Protein (Milk and Soy) Quality and Labeling Standard
JHFC-S-034 Enacted: 7 September 2026 / Effective: the same day
Japan Certified Health Food Council (JHFC) — English translation of the standard. In case of discrepancy the Japanese text prevails. Japanese original
Japan Certified Health Food Council (JHFC)
Enacted: 7 September 2026 / Effective: the same day
Preamble (Rationale for Enactment)
The composition of protein made from milk or soy changes through fractionation, concentration, isolation, and hydrolysis. Powder weight, protein amount calculated from nitrogen, and formulation proportions by source represent different information. In products with added free amino acids or similar components, or mixtures from multiple sources, nitrogen measurement alone cannot establish raw material authenticity. This Standard is established to connect descriptions of raw material categories, manufacturing methods, and allergens with measurement documentation.
Article 1 (Purpose)
The raw material sources and quantity labeling of milk and soy protein shall be clarified, and the presence of non-protein components, process hygiene, and handling after preparation shall be evaluated. On the premise of information disclosure based on the five criteria of JHFC-A-001, this document supplements the scope of calculation in protein analysis.
Article 2 (Scope)
This Standard applies to foods for oral consumption whose principal raw materials are concentrates, isolates, or hydrolysates of whey, casein, milk protein, or soy protein. It includes blended powders, beverages, and formed foods. When other animal or plant proteins are used in combination, their portions in the formulation shall be identified separately.
Article 3 (Terms and Definitions)
- 1. Milk protein category: A raw material category distinguishing milk-derived proteins such as whey and casein.
- 2. Soy protein category: A classification of raw materials based on processing such as concentration, isolation, or hydrolysis.
- 3. Nitrogen conversion factor: A factor used to calculate the protein amount from the measured nitrogen amount.
- 4. Non-protein nitrogen: Nitrogen originating from components other than proteins, such as free amino acids.
- 5. Formulation proportion by source: The proportion of each raw material, such as milk or soy, in a formulation, with an explicit indication of whether the value is based on raw material weight or protein amount.
Article 4 (Requirements)
1. Quality Requirements—Authenticity of Fractionated Raw Materials
Acceptance specifications shall state the fractionation of milk raw materials, defatting and extraction of soy raw materials, and each purification step. Protein profiles and amino acid composition shall be examined as appropriate to the degree of processing and cross-checked against origin documentation. For hydrolysates, identifying information such as molecular size shall be added. The business operator shall establish purity specifications covering moisture, ash, fat, and similar constituents and shall present their correspondence to the raw material category.
2. Quality Requirements—Process Hygiene and Changeover
Holding of liquid intermediates, heating, drying, and recontamination after drying shall be established as control points. For soy raw materials, heat treatment control indicators and the reasons for their selection shall be recorded. For equipment shared between milk and soy, material input cross-checks and cleaning verification shall be performed, and carryover into other products shall be evaluated. Hygienic conditions shall be assessed using process records, environmental checks, and microbiological test results for the product.
3. Testing—Distinguishing Nitrogen from Protein
The nitrogen analysis method and the basis for the conversion factor shall be established, and the treatment of mixed raw materials and added amino acids shall be recorded. Protein amounts by source shall not be asserted solely from nitrogen values; the necessary compositional tests shall also be used. Third-party test results shall include the sample's dry-weight basis, analytes, conversion, institution, and final product lot. It shall be possible to inquire about the original certificate of analysis from the publicly disclosed results.
4. Labeling Requirements—Powder Amount and Source
The protein amount per recommended daily intake shall be labeled and distinguished from the powder weight measured with the supplied spoon or similar utensil. The denominator for formulation proportions by source shall be clearly stated, and raw material formulation ratios shall not be unconditionally reinterpreted as ratios of protein composition. Milk and soy allergen statements shall be verified against the [reference on food allergy labeling](https://www.caa.go.jp/policies/policy/food_labeling/food_sanitation/allergy/) and the final ingredient list.
5. Quality Requirements—Storage and Handling After Preparation
For powders, moisture absorption, caking, odor, and dispersion shall be observed; for beverages, sedimentation and aggregation shall be observed. For formed products, the condition of fats and oils and moisture migration shall be verified. Products prepared with water or similar liquids before use shall provide handling instructions that account for hygienic conditions after preparation. The business operator shall establish specifications at the end of shelf life for each dosage form and their basis, and shall label the method of tightly closing the container and the handling of utensils used.
6. Precautions for Intake
Cautionary statements shall be provided to enable persons with milk or soy allergies to check the ingredients. The absence of allergens shall not be claimed solely on the basis of a processing designation such as hydrolysis. Where statements about lactose are made, supporting evidence shall be provided separately from milk protein information. Persons whose protein intake is under medical management shall be advised to consult a physician, and draft cautionary statements shall be cross-checked against the formulation.
7. Documentation Management
The respective bases for raw material categories, formulation by source, nitrogen conversion, and allergens shall be registered for each labeling field. The [analytical reference for food composition tables](https://www.mext.go.jp/a_menu/syokuhinseibun/) shall be used as a reference for method selection, and verification of applicability to the actual product shall be retained separately. A retention period shall be established, and calculations and product test results before and after changes to raw material categories or added amino acids shall be retained in a manner that permits comparison.
Article 5 (Evaluation Categories)
- Conformity: All requirements are met, and the milk and soy categories, quantity calculations, and allergen information can be verified for each product unit.
- Partial conformity: There are no deficiencies in documentation on origin, labeled amounts, and hygiene, and a deadline for supplementation is established for minor deficiencies such as public indexes.
- Nonconformity: Origin is asserted solely from nitrogen amounts, formulation weight is treated as protein amount, or allergen documentation is omitted on the grounds of processing.
Article 6 (Implementation)
The self-declaration of conformity shall be accompanied by the raw material categories and the method for calculating protein amounts. The Council shall cross-check the labeling, formulation ratios, and nitrogen conversion of the product submitted for application. A review shall be conducted when the milk-to-soy ratio, hydrolysis process, or extent of shared use of manufacturing equipment changes.
Supplementary Provisions
This Standard shall take effect on 7 September 2026. Inquiries concerning raw material categories or mixing proportions shall include the basis of calculation.
※ This Standard sets out evaluation criteria for information disclosure and quality management practices and does not guarantee the efficacy or safety of individual products.