gtz/safo standard setting tool

Date: October, 27 2009 By: Leonie Vierck

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GTZ/SAFO Standard Setting Tool For National Food Fortification Programmes Especially in Developing Countries Note: A CD-ROM accompanying this tool kit contains cited legal texts and further resources. A. Introduction To effectively ensure public health benefits, food fortification requires a legal framework. The process of developing or applying this legal framework can be called standardization. Yet the terms standardization and standard are used in varying terms. The fundamental understanding of the term standardization coined in this document is a broad one, describing the process and elements of food fortification regulations. (Yet, other shades of the term will be analysed as well.) This is due to the fact that a global perspective on food legislation as relating to food fortification can naturally only draw attention to overall requirements. And while general food legislation will usually be in place (also governing related and complementary areas like supplementation or consideration of dietary diversification), national food fortification programmes need to standardize proceedings in accordance with the existing framework. While it is impossible to analyse all legal frameworks worldwide to a range of reasons (language, legal families, or even availability of the documents), a comparative analysis can highlight the functions required by law to make national food fortification programmes work (functional analysis of laws as a method of comparative law). Additionally, the international legal framework in the area of food fortification seeks to harmonize sub-level legal frameworks and to set basic requirements based on different purposes. Next to influencing national legal frameworks, international law in this area sets requirements, which can be actively used for consulting. In this sense, this document would like to illustrate process requirements and benchmarks from a legal perspective. This legal tool kit can be used for the functions that food fortification law needs to fulfil and the question on how to proceed. B. What are standards? I. GTZ/BMZ Approach towards Standards Generally, standards are referred to as one type of standards within the German development framework, namely social and ecological standards. The three-dimensional structure of sustainability is applied by inter-relating business to society and the environment. This goes in line with C(S)R activities of corporate citizens. Food fortification standards determine product quality and cannot be understood as social or ecological standards. Yet, naturally structural parallels apply as both sets of standards fit into a general framework of standard setting. First, food fortification industries often act within a broader C(S)R framework. More directly, food fortification throughout the value chain is – though linked to broader social and ecological impacts as well – part of food industry’s core business. The idea of inclusive business (see e.g. http://www.growinginclusivemarkets.org/) or BoP (bottom or base of the pyramid) is to develop products that are cost-effective for the four billion consumers of poor and poorest population groups. While their individual consuming power may not be profitable, their collective is – at the same time profitable business products fulfil development goals (double bottom line). Overarching similar criteria between social and ecological as well as product standards are the application of criteria and indicators for business production, consulting on the moderation of multi-stakeholder processes, PPP structures, capacity building aspects and institution strengthening, as well as technical support and monitoring. All these issues will pop up in this outline. In sum, food fortification standards can be embraced as long as the standard terminology is not narrowed down to a single type of standards. Further connections are taken up below.


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Standardization process

II. Standards and Food Fortification Standardization can be conceived very broadly as the multi-stakeholder process leading to a regulation of a subject matter through soft and hard law. Standardization can also be understood more narrowly as the private standard setting undertaken by standards bodies at national level. For purpose of distinction, this standardization is in the following described as industry, industrial or technical standardization. Industrial standardization offers an interface between market demands, technology, and know-how as well as legal requirements. Standard setting then reflects the interrelations between the public and the private sector in the process of norm creation. 1. Voluntary and Mandatory FF Note: For a national food fortification programme, one approach or a combination of them needs to be found. This depends on criteria such as:

• Public health needs and consumption patterns • Requirements of existing food law • Nutrition policy • Stakeholder commitment and agendas • Consumer knowledge (leading e.g. to voluntary fortification based on consumer

interest) • Chances of implementation (if low, a voluntary scale-up towards mandatory

fortification could e.g. be the answer) • Clarification of preliminary concerns (if scientific data needs to be developed first,

voluntary fortification can e.g. be used as a pilot for later mandatory fortification) • General (mandatory fortification) or specific outreach (e.g. towards specific groups

through voluntary or governmental regulated food fortification) • If fortification as such is regulated, one approach may fit all – however, if fortification

covers e.g. specific staple foods, approaches may coexist within one country It is possible to distinguish three types of approaches:

a. Non-governmental voluntary fortification; b. Governmental regulated voluntary fortification; and c. Mandatory fortification.

a. Non-governmental voluntary fortification is based upon individual industry commitment and can be additionally based upon private legal agreements. Memoranda of understanding (MoUs) or Letters of Intent (LoIs) can serve as legally non-binding gentlemen agreements. Contracts establish a legally binding foundation as expressed by the free will of

Industrial standard


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partners. Such contracts can e.g. be concluded within industry associations or even between governmental entities and the private industry (as was e.g. the case in Mexico between the central government and the associations regarding wheat and corn flour based upon the Convenio para la adición de nutrimentos a las harinas del Septiembre 9, 1998). National standard bodies serving as an interface between industry-based knowledge and regulation as well as public regulatory mechanisms may also lay down technical requirements. Yet, should the standard be rendered compulsory by the public sector, e.g. through ministerial decree, the programme shifts towards mandatory fortification.

• Possible legal instruments based on private law: o Non-binding gentlemen agreements o Contracts o Industrial standards

• Possible artners: o Industries o Industry associations o Government when entering into private agreements

b. Governmental regulated voluntary fortification is often called ‘market-driven fortification’ in the sense that micronutrients are added to processed foods within legally binding regulatory limits. This is well true for industrialized and emerging countries that count with markets for luxury-fortified foodstuffs targeted at non-poor people. Governmental regulated fortification thus often establishes a tool for necessary controls in industrialized countries. They are based on the idea that industry sees an asset in fortifying as such while the government wants to regulate public health effects. In contrast, mandatory fortification requires industry legally to fortify while here industry is the driving force behind the programme.

• Possible legal instruments based on private law: o Non-binding gentlemen agreements o Contracts

• Possible legal instruments based on public law: o Legal umbrella laws o Administrative legal acts o Intra-administrative rules on interpretation and application o Industrial standards

• Possible partners: o Industries (market-drive) o Governmental entities

c. Mandatory fortification refers to legislation whereby the state obliges all or specific industries to fortify a given foodstuff. Thus, a level playing field for the whole industry is being created. This type of fortification is driven by a public health interest to fight micronutrient deficiencies on part of the state. It can but does not necessarily have to be mirrored by a commitment rendered by the industry. Mandatory fortification is targeted at population groups in need. To this end, research needs to be carried out defining levels of fortification, and effective control mechanisms need to be established. The social sector, advocating food fortification may also develop an interest in mandatory fortification and support such initiatives through i.a. social marketing campaigns. Such social marketing campaigns also offer an asset for the private sector leading e.g. to logo, labelling, and advertisement regulations. Scientific studies may deliver the necessary data to set minimum and maximum fortification levels. In sum, mandatory fortification can be displayed as multi-sectoral by nature.

