|Food Safety Law of the People’s Republic of China|
|Administrative Permission Law of the People’s Republic of China|
|NHC (National Health Commission)|
|Main Supporting Rules|
|Oct. 1, 2013||Administrative Measures for the Safety Review of New Food Raw Materials|
|Jul. 23, 2004||Measures for the Administration of Sanitary Administrative Licenses|
|Oct. 15, 2013||Regulations on Declaration and Acceptance of New Food Raw Materials|
|Oct. 15, 2013||Safety Review Procedure of New Food Raw Materials|
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.
Part I. What is new food raw material?
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)
Part II. Regulatory framework
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.
85 new food raw materials had been approved from 2008 to 2013 (until January 2014).
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
Part III. 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
Product category diagram for new food raw material declaration
Part IV. 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
Research and development, carrying out safety evaluation, and submitting declaration materials (on-site debate when necessary, and accepting on-site examination)
National Center for Health Inspection and Supervision
Expert reviewing committee is established to arrange the date and venue for reviewing, and record and deal with the reviewing comments. Time for transaction, declaration requirements, declaration procedure, and time limit should be notified, and consultancy service for declaration should be provided.
Expert reviewing committee
Chairman of the committee
Vice chairman of the committee
Recommended by committee members to coordinate the reviewing activity and organize to identify relevant problems and solutions
Reviewing the materials by group, putting forward and discussing the problems, and signing the reviewing comments
Collecting the reviewing data and comments
National Health Commission of the People’s Republic of China
Making decisions on administrative licensing according to the technical reviewing conclusions of the experts
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
Part of new food raw materials that have been approved:
Macro fungi (8)
The type with changed structure or composite structure (6)
Sessileflower acanthopanax bark, aloe vera, gynura divaricate, golden camellia, inula nervosa wall, Noni puree, MACA powder, ginseng (cultivated ginseng), horseradish tree leaves, lindera aggregata leaves, tea flower, Acai, Paeonia ostii T.Hong et J.X.Zhang, isodon lophanthoides var.gerardianus, cyclocarya, ampelopsis grossedentata
Lactobacillus casei, lactobacillus paracasei, lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus plantarum, lactobacillus plantarum, lactobacillus plantarum
Cordyceps militaris, dunaliella salina, haematococcus pluvialis, chlorella pyrenoidosa, Phylloporia ribis（Schumach:Fr.）Ryvarden, cordyceps guangdongensis, euglena gracilis, kluyveromyces marxianus
12 vegetable oils, 10 polysaccharides, 7 protein peptides, and 13 other extracts
Diglyceride, sucrose polyester, long-chain fatty acid triglyceride, arochidonic acid oil, Calcium β-Hydroxy-β- Methyl-Butyrate, D-Fructose-1,6-diphosphate trisodium salt octahydrate
42 extracted new food raw materials that have been approved:
Vegetable oil (12)
Protein, peptide and amino acid (7)
Mawseed oil, eucommia seed oil, tea seed oil, acer truncatum buge oil, peony seed oil, samara oil, suaeda salsa seed oil, sacha inchi oil, sumac fruit oil, amygdalus pedunculatus pall oil, swida wilsoniana oil, krill oil
Polyfructosan, xylooligosaccharide, galactooligosaccharide, inulin, hyriopsis cumingii polysaccharide, isomaltitol, L- arabinose, raffino-oligosaccharide, yeastβ-glucan, mannan-oligosaccharide
Milk basic protein, earthworm protein powder, wheat oligopeptides, colostrum basic protein, corn oligopeptides, globin peptide, phosphatidylserine
Lutein esters, phytosterol, phytosterol ester, plant stanol ester, dunaliella salina extract, fish oil extract, milk minerals, conjugated linoleic acid, conjugated linoleic acid glycerides, sodium hyaluronate, γ-aminobutyric acid, DHA algae oil, saussurea extract, epigallocatechin, gallate
Number of New Food Raw Materials for Declaration and Approval (2004-2013)
Declaration for domestic products
Declaration for imported products
Total of declaration
Total of approval
Notes: some of the declared products are still under approval. All the approved China new food raw materials can also be checked in our F-lists.
Part V. Our services
Food raw material compliance evaluation
(1) Inquire the regulatory compliance situation of the product in China.
(2) Inquire relevant information of toxicology of the product.
(3) Give the suggestions of Chinese sales experts of the product.
Judgment of new food raw materials
(1) Inquire the list of current food raw materials in China.
(2) Communicate with CFDA (now special food registration department of SAMR) for the situation of new food raw materials.
(3) Give the conclusion of whether the product can be classified as new food raw material.
Pre-evaluation of food new raw material registration
(1) Evaluate and verify the application amount of the substance in foods and the use condition in other countries to confirm the materials that need to be prepared and the experimental projects
(2) Verify the toxicology of the product, and ask relevant experts to evaluate the success ratio of its registration.
(3) List detailed materials and requirements for the declaration, and special suggestions given by relevant experts based on the product characteristics.
Food new raw material registration declaration
(1) Analyze the differences between materials available and the materials required for declaration.
(2) Contact with laboratories to arrange the testing.
(3) Track the testing progress and review the testing result.
(4) Compile the declaration materials of food new raw materials according to the information of the enterprise.
(5) Make pre-evaluation of the declaration materials.
(6) Submit the declaration materials and communicate with experts.
(7) Assist the debate with reviewing experts and supplement the materials.
(8) Get the registration certificate and give it back to the enterprise.
Supervision of food new raw material testing
(1) Acquire the basic condition of the laboratory and give relevant suggestions.
(2) Acquire the testing plan and suggestions.
(3) Assist to sign the testing contract.
(4) Track the testing progress and make report of it.
(5) Assist to solve the problems during the testing.
(6) Get the testing result evaluated.
Regulatory consultancy and training