China CDC Weekly

Perspectives

Risk Assessment of Food Allergens

Hongbing Chen1,2; Yongning Wu3,#

GLOBAL STRATEGIES FOR RISK choices in daily life. Therefore, the labeling of
allergenic foods and food ingredients on pre-packaged
ASSESSMENT OF FOOD ALLERGENS foods can play a critical role in protecting food-allergic
individuals. Based on the recommendations of an
Held on the 8th of July every year, World Allergy expert consultation convened by WHO and the Food
Day is a global joint initiative launched by the World and Agriculture Organization of the United Nations
Health Organization (WHO) and the World Allergy (FAO), the labeling of the eight most common
Organization (WAO) as well as other national allergy allergenic foods (commonly known as the “Big Eight”)
agencies, which aims to raise the general public was incorporated into the Codex General Standard for
awareness of the importance of managing and the Labeling of Packaged Foods (GSLPF) in 1999 (2).
preventing allergic diseases. Food allergies are a major Subsequently, member countries of the Codex
source of exposure to allergens and a significant public Alimentarius Commission developed their own
health problem globally with increasing prevalence (1). national lists for labeling of allergens in pre-packaged
Importantly, there is currently no effective cure for food based on the Codex list and on evidence of
food allergies and the only strategy for preventing food allergenicity of other foods and food ingredients
allergic reactions is to practice a strict avoidance diet. (Figure 1).
Notably, implementation and adherence to a diet that Since the original drafting of the GSLPF, scientific
is free of allergenic foods is challenging because a understanding of food allergens and their management
consumer may be allergic to more than one food or have evolved. In response, Codex requested the
food ingredient and must face a wide variety of food WHO/FAO to provide updated advice, and a series of

Allergen Exceptions
· Refined, bleached, and deodorized oils
· Cultures and enzymes produced by
fermentation process
· Wheat derived glucose, glucose syrup,
dextrose, dextrose monohydrate,
maltodextrin, and sugar alcohols.

FIGURE 1. The eight most common food allergens (i.e., “Big Eight” or “Big 8”) in the Codex with evidence-based process to
mandate labeling of ingredients.

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meetings of the Joint FAO/WHO Expert Consultation • specific tree nuts (hazelnut, walnut, pecan, cashew,
on Risk Assessment of Food Allergens were held during pistachio, and almond).
2020 and 2022 (2). It is worth noting that soybeans have been excluded
The establishment of priority allergenic foods from the list of global priority allergens, which has
recommended by the Expert Consultation was based been replaced by sesame as a new member among the
on three criteria: 1) prevalence (e.g., the proportion of “Big Eight”. In addition, some potential allergens, such
a defined population known to have experienced an as buckwheat, mustard, soybean, lupin, Brazil nut, oat,
immune-mediated adverse reaction to the specific molluscan shellfish, and others may still be considered
food); 2) potency (e.g., the amount of the total for inclusion in priority allergen lists in individual
proteins from the food/ingredient required to cause countries or regions (Figure 2).
objective symptoms in a specified proportion of the
population allergic to that specific food); and 3) PRACTICAL ACTIONS FOR RISK
severity (e.g., frequency or proportion of severe
objective reactions to a food/ingredient, such as ASSESSMENT OF FOOD
anaphylaxis). After a systematic and thorough ALLERGENS IN CHINA
assessment based on these three criteria, the Expert
Consultation recommended the following allergenic China has gradually established a research
foods should be listed as priority allergens in the framework for risk assessment of food allergens.
GSLPF: Research efforts have included work on the three key
• cereals containing gluten criteria of food allergy needed to implement a risk
• crustacean shellfish assessment framework — namely, prevalence, potency,
• eggs and severity. Regarding food allergy epidemiology,
• fish more than 60 articles on the prevalence of food allergy
• milk in China have been published since 1996. These
• peanuts epidemiological studies were geographically
• sesame distributed, including Beijing, Shanghai, Hangzhou,

FIGURE 2. The list of global priority allergens by ad hoc Joint FAO/WHO expert consultation on risk assessment of food
allergens: sesame has replaced soybeans as a new member among “Big Eight”.
Abbreviation: FAO=Food and Agricultural Organization of the United Nations; WHO=World Health Organization;
WAO=World Allergy Organization; JECFA=FAO/WHO Joint Expert Committee on Food Additives.

