Abstract
The SPS Agreement has formally elevated the importance of Codex Alimentarius as a reference point for domestic food regulations. However, the actual influence of this standard-setting body on national policy-making has not been closely examined. This chapter seeks to enrich understanding of the substantive impact of transnational food governance by tracing the uptake of international standards across domestic legislation worldwide. It first draws on the work of international relations scholars to develop a conceptual framework for analysing transnational norm dissemination. It then analyses Codex’s standard-setting in two contested areas of food policy: food additives, and vitamin and mineral supplements. After explaining the history and controversies of Codex’s work in each area, it uses the framework developed to characterise national regulatory responses to international standards. A complex picture emerges: the levels of attention paid to international norms are shown to vary widely across both countries and issues. The study confirms that substantive standards can contribute importantly to domestic regulations, but their influence is neither automatic nor uniform.
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Notes
- 1.
- 2.
MA Livermore, ‘Authority and Legitimacy in Global Governance: Deliberation, Institutional Differentiation, and the Codex Alimentarius’ (2006) 81 New York University Law Review 766, 776.
- 3.
G de Búrca, ‘Developing Democracy Beyond the State’ (2008) 46 Columbia Journal of Transnational Law 221, 233.
- 4.
RA Pereira, ‘Why Would International Administrative Activity Be Any Less Legitimate?—A Study of the Codex Alimentarius Commission’ (2008) 9 German Law Journal 1694. See also Masson-Matthee (n 1) 277 (arguing that standards ‘do not leave Codex Members with a high degree of discretion to respond to domestic concerns’).
- 5.
In particular, the questionable legitimacy of Codex decision-making processes has been well documented. See T Hüller and ML Maier, ‘Fixing the Codex?: Global Food-Safety Governance under Review’ in C Joerges and E-U Petersmann (eds), Constitutionalism, Multilevel Trade Governance and Social Regulation 268 (Oxford, Hart Publishing, 2006); J Steffek and MP Ferretti, ‘Accountability or “Good Decision”? The Competing Goals of Civil Society Participation in International Governance’ (2009) 23 Global Society 37, 49–56; Masson-Matthee (n 1) Chap. V; Livermore (n 2); de Búrca (n 3); Pereira (n 4).
- 6.
One exception is D Livshiz, ‘Updating American Administrative Law: WTO, International Standards, Domestic Implementation and Public Participation’ (2007) 24 Wisconsin International Law Journal 961, 975–982 (noting at 977 that ‘it is not immediately obvious whether international standards have altered the substance of US regulations’).
- 7.
Codex STAN 192-1995. A regularly updated version of the GSFA is available at www.codexalimentarius.net/gsfaonline/index.html.
- 8.
CAC/GL 55–2005.
- 9.
T Josling, ‘Norms and Standards’ (Institute for International Studies, Stanford University 2003) 12, www.ycsg.yale.edu/documents/papers/Josling.doc.
- 10.
Hüller and Maier (n 5) 272–275 (discussing the dominance of rich states in Codex standard setting).
- 11.
SPS Agreement Art 3.1, it will be remembered, only obliges Members to ‘base’ their sanitary measures on agreements reached by Codex.
- 12.
For an account of the intellectual backdrop to this work, see generally HH Koh, ‘Why Do Nations Obey International Law?’ (1997) 106 Yale Law Journal 2599, 2616–2634.
- 13.
M Finnemore and K Sikkink, ‘International Norm Dynamics and Political Change’ (1998) 52 International Organization 887, 895–905.
- 14.
T Risse and K Sikkink, ‘The Socialisation of International Human Rights Norms into Domestic Practices: Introduction’ in T Risse, SC Ropp and K Sikkink (eds), The Power of Human Rights: International Norms and Domestic Change (Cambridge, CUP, 1999).
- 15.
Koh, ‘Why Do Nations Obey International Law?’ (n 12) 2651.
- 16.
HH Koh, ‘The 1998 Frankel Lecture: Bringing International Human Rights Home’ (‘Bringing Rights Home’) (1998) 35 Houston Law Review 623, 644.
- 17.
See, e.g. H Entwisle, ‘Tracing Cascades: The Normative Development of the UN Guiding Principles of Internal Displacement’ (2005) 19 Georgetown Immigration Law Journal 369; RP Alford, ‘The Nobel Effect: Nobel Peace Prize Laureates as International Norm Entrepreneurs’ (2008) 49 VJIL 61; A Peck, ‘The New Imperialism: Toward an Advocacy Strategy for GMO Accountability’ (2008) 21 Georgetown International Environmental Law Review 37; EC Lim, ‘A Long “TRIP” Home: Intellectual Property Rights, International Law and the Constructivist Challenge’ (2008) 4 Journal of International Law and International Relations 57.
- 18.
See Finnemore and Sikkink (n 13) 914 (noting that ‘actors must choose which rules or norms to follow and which obligations to meet at the expense of others in a given situation…’); Koh (n 16) 675 (recognising the importance of the ‘degree to which particular rules are or are not internalised into domestic infrastructure’). T Risse and SC Ropp, ‘International Human Rights Norms and Domestic Change: Conclusions’ in Power of Human Rights (n 14) 236 (acknowledging that ‘[w]e also need to account for the variation in the impact of principled ideas and norms on domestic actors’).
- 19.
As Keohane notes, in practice ‘there are barriers and blockages: norm internalization does not take place’. RO Keohane, ‘When Does International Law Come Home?’ (1998) 35 Houston Law Review 683, 701. Such lapses into determinism incite criticisms of naivety and a lack of explanatory rigour. For an example of the former, see TM Franck, ‘Dr. Pangloss Meets The Grinch: A Pessimistic Comment on Harold Koh’s Optimism’ (1998) 35 Houston Law Review 683 and of the latter, see EA Posner, ‘Transnational Legal Process and The Supreme Court’s 2003–2004 Term: Some Skeptical Observations’ (2004) 12 Tulsa Journal of Comparative and International Law 23.
