War” if EU Regulates Clone Offspring’ (n 5).
- 153.
General Agreement on Tariffs and Trade, opened for signature 15 April 1994, 55 UNTS 194, 1867 UNTS 187 (1 January 1995).
- 154.
For a discussion of the interrelationship of the GATT and the TBT Agreement, see G Marceau and JP Trachtman, ‘The Technical Barriers to Trade Agreement, the Sanitary and Phytosanitary Measures Agreement, and the General Agreement on Tariffs and Trade–Map of the World Trade Organization Law of Domestic Regulation of Goods’ (2002) 36 JWT 811, 873.
- 155.
See MM Du, ‘Domestic Regulatory Autonomy under the TBT Agreement: From Non-Discrimination to Harmonisation’ (2007) 6 Chinese Journal of International Law 269, 287–88. This decision finds support from the Appellate Body’s (AB) focus on physical factors in its definition of ‘characteristics of a product’. See European Communities—Measures Affecting Asbestos and Asbestos-Containing Products (EC—Asbestos); Appellate Body Report (adopted 12 March 2001) WT/DS135/AB/, para 67. However, the second sentence of the definition in TBT Annex 1, para 1 reads: ‘It may also include… labelling requirements as they apply to a product, process or production method.’ It is unclear whether PPMs labelling constitutes a subset of the regulations defined in the first sentence (and excluding non-product PPMs) or an independent discipline applicable to non-product PPMs.
- 156.
For a discussion of the interpretation of ‘like product’, see S Charnovitz, ‘The Law of Environmental “PPMs” in the WTO: Debunking the Myth of Illegality’ 27 YJIL 59, 76–77 (2002), and see generally R Howse and DH Regan, ‘The Product/Process Distinction—An Illusionary Basis for Disciplining “Unilateralism” in Trade Policy’ (2000) 11.
- 157.
See, e.g. United States—Standards for Reformulated and Conventional Gasoline, Appellate Body Report (adopted 29 April 1996) WT/DS2/AB/R, para 6.8.
- 158.
EC—Asbestos, Appellate Body Report, para 117.
- 159.
ibid para 109 (emphasis in original).
- 160.
ibid para 145.
- 161.
For discussion of the dangers associated with eliminating the product/process distinction, see generally JH Jackson, ‘Comments on Shrimp/Turtle and the Product/Process Distinction’ (2000) 11 EJIL 303.
- 162.
United States—Measures Affecting the Production and Sale of Clove Cigarettes (US—Clove Cigarettes), Appellate Body Report (adopted 4 April 2012) WT/DS406/AB/R, paras 108–12.
- 163.
See respectively GATT Art III.4 and TBT Art 2.1.
- 164.
Korea—Measures Affecting Imports of Fresh, Chilled and Frozen Beef (Korea—Beef), Appellate Body Report (adopted 11 December 2000) WT/DS161/AB/R, WT/DS169/AB/R, paras 135–37.
- 165.
An asymmetric test (evaluating the impact on domestic cloned and non-cloned meat versus imported cloned and non-cloned meat) is more stringent than the possible diagonal test (evaluating the treatment of a conventional food versus a clone-derived equivalent). For an explanation of these methods for testing impact, see L Ehring, ‘De Facto Discrimination in World Trade Law’ (2002) 36 JWT 921, 924–25.
- 166.
US—Clove Cigarettes, Appellate Body Report, para 174.
- 167.
See discussion on trade restrictiveness in ns 189–193 below and related text.
- 168.
For example, in US—COOL, the Appellate Body took exception to the amounts of information required by upstream producers for meat which did not require origin labelling. United States—Certain Country of Origin Labelling (COOL) Requirements (US—COOL), Appellate Body Report (adopted 29 June 2012) WT/DS384/AB/R, WT/DS386/AB/R,paras 346–49.
- 169.
Art XX(b) permits WTO-inconsistent policies where necessary to protect human, animal or plant life or health. However, commentators generally consider this provision not to be applicable to a purely welfare-oriented measure where human health is not directly implicated. See P Stevenson, ‘The World Trade Organisation Rules: A Legal Analysis of Their Adverse Impact on Animal Welfare’ (2007) 8 Animal Law 107, 136; EM Thomas, ‘Playing Chicken at the WTO: Defending an Animal Welfare-Based Trade Restriction under GATT’s Moral Exception’ (2007) 34 Boston College Environmental Affairs Law Review 605, 618; R Galantucci, ‘Compassionate Consumerism within the GATT Regime: Can Belgium’s Ban on Seal Product Imports be Justified under Article XX?’ (2009) 39 California Western International Law Journal 281, 304.
