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What you don’t know about the Codex can hurt you: How modern trade policy shapes public health governance of infant and young child nutrition

Katheryn Russ1*, Phillip Baker2, Michaela Byrd1, Manho Kang1, Rizki Nauli Siregar1, Hammad Zahid1, David McCoy3 1. University of California, Davis California, USA 2. Institute for Physical Activity and Nutrition, Deakin University, Geelong, Australia 3. Centre for Primary Care and Public Health, Queen Mary University, London, United Kingdom

*Address for corresponding author: Katheryn Russ, University of California, Davis, One Shields Avenue, Davis, California 95616 USA

Acknowledgements: The authors thank Karin Lapping, Roger Mathisen, and Elizabeth Zehner for helpful comments.

Conflict of interest statement: Dr. Russ reports a grant from Alive & Thrive/FHI 360 during the conduct of the study.

Keywords: infant formula, breastmilk substitutes, infant and young child feeding, trade policy, commercial determinants of health, political economy

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Abstract

Background: This paper documents how the new emphasis on an international standards-setting

body called the Codex Alimentarius Commission (CAC) as arbitrator for what is science-based

has created what is known as a “regime complex” at the nexus of trade and public health policy.

Implementation of World Trade Organization (WTO) Agreements referencing these standards are

shaping limits on domestic regulation in support of public health in realms like infant and young

child nutrition, posing risks to infant, child, and maternal health.

Methods: Using trade in breastmilk substitutes (BMS) as a case study, we collect data on

interventions by industry interests and exporting governments at the CAC (2016-2019) and WTO

(1995-2019) related to BMS. We assemble and analyse data on lobbying activities in a large

exporting country to quantify expenditures on efforts to influence the US government on issues

related to BMS and trade.

Results: There is an effort by exporters to narrow standards on follow-up formula at the CAC in a

way that conflicts with recommendations in the World Health Organization International Code of

Marketing of Breastmilk Substitutes. At the WTO, exporting countries use complaints of

deviations from the CAC’s international standards to protest adoption of the Code by WTO

members. Industry interests spend millions of dollars annually to influence the US government’s

positions in these proceedings.

Conclusion: Industry interests are magnifying conflicts between standards-setting at the CAC and

health guidelines set by the WHO, posing concerns for the ability of countries to regulate in the

interests of public health.

Key Messages:

Implications for policy makers

• Screening for conflicts of interest in CAC standards-setting should be strengthened.

• Countries should evaluate how language in the WTO jurisprudence related to the

Agreement on Technical Barriers to Trade and other provisions is affecting the ability to

implement regulations in support of public health.

• Arbitration for what satisfies the legal threshold for “science-based” is becoming

politicized and threatens to weaken the precautionary principle used in some countries to

guide regulation for public health and the environment.

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Background

By strengthening the specificity and enforcement of requirements to adhere to international

standards in the design of domestic regulation, the birth of the World Trade Organization (WTO)

in 1995 initiated a quiet but massive shift in the scope for domestic regulation of public health. In

principle, harmonization of standards can help eliminate unnecessary hindrances to trade, leading

to efficiency gains.1 However, the WTO brought a stronger arbitration process for enforcement,

as well as stronger language in the WTO Agreement on Technical Barriers to Trade (TBT)

specifying that domestic regulatory measures not be more trade-restrictive than necessary to

fulfill a legitimate objective. It also required that assessing the appropriateness of any domestic

regulatory measure be based on risk, using available scientific and technical information.2,3 This

reached beyond the primary goal evident in prior agreements of preventing nations from

formulating regulations in a way that discriminated against imported goods. The shift in

language opened the door for countries to levy more complaints against domestic regulatory

measures on the grounds of being “overly trade-restrictive” or “not science-based.”4,5 The

implementation of the WTO Agreements therefore has intensified incentives for private-sector

lobbying over standards used to determine criteria to judge the validity of these complaints.6

These heightened incentives for exporters to lobby for accommodative standards have emerged

before strong protections against conflicts of interest were established in all bodies referenced as

arbitrators of what constitutes a “science-based” standard for public health.7 The evolution of

WTO jurisprudence in deliberations over trade concerns related to public health, combined with

explicit reference to a set of standards called the Codex Alimentarius (Codex) in the WTO

Sanitary and Phytosanitary Agreement (SPS), made a little-known body within the United

Nations family called the Codex Alimentarius Commission (CAC) the main arbitrator of science

for food safety in trade policy.8,9 The proportion of specific trade concerns related to food raised

in WTO committees citing deviation from Codex standards increased more than fivefold between

2007 and 2016.10 The Codex, with a “dual mandate” to serve both public health and facilitate

trade, has now become a tool to fight against domestic measures that exporters feel hinder

market access across a wide variety of industries, from baby foods to pesticides.

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This paper documents how the new emphasis on this international standards-setting body as

arbitrator for what is science-based has created what is known as a “regime complex” at the

intersection of trade and public health policy. The term regime complex refers to “…a set of

overlapping and perhaps even contradictory regimes that share a common focus,” such that

“…decisions made in one forum can be influenced, revised, or undermined by decisions and

politics within a parallel or overlapping domestic or international forum.” 6,11 To do so, we focus

on commercial breastmilk substitutes as a case study, examining recent treatment of related

standards within the CAC and the WTO. Our research illustrates a system now rife with

conflicting authority over public health governance. Industry interests and certain government

agencies have been increasingly exploiting the ambiguity within the CAC—where screening for

conflicts of interests is sorely lacking7—and steadily marginalizing public health advocates in

international standards-setting, presenting serious concerns for infant, child, and maternal health.

Nowhere has this shift in policy had more jarring effects than on efforts to protect and promote

breastfeeding. The World Health Organization (WHO) recommends that “infants should be

exclusively breastfed for the first six months of life to achieve optimal growth, development and

health […and thereafter] receive nutritionally adequate and safe complementary foods while

breastfeeding continues for up to two years of age or beyond.”12 Few interventions can surpass

breastfeeding as a positive health measure for children. Not breastfeeding is estimated to cause

595,379 child (6 to 59 months) deaths annually from diarrhoea and pneumonia and 98,243 adult

deaths from breast and ovarian cancers and type-2 diabetes.13,14 Although the rate of exclusive

breastfeeding in the first 6 months improved globally from 33% in 1995 to 42% in 2018,15 this is

an insufficient rate of progress to meet the World Health Assembly’s global target of 50% by

2025. Thus, the World Health Organization-UNICEF Global Strategy for Infant and Young

Child Feeding12 calls on governments and other actors to protect, promote, and support

breastfeeding.

One factor contributing to low worldwide breastfeeding rates is the inappropriate marketing and

aggressive promotion of breastmilk substitutes (BMS), defined as foods marketed or otherwise

represented as partial or total replacements for breastmilk.16 This includes any milk products

marketed for consumption by children up to 36 months of age. Numerous studies document the

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prevalence of inappropriate BMS marketing in both advanced and developing countries,17,18

which can depress rates of breastfeeding. Exposure to marketing— including product labelling

practices, engagement with health professionals, and direct-to-consumer advertising —is

associated with reduced breastfeeding exclusivity and duration, with women in many countries

being more likely to recall BMS advertisements than information about the benefits of

breastfeeding.18–20

The WHO-UNICEF Global Strategy includes enacting and enforcing provisions of the 1981

International Code of Marketing of Breast-Milk Substitutes21 and subsequent World Health

Assembly (WHA) resolutions, hereafter called the International Code. The International Code is

a response to a longstanding concern that the marketing and promotion of BMS undermines

breastfeeding and harms infant, child and maternal health in all countries.21 The International

Code is further supported by state obligations under the Convention on the Rights of the Child,22

including Article 24 on the right to health and nutritious food.