• Legal instruments based on private law:


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Voluntary or privately regulated (CSR or BoP) commitment by the industry involved

• Legal instruments based on public law: o Legal umbrella laws o Administrative legal acts o Intra-administrative rules on interpretation and application o Industrial standards

• Partners: o Governmental entities o Industry o Social sector o Academia

d. Inter-connections Mandatory and voluntary fortification should not be considered as purely opposed models. While voluntary fortification fits private sector led food fortification policies, mandatory fortification is government-particular. In a multi-stakeholder environment both may be applied complementarily and on different levels of governance as described above. This even opens the floor for intermediate forms. All approaches centre on questions of governmental prohibition and/or permission (and according stakeholder interests and agendas) based upon public health aspects in determining basic prohibition (like in some developing countries with overall sufficient micronutrient intake) or permission (as in the case of market-driven fortification) or setting minimum (obligation) and maximum (permission and prohibition to exceed) fortification levels. Food fortification is particular, as it requires industry implementation in market economies (with exceptions in case of emergency food fortification undertaken by state agencies e.g.).

Madatory and Voluntary FF

Voluntary FF Regulated Voluntary FF Mandatory FF

FF

Further resources:

• Blüthner, Andreas/Vierck, Leonie: Setting Standards for Business & Development – How Legal Frameworks can Support Market-Based Nutrition Partnerships, European Food and Feed Law Review (EFFL) 2/2009, 104-118 (electronic resource of proof text only and offprint)

• Mattli, Walter/Büthe, Tim: Setting International Standards – Technological Rationality or Primacy of Power?, World Politics 56 (October 2003), 1-42 (electronic resource)

• Schepel, Harm: The Constitution of Private Governance – Product Standards in the Regulation of Integrating Markets, Oxford and Portland 2005 (copy of the first introductory chapter)


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C. International Legal Influences Global policy efforts to (re-)position nutrition programmes such as food fortification are reflected and framed by international law. International law sets requirements for national law and forms a framework of opportunities. Important entities are i.a. the UN Standing Committee on Nutrition (UNSCN), a food and nutrition policy harmonization forum (http://www.unscn.org/), the FAO Global Forum on Food Security and Nutrition (FSN, http://km.fao.org/fsn/fsn-home/en/?no_cache=1) or the non-governmental International Food Policy Research Institute (IFPRI, http://www.ifpri.org/). Further resources:

• Levine, Ruth/Kuczynski, Danielle (Center for Global Development Essay): Global Nutrition Institutions: Is there an Appetite for Change?, August 2009 (electronic resource)

• The World Bank: Re-Positioning Nutrition as Central to Development – A Strategy for Large-Scale Action, Overview, 2006 (electronic resource)

• The World Bank: Re-Positioning Nutrition as Central to Development – A Strategy for Large-Scale Action, Full Report, 2006 (electronic resource)

I. Soft Law Note: Soft law is legally non-binding international law that works on persuasion and factual enforcement. It exists at the interface between politics and law and may as such be influential as is the case of the MDGs policy impact. Moreover, international food law is convincingly regulated on the base of the FAO/WHO Codex Alimentarius Commission (CAC). CAC counts with such high degrees of expertise and knowledge that adding the trade benefits of harmonizing food industries, CAC documents are heavily adopted into regional and national legal frameworks, also due to their inter-connection with WTO law. Moreover, they set international standards for effective consulting in the area. 1. MDGs Food fortification initiatives connect to the Millenium Development Goals or MDGs (http://www.un.org/millenniumgoals) as important soft law on the international level. The eight MDGs form a blueprint agreed to by all the world’s countries and all the world’s leading development institutions through the legally non-binding (Art. 12-14 UN Charter) UN General Assembly Resolution A/Res/55/2 from 18 September 2000. They aim to enhance sustainable development for the world’s poorest based on specific goals to be reached by 2015 (the website contains detailed information on sub-targets and indicators): MDG 1: End Poverty and Hunger (Half the people by 2015 who earn less than a dollar

a day, and those suffering from hunger or lack of access to water) MDG 2: Universal Education (Achieve full primary education and equal access to all

levels of education) MDG 3: Gender Equality (Promotion) MDG 4: Child Health (Reduced child mortality by two thirds) MDG 5: Maternal Health (Reduced maternal mortality by three quarters) MDG 6: Combat HIV/AIDS (To halt and reverse the spread of HIV/AIDS, Malaria, and

other major diseases) MDG 7: Environmental Sustainability (Promotion) MDG 8: Global Partnership (Strong partnership development with the private and

social sector for poverty eradication)


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Food fortification most directly links to MDG 1. Malnutrition or so-called hidden hunger and especially child malnutrition are covered by this goal. At the same time, an independent expert committee, counting with five Nobel Prize winners, namely the Copenhagen Consensus (http://www.copenhagenconsensus.com) counted malnutrition as one of the ten challenges faced by worldwide development, and advocated i.a. for supplementation, fortification, and community-based nutrition promotion as some of the top ten cost-effective solutions combating malnutrition. MDGs 2, 4, 5, and 6 also interlink with food fortification policies as malnutrition interlinks with poor health affecting especially certain vulnerable groups like children and mothers. MDG 8 is institutionally closely linked to food fortification programmes. MDG 8 promotes global partnerships and such at national levels. An overall consensus between the public, private, and social sector as well as academia needs to be established in order to food fortification programme on track. 2. Codex Alimentarius The Codex Alimentarius Commission (CAC) influences national food fortification legislation. Its content needs to be taken into account for the legal drafting envisaged. It was created in 1961 by FAO and is in charge of the Joint FAO/WHO Food Standards Programme since 1962. Its specific focus lies on food safety and hygiene by regulating through standards, guidelines, and codes of practice. CAC instruments are often directly mentioned in regional and national food fortification legislation. CAC instruments are as such not legally binding but influential soft law and interact intensively with WTO law as discussed below. Soft law is still important as a reference point often showing factual consensus reached at international level. As such it helps to create harmonization. Soft law can be convincingly used for recommendations, and is even often adhered to when showing a high degree of technical expertise – as is precisely the case with CAC. There are strong incentives to apply Codex instruments, which facilitate trade through harmonization. a. General Principles for the Addition of Essential Nutrients to Foods, CAC/GL 09-

1987 (amended 1989, 1991) Note: These principles offer basic definitions for food fortification terms, specifies public health and consumer protection (e.g. by requiring reasonable cost increases) aspects of food fortification. Most importantly, the principles call for legal provisions based upon five food fortification requirements.

• Intentions: Providing guidance; establishment of uniform set of principles; maintaining and improving the overall nutritional quality of foods; preventing excesses, deficits, or imbalances; facilitating trade

• 2 – Description: Nutrient definition (2.1, see below in the Guidelines on Nutrition Labelling, CAC/GL 2-1985, 2.2.5); essential nutrient means any substance normally consumed as a constituent of food which is needed for growth and development and the maintenance of healthy life and which cannot be synthesized in adequate amounts by the body (2.2); fortification or enrichment means the addition of one or more essential nutrients to a food whether or not it is normally contained in the food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups (2.5); restoration means the addition to a food of essential nutrient(s) which are lost during the course of good manufacturing practice, or during normal storage and handling procedures, in amounts which will result in the presences in the food of the level of nutrient(s) present in the edible portion of the food before processing, storage or handling (2.6);

Thus, the CAC General Principles for the Addition of Essential Nutrients to Foods promote an integrated understanding of the terms fortification and


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enrichment (as opposed to a separated one whereby fortification is the addition of nutrients which are not normally contained in the food). Yet, a difference is drawn towards restoration, which could also be understood as a sub-category of enrichment in the other concept.