- 170.
NF Diebold, ‘The Morals and Order Exceptions in WTO Law: Balancing the Toothless Tiger and the Undermining Mole’ (2008) 11 JIEL 43, 69. However, other commentators consider it unlikely that animal welfare concerns could be included in this way. See A Hobbs, ‘Ethics, Domestic Food Policy and Trade Law: Assessing the EU Animal Welfare Proposals to the WTO’ (2002) 27 Food Policy 437, 450.
- 171.
MA Gonzalez, ‘Trade and Morality: Preserving “Public Morals” without Sacrificing the Global Economy’ (2006) 39 Vanderbilt Journal of Transnational Law 939, 943–45.
- 172.
United States Measures Affecting the Cross-Border Supply of Gambling and Betting Services (US—Gambling), Panel Report (adopted 10 November 2004) WT/DS285/R, para 6.461.
- 173.
ibid para 6.472.
- 174.
For discussion of the uncertain evidentiary requirements in this respect, see M Wu, ‘Free Trade and the Protection of Public Morals: An Analysis of the Newly Emerging Public Morals Clause Doctrine’ (2008) 33 YJIL 215, 233–35. The Council’s Legal Service has expressed doubts about the applicability of Art XX(a) in the light of the ambivalent response (41 % agreement) of EU citizens, when questioned ‘whether animal cloning would cause animals unnecessary pain’. Council of the European Union, Opinion of the Legal Service, 7771/11 (15 March 2011) (Council Legal Opinion), para 11 and fn 6. However, the relevance of this finding is questionable as it provides an indication of knowledge rather than moral judgement.
- 175.
Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes [1998] OJ L221/23, Annex, para 20.
- 176.
Certainly, WTO Members have called upon public morals to justify variety of issues, seemingly more tenuous than the cloning issue, ranging from lottery tickets to automobile radar detectors. See JC Marwell, ‘Trade and Morality: WTO Public Morals Exception after Gambling’ (2006) 81 New York University Law Review 802, 818; See also generally S Charnovitz, ‘The Moral Exception in Trade Policy’ (1997) 38 VJIL 689.
- 177.
The discussion is limited to the exposition of a philosophical strand that analogises human and non-human animals as moral entities. EGE Cloning Opinion (n 126) 33–34.
- 178.
See G Matheny and C Leahy, ‘Farmer-Animal Welfare, Legislation, and Trade’, 70 Law and Contemporary Problems (2007) 325, 325–27 (illustrating the range of farming techniques systematically employed in US agriculture which compromise animal welfare).
- 179.
Council Legal Opinion (n 174) 5, n 7.
- 180.
71 % of US respondents in a FOX News/Opinion Dynamics Poll answered that cloning to reproduce livestock was unacceptable and 65 % of respondents to a Gallup Poll found the practice immoral. See JF Murphy, ‘Mandatory Labelling of Food Made from Cloned Animals: Grappling with Moral Objections to the Production of Safe Products’ (2008) 63 Food and Drug Law Journal 131, 138.
- 181.
US—COOL, Appellate Body Report, para 445.
- 182.
Korea—Beef, Appellate Body Report, para 164. This is assuming that paragraph (a) would be interpreted in the same manner as other clauses under Art XX, as suggested by the AB’s similar approach to Art XX(b) in Asbestos. See EC—Asbestos, Appellate Body Report, para 172.
- 183.
United States—Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, Appellate Body Report (adopted 16 May 2012) WT/DS381/AB/R, para 318.
- 184.
Korea—Beef, Appellate Body Report, para 164. The equivalent factors under TBT Art 2.2 are (in the same order) ‘the nature of the risks at issue and the gravity of consequences that would arise from non-fulfilment’, ‘the trade restrictiveness of the measure’, ‘the degree of contribution made by the measure to the legitimate objective at issue’ and ‘in most cases, a comparison of the challenged measure and possible alternative measures’. ibid para 322.
- 185.
Korea—Beef, Appellate Body Report, para 162.
- 186.
See B McGrady, ‘Necessity Exceptions in WTO Law: Retreaded Tyres, Regulatory Purpose and Cumulative Regulatory Measures’ (2009) 12 JIEL 153, 161–63.
- 187.
US—Gambling, Panel Report, para 6.461.
- 188.
EC—Asbestos, Appellate Body Report, para 172.
- 189.