Figure 1. The Regime Complex for Infant and Young Child Nutrition

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Figure 1 illustrates the international health-trade regime complex that influences breastfeeding

and use of BMS worldwide. There are two regimes, the global public health regime for infant

and young child nutrition and the international trade policy regime. In the middle lies the Codex

Alimentarius, a compilation of international standards for food quality, safety, and labelling. For

the purpose of this research study, the global public health regime contains three agencies of the

United Nations system: UNICEF, WHO, and FAO. The WHA is the main governing body of the

WHO, whose mandate includes establishing and monitoring international health standards,

which guides health policy development among member states.23 The WHO and the FAO are

charged with jointly administering the Codex through the Codex Alimentarius Commission

(CAC). The CAC’s 187 member countries plus the EU populate the CAC and its committees and

vote on the final standards.

The Codex has a “dual mandate,” to both support public health and facilitate fair and free trade

by setting standards suitable as international benchmarks. Using the Codex to define the

international safety and quality standards of products, including the way those products are

labelled and packaged, is one way of reducing barriers to trade, by harmonising standards. In

principle, the Codex is part of the global public health regime only, with FAO and WHO

administering the CAC, and the CAC and its committees setting Codex standards outside of the

international trade regime. However, because Codex standards are used as benchmarks by WTO

arenas, it is drawn into the trade regime.

Both the WTO agreements and many preferential (bilateral and other regional) trade agreements

integrating provisions of these WTO agreements either implicitly or explicitly reference the

Codex.10,24 Sub-arbitration-level pressure against adoption of the International Code into

domestic law can occur within a variety of WTO committees, including the TBT Committee,

SPS Committee, and the TRIPS Council, bodies which each oversee the agreement of the same

name shown in Figure 1. Due to uncertainty surrounding how Codex standards might be

interpreted or enforced in trade dispute settlement processes, national governments may also be

subject to ‘regulatory chill,’ where just the possibility of trade sanctions or costly arbitration is

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enough to deter regulatory action,4,25 especially in preferential trade agreements containing

investor protections in the form of investor-state dispute settlement (ISDS) provisions.

Within both regimes are member governments and their industry constituents. We document

how industry actors work to influence in the international arenas of the respective public health

and trade regimes, and how this in-turn reflects influence and outcomes in national arenas for a

BMS importer and exporter. With this multi-tiered approach, our research addresses two

neglected aspects of the literature on the trade-health policy nexus. First, unlike much existing

scholarship which tends to focus on single institutions (e.g. WTO) or trade agreements (e.g.

NAFTA), this paper examines the complex reality of a multi-institutional and multi-agreement

trade regime, shaped fundamentally by the power relations of different actors and interests. Only

one previous study has investigated how these evolving public health and trade regimes interact

in relation to breastfeeding and BMS marketing: a 2020 policy brief by the WHO and

UNICEF.26 Here, we examine how relevant international trade policies, processes, rules and

standards are used by commercial actors (and the governments that represent them) across

multiple national and international institutional arenas to obstruct public health policies that

support breastfeeding. Second, we go beyond the tendency of trade policy scholars to focus only

on the influence of industry actors on national trade policies by looking at how they influence

multilateral institutions, including bodies involved in international standard-setting and

enforcement, both directly and through their representative governments.

Methods

Given the complex nature of the topic, and the diverse literature and data sources needed to

address the study aim, we adopted a theoretically guided illustrative case study design, involving

the synthesis of documentary and quantitative data sources.27,28 The analysis involved five steps.

Step 1: Describing global BMS Production, Trade and Breastfeeding Rates

We used quantitative data from UN Comtrade and Victora et. al (2016)13 to describe the origins

and destinations of BMS exports and examined breastfeeding rates across groups of countries,

and the extent of implementation of the International Code as reported annually by the WHO.29

For trade statistics we used HS code 190110 for dairy-derived formula in accordance with the

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US Dairy Export Council and the US Department of Agriculture Economic Research Service

(LDPM-270-01 2016). We omitted non-dairy-based formulas, pacifiers and infant feeding

bottles because there is no HS code sufficiently specific to isolate these in data on trade flows.

Step 2: Collecting Data on Positions of Actors within Multilateral Arenas

Next, we examined the workings of institutions involved in shaping global trade policy as it

affects BMS. To do this, we searched grey literature and assembled a database of documentary

evidence from the online archives of relevant organizations including the Codex Alimentarius

and the WTO. Since the focus of our study is trade policy, we conducted an especially

exhaustive search for interventions at the WTO, described in Supplemental File 1. Supplemental

File 1 also contains a table describing the WTO bodies where we document interventions related

to BMS.

Step 3: Synthesis of Interventions within Multilateral Arenas

We then categorized and quantified various types of recent interventions pertaining to BMS sales

and marketing in committees with jurisdiction over BMS at the Codex Alimentarius Commission

(the Nutrition and Foods for Special Dietary Uses Committee and the Food Labelling

Committee) and the WTO (a range of committees), drawing on data from Codex and WTO

archives gathered in Step 2. This allowed us to show how WTO members have sought to shape

Codex standards in a recent review of standards for Follow-up Formula, and how they

interpreted and used Codex standards to advance negotiating positions in opposition to

implementation of the International Code within the WTO.

Step 4: Collection of Data on Industry Actors within US National Arena

Next, we assembled data on the actors involved directly or indirectly in US trade interventions.

The US provides a useful case study of industry efforts to exert influence on national trade policy

because various federal laws[1] require detailed public disclosure of expenditures on lobbying

activity and political contributions, including the source and destination of the funds and often

the issue being discussed. We also show how US-based industry actors are similarly active in

influencing the multilateral trade policy regime through, for example, the major role it plays in

funding the United Nations System, wielding disproportionate influence in WHO technical and

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global health policy-making processes30 and the standards and processes governing BMS

markets.

We retrieved bulk raw data on US industry lobbying and political donations from the Centre for

Responsive Politics Open Secrets database (opensecrets.org) and organized the data in two

different ways: firm-focused and issue-focused (BMS-related). For the firm-focus, we collected

merger histories from company annual reports and online news articles, tracing the ownership of

BMS manufacturers to carefully match lobbying and political donations to individual firms.

Lobbying disclosed as BMS-related and lobbying by BMS producers are overlapping but not

identical sets. Due to the range of actors and the frequency of mergers, acquisitions, and spinoffs,

the firm-focused breakdown is less informative of the volume of resources devoted to lobbying

for the purpose of influencing BMS-related US regulatory and trade policy. Therefore, we

included a breakdown of the lobbying data by issue. To do this, we used word searches of the

lobbying disclosures to identify BMS-related lobbying. We also searched lobbying disclosure

notes for the names of countries receiving complaints by the US and others in the years where

we know from data gathered in Step 2 that interventions regarding BMS marketing took place at

the WTO, followed by manual inspection to identify lobbying likely related to WTO

interventions.[2] We searched archives from the US Trade Representative and US Department of

Agriculture for mention about where policy actions had achieved aims coinciding with private-

sector stakeholder positions. See Supplemental File 2 for full details.

Step 5: Analysis of Data

In Step 5, we generate descriptive statistics to illustrate the trade and public health regime

complex on breastfeeding and BMS consumption by tallying the types and frequency of

interventions at the WTO, mapping patterns of lobbying expenditures over time, and creating

charts with data detailing major themes or alliances in deliberative processes at the CAC and the

WTO. A replication package with data and Stata v13 code is available from the corresponding

author upon request.

