Administrative Measures For The New Food Ingredient Safety Review

Original Language Title: 新食品原料安全性审查管理办法

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Administrative measures for the new food ingredient safety review

    (May 31, 2013 national health planning Commission released 1th come into force October 1, 2013) first to standardize the new food ingredient safety assessment material review process under the People's Republic of China Food Safety Act and its regulations for the implementation of the relevant provisions of these measures.

    Second new food ingredients means there is no traditional eating habits of the following items:

    (A) the animals, plants and micro-organisms;

    (B) separation of components from the animals, plants and micro-organisms;

    (C) the original structure changes of food ingredients;

    (D) other new food ingredients.

    Third new food ingredient should have the characteristics of food raw materials, in line with the proper nutritional requirements, and nonpoisonous, harmless to human health do not cause any acute, subacute, chronic, or other potential hazards.

    Four new food ingredient safety review shall, through the National Health Commission before they can be used for food production.

    Fifth National Health Commission is responsible for the new food ingredient safety assessment material review and licensing work.

    State family planning Commission is a member of health and health monitoring centre assumed new food ingredient safety assessment materials declared inadmissible, review of the Organization to carry out security assessments and other specific tasks.

    Sixth proposed new food raw material producing, using or importing entity or individual (hereinafter the applicant), shall apply and submit the following materials:

    (A) the application form;

    (B) report of the development of new food ingredients;

    (C) the safety assessment report;

    (D) the production process;

    (E) implementation of relevant standards (including safety requirements, specifications, test methods, and so on);

    (F) the labels and instructions;

    (VII) safety assessment research and related information;

    (H) other information useful to review.

    Not unsealed by the attached sample 1 or 30 grams of raw materials.

    Article seventh application for import of new food ingredients, except as provided in article sixth of the materials, shall also submit the following materials:

    (A) the exporting country (region) issued by the relevant departments or agencies allows the product to national (regional) production or sale of documents;

    (B) the State in which the manufacturer (area) issued by relevant agencies or organizations of production enterprises review or certification of documents.

    Article the applicant shall submit the relevant materials and reflect the true situation, responsible for the authenticity of the content of the application materials, and legal responsibilities.

    Article the applicant submitted to the first paragraph of this article sixth second to sixth when material, you should indicate which does not involve trade secrets, content that can be offered to the public.

    Tenth State Health Commission accepted new food ingredient applications, to the public for comment.

    11th National Health Commission from accepting new food ingredient within 60 days from the date of application, should organize experts to review the new food ingredient safety assessments, conclusions of the review.

    Article 12th review process requires additional information, it shall promptly inform the applicant in writing, the applicant shall request additional relevant information in a timely manner.

    According to review needs and may require the applicant to respond to questions about technical issues, shall cooperate with the applicant. 13th in the process of reviewing the need for field verification, production, may appoint an expert to verify the development and production of new food ingredients, and provide on-site verification, experts on the issue of on-site verification responsibilities.

    Provincial health inspection agencies shall cooperate with.

    Experts participating in the on-site verification product safety assessment review does not participate in the vote.

    14th new food ingredient safety assessment material review and licensing of specific procedures in accordance with the administrative licensing law, the administrative authorization management procedures and other relevant laws and regulations shall apply.

    15th national health family planning according to the new food ingredient safety review findings, to meet the food safety requirements, granted permission and notice does not meet the food safety requirements, grant licenses, and state the reason in writing.

    With the food or the announcement of substantial equivalence to the new food ingredients, terminate the review decision should be made, and shall inform the applicant.

    16th according to different characteristics of the new food ingredients, notice may include the following:

    (A) name;

    (B) the source;

    (C) the production process;

    (D) the main component;

    (E) the quality specifications;

    (Vi) labeling requirements;

    (VII) other contents of the notice.

    17th under any of the following circumstances, the National Health Commission shall organize a review published new food ingredients:

    (A) with the development of science and technology, questions about the safety of new food ingredients;

    (B) there is evidence that the safety of new food ingredients there may be a problem;

    (C) other circumstances that need to be re-examined.

    Review does not meet the food safety requirements the new food ingredients, the National Health Commission may revoke the license.

    18th new food ingredients production unit shall be announced in accordance with new food ingredients required for production, ensure the safety of new food ingredients.

    19th new food ingredients in the food, their product labels should be consistent with national laws and regulations, food safety standards and requirements of the national sanitary Commission bulletin.

    20th article violates these rules, production or use of safety assessment of new food ingredients, in accordance with the relevant provisions of the food safety law.

    21st the applicant to hide relevant information or provides false information to apply for a new food ingredient licensing, the National Health Commission was inadmissible or not to license, and give a warning, and the applicant may not apply again in a year if the new food materials license.

    Through deception, bribery or other improper means to adopt new food ingredient safety assessment material review and authorization, the State Health Commission will be revoked.

    22nd article this way the meaning of the following terms:

    Substantial equivalence refers to a new declaration of food raw materials and foods or announced new food ingredients genera, source, biological characteristics, main ingredient, cooking area, amount of usage, use the scope and application of the crowd the same, using technical and quality requirements are basically the same, can be seen as they are equally safe, substantial equivalence.

    The traditional eating habits, refers to some