Global Allergy & Asthma Laws

Food (Amendment) Regulations 2025

Adopts the Codex 20 ppm threshold for 'gluten-free' claims and introduces requirements for nutrient replacement in gluten-free substitutes, effective 2026.

Sponsor / Authority

Singapore Food Agency

ISO 21415-2:2015 Wheat and wheat flour — Gluten content

Specifies a method for determining the content of wet gluten and gluten index in wheat flours by mechanical means, used primarily for industrial quality control.

Food and Drug Regulations (Allergens, Gluten Sources and Sulphites)

Requires priority allergens, gluten sources, and added sulphites to be declared by their common names on food labels.

Sponsor / Authority

Health Canada

Food Labeling Act (Food Labeling Standards)

Requires mandatory labeling for 8 specific ingredients (including walnuts as of 2023) and recommends it for 20 others.

Sponsor / Authority

Consumer Affairs Agency (CAA)

General Standard for the Labelling of Prepackaged Foods

Provides the global framework for allergen labeling adopted by most countries, listing priority foods like milk, eggs, and wheat.

Notification of the Ministry of Public Health No. 367 B.E. 2557 (2014) Re: Labeling of Prepackaged Foods

Mandates that allergens must be clearly listed on the labels of prepackaged foods in Thai.

Sponsor / Authority

Ministry of Public Health

Singapore Food Regulations

Requires the declaration of eight specific foods and ingredients that are known to cause hypersensitivity on labels.

Sponsor / Authority

Singapore Food Agency (SFA)

Canada Gluten-Free Regulation

Food and Drug Regulations, Division 24 (Foods for Special Dietary Use)

Prohibits labeling food as gluten-free if it contains any gluten, with an administrative threshold of 20 ppm for cross-contamination.

Sponsor / Authority

Health Canada

ISO Gluten Content Standard

Wheat and wheat flour — Gluten content — Part 4: Determination of wet gluten by mechanical means

Provides the international standard method for mechanical determination of gluten content in wheat and wheat flour.

NSW Health Nutrition Standards for Adult Inpatients in NSW Public Hospitals

Establishes a mandatory 'Mammalian product free diet' specification for all public hospitals in New South Wales to accommodate patients with Alpha-gal syndrome.

Sponsor / Authority

NSW Ministry of Health

Technical Rules for Hazardous Substances: Risks resulting from skin contact (TRGS 401)

Requires employers to perform risk assessments for latex exposure and mandates the replacement of powdered, high-protein latex gloves with latex-free or low-protein alternatives.

Sponsor / Authority

Federal Institute for Occupational Safety and Health (BAuA)

Allergen Products Development for Immunotherapy and Allergy Diagnosis in Moderate to Low Sized Study Populations

Provides a flexible regulatory pathway to facilitate the development and clinical authorization of venom immunotherapy (VIT) for rare insect sting allergies.

Sponsor / Authority

European Medicines Agency

Avapritinib for treating advanced systemic mastocytosis

Mandates NHS coverage of Avapritinib for adults with aggressive systemic mastocytosis or mast cell leukemia, ensuring patient access to targeted biological therapy.

Sponsor / Authority

National Institute for Health and Care Excellence

Medicines and Related Substances Act: General Regulations regarding medical devices

Regulation 6 mandates that the labels of medical devices must declare any substances derived from natural rubber latex to protect sensitive healthcare workers and patients.

Sponsor / Authority

South African Health Products Regulatory Authority (SAHPRA)

School Epinephrine Access Law

The Human Medicines (Amendment) (No. 2) Regulations 2014

Amends legislation to allow schools to purchase adrenaline auto-injectors (AAIs) without a prescription for use in emergencies.

Sponsor / Authority

Department of Health

GB 7718

National Food Safety Standard - General Rules for the Labeling of Prepackaged Foods

Sets out the requirements for labeling prepackaged foods in China, including voluntary and mandatory allergen declarations.

Sponsor / Authority

National Health Commission of China

South Korea Food Labeling Act

Food Labeling and Advertising Act

Consolidates food labeling laws and mandates the labeling of 22 allergen types to prevent health risks for allergic consumers.

Sponsor / Authority

Ministry of Food and Drug Safety

French Allergen Disclosure Decree

Décret n° 2015-447 relatif à l'information des consommateurs sur les allergènes et les denrées alimentaires non préemballées

Mandates that restaurants and establishments serving non-prepackaged food must provide written documentation of allergens present in their dishes.

Sponsor / Authority

Ministry of the Economy

Argentine Food Code

Código Alimentario Argentino - Alimentos Libres de Gluten

Specifies that gluten-free products (sin TACC) must contain less than 10 mg/kg (10 ppm) of gluten to be certified for sale.

Sponsor / Authority

ANMAT

FDA Gluten in Drugs Guidance

Gluten in Drug Products and Associated Labeling Guidance for Industry

Recommends that drug manufacturers voluntarily label products as 'gluten-free' if they contain less than 20 ppm of gluten to assist celiac patients.

Sponsor / Authority

Food and Drug Administration

EMA Wheat Starch Guideline

Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'

Mandates warnings for wheat starch used as an excipient, specifically noting it is safe for celiac patients if the gluten content is below 20 ppm.

Sponsor / Authority

European Medicines Agency

FSAI Gluten-Free Guidance

Guidance Note 31: Gluten-free Foods

Outlines compliance requirements for food businesses using gluten-free and very low gluten labels according to the 20 ppm and 100 ppm standards.

Sponsor / Authority

Food Safety Authority of Ireland

Regulation Relating to the Labelling and Advertising of Foodstuffs

Regulates the labeling of allergens and identifies meat/gelatin as uncommon allergens, providing a framework for alpha-gal syndrome patient safety.

Sponsor / Authority

Department of Health

Singapore Medical Device Labeling

GN-23: Guidance on Labelling for Medical Devices

Specifies labeling requirements for medical devices, including mandatory disclosure of potential allergens like natural rubber latex.

Sponsor / Authority

Health Sciences Authority (HSA)

Venom Immunotherapy (VIT) Reimbursement Policy

National clinical guidelines and reimbursement mandates for venom immunotherapy in patients with systemic allergic reactions to stings.

Sponsor / Authority

Haute Autorité de Santé (HAS)

Pharmaceutical Benefits Scheme (PBS) Jorveza Listing

Provides government subsidies for Jorveza (budesonide) specifically for the treatment of Eosinophilic Esophagitis.

Sponsor / Authority

Department of Health and Aged Care

Special Authority for Amino Acid Formula

New Zealand Pharmaceutical Schedule Section D

Provides funding for amino acid formulas for patients with a confirmed diagnosis of Eosinophilic Esophagitis or FPIES.

Sponsor / Authority

PHARMAC

Second List of Rare Diseases (2023)

Officially recognizes Mastocytosis and Eosinophilic Gastroenteritis as rare diseases, enabling priority drug review and research funding.

Sponsor / Authority

National Health Commission

SMPPi Category

Australia New Zealand Food Standards Code - Standard 2.9.1

Establishes 'Special Medical Purpose Products for Infants' (SMPPi) category, regulating formula for medical conditions including FPIES and EoE.

Sponsor / Authority

FSANZ

SFDA.FD GSO 9:2022 Labeling of Prepackaged Food Stuffs

Adopts the GSO technical regulation requiring mandatory Arabic-language labeling and highlighting of major allergens on food products.

Health (Provision of Food Allergen Information to Consumers in respect of Non-Prepacked Food) Regulations 2014

Mandates that food businesses in Ireland provide written allergen information for non-prepacked food at the point of presentation, sale, or supply.

Sponsor / Authority

Minister for Health

Food for Specific Groups (FSG)

Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control

Governs 'Food for Special Medical Purposes' (FSMP), providing the legal framework for clinical foods used in managing conditions like EoE or FPIES.

Sponsor / Authority

European Commission

FSSAI Gluten Regulation

Food Safety and Standards (Health Supplements and Food for Special Dietary Use) Regulations

Prescribes that 'gluten-free' products must not exceed 20 ppm and 'low gluten' must not exceed 100 ppm.

EMA Excipients Guideline

Excipients in the labelling and package leaflet of medicinal products for human use

Requires labeling for wheat starch in medicines; products with <20 ppm gluten are considered gluten-free for pharmaceutical labeling purposes.

Sponsor / Authority

European Medicines Agency

TGO 91

Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines

Requires that the presence of natural rubber latex in medicines or their packaging be disclosed on labels as a mandatory allergen warning.

PNMR4

French Fourth National Rare Diseases Plan (PNMR 4)

Allocates €36 million to expand the network of 603 rare disease reference centers, providing standardized care pathways and research for conditions like systemic mastocytosis and EoE.

Sponsor / Authority

Ministry of Labour, Health, Solidarity and Families

G-BA EoE Reimbursement Decision

G-BA Resolution on the Benefit Assessment of Dupilumab for Eosinophilic Esophagitis

A legally binding decision determining the reimbursement criteria and additional benefit status for biologic therapy in patients with EoE under the German Social Code.

Sponsor / Authority

Federal Joint Committee (G-BA)

Law 13.301

Law No. 13.301/2016 on Mosquito and Tick-Borne Disease Control

Provides for public health measures and surveillance for diseases transmitted by the Aedes aegypti mosquito and ticks, creating the statutory basis for Alpha-gal syndrome monitoring in high-risk rural areas.

Sponsor / Authority

Federal Government of Brazil

Enhanced Food Allergen Labelling Regulations

Food and Drug Regulations (Allergens, Gluten Sources and Added Sulphites)

Requires mandatory identification of priority allergens, gluten sources, and sulphites on prepackaged food labels in plain language.

Sponsor / Authority

Health Canada

Regulations Relating to the Labelling and Advertising of Foodstuffs (R146/2010)

Requires mandatory declaration of common allergens including egg, cow's milk, crustaceans, peanuts, soy, tree nuts, and gluten-containing cereals.

Sponsor / Authority

Department of Health

Ley Celíaca Chilena

Ley que modifica diversos cuerpos legales con el objeto de regular el etiquetado, publicidad y venta de alimentos libres de gluten

Requires mandatory gluten-free labeling and dedicated separate shelves in supermarkets for gluten-free products.

Sponsor / Authority

Ministry of Health

Singapore Food Regulations (Regulation 5: Labelling of pre-packed food)

Requires pre-packed food products containing ingredients known to cause hypersensitivity (such as gluten, shellfish, and peanuts) to be clearly declared.

Sponsor / Authority

Singapore Food Agency

Public Health Protection Law (Food) 2015 (with Allergen Labeling Amendments)

Mandates allergen highlighting in the ingredient list and establishes unique requirements for fava bean labeling (for G6PD deficiency).

Sponsor / Authority

Ministry of Health

Food Labeling Standards (Ministry of Food and Drug Safety Notification)

Mandates allergen disclosure for 19 specific items, including beef, chicken, and pork (aiding those with Alpha-gal syndrome).

Sponsor / Authority

Ministry of Food and Drug Safety

PNAE Law

Ley de Alimentación Escolar (Ley No. 11.947)

Establishes that the National School Feeding Program must meet the nutritional needs of students with specific dietary restrictions (including food allergies).

Sponsor / Authority

Fundo Nacional de Desenvolvimento da Educação

NDIS Act

National Disability Insurance Scheme Act 2013

Provides funding and support for Australians with significant and permanent disabilities, which can include functional impairment from conditions like Eosinophilic Esophagitis (EoE).

Sponsor / Authority

Department of Social Services

FSSAI Gluten-Free Rule

Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011

Requires foods labeled as 'gluten-free' to contain less than 20 mg/kg (20 ppm) of gluten and mandates specific label declarations regarding manufacturing facilities.

Sponsor / Authority

Food Safety and Standards Authority of India

ISO Gluten Mechanical Method

Wheat and wheat flour — Gluten content — Part 2: Determination of wet gluten and gluten index by mechanical means

Provides a standardized mechanical washing method for determining wet gluten content in wheat flours, widely used in industrial and regulatory laboratories.

Gulf Gluten Labeling Standard

GSO Technical Regulation on Labeling of Prepackaged Food Stuffs

Harmonizes food labeling across GCC states, requiring the mandatory declaration of gluten-containing cereals and aligning with the 20 ppm Codex threshold.

Sponsor / Authority

Gulf Cooperation Council (GCC)

Israel Gluten Labeling Rule

Public Health Regulations (Food) (Gluten Marking)

Regulates the labeling of gluten-free products in Israel, adopting a 20 ppm threshold and mandatory allergen highlighting in ingredient lists as per EU standards.

Sponsor / Authority

Ministry of Health

MO 706

Ministerial Order 706: Anaphylaxis Management in Victorian Schools

Mandates that all Victorian schools have policies for managing students at risk of anaphylaxis from triggers including bee and insect stings and FPIES-related allergens.

NICE Guidance on Jorveza

Budesonide orodispersible tablets for treating eosinophilic oesophagitis (TA605)

Official technology appraisal mandating NHS funding and clinical recognition for budesonide as a primary treatment for EoE in adults.

Sponsor / Authority

National Institute for Health and Care Excellence

PBS Listing for EoE

Pharmaceutical Benefits Scheme - Budesonide (Jorveza)

Formal government recognition and subsidization of Budesonide specifically for biopsy-confirmed eosinophilic esophagitis.

Sponsor / Authority

Department of Health and Aged Care

Essential Principles

Therapeutic Goods (Medical Devices) Regulations 2002

Essential Principle 13.3 (2)(m) requires that device labels must indicate the presence of natural rubber latex if it is a constituent.

Sponsor / Authority

Therapeutic Goods Administration

NOM-137-SSA1-2008, Labeling of Medical Devices

Mandatory standard requiring the label of health products to clearly state if they contain natural rubber latex to prevent allergic reactions.

Resolution RDC No. 67/2010 on Latex Labeling

Mandates warnings on health product labels about the presence of natural rubber latex and risks of allergic reactions.

Sponsor / Authority

Anvisa

Pharmaceuticals and Medical Devices Act (PMD Act)

Under MHLW notifications tied to this Act, Japanese manufacturers must state latex risks in product manuals for medical devices.

HSA Guidance on Labelling of Medical Devices

Requires that labels of medical devices containing natural rubber latex must include a warning statement for users with latex sensitivity.

TiMMA Management Protocol

NSW Health Clinical Practice: Tick-induced Mammalian Meat Allergy

Official recognition and clinical management mandate for Alpha-gal Syndrome (MMA) caused by tick bites, providing guidelines for diagnosis and first aid.

Rydapt Approval

EMA Orphan Designation for Midostaurin (EU/3/04/218)

Officially designated midostaurin as an orphan medicine for the treatment of systemic mastocytosis, facilitating research and patient access.

Sponsor / Authority

European Medicines Agency

Enhanced Allergen Labelling

Food and Drug Regulations (B.01.010.1 - B.01.010.4)

Requires the mandatory declaration of priority food allergens, gluten sources, and added sulphites using simple, common names on prepackaged food labels.

Sponsor / Authority

Health Canada

Food Labeling Act (Cabinet Office Ordinance No. 10 of 2015)

Defines mandatory (currently 9 items) and recommended (20 items) allergens for declaration on all prepackaged processed foods in Japan.

Singapore Food Regulations (Part III, Regulation 5)

Mandates that all prepacked food labels must declare ingredients known to cause hypersensitivity, following international Codex standards.

Sponsor / Authority

Singapore Food Agency

NICE Venom Immunotherapy Guidance

Pharmalgen for the treatment of bee and wasp venom allergy (Technology Appraisal 100)

Mandates NHS coverage and access to venom immunotherapy for patients who have had severe systemic reactions to bee or wasp stings.

Sponsor / Authority

National Institute for Health and Care Excellence

Education and Care Services National Law Act 2010

Requires all education and care services to have an anaphylaxis management policy that covers triggers including insect stings.

Jorveza Approval

Orphan Designation for Budesonide for Eosinophilic Esophagitis (EU/3/13/1168)

Formally recognizes EoE as a rare disease at the supranational level, granting market exclusivity and research incentives for specific treatments.

Sponsor / Authority

European Medicines Agency

Public Health Act 2010 - Notifiable conditions (Tick-borne diseases)

Provides the legal framework for the surveillance of tick-borne pathogens which are directly linked to the development of Alpha-gal syndrome in the region.

Sponsor / Authority

NSW Ministry of Health

Rydapt Orphan Mandate

Orphan Designation for Midostaurin for Systemic Mastocytosis (EU/3/10/765)

Designates systemic mastocytosis as a rare disease, mandating specific pathways for drug development and research funding.

Sponsor / Authority

European Medicines Agency

PMDA Latex Labeling Guidance

Notification on the handling of medical devices using natural rubber (Notification No. 0328-4)

Instructs manufacturers to clearly label medical devices containing natural rubber to protect patients with latex allergies.

COSHH

Control of Substances Hazardous to Health Regulations 2002 (COSHH)

Mandates employers to control exposure to natural rubber latex in the workplace to prevent occupational asthma and dermatitis.

National Allergy Strategy

National Allergy Strategy (Funded Implementation)

An officially funded national policy that includes specific resource development and support for managing FPIES in clinical and community settings.

Sponsor / Authority

Department of Health and Aged Care

GN-23: Guidance on Labelling of Medical Devices

Specifies that the presence of natural rubber latex must be declared on the label of medical devices sold in Singapore.

FSMP Regulation

Commission Delegated Regulation (EU) 2016/128 on food for special medical purposes

Establishes compositional and information requirements for foods used in the clinical dietary management of diseases like EoE and FPIES.

Sponsor / Authority

European Commission

Singapore Food Regulations (Regulation 5)

Requires prepackaged foods to declare ingredients known to cause hypersensitivity, including cereals containing gluten, nuts, and fish.

Sponsor / Authority

Singapore Food Agency

Notification of the Ministry of Public Health No. 450 B.E. 2567 (2024)

Updates labeling requirements for prepackaged foods, adding specific mandatory language for allergen and cross-contamination warnings.

Sponsor / Authority

Ministry of Public Health

Draft Regulations Relating to the Labelling and Advertising of Foodstuffs

Proposes stricter allergen labeling and specific 'meat species' identification rules relevant to mammalian meat allergy (Alpha-gal) safety.

Sponsor / Authority

Department of Health

Bill 201

Protection of Students with Life-Threatening Allergies Act

Requires all Alberta school boards to create a life-threatening allergy policy and maintain unassigned epinephrine auto-injectors on site.

MERCOSUR Technical Regulation on Allergen Labeling

Harmonizes allergen labeling requirements across member states (Argentina, Brazil, Paraguay, Uruguay) to ensure clear consumer warnings.

Codex Gluten Standard

Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten

Establishes the international threshold of 20 mg/kg (ppm) for foods labeled as 'gluten-free' and 20-100 ppm for 'very low gluten' products.

CAA Art 1383

Argentine Food Code Article 1383

Strictly defines 'Sin TACC' (Gluten-Free) products as those containing less than 10 mg/kg (10 ppm) of gluten.

Sponsor / Authority

ANMAT

EMA Annex to Guideline on Excipients in Labeling

Specifies that wheat starch in medications is considered gluten-free if it contains no more than 20 micrograms of gluten per gram.

Sponsor / Authority

European Medicines Agency

FSSAI Gluten Regulation

Food Safety and Standards (Special Dietary Foods) Regulations

Defines 'gluten-free' food as having a gluten level below 20 mg/kg and sets labeling requirements for low-gluten foods.

Law No. 10.674

Mandatory Labeling of Products Containing Gluten

Mandates that all industrialized food products must state 'CONTÉM GLÚTEN' or 'NÃO CONTÉM GLÚTEN' on their labels.

Codex ELISA Standard

Recommended Methods of Analysis and Sampling

Endorses the R5 Mendez Enzyme-Linked Immunosorbent Assay (ELISA) as the Type 1 method for gluten detection in food with a detection limit of approx 5 ppm.

CAA Allergen Labeling

Japan Food Labeling Standard for Allergens

Mandates labeling for wheat as a top-priority allergen; voluntary 'gluten-free' rice flour standards require less than 1 ppm of gluten.

Monash Jack Jumper Funding

Victorian Jack Jumper Ant Clinic Initiative

Government funding mandate establishing a specialized clinic for Jack Jumper ant venom immunotherapy to prevent fatalities from this rare ant allergy.

National Strategic Action Plan for Rare Diseases

A federally mandated strategic framework that prioritizes diagnostic pathways and research for rare conditions including Mast Cell Activation Syndrome (MCAS).

ICD-10 FPIES Recognition

International Statistical Classification of Diseases and Related Health Problems (10th Revision)

Established a specific medical code (K52.2) for Food Protein-Induced Enterocolitis Syndrome (FPIES), enabling global clinical tracking and insurance billing for the condition.

Alpha-gal Syndrome Inquiry

Senate Inquiry into Tick-borne diseases

Official legislative inquiry and resulting mandate focused on improving access to diagnosis and surveillance for mammalian meat allergy (Alpha-gal) following tick bites.

NHS Glove Procurement Policy

NHS Supply Chain Framework Agreement: Examination Gloves

Mandates that all products and packaging must be latex-free where possible and requires clear labeling of any latex content in medical gloves supplied to the NHS.

SNSF Project P32470

Swiss National Science Foundation (SNSF) EoE Research Mandate

National research funding mandate to develop process-of-care measures and long-term treatment targets for adults with Eosinophilic Esophagitis.

EMA Excipients Annex

Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products

Requires wheat starch in medicines to be declared and allows 'gluten-free' claims for pharmaceutical products containing less than 20 ppm gluten.

Sponsor / Authority

European Medicines Agency

MFDS South Korea Food Code

Korean Food Code (Labeling of Gluten-Free Foods)

Permits 'gluten-free' labeling only when the total gluten content in the finished product is confirmed to be 20 mg/kg (20 ppm) or less.

Crossed Grain Trademark Standard

AOECS Standard for Gluten-Free Foods

The global private standard for the 'Crossed Grain' certification symbol, requiring 20 ppm compliance and annual independent facility audits.

Argentina Sin TACC Law

Joint Resolution No. 32/2023 (Amending Article 1383 of the Argentine Food Code)

Stipulates a strict gluten-free threshold of 10 ppm (10 mg/kg) for products labeled with the 'Sin TACC' (Gluten-Free) logo.

National Strategy for Drugs for Rare Diseases

An official policy mandate with $1.5 billion in funding to improve access to rare disease drugs, specifically targeting uniform provincial coverage for EoE treatments like Jorveza.

Sponsor / Authority

Health Canada

PPM 161

Supporting Children and Students with Prevalent Medical Conditions in Schools

Mandates that Ontario school boards create Plans of Care for students with non-IgE mediated conditions like FPIES that have the potential for life-threatening incidents.

Rare Disease Management Act

Provides the legislative framework for the national management of rare diseases, mandating coverage of medical expenses and research funding for listed conditions including EoE and systemic mastocytosis.

Management of Insect Sting Anaphylaxis in Primary Care

Sets official protocol for the immediate management of insect sting anaphylaxis and mandates referral to specialized allergy clinics for venom immunotherapy evaluation.

MMA Pathway

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) Clinical Pathway

Establishes the official clinical pathway and surveillance mandate for Mammalian Meat Allergy (MMA/Alpha-gal) resulting from tick bites in Australia.

Sponsor / Authority

Department of Health and Aged Care

Benedict's Law

Allergy Safety in Schools: Statutory Guidance

Mandates that all schools in England maintain a whole-school allergy policy and individual healthcare plans specifically covering venom and food allergies.

ASCIA Action Plan for FPIES

An official medical directive mandated for use in Australian schools and childcare centers to manage and treat Food Protein-Induced Enterocolitis Syndrome emergencies.

UK MDR

The Medical Devices Regulations 2002 (as amended)

Establishes primary labeling requirements for medical devices in the UK, including the mandatory disclosure of latex components in accordance with safety standards.

Intractable Disease Act

Act on Medical Care for Patients with Intractable Diseases

Designates Eosinophilic Esophagitis (EoE) as a 'Designated Intractable Disease' (Nanbyo), providing legal rights for financial subsidies, standardized care, and inclusion in national registries.

Global Food Safety Body Sets New Standard for “May Contain” Allergen Labels

Codex Alimentarius Guidelines on Precautionary Allergen Labelling (PAL)

The FAO/WHO Codex Alimentarius Commission adopted new science-based international guidelines on precautionary allergen labelling, making “may contain” statements risk-based, harmonized, and consistent worldwide.

Budesonide orodispersible tablet for treating eosinophilic esophagitis

Official national health technology mandate requiring the NHS to cover budesonide for treating EoE in adults.

Sponsor / Authority

National Institute for Health and Care Excellence

Walking the tick-borne disease tightrope

Formal government recommendation and report mandating surveillance and public education regarding tick-borne allergies including Alpha-gal.

National Strategic Action Plan for Allergic Diseases

A government-funded mandate that specifically includes FPIES and EoE in national allergy education and clinical support programs.

Sponsor / Authority

Department of Health and Aged Care

Real Decreto 1030/2006, de 15 de septiembre, por el que se establece la cartera de servicios comunes

Establishes the common service portfolio of the national health system, which mandates coverage for rare digestive diseases like EoE.

EU/3/13/1155: Orphan designation for budesonide for the treatment of eosinophilic esophagitis

Formally recognizes EoE as a rare disease within the EU, providing research incentives and regulatory protection for treatments.

Sponsor / Authority

European Medicines Agency

Pharmalgen for the treatment of bee and wasp venom allergy

Mandates NHS coverage for Pharmalgen venom immunotherapy for patients who have had severe systemic reactions to bee or wasp stings.

Sponsor / Authority

National Institute for Health and Care Excellence

ICD-11 4B02.2 Mast cell activation syndrome

Official international diagnostic classification mandate that formally recognizes MCAS as a distinct disease entity.

EU/3/05/275: Orphan designation for midostaurin for the treatment of systemic mastocytosis

Provides formal recognition and research incentives for aggressive systemic mastocytosis as a rare disease.

Sponsor / Authority

European Medicines Agency

Resolução da Diretoria Colegiada - RDC Nº 37 de 2014

Establishes mandatory labeling for medical and dental products that contain natural rubber latex.

Medical Devices Rules, 2017

Mandates that medical device labels must specify if they contain natural rubber latex under Rule 44.

Sabrina's Law

An Act to protect anaphylactic pupils (Sabrina's Law)

Requires every school board to establish anaphylaxis policies, including individualized plans for pupils at risk from insect stings.

NICE Venom Immunotherapy Guidance

NICE Technology Appraisal: Pharmalgen for the treatment of bee and wasp venom allergy

Mandates NHS coverage of venom immunotherapy for patients who have had severe systemic reactions to bee or wasp stings.

Japan Food Labeling Standard

Food Labeling Act: Mandatory Allergen Labeling

Specifies 8 mandatory (including walnut and buckwheat) and 21 recommended ingredients for allergen labeling on packaged food.

Sponsor / Authority

Consumer Affairs Agency (CAA)

Food Reform 2025

Public Health Protection (Food) Law: Adoption of EU Regulation 1169/2011

Adopts advanced EU labeling standards requiring bolded allergens in the ingredient list and special labeling for fava beans for G6PD protection.

Sponsor / Authority

Ministry of Health

Ryan's Law

Ryan’s Law (Ensuring Asthma Friendly Schools)

Requires Ontario school boards to develop asthma policies and allows students to carry their emergency inhalers with parental permission.

EU Medical Device Regulation (MDR)

Regulation (EU) No 2017/745 on medical devices

Mandates explicit labeling of medical devices containing natural rubber latex to protect sensitive patients and healthcare workers.

Singapore Food Regulations: Regulation 5 and the Tenth Schedule

Requires the declaration of ingredients known to cause hypersensitivity, including cereals containing gluten, nuts, and fish products.

Sponsor / Authority

Singapore Food Agency (SFA)

Sabrina's Law

Sabrina’s Law: An Act to protect anaphylactic pupils

Mandates that every publicly funded school board in Ontario establish and maintain an anaphylaxis policy to protect students with life-threatening allergies.

Benedict's Law

Benedict's Law (The School Allergy Safety Bill)

Mandatory national protections requiring schools in England to have whole-school allergy policies, trained staff, access to spare adrenaline auto-injectors, and individual allergy action plans — named in memory of five-year-old Benedict Blythe, who died from anaphylaxis at school in 2021.

MFDS Gluten Standard

Food Labeling Standards

Establishes a 20 ppm threshold for labeling food products as 'gluten-free' in South Korea.

Sponsor / Authority

Ministry of Food and Drug Safety

CAA Gluten Labeling

Food Labeling Standards

Japan's voluntary gluten-free labeling guidelines for rice flour and other products set a 10 ppm threshold based on the ELISA method.

Commission Implementing Regulation (EU) No 828/2014

Mandates a maximum limit of 20 ppm for 'gluten-free' labels and 100 ppm for 'very low gluten' labels across all EU member states.

Sponsor / Authority

European Commission

EU FIC Regulation

Regulation (EU) No 1169/2011 - Provision of Food Information to Consumers

Annex II mandates the clear declaration of cereals containing gluten (wheat, rye, barley, oats) in the ingredient list of prepacked foods.

Brazil Gluten Labeling Law

Lei Nº 10.674, de 16 de Maio de 2003

Mandates that all industrialized food products include either 'Contém Glúten' (Contains Gluten) or 'Não Contém Glúten' (Does Not Contain Gluten) on their labels.

FSSAI Gluten Regulation

Food Safety and Standards (Packaging and Labelling) Regulations, 2011

Sets the standard for 'Gluten-Free Food' at below 20 mg/kg (20 ppm) and mandates specific label declarations.

Sponsor / Authority

Food Safety and Standards Authority of India

EMA Wheat Starch Guidance

Information for the package leaflet regarding wheat starch (containing gluten) used as an excipient

Specifies that medicinal products with wheat starch containing less than 20 ppm gluten are regarded as 'gluten-free' for labeling purposes.

Sponsor / Authority

European Medicines Agency

Joint Resolution 32/2023 - Amendment to Article 1383 of the Argentine Food Code

Updates the definition of 'gluten-free' in the Argentine Food Code to a maximum threshold of 10 mg/kg (10 ppm).

R5 Mendez Method Standard

Methods of Analysis for Gluten in Foods

Endorses the R5 Mendez ELISA method as the Type I method for the determination of gluten in food with a detection limit of 5 ppm.

Medicinal Milk Law

Ley 27.305: Leches Medicamentosas

Requires all health insurance and social security providers to provide 100% coverage for medicinal formulas for conditions including FPIES and EoE.

Government Response to Senate Inquiry: Growing evidence of an emerging tick-borne disease

Officially recognizes mammalian meat allergy (Alpha-gal) as a tick-borne condition and commits to funding research and awareness initiatives.

Norma Oficial Mexicana NOM-006-SSA3-2011, Para la práctica de la anestesiología

Sets mandatory standards for anesthesia practice requiring the identification and clinical management of patients with latex allergy.

Health Products (Medical Devices) Regulations

Regulates the labeling of natural rubber latex in medical devices to ensure appropriate warnings are provided to healthcare users and patients.

Medical Device Act (South Korea)

Mandates labeling requirements for medical devices containing natural rubber latex to prevent severe hypersensitivity reactions in clinical settings.

Sponsor / Authority

Ministry of Food and Drug Safety

Arrêté du 8 juin 2006 relatif au projet d'accueil individualisé pour raisons de santé

Establishes the Individualized Care Project (PAI) protocol in schools for managing children with severe allergies, including insect sting anaphylaxis.

Natural Health Products Regulations (SOR/2003-196)

Mandates that any natural health product containing natural rubber latex must disclose it on the label to protect allergic consumers.

Sponsor / Authority

Health Canada

Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015

Allows trained non-medical persons to administer adrenaline in emergency situations to treat anaphylaxis caused by stings or other allergens.

Sponsor / Authority

Minister for Health

PBS Formula Subsidy

National Health (Listing of Pharmaceutical Benefits) Instrument 2012

Provides federal subsidies for specialized amino acid formulas specifically for infants and children diagnosed with Eosinophilic Esophagitis and FPIES.

Sponsor / Authority

Department of Health and Aged Care

Resolução da Diretoria Colegiada - RDC nº 67/2016

Establishes mandatory warning requirements for the presence of natural rubber latex in health products to ensure patient and worker safety.

Food and Drug Regulations (Allergen Labelling)

Requires the declaration of priority food allergens, gluten sources, and added sulphites on the labels of most prepackaged products.

Sponsor / Authority

Health Canada

Food Labeling Act

Establishes a dual system of mandatory (e.g., egg, milk, wheat, buckwheat, peanut, shrimp, crab, walnut, cashew) and recommended allergen labeling.

Sponsor / Authority

Consumer Affairs Agency (CAA)

NOM-051-SCFI/SSA1-2010 General labeling specifications for prepackaged food

Sets mandatory standards for Mexican food labeling, including the identification of ingredients that cause hypersensitivity or allergies.

Food Regulations (Chapter 283, Section 7)

Requires the declaration of specific ingredients known to cause hypersensitivity, such as cereals containing gluten, nuts, and eggs.

Sponsor / Authority

Singapore Food Agency (SFA)

The Human Medicines (Amendment) (No. 2) Regulations 2017

Allows schools to obtain and hold spare adrenaline auto-injectors (AAIs) without a prescription for emergency use on pupils at risk of anaphylaxis.

PEAL

Food Standards (Proposal P1044 – Plain English Allergen Labelling) Amendment Code

Amends the Food Standards Code to require allergen declarations in simple, consistent terminology and bold formatting in specific label locations.

Health (Miscellaneous Provisions) Act 1911 - Anaphylaxis Management

Enables the supply and administration of epinephrine by trained non-medical persons in emergency settings like schools.

Food Safety and Standards (Labelling and Display) Regulations, 2020

Mandates the bold declaration of common allergens, such as milk, nuts, and cereals containing gluten, on prepackaged food labels.

Resolução da Diretoria Colegiada RDC Nº 727/2022 (General Labelling of Pre-packaged Foods)

Consolidates mandatory labeling requirements for allergens, requiring specific alerts like "ALÉRGICOS: CONTÉM..." for major food triggers.

Act on Labeling and Advertising of Foods

Requires the mandatory declaration of 21 food allergens, including meat products like pork, beef, and chicken, on packaged food labels.

LIV

Ordinance on the Information on Foodstuffs

Mandates the declaration of 14 categories of allergens in all food products, including strict thresholds for 'may contain' trace labeling.

Health Canada's Position on Gluten-Free Claims

Prohibits gluten-free claims if gluten is intentionally added or exceeds 20 ppm due to cross-contamination.

Sponsor / Authority

Health Canada