The harmonization of food legislation helps ensure food safety with widely accepted standards established using a recognized global process that protects consumers’ rights and facilitates the movement of foods between countries, without arbitrary legal constraints or unjustifiable inequities.¹

The harmonization of laws and regulations for food products is considered to be highly desirable, and the need has been recognized since the early 1900s.²Several international organizations are actively working on this goal, but the degree of harmonization still varies in different international jurisdictions.³

The main milestones in global standardization and harmonization of food legislation are shown in Table 1.^1,2,4,5

Policy Differences and Degree of Harmonization

The degree of harmonization varies widely, depending on the regional/national legislative policies in different jurisdictions. In Southeast Asia, significant differences are found in nutrition labeling and food claims among the countries, and harmonization does not seem to be important at this time.⁶ In the U.S., the Nutrition Labeling and Education Act of 1990 established the first legal requirements for food labeling. Revisions were adopted in April 2008, October 2009, and January 2013.⁴

In the Europe Union, Regulation No. 1169/2011 on the provision of food information to consumers became effective in December 2014 and declared to be mandatory in all Member States after December 2016. Also, since May 2015, the labeling of origin country or place of provenance became mandatory for milk, milk used as an ingredient in dairy products, and certain types of meat other than beef, swine, sheep, goat, and poultry.⁷

In the current context of major differences between nutrition legislation in different jurisdictions, I propose the use of an estimation of similitudes (k is the ratio of similitude) and gap indices (g is the absolute inconsistency value) as objective harmonization indicators. These are used to measure the similarities and differences among current global standards for nutrients, energy daily reference value (DRV), and reference daily intake (RDI).⁸

The following is proposed: A similitude factor (k) that can be calculated using equation 1:

k = L STAN 1/L STAN 2

where the k is ratio of similitude, L STAN 1 is the absolute value of DRV, and L STAN 2 represents the DRV for a second standard, with an L STAN 1 value less than or equal to L STAN 2.⁹

This equation measures the degree to which two existing standards from two different jurisdictions are harmonized.

A k value of 1 represents totally harmonized criteria/standards, whereas values between 0 and 1 depend on the degree of similitude between two compared standards.

A second proposed indicator is the gap index g, which is calculated using equation 2:

g = |L STAN 1 – L STAN 2|

where g is the absolute inconsistency value and L STAN 1 and L STAN 2 represent the DRV required within standards 1 and 2, respectively.

The g value tends to 0 (g→0) for totally harmonized criteria/standards.⁹

 Depending on the current degree of harmonization (dependent on the k value), specific recommendations are proposed (Table 2 ¹⁰) to progressively improve the current harmonization level over a 4-year cycle agreed upon by specific jurisdictions, if the declaration of intent to follow the harmonization pathway is signed and adopted.

Also, the new paradigm in the harmonization of global nutrition legislation needs to respond to the huge expectation regarding equity in food quality assessment and international trade. Consumers have the difficult task of choosing suitable nutritional foods without a simple, comprehensive tool that provides consistent nutritional information.

A Demand for Quality and Equity in Food

An honest scientific assessment, using global harmonized nutritional quality indicators and global reference food standards, needs to be developed to solve this issue.

In international food trade, coherent food standards are crucial for comparing and assessing food nutritional quality using a widely adopted nutritional standard of reference for each food and beverage group.⁸

Nutrition labeling needs to serve the final consumer in terms of their daily food selection, enabling healthier choices for their particular age, gender, health status, preferences, eating habits, etc. In particular, front-of-pack (FOP) labeling must support the global food industry by providing clear information on food formulations using suitable food production systems.