- 20.
Finnemore and Sikkink (n 13) 889–890.
- 21.
Koh (n 16) 635.
- 22.
See PS Berman, ‘From International Law to Law and Globalisation’ (2005) 43 Columbia Journal of Transnational Law 485, 545 (pointing to the need for a more nuanced understanding of how international norms influence actors on the ground). See also GA Sarfaty, ‘International Norm Diffusion in the Pimicikamak Cree Nation: A Model of Legal Mediation’ (2007) 48 Harvard International Law Journal 441, 445.
- 23.
See J Brunnée and SJ Toope, Legitimacy and Legality in International Law (Cambridge, CUP, 2010) 62. The failure of early IR constructivist accounts to acknowledge the mutual constitution of norms and the need to ‘bring agency back in’ was recognised by Checkel. See JT Checkel, ‘The Constructivist Turn in International Relations Theory’ (1998) 50 World Politics 323, 339–341.
- 24.
A Liese, ‘Exceptional Necessity. How Liberal Democracies Contest the Prohibition of Torture and Ill-Treatment When Countering Terrorism’ (2009) 5 Journal of International Law and International Relations 17, 24.
- 25.
A Wiener and U Puetter, ‘The Quality of Norms Is What Actors Make of It’ (2009) 5 Journal of International Law and International Relations 1, 7.
- 26.
I Venzke, ‘Legal Contestation about “Enemy Combatants”: On the Exercise of Power in Legal Interpretation’ (2009) 5 Journal of International Law and International Relations 154, 162. See also S Park, ‘The World Bank, Dams and the Meaning of Sustainable Development in Use’ (2009) 5 Journal of International Law and International Relations 93.
- 27.
Their study concludes that ‘[i]n all cases… norms are not unidirectional projections; they are created and sustained in social interaction’. Brunnée and Toope (n 23) 351.
- 28.
R Goodman and D Jinks, ‘Incomplete Internalization and Compliance with Human Rights Law’ (2008) 19 EJIL 725.
- 29.
ibid 731.
- 30.
A Acharya, ‘How Ideas Spread: Whose Norms Matter? Norm Localization and Institutional Change in Asian Regionalism’ (2004) 58 International Organization 239.
- 31.
ibid 245–246.
- 32.
ibid 251–252.
- 33.
For a detailed illustration of this process, see Twining’s discussion of the adoption of the UK Human Rights Act of 1998, ‘a story of complex borrowing from theories of human rights, public international law, national laws and the specific ideas of a British Draftsman.’ W Twining, ‘Diffusion of Law: A Global Perspective’ (2004) 49 Journal of Legal Pluralism and Unofficial Law 1, 16.
- 34.
Acharya (n 30) 254 (describing displacement as ‘a rarer occurrence’). This is echoed in Twining’s criticisms of research into the transnational diffusion of law. Rather than displacing norms, ‘[n]early all modern detailed studies of reception recognise that it usually involves interaction with pre-existing normative orders’. ibid 29.
- 35.
L Wexler, ‘The International Deployment of Shame, Second-Best Responses, and Norm Entrepreneurship: The Campaign to Ban Landmines and the Landmine Ban Treaty’ (2003) 20 Arizona Journal of International and Comparative Law 561.
- 36.
Acharya (n 30) 254.
- 37.
Brunnée and Toope (n 23) 76.
- 38.
Farrell argues that this type of change, what he describes as ‘radical norm diffusion’ only occurs in specific conditions, usually as a result of an ‘external shock to the local culture system with effective norm entrepreneurs and/or personnel change in the target community’. T Farrell, ‘Transnational Norms and Military Development: Constructing Ireland’s Professional Army’ (2001) 7 European Journal of International Relations 63, 65.
- 39.
Consider, for example, the rapid consensus that developed around treaties governing the protection of the ozone layer and common understandings that swiftly extended to the international system. See JK Setear, ‘Ozone, Iteration, and International Law’ (1989) 40 VJIL 193.
- 40.
See JW Legro, ‘Which Norms Matter? Revisiting the “Failure” of Internationalism’ (1997) 51 International Organization 31, 35 (describing how states seek reaffirmation of norms during international negotiations).
- 41.
See SM Tarzi, ‘International Norms, Trade, and Human Rights: A Perspective on Norm Conformity’ (2002) 27 The Journal of Social, Political, and Economic Studies 187 (describing the additional power given to essentially US norms such as ‘reciprocity’, ‘liberalisation’ and ‘nondiscrimination’ when embodied in the GATT).
- 42.
See, by way of comparison, the earlier Codex Alimentarius General Principles for the Use of Food Additives 1, CAC/MISC 1-1972, 6.a. and the Preamble of the Codex General Standard for Food Additives (GSFA) of 2005 (n 7).
- 43.
GSFA, Preamble, 3.2.
- 44.
See, for example, Codex Commodity standards 003-1981 (Canned Salmon), 012-1981 (Honey) and 013-1981 (Tinned Tomatoes) available at www.codexalimentarius.net/web/standard_list.jsp.
- 45.
This paper has been reproduced in WHB Denner, ‘Food Additives: Recommendations for Harmonisation and Control’ (1990) 1 Food Control 150.
- 46.
ibid 156 (recommendation 8).
- 47.
FAO/WHO, ‘Report of the FAO/WHO Conference on Food Standards, Chemicals in Food and Food Trade’ (ALICOM 91/22).