Korea—Beef, Appellate Body Report, para 163.
- 190.
This assumes that EU bans are not considered indispensable in which case, according to the interpretation of the AB in Korea—Beef, they would not be subjected to a necessity analysis. See DH Regan, ‘The Meaning of “Necessary” in GATT Article XX and GATS Article XIV: The Myth of Cost-Benefit Balancing’ (2007) 6 World Trade Review 347, 354.
- 191.
As the Commission has noted, only 2 % of the calves born in the EU each year results from insemination of imported bovine semen, of which most probably only a tiny proportion would be semen from cloned bulls. Likewise, imports of embryos were limited to 747 consignments. Report from the Commission to the European Parliament and the Council on animal cloning for food productionCOM (2010) 585 final (19 October 2010) (Commission Cloning Report) 9.
- 192.
J Gunning et al., Challenges in Regulating Farm Animal Cloning (Danish Centre for Bioethics and Risk Assessment, 2006) 27, www.curis.ku.dk/ws/files/50665433/CHALLENGES_IN_REGULATING.pdf. See also EGE Cloning Opinion (n 126) 43. However, note that some MEPs were not convinced about the technical constraints associated with labelling. See EP Group Alliance of liberals and Democrats Press Release, ‘Cloning: Council Distorts the Debate, ALDE’ (12 May 2011) www.alde.eu/press/press-and-release-news/press-release/article/cloning-council-distorts-the-debate-37396/.
- 193.
See generally European Livestock and Meat Trades Union [UECBV], ‘Cloning for food production—UECBV Position’, UECBV Ref. 248 (31 January 2011) www.uecbv.eu/doc/UECBV-%20Position%20on%20Cloning%200.13.pdf. The US currently maintains a voluntary tracking system for animal clones, but provides for no traceability at all for the offspring of clones. Commission Cloning Report (n 191) 7.
- 194.
United States—Import Prohibition of Certain Shrimp and Shrimp Products, Appellate Body Report (adopted 12 October 1998) WT/DS58/AB/R, para 141.
- 195.
Brazil—Measures Affecting Imports of Retreaded Tyres, Appellate Body Report (adopted 3 December 2007) WT/DS332/AB/R, para 151. For the purposes of argument (and because the EU would strategically be unwise to claim otherwise), the assumption in this case is that the animal cloning measures are not deliberately aimed at extraterritorial impact, but rather measures foreseen for the EU territory with extraterritorial effects.
- 196.
This is one characterisation of the motivation for regulating PPMs provided by Howse and Regan (n 156) 275.
- 197.
For example, lead EP negotiators, Gianni Pittella and Kartika Liotard stated they were ‘not willing to betray consumers on their right to know whether food comes from animals bred using clones’. Cited in ‘Bid to Ban Cloned Foods In Europe Collapses’ EU Food Policy (29 March 2011).
- 198.
See I Cheyne, ‘Proportionality, Proximity and Environmental Labelling in WTO Law’ (2009) 12 JIEL 927, 939 (arguing that the freedom of consumers is constrained and must be proportionately applied in order not to infringe on the rights of others). In fact, this limit was acknowledged by the EP rapporteur, Liotard, who reassured: ‘We are probably not going to go down to the 100th generation’. Cited in ‘Deadlock over Cloning Set Scene for Novel Foods “High Noon”’ EU Food Policy (18 March 2011).
- 199.
‘Sweets Would Have Been Labelled “Cloned” under Parliament’s Proposals’ EU Food Policy (1 April 2011) (citing comments by Commission officials).
- 200.
‘“No Control” over Cloning, Warns Dalli’ EU Food Policy (1 April 2011).
- 201.
The balancing or relational analysis creates a dilemma in this respect. The more comprehensive the labelling of those foods indirectly related to the cloning process, the more convincing the argument that it serves to attain ethical objectives. Yet, at the same time, the more rigorous this measure becomes, the more costly and burdensome the effects on international trade.
- 202.
See McGrady (n 186) 159–60 (suggesting that the identification of regulatory goals has been treated rather cavalierly in past disputes).
- 203.
However, on the limitations of voluntary labelling, see S Keane, ‘Can the Consumers’ Right to Know Survive the WTO: The Case of Food Labelling’ (2006) 16 Transnational Law and Contemporary Problems 291, 295; Hobbs (n 170) 451.
- 204.
As Regan points out, the Appellate Body has yet to say that any specific legitimate regulatory purpose is less valuable than any other. Regan (n 190) 363.
- 205.