Standardization means the addition of nutrients to a food in order to compensate or natural variations in nutrient level (2.9)

Standardization is here understood as the factual process of applying a set standard or following it.

• 3 – Basic principles: Essential nutrients may be added for the purpose of fortification (3.1.3); addition of nutrients should not lead to excessive or insignificant intakes given the overall diet, and should not result in adverse effects (3.2 and 3.3); the essential nutrient should be stable, biologically available, and without undesirable characteristics (3.4-3.6); technology and processing facilities should be made available (3.7); addition should not lead to consumer misleading or deceiving (3.8); the additional cost should be reasonable for the consumer (3.9); methods of measuring, controlling, and/or enforcing should be available (3.10); specific legal provisions are needed (3.11)

• 6 – Nutrient addition for the purpose of fortification: Fortification should be governed by national authorities because FF depends on the particular nutritional problems to be corrected, the characteristics of the target population, and the food consumption patterns of the area (6.1); Fortification requirements (6.2): (1) Demonstrated need for increased nutrient intake (based on (sub-)clinical evidence of deficiency; estimates of low nutrient intakes; or possible deficiencies likely to develop because of changing food habits); (2) Consumption of the selected food vehicle by the population; (3) Intake of the food vehicle should be stable and uniform and the lower and upper intakes should be known; (4) Sufficient amount of the selected nutrient to correct or prevent the deficiency; (5) And the amount of the added nutrient should not result in excessive intakes by individuals with a high food intake of the selected vehicle.

b. Guidelines on Nutrition Labelling, CAC/GL 2-1985 Note: These guidelines regulate food labelling, including micronutrient declarations in order to balance private marketing, consumer protection, and the additional benefit of consumer awareness and education programmes (including e.g. logos and linking efforts of dietary diversification).

• Purpose of the guidelines: I.a. consumer information and protection from false, misleading, deceptive or insignificant labelling; establishment of sound nutrition principles in food formulation; discouragement of nutritional claims without labelling

• 2.2.5 – Definition: Nutrient means any substance normally consumed as a constituent to food (…) (b) which is needed for growth, development and maintenance of life; or (c) a deficit of which will cause characteristic bio-chemical or physiological changes to occur.

• 3.2.6 – Listing of nutrients: This section establishes criteria for the listing of vitamins and minerals. 3.2.6.1 requires establishing recommended intakes. Amounts of less than 5% should not be declared (3.2.6.2)

• 3.4 – Presentation of nutrient content: The declaration should be numerical (3.4.1), and be expressed in metric units and/or as a percentage of the Nutrient Reference Value per 100 g or per 100 ml or per package single portions. Additionally, the


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information may be given per serving. The stated Nutrient Reference Value for vitamin A is 800 µg. It is proposed that for the declaration of β-carotene (provitamin A) the following conversion factor should be used: 1 µg = 6 µg β-carotene (3.4.4).

• 3.5.1 – Setting of tolerance limits • 4 – Supplementary nutrition information: In order to increase consumer awareness

(4.1). Generally, the information should be optional but in countries with a high illiteracy rate food group symbols or other pictorial or colour presentations may be used without the nutrient declaration (4.2). Consumer education programmes are recommended to increase consumer awareness and the use of information (4.3).

• 5 – Periodic review of nutrition labelling c. Guidelines for Use of Nutrition and Health Claims, CAC/GL 23-1997 (amended

2001, 2008) These Codex guidelines seek to harmonize nutrition claims (in food labelling and possibly advertising), which are widely used as marketing tool but often create consumer confusion. The guidelines specify that nutrition claims should be consistent with and support national nutrition policies. The guidelines lay down specific requirements for possible health or dietary claims. As micronutrient food fortification is a public health intervention, section 7 on health claims is especially relevant: Health claims must be i.a. accepted by competent authorities, should have a clear regulatory framework, and name the target group(s) if appropriate. d. Recommended International Code of Practice, General Principles of Food

Hygiene, CAC/RCP 1-1969 Note: These recommendations provide highly technical information relevant for food industries and monitoring bodies. Annex E of the WHO/FAO Guidelines on Food Fortification with Micronutrients (electronic source) gives a case analysis of the establishment of a control monitoring system for fortified vegetable oils in Morocco. These recommendations cover food hygiene throughout the food chain and address governments, food industries, and consumers alike. Next to classical hygiene requirements, the recommendations cover training activities and consumer education issues. They additionally provide guidelines for the application of the Hazard Analysis and Critical Control Point (HACCP) system. A case study in Morocco on fortified cooking oil identified 4 possible critical control points for food fortification: the food vehicle, the quality of the fortificant premix, its storage, and its addition. The following corrective actions were proposed: product sampling and frequency, labelling, distribution records, documentation, inspection and technical audits, as well as training activities. (Additionally, quality management systems can be certified through ISO 9001:2000.) e. Standards for Specific Staple Foods Codex Alimentarius contains food standards for a wide range of specific staple foods, which could be suitable for food fortification with micronutrients, especially if fortification provisions are to be integrated into a general food standard. Standards can be researched at: http://www.codexalimentarius.net/web/standard_list.do?lang=en Further resource: Ottaway, Peter Berry (ed.): Food fortification and supplementation – Technological, safety and regulatory aspects, Cambridge 2008 (Chapter 12 on CAC; printed version available)


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II. Hard Law Note: Hard law is legally binding international law for those states that signed and ratified the according treaty. All treaties cited count with monitoring mechanisms ranging from notification obligations in WTO law to state reporting obligation to human right bodies. If and how a treaty is applicable for a specific state and how the international obligations are translated into the national legal order, needs to be researched on a case-by-case basis. 1. World Trade Law (Micronutrients and Food as Public Health Commodities) Note: World trade law is a very complex international legal regime that requires careful analysis. Most notably, national food fortification law and standards need to be drafted in a way that possible WTO violations are justified. Procedurally, country specific research on WTO notification mechanisms is necessary to comply with WTO law and avoid possible litigation within the WTO dispute settlement scheme. Food fortification standardization needs to take into account WTO law, so as not to violate its norms, and to follow the according notification procedure. Compulsory food fortification involves a WTO-dimension as the purpose of mandatory standard setting is meant to create a level playing field for industries involved. This would be seriously counteracted if an importer were able to import unfortified cooking oil at lower cost and thus dumping the market. To this end, countries usually introduce trade barriers for unfortified imported food in order to reinstall the level playing field. Likewise, in case of voluntary fortification, additional tariffs for non-fortified products can be introduced in order to food fortification with micronutrients. a. Violation and Possible Justifications of GATT Norms Such measures violate basic norms of the 1994 General Agreement on Tariffs and Trade (GATT), the main binding WTO treaty. Art. I: 1 GATT requires general most-favoured nation treatment: “With respect to customs duties and charges of any kind imposed on or in connection with importation or exportation or imposed on the international transfer of payments for imports or exports, and with respect to the method of levying such duties and charges, and with respect to all rules and formalities in connection with importation and exportation, and with respect to all matters referred to in paragraphs 2 and 4 of Article III, any advantage, favour, privilege or immunity granted by any contracting party to any product originating in or destined for any other country shall be accorded immediately and unconditionally to the like product originating in or destined for the territories of all other contracting parties.” This means essentially that any favoured treatment to a cross-border trade product has to be applied to all other like products as well. Art. III: 4 GATT meanwhile requires non-differentiation between domestic and foreign like products (national treatment): “The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favourable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution or use. […]” (i) Condition: Like Products For an application of both provisions it has first of all to be determined if fortified and non-fortified products (e.g. iodized salt as compared to ordinary table salt) are like products. The