- 48.
This work has been carried out by the Codex Committee on Food Additives and Contaminants (CCFAC) reorganised and renamed in 2006 as the Codex Committee on Food Additives (CCFA).
- 49.
In support of this goal, the US has frequently evoked the flexibility advocated by the Denner Paper. See, e.g. CX/FAC 03/06, Add.1, 5. This is somewhat disingenuous as the relevant recommendation (number 7), unlike many of Denner’s recommendations, was never formally adopted by Codex. For an overview of CCFAC’s response to the Denner Paper, see CX/FAC 03/06, 23–24.
- 50.
As the US reminded the CCFAC in 2003, ‘food additives can preserve an additional quality, prolonged durability, improve the taste and texture, and ensure the safety of food’. CX/FAC 03/06–Add.1, 1.
- 51.
Although there are strong economic incentives for food producers to limit additive use as far as possible, the EU often appears to assume escalation in use. For example: ‘Even if the use of an additive in the GSFA is governed by the GMP [ie lowest level to meet need] principle, it is very probable that the use of food additives in standardised foods will be increased.’ CX/FAC 06/37, Add.1, 3.
- 52.
Discussions became particularly heated in 2004, when the Swiss delegation prepared a Discussion Paper which failed (in a manner untypical of Codex) to reflect the concerns of many Members, thus leading Australia to formally express concerns about Swiss behaviour. CX/FAC 04/36/6–Add.1, 1–3.
- 53.
This was the Swiss description included in Discussion Paper CX/FAC 04/36/6, para 9.
- 54.
Denner (n 45) 154.
- 55.
ibid (stressing that the ‘only realistic way forward’ was the establishment of a single source of scientific knowledge in which Codex Members could have confidence).
- 56.
ALINORM 93/12A, para 30. The US initially objected to this approach, fearing the list of additives would be far from comprehensive given that JECFA’s work had been limited to standardised foods. ALINORM 91/12, para 32.
- 57.
1 CAC/MISC 1-1972, 6.a.
- 58.
ALINORM 93/12, para 31.
- 59.
ALINORM 95/12A, para 44.
- 60.
ALINORM 93/12, para 31. This system was based on a pre-existing categorisation used by the European food industry.
- 61.
GFSA, Preamble, para 5. There is the possibility to make specific exceptions for individual foodstuffs or sub-categories.
- 62.
CX/FAC 04/36/6, para 18.
- 63.
For example, in 2001, the EU declared that the GSFA ‘generally allows too many additives in too many food products’. CX/FAC 01/8, para 154.
- 64.
GFSA, Preamble, para 1.2.
- 65.
CX/FAC 03/06, 20 (amending the Codex Procedural Manual).
- 66.
See comments respectively in CX/FAC 03/06, Add.1, 8; CX/FAC 04/36/6, Add.1., 4; CX/FAC 06/38/7, Add.1, 2.
- 67.
CX/FAC 04/36/6, Add.1, 4
- 68.
CX/FAC 06/38/7, Add.1, 4.
- 69.
ALINORM 07/30/12, para 95.
- 70.
In their assessment of new additives, the tendency among West European countries was to interpret need in the context of the existing additive market. In other words, an applicant seeking authorisation of a new additive would typically have to demonstrate a technological purpose not yet served by an existing additive. In the US, by contrast, the emphasis was on demonstrating that an overall need was met, or rather that the additive was ‘effective’. See J Abraham and E Millstone, ‘Food Additive Controls: Some International Comparisons’ (1989) 14 Food Policy 43, 46–49.
- 71.
This proposal was set out in a discussion paper prepared by New Zealand, Australia and Iceland. See ALINORM 97/12A, para 35.
- 72.
ALINORM 99/12, para 47.
- 73.
ALINORM 03/12, para 50.
- 74.
CX/FAC 03/06, Add.1, 6. The EU therefore proposed greater scrutiny of Member proposals and also unsuccessfully attempted to shift the goalposts by suggesting that support from two or more Codex regions rather than individual Members should be required. CX/FAC 05/37/7, Add. 1, 3.
- 75.
CX/FAC 04/36/6, para 37.
- 76.
A Working Group had proposed that only additives ‘which are widely permitted for use in the food’ be included in line with the existing rules set out in Codex Procedure Manual. This was supported by the EU on the basis that it demonstrated international trade, but rejected by the US as an ‘obsolete practice’ reflecting pre-GSFA thinking. See CX/FAC 03/06, Add.1, 7 and 2 respectively. The latter view prevailed.
- 77.
The EU noted its satisfaction at this revision. CX/FAC 05/37/7, Add.1, 2.
- 78.
ALINORM 07/30/12 Rev, para 84.
- 79.
ALINORM 91/12A, para 36.
- 80.
It cited the example of caramel colours, for which the intensity of the colouring can vary greatly and high intensity sweeteners whose use in food is self-limiting for reasons of taste. CX/FAC 03/06, Add.1, 3.
- 81.
ALINORM 91/12A, para 44.
- 82.
ALINORM 99/12, para 47. This is not the case where the food is an obscure or unrepresentative one. In such cases, a specific level could be given for that food and a more representative one for the whole food category.
- 83.
See EU recommendations in CX/FAC 03/06–Add.1, 7. The Swiss took up the recommendation in its controversial Discussion Paper in December of the same year. See CX/FAC 04/36/6, 19.
- 84.
ALINORM 03/12A, para 46.
- 85.