The situation would possibly be analogous to that confronting the AB in Korea—Beef, where they dismissed the relevance of idealistic goals, namely the total elimination of fraud on the basis that this ‘would probably require a total ban of imports’. Korea—Beef, Appellate Body Report, para 178. For a discussion of this quasi-proportionality approach, see P Eeckhout, ‘The Scales of Trade–Reflections on the Growth and Functions of the WTO Adjudicative Branch’ (2010) 13 JIEL 3, 20.
- 206.
In this context, the Council Legal Service’s reassurance that a ‘simple labelling requirement would pass the necessity test’ established by Art XX must be viewed sceptically. Its conclusion is drawn on a misinformed characterisation of labelling measures as simple and therefore a failure to engage in the type of balancing exercise that would be required from a Panel. Council Legal Opinion (n 174) para 44. The services noted the relevance of considering the impact of the measure on international commerce (see para 40), but failed to do so.
- 207.
M Weimer, ‘The Regulatory Challenge of Animal Cloning for Food–The Risks of Risk Regulation in the European Union’, 1 European Journal of Risk Regulation 31, 36 (2010).
- 208.
See ns 58–60 and related text.
- 209.
See EFSA Cloning Opinion (n 124) 28. EFSA’s original assessment was not amended by further evaluations in 2009 and 2010. See generally EFSA Statement, ‘Further Advice on the Implications of Animal Cloning (SCNT)’ (2009) RN 319 EFSA Journal 1; See generally EFSA Statement, ‘Update on the State of Play of Animal Cloning’ (2010) 8 EFSA Journal 1784.
- 210.
Commission Cloning Report (n 191) 10.
- 211.
ibid.
- 212.
There is no formal evidence of this position. It reflects conversations held with Commission officials in the summer of 2010, but is certainly entirely consistent with the US’s non-criticism of the CNFR. If other trading partners shared the US position, the Commission theoretically also had recourse to the argument that the measure would not ‘directly or indirectly, affect international trade’ as set out in Art 1 of the SPS Agreement, and therefore falls outside the scope of the Regulation.
- 213.
European Commission, ‘Communication concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on novel foods, amending Commission Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001’, COM(2010)124 final, 5.
- 214.
EFSA Cloning Opinion (n 124) 32.
- 215.
Greece, for example, invoked the precautionary principle, claiming that ‘potential future dangers arising from the application of animal cloning technique to food production cannot be ruled out’. Council PA (n 144) 4.
- 216.
It was certainly the view of ‘some Member States that food produced from the offspring would share the same problematic (sic) as food produced from cloned animals’. Council of the European Union, ‘Progress report’, 17100/08 DENLEG 159 CODEC 1797, 4 (12 December 2008).
- 217.
See ns 61–62 and related text.
- 218.
Arguably, the need for the US to challenge may not have arisen. With the cloned nature of produce from offspring unidentifiable, and with no incentive to place cloned food through the NF authorisation procedure, actual disruption of trade may not have occurred. This was not a risk the Commission was prepared to take.
- 219.
For an illustration of this type of view, see comments by Ralph Nader cited in JH Jackson, ‘Sovereignty-Modern: A New Approach to an Outdated Concept’ (2003) 97 AJIL 782, 790.
- 220.
Monique Goyens of the European consumer organisation BEUC criticised the Commission for its ‘use [of] commercial arguments to endanger the choice of EU consumers’. ‘Cloning: de Gucht Warns of Trade War if There is a Ban on Offspring’ EU Food Policy (11 March 2011) (de Gucht Warns of Trade War).
- 221.
See comments by Commissioner Dalli, May 2011 EP debate (n 5).
- 222.
Following the breakdown in negotiations, the Hungarian Presidency confirmed the Council’s support for ‘the gradual introduction of labelling to provide a basis for informed consumer choice’. Cloned Foods Unleashed (n 4).
- 223.
In this context, it is worth noting that the complex dilemma associated with establishing the appropriate amount of consumer information to provide is one not caused by WTO considerations as such. For instance, see G Brookes et al., ‘The Global GM Market: Implications for the European Food Chain. An Analysis of Labelling Requirements, Market Dynamics and Cost Implications’ (2005), Appendix 2 (pointing to the wide range of ingredients currently derived from GMOs, but not known to consumers as not labelled under current EU rules) www.pgeconomics.co.uk/pdf/Global_GM_Market.pdf.
- 224.
‘Trade War Comments Sour Mood before Crucial Novel Food Talks’ EU Food Policy (11 March 2011).