Results

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We organized the findings as follows. First, we describe the geography of BMS importers and

exporters. Second, we provide an overview of the public health regime that has evolved to

protect breastfeeding against the inappropriate marketing of BMS, presenting an instance of

industry influence—both direct through an industry association and indirect through

representative governments—in shaping international standards for follow-up formula. Third, we

examine the treatment of BMS within the trade policy regime, presenting the new data on trade-

related interventions involving BMS both inside and outside the WTO. Finally, we present an

analysis of the political activities used by the BMS industry to influence US State actions in trade

and health policy arenas.

The Geography of BMS Production, Trade and Breastfeeding

The global BMS market has grown rapidly in recent decades and is projected to keeping

growing. The global market value was roughly US$4 billion in 1983,31 growing to US$23

billion by 2005. Industry estimates suggest it reached $47 billion in 2017 and will grow further

to $100 billion by 2026.32,33 Roughly one-fifth of these transactions involve international trade.

World BMS exports reached US$11 billion in 2018, more than double its level a decade before

and about ten times the level in 1998 (see Figure 2).

The geography of BMS trade suggests a contrast in the participation of advanced and developing

economies. Since 1995, the top-10 exporters have been almost exclusively advanced economies

of the OECD group of countries.[3] Figure 2 illustrates how Australia, New Zealand, the US, and

the top-5 exporters of BMS from the European Union accounted for about three-

quarters of world exports in 2018. Since then, China has entered the top ranks of BMS

exporters. Closely related is the export of milk powder (dried milk), a key input into production

of BMS and the reason why dairy interests are aligned with BMS producers in trade policy

spheres. Figure 3 shows New Zealand as the top milk-powder exporter, followed by the US and

the Netherlands.

Figure 4 reveals that transitional and emerging markets populate the top-4 importers outside of

Europe: China, Malaysia, Russia, and Saudi Arabia. Between 2005 and 2018, the Philippines,

Thailand, and Vietnam dropped out of the top-10 importing countries, coinciding with the

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Figure 2. Global exports of BMS, 1988-2018, with share of top exporting countries

Notes: UN COMTRADE HS code 190110.

Figure 3. Global exports of milk powder 1988-2018, with share of top exporting countries

Notes: UN COMTRADE HS codes 040221, 040229, and 040210.

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adoption of policies to promote breastfeeding and legislation to impose or tighten marketing

restrictions.[4] Overall, BMS exports flow from advanced economies to developing economies,

Figure 4. Global imports of BMS 1988-2018, with share of top importing countries

Notes: UN COMTRADE HS code 190110. Exports and imports do not match precisely due to small discrepancies across reporting countries.

with the main exception being China, which serves markets in Nigeria, Indonesia, Pakistan, and

Malaysia.

The transnationalisation of the BMS industry and its marketing practices is a driver of global

sales expansion.17,18,34 Data on global BMS marketing expenditures are unavailable, making it

difficult to quantify the causal relationship. Yet growth in BMS consumption has far outpaced

growth in per capita income in a host of emerging markets, while marketing is ubiquitous.34

Assuming that a sum between 3-10% of sales33,35 is spent on marketing, we estimate that global

BMS marketing expenditure was between US$1.68 and US$5.56 billion in 2013.32 These

amounts far exceed state expenditures on breastfeeding promotion, which are estimated to be

between $10 million and $250 million annually, depending on whether medical interventions to

support breastfeeding are included, or only public education and social messaging campaigns.17

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Trade patterns, breastfeeding rates and implementation of the International Code

Figure 5 shows the percentage of children breastfed at one year (12-15 months) by country.

Seven of the top eight exporters in Figure 2 are in the bottom quintile of breastfeeding rates. The

United Kingdom, Ireland, and France have some of the lowest rates of breastfeeding globally,

with less than 10 percent of infants breastfed at 12 months. There is a negative correlation

between the rate of breastfeeding at 12 months and exports, demonstrating that breastfeeding

rates are lower among exporters.[5] The top quintile of breastfeeding rates is dominated by

developing countries in Africa and Asia. Overall, Figures 2 and 3 show exports of BMS and its

milk powder components being concentrated in advanced economies where Figure 5 shows low

breastfeeding rates, further indicating that markets may be saturated in countries where

production is concentrated, making exports crucial to continued sales growth. Countries with

higher rates of breastfeeding also tend not to have a domestic BMS industry.

Figure 6 shows that legal measures restricting the marketing of BMS are strongest in countries

with relatively high breastfeeding rates – primarily in Africa and developing Asia. Among the key

exporters, no legal provisions are in place in the US, and few legal provisions exist in EU producer

countries. In countries where many or full provisions are in place, numerous studies document

widespread violations of the International Code36 and also find that claims in marketing messages

regarding the benefits of BMS are often inaccurate or misleading.37,38

Overall, we observe a general pattern of high-income countries with extremely low breastfeeding

rates and very weak or no restrictions on BMS marketing exporting to developing countries with

higher breastfeeding rates and stronger restrictions on BMS marketing.

Conflicts between the public health and international trade regimes

The World Health Assembly and World Health Organization

The design and adoption of the original International Code and its subsequent resolutions have

been highly politicised. Industry actors actively fought the adoption of the International Code in

1981 and sought to weaken its language prior to adoption.39,40 When it was eventually passed by

118 member states at the World Health Assembly, the US was the only country to vote against it,

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after having acted to weaken its language and to ensure its introduction on an opt-in basis, rather

than a stronger opt-out basis. After the vote, the BMS industry circulated its own interpretations

Figure 5. Percentage of children breastfed at 12 months, by country (latest available data)

Notes: UNICEF (2019), Victora et. al (2016); data for most recent year available

Figure 6. Country implementation status of the International Code, 2018

Notes: WHO (2018)

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of the International Code which health advocates interpreted as instructions to aid marketers in

circumventing it.41

The WHA reviews the International Code every two years, revising and refining it through new

resolutions in response to evolving industry marketing practices and WHO technical guidance.

These efforts to strengthen provisions of the International Code have been similarly subjected to

international political dynamics. The most recent contestation occurred in 2018 when Ecuador

set out to introduce a resolution encouraging governments to strengthen their efforts to

implement the International Code, and urging the WHO to provide greater support for national

monitoring and enforcement. Responding to concerns raised by its domestic industry

stakeholders,42,43 the US acted to prevent Ecuador from introducing its proposed resolution by

threatening punitive trade sanctions and the withdrawal of military aid. More than 10 other

countries, most in Africa and Latin America, declined to support the resolution for fear of similar

retaliation.44

Eventually, Russia introduced a version of the proposed resolution, withstanding resistance from

the US in the form of a contentious series of procedural manoeuvres. This included proposing an

unsuccessful alternative resolution that excluded reference to the International Code and called

for support to help countries build an “evidence base” for infant and young child feeding

strategies as though the benefits of breastfeeding have not been scientifically demonstrated.45,46

A revised version of Russia’s proposed resolution, with guidance to support breastfeeding but

without language on enforcement, eventually passed as WHA71.9.44,47,48

The Codex Alimentarius

Beyond the International Code, the Codex may be considered the second major plank of the global

public health regime for infant and young child feeding. It consists of a set of science-based

minimum safety standards for food and food production, including BMS products, and is therefore

referenced in WHA resolutions related to the International Code. For example, the 2016 WHA

resolution 69.9 calls on the CAC to “give full consideration to WHO guidelines and

recommendations, including the [International Code] and relevant WHA resolutions.”[6]