The debate, however, was far from over. In subsequent discussion on reconciling the GSFA and Commodity standards, the issue was played out once more in similar terms. See the pragmatic proposal of China for an inclusive approach in CX/FAC 06/38/7, para 13(m) and the EU’s critical response in CX/FAC 06/38/7, Add.1, 4. The compromise found on this occasion was to accept the Chinese approach, but place all the information from Commodity standards into an Annex to the GSFA as a list of exceptions to be subjected to further reflection. See ALINORM 07/30/12 Rev, para 85.
- 86.
GSFA, Preamble, para 2 (d) (amended in 2005). See EU comments, CX/FAC 05/37/7–Add.1.
- 87.
For example, in its 2010 meeting, the Committee resisted requests for a fundamental rediscussion of the place of consumer perception in the Preamble. ALINORM 10/33/12, para 100. Nevertheless, at the same meeting EU representatives continued a recent tendency to adopt the use of individual additives with a caveat, known as ‘note 161’ (see Codex General Standard for Food Additives, Codex Stan 192-1995, 246). In this way, the EU accepts a substance only ‘subject to national legislation’. The practice threatens to paralyse discussions and has caused considerable frustration among other Codex Members. See Codex Alimentarius Commission Document ALINORM 10/33/12, para 70–75. See generally C Downes, ‘Only a Footnote? The Curious Codex Battle for Control of Additive Regulations’ (2012) 7 European Food and Feed Law Review 232.
- 88.
For instance, additives have been approved for use in pre-cooked pasta in spite of the EU’s persistent objections to this practice, such as those in ALINORM 08/31/12, para 68.
- 89.
See, for instance, the Committee’s work on food additives containing aluminium. ALINORM 09/32/12, para 64.
- 90.
DL Post, ‘Food Fights: Who Shapes International Food Safety Standards and Who Uses Them?’ (PhD Thesis, University of California Berkeley, 2005) 63–64.
- 91.
For the most elaborate attempt to assess the impact of international standards, see DL Post, ibid and DL Post, ‘Diffusion of International Food Safety Standards: Food Additive Regulation and the Codex Alimentarius Commission’ (‘Diffusion of Food Standards’) (American Political Science Association annual meeting, Philadelphia, August 2003).
- 92.
The first and third set of factors are equally relevant to the study below on food supplements.
- 93.
A fair number of changes to food additive measures have been notified under SPS Agreement Article 7 (and under the Agreement on Technical Barriers to Trade (TBT Agreement)), but not all legislation is therefore necessarily easily accessible to the general public.
- 94.
The FAO’s Legal Office provides a very useful service—FAOLEX, available at faolex.fao.org—in this respect, although inevitably this is not comprehensive in coverage or fully up to date. This type of research, unthinkable just a few years ago, is now viable due to online translation facilities, although this only remains suitable for the type of broad brush approach taken here—identifying the replication of standards in national legislation—and clearly not more fine-grained textual analysis. In some instances, national authorities were contacted with requests for information, but this generally proved ineffective. The survey strove to be as comprehensive as possible.
- 95.
Some national standards e.g. Russia, Guatemala must be (but were not!) purchased. In such instances, the US Department of Agriculture’s (USDA) Foreign Agricultural Services Global Agriculture Information Network (GAIN) can often provide extremely helpful overviews of food legislation. The GAIN reports referred to below are available at gain.fas.usda.gov.
- 96.
The INS, first adopted by Codex in 1989, aims to simplify the labelling of foods by providing a numerical alternative to lengthy additive names. See CAC/GL 36-1989.
- 97.
Given that the exercise undertaken in the GSFA was the result of pragmatic compromise rather than the implementation of an existing national approach, the category ‘accentuation’ is less relevant in this case study.
- 98.
See, for example, Ugandan Standard US 45: 2009, reported in G/TBT/N/UGA/123 (18 May 2010). Similar examples are offered by Bahrain and the Dominican Republic. See respectively G/SPS/GEN/537 (18 January 2005); Draft Proposal for Food Sanitary Regulations for the Dominican Republic (2009), in particular Title VII, otcasea.gob.do/wp-content/uploads/2009/06/propuesta-regl-sanitario-alimentos-rd.pdf, as notified to the SPS Committee under G/SPS/N/DOM/20 (7 July 2006). For a detailed discussion on the development of additive rules in the latter, see Post, ‘Diffusion of Food Standards’ (n 91) 18–21.
- 99.
See Laos Ministry of Health, Regulation No. 586/MoH, Art 5 (12 May 2006); Nicaraguan Ministry of Agriculture and Forestry, Ministerial Agreement No. 23-2000, Art 1, paras (b) and (c) (2000) (establishing the legality of those additives accepted by Codex Alimentarius); Myanmar Ministry of Livestock and Fisheries, Directive No. (9/96), November 6 1996, 1.1 (specifically relating to fishery products).
- 100.
In Pakistan, there is no food additive legislation as such, but the Ministry of Commerce is reported to allow the entry of imported food additives on the basis of Codex standards. See USDA, ‘GAIN Report’ (PK:9012, August 2009) 5–6.
- 101.
For instance, Mali also reports a high level of harmonisation of food standards with Codex standards (see CX/AFRICA 09/18/6, 1), although it has not been possible to confirm this in the case of food additives.
- 102.
Following a survey of use of Codex standards by African countries, FAO/WHO Coordinating Committee for Africa reported that ‘many countries based their national food standards/regulations on Codex standards or used them as reference’. ALINORM 09/32/28, para 47.
- 103.
See CX/AFRICA 09/18/6.
- 104.
One such programme is the EU’s ‘Strengthening Fishery Products’ Health Conditions in ACP/OCT Countries Programme’ running since 2002. See sfp.acp.int/.
- 105.