- 225.
If feasibility alone had been the issue, the institutions could have agreed, as is frequently the case, to the principle and provided for the subsequent development of detailed implementing rules.
- 226.
R Howse, ‘Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organisation’ (2000) 98 Michigan Law Review 2329, 2357.
- 227.
Commission Cloning Report (n 191).
- 228.
See de Gucht Warns of Trade War (n 219).
- 229.
See Council NNFR PR (n 147).
- 230.
See n 6 and related text.
- 231.
This comment is intended not to cast aspersions about the available expertise in the European Parliament, but reflects a simple observation that the only legal expertise seemingly on offer to that institution’s rapporteur was a leaked Council document.
References
Alemanno A, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO (London, Cameron May, 2007).
Becker GS and Cowan T, ‘Biotechnology in Animal Agriculture: Status and Current Issues’ (Congressional Research Service Reports, 32, 2009).
Binns N and Howlett J, ‘Functional Foods in Europe: International Developments in Science and Health Claims’ (2009) 48 European Journal of Nutrition 48 (Suppl 1): S3–S1.
Bronckers M and Soopramanien R, ‘The Impact of WTO Law on European Food Regulation’ (2008) 6 European Food and Feed Law Review 361.
Brookes G, ‘Economic Impact Assessment of the Way in Which the EU Novel Foods Regulatory Approval Procedures Affect the EU Food Sector’ (July 2007).
Brookes G, Craddock N and Kneil B, ‘The Global GM Market: Implications for the European Food Chain. An Analysis of Labelling Requirements, Market Dynamics and Cost Implications’ (2005).
Charnovitz S, ‘The Moral Exception in Trade Policy’ (1997) 38 VJIL 689.
Charnovitz S, ‘The Law of Environmental “PPMs” the WTO: Debunking the Myth of Illegality’ (2002) 27 YJIL 59.
Cheyne I, ‘Proportionality, Proximity and Environmental Labelling in WTO Law’ (2009) 12 JIEL 927.
Craddock N, ‘The EU Novel Food Regulation. Impact on the Potential Export of Exotic Traditional Foods to the EU: Suggestions for revision’ (Discussion paper prepared for UNCTAD and CBI, in cooperation with GTZ, GFU and IPGRI, 2005).
Cumming Smith EM, ‘The European Novel Foods Regulation: The Case of Exotic Foods’ (Wageningen University 2009).
Diebold NF, ‘The Morals and Order Exceptions in WTO Law: Balancing the Toothless Tiger and the Undermining Mole’ (2008) 11 JIEL 43.
Du MM, ‘Domestic Regulatory Autonomy under the TBT Agreement: From Non-Discrimination to Harmonisation’ (2007) 6 Chinese Journal of International Law 269.
Eeckhout P, ‘The Scales of Trade—Reflections on the Growth and Functions of the WTO Adjudicative Branch’ (2010) 13 JIEL 3.
Ehring L, ‘De Facto Discrimination in World Trade Law’ (2002) 36 JWT 921.
Epps T, ‘Pre-market Approval Systems and the SPS Agreement’ in G Van Calster and D Prévost (eds), Research Handbook on Environment, Health and the WTO (Cheltenham, Edward Elgar, 2013).
Foster CE, ‘Prior Approval Systems and the Substance—Procedure Dichotomy under the WTO SPS Agreement’ (2008) 42 JWT 1203.
Galantucci R, ‘Compassionate Consumerism within the GATT Regime: Can Belgium’s Ban on Seal Product Imports be Justified under Article XX?’ (2009) 39 California Western International Law Journal 281.
Gonzalez MA, ‘Trade and Morality: Preserving “Public Morals” without Sacrificing the Global Economy’ (2006) 39 Vanderbilt Journal of Transnational Law 940.
Gunning J, Hartlev M and Gamborg C, ‘Challenges in Regulating Farm Animal Cloning’ (Danish Centre for Bioethics and Risk Assessment, Project report 13, 2006).
Hermann M, ‘The Impact of the European Novel Food Regulation on Trade and Food Innovation Based on Traditional Plant Foods from Developing Countries’ (2009) 34 Food Policy 499.
Hobbs AL, ‘Ethics, Domestic Food Policy and Trade Law: Assessing the EU Animal Welfare Proposals to the WTO’ (2002) 27 Food Policy 437.
Howse R, ‘Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organisation’ (2000) 98 Michigan Law Review 2329.