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Administered by the WHO and FAO, the Codex is maintained by a Codex Secretariat and various

committees of the CAC.49

In addition to representatives of member country governments and officials of the Codex

Secretariat, WHO and FAO, representatives of inter-governmental organizations (IGOs) and non-

governmental organizations (NGOs) are able to attend the various Codex Committee meetings as

observers. Observers cannot vote, but can participate in working groups and meetings and post

written comments, so can be quite influential. Two committees have primary jurisdiction over

BMS: the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) and

the Codex Committee on Food Labelling (CCFL). (See Supplemental File 3 for a description of

the CAC’s organizational structure.) Figure 7 shows the prominence of industry participation

during the annual meetings of these two committees in 2019. Industry representatives within

member country government delegations (with full voting rights) as well as industry-advocate

observers made up more than 40 percent of total participants in the CCNFSDU meeting—nearly

Figure 7. Attendance at Codex Committee Meetings Discussing BMS Standards in 2019

Notes: Data gathered from participant lists in REP19/FL and REP20/NFSDU.

0

50

100

150

200

250

300

350

400

450

FL NFSDU

Government UN-IGOs and Codex

Industry and industry-advocate NGOs Public-health and consumer-driven NGOs

Academia Non-UN IGOs

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matching the number of officials from national governments, WHO, FAO, and the CAC

Secretariat combined. Industry participants made up exactly one third of all attendees in the CCFL

meeting. Often, industry participants attend as part of a member government delegation.

Conflicts and conflicts of interest in BMS standard-setting at the CAC

The process for establishing standards for BMS products through the Codex committees is partially

observable in meeting summaries and written comments posted by participants. Koletzko and

Shamir (2006) discuss the adoption and revision of standards for BMS under the purview of the

CCNFSDU.50 Reporting on a meeting to update BMS standards in 2005, the authors describe the

considerable influence of commercial enterprises in the deliberation of the committee, such that

“scientific and medical arguments may be unduly influenced by commercial considerations

(p.621).” Other observers also have noted heavy industry influence in Codex deliberations that

works against public health considerations,6 including interference in providing scientific advice

to inform standards.

As an example of conflicts in deliberations over BMS standards, Table 1 presents some of the

issues under contention during an ongoing review of the 1987 Standard for Follow-up Formula

(Codex Stan 156-1987), which began in 2017. Two of three co-chairs were representatives of top

BMS producer-exporter countries (New Zealand and France), a common practice in Codex

processes.7 During the meetings, members were divided on whether the uniform standard for

products made for persons 6 to 36 months of age should be divided into two standards: one for

formula for “older infants” (6-12 months) and one for formula for “young children” (12-36

months). As a compromise, the CCNFSDU decided to have one standard with two sections. This

is helpful for the achievement of health objectives because it opens the door to require higher

nutritional standards for “formula for older infants.” Before the change, formula for infants 6-12

months was held to the weaker uniform standards for all formula products in the 6-36 months

range. In the revised draft, products for older infants have higher nutritional standards than

products for toddlers. Participants also debated other aspects of composition, such as whether

ingredients with a sweet taste, certain types of sugars, or caps on sugar content should be allowed

or recommended.

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Members currently have not agreed on what to call products meant for young children 12 to 36

months old. Industry actors and governments in countries where the BMS industry is influential

have advocated for the words “formula” or “formulated” to be included. Public health

proponents have argued that this would confuse consumers, risking inappropriate use for babies

0-12 months old and falsely suggesting nutritional adequacy or special health benefits.[7] The

debate over the name of these product is also closely related to a debate over “cross-promotion.”

Cross-promotion refers to the marketing of follow-on and toddler formula that simultaneously

promotes use of infant formula because companies label and brand the products in a similar way.

Research shows that even in advanced economies, cross-promotion can lead parents to feed

infants with follow-up and toddler formula instead of the infant formula, which has stricter

nutritional requirements. The confusion of parents puts infant health at risk.51–53

The relevance of the International Code to the Codex has also been a point of contention.

Proponents of breastfeeding have sought to reference the International Code in the Preamble to the

revised Codex standard and frequently cite the International Code and related supporting evidence

to justify their positions. But as seen in Table 1, BMS industry proponents have sought to prevent

citation of the International Code in the standard. They also rejected a number of recommendations

during deliberation of the standard, including the prohibition of cross-promotion of infant formula

and products for young children and the categorisation and regulation of products for young

children (13-36 months) as breastmilk substitutes. Public health advocates succeeded in ensuring

that a footnote was inserted into the standard noting that “In some countries these products are

regulated as breast milk substitutes.”54 In principle, this acknowledgment in the Codex that some

countries regulate products for young children as BMS—if it survives final deliberations in the

FUF review and is not deleted in future reviews—provides grounds to argue that such regulations

are consistent with international standards. The US opposed the footnote, arguing that the use of

footnotes when it is difficult to reach consensus is generally problematic, as Codex standards

should be “global in nature.”54

The ability to limit the sugar content in formula for older infants and to prevent use of sucrose,

fructose, and other sweeteners in both formula for older infants and follow-up formula similarly

each hang by two footnotes. The footnote allowing these limits on the use of sweeteners in the

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Table 1. Debates during the review of the Codex Standard for Follow-up Formula (CXS 156-1987)

Issue Perspectives Position Proponents at meetings of Codex Committee on Nutrition and Foods

for Special Dietary Uses

Labelling of products of young children, aged 12-36 months

Public health Do not allow "formula" or "formulated" in proposed product name, "[formulated] drink for young children."

Brazil, Cambodia, Colombia, Cote d'Ivoire, EU, HKI, Jamaica, Nepal, Sri Lanka

Industry-lenient Include "formulated" or "formula" in the product name, "[formulated] drink for young children."

Australia, Indonesia, India, ISDI, Malaysia, New Zealand, USA

Definition of products for young children, aged 12-36mos (Section B, 2.1.1)

Public health Products for young children are used as BMS (defined in WHA 69.9).

Cambodia, Cote d'Ivoire, Ecuador, HKI, IBFAN, India, Jamaica, Lao PDR, Mali, Mexico, Nepal, Philippines, Senegal, UNICEF, WPHNA

Industry-lenient Products for young children are not manufactured for use as BMS.

Argentina, Australia, Brazil, Canada, Colombia, Costa Rica, EU, Ghana, Indonesia, ISDI, Malaysia, New Zealand, Switzerland, Thailand, USA

How to structure the standard for Follow-On Formula, which originally covered products labelled for ages 6-36 months

Public health Products for older infants (6-12 months) and products for young children (12-36 months) are governed by one standard with two parts.

Cambodia, Ecuador, EU, HKI, IBFAN, Nepal, Sri Lanka, UNICEF

Industry-lenient Products for older infants (6-12 months) and products for young children (12-36 months) are governed by two separate standards.