See Congo Ministry of Forestry Economy and Fisheries, Decree 3642 (29 September 2000) (establishing a list of food additives permitted in fish products); Eritrean Government Legal Notice No. 65/2003 Fishery Products Additives Regulations (30 April 2003). Both laws refer to the EU numbering system for additives with the former citing explicitly EU Directive 95/2/EC on food additives other than colours and sweeteners.
- 106.
Given that China, Australia and New Zealand do not entirely replicate the GSFA, it could be argued that their regulations represent examples of localisation. However, the significance of their changes in policy particularly marks out these cases. Strictly speaking there is a third case, as Hong Kong China has pursued a very similar course to China.
- 107.
See European Commission, DG Trade, SPS Newsletter (July 2010) trade.ec.europa.eu/doclib/docs/2010/august/tradoc_146404.pdf.
- 108.
Chinese Ministry of Health National Standard GB-2760-2007 (27 August 2007), an unofficial translation of which is available in USDA, ‘GAIN Report’ (CH8018 20, March 2008). The notable exceptions are that the Standard also incorporates flavouring agents and processing aids in addition to other additives and does not spell out the concept of good manufacturing practice.
- 109.
Following complaints in 2008 by the EU as to quantitative restrictions on the use of sulphur dioxide in sweet white wines, China raised the maximum level from 250 to 400 mg/l in 2010, thus opening the Chinese market to these wines. See European Commission DG Trade, Market Access Flash Note 36 (19 May 2009). For the relevant discussion on this topic within the WTO TBT Committee, see G/TBT/M/48 (29 September 2009) paras 199–200.
- 110.
Australia New Zealand Food Standard 1.3.1, Commonwealth of Australia Gazette No. P 10 (22 June 2000). For an account of this process, see S Brooke-Taylor et al., ‘Reforms to Food Additive Regulation in Australia and New Zealand’ (2003) 14 Food Control 375.
- 111.
See Australia and New Zealand Food Authority (ANZFA), User Guide to Standard 1.3.1—Food Additives (July 2001) (‘ANZFA’s User Guide’) 4–5 (drawing attention to the new Code’s aim of ‘eliminating unnecessary prescriptiveness’).
- 112.
See Brooke-Taylor (n 110) 381.
- 113.
The permitted justifications for use of additives established by Codex are not found in Australia New Zealand Food Standard 1.3.1, but are included in the ‘ANZFA’s User Guide’ (n 111).
- 114.
Australia New Zealand Food Standard 1.3.1, Schedule 1. It should be noted that Australian and New Zealand have introduced some amendments into the categorisation. See Brooke-Taylor (n 110) 380.
- 115.
ibid 378.
- 116.
Australia New Zealand Food Standard 1.3.1, Clause 3.
- 117.
See Appendix II for an overview of these countries. For a comprehensive account of the US’s 50-year experience of regulating food additives, see L Noah and R Merrill, ‘Starting from Scratch?: Reinventing the Food Additive Approval Process’ (1990) 78 Boston University Law Review 329. Some other countries such as Egypt and Morocco appear to have maintained positive lists of functional classes of additives without reference to Codex. See USDA, ‘GAIN Report’ (EG9014 July 2009) and USDA ‘GAIN Report’ (MO8011 June 2008). However, unfortunately the legislation is not publicly available to verify their precise relationship with Codex norms.
- 118.
The US, for one, does not appear unduly concerned about such divergences. Although the sweeteners cyclamates have long been banned in the US, during the Codex adoption process for the inclusion of the sweeteners into the GSFA, the US delegation simply noted ‘that they had not approved cyclamates and ponceau 4R, but respected the Codex process and would not block adoption.’ ALINORM 10/10 /33/REP, para 40.
- 119.
Korean Food Sanitation Act No 3823 (10 May 1986). This Act has been amended on several occasions, most recently in 2009 by Law No. 9692.
- 120.
Korean Food Sanitation Act No 3823, Art 6.
- 121.
Korea Food Additive Code 2004, fa.kfda.go.kr/foodadditivescode.html. See also Guidelines for Designation of Food Additives fa.kfda.go.kr/process/food1_5_4.html.
- 122.
The only reference to international standards is an oblique one, a provision allowing the Deliberational Council to appoint ‘research commissioners’ to study such standards. Korean Food Sanitation Act No 3823, Art 43.
- 123.
See USDA, ‘GAIN Report’ (KS8044, 31 July 2008).
- 124.
Japan’s first Ministerial decree on food colouring dates back to 1878. The first specifications for food additives were produced in 1960. For the latest edition adopted in 1999 (including a history of the standard’s development), see The Ministry of Health and Welfare, ‘Japan’s Specifications and Standards for Food Additives’ (English translation, 7th edn, September 2000) www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/spec.stand.fa.
- 125.
For an overview of Japanese regulatory activity on additives, see the Ministry of Health, Labour and Welfare website: www.mhlw.go.jp/english/topics/foodsafety/foodadditives/index.html.
- 126.
U-J Salzer, ‘Legislation/Toxicology’ in H Ziegler (ed), Flavourings (Weinheim, Wiley-VCH, 2007) 786.
- 127.
In particular, the EU bemoaned the 7 years taken by Japan to assess only 25 of 46 active submitted by the EU for authorisation, in spite of their international approval, WT/TPR/M/179/Add.1 (22 June 2007) 54. In addition, both the US and India have challenged Japan’s regulatory practices. See respectively G/SPS/R/28 (5 February 2003) 7 and WT/TPR/M/179/Add.1, 153.
- 128.
Additives not subject to specific numerical limits are simply left blank within the Japanese standards without reference to GMP or quantum satis.
- 129.
Council Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs [1989] OJ L40/27.
- 130.
Council Directive 89/107/EEC, Annex II.
- 131.
See respectively Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives [2008] OJ L354/16 and Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings [2008] OJ L354/1.
