Global Regulatory Landscape for Bovine Colostrum: A Comparative Review of United States, European Union, and China

Bovine colostrum occupies a unique position at the intersection of food, dietary supplement, and functional ingredient regulatory frameworks. The classification and compliance requirements for colostrum products differ substantially across major markets, creating challenges for manufacturers seeking global distribution. This article provides a systematic comparison of the regulatory landscapes in the United States, European Union, and China, examining classification criteria, safety requirements, allergen obligations, health claim substantiation, and practical compliance considerations for B2B stakeholders.

1. Introduction

The global market for bovine colostrum has expanded significantly over the past two decades, driven by growing consumer awareness of immune health and the functional properties of colostrum-derived ingredients. As an ingredient that straddles the boundaries between food, dietary supplement, and functional food categories, bovine colostrum encounters different regulatory treatments depending on the jurisdiction, intended use, and product formulation [1]. Understanding these regulatory distinctions is essential for manufacturers, exporters, and brand owners who operate across multiple markets.

In the United States, bovine colostrum is typically regulated as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) of 1994, provided it is not represented as a conventional food or sole item of a meal or diet [2]. The European Union presents a more complex regulatory picture, where the classification depends on whether the product qualifies as a novel food under Regulation (EU) 2015/2283 [3]. In China, bovine colostrum is subject to a regulatory framework centered on industry and group standards, with particular restrictions regarding infant food applications and health food claims [5].

This review examines the regulatory frameworks governing bovine colostrum in these three major markets, comparing classification criteria, safety assessment requirements, allergen labeling obligations, allowable health claims, and practical compliance considerations. The analysis draws on official regulatory documents and industry guidance to provide an evidence-based overview for stakeholders in the colostrum supply chain.

2. United States: Dietary Supplement and Food Ingredient Frameworks

2.1 Regulatory Classification Under DSHEA

In the United States, bovine colostrum is most commonly classified as a dietary supplement when it is intended to supplement the diet and is labeled accordingly [2]. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines dietary supplements as products intended to supplement the diet that contain one or more dietary ingredients, including vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites [2]. Bovine colostrum falls within this definition as a natural substance derived from animal tissue.

The regulatory pathway for bovine colostrum dietary supplements is relatively streamlined compared to pharmaceutical or food additive approval processes. Under DSHEA, dietary ingredients marketed in the United States prior to October 15, 1994, are classified as Old Dietary Ingredients (ODIs) and do not require pre-market notification to the FDA [2]. Ingredients introduced after this date are classified as New Dietary Ingredients (NDIs) and require submission of a 75-day pre-market safety notification to the FDA.

Bovine colostrum has a documented history of use in the United States dating back several decades prior to 1994, and the industry generally considers it to qualify as an ODI based on this pre-1994 use history. However, it is important to note that FDA has not issued a formal public determination confirming bovine colostrum’s ODI status. The ODI classification represents the industry’s self-assessment of compliance responsibility rather than an FDA-confirmed designation [2]. High-IgG concentrated colostrum products that significantly alter the composition or biological effect of the ingredient may raise NDI questions and should be evaluated on a case-by-case basis. Currently, there is no industry-recognized IgG concentration threshold that serves as a definitive boundary between ODI and NDI status; the core criterion is whether the compositional or biological properties of the ingredient have been substantially altered.

2.2 GRAS Status and Food Ingredient Pathway

Beyond the dietary supplement pathway, bovine colostrum or its components may also be used as food ingredients under the Generally Recognized as Safe (GRAS) framework. While whole bovine colostrum has not undergone a formal GRAS self-affirmation or FDA notification process as a whole ingredient, certain colostrum-derived components have achieved GRAS status. Notably, the FDA issued a letter of no objection regarding the GRAS notice for bovine lactoferrin (GRN 000077), recognizing its safety for use as a food ingredient [4]. Manufacturers may pursue GRAS self-determination for colostrum-based ingredients intended for food applications, provided they can demonstrate safety through scientific procedures or a history of safe use in food in the United States prior to 1958; use histories from other countries do not directly serve as the basis for GRAS determination under US regulations.

The safety of bovine colostrum for human consumption is supported by decades of use as a traditional food in various cultures and a body of clinical research. Reported adverse effects are minimal, typically limited to mild gastrointestinal symptoms such as bloating or nausea at high doses [2]. The primary contraindication is allergy to bovine milk proteins. It should be noted that most clinical studies have been short-to-medium term, and safety data for special populations remain limited.

2.3 Allergen Labeling Requirements

Under the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 and the FASTER Act of 2021, milk is designated as one of the nine major food allergens that must be declared on FDA-regulated packaged foods, including dietary supplements [6]. Bovine colostrum, as a milk-derived ingredient, triggers this mandatory allergen declaration requirement.

Manufacturers must declare the presence of milk-derived ingredients using one of two methods: either by including the common name in parentheses after the ingredient (e.g., “bovine colostrum (milk)”) or by using a separate “Contains” statement immediately adjacent to the ingredient list (e.g., “Contains: Milk”) [6]. This requirement applies regardless of whether the product is marketed as a dietary supplement or a conventional food. Failure to properly declare milk allergens can result in product recalls, enforcement actions, and liability exposure.

2.4 Health Claims and Labeling Requirements

Under DSHEA, dietary supplement manufacturers may make structure-function claims describing the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans [2]. These claims do not require pre-approval by the FDA but must be substantiated by competent and reliable scientific evidence and must include a mandatory disclaimer stating that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease [2].

For bovine colostrum, common structure-function claims include support for immune function, gastrointestinal health, and exercise recovery. Disease claims, which would require FDA pre-approval as health claims or drug claims, are not permitted for dietary supplements. The distinction between permissible structure-function claims and impermissible disease claims requires careful attention in product labeling and marketing materials [2].

2.5 Current Good Manufacturing Practices (cGMPs)

Dietary supplement manufacturers must comply with 21 CFR Part 111, which establishes current Good Manufacturing Practice (cGMP) regulations for dietary supplements [2]. These regulations cover quality control, manufacturing processes, labeling, and record-keeping requirements. For colostrum products, cGMP compliance includes verification of ingredient identity, purity, strength, and composition, as well as ensuring that products are manufactured in a manner that guarantees their safety and quality [2].

3. European Union: Novel Food and Food Supplement Framework

3.1 Novel Food Classification Under Regulation (EU) 2015/2283

The European Union presents a nuanced regulatory landscape for bovine colostrum. Regulation (EU) 2015/2283 on novel foods defines “novel food” as food that was not used for human consumption to a significant degree within the Union before 15 May 1997 [3]. The classification of bovine colostrum products under this regulation depends critically on the product’s composition and processing history.

Classic bovine colostrum powder, produced through conventional processes such as spray-drying or freeze-drying without significant modification of composition, has been discussed in novel food consultations in certain EU Member States. Denmark and certain other Member States have issued informal guidance suggesting that such products may not qualify as novel foods, provided the applicant can demonstrate a history of consumption prior to May 1997 [3]. However, there is no uniform EU-wide official conclusion on this matter. Each Member State’s competent authority may apply its own assessment, and manufacturers must obtain confirmation from the relevant national authority in each jurisdiction where they intend to market the product. The determination of whether a product has a sufficient history of consumption is the responsibility of the food business operator, who must provide adequate evidence to support this claim.

Concentrated colostrum products with significantly elevated immunoglobulin content represent a different regulatory category. In 2021, the Danish Veterinary and Food Administration issued an Article 4 consultation request regarding bovine colostrum immunoglobulin concentrate with immunoglobulin content increased from approximately 31% in ordinary colostrum powder to 50-70% in the processed product [3]. The assessment concluded that this product qualified as a novel food under Article 3(2)(a)(vii) of Regulation (EU) 2015/2283, as the production process (involving ultrafiltration, ion exchange chromatography, and diafiltration) resulted in significant changes in composition affecting nutritional value [3].

3.2 Food Supplement Classification

Bovine colostrum products that are not classified as novel foods may be marketed as food supplements under Directive 2002/46/EC, provided they comply with applicable national legislation in the Member State where they are sold [3]. Food supplements are defined as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect [3].

The regulatory requirements for food supplements vary among EU Member States, as Directive 2002/46/EC provides a harmonized framework but allows Member States to set specific rules regarding the substances that may be used in food supplements and their maximum levels [3]. Manufacturers must ensure compliance with the national regulations of each Member State where their products are marketed. The term “food supplement” is the standardized EU designation; it is equivalent to “dietary supplement” in US terminology.

3.3 Allergen Labeling Requirements

Under EU Regulation 1169/2011 on the provision of food information to consumers, milk and milk-based products are listed among the 14 major allergens that must be clearly declared on food labels [7]. Bovine colostrum, as a milk-derived ingredient, falls within this category. The allergen must be visually emphasized in the ingredient list (e.g., by bold typeface) so that it is clearly distinguishable from the rest of the ingredients [7].

This requirement applies to all food products marketed in the EU, including food supplements. Precautionary allergen labeling (e.g., “may contain milk”) is permitted on a voluntary basis but must not be used as a substitute for good manufacturing practices. Non-compliance with allergen labeling requirements can result in significant fines and product withdrawal from the market [7].

3.4 Health Claims Regulation

Health claims on food and food supplement products in the EU are governed by Regulation (EC) 1924/2006 [3]. Only health claims listed in the EU Register of nutrition and health claims made on foods are permitted, and each claim must be scientifically substantiated according to standards established by the European Food Safety Authority (EFSA) [3].

As of the current date, no specific health claims for bovine colostrum have been authorized by EFSA and entered into the EU Register [3]. This means that manufacturers cannot make authorized health claims for colostrum products in the EU market. The immune-related general claims authorized in the EU Register are all directed at specific nutrients (e.g., vitamin D, zinc), not at complex ingredients such as bovine colostrum; applying nutrient-specific claims to colostrum presents compliance risks. Some Member States may adopt a broader interpretation of general wellness-related statements, but the allowable scope varies significantly. Manufacturers should consult the competent authority of the target Member State before using any health-related messaging [3].

3.5 EFSA Scientific Opinions and Safety Assessments

EFSA has not issued a comprehensive scientific opinion specifically addressing the safety of bovine colostrum for human consumption. However, the safety assessment framework established under the novel food regulation requires that novel food applications include a comprehensive safety dossier addressing potential toxicity, allergenicity, and nutritional impact [3]. As of the current date, EFSA has not issued a negative safety assessment for conventionally processed bovine colostrum. This absence of an adverse opinion, combined with the long history of use in certain EU Member States, is consistent with the safety of non-novel colostrum products, though it does not constitute a formal EFSA safety endorsement.

4. China: Regulatory Framework

4.1 Standard System and Regulatory Status

China’s regulatory framework for bovine colostrum operates primarily through industry and group standards, such as RHB601, RHB602, QB/T5804. Products must comply with general requirements for microbial safety, contaminant limits, and labeling, but there is no national mandatory standard that specifically defines colostrum quality grades or immunoglobulin content thresholds for ordinary food products. Products must still comply with general food safety national standards, including contaminant limits (GB 2762), microbiological standards (GB 29921), food additive provisions (GB 2760), and labeling requirements (GB 7718). If marketed under an established food category such as formulated milk powder, the product must also meet the corresponding national food safety standard for that category.

4.2 Infant Formula Ban

A critical regulatory restriction in China is the prohibition on the use of bovine colostrum in infant formula. In April 2012, the Ministry of Health (now the National Health Commission, NHC) issued Response Letter No. Wei Ban Jian Du Han [2012] 335 on applicable standards for bovine colostrum products, banning the addition of bovine colostrum and colostrum-derived dairy products to infant formula foods, effective from September 1, 2012 [5]. The ban was based on two primary considerations: the lack of sufficient safety data on the long-term consumption of bovine colostrum by infants, and the fact that bovine colostrum had not been included in relevant international infant formula standards [5].

This restriction applies specifically to infant and young child formula foods (0-36 months, covering both GB 10765 for infant formula and GB 10767 for follow-up formula) and does not affect the use of bovine colostrum in health foods, ordinary foods, or products intended for adults, children over three years, or other populations [5]. Products manufactured or imported before the effective date were permitted to be sold until their expiration date [5].

4.3 Health Food Claims and Functional Boundaries

In China, products making specific health claims must obtain health food certification (commonly known as “Blue Hat” approval) from the State Administration for Market Regulation (SAMR). Bovine colostrum health food products approved to date have been limited to a single permitted health claim: “enhancing immunity” (增强免疫力), corresponding to the “immune enhancement” function item in China’s health food function directory. No other health claims (such as improving gastrointestinal function, promoting growth and development, or anti-fatigue) have been approved for bovine colostrum under the current regulatory framework.

For ordinary food products (non-health-foods), the Food Safety Law and Advertising Law of China prohibit any function-related health claims. Ordinary food products containing bovine colostrum may not reference immune function, health benefits, or physiological effects in their labeling or marketing materials. Nutrient content claims that comply with GB 28050 (such as “high in protein” or “rich in calcium”) are permitted for ordinary foods. Making function-related health claims on ordinary food products constitutes a regulatory violation that can result in product seizure, fines, and revocation of business licenses [10][11]. This distinction between health foods (with Blue Hat certification and approved function claims) and ordinary foods (function claims prohibited, nutrient content claims permitted) is a critical compliance boundary for manufacturers and marketers.

4.4 Import Requirements and Customs Compliance

Importation of bovine colostrum products into China is subject to several regulatory requirements administered by the General Administration of Customs (GAC). Under the Regulations on the Registration and Administration of Overseas Producers of Imported Food (GAC Order No. 280, promulgated on October 14, 2025, effective June 1, 2026), overseas dairy production enterprises must be registered with the GAC before their products can be exported to China [12]. Dairy products fall within the catalog of foods requiring official recommendation for registration, meaning that the overseas producer must be recommended by the competent authority of the exporting country and undergo assessment by Chinese customs authorities [12].

Imported colostrum products must comply with China’s food safety standards, undergo inspection and quarantine at the port of entry, and be accompanied by a sanitary certificate issued by the competent authority of the exporting country. The label must comply with Chinese national food labeling standards (GB 7718), including mandatory Chinese-language labeling of the product name, ingredient list, net content, manufacturer information, production date, shelf life, storage conditions, and country of origin [12].

4.5 Allergen Labeling Requirements

Under GB 7718-2025 “General Rules for the Labelling of Prepackaged Foods” (issued on 16 March 2025, effective from 16 March 2027) and the Food Safety Law, products containing milk-derived ingredients must declare the presence of milk allergens on the label. GB 7718-2025 has elevated allergen labelling from a recommended practice to a mandatory requirement. Bovine colostrum, as a milk-derived ingredient, triggers this declaration requirement. The allergen information should be clearly presented in the ingredient list, typically through typographic emphasis (e.g., bold or a different font) to ensure consumer visibility [10].

5. Comparative Analysis of Regulatory Requirements

5.1 Classification Summary

The regulatory classification of bovine colostrum products varies significantly across the three jurisdictions. In the United States, the classification is relatively straightforward: colostrum is most commonly a dietary supplement under DSHEA, with no requirement for pre-market approval, though a food ingredient pathway via GRAS self-determination is also available [2]. In the European Union, classification depends on whether the product is considered a novel food, with Member State-level variation in how classic colostrum powder is assessed; concentrated IgG products generally require novel food authorization [3]. In China, colostrum operates under a standards framework of industry and group standards, with specific restrictions on infant food applications and a single approved health claim for certified health food products [5][10][11].

5.2 Allergen Labeling Comparison

All three jurisdictions mandate allergen labeling for milk-derived ingredients, though the specific requirements differ. The United States requires declaration of milk under FALCPA/FASTER using either parenthetical ingredient labeling or a “Contains” statement [6]. The EU requires visual emphasis (e.g., bold type) of milk in the ingredient list under Regulation 1169/2011 [7]. China requires allergen declaration under GB 7718, typically through typographic emphasis in the ingredient list [10]. B2B suppliers should ensure that product labeling can be adapted to meet all three allergen declaration formats for multi-market distribution.

5.3 Safety Assessment Requirements

Safety assessment requirements differ in scope and stringency. The United States relies on the manufacturer’s responsibility to ensure safety, with post-market surveillance and FDA enforcement actions serving as the primary oversight mechanisms [2]. The European Union requires comprehensive safety dossiers for novel food applications, including toxicity, allergenicity, and nutritional assessments [3]. China applies general food safety requirements under the Food Safety Law, with health food products requiring additional toxicological and functional assessment for Blue Hat approval [10].

5.4 Health Claims and Marketing

Health claim regulations present the most significant divergence across jurisdictions. The United States permits structure-function claims without pre-approval, subject to substantiation requirements and mandatory disclaimers [2]. The European Union permits only authorized health claims from the EU Register, with no colostrum-specific claims currently authorized; permissibility of general claims varies by Member State [3]. China permits only the single approved claim of “enhancing immunity” for Blue Hat-certified bovine colostrum health foods, with ordinary foods prohibited from making any health-related claims whatsoever [8].

5.5 Concentrated IgG Products: Escalating Regulatory Risk

Products with elevated IgG concentrations face more stringent regulatory scrutiny across all three jurisdictions. In the EU, the Danish Article 4 consultation established that IgG concentrates (50-70%) qualify as novel foods requiring authorization [3]. In the United States, high-IgG concentrated products that significantly alter the composition or biological effect of the ingredient may raise NDI questions under DSHEA, particularly if the concentration process introduces new constituents or changes the metabolic fate of the ingredient. In China, concentrated colostrum ingredients used in health food manufacturing must meet the specifications declared in the health food registration dossier, with deviations potentially triggering compliance violations. Additionally, if a high-IgG concentrated colostrum product differs substantially in composition from conventional colostrum powder, there is a theoretical risk that it could be classified as a “new food raw material” under China’s new food material regulatory system, which would require pre-market approval by the National Health Commission before production and sale. As of the current date, no high-IgG bovine colostrum concentrate has received new food raw material approval in China, underscoring the regulatory uncertainty for such products. B2B suppliers of concentrated colostrum ingredients should communicate these jurisdiction-specific risks to their customers and recommend regulatory consultation before product launch.

6. Practical Compliance Recommendations

6.1 Product Development and Formulation

When developing colostrum products for multiple markets, manufacturers should consider the regulatory requirements of each target jurisdiction during the formulation stage. Products intended for the EU market should be evaluated against novel food criteria in each target Member State, with particular attention to IgG concentration thresholds that may trigger novel food classification [3]. For the Chinese market, formulations should ensure compliance with general food safety requirements, and manufacturers should determine whether health food certification (for “enhancing immunity” claims) or ordinary food classification (no claims permitted) is the appropriate regulatory pathway [8]. Concentrated IgG products should undergo regulatory review in all target markets before commercialization.

6.2 Labeling and Marketing Compliance

Labeling must be tailored to the specific requirements of each market, with particular attention to allergen declaration formats and health claim boundaries. US labels must include the DSHEA disclaimer for structure-function claims, comply with FALCPA/FASTER allergen declaration requirements, and use the Supplement Facts panel format for dietary supplements [2][6]. EU labels must comply with food supplement labeling requirements under Directive 2002/46/EC and Regulation 1169/2011, visually emphasize milk allergens in the ingredient list, and must not make unauthorized health claims [3][7]. Chinese labels must comply with GB 7718 food labeling standards, declare milk allergens, and must not make function-related health claims unless the product holds valid health food (Blue Hat) certification with the approved “enhancing immunity” claim [10][11][12].

6.3 Documentation, Traceability, and Import Compliance

Comprehensive documentation of raw material sourcing, processing methods, quality testing, and batch records is essential for compliance across all jurisdictions. For imports into China, overseas producers must obtain GAC registration (under Order No. 280), and products must be accompanied by official sanitary certificates from the exporting country’s competent authority [12]. Third-party testing reports, certificates of analysis, and supply chain traceability documentation support both regulatory compliance and B2B customer confidence. The adoption of internationally recognized testing methods facilitates acceptance in multiple markets.

7. Summary and Outlook

The regulatory landscape for bovine colostrum is characterized by significant variation across major markets, reflecting different historical approaches to food and supplement regulation. The United States offers the most streamlined pathway, with colostrum regulated primarily as a dietary supplement under DSHEA without pre-market approval requirements, though the ODI status represents an industry self-assessment rather than FDA confirmation [2]. The European Union presents the most complex framework, with novel food classification creating additional compliance requirements for concentrated or modified colostrum products, and Member State-level variation in the assessment of classic colostrum powder [3]. China’s regulatory framework operates through industry and group standards, with strict boundaries between health food claims (limited to “enhancing immunity”) and ordinary food (function claims prohibited, nutrient content claims permitted) [10][11].

For B2B stakeholders in the colostrum supply chain, success in global markets requires a thorough understanding of these regulatory distinctions and proactive compliance strategies. Key compliance priorities include: ensuring proper milk allergen labeling in all target markets; respecting the boundary between structure-function and disease claims in the US; obtaining Member State-level confirmation for non-novel food status in the EU; and clarifying the health food versus ordinary food classification in China. As regulatory frameworks continue to evolve, the ability to navigate multiple regulatory environments will become an increasingly important competitive advantage.

References

[1] Costa A, et al. Invited review: bovine colostrum, a promising ingredient for humans and animals - properties, processing technologies, and uses. J Dairy Sci. 2023;106(8):5197-5217.

[2] U.S. Food and Drug Administration. Dietary Supplement Health and Education Act of 1994. Public Law 103-417, 108 Stat. 4325.

[3] European Commission. Consultation request to determine the status of bovine colostrum immunoglobulin concentrate pursuant to Article 4(2) of Regulation (EU) 2015/2283. 2021.

[4] U.S. Food and Drug Administration. GRAS Notice No. GRN 000077: Bovine lactoferrin. 2001.

[5] Ministry of Health of the People’s Republic of China. Response letter on applicable standards for bovine colostrum products (Wei Ban Jian Du Han [2012] No. 335). April 2012.

[6] U.S. Food and Drug Administration. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Public Law 108-282.

[7] European Parliament and Council. Regulation (EU) No 1169/2011 on the provision of food information to consumers. OJ L 304, 22.11.2011.

[8] Ministry of Agriculture of the People’s Republic of China. NY/T 2044-2011 Raw bovine colostrum. 2011.

[9] China Nutrition and Health Food Association. T/CNHFA 005 Bovine colostrum powder (group standard).

[10] Food Safety Law of the People’s Republic of China.

[11] Advertising Law of the People’s Republic of China.

[12] General Administration of Customs of the People’s Republic of China. Regulations on the Registration and Administration of Overseas Producers of Imported Food (GAC Order No. 280). Promulgated October 14, 2025; effective June 1, 2026.

Disclaimer

The content herein is provided solely for the purpose of academic exchange and industry information reference, and does not constitute any claims regarding product efficacy. Products of Kangping Bio are food ingredients and do not possess disease prevention or treatment functions. The research data cited herein are sourced from published academic papers and do not represent the position or product statements of Kangping Bioengineering Co., Ltd.