Argentina, Australia, Brazil, Canada, Colombia, ISDI, Malaysia, New Zealand, Switzerland, USA

Preamble for standard Public health Reference the International Code and subsequent resolutions (like WHA 69.9) in the Preamble

Cambodia, Ecuador, Egypt, Jamaica, Nepal, Philippines, HKI, IBFAN, UNICEF

Industry-lenient Do not reference sources "external to Codex" in the Preamble

USA

Sweeteners Public health Additives with sweet taste should not be used

EU, HKI, India, Lao PDR, Kenya, S Korea, Mali, Mexico, Morocco, Nigeria, Panama, WPHNA

Industry-lenient Additives with sweet taste should not explicitly be restricted in the standard

Chile, Costa Rica, ISDI, Russia

Cross-promotion (Section B, 9.6.4)

Public health Cross-promotion must be prohibited Burkina Faso, Cambodia, Chile, Ecuador, HKI, IBFAN, India, Kenya, Kuwait, Lao PDR, Mali, Mexico, Nepal, Nigeria, Senegal, Sri Lanka, Switzerland, Uruguay, UNICEF, WPHNA

Industry-lenient Cross-promotion is not clearly defined hence should not be regulated by the standard.

Argentina, Australia, Brazil, Costa Rica, Dominican Republic, EU, Guatemala, IDF/FIL, Indonesia, ISDI, Korea, New Zealand, Panama, Peru, USA, Vietnam

Mixed Amend the provision on cross-promotion

Australia, Canada, Colombia, Costa Rica, Indonesia, Malaysia, New Zealand

Notes: Positions from CS/NFSDU 18/40/4, CS/NFSDU 18/40/5, CS/NFSDU 19/41/5, NFSDU/41, and REP20/NFSDU (including all appendices and posted related comments).

20

standards for follow-up formula allows “national and/or regional authorities” to limit non-lactose

carbohydrates to 1.25g/100 kcal, less than the Codex maximum of 2.5g/100 kcal and remains

contested.54

The CCFL is also consequential for implementation of the International Code where contentious

debates are occurring over how foods can be labelled to warn consumers of the potential hazards

from the inappropriate use of BMS. The CCNFSDU consulted heavily with the CCFL to ensure

that proposed revisions to the standard for follow-up formula would be consistent with standards

on labelling. These consultations resulted in replacing some text with references to the labelling

standards set by the CCFL that also can be reviewed and revised over time, subject to the same

tensions seen in the review of the standard for follow-up formula.

In a parallel but separate process, the CCFL has been drafting proposed guidelines for ‘Front of

Package Labelling’ since 2018.6,35,55,56 According to the WHO, front-of-package labelling systems

are designed to provide simple information on nutritional quality of products, like “high/low in…,”

etc. An energetic debate is evident over how much leeway countries are permitted to have in

requiring front-of-package labels to indicate high levels of nutrients such as fat, sugar and salt.6,57

The most recent draft contained language that any regulatory system should be optional, even

though a number of countries already have adopted mandatory systems.62 The WHO had already

drafted its own guidelines in 2017, with an update in 2019. A number of member countries have

subsequently expressed concern that the evolving new Codex standard is already in conflict with

the WHO guidelines.58 For instance, WHO guidelines expressly urge that BMS products contain

no front-of-pack nutritional claims,59 but a provision exempting BMS products from the new

Codex front-of-package labelling standard is still under contention within CCFL’s deliberations.58

Thow et. al (2019) explore in depth how conflicts of interest are influencing the deliberations,

making it likely that standards will conflict with WHO guidelines in a way that limits the ability

of national governments to implement them without incurring the risk of inciting a trade dispute.6

Conflicts over standards and governance between the WHO, Codex, and WTO

Indeed, discrepancies already exist between Codex standards and the public health guidelines of

its parent bodies (WHO and FAO) that are generating growing institutional frictions within both

21

the public health and trade regimes. At the 2016 annual meeting of the Codex Executive

Committee (CCEXEC), representatives of the FAO and WHO protested strongly that CAC

members are not weighing FAO and WHO policies in their work.60 FAO and WHO officials

submitted a background document citing eight examples of Codex guidance or processes—

including on drinking-water quality, nutrition labelling, and BMS—that were in conflict with

FAO/WHO policies or UN public health initiatives.61 The meeting ended without discussion of

the issue, but the topic was raised again at the next meeting in 2017. The WHO representative

pointed out that the effects of this inconsistency were that WTO member states who are trying to

implement measures adopted by the WHA are being accused in the WTO TBT Committee of

creating trade barriers by failing to comply with the Codex.62 A WHO representative argued that

international food standard setting was also a function delegated to WHO in its Constitution. Thus,

the representative argued that even though Codex standards are cited in the WTO SPS Agreement,

WHO standards could be considered as international standards referred to in the WTO TBT

Agreement.62,63

However, rather than pursue the issue within the CCEXEC, member countries disagreeing with

the WHO and FAO took up the discussion in a WTO SPS Committee meeting in November 2017.

The US argued fervently in support of CAC independence from WHO and FAO as key to ensuring

fair trade in food products.64 Argentina and the US argued again at a WTO SPS Committee meeting

in March 2018 that because the Codex is explicitly cited in the WTO SPS Agreement, it takes

precedence over FAO and WHO standards, using this as an argument for Codex independence

from its parent bodies, with member-driven processes and decisions.65

At the same time some WTO members arguing that the Codex must be an independent standards-

setting organization, they concurrently have been organizing within WTO committee deliberations

to change its governance, funding, and standards-setting procedures. The FAO and WHO provide

USD$12 million in technical support for Codex processes largely through their Scientific Advice

Program, but within the CAC, some members have expressed concern that these funds are not

from sustainable sources and are too little, requiring the CAC to turn often to member states and

even industry for donations.62 In response, WHO officials at the CAC have noted hesitation

developing within the WHO to increase funding for CAC processes because Codex guidelines

22

“were not always developed consistent with WHO policies, guidelines, and recommendations.”66

Recently, Canada, the EU, and the US have put out calls within the SPS Committee for members

to urge the WHO and FAO to set aside sustainable funding for scientific advice, possibly by setting

aside funds from the WHO core budget, as well as to encourage members to contribute financially

to support CAC risk-assessment bodies.65

A communication from Mexico to the WTO TRIPS Council in November 2019 highlights another

example of other components of the trade regime influencing processes or standards-setting by

CAC. Several weeks before the annual 2019 CCNFSDU meeting, Mexico alerted the WTO

membership to proposals being considered in the Codex Committees aimed at prohibiting cross-

promotion of infant and follow-up formula under the same brand.67 Mexico argued that the

proposals, based on scientific evidence of likely harm to infants and consistent with WHA

resolutions, should be screened for consistency with the protection of the value of trademarks

under TRIPS and that TRIPS should take precedence in the design of the Codex standard:67

Mexico’s communication is one example of how, in practice, the politics of trade influences the

Codex standards, rather than only “available scientific and technical information” as specified

within the TBT Agreement as the yardstick to determine the appropriateness of domestic

regulatory measures for public health. Table 1 documents how countries eventually lined up on

this issue at the CCNFSDU. In the end, while the Committee agreed that labelling of follow-up

formula would not be allowed to “refer” to infant formula, it did not explicitly prohibit the labelling

of infant and follow-on formula from resembling each other. The committee also decided to

remove all reference to the term “cross-promotion” from the draft standard.54 Industry is still

striving to have the word “formula” or “formulated” included in the name for drinks for young

children, which public health advocates argue supports cross-promotion.

The WTO and the regulation of BMS marketing

The treatment of restrictions on marketing of BMS by the WTO has not been systematically

documented in the literature. Concerns related to the marketing, labelling and safety of BMS have

been expressed in a variety of ways by WTO members. In this section, we use newly collected

23

data from the WTO archives to document the tensions between WHO guidance and Codex

standards and how this influences domestic regulations through trade policy.