- 132.
Acknowledgement of Codex’s work is limited to the discussion of whether the EU should revise the definition of processing aids. Its evaluation on the impact of the proposal on third countries and international relations simply reads: ‘This proposal will further harmonise the legislation on additives and will create a uniform market within the EU.’ European Commission, ‘Staff Working Document, Annex to the proposal for a European Parliament and Council Regulation on food additives: Impact Assessment’ SEC (2006) 1040 (19 and 22 respectively).
- 133.
The lack of reference to Codex or the EU’s international commitments in the context of food additives stands in obvious contrast to the specific recognition of the body’s work in the EU’s contaminants legislation. See, for example, Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs [2006] OJ L364/5, recital 1.
- 134.
Regulation (EC) No 1333/2008, Art 6.
- 135.
See Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives [2011] OJ L 295/1, especially rec 4 (explaining the Regulation’s relationship to the GSFA).
- 136.
For example, in its 2004 WTO Trade Policy Review, Korea reported: ‘The KFDA approves new food additives generally twice a year, and continues to relax usage level provisions, in order to harmonize KFDA’s standards and usage levels with international standards.’ WTO Document WT/TPR/M/137/Add.1 (20 December 2004) 4. Likewise, Japan has moved to incorporate Codex criteria on technological justification into its guidelines for the designation of food additives and acknowledges Codex standards as a source for scientific assessments. See Japanese Ministry of Health and Welfare Guidelines for designation of food additives and for revision of standards for use of food additives (2006) www.mhlw.go.jp/english/topics/foodsafety/foodadditives/index.html.
- 137.
By way of illustration, when Korea threatened to ban ‘tar colours’ permitted by international standards, it came under immediate pressure from the US and abandoned the initiative. See United States Trade Representative, ‘2010 Report on Sanitary and Phytosanitary Measures’, www.ustr.gov/sites/default/files/SPS%20Report%20Final(2).pdf.
- 138.
See the Mexican Ministry of Health, Agreement determining the substances permitted as additives and processing aids in food, beverages and nutritional supplements, Diaro Oficial (July 17 2006) 8, www.salud.gob.mx/unidades/cdi/nom/compi/a170706.pdf.
- 139.
Kenya is one example of this approach. See Food, Drugs and Chemical Substances (Food Labelling, Additives and Standards) (Amendment) Regulations 2010, www.kenyalaw.org.
- 140.
Mercosur stands for Mercado Común del Sur or Southern Common Market, the political and economic agreement signed in 1991 by Argentina, Brazil, Paraguay and Uruguay.
- 141.
Mercosur standards are intended to serve as a basis for domestic regulations adopted by its Members and are as such a reasonable indication of the influence of Codex in the region. However, the rate of incorporation into national law of Mercosur standards may be slow. For example, while the standard MERCOSUR/GMC/RES Nº51/00 on additives and their maximum concentration levels was due to be incorporated by January 1 2000, the relevant Argentinean legislation was only published in January 2004, See G/TBT/N/ARG/154 (23 January 2004). All the Mercosur standards cited are available at www.mercosur.int.
- 142.
The last major overhaul of the General List of Additives permitted can be found in MERCOSUR/GMC/RES Nº11/06.
- 143.
MERCOSUR/GMC/RES Nº31/92, Art 1(c).
- 144.
By way of example, Mercosur updated the list of food additives permitted for use according to GMP, but retained restrictions for certain food categories e.g. breads made only with flour wheat, water, raising agents and salt (7.1.1 and 7.1.2), a category of products for which Codex does not foresee specific restrictions. See GSFA, Table III, Annex; MERCOSUR/GMC/RES Nº34/10, Annex (c).
- 145.
MERCOSUR/GMC/RES Nº52/98, Annex, para 3.
- 146.
MERCOSUR/GMC/RES Nº17/93, Annex A, point 1.
- 147.
MERCOSUR/GMC/RES Nº52/98, Annex A, footnote.
- 148.
See Salzer (n 126) 798.
- 149.
Thailand Ministry of Public Health Notification, No. 281 B.E. 2547 (2004) Art 6.
- 150.
ibid Art 4.
- 151.
Republic of Philippines, Department of Health, Administrative Order No. 88-A s (1984). US regulations served as a basis approach for this list of permitted additives and conditions. See Salzer (n 126) 794.
- 152.
Administrative Order No. 88-A s, Art 3.2(d).
- 153.
Republic of Philippines, Department of Health, Bureau of Food and Drugs Circular 2006-016 (18 October 2006).
- 154.
Circular 2006-016, para VII.
- 155.
Circular 2006-016, para III.A.3.
- 156.
See, for example, the inclusion of soya bean curd into food category 04.2.2.6, Circular 2006-016, Table 1.
- 157.
CAC/GL 55–2002 (‘VMS Guidelines’).
- 158.
See KP Miller’s 2005 documentary ‘We Become Silent: The Last Days of Health Freedom’, narrated by Dame Judi Dench.
- 159.
A quick enquiry using any Internet search engine, using the keywords ‘Codex’ and ‘supplements’ will provide a wealth of material on this topic. From mainstream journalism, see J Blythman, ‘Health supplement: RIP’ The Guardian (14 September 2002) www.guardian.co.uk/society/2002/sep/14/medicineandhealth.lifeandhealth.
- 160.
‘Health Threat from the EU and UN’ The New American (4 February 2008).
- 161.
See ALINORM 91/26, para 126. The format of the document was confirmed by the CCNFSDU in 1995 (see ALINORM 95/26, 48), although the question as to whether to proceed at all with the Guideline rumbled on until 2000. See ALINORM 01/26, para 38.
- 162.