Howse R and Regan D, ‘The Product/Process Distinction—An Illusionary Basis for Disciplining “Unilateralism” in Trade Policy’ (2000) 11 EJIL 249.
Jackson JH, ‘Comments on Shrimp/Turtle and the Product/Process Distinction’ (2000) 11 EJIL 303.
Jones D, ‘Safety Evaluation of Novel Foods: A European and International Perspective’ (EUFIC Review 04/2000).
Kirkham C, ‘Legislative Developments. Novel Foods and Food Ingredients’ (1997) 3 Columbia Journal of European Law 317.
Knudsen I, Søborg I, Eriksen F, Pilegaard K and Pedersen J, ‘Risk Management and Risk Assessment of Novel Plant Foods: Concepts and Principles’ (2008) 46 Food and Chemical Toxicology 1681.
Kysar DA, ‘Preferences for Processes: The Process/Product Distinction and the Regulation of Consumer Choice’ (2004) 118 Harvard Law Review 525.
Marceau G and Trachtman JP, ‘The Technical Barriers to Trade Agreement, the Sanitary and Phytosanitary Measures Agreement, and the General Agreement Tariffs and Trade—A Map of the World Trade Organisation Law of Domestic Regulation of Goods’ (2002) 36 JWT 811.
Marwell JC, ‘The Trade and Morality: WTO Public Morals Exception after Gambling’ (2006) 81 New York University Law Review 802.
Maryanski JH, ‘Special Challenges of Novel Foods (Biotechnology)’ (1990) 45 Food, Drug, Cosmetic Law Journal 549.
Matheny G and Leahy C, ‘Farmer-Animal Welfare, Legislation, and Trade’ (2007) 70 Law and Contemporary Problems 325.
McGrady B, ‘Necessity Exceptions in WTO Law: Retreaded Tyres, Regulatory Purpose and Cumulative Regulatory Measures’ (2009) 12 JIEL 153.
Mück O, ‘Trade Barrier NFR? Underutilised Species under the European Union’s Novel Food Regulation’ (Paper commissioned by Deutsche Gesellschaft für Technische Zusammenarbeit 2003).
Murphy JF, ‘Mandatory Labelling of Food Made from Cloned Animals: Grappling with Moral Objections to the Production of Safe Products’ (2008) 63 Food and Drug Law Journal 131.
Rudenko L, Mathesen JC and Sundlof SF, ‘Animal Cloning and the FDA—The Risk Assessment Paradigms under Public Scrutiny’ (2007) 25 Nature Biotechnology 39.
Scott J, The WTO Agreement on Sanitary and Phytosanitary Measures. A Commentary (Oxford, OUP, 2007).
Stevenson P, ‘The World Trade Organisation Rules: A Legal Analysis of Their Adverse Impact on Animal Welfare’ (2007) 8 Animal Law 107.
Suk J, Bruce A, Gertz R, Warkup C, Whitelaw CBA, Braun A, Oram C, Rodriguez-Cerezo E and Papatryfon I, ‘Dolly for Dinner? Assessing Commercial and Regulatory Trends in Cloned Livestock’ (2007) 25 Nature Biotechnology 47.
Thomas EM, ‘Playing Chicken at the WTO: An Animal Welfare-Based Trade Restriction under GATT’s Moral Exception’ (2007) 34 Boston College Environmental Affairs Law Review 605.
US National Research Council, Lost Crops of the Incas (Washington, D. C, National Academy Press, 1989).
Waters S, ‘The Regulation of Herbicide Resistant Crops in Europe’ in SO Duke (ed), Herbicide-Resistant Crops: Agricultural, Economic, Environmental, Regulatory, and Technological Aspects (Cleveland, CRC Press, 1995).
Weimer M, ‘The Regulatory Challenge of Animal Cloning for Food—The Risks of Risk Regulation in the European Union’ (2010) 1 European Journal of Risk Regulation 31.
Wu M, ‘Free Trade and the Protection of Public Morals: An Analysis of the Newly Emerging Public Morals Clause Doctrine’ (2008) 33 YJIL 216.
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Downes, C. (2014). Bringing in the Old and the New: The Influence of the SPS Agreement on the EU Novel Food Saga. In: The Impact of WTO SPS Law on EU Food Regulations. Studies in European Economic Law and Regulation, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-319-04373-9_5
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Publisher Name: Springer, Cham
Print ISBN: 978-3-319-04372-2
Online ISBN: 978-3-319-04373-9
eBook Packages: Humanities, Social Sciences and LawLaw and Criminology (R0)