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 China CDC Weekly

Guangzhou, Shenzhen, Wenzhou, Chongqing, and upon the actual situation of the Chinese population is
other cities. Interestingly, research on the prevalence of not currently available. Accordingly, the relevant
celiac autoimmunity disease (0.36%; 95% Cl: provisions on allergenic food labeling in China’s
0.28%–0.46%) was first reported in the general General Rules for the Labeling of Pre-Packaged Foods
Chinese youth population (3). This was followed by a (GB 7718) were basically the same as the
report on the prevalence of celiac disease (0.35%; 95% corresponding Codex provisions.
Cl: 0.11%–0.59%) in Xinjiang Uyghur Autonomous
Region (4). To evaluate the allergenic potency of FUTURE STRATEGIES FOR RISK
specific allergenic foods among the Chinese
population, oral food challenge testing (OFC) is
ASSESSMENT OF FOOD
essential. Thankfully, ten tertiary grade A hospitals ALLERGENS IN CHINA
have established a base for conducting OFC in China.
Peking Union Medical College Hospital was the first Risk assessment techniques provide a scientific basis
to release a ranking of the causes of food-related for governments to make scientifically sound
anaphylaxis among Chinese people and validated that regulatory decisions, for companies to set appropriate
there were significant regional differences in the causes safety standards, and for populations to make safe
of anaphylaxis (5). This clinical research will also help consumption choices. Regarding risk assessment of
to fill a void of information on the severity of food food allergens, regulators need to consider the current
allergy in China (5). Furthermore, the Chinese quality assurance practices of food companies and
government has financed special projects, including the balance those practices against the desired level of
National Key Basic Research Program (“973” protection of allergic populations. Companies are
Program), the National High Technology Research concerned with the products they produce in light of
and Development Program (“863” Program) and the “farm-to-table” safety assurance and the need to
National Science and Technology Supporting Program prevent/minimize cross and carry-over contamination
to support scientific research on the risk assessment of of allergens during the transportation of raw materials,
food allergens, leading to the formulation of more than product processing, and packaging and to assess the
20 national standards. Meanwhile, many national and risk of their products according to safety limits.
international conferences on food allergy were held in Ultimately, food allergy risk assessment is about
China during the past 5 years, which strengthened safeguarding food safety for consumers.
multidisciplinary collaboration, innovation and The future scientific development of food allergen
academic exchange in food science, basic immunology, risk assessment in China must address several different
clinical medicine, public health nutrition and aspects of the current situation. The first step is to
sociology. carry out a nationwide epidemiological survey on the
Although China has carried out some relevant prevalence and incidence of food allergy to understand
research on risk assessment of allergenic foods, certain the existing level of risk faced by food-allergic Chinese
limitations still remain. Most studies on the prevalence consumers. This survey should lead to knowledge of
of food allergy were restricted to specific regions, and the most common allergenic foods in China and a
high-quality data on prevalence were limited, in part, realistic gauge of the severity of food allergic reactions
due to the lack of a uniform diagnostic protocol based that happen within China. The survey should focus on
on OFC using well-defined food challenge materials. the risk factors for food-allergic reactions within the
The determination of the threshold doses for specific Chinese population and determine which of those
allergenic foods among Chinese food-allergic factors can be better controlled with improved and
individuals has not been conducted and presents targeted interventions.
clinical challenges in China. Furthermore, allergen risk Moreover, based on the best practice for food allergy
assessment also requires detailed information on eating diagnosis, a double-blind placebo-controlled food
patterns of Chinese consumers and sub-groups of those challenge trial in multi-center hospitals should be
consumers. There are no specific dietary surveys based conducted to establish individual and population
on consumers with food allergy in China even though thresholds, and further quantitative risk assessment
total diet databases were established for dietary should be carried out based on the thresholds of the
exposure assessment purposes. Under the major allergens. The monitoring of individual clinical
circumstances, a list of priority allergenic foods based symptoms should be strengthened and the severity of

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 China CDC Weekly

allergic reactions at various doses used in the clinical Beijing, China.

challenges could be recorded. That clinical data can Submitted: July 08, 2022; Accepted: August 15, 2022
then be compared to the symptoms reported by food-
allergic consumers to better assess the nature of the
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Hongbing Chen, PhD

Professor of Food Science
Deputy Director of the State Key Laboratory of Food Science and Technology, Nanchang
University, Nanchang，Jiangxi, China
President of the Sino-German Joint Research Institute, Nanchang, Jiangxi, China
Member of FAO/WHO Expert Consultation on Risk Assessment of Food Allergens

Yongning Wu, MD, PhD

Chief Scientist, China National Center for Food Safety Risk Assessment
Director of NHC Key Laboratory of Food Safety Risk Assessment
Director of Chinese Academy of Medical Science Research Unit (2019RU014)
Member of WHO Technical Advisory Group of Food Safety
Roster of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

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