The provisions of the SPS and TBT Agreements set parameters for regulations of the composition

and marketing of BMS to the extent that they rest any possible WTO arbitration over these matters

on the provisions of the Codex. Concerns over implementation of the International Code have

arisen in various units of the WTO, especially the SPS Committee and TBT Committee. They have

also arisen during the Accession process by which countries apply to become members of the

WTO as well as during periodic, routine reviews of countries known as Trade Policy Reviews

(TPRs). Ultimately, any concerns that members do not resolve in committee may end up being

filed as disputes adjudicated by the Appellate Body.

As Table 2 shows, the vast majority of BMS-related interventions take place in the Committee on

Agriculture, the TBT Committee, and during Trade Policy Reviews, with more than half occurring

in the TBT Committee. Figure 8 shows countries making BMS-related interventions at the WTO

along the horizontal axis, with the countries on the receiving end of the interventions denoted by

colors. It illustrates again the same pattern of interventions generally being made by exporters of

BMS (the US, European Union, Australia, and New Zealand), voicing concerns about policies

implemented or proposed mainly in developing countries.

Table 2. Interventions regarding BMS made by WTO members, 1995-2019

Committee, Council, or Process Interventions Agriculture 15 Council for Trade in Goods 1 Sanitary and Phytosanitary 6 Technical Barriers to Trade 58 Trade Policy Review 29 TRIPS Council 1 Accession Process 135 Total 245

Notes: Data collected from WTO online archives.

24

Pre-Accession

Not all pre-Accession proceedings are made public. However, we were able to identify 135

instances of countries receiving questions during “Question and Response” processes and Initial

Negotiating Rights (INRs) in WTO website archives. INRs involve negotiations by individual

members of the WTO with a country being considered for Accession over access to its domestic

market for a specific product.[8] 30 of 35 countries who participated as an applicant in the

Accession process between 1996 and 2019 experienced one or both of these types of interventions,

with 18 of these 30 countries asked specific questions about their domestic treatment of BMS

Figure 8. Member countries making vs receiving WTO interventions involving BMS, 1996-2019

Notes: Data collected from WTO online archives. WTO members along horizontal axis make interventions against countries denoted by colors.

0

10

20

30

40

USA EUR AUS NZL JPN KOR ARG RUS CAN IDN CHL UKR DNK TUR

CHN JPN THA ISR PAN HKG IDN EGY OMN PER CAN

Num

ber o

f int

erve

ntio

ns

Country making intervention

25

products. More than half of the 18 received multiple questions, with Saudi Arabia, Ukraine, and

the Russian Federation asked to answer between 15 and 20 BMS-related questions. Ten countries

applying for Accession engaged in INRs with a WTO member for one or more BMS products.

Similar to the overall patterns discussed above, most of these INRs were granted by Accession

applicants who were developing or transitional economies to advanced economies (the US,

Australia, and the European Union) requesting additional access for their BMS exports.

Post-Accession

Interventions related to BMS have taken place across a number of bodies within the WTO. We

define “intervention” as a complaint or expression of concern about restrictions or proposed

restrictions on the marketing, distribution, and sales of BMS in one member country registered by

a committee or council, or by a delegation from another country, either in person or in writing. 110

such interventions have taken place since 1995.[10]

Quantifying use of new TBT criteria for domestic public health regulation

Figure 9 shows that the number of interventions has grown significantly in the last 5 years. In

addition, their content has changed. Prior to 2014, concerns about measures affecting BMS centred

on questions about the transparency of measures and whether they were discriminatory toward

imports. Since then, interventions have been dominated by TBT-related concerns such as

compliance with Codex/international standards, whether there is a scientific basis for regulation,

and whether regulation is trade restrictive or unfairly imposes costs on foreign suppliers. This is

in line with Thow et al. (2020), who document the importance of Codex in justifications of specific

trade concerns at the WTO levied in regard to policies regulating nutrition labelling in Thailand,

Chile, Peru, Indonesia, and Ecuador.68

The regime complex and health policy in a BMS importer

One example from Thailand illustrates how these developments impeded implementation of the

International Code. Figure 10 is a flowchart showing the progression of interventions against

Thailand after it introduced domestic legislation to restrict inappropriate marketing of BMS. The

first interventions consisted of concerns expressed about the proposed legislation during the WTO

26

Figure 9. Percentage of BMS-related interventions mentioning particular concerns, 1996-2019

Notes: Data collected from WTO online archives. Percentages do not add up to 100 percent, as interventions may mention more than one concern and this list is not exhaustive.

Trade Policy Review of Thailand in 2015.[9] Both the US and New Zealand suggested that the

proposed legislation did not conform to international standards and requested an explanation of its

scientific rationale. Almost every one of the 21 interventions over the next 20 months involved a

questioning of Thailand’s scientific rationale or a complaint about the proposed legislation not

conforming to Codex standards.

Criticisms of Thailand’s proposed legislation continued in the TBT Committee. US delegates

expanded their concerns at the March 2016 meeting, posing questions about the scientific rationale,

the use of criminal penalties, and the application of restrictions to follow-up formula. At the June

meeting, Australia, the European Union, and New Zealand formed a coalition with the US to echo

these concerns, with Canada joining later. The coalition explicitly and repeatedly referenced

Codex standards in its concerns about whether there was adequate scientific rationale for the

0

10

20

30

40

50

60

70

80

90

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

technical engagement

tariff quota underfill

consumer choice

transparency

trade costs

import discrimination

trade restrictiveness

scientific rational and health/safety basis

Codex and international standards

27

Figure 10. Interventions at the WTO involving Thailand’s proposed domestic legislation to regulate the marketing of BMS

Notes: Data sourced from WTO online archives. Text in light blue bars at top and bottom are descriptors of the complaints levied by countries shown as having intervened against Thailand’s proposed legislation in each meeting. Interventions are denoted by an arrow from a meeting to an intervening country. Text is matched to intervening country by color.

28

proposed legislation. In November 2016, the coalition added concerns about Thailand’s

requirements for product labelling, with the US asking whether measures complied with

Thailand’s own laws on food labelling. At the March 2017 TBT meeting, three of the five coalition

members again voiced concerns about compliance with Codex standards and four complained

about trade-restrictiveness.

This is a rare case where we can see the original proposed legislation and the final version of the

legislation as passed as reported by the US Department of Agriculture Foreign Agricultural Service

(FAS), included here in Supplemental File 3. Both the US Department of Agriculture and the US

Trade Representative69 detailed the changes integrated into to the proposed law before it was

passed that may benefit US exporters. In particular, the US Department of Agriculture Foreign

Agricultural Service70 notes that

“The approved legislation limits the prohibition on advertising to just food for

infants and supplementary food for infants. Advertising for food for young children

is now permitted as long it does not cause the public to believe the product is for

infants or cause the public to believe that the product was suitable for feeding

infants. The approved legislation reduces the maximum criminal penalty of

imprisonment from 3 years to 1 year and the maximum fine from 300,000 baht to

100,000 baht for violations of the advertising prohibitions.” [10]

These changes weakened the law by exempting drinks for children 13 months and older

from being regulated in the same way as infant formula, including allowing demonstrations

of follow-up formula in health centers, and by reducing criminal penalties for violations of

marketing restrictions. This exemption can be a loophole for cross-marketing. Reducing

the penalty may weaken the enforcement mechanism.

Industry influence in the regime complex through the national arena of the United States

Trade regime theory considers interactions between and within the parallel or overlapping

domestic and international fora. Here we describe how the political influence of the BMS industry

within US domestic political arenas influences the position the US government takes in

international fora. The US is home to several of the world’s largest BMS manufacturers, and a

large dairy industry that supplies ingredients used in BMS manufacturing.

