New food raw material was originally regulated in China under the name “novel foods”. In 2009, “novel food” was changed to “new food raw material” in the Food Safety Law. From 2008 to 2013, 85 new food raw materials have been approved in China.

1. What is new food raw material?

1.1 Definition

The materials that are used for food processing and are not traditionally consumed in China are classified as new food raw materials, including:

(1)    The materials that are derived or separated from animals, plants and microorganisms;

(2) The food materials whose original structure changes;

(3) Other newly developed food raw materials

1.2 Characteristics of new food raw materials

(1) Not traditionally consumed in China

(2) With the characteristics of food raw material

(3) Conforming to current nutritional requirements

(4) Non-toxic and harmless, will not have any form of harm whether it is acute, sub-acute or chronic or have other potential hazards

It is not classified as new food raw material in one of the following circumstances:

(1) The new food raw materials that are traditionally consumed in China: it has been manufactured or sold in China for more than 30 years as standardized packaged food or non-standardized packaged food, which has not been recorded in Chinese Pharmacopoeia.

(2) The new food raw materials that are equal to traditional foods or have been approved

It is not in the scope of declaring as new food raw materials in the following circumstances:

(1) Without the characteristics as food raw material;

(2) Having been listed in Food Safety National Standard for Uses of Food Additives (GB 2760) and Food Safety National Standard for Uses of Food Nutrition Enhancer (GB14880);

(3) The decision of non-administrative licensing made by National Health Commission now;

(4) Other situations that do not conform to relevant laws, regulations and requirements for new food raw material management

1.3 Products related to new food raw materials

Drugs (including traditional Chinese medicinal materials) – It is the materials that are used for preventing, curing and diagnosing diseases, adjusting the physiological function with adaptation diseases, main functions, usage and dosage, which is managed by batch numbers.

Health food – It refers to the foods that are claimed with specific healthcare functions. It is approved and supervised by China Food and Drug Administration by batch numbers.

Food additives –managed by standards (GB 2760): New varieties or the products with extended application scope and dosage should be approved by National Health Commission.

Nutrition enhancers – managed by standards (GB 14880): New varieties or the products with extended application scope and dosage should be approved by National Health Commission.

The materials both consumed as foods and traditional Chinese medicinal materials traditionally should be managed according to the Administrative Measures on Ban on Adding Medicines in Foods issued by former Ministry of Health (87 in total).

Imported foods without food safety national standards – It refers to the foods that are imported without applicable food safety national standard formulated in China (applicable standard upon approval)

2. Regulatory framework

2.1 History

According to Food Hygiene Law (For Trial Implementation) (1982), for food production with new materials, the materials and samples needed by hygienic assessment and nutritional evaluation of the products must be submitted before production for approval.

In 1987, former Ministry of Health (MOH) issued Hygienic Administrative Measures on Novel Foods, which was amended in 1990 and 2007 respectively.

From 1987 to 2007, 76 novel foods were approved by former Ministry of Health (MOH).

In 2009, the name of “novel foods” was replaced by “new food raw materials” according to Food Safety Law.

On May 31st 2013, Administrative Measures for the Safety Review of New Food Raw Materials was issued by National Health and Family Planning Commission (National Health Commission now) according to Food Safety Law (2009), which came into force on Oct 1st 2013.

2.2 Legal basis

Food Safety Law of the People’s Republic of China

Administrative Permission Law of the People’s Republic of China

Measures for the Administration of Sanitary Administrative Licenses

Administrative Measures for the Safety Review of New Food Raw Materials

Regulations on Declaration and Acceptance of New Food Raw Materials

Administrative Measures on Safety Examination of New Food Raw Materials

Guideline for Application Materials for Safety Assessment Opinions of New Food Raw Materials (Trial)

3. Declaration of new food raw materials

3.1 Product categories of new food raw material declaration

(1) The animals, plants and microorganisms that are not traditionally consumed in China, including animals, plants, bacteria, macro fungi, and algae;

(2) The food raw materials separated from animals, plants and microorganisms that are not traditionally consumed in China;

(3) The food raw materials whose original ingredients or structures change due to the new production techniques;

(4) New varieties of microorganism used in food processing;

(5) Others (such as the new food raw materials after chemical synthesis)

3.2 Product analysis of new food raw material declaration

(1) New oils and functional oligosaccharide

New varieties of oil extracted from the fruits or seeds of plants (trees, flowers, vegetables and traditional Chinese medicinal materials)

Unsaturated fatty acid grease extracted from animals, algae and fungi

Fatty acid and lipid converted from esterification reaction

(2) Declaration of traditional Chinese medicinal materials

(3) Declaration of non- medicinal parts of medicinal plants

4. New food raw material registration

4.1 Materials submitted for new food raw material registration

According to Regulations on Declaration and Acceptance of New Food Raw Materials, the materials that should be submitted for new food raw material registration include:

(1) Application form

(2) Research report

(3) Safety evaluation report

(4) Production technology

(5) Relevant standards (including safety requirements, quality specifications, inspection approaches, etc.)