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WTO appellate body sets forth three basic criteria (1) products properties, nature, and quality, (2) end-use, as well as (3) consumer taste and habit to evaluate the likeliness of products. In an overall assessment, although fortified products bear a higher nutritional value, they are in the same way applied in the kitchen as non-fortified products, and the nutritional change is not even recognizable for the ordinary consumer. Even more so, food fortification policies are especially targeted at requiring no change of eating habits in order to work as large-scale programs. In sum, fortified and non-fortified staples establish like products under the GATT clauses. (ii) Justification Such de facto discriminations, which are covered by the cited provisions, may find a justification. There are two ways in this case to establish such justification. In any case, justification departs from Art. XX (b) GATT providing the following general exception: “(Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting party of measures: […] (b) necessary to protect human, animal or plant life or health; […]” Analogous application of the SPS agreement – general presumption of justification: The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement) is referred to in this context. Art. 2 (4) grants a general presumption for a Art. XX:(b) GATT exemption, which then does not require an analysis of each individual case: “Sanitary of phytosanitary measures which conform to the relevant provisions of this Agreement shall be presumed to be in accordance with the obligations of the Members under the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Art. XX (b).” In this respect Art. 3 (2) calls for the following harmonization: “Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.” Further, Annex A, 3 (a) specifies which international standards, guidelines, and recommendations can be taken into account: “[…] for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice; […]” The only relevant Codex Alimentarius texts in this respect could be the above mentioned and discussed ones, namely:

• General Principles for the Addition of Essential Nutrients to Foods, CAC/GL 09-1987 (amended 1989, 1991);

• Guidelines on Nutrition Labelling, CAC/GL 2-1985; • Guidelines for Use of Nutrition and Health Claims, CAC/GL 23-1997 (amended 2001,

2008); • Recommended International Code of Practice, General Principles of Food Hygiene,

CAC/RCP 1-1969; and • Specific food standards.


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While the latter recommendations obviously are covered as principles of hygienic practice, this is not the case with the remaining norms. These then would need to refer to food additives or in other words micronutrients would need to be considered as food additives. An interpretation based on strict wording would not count micronutrients as food additives. First, the Codex Alimentarius itself does not list single micronutrients as such additives (see http://www.codexalimentarius.net/gsfaonline/index.html?lang=en). When vitamin C is listed as food additive, then this takes into account that vitamin C can be used as an antioxidant, e.g. to maintain red colour of corned beef. This use is different to the addition of vitamin C in order to improve the nutrition value of a given product. Further, the SPS defines its measures as protecting from risks arising from additives (Annex A, 1 (b)) while micronutrients are generally added to improve health. Thus, the SPS agreement is not directly applicable in this context. Yet, for different reasons, an analogy might be drawn. First, although fortification serves public health interests, it is regulated partly within the broader framework of food safety for implementation. That food safety regulations may lead to an overall improvement of human health is recognized by the SPS preamble itself. Secondly and more importantly, the SPS agreement accepts the strict Codex Alimentarius norms as harmonizing norms granting exemption presumptions (CAC standards are considered as “gold” standards). If in case of risky additive usage such a general presumption is possible, this should even more so apply to the health protective addition of micronutrients when conforming to the Codex Alimentarius. This would then indirectly grant the Codex Alimentarius norms connecting to food fortification a greater harmonization effect at the international level. This is in line with the purpose of CAC instruments, which seek to eliminate the need for each country to individually undertake a risk assessment. Individual justification under GATT: Even in case of non-application of the SPS agreement, individual justification can be found under Art. XX:b GATT. A fortification programme has then to protect human health, which will generally be the case as these programmes are designed as public health programmes targeted at combating malnutrition. Further, the measure needs to be necessary, i.e. the least trade-restrictive means with regard to the policy objective at stake. In case of mandatory fortification ensuring a level playing field, banning the importation of non-fortified foods is the only measure thinkable in this respect, so that the necessity test will be met. Result: GATT violations arising from the introduction of food fortification laws are justifiable. b. Dispute Settlement under GATT – Notification Procedure According to the Understanding regarding Notification, Consultation, Dispute Settlement and Surveillance adopted on 28 November 1978, Art. 3, contracting parties undertake to the maximum extent possible to notify contracting parties of their adoption of trade measures affecting the operation of GATT without prejudice on the consistency of such measures with GATT. The notification shall be made in advance of implementation or in case this were not possible promptly ex post facto. The Uruguay Round Agreement reaffirms this with its Decision on Notification Procedures in its Art. 1 (General obligation to notify) and establishes through Art. 2 a Central Registry of Notifications within the WTO Secretariat. Result: The introduction of such food fortification laws needs to be notified to the Central Registry of Notifications at the WTO according to the established national procedure.


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c. TBT norms The Agreement on Technical Barriers to Trade (TBT agreement) is built upon the purpose to harmonize technical regulations, standards, and conformity assessment systems in order not create unnecessary obstacles to international trade. At the same time these legally binding norms seek to allow countries to protect i.a. public health. (TBT is in this case not trumped by SPS as it was shown above that single SPS clauses could only be applied by analogy but not as such.) The TBT agreement uses its own definitions and distinguishes a technical regulation from a standard in its Annex 1 as follows: “1. Technical regulation Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. 2. Standard Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.” (i) A Side Note to ISO/IEC Directives, Part 2 Note: These directives provide most detailed information about step-by-step drafting of technical standards like food fortification ones. In this sense, technical regulations are what is in other contexts a mandatory standard, while the term standard means voluntary standard. The explanatory notes in this respect make this very clear by distinguishing the terms from the ISO/IEC Directives, Part 2 (Rules for the structure and drafting of International Standards), 5th ed. 2004. Generally, all other terms in the TBS agreement are defined accordingly to these directives (as stated in their 1991 ed.). In 3.1 these directives apply a broad standard definition: “standard document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context NOTE Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits. [ISO/IEC Guide 2:2004, definition 3.2]” The following rules of the directives serve as a perfect reference guide for the drafting of technical standards by providing detailed information on:

• General standard principles • Structure of standards • Drafting process • Preparation and presentation of documents • Basic reference works • Numbering • Patent rights • Designation of internationally standardized items • Verbal forms of the expression of provisions • Quantities and units


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(ii) TBT requirements Note: Food fortification standards need to comply with TBT requirements. Following CAC instruments as “gold” standards will most likely ensure legality. The Code of Good Practice lays down more requirements for less trade-restrictive impacts (e.g. performance based standard drafting and information on possible derivations from international standards). Conformity assessments by other states should be accepted. Art. 11 TBT grants technical assistance upon request from member states to other member states, especially developing country members on all matters concerned with standards. Art. 12 TBT requires special and differential treatment of developing country members. Art. 2 TBT sets the following basic substantial rules for technical regulations:

• In respect of technical regulations imported products shall be accorded treatment no less favourable than like national products (2.1).

• No unnecessary obstacle to international trade shall be created through technical regulations. To this end, a technical regulation shall not be more trade-restrictive than necessary to fulfil a legitimate objective.

• The protection of human health is stated as a rule example for a legitimate objective. • Criteria for risk-assessment are i.a. available scientific and technical information,

related processing technology or intended end-use of products. (2.2) Naturally, all TBT requirements can only link to de jure discrimination, as de facto discrimination is necessarily entailed in every technical product regulation. Further Art. 2.4 TBT connects them to international standards: “Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.” According to Annex 1, in this case the definition 3.2 of the ISO/IEC Directives, Part 2 applies: “international standard standard that is adopted by an international standardizing/standards organization and made available to the public [ISO/IEC Guide 2:2004, definition 3.2.1.1]” Again, the word standard also covers rules and guidelines (Annex 1, 2 TBT or 3.1 ISO/IEC Directives, Part 2). Again, this calls for the application of the following norms in the context of food fortification with micronutrients:

• General Principles for the Addition of Essential Nutrients to Foods, CAC/GL 09-1987 (amended 1989, 1991);

• Guidelines on Nutrition Labelling, CAC/GL 2-1985; • Guidelines for Use of Nutrition and Health Claims, CAC/GL 23-1997 (amended 2001,

2008); • Recommended International Code of Practice, General Principles of Food Hygiene,

CAC/RCP 1-1969; and • Specific food standards.

In case that the proposed technical norm were not in accordance with these international instruments and in case of a significant effect on trade, Art. 2.9 TBT lays down a detailed notification procedure. Art. 2.10 TBT applies with less restrictive notification requirements as an exception in case of urgent, i.a. health, problems. Art. 3 TBT adopts the provision of Art. 2 TBT to decentralized stating full responsibility of the central state to comply with Art. 2 TBT (Art. 3.5 TBT), and generally requiring, ensuring, and


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supporting compliance by the decentralized level. Annex 1.6 and 7 defines the different levels: “6. Central government body Central government, its ministries and departments or any body subject to the control of the central government in respect of the activity in question. […] 7. Local government body Government other than a central government (e.g. states, provinces, Länder, cantons, municipalities, etc.), its ministries or departments or any body subject to the control of such a government in respect of the activity in question.” Art. 4 TBT and Annex 3 (Code of Good Practice for the Preparation, Adoption and Application of Standards or Code of Good Practice (CGP)) regulate standards under the TBT agreement. Member states, according to Art.1 TBT, need to ensure compliance with the CGP at all possibilities. Letters A-C of the CGP lay down the institutional framework. The code may be accepted by standardizing bodies and is connected to ISO and IEC. Letter D again requires that product treatment may be no less favourable to like imported products than the ones of national origin. Letter E again calls to ensure that no unnecessary obstacles to international trade are created. Again, letter F CGP calls to use existing or imminent international standards, except where this were ineffective or inappropriate, for instance, because of an insufficient level of protection or fundamental climatic or geographical factors or fundamental technology problems. This connects to the mentioned CAC instruments as laid down above. Other relevant provisions:

• Letter I: Standards should rather be focused on terms of performance than design or descriptive characteristics.

• Letter L: Notification procedure – The notification shall include, as far as practicable, whether the draft standard deviates from relevant international standards.

Art. 5 TBT explores in depth the procedures for conformity assessment by government authorities concerning foreign products. Again, conditions may not be less favourable, nor may unnecessary obstacles to international trade be imposed (Art. 5.1.1 and 5.1.2 TVT). Art. 5.2 TBT requires i.a. expedition, information disclosure, confidentiality, non-creation of inconvenience and a complaints mechanism as procedural rules. Again, relevant international guides and recommendations need to be used except where they are inappropriate i.a. for public health reasons. Yet, the mentioned CAC instruments all precisely strive for public health protection. Otherwise, i.e. in case of non-application, the member state again needs to fulfil notification requirements. Further, Art. 6 TBT requests states to ensure that conformity assessment procedures in other member states are accepted. Art. 7 TBT reaches out to the non-central level. Finally, Art. 10-12 TBT lay down rules for information as well as technical assistance in the area of technical regulations and standards for developing countries. Countries need to establish enquiry points and provide copies of documents at an equitable price [sic!] and if possible in English, French or Spanish. Technical assistance upon request entails several forms of advise (Art. 11 TBT) as well as special and differential treatment of developing country members (Art. 12). Institutionally, Art. 13 TBT sets up a TBT Committee; procedurally, arising disputes are referred to the Dispute Settlement Body (DSB) under Art. 14 TBT. Further resource: WHO/WTO: WTO Agreements and Public Health – A Joint Study by the WTO and WHO Secretariat, 2002


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2. Human Rights Law (In Concrete Terms) Note:

• The human right to food provides a qualitative approach next to MDG 1 • Its application does not stop with buzzwords but detailed parameters influence the

legal food framework within a country and set benchmarks • International assistance is a covered requirement by the right to food • Special nutrition needs are addressed

a. The Right to Food: Basic Provisions While seeking to prevent micronutrient deficiencies as a public health issue, food fortification interventions are preventive, and not curative in nature. Consequently, the main human right applicable is the right to food. The legally non-binding UN General Assembly resolution 217 A (III) from10 December 1948 declared the UN Declaration on Human Rights (UNDHR), which contains a relevant provision in its Article 25 granting everyone the right to a standard of living adequate for the health and well-being, including food as well as entitling motherhood and childhood to special care and assistance. In legally binding terms, the International Covenant on Economic, Social, and Cultural Rights (ICESCR) provides in its Art. 11: “1. The States Parties to the present Covenant recognize the right of everyone to an adequate standard of living for himself and his family, including adequate food, clothing and housing, and to the continuous improvement of living conditions. The States Parties will take appropriate steps to ensure the realization of this right, recognizing to this effect the essential importance of international co-operation based on free consent. 2. The States Parties to the present Covenant, recognizing the fundamental right of everyone to be free from hunger, shall take, individually and through international co-operation, the measures, including specific programmes, which are needed: (a) To improve methods of production, conservation and distribution of food by making full use of technical and scientific knowledge, by disseminating knowledge of the principles of nutrition and by developing or reforming agrarian systems in such a way as to achieve the most efficient development and utilization of natural resources; (b) Taking into account the problems of both food-importing and food-exporting countries, to ensure an equitable distribution of world food supplies in relation to need.” Art. 2 ICESCR calls upon the progressive realization of economic, social, and cultural rights to the maximum of a state’s available resources and within international assistance and cooperation, especially technical and economical. Art. 23 ICESCR sets forth international action including the furnishing of technical assistance and the holding of regional meetings and technical meetings for the purpose of consultation and study organized in conjunction with the Governments concerned. Yet, while the right to foods governs the setting of minimum fortification levels to effectively tackle a public health problem, the right to health requires to set maximum fortification levels, in order not to reach adverse health effects in (parts of) the population. b. Application of the Right to Food (i) GC 12 (CESCR) Note:

• Micronutrient value is covered by food quality • Limited consumer choice may be justified on public health grounds, but requires legal

exceptions • Food fortification (mid-term intervention) should be complementary to other nutrition

interventions like short-term supplementation and long-term dietary diversification


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The UN Committee of Economic, Social, and Cultural Rights (CESCR) interprets i.a. authoritatively the ICESCR. General Comment (GC) 12 covers the right to adequate food (The right to adequate food (Art.11): 12/05/99.E/C.12/1999/5. (General Comments)). The right to food contains four key elements:

• Availability • Access • Adequacy • Quality

Specifically, food needs to be available in sufficient quality to satisfy dietary needs (8 and 9). Quality entails micronutrient nutrition values. The right to adequate food, like any other human right, imposes three types or levels of obligations on states: the obligations to respect, to protect and to fulfil (facilitate and provide). Food fortification restricts in case of its mandatory application individual’s choice and liberty being forced to consume fortified food. While this might pose an infringement on the obligation to respect, justification can usually found on overarching public health benefits combined with a limited intervention. This means in turn that an over-arching public health problem (micronutrient deficiencies) needs to be scientifically validated and that consumer awareness is so low that voluntary fortification alone would not lead to sufficient consumption of enriched foods. In any case, exceptions e.g. in case of allergies should be provided within the legal framework. In market economies, food fortification involves industries for programme implementation. Yet, the state provides a regulatory framework to facilitate its set-up. Careful legislation needs to balance the public health goal, consumer protection, and market interests. FAO points out that food fortification works best when covered by a complementary interaction with other approaches such as short-term supplementation and long-term dietary diversification. In this line, it is not the consumption of staple foods like cooking oil, flour, or sugar, that should be advocated but the sufficient intake of micronutrients in all forms with the long-term goal of dietary diversification. These considerations can also lead to carefully selecting candidate staple foods based on their natural nutritional value (see e.g. the FAO/WHO Expert Consultation on Diet, Nutrition, and Prevention of Chronic Disease). In cases of emergency, the state is required to directly provide foodstuffs. Attention should be likewise paid to the nutritional value. States should further develop a national policy strategy (notably 21) and framework legislation (29), as well as monitoring (31) on all elements of the right to food. Likewise, international cooperation is addressed (36). Further resources:

• FAO: Fortification of food with micronutrients and meeting dietary micronutrient requirements – Role and position of FAO (electronic resource)

• FAO/WHO: Expert Consultation on Diet, Nutrition, and Prevention of Chronic Disease, 2003 (electronic resource)

(ii) FAO Voluntary Guidelines on the Right to Food Note: Application of the right to food reaches down to the institutional and content-based national legal framework (obligation to facilitate). The FAO voluntary guidelines to support the progressive realization of the right to adequate food in the context of national food security contain concrete directions for implementing the right to food. Relevant guidelines in the context of food fortification are as follows:

• Guideline 2: Economic development policies • Guideline 3: Strategies (entailing multi-sectoral governance)


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• Guideline 4: Market systems (food industry CSR, trade law, and food production value chain)

• Guideline 5: Institutions (strengthening) • Guideline 6: Stakeholders • Guideline 7: Legal framework • Guideline 9: Food safety and consumer protection (food safety and food control

systems, CAC, WTO, technical assistance, multi-stakeholder approaches) • Guideline 10: Nutrition – 10.3: Micronutrient interventions (states may consider

adopting regulations for fortifying foods to prevent and cure micronutrient deficiencies, in particular of iodine, iron and Vitamin A)

• Guideline 11: Education and awareness raising These aspects are further detailed by the FAO guide on legislating on the right to food, and the according tool box. The legal framework basically requires states to consider within the legal hierarchy:

• Constitutional provisions • Framework law with key provisions • Emergency preparedness • Institutional arrangements, i.e. coordination • Monitoring and recourse • Financing • Sectoral legislative review (multi-sectoral nature of food law)

Further resources:

• FAO: How to legislate for the right to food (electronic resource) • FAO: Guide on Legislating for the Right to Food, Rome 2009 (electronic resource) • IBSA (Indicators, Benchmarks, Scoping and Assessment): Country-level Piloting of

Indicators for the Right to Food, Report, Berlin 2009 (electronic resource) c. Groups with Special Nutrition Needs Note: Special micro nutrition needs of children and (future) mothers are recognized within ICESCR and special treaty mechanisms. The 2002 UN Special GA Session on Children “A World Fit for Children” and its according resolution establish concrete parameters to reduce malnutrition. Food fortification within partnerships based upon nutrition policies and law are detailed. Children and (future) mothers have special nutrition needs in terms of micronutrients, as they require higher amounts of intakes. Support for groups with special needs and according non-discrimination is already contained in Art. 2 (2) ICESCR and further outlined within FAO Voluntary Guideline 13. Childhood micronutrient deficiencies are most severe, as individual development will be seriously harmed. Likewise (future) mothers require higher micronutrient intakes for their own and their child’s sake. The Convention on the Rights of the Child (CRC) recognizes – legally binding – in its Art. 24 that children have the right to enjoy the highest attainable standard of health. To this end, state parties are required to diminish infant and child mortality, to combat malnutrition i.a. through the provision of adequate nutritious food, to ensure appropriate pre- and post-natal health care for mothers, and to develop preventive health care. (Nutrition can in this case be covered through the right to health as this is widened so as to include preventive health care interventions.) Likewise, Art. 12 of the Convention on the Elimination of All Forms of Discrimination against Women re-quires state parties to take all appropriate measures to eliminate discrimination against women in the field of health care. State Parties also shall ensure to women appropriate services in


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connection with pregnancy, confinement and the post-natal period, granting free services where necessary, as well as adequate nutrition during pregnancy and lactation(see as well the according Committee General Recommendation No. 24 (20th session, 1999) (Article 12: Women and health), http://www.un.org/womenwatch/daw/cedaw/recommendations/recomm.htm#recom24). GC No. 7 (2005) “Implementing child rights in early childhood” by the Committee on the Rights of the Child contains further interpretation. The 27th UN Special GA Session on Children in 2002 brought about the adoption of Resolution S-27/2 named “A world fit for children”. Malnutrition is addressed in concrete terms: As part of the care for every child recognizing nutrition essential for human development (7.4) and by stating officially that more than 10 million children die every year although most deaths could be prevented and that 150 million children suffer from malnutrition (12 and 35). Partnerships are encouraged addressing especially the private sector and corporate entities as well as regional and international organizations (32.6 and 9). The promotion of healthy lives takes nutrition directly into account to break the intergenerational cycle of malnutrition and poor health by reducing malnutrition at least one third (36.d). In order to intensify proven, cost-effective actions against diseases and malnutrition (37.11) the sustainable elimination of micronutrient deficiencies is called upon towards their reduction through dietary diversification, food fortification and supplementation (37.22) This includes the development of legislation policies and programmes (37.25). The right to food is included as well (44.5). The private sector is urged to assess the impact of its policies and practices on children and to make the benefits of research and development in i.a. food fortification available to children (57). d. A Side Note on Food Industries Involved Note: Working with particular food industries on food fortification targeting deficient population groups means to strengthen a CSR/BoP approach and can involve further questions on sustainability policies. Especially in developing countries, such information on particular businesses is scarce. Initial questionnaires form an option, as do general networks that can support industry efforts in this direction. As described above, food fortification often entails a CSR or inclusive business/BoP aspect for corporations. This automatically and indirectly links to other parts of sustainability aspects. Working with particular business enterprises, especially in case of voluntary, i.e. industry-led, fortification, offers chances to assess, promote, and support sustainability programmes. This also offers an interface to social and ecological standards as applied by businesses. Additionally, the application of the human right to food interacts with food industry conduct. In order to assess or support a certain food industry especially in developing countries information is needed but scarce. Questionnaires provide a means for scoping and a basis for cooperation. Sources for further information and methods of support can be found at:

• UN Global Compact (GC) is an initiative for voluntary application of 10 human rights, labour, environment, and anti-corruption principles and forms a global business network between small-, medium-, and large-scale enterprises, http://www.unglobalcompact.org/

• ISO 26000 project establishing a social responsibility standard, http://isotc.iso.org/livelink/livelink/fetch/2000/2122/830949/3934883/3935096/home.html?nodeid=4451259&vernum=0

• Reports of the Special Representative of the Secretary-General on human rights and transnational corporations and other business enterprises, http://www2.ohchr.org/english/issues/trans_corporations/reports.htm


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• Amnesty international on business and human rights, http://www.amnesty.org/en/business-and-human-rights

• FIAN, the main NGO on the right to food, www.fian.org • The Business and Human Rights Resource Centre tracks business impacts of over

4000 companies worldwide, http://www.business-humanrights.org/Home Further Resources:

• Marsella-Sende, Analía: The Responsibility of States for Actions of Transnational Corporations Affecting Social and Economic Rights: A Comparative Analysis of the Duty to Protect, The Columbia Journal of European Law Online, Vol. 15 (2009), 34-39 (electronic resource)

• New York University Law Students for Human Rights: Transitional Corporations and the Right to Food (electronic resource)

• World Economic Forum: The Next Billions: Business Strategies to Enhance Food Value Chains and Empower the Poor – Executice Summary, January 2009 (electronic resource)

• World Economic Forum: The Next Billions: Business Strategies to Enhance Food Value Chains and Empower the Poor, January 2009 (electronic resource)

D. Regional Legal Frameworks Note: A country-based assessment should include the analysis of existing relevant regional laws and/or the possible benefits of introducing e.g. regional standards based upon similar consumption and deficiency patterns, trade facilitation, and/or consumer safety. Regional organizations provide a further means for effective food fortification standardization. Micronurient deficiency patterns are often similar, trade can be facilitated, and a common public health goal pursued. Sometimes harmonization is not practical otherwise as is the case in the Caribbean scattered into many small islands. The Caribbean Community (CARICOM) Standard Specification on Wheat Flour from 1991 finds an answer to this problem as does the Commonwealth Regional Health Community in East, Central, and Southern Africa (ECSA, http://www.crhcs.or.tz/rffn/). Likewise EU regulations can be understood within a regional safety-based and less nutritional need based approach: Regulation (EC) No. 1924/2006 of 20 December 2006 on nutrition health claims made on food, Regulation (EC) No. 1925/2006 of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, and Regulation (EC) 108/2008 amending the latter regulation. Sometimes, regional agreements may not be found on governance aspects but rather for interlinked stakeholders like research institute. This is the case e.g. with the Kazakh Academy of Nutrition (http://www.kan-kaz.org/english/index.php) which, though not indicated by the name, scientifically founds nutrition policies for Central Asia supported by a network partnering with WHO, UNICEF, ADB, and USAID. Further resource: Ottaway, Peter Berry (ed.): Food fortification and supplementation – Technological, safety and regulatory aspects, Cambridge 2008 (Chapter 13 on EU law; printed version available)


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E. National Legal Frameworks To do:

• Look up details on the existing country-specific legal framework relevant to food fortification in the three tables providing a comparative overview

• National legal frameworks depend on the individual legal culture; international and regional influences as well as comparative analysis can only pinpoint the functions that need to be fulfilled by country-specific legislation on food fortification

• These functions need to be integrated into the national legal hierarchy: o Research and analyse the existing legal frameworks o Find out where to introduce norms on food fortification

• Find out how to introduce food fortification norms (including institutionalization) • Development of industrial standard

I. Functional Approach National legal frameworks can and in the case of hard law requirements must adopt the provisions laid down above, which cover all aspects of food fortification. While it is possible to determine these functions that food fortification laws need to fulfil, it is virtually impossible to provide model drafts on legislation as these will depend on the legal settings of individual countries and food fortification standards need to be integrated into the national legal framework on food. Attempts to do so usually depart from specific legal cultures or specific national regulations (the MI manual is a useful illustration of the common law context providing additional technical background information). Yet, it is possible to provide for comparative analysis and to give an overview on existing food fortification laws. The attached tables provide three regional overviews on country-specific legislation focusing on developing countries. Additionally, a good research tool on food law worldwide is FAOLEX: http://faolex.fao.org/faolex/. II. Legal Framework 1. Legal Hierarchy Food fortification is very rarely determined through a law as a parliamentary act as such. Food fortification is rather based upon administrative decisions and technical standards, which in turn are covered by general food laws. This combination allows for flexible and efficient administrative setting of fortification details while the general provisions ensure safety and quality. The legal hierarchy can be displayed as follows: (1) Constitution (Fundamental Principles and Rights, Institutions) (2) Legislative Acts or Laws (General Provisions) (3) Administrative Acts (Details – if not exceptionally already contained in (2)) Usually, each level needs to be authorized and follow the superior level. These levels in the context of food law can be developed through the FAO legislative tools discussed above. 2. Relevant Areas of Law The following areas of national law usually need to be considered when introducing food fortification programmes – the functions described can be traced back to the international influences explained above: a. Food and Consumer Protection Law Special law governing food and nutrition prevails in many countries. Yet, nutrition is sometimes covered rather by health or agriculture law. Regulation departs from two purposes: to ensure food safety and consumer protection (food safety approach), and at the same time to address nutritional needs (nutritional need approach). Food fortification is targeted at solving a macro-economically relevant public health problem of poor and poorest population groups (nutritional need) or at providing enhanced food products for other


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population groups (luxury fortification, which is not mainly addressed here but generally follows similar proceedings). At the same time, nutritional over-consumption needs to be avoided for population groups with sufficient average intake, safe food processing needs to be ensured, and marketing strategies may not be misleading. In particular

• Constitution: Basic acknowledgment of the right to food providing the ground for framework legislation; institutionalization

• Framework legislation: o Basic definitions if appropriate and adequate to the legal culture o Nutrition policies and planning o Coordination of nutrition interventions (e.g. supplementation and food

fortification) and e.g. determination of reference daily intakes o Fortification requirements, see CAC section o Exemptions for persons with medical contraindications, see section on the

right to food o Emergency food supply, see section on the right to food o Import control to create a legal level playing field, see WTO section o Warranties o Institutional framework and authorization o Enforcement provisions (civil, criminal, and/or administrative enforcement

depending on the legal system ranging from control investigations, to fees and imprisonment in case of non-compliance)

• Part on food and drug control: o License and legislation requirements o Labelling and claims, see CAC section o Quality assurance and control of fortification levels, shelf-life, and packaging

• Administrative acts: o Administrative decrees, e.g. rendering technical standards mandatory, based

upon authorization o Individual implementation of the legal framework based on authorization

granted by the law c. Health Law Health law from a nutrition perspective focuses on nutritional needs and the protection from adverse effects. Sometimes nutritional framework legislation is contained within the health law system and the subsequent administrative outline. d. Agriculture Law Food industry provisions are sometimes specifically ruled on by agricultural law focusing on basic food production and farming conditions. Especially the legal framework for food production associations might be contained within the agricultural law. e. Industry and Trade Law Industry and trade law may contain import, registration or labelling provisions if not contained within a general food law framework. WTO notification procedures are usually regulated through this area of law, as are e.g. provisions on CSR activities. The work of standard bodies is normally recognized within this framework. f. Local Laws Local laws might be important in two cases:

• If malnutrition prevails endemically or if trials or pilots need to be carried out, local food fortification regulations might be relevant.

• In decentralized states enforcement power often rests with the local administration and not central entities.


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g. Other Relevant Law General compliance with the body of law is required. E.g. in case of specific research studies on micronutrient deficiencies attention must be paid to criminal law requiring basic consent by all individuals involved as laid down by the national legal provisions. 3. Development of Law Policies Legal aspects of food fortification interrelate and partly determine other parts of national food fortification programmes. E.g. marketing campaigns interrelate with possible label requirements. To introduce such programmes as a whole and likewise create a background for legal regulation, food fortification policies are needed. Strategic planning in food fortification should start with an institutional mapping of stakeholders. This will allow to set roles and responsibilities as well as steps to be taken including the introduction of legal norms according to the national requirements. Stakeholder mapping in food fortification is usually multi-level: (1) International level (2) Regional level (3) Bilateral level (4) National level (5) Local level And multi-sectoral: (1) Public sector (addressing a public health problem) (2) Private sector (selling fortificants and/or fortified foods) (3) Social sector (addressing a social problem) (4) Academia (delivering necessary research). A matrix can display individual and common benefits. International organizations concerned with food fortification are e.g. WHO (http://www.who.int/nutrition/en/), FAO (http://www.fao.org/ag/agn/index_en.stm), UNICEF (http://www.unicef.org/nutrition/), WFP (http://www.wfp.org/nutrition), and WB (http://wwwr.worldbank.org/nutrition). Non-governmental organizations promoting food fortification from the international side are e.g. GAIN (http://www.gainhealth.org/), HKI (http://www.hki.org/), MI (http://www.micronutrient.org/), and FFI (http://www.sph.emory.edu/wheatflour/index.php). National public bodies concerned with food fortification are usually according ministries (on food, health, or agriculture e.g.) and the national food and drug authority. Social sector NGOs advocating food fortification or consumer protection can often be likewise found. The multi-sectoral process itself can be institutionalized ranging from political (e.g. informal meetings) to semi-legal (e.g. round tables) to legal (e.g. committees) means. Higher institutionalization usually reflects increased commitment and grants a more long-lasting or sustainable approach towards food fortification. To reach a higher degree of institutionalization also means to create a leading body. This makes it more likely that food fortification is regulated and brings about results in public health terms. Such bodies and/or members can also assist in very practical terms in legal drafting and/or commenting as well as discussion. Different sets of nutrition policies – also in relation to legal aspects – are analysed by the World Bank HNP discussion. Interestingly, it contains a case analysis of the Kenyan fortification programme as an example of a multi-sectoral rapid results approach in nutrition (pages 22 to 25). 4. Technical Standardization All types of voluntary and/or mandatory food fortification, technical standards are needed for industry production – and likewise form the technical base for food fortification legislation creating a level playing field. The worldwide landscape of standard bodies is diverse including purely industry led bodies, bodies integrated into the governance structure, or co-


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existence of parallel bodies. Likewise, standards can be based on industry self-regulation, co-regulation, or government regulation. In any case, technical standards require industry involvement to some degree for scientific and technical expertise. ISO, itself an international NGO, provides a good overview on existing worldwide standard bodies through its website listing: http://www.iso.org/iso/about/iso_members.htm#at. As a result, technical standards on food fortification can be integrated or stand apart from the general legal framework governing food fortification. In case of industry self-regulation a mandatory fortification programmes requires a nexus in as far that the industrial standard needs at least to be rendered compulsory. As discussed in the WTO section, the ISO/IEC Guidelines explain general industry standard drafting. The WHO/FAO Guidelines on food fortification provide in-depth analysis with a scientific-technical background on how to develop food fortification programmes. Reference is paid to the evaluation of a programme’s public health significance, as well as fortificant physical characteristics, selection, and use with specific food vehicles. This includes sections on communication and social marketing strategies as well as monitoring and evaluation. Chapter 11 on national food law includes details on technical standard setting interacting with other parts of the Guidelines providing the scientific background for determining technical food fortification issues. In simplest terms, the technical regulation of fortified food composition will take the following form: “[Nominated food] must [contain]: (i) no less that [x] mg/kg of [micronutrient name], and, where appropriates (ii) no more than [y] mg/kg of [micronutrient name].” So far, no international technical model standard on food fortification as such exists (but naturally certain staple foods are standardized through CAC or ISO) – which in part is due to the fact that the determination of minimum and maximum levels depends on the scientific analysis of micronutrient deficiencies prevailing in a country. Yet, efforts in this direction are being undertaken. The so-called Atlanta recommendations provide a consensus statement from WHO, FAO, UNICEF, GAIN, MI and FFI to suggest micronutrient levels for flour fortification. CAC instruments as described above furthermore influence industry standard development heavily. Next to purely technical standards, other aspects of production like labelling or monitoring can be incorporated into relevant standards but also regulated through administrative acts. The CAC section above deals with according requirements. Additionally, regional standardization can substitute national one as mentioned. Technical assistance in the field of standard development is regulated by the TBT, see WTO section. Further resources:

• Allen, Lidsay/De Benoist, Bruno/Dary, Omar/Hurrell, Richard: WHO/FAO Guidelines on food fortification with micronutrients, 2006 (electronic resource, second edition in preparation)

• Nathan, Rose: Regulation of Fortified Foods to Address Micronutrient Malnutrition: Legislation, Regulations, and Enforcement, MI 1995 (printed version)

• Natalicchio, Marcela/Garrett, James/Mulder-Sibanda, Menno/Ndegwa, Steve/Voorbraak, Doris (eds.): Carrots and Sticks: The Political Economy of Nutrition Policy Reforms, HNP Discussion Papers, HNP Discussion Papers (World Bank), February 2009 (electronic resource)

• WHO: Recommendations on Wheat and Maize Flour Fortification Meeting Report: Interim Consensus Statement (Atlanta recommendations), 2009 (electronic resource)

gtz/safo standard setting tool

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