29

Political contributions by the BMS industry

The “Big-6” BMS manufacturing conglomerates—Abbott-Alere, Dannon-Nutricia, Kraft-Heinz,

Nestle-Gerber-Wyeth, Perrigo-PBM, and RB-Mead Johnson—as a group have made substantial

political contributions over the last three decades to candidates for the US Congress, candidates

for President, and Political Action Committees. There has been a lot of changing of hands of some

firms over the last two decades, so we account carefully for mergers and acquisitions in our

tabulations. In the 1990s, Kraft-Heinz was the major donor within this group, then Nestle-Gerber-

Wyeth and RB-Mead Johnson in the 2000s. In the last ten years, Abbott’s contributions have

steadily grown and now dominate industry political contributions. Total political contributions

from the Big-6 BMS conglomerates peak at close to $6 million in 2000, but averaged about US$2

million per year in the 1990-1999, US$3 million per year 2000-2012s, and have been steady at $1

million per year 2013-2018.

In the 1990s, a greater proportion of donations went to Republican candidates for office. Since

2008, donations have been evenly divided between Republicans and Democrats. More funds went

to candidates for the House of Representatives than for the Senate or White House and most

recipients of funds won their election.

Industry lobbying for BMS-related interventions

Expenditures on lobbying activity dwarf political contributions in the typical year. Figure 11

shows total expenditures on lobbying activity where the lobbyist reports a BMS-related subject in

their disclosure between 2007 and 2018. Total annual expenditure on lobbying federal agencies

and elected officials in the federal government (distinct from political contributions to candidates

discussed above) can exceed $12 million, though it averages about $7 million, more than three

times the average level of political contributions over the last decade. Disclosures do not always

provide detail on the topics discussed, possibly why there are some apparent gaps in disclosed

trade-related BMS lobbying in Figure 11. However, it is clear that since 2016, BMS-related

lobbying has been focused on trade, as opposed to exclusively domestic market access concerns

(such as participation in the Women, Infants, and Children supplemental nutrition program).

30

In Figure 12, we show lobbying expenditures that are possibly linked to US interventions at the

WTO or toward other countries in bilateral or regional talks, with the links suggested both by

general disclosure of issues reported and by timing relative to interventions at the WTO. The

largest expenditures by far are from Abbot Laboratories, followed by a group of organizations

representing dairy interests, as well as the Infant Nutrition Council of America, which is funded

by BMS exporters Abbott Nutrition, Gerber Products Company (later part of Nestle), Perrigo

Nutritionals, and Reckitt Benckiser (Mead Johnson). Lobbying activity by BMS producers is

spread across the federal government, especially in the House of Representatives, the Senate, and

at various times, the Food and Drug Administration, State Department, US Trade Representative,

and the Department of Agriculture.

Figure 11. BMS-related lobbying expenditures

Notes: Data sourced from the Center for Responsive Politics; author calculations of phrase-filtered BMS-related lobbying expenditure, plus lobbying by BMS manufacturers and their associations with disclosures noting particular countries in periods where events linked to BMS regulation took place.

Some disclosures contain explicit descriptions of non-WTO/WHO issues linked to the lobbying

activity. For instance, in 2007 Bristol-Myers-Squibb summarised the purpose of lobbying as

31

“Philippines/Ban on Advertising and Marketing” and “lobbied to ensure compliance with laws

allowing advertising and marketing of infant formulas.” When checking the issue focus of each

lobbying expenditure, a number of issues emerged that do not appear among the WTO

interventions. These are listed in greater detail in Baker et al (2021). The list includes concerns

about enforcement actions across a number of countries, as well as discussions about WHO

initiatives around “infant formula regulatory issues” and “pediatric nutrition,” or trade and

unspecified “WHO initiatives” as they related to intellectual property.

Figure 12. BMS producer interest group expenditure on lobbying related to possible policy interventions at the WTO or in bilateral or regional discussions

Notes: Data sourced from the Center for Responsive Politics, and author calculations

Discussion

Our findings elucidate a trading system in which there is a net North-South flow of BMS

products.[11] A large contingent of developing and transitional economies is striving to restrict

32

inappropriate marketing of BMS by implementing the WHO’s International Code. But in doing

so, they run into opposition from BMS exporters that is channelled through the institutions of the

international trade regime. At the center of this turmoil between the international public health and

trade regimes is the CAC which sets standards for the composition, labelling, and marketing of

BMS products and therefore is ideally situated to help resolve these conflicts by providing

international benchmarks.

Recent advances in the economics of international trade show that under conditions where lobbies

have sufficient influence over international standards relative to domestic standards, trade

agreements requiring harmonized standards can be detrimental to economic welfare.71 In principle,

the CAC is administered by the FAO and WHO, both of which have strong procedures to limit

industry influence or screen for conflicts of interest, with a mandate to protect public health. In

practice, CAC processes lack strong screening for conflicts of interest.7 Conflicts of interest among

industry participants need not always outweigh the benefits of added information from industry

input into health policy.72 However, our analysis of the review of the standard for follow-up

formula shows that BMS and milk-powder exporting countries and industry actors flooding the

CCNFSDU as observers and as member-country delegates intentionally strive to shape standards

in conflict with WHO policies and guidelines in ways that can harm infant and maternal health.

The success of industry interests in shaping parts of Codex standards in ways that conflict with

WHO recommendations strongly suggests that industry has more influence at the CAC than in

other parts of the public health regime shown in Figure 1—namely, the UN bodies that have

committed to support the International Code—or in countries with political will to adopt the

International Code in domestic regulation. Figures 11 and 12 show that much of BMS-related

lobbying in the United States is related to trade and coincides with US interventions at the WTO

(many of which mention Codex or international standards). This is also strongly suggestive of the

intention of industry to influence the application and enforcement of international standards

through national governments. These are the conditions in which Maggi and Ossa (2020) show

that harmonizing standards through trade agreements can reduce welfare.71

33

At the same time, measured by the increasing prevalence of trade complaints citing deviation from

Codex standards, domestic regulatory standards are growing increasingly subordinate to Codex

benchmarks since the WTO Agreements and arbitration went into force. In the case of BMS, we

see this clearly in Figure 6 above. In the current review of the standard for follow-up formula, the

right to regulate marketing of BMS products for young children 13-36 months as BMS in the same

way as products for infants 0 to 12 months, as stipulated in the International Code, hangs on a

contested footnote acknowledging that “some countries” do so. Yet we see Thailand’s attempt to

adopt similar restrictions in its Milk Code thwarted after a barrage of sub-arbitration-level

complaints within the WTO TBT Committee. Our example of the proposed versus final Milk Code

in Thailand demonstrates that trade complaints referencing the Codex need not reach arbitration to

be effective in watering down legislation.

A contested footnote also applies for countries who wish to restrict sugars to less than 2.5g per

100kcal or prevent companies from adding sucrose to follow-up formulas. Outside the scope of

our study, additional challenges for advocates of the International Code lie in the mounting battles

across multiple Codex committees over cross-promotion, food packaging, and cautionary nutrition

labelling.

Lester notes that this general push toward insisting that food safety regulations be “science-based”

presents additional challenges. The movement creates even more stringent constraints upon

domestic regulation by challenging regulations that may not only exist to discriminate against

exports, but also those that exist to protect animal welfare or the environment.5 Equally

problematic, science evolves and scientists may have differing approaches to assessing health

risks.

