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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