The acceptance procedure, which never really operated effectively, was abandoned in 2005. For a discussion of this procedure, see Masson-Matthee (n 1) 83–85.
- 163.
Joint WHO/FAO Food Standards Program, Codex Alimentarius Commission, Procedural Manual (Rome, FAO/WHO, 16th ed, 2006) 30.
- 164.
The US, UK (ALINORM 95/26, para 45), later joined by Japan (ALINORM 97/26, para 42) were particularly vocal in their opposition to the development of Guidelines.
- 165.
The fact that the SPS and TBT Agreements did not draw a distinction between ‘mandatory’ and ‘advisory’ Codex texts was a central counter-argument to those countries such as Malaysia who were intent on maintaining two tiers of Codex texts. See ALINORM 07/30/33, paras 143–145.
- 166.
Whatever their form, the Manual now clarifies that Codex texts are ‘not a substitute for, or alternative to national legislation.’ Joint WHO/FAO Food Standards Program, Codex Alimentarius Commission, Procedural Manual (Rome, FAO/WHO, 19th ed, 2010) 17.
- 167.
ALINORM 01/26, para 53.
- 168.
This discrepancy was noted by the Committee at one point, but not rectified. ALINORM 04/27/26, para 52.
- 169.
This sentiment, in particular that the document does not contain ‘any indication of its purpose’, was expressed in the Codex Alimentarius Commission even at the moment of its adoption. See ALINORM 05/28/41, para 52.
- 170.
The 2000 discussion paper produced by Brazil, Canada, the EU, Mexico and the USA elaborates helpfully on these issues. See CX/NFSDU 00/5, 5.
- 171.
ALINORM 95/26, para 44 (introduced at the request of Codex Observer, Consumers International).
- 172.
ALINORM 97/26, para 45 (emphasis added).
- 173.
CX/NFSDU 02/06, 5 (fearing use of supplements ‘without control by consumers’).
- 174.
CX/NFSDU 02/06, 8 (arguing that supplements were ‘required only in cases when the intake of food is insufficient’).
- 175.
Consumer ‘rights’ and ‘choice’ arguments were put forward in ALINORM 99/26, para 43 and ALINORM 01/26, para 38 respectively.
- 176.
‘VMS Guidelines’, Preamble.
- 177.
This was the view of Australia (ALINORM 93/26, para 100), Canada, India and Kenya (ALINORM 01/26, para 38).
- 178.
‘VMS Guidelines’, 1.2. The Codex Commission included the word ‘only’ at the very end of negotiations to firmly rule out any ambiguity as to the requirements of medicine-oriented Codex Members. See ALINORM 05/28/41, para 54.
- 179.
CX/NFSDU 02/6, 11.
- 180.
This irony was not lost on Germany who rather tetchily recommended in 2003 ‘that all countries in the jurisdiction of which vitamin and mineral supplements are regulated as drugs should from now on refrain from participating in the discussion’. CX/NFSDU 03/5, 7.
- 181.
European Commission, ‘Staff Working Document, Characteristics and Perspectives of the Market for Food Supplements Containing Substances other than Vitamins and Minerals’ (SEC (2008) 2976) 2.
- 182.
The Russian Federation belatedly and unsuccessfully tried to extend the discussion to other substances. ALINORM 03/26A, para 94.
- 183.
A report undertaken at the request of the European Commission found that vitamin and mineral supplements account for 50 % of the European Market. European Advisory Services, ‘The Use of Substances with Nutritional or Physiological Effect other than Vitamins and Minerals in Food Supplements’ (28 March 2007) ec.europa.eu/food/food/labellingnutrition/supplements/documents/2007_A540169_study_other_substances.pdf.
- 184.
See C Aschwanden, ‘Herbs for Health, but How Safe Are They?’ (2001) 79 Bulletin of the World Health Organization 692 (in particular the view of Dr Alan Randell, formerly working for the FAO/WHO Codex Secretariat, that the food supplement industry is ‘out of control and has been for a very long time. By and large, the people running the industry want it to stay that way’).
- 185.
ALINORM 93/26, para 104. The original list can be found in CX/NFSDU 92/11, 5–6.
- 186.
ALINORM 97/26, para 55.
- 187.
See CX/NFSDU 00/5, 7–8.
- 188.
‘VMS Guidelines’, para 3.1.1. This provision is softened still further by including the conditional ‘should’, compared to ‘shall’ elsewhere in the Guidelines.
- 189.
See this WHO/FAO, Vitamin and Mineral Requirements in Human Nutrition (Sun Feng, 2nd ed, 2004).
- 190.
See ALINORM 10/33/26, para 84, Appendix IV.
- 191.
‘Codex Breakthrough on Risk Assessment for Max Nutrient Levels’ (‘Codex Breakthrough’) Nutraceuticals International (November 2003).
- 192.
In other words, food supplements should contain a maximum amount of 100 % of the RDI.
- 193.
For a fuller discussion of these options, see CX/NFSDU, 8–11.
- 194.
CX/NFSDU 95/6, 16 (Germany arguing that ‘there are no objective reasons for supplementing the ordinary diet with more than 100 % of the recommended daily intake’).
- 195.
ALINORM 97/26, para 58.
- 196.
See CX/NFSDU 02/06; CX/NFSDU 03/5; 01/4-Add.2; CX/NFSDU 03/5; ALINORM 04/27/26.
- 197.
Indeed, it seemed that for some time the Committee was not prepared to discuss the issue, with the Chair of the CCNFSDU in the 2000 session reported to have ‘moved the subject swiftly through the agenda’. See ‘Differences Continue at Codex on Vitamins and Mineral Supplement Guidelines’ Nutraceuticals International (August 2000).
