Analysis and Comparison of New Food Raw Material Management Measures in Domestic and Overseas

In recent years, with the rapid development of science and technology in food industry, new food raw material has become a research hotspot in the field of food, more and more raw materials have also been developed and applied. In order to ensure the food security, new food raw materials need to be evaluated, only after passing the safety assessment can raw materials enter the market.

For the purpose of regulating the use of new food raw materials, many developed countries or regions such as the European Union, the United States, Australia and New Zealand have formulated regulations and standards. CIRS will make comparison between the regulations of new food raw materials from the following three aspects to help enterprises clearly understand the relevant provisions:

Regulation

The main management regulations for new food raw materials/ novel food in domestic and overseas are detailed in Tab 1.

Table 1 The list of new food raw material management regulations in domestic and overseas

Country/Region

Regulation

China

Food Safety Law of the People’s Republic of China

Safety Review of New Food Raw Material Regulation

New Food Raw Material Registration and Acceptance Regulation

Process of New Food Raw Material Safety review

Guideline on Application Materials of New Food Raw Material Safety Evaluation Opinion (Trial)

The European Union

Regulation (EU) 2015/2283 of the European Parliament and of the Council

The United States

Federal Register Notice – the GRAS Final Rule (81 FR 54960)

Code of Federal Regulations – Title 21

Australia and New Zealand

Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods

Food Standards Australia New Zealand Regulation of novel foods (July 2017)

Definition

Table 2 Name and definition of new food raw material in domestic and overseas

Country/Region

Name

Definition

China

New food raw material

(former new resource food)

Refers to the following items which does not have the traditional history of consumption in China:

1) Animals, plants and microorganisms;

2) Ingredients isolated from animals, plants and microorganisms;

3) Food ingredient with different original structures;

4) Other newly developed food raw materials.

Note: New food raw material should have the characteristics of food ingredient and meet nutritional requirements of human. It should be non-toxic and harmless, without causing any acute, sub-acute, chronic or other potential harm to human health.

The European Union

Novel Food

Means any food that was not used for human consumption to a significant degree within the Union before 15th May 1997, generally includes following four categories:

1) Food consisting of, isolated from or produced from animals, plants, microorganisms, fungi, algae and mineral materials;

2) Food consisting of, isolated from or produced from cell culture or tissue culture;

3) Food produced with new technology and new structure (including nanometer food and food with molecular modification and new molecular structure, as well as the food, vitamins and minerals with changed composition and structure);

4) Food used exclusively in food supplements.

*Note: Novel food in the EU also include “traditional food from the third country”, which refers to the other food categories in the definition of general novel food except 3) food produced with new technology and new structure 4) food used exclusively in food supplements.

The United States

No specific definition of novel food, managed according to GRAS (generally recognized as safe)

For the substance that can be included in GRAS:

1) The substance is safe or it is deemed to be safe under the conditions of its intended use;

2) The safety of this substance is evaluated and approved by experts qualified by scientific training and experience;

3) The substance has been adequately shown through either scientific procedures or experience based on common use in food to be safe under the conditions of its intended use.

Note: scientific procedures: organize qualified experts to conduct safety assessment of the existing scientific literature and test results, and submit application materials to The FDA Center for Food Safety and Applied Nutrition (CFSAN) for judgment.

Australia and New Zealand

Novel Food

Means a non-traditional food that requires an assessment of the public health and safety considerations, categories of novel foods may include, but are not limited to, the following:

1) plants or animals and their components;

2) plant or animal extracts;

3) herbs, including extracts;

4) dietary macro-components;

5) single chemical entities;

6) microorganisms, including probiotics;

7) foods produced from new sources, or by a process not previously applied to food.

The definition of new food raw material/ novel food in different countries and regions all mentioned “traditional history of consumption” or “human consumption”, while different countries and regions have different interpretations. Specific interpretations are detailed in Tab 3.

Table 3 Definition of traditional history of consumption/ non-traditional food in domestic and overseas

Country/Region

Name

Definition

China

Traditional history of consumption

Refers to a certain stereotyped or non-stereotyped packaged food which has more than 30 years for operation and production in any province in China, and has not been included in the ‘Chinese Pharmacopoeia’.

