Food for Special Medical Purpose(FSMP) Regulation
Jul 10, 2019
Jocelyn Sun
Pedia Details Our Service Read More
CONTENTS

1. Definition


Food for special medical purpose (hereinafter FSMP) refers to formula foods specially processed and prepared in order to meet special needs for nutrient or diet of those suffering from food intake restriction, disorder of digestive absorption, disorder of metabolic or certain diseases. Such foods shall be used alone or together with other foods under the guidance of a doctor or clinical nutritionist. FSMP is special dietary food, not medicine, but not ordinarily eaten by normal people. It is specially developed by clinicians and nutritionists based on scientific facts after extensive medical research.

2. Background



fsmp_bg.png

3. Classification


fsmp_classification.pngTable 1 FSMP for infants between 0-12 months (below)

Categories

Future Trends

  • Lactose free or low lactose formula food

  • Partially hydrolyzed milk protein formula food

  • Extensively hydrolyzed milk protein formula food

  • Amino acid-based formula food

  • Premature or low birth weight infant formula food

  • Infant nutrition food

  • Amino acid metabolism disorder formula food

  • Ketogenic formula

  • Anti-reflux formula

  • abnormal lipid metabolism

  • High energy formula

  • Protein components

  • Medium chain triglycerides

For more details: SAMR Adjusts Generic Names of FSMP Products

Table 2 FSMP for young children and people over 1 year old (below)

Categories

Particular Group

Nutritionally Complete Formula Food

 For people aged 1-10 years

 For people aged above 10 years

Specific Full Nutritional Formula Food

  1. For diabetics;

  2. For respiratory system disease patients;

  3. For kidney disease patients;

  4. For cancer patients;

  5. For hepatic insufficiency

  6. For muscle attenuation syndrome patients;

  7. For patients with trauma, infection, surgery or other stress condition;

  8. For patients with inflammatory bowel disease;

  9. For food protein allergy sufferers;

  10. For patients with intractable epilepsy;

  11. For patients with gastrointestinal disorders, pancreatitis;

  12. For patients with fatty acid metabolism;

  13. For patients with obesity, fat reducing surgery.

Nutritionally Incomplete Formula Food

  1. Nutrient component

  2. Electrolyte formula

  3. Thickener component

  4. Liquid component

  5. Formula for amino acid metabolic patients

Definition:

  • Nutritionally Complete Formula Food: FSMP that can be used as the sole source of nutrition to meet all the nutritional needs of the target population.

  • Specific Full Nutritional Formula Food: FSMP that can be used as a single source of nutrients to meet the nutritional needs of the target population in specific diseases or medical conditions.

  • Nutritionally Incomplete Formula Food: FSMP that can meet some of the nutritional needs of the target population, not suitable as a sole source of nutrition.

For more details: Detailed Rules for Licensing and Review of FSMP Production

4. Supervision System


fsmp_supervision.png*Note:

  • SAMR: State Administration for Market Regulation

  • NHC: National Health Commission

  • GAC: General Administration of Customs

4.1 Regulatory Framework

Law

Food Safety Law

Product Standards

GB 29922-2013 National Food Safety Standard General Rules for Foods for Special Medical Purposes

GB 25596-2010 National Food Safety Standard General Rules of Infant Formula Foods for Special Medical Purposes

GB 29923-2013 National Food Safety Standard Production Standard for Food for Special Medical Purposes Enterprise

Registration Regulations

Application Materials and Requirements for Registration of Formula Food for Special Medical Purposes (For Trial) (2017)

Measures for the Administration of Registration of Formula Food for Special Medical Purposes (2016)

Key Points and Judgment Principles of On-Site Inspection for Registered Manufacturers of Formula Food for Special Medical Purposes (For Trial) (2016)

Research Requirements on Stability of Formula Food for Special Medical Purposes (For Trial) (2017)

Manufacture & Operation   Regulations

Measures for the Administration of Food Production Licenses (2015)

Detailed Rules for Examination of the Production License of Formula Food for Special Medical Purposes (2019)

Labeling

Requirements for Labels and Sample Instructions of Formula Food for Special Medical Purposes (For Trial) (2016)

GB 13432-2004 General Standard for the Labeling of Prepackaged Foods for Special Dietary Uses (2004)

Guidelines for Clinical Trails

Quality Control Standards for Clinical Trials of Formula Food for Special Medical Purposes (For Trial) (2016)

5. Management Mechanism


5.1 Registration System

Process

fsmp_process1.png


Flow Chart 1 Applicant Material Preparation Process (above)

fsmp_process2.png

Flow Chart 2 Administrative Process (above)

Requirements & Materials

  • Applicant:

For domestic applicants: Enterprises manufacture and sell formula food for special medical purpose within the territory of the People's Republic of China.

For overseas applicants: Enterprises that export formula food for special medical purpose to the People's Republic of China.

  • Requirements:

  1. Having necessary capacities in research and development, production and inspection to manufacture FSMP.

  2. A research and development institution for FSMP shall be established, with full-time product research and development personnel, food safety management personnel and food safety professional and technical personnel.

  3. Establish production quality management system according to good production specification

  4. Having the ability to inspect all items batch by batch according to the national standard of FSMP.

  5. There shall be persons with senior titles or corresponding professional abilities in research and development institutions.

  • Materials:

  1. Registration application form of FSMP;

  2. Product research and development report, product formulation      design and basis;

  3. Production process materials;

  4. Product standard requirements;

  5. Product label and specification sample;

  6. Test sample inspection report;

  7. Research and development, production and inspection capability      certification materials;

  8. To apply for the registration of specific full nutritional      formula food, a clinical trial report shall also be submitted;

  9. Supporting documents related to the registration application.

5.2 Labeling System


It is not allowed for FSMP to claim that it can guarantee the prevention or treatment of diseases.

For more detailed labeling requirements, please refer to: Requirements for Labels and Sample Instructions of Formula Food for Special Medical Purposes (For Trial)

6. Our Service


pedia_infant_formula_service.png