- 198.
Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements [2002] OJ L183/51 (EU Food Supplement Directive).
- 199.
ALINORM 03/26A, Appendix IV, 3.2.2.
- 200.
See ALINORM 04/27/26, para 46; ‘Codex Breakthrough’ (n 191).
- 201.
See ‘VMS Guidelines’ 3.2.2 and ALINORM 05/28/26, para 31.
- 202.
US Council of Responsible Nutrition Board member MA Le Doux, cited in ‘Codex Breakthrough’ (n 191).
- 203.
In particular, establishing minimum levels for minerals, such as calcium and magnesium, could lead to excessively bulky products in the case of multivitamin and mineral products. See CX/NFSDU 00/5, 11.
- 204.
For example, Australia, Germany, Spain, Malaysia supported a level of 15 %, Norway 25 %, Denmark 25–30 %, Cuba 30 %, Hungary 33 % and Brazil a range of 15–33 %. See CX/NFSDU 01/4 Add.1; CX/NFSDU 01/4-Add.2; CX/NFSDU 02/06; CX/NFSDU 03/5.
- 205.
ALINORM 04/27/26, para 44.
- 206.
This was the original German proposal presented in CX/NFSDU 92/11, 9.
- 207.
See ALINORM 01/26, para 56; ALINORM 04/27/26, para 59.
- 208.
See, for example, Australia’s proposal in CX/NFSDU, 4.
- 209.
The one remaining piece of nutritional advice is provision 5.8 requiring labelling that ‘supplements cannot be used for the replacement of meals or a varied diet’.
- 210.
Only one provision in the labelling section of the ‘VMS Guidelines’ (proposing labelling on how the product is used) is not contained in the Articles 6–8 of the EU Food Supplement Directive 2002/46/EC. However, the Commission was not successful in removing a reference to nutrient information per ‘single use’ which it deemed to be confusing. See CCNFSDU Twenty-sixth Session, CRD 6 (October 2004) 9.
- 211.
Legislation typically covers a wide range of substances including botanical ingredients. Of the countries surveyed, only Brazil, Chile and Venezuela limit the scope of food supplement legislation to VMS. See Appendix III.
- 212.
See Appendix III.
- 213.
See the SPS notifications by Colombia (G/SPS/N/COL/123, 30 November 2006) and Korea (G/SPS/N/KOR/206, 9 June 2006). A number of countries do not notify new supplement measures to the WTO, or only do so to the TBT Committee. See, for example, Argentina’s notification in G/TBT/N/ARG/221 (1 August 2007).
- 214.
See the Health Canada website at www.hc-sc.gc.ca/fn-an/intactivit/codex/activit/vit_min_sup-eng.php.
- 215.
See the Australia Department of Health Ageing Therapeutic Goods Administration website at www.tga.gov.au/archive/cm-codex-050504.htm.
- 216.
See the US FDA website, ‘Responses to Questions about Codex and Dietary Supplements’, www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm113860.htm.
- 217.
See Appendix III.
- 218.
These trends are ambiguous however. Since 2005, Thailand and India have introduced new rules limiting VMS content to nutritional levels.
- 219.
B Bouckley, ‘IADSA: diverse regulations hinder Latin America food supplement markets’ NUTRAingredients.com. (12 November 2010) (citing P Zambetti, Chair of the International Alliance of Dietary Supplement Associations (IADSA)) www.nutraingredients.com/Industry/IADSA-diverse-regulations-hinder-Latin-America-food-supplement-markets.
- 220.
H Tanaka et al., ‘Current System for Regulation of Health Foods in Japan’ (2004) 47 Japan Medical Association Journal 436, 441.
- 221.
‘Comments from The Danish Veterinary and Food Administration to the Discussion Paper, June 2006, on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs’ (29 September 2006) 4, ec.europa.eu/food/food/labellingnutrition/supplements/documents/denmark_en.pdf 26 September 2011.
- 222.
See n 196 and related text.
- 223.
ASEAN, ‘Minutes of the Fourth Meeting of the ASEAN Traditional Medicines and Herbal Supplements Scientific Committee (ATSC)’ (12–13 January 2009) para 30 (on file with author).
- 224.
At the outset of discussions, only the UK was significantly opposed to the proposal then under discussion to limit VMS content to 1.5 times the RDI. See P Berry Ottoway, ‘The Promised European Supplements Directive—10 Years On’ Nutraceuticals International (May 1999) 8–9.
- 225.
The reluctance of some Member States to relinquish their traditional policy on VMS is demonstrated through the number of continuing trade problems for these products. See European Commission, ‘Discussion Paper on the Setting of Maximum and Minimum Amounts for Vitamins and Minerals in Foodstuffs’ (June 2006) para 15, ec.europa.eu/food/food/labellingnutrition/supplements/discus_paper_amount_vitamins.pdf.
- 226.
In response to the Commission’s Discussion Paper (ibid) only Ireland explicitly called for limits related to nutritional intake. See Member State responses ec.europa.eu/food/food/labellingnutrition/supplements/.
- 227.
The failure of the Commission to present maximum levels 6 years after the completion of its consultation process gives some indication of the lingering controversy surrounding the topic.
- 228.
However, it should be noted that the legal basis for trade complaints made to the SPS Committee is often not clearly articulated and would not necessarily dissuade complaints.
- 229.
The latter point reflects the views of the staff of IADSA as expressed in an interview in December 2010. Even where supplements require registration under medicinal law, the regulatory demands are often not such as to create a true barrier to a market, although they will require additional efforts on the part of the exporter.
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Downes, C. (2014). Is Codex Alimentarius All Talk? The Importance of Standards in Transnational Food Governance. 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_7
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