An example is the question of when a hazard-based approach is adequate to assess the legitimacy

and proportionality of public health measures, versus when a risk-based approach to assessment is

necessary. The hazard-based approach calls into question the safety of using a substance or practice

that may cause harm. This approach is closely related to the precautionary principle, a premise

with origins in German legislation to reduce air pollution crafted in the 1970s. The principle was

later embedded in the Maastricht Treaty in 1992 and in national laws in Belgium, France,

34

Germany, the Netherlands, Sweden, and outside the EU in Australia. The precise definition of the

precautionary principle varies across countries, but it uniformly embodies the goal of avoiding

harm in situations clouded by scientific uncertainty.73

A risk-based approach goes beyond the hazard-based approach, attempting also to quantify the

actual impact of the hazard on real people by taking into account the probabilities of various

degrees of exposure and adverse effects.74 The four steps of a full risk assessment as performed to

provide scientific advice for the CAC are hazard identification, hazard characterization (or dose-

response assessment), exposure assessment, and risk characterization.75 As the Joint Meeting on

Pesticide Residues that provides scientific advice to the CAC explains, a lion is a hazard, but a

lion viewed in a zoo presents little risk.76

While the risk-based approach is clearly superior insofar as it brings more information to bear in

judging the safety of a substance or practice, it is not always an appropriate bar for judging the

legitimacy or proportionality of a public health measure for trade policy. First, it is not always

feasible or ethical to conduct a risk-based assessment. Second, the extra steps required beyond the

identification of the hazard make it more challenging and costly. By pushing within the CAC for

regulatory decisions to be made only on the basis of a risk assessment, industry and exporter

countries are not only increasing the burden of proof required to justify a regulation, but also

weakening the general standing of the precautionary principle in WTO jurisprudence. Third, a

strong movement has arisen among some members of the CAC to create “harmonized” approaches

to risk assessment and require the standard to be adopted across agencies and national

governments, which may sweep away diversity in experimental design or probability estimates.77

Finally, the approach as practiced at the CAC largely ignores consumer perceptions and

preferences for risk in formulation of risk assessment policy rules used to guide the risk

assessments,78,79 while we see a heavy influence of industry interests in formulation of risk

assessment policy rules in the case of the review of the Codex FUF standard above. All of these

issues can lead to unnecessary harm if Codex standards are treated as a ceiling rather than a floor

for public health policy measures.

35

In the current setting, scientific processes are likely to become increasingly subject to conflicts of

interest. We observe instances above of WTO members in the SPS Committee and the TRIPS

Council organizing to influence the governance, structure, and funding of the CAC and its

scientific advice, rather than working exclusively through their country counterpart delegates to

the parent bodies, the FAO and WHO, where restrictions on participation of industry interests are

tighter. Organizing at WTO to marshal alternative sources of funding or encourage mandatory

allocations from WHO core funding may become a way to further weaken CAC observance of

FAO and WHO health guidelines and introduce trade policy aims as a bigger influence in scientific

processes and deliberations. If the US ever reduced or withdrew funding from WHO, as it recently

threatened, and diverted a portion of these funds directly to the CAC, this in particular could

weaken the commitment of the CAC to the public health half of its mandate.

Industry influence within the WHO itself also is likely to intensify through new avenues for direct

participation. Inflows of private-sector funding may become even more important if member

countries like the US curtail contributions. In 2016, the WHA also approved a Framework of

Engagement with Non-State Actors (FENSA), allowing greater non-state actor participation,

including by businesses and business-interest NGOs.[12] Stakeholders involved in advocating for

breastfeeding under the International Code oppose loosening restrictions on participation of the

BMS industry in WHA processes80 in light of the industry’s past history of working to weaken the

Code, arguing that FENSA does not include adequate safeguards against conflicts of interest.41,81,82

We discuss these issues of conflicts of interest and politicization of science through the trade

regime in the context of BMS, but they are more general. The ambiguities and conflicts evident in

the regime complex governing infant and young child nutrition are not unlike those of the regime

complex governing environmental issues.9,78,83 The arenas of the battles are similar—WTO

committees, the Codex, the domestic political arena, and various preferential trade agreements.

The scientific debate bears some resemblance, as well: The US is pushing aggressively for

adherence to a risk-based approach to setting maximum residual limits for pesticides, for instance,

while even within US jurisprudence, the issue has not been settled.9,84 WTO jurisprudence related

to the TBT Agreement is also evolving quickly, with many open questions as to how broadly trade

law should apply to and interfere with domestic regulations for public health.4

36

Since 2016, the Codex Executive Committee has been urgently pushing the WHO to provide

increased funding for an “enhanced work programme” to harmonize risk assessment across the

FAO, the WHO, and the CAC’s joint scientific committees, focusing on risk-based assessments

for food safety standards. Part of the agenda is to push national governments to adopt the same

risk-based approach to food safety. The issue of harmonization of standards and its institutional

context within the regime complex for public health and trade deserves much more research to

understand the costs and benefits of such initiatives.

Endnotes

[1] The US Federal Election Campaign Act of 1971, the Lobbying Disclosure Act of 1995, and

the Honest Leadership and Open Government Act of 2007 governing election and lobbying

oversight combine to require more detailed disclosures than in many countries.

[2] We further inspected lobbying disclosure notes flagged in the word search for BMS issues

that were not linked to happenings at the WTO but which pointed to BMS-related activities in

specific countries. In this way, we found several specific market access challenges facing BMS

producers in US trading partner countries (see Appendix 2 for further details).

[3] See Panel A of Table S1 for detail.

[4] The Philippine Department of Health tightened restrictions in 200685 and the legislature

adopted the Expanded Breastfeeding Promotion Act of 2009.86 Thailand adopted its Milk Code

restricting marketing in 2017.87 Vietnam passed adopted statutes in 2012 and 2014 restricting

advertising and establishing public policies in support of breastfeeding.88,89

[5] Using these data, the correlation between the percentage of infants breastfed at 12 months

and exports is -0.40, significant at the 5 percent level. The correlation between imports and the

rate of breastfeeding is -0.20, half as large and statistically different than the correlation for

exports.

[6] A companion report for that resolution16 cites relevant Codex provisions including the

‘commodity-specific’ 1981 Standard on Infant Formula (CXS 72-1981), the 1987 Standard on

Follow-up Formula (CXS 156-1987) and a number of ‘horizontal standards’ including the

Standard for Labelling of and Claims for Foods for Special Medical Purposes (CXS 180-1991)

under the Codex Committee on Food Labelling (CCFL).90

37

[7] Public health advocates note that the drinks often have excessive levels of sugar and are not

necessary or especially beneficial to health compared to, for instance, less expensive cow’s milk.

[8] Table S1.5 in Supplemental File 1 presents data by country receiving questions or requests for

INRs.

[9] This suggests that Thailand did not notify the WTO of its proposed policy when it was drafted,

an observation confirmed within a 2018 report to Congress by the US Trade Representative.69

[10] The web address where this document was posted is no longer works, so we include the full

document in Supplemental File 4, along with the original website address. It is particularly rare

because the FAS uploaded the “redlined” revisions to the original.

[11] BMS inputs and products are largely (though not exclusively) produced and promoted by

multinational firms headquartered in advanced economies such as Australia, France, Germany,

New Zealand, and the US. Production in developing countries is increasing.

[12] Stakeholders involved in advocating for breastfeeding under the International Code opposed

participation of the BMS industry in WHA processes because of the clear conflicts of interest it

would involve80 and the industry’s past history of working to weaken the initial provisions of the

Code, and then circulating a watered-down interpretation of the International Code after it was

adopted.41

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