(6) Labels and instructions

(7) Research and utilization status at home and abroad and relevant safety evaluation materials

(8) Other materials useful for the evaluation

One sample of the product that has not been opened, or 30g raw materials

Declaration of imported products: sales certificate allowable by exporting countries or districts + legal business certificate of the enterprise

4.1.1 Research report includes:

(1) Background, objective and basis of R&D

(2) Names: including product name, generic name, chemical name (including chemical unified code, English name, Latin name, etc.

(3) Source of raw materials: described as required according to the characteristics of the category

(4) Major nutritional ingredients and contents, or natural hazardous substances that may possibly contain (such as natural toxins or anti-nutritional factors)

(5) Consumption data: geographical consumption data at home and abroad, groups of people, consumption volume, time for consumption, and adverse reaction, etc.

(6) Range of application, application amount, and relevant evidence for identification

(7) Recommended nutrient intake, suitable group of people, and relevant evidence for identification

(8) Contrastive analysis materials should also be provided if it is essentially equivalent to foods or approved new food raw materials

4.1.2 Safety evaluation report includes:

(1) Ingredient analysis report: including major ingredients, inspection result and approach for the ingredients that may possibly be harmful

(2) Hygienic inspection report: the inspection result and approach of pollutants and microorganisms of 3 batches of representative samples

(3) Toxicological evaluation report: it will be evaluated according to the classification, consuming history, consuming scope, potential harm, etc.

(4) Microorganism drug resistance testing report and toxin-producing capability testing report

(5) Safety evaluation: issued by qualified risk evaluation technique institute

Item (1), (3) and (4) should be issued by the inspection institute in China with China Metrology Accreditation of Food (CMAF), and Item (3) and (4) for imported products should be issued by overseas laboratories that conform to Good Laboratory Practice (GLP).

4.1.3 Production technology

Generally, the technological process, major raw materials, ingredients and auxiliaries as well as the impurities and hazardous substances that may possibly be generated should be described in details.

The requirements are as follows for different sources:

(1) For animals and plants: production technological process, key steps and conditions, collection site, collection date, environmental background, and possible pollution sources, etc.

(2) For microorganisms: fermentation medium components, condition of culture, key technical parameters of all links, etc.

(3) The food ingredients that are separated from animals, plants and microorganisms or with changed original structure: process flowchart and instructions of raw material processing and extracting

(4) For the food ingredients with changed original structure should also be provided with the approaches, principles and technologies for the structural change.

4.1.4 Imported new food raw materials

(1) Relevant departments or institutes of the exporting countries (districts) issue the certification materials that allow the production and sales of the product in the country (district) (issued by governmental competent authorities or industrial associations).

(2) Relevant departments or institutes of the exporting countries (districts) where the manufacturers are located issue the certification materials for the examination or authentication of the manufacturers.

(3) The declaration materials for signature or the signature and document issuance date of the legal representative (or the authorized person) should be recorded. The recorded name of new food raw materials and the name of the applicant should be identical to the application content.

(4) If the certification documents are written by foreign language, it should be translated into Chinese, which will then be notarized by Chinese notary public.

(5) On-site inspection can be organized if the certification materials cannot be submitted.

4.2 Registration procedure

4.3 Participants of new food raw material registration and their major responsibilities

4.4 Technical review conclusions

(1) Suggested for approval:

Announced to approve as new food raw materials (or for revision)

(2) Terminated for approval:

• Managed as food

• Managed as food and in accordance with specified implementation standard

• Substantial equivalence: managed as food or new food raw materials that have been approved

• Managed as recognized traditional consumption history

(3) Suggested for non-approval:

• Without the characteristics of food raw materials

• Not conforming to the nutritional requirements

• Security cannot be guaranteed

• Declaration materials or samples are not true

• Other conditions that do not comply with relevant laws and regulations of China

Notes: All the approved China new food raw materials can also be checked in our F-lists.

5. Our services