The European Union

Human consumption

Refers to the food which was used for human consumption to a significant degree within the Union before 15th May 1997.

 

*Note: history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country.

The United States

History of consumption for food

Refers to the substance which has the substantial history of consumption for food use by a significant number of consumers before 1st January 1958.

 

Note: If the substance was found having the adverse health effects during the use before 1st January 1958, or the substance was not generally used, it must be declared accordance with other procedures.

 

Australia and New Zealand

Non-traditional food

1) Food that does not have a history of human consumption in Australia or New Zealand;

2) Substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food;

3) Any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia or New Zealand.

It can be seen from Tab 3 that, most traditional histories are managed by years or specific dates. “Traditional history of consumption”, “Human consumption” and “Non-traditional food” proposed by China, The European Union, Australia and New Zealand are the basis for defining new food raw material. They combine traditional history habits and other aspects to determine whether a substance is a new food raw material or not. As for the “Consumption history” proposed by United States is one of the criteria for judging whether the substance can be included in GRAS. If there is no consumption history, it must be judged according to the “scientific procedure”.

Management system

1) China

  • Management agency: National Health Commission (NHC)
  • Management measure: declaration and approval
  • Main process:
    • The applicant submits the application, Government Hall of the National Health Commission accepts the materials;
    • After the related materials are complete, China National Center for Food Safety Risk Assessment (CFSA) carries out technical review;
    • After passing the technical review, CFSA issues draft for public comments;
    • National Health Commission makes the permission based on the review conclusion from CFSA, and issues the approval announcement.

2) The European Union

  • Management agency:
    • European Commission;
    • European Food Safety Authority, EFSA;
    • Standing Committee for Foodstuffs
  • Management measure: declaration and approval
  • Main process:

Food within the Union

Traditional food from a third country

a) After receiving the application materials, European Commission evaluates its validity;

b) Within 1 month, forward to EFSA for safety assessment;

c) EFSA shall adopt its opinion within 9 months from the date of receipt of a valid application;

d) Within 7 months from the date of publication of the EFSA's opinion, the Commission shall submit to Standing Committee for Foodstuffs a draft implementing act authorising the placing on the market within the Union of a novel food and updating the Union list.

a) After receiving the application materials, European Commission evaluates its validity;

b) Within 4 months from the date on which a valid notification is forwarded by the Commission, a Member State or the Authority may submit to the Commission duly reasoned safety objections to the placing on the market within the Union of the traditional food concerned;

c) Within 1 month, forward to EFSA for safety assessment;

d) EFSA shall adopt its opinion within 6 months from the date of receipt of a valid application;

e) Within 3 months from the date of publication of the Authority's opinion, the Commission shall submit to Standing Committee for Foodstuffs a draft implementing act authorising the placing on the market within the Union of the traditional food from a third country and updating the Union list.

3) The United States

  • Management agency:
    • U.S. Food and Drug Administration, FDA
    • The FDA Center for Food Safety and Applied Nutrition, CFSAN
  • Management measure: managed by GRAS proposed by FDA
  • Main process:

Any person or institution can submit application to FDA stating that a substance belongs to GRAS.

  1. Based on the existing scientific literature and test results, the applicant organizes qualified experts to evaluate and submit materials to CFSAN;
  2. CFSAN evaluates the substance based on the three aspects: ubiquity, utilizability and acceptability;
  3. With the conclusion “FDA has no questions”, the substance can be included in GRAS list.

4) Australia and New Zealand

  • Management agency:
    • Food Standards Australia New Zealand, FSANZ
    • Advisory Committee on Novel Foods, ACNF
  • Management measure: declaration and approval
  • Main process:
    • Applicants can consult ACNF to determine whether the substance is novel food;
    • If the substance conforms to the properties of food, it is necessary to further determine whether it is "non-traditional food";
    • After determining the category of applied substance, ACNF will further clarify whether the product needs to be evaluated for safety;
    • If necessary, the evaluation shall be carried out in accordance with the procedures stipulated by FSANZ. After passing the evaluation, this substance will be included in the list of novel food.
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