The European Commission request SANTE/E1/AVS/ko (2020) 8242215, which was addressed to the European Food Safety Authority (EFSA) regarding its “farm to fork” strategy, asked that reference nutrients and labeling tools be provided by EU food producers to support public health, energy, and nutritional food profiling, as well as to assist the EU population in choosing foods with healthy nutrient profiles as a mandate.¹¹

 Several issues must be considered prior to implementing a mandate for harmonized FOP nutrition labeling:

• Harmonized mandatory food labeling statements of food name, list of ingredients, additive and allergen declarations, the nature (natural: vegetal, animal; other/synthetic: chemical, genetically modified, cultured from stem cells, plant based) and origin (main ingredients and geographical origin) of the nutrients, and food safety and quality declarations (mandatory format for declaration of the packaging/manufacturing/delivery date marks, quality and safety shelf life)
• Harmonized food labeling systems for nutrient-profile analysis, scoring algorithm, and a scoring scale for foods and beverages
• Harmonized mandatory food labeling content (mandatory energy and nutrient profile declarations per 100 g, per portion size, and percentage of the DRV and RDI, mandatory nutrition component declarations: energy, fats, saturated fats, carbohydrates, sugar, proteins, fibers, salt) and format (mandatory tabular design for adequate readability)
• Harmonized mandatory science-based food nutrition grading/scoring systems (harmonized algorithm for energy and nutritional scoring scale/grading indicator per portion size reported as the DRV and RDI and nutrient bioavailability, considering the product’s nature and origin, nutritional QR code, cautionary labels, etc.) to support healthier consumer choices
• Harmonized food labeling with logos and images (number, format, type, color, position on the label, etc.) for food nutritional scoring/grading tools, identity and authenticity food images, nutrition and health claims, origin, number of servings, conditions of standard preparation, packaging recycling, etc., with significant and science-based healthy value declaration (dietary sugars, salt, trans/saturated or replaced fats, shortening, ingredients origin, etc.)
• Harmonized mandatory FOP energy and nutritional labeling standards, specific guidelines and procedures for promoting EU healthy nutrition, addressing regular and special dietary needs, diet-related diseases, considering mandatory nutrition labeling declarations, rules about health and nutrition claims, DRV and RDI, quantitative ingredient declarations, additive declarations, fair food scoring/grading tools, and origin and quality logos

EFSA Aims to Walk a Politically Sensitive Line

After March 2022, when EFSA will accomplish its mandated “Request to the European Food Safety Authority for scientific advice on the development of harmonized mandatory front-of-pack nutrition labelling and the setting of nutrient profiles for restricting nutrition and health claims on foods,” the European Commission will introduce a legislative proposal on this “politically sensitive" subject in line with the "European Green Deal" (2019) and farm-to-fork strategy. The aim of farm to fork for the fourth quarter of 2022 is "to restrict the promotion of food high in salt, sugars, and/or fat." The World Health Organization has recommended the implementation of FOP labeling, and other stakeholders support the introduction of a harmonized mandatory EU FOP scheme. The Global Harmonization Initiative Nutrition Working Group is working on harmonized FOP labeling as a flag project and will soon publish an official opinion on this important topic to be solved at the EU level.

Further, a descriptive harmonization checklist for food nutrition and health claims, including six mandatory declarations that give food producers legal responsibilities, needs to be implemented, as follows:

• Declaration 1: Clear list of nutrients/substances related to the health claim
• Declaration 2: Absolute content per serving and commercial unit
• Declaration 3: Comparative content of claim basis for nutrients/substances up to an efficacious dose for the claimed effect (up to 15% of DRV for “source of” or up to 30% for “high in” claim)
• Declaration 4: Statement of quality grade created with scientifically proven data about the direct cause-and-effect relationship for the demonstrated impact of the claimed (beneficial) effect
• Declaration 5: Statement of recommended daily servings (quantity standard) and patterns of consumption for the claimed effect in a variety of diets and for a healthy lifestyle
• Declaration 6: Statement of health risks caused by excessive consumption (up to recommended daily intake)⁹

The total harmonization of global nutrition legislation is the ultimate goal, with the following considerations:

• DRV/RDI for nutrients and energy
• Labeling: Nutrition and health claims
• Nutrition standards for foodservice establishments
• Nutrition advertising, nutrition scoring systems, etc.
• Scientific research methodology for supporting nutrition and health claims (biomarkers of intake, outcomes indicators, standards for intake recommendations)
• Standards for education and training programs⁵

Food safety will be strongly improved by adopting objective scientific assessment systems at the national/regional/continental/global levels with the goal of nutrition legislation harmonization because the final consumer will be reassured about food quality, and international trade will be transparent, unrestricted, well-known, and globally accepted.

Harmonization requires a strong will, both politically and scientifically, as well as deep knowledge about legislation similarities and differences, to make the effort to reach consensus based on sound scientific evidence.⁹

Conclusions

In conclusion, harmonization is key for deep and durable progress for the benefit of consumers, the food industry, market traders, and all involved stakeholders.

The science-based analysis of globally harmonized legislation needs to pivot from current descriptive policy gaps or limitations toward an objective scientific assessment of harmonization level using objective harmonization indicators.¹⁰

In perspective, harmonization is the ideal future solution and practical tool for improving the quality of food nutrition and fair international trade that avoids inequities due to inconsistencies in international law and noncompliance with regulations, policies, standards, or internal guidelines, procedures, and codes of practices.

In the case of union states, like the EU, and U.S., all states need to comply with the federal mandatory requirements regarding food labeling, for example. Voluntary declarations could be admitted in addition to the mandatory ones. Objective indicators for levels of compliance must be adopted by all jurisdictions to improve the accomplishments of the mandatory food nutrition regulations. Also, federal regulations must emerge from the requirements of food producers and retail associations but without changing the core principles of the mandatory legal declarations.

The food labeling legislation in use is mandatory for all producers and retailers when they produce for or trade with a specific jurisdiction. Regulators consult all the stakeholders until they release the law, but then every single actor in the food industry must comply with the law.

In all situations, an honest, legal compliance assessment, based on clear and transparent guidelines, needs to be implemented at the global level because the consumer must judge the quality. The consumer knows very well to appreciate the balance between quality and price, select the best foods for their needs, and protest unfair nutrition labeling (no declarations, incomplete or misleading declarations of country/place of origin, nature, composition, DRV for nutrients and energy, etc.).

References

1. www.globalharmonization.net/sites/default/files/pdf/articles/2001_FoodControl_Motarjemi_etal.pdf.
2. www.fao.org/3/y8705e/y8705e.pdf.
3. www.globalharmonization.net/sites/default/files/presentations/2017_Why-harmonize-food-regulations-and-what-is-needed-to-make-it-work.pdf.
4. www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm.
5. Vintilă, I., et al. 2019. “Current Legislation in Nutrition and Issues Requiring Global Harmonisation,” Qual Assur Safety Crops Foods 11(7): 593–601.
6. Tee, E.-S., et al. 2002. “Current Status of Nutrition Labelling and Claims in the South-East Asian Region: Are We in Harmony?” Asia Pac J Clin Nutr 11(2): S80–S86.
7. https://ec.europa.eu/food/safety/labelling_nutrition/labelling_legislation_en.
8. Vintilă, I. 2021. “Global Food Nutrition Regulations – New Approach in Nutritional Standards Harmonisation Process.” EC Nutr 16(4): 48–49.
9. Vintilă, I. 2019. “Global Issues in Harmonization of Nutrition Legislation.” 1st GHI World Congress on Food Safety and Security (Leiden, Netherlands).
10. www.researchgate.net/publication/344499128_BUSINESS_MANAGEMENT_INSIGHTS_AND_SOCIETY_TRANSFORMATION_PROCESS.
11. www.efsa.europa.eu/en/news/efsas-scientific-advice-inform-harmonised-front-pack-labelling-and-restriction.

Iuliana Vintilă, Ph.D., is an associate professor in the Food Science, Food Engineering, Applied Biotechnology, and Aquaculture Department at the Universitatea Dunarea de Jos Galati in Romania.