Comparison of Domestic and Foreign Laws and Regulations on Foods for Special Medical Purposes

China,Food,Regulation,Special,Medical,Purpose

Foods for special medical purposes (FSMP) are a category of foods for special dietary uses which are specially processed or formulated and presented for the dietary management of patients and can be used only under the guidance of doctor or clinical dietitian. They are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb or metabolize ordinary foodstuffs or certain nutrients contained therein, or who have other special medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for special dietary uses, or by a combination of the two.

FSMP have been widely used in many developed countries such as USA, EU, Japan, Australia and New Zealand, as early as the 1980s, and the corresponding management regulations and standards have been formulated. Based on these regulations and experience as well as the clinical nutrition research, relevant standards and regulations have been developed in China as well, such as GB 29922 General Rules of Foods for Special Medical Purposes, and GB 25596 General Principles of the Formulas for Special Medical Purposes Intended for Infants.

CIRS has compared and analyzed the regulations and standards related to FSMP in different countries in order to help enterprises to understand them better. The details are demonstrated below in table 1.

Table 1. Comparison of domestic and foreign laws and regulations on FSMP

	China	CAC	USA	EU	ANZ	Japan
Name	FSMP	FSMP	Medical Foods	FSMP	FSMP	Food for Sick
Category	lformulas for special medical purposes intended for infants lnutritionally complete foods lspecific nutritionally complete foods lnutritionally incomplete foods	/	lnutritionally complete foods lnutritionally incomplete foods lformulas for metabolic (genetic) disorders in patients over 12 months of age loral rehydration product	lnutritionally complete foods with a standard nutrient formulation lnutritionally complete foods with a nutrient-adapted formulation specific for a disease, disorder or medical condition lnutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation	lnutritionally complete foods lformulate for very low energy diets	lnutritionally complete formulas llow protein formulas lanaphylaxis formulas llactose free formulas
Food additives	Comply with GB 2760 and relevant quality Standards	Comply with CODEX STAN 72-1981	Comply with the requirements specified in Food Additive and quality Standards within the countries			Evaluation and approval of products by the Ministry of Health and Welfare of Japan
Nutrients	Comply with the requirements specified in GB25596、GB29922	Comply with the requirements specified in CODEX STAN 72-1981	GRAS(Generally Recognized as Safe) permitted substances	Comply with the requirements specified in COMMISSION DIRECTIVE 1999/21/EC and COMMISSION REGULATION(EC) No 953/2009	Comply with the requirements specified in Australia New Zealand Food Standards Code standard 2.9.5 and schedule 29
Labeling	Comply with the requirements specified in GB13432、GB25596、GB29922	Comply with the requirements specified in CODEX STAN 180-1991	/	Comply with the requirements specified in COMMISSION DIRECTIVE 1999/21/EC	Comply with the requirements specified in Australia New Zealand Food Standards Code standard 2.9.5
Microorganism	Comply with the requirements specified in GB25596、GB29922	Comply with the requirements specified in CODEX STAN 72-1981	/	Comply with the requirements specified in COMMISSION REGULATION (EC) No 2073/2005	/
Contaminants	Comply with the requirements specified in GB25596、GB29922	Comply with the requirements specified in CODEX STAN 72-1981	/	/	Comply with the requirements specified in Australia New Zealand Food Standards Code standard 1.4.1 and Schedule 19
Production and quality supervision	Comply with the requirements specified GB 29923	Comply with the requirements specified in CAC/RCP 1-1969	Comply with the requirements specified in Code federal regulation-Title 21 Part 110	Comply with the requirements specified in REGULATION (EC) No 852/2004	/
Listing license	Necessary	/	Unnecessary	Unnecessary	Unnecessary	Necessary

Since 2010, Chinese government has published the GB 25596, GB 29922 and Administrative Measures on Foods for Special Medical Purposes Registration, etc. The major laws and regulations for FSMP around the world are summarized by the CIRS group, as shown in table 2.

Table 2. The summarization of the major laws and regulations for FSMP around the world

Countries	The laws and regulations
China	Food Safety Law of the People’s Republic of China (2015 version) Administrative Measures on Foods for Special Medical Purposes Registration Dossiers Requirements for Foods for Special Medical Purposes Registration (trial)( 2017 revision) Clinical Trials Quality Control Specification of Foods for Special Medical Purposes (trial) Stability Research Requirements for Foods for Special Medical Purposes (trial)( 2017 revision) Labeling and Instructions Manuscript Requirements for Foods for Special Medical Purposes (trial) Key Points and Judgment Principles of On-site Inspection for Manufacturers of FSMP Registration (trial) GB 25596-2010 Food Safety National Standard, General Rules of the Formulas for Special Medical Purposes Intended for Infants GB 29922-2013 Food Safety National Standard, General Rules of Foods for Special Medical Purposes GB 29923-2013 Food Safety National Standard, Good Manufacturing Practices for Foods for Specific Medical Purposes GB 13432-2013 Food Safety National Standard, General Rules for the Labeling of Prepackaged Food for Special Dietary Uses GB 14880-2012 Food Safety National Standard, the Usage of Nutrition Enhancers GB 2760-2014 Food Safety National Standard, the Usages of Food Additives
CAC	CODEX STAN 72-1981 Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants CODEX STAN 180-1991 Standard for Labeling of and Claims for Foods for Special Medical Purposes） CAC/RCP 1-1969 General Principles of Food Hygiene
USA	Code federal regulation- Title 21
EU	COMMISSION DIRECTIVE 1999/21/EC Dietary Foods for Special Medical Purposes COMMISSION REGULATION(EC) No 953/2009 Substances that May Be Added for Specific Nutritional Purposes in Foods for Particular Nutritional Uses COMMISSION REGULATION (EC) No 2073/2005 Microbiological Criteria for Foodstuffs REGULATION (EC) No 852/2004 The Hygiene of Foodstuffs
ANZ	Australia New Zealand Food Standards Code Standard 2.9.5 Food for Special Medical Purposes Australia New Zealand Food Standards Code Schedule 29 Special Purpose Food Australia New Zealand Food Standards Code Standard 1.4.1 Contaminants and natural toxicants Australia New Zealand Food Standards Code Schedule 19 Maximum levels of contaminants and natural toxicants
Japan	Health Promotion Act in Japan (Law No. 103 of 2002)

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