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WIP: milestone 3 updates
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‎iSRL-26-03-R-Allergen/SP-03/milestone3_anushree.md‎

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@@ -100,36 +100,33 @@ Jurisdictions: United States (FALCPA + FASTER Act) and Japan
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* What I infer: The Act mandates allergen disclosure but does not specify which allergens, indicating that the specific list of allergens is defined in separate Food Labeling Standards (Cabinet Office Ordinance).
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*2. are allergens labeled regardless of quantity or only above thresholds?*
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* Source: [USDA/FAS report “Japan – An Overview of the Food Labeling Standard” (2014)](https://www.fas.usda.gov/data/japan-overview-food-labeling-standard), [LINK1](https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=An%20Overview%20of%20the%20Food%20Labeling%20Standard_Tokyo_Japan_5-26-2017.pdf)
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* Note:
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* The USDA/FAS report was used to understand the Japanese labeling system, but it is not a primary legal source.
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* Excerpt:
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* (LINK1) `At this time, there are seven allergens for which labeling is mandatory and twenty allergens for which labeling is recommended`(page 3)
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* `f a product contains the same allergen in multiple ingredients in aprocessed product (e.g., egg salad contains both eggs as well as mayonnaise containing eggs), then the individual allergen labeling provision requires that the allergen be labeled each time it appears in an ingredient, further crowding package labeling. The Standard does not permit the use of “may contain” language; the CAA’s current practice of explicitly labeling only that which a product does contain remains in place. For the latest list of allergen labeling, please see the CAA’s website at http://www.caa.go.jp/foods/index18.html (in Japanese).`
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* A table under that that lists the labelling requirement vs allergen: `Abalone, Mackerel, Squid, Salmon, Salmon Roe, Cashew Nut, Walnut, Matsutake Mushroom, Sesame, Soybean, Yam, Apple, Banana, Kiwifruit, Orange, Peach, Beef, Chicken, Gelatin, Pork`
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* `The Standard separates nutritional labeling components into three groups: mandatory, voluntary but recommended, and voluntary (see table below). The Standard also allows manufacturers or importers to utilize GOJ nutritional reference values for individual ingredients in order to calculate a product’s overall nutritional value. In addition, importers may convert nutritional values of imported products into the Standard’s format. `
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* Table under lists: `Saturated Fat, Dietary Fiber` as required labelling
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* Why this answers the question: This excerpt indicates that allergen labeling in Japan is based on the presence of allergens within ingredients, as allergens must be labeled each time they appear, rather than being tied to any explicit quantitative threshold.
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* Source: [Food Labeling Standards (食品表示基準) – Consumer Affairs Agency (CAA)](https://www.caa.go.jp/en/policy/food_labeling/assets/food_labeling_cms204_240425_01.pdf), [Consumer Affairs Agency of Japan](https://www.caa.go.jp/en/policy/food_labeling/)
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* Excerpt:
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* `Presence of the following items must be indicated.`
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* `Labelling is mandatory if the packaged food includes these allergens.`
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* Allergen labeling section, p. 2
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* Why this answers the question: The excerpt establishes that allergen labeling is required when specified allergens are present in food products, indicating that the obligation to label is triggered by the inclusion of allergens rather than by any defined quantitative threshold.
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* What the source directly states:
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* There are mandatory and recommended allergen categories for labeling.
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* Allergens must be labeled each time they appear in ingredients.
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* The system focuses on explicit identification of contained allergens in products.
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* What I infer: Japan appears to follow a presence-based labeling approach, where allergens are declared when present in ingredients, but the source does not explicitly specify whether quantitative thresholds exist or not.
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* Allergen labeling is mandatory when specified allergens are included in packaged food.
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* The requirement is explicitly tied to the presence of allergens in the product.
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* What I infer: Since the regulation requires labeling based on the presence of allergens and does not specify any quantitative threshold, the system follows a presence-based labeling approach.
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* Gap:
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* No explicit primary legal source confirming whether quantitative thresholds apply in Japan.
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* No explicit provision specifying quantitative thresholds for allergen declaration is identified in the Food Labeling Standards.
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*3. are "may contain" / precautionary labels required, regulated, or voluntary?*
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* Source: [USDA/FAS report “Japan – An Overview of the Food Labeling Standard” (2014)](https://www.fas.usda.gov/data/japan-overview-food-labeling-standard), [LINK1](https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=An%20Overview%20of%20the%20Food%20Labeling%20Standard_Tokyo_Japan_5-26-2017.pdf)
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* Note:
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* The USDA/FAS report was used to understand the Japanese labeling system, but it is not a primary legal source.
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* Source: [Food Labeling Standards (食品表示基準) – Consumer Affairs Agency (CAA)](https://www.caa.go.jp/en/policy/food_labeling/assets/food_labeling_cms204_240425_01.pdf), [Consumer Affairs Agency of Japan](https://www.caa.go.jp/en/policy/food_labeling/)
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* Excerpt:
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* Again, same page3, point 3
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* `Allergen Labeling – The previous food labelling... The Standard does not permit the use of “may contain” language;...`
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* Why this answers the question: This excerpt directly addresses whether precautionary (“may contain”) labeling is allowed under Japanese regulations, clearly indicating its regulatory status.
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* `Presence of the following items must be indicated.`
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* `Labelling is mandatory if the packaged food includes these allergens.`
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* `Allergens included are listed in ( ).`
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* `Allergens are listed individually.`
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* Why this answers the question: The Standards define allergen labeling in terms of indicating the presence of specified allergens and integrating them into ingredient labeling. The framework focuses on declaring allergens that are actually present in food products and does not include any provisions addressing precautionary or advisory labeling such as “may contain” statements.
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* What the source directly states:
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* The Food Labeling Standard does not permit the use of “may contain” language.
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* Allergen labeling is restricted to explicitly declaring allergens that are actually present in the product.
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* What I infer: Precautionary allergen labeling is not allowed in Japan, and the system relies solely on definitive, presence-based disclosure rather than advisory warnings.
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* Allergen labeling is mandatory when specified allergens are present in food products.
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* Allergens are declared through ingredient labeling and are listed explicitly.
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* What I infer: Since the regulatory framework specifies labeling only for allergens that are present and does not define or include precautionary labeling mechanisms, precautionary (“may contain”) labeling is not a standardized or regulated category under the Food Labeling Standards.
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* Gap:
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* No explicit provision permitting or regulating precautionary (“may contain”) labeling is identified in the Food Labeling Standards.
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*4. how must allergen information appear on the package?*
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* Source: [Food Labeling Act plus](https://www.japaneselawtranslation.go.jp/en/laws/view/2601/en)
@@ -157,4 +154,4 @@ ALLER.JP.C.01 – Japan mandates allergen labeling
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ALLER.JP.C.02 – Allergen list defined outside Act
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ALLER.JP.C.03 – Japan has 7 mandatory allergens
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ALLER.JP.C.04 – Presence-based labeling system
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ALLER.JP.C.05 – PAL not permitted
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ALLER.JP.C.05 – No explicit provision for precautionary allergen labeling

‎iSRL-26-03-R-Allergen/SP-03/milestone3_anushree.papertable.md‎

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**Sub-part: US and Japan Allergen Declaration**
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**Anushree Balaji**
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| S.No | Document | DOI / Link | Claim Supported | Type of Support | Relevance |
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|------|----------|------------|-----------------|-----------------|-----------|
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| 1 | FALCPA (2004) | FDA website | ALLER.US.C.01 | Direct | Defines 8 major food allergens |
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| 2 | FASTER Act (2021) | FDA website | ALLER.US.C.02 | Direct | Adds sesame as 9th major allergen |
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| 3 | FALCPA | FDA website | ALLER.US.C.03 | Direct + Inferred | Presence-based labeling (no threshold specified) |
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| 4 | FDA Guidance (21 CFR 117) | FDA website | ALLER.US.C.04 | Direct + Inferred | “May contain” labeling voluntary, not sufficient |
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| 5 | FALCPA Sec. 204 | FDA website | ALLER.US.C.05 | Inferred | Advisory labeling treated as industry practice |
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| 6 | Food Labeling Act (Japan) | Japanese Law Translation | ALLER.JP.C.01 | Direct | Allergen information required in labeling |
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| 7 | Food Labeling Act (Japan) | Japanese Law Translation | ALLER.JP.C.02 | Inferred | Allergen list defined outside Act (delegated) |
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| 8 | USDA/FAS Report (Japan) | FAS website | ALLER.JP.C.03 | Direct | 7 mandatory allergens identified |
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| 9 | USDA/FAS Report (Japan) | FAS website | ALLER.JP.C.04 | Direct + Inferred | Presence-based labeling; allergens labeled per ingredient |
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| 10 | USDA/FAS Report (Japan) | FAS website | ALLER.JP.C.05 | Direct | “May contain” labeling not permitted |
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| S.No | Document | DOI / Link | Claim Supported | Type | Relevance |
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| ---- | -------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------- | ----------------- | ------------------------------------------------------------------------- |
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| 1 | FALCPA (2004) | [https://www.congress.gov/108/plaws/publ282/PLAW-108publ282.pdf](https://www.congress.gov/108/plaws/publ282/PLAW-108publ282.pdf) | ALLER.US.C.01 | Direct | Sec. 201 – defines 8 major allergens |
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| 2 | FASTER Act (2021) | [https://www.congress.gov/117/plaws/publ11/PLAW-117publ11.pdf](https://www.congress.gov/117/plaws/publ11/PLAW-117publ11.pdf) | ALLER.US.C.02 | Direct | Sec. 2 – adds sesame as 9th allergen |
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| 3 | FALCPA (2004) | same as above | ALLER.US.C.03 | Direct + Inferred | Sec. 203 – labeling triggered by presence of allergen |
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| 4 | FDA Guidance (Food Allergen Q&A) | [https://www.fda.gov/media/117410/download](https://www.fda.gov/media/117410/download) | ALLER.US.C.04 | Direct | Q D.15 – advisory (“may contain”) not sufficient |
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| 5 | FALCPA (2004) | same as above | ALLER.US.C.05 | Inferred | Sec. 204 – advisory labeling recognized as industry practice |
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| 6 | Food Labeling Act (Japan) | [https://www.japaneselawtranslation.go.jp/en/laws/view/2601/en](https://www.japaneselawtranslation.go.jp/en/laws/view/2601/en) | ALLER.JP.C.01 | Direct | Art. 4 – allergen labeling required |
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| 7 | Food Labeling Act (Japan) | same as above | ALLER.JP.C.02 | Direct + Inferred | Delegates detailed requirements to Food Labeling Standards |
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| 8 | Food Labeling Standards (食品表示基準) | [https://www.caa.go.jp/en/policy/food_labeling/assets/food_labeling_cms204_240425_01.pdf](https://www.caa.go.jp/en/policy/food_labeling/assets/food_labeling_cms204_240425_01.pdf) | ALLER.JP.C.03 | Direct | Allergen labeling section – specified allergens list |
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| 9 | Food Labeling Standards (食品表示基準) | same as above | ALLER.JP.C.04 | Direct + Inferred | Allergen labeling section – presence-based (ingredient-level) declaration |
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| 10 | Food Labeling Standards (食品表示基準) | same as above | ALLER.JP.C.05 | Inferred | No explicit provision for precautionary (“may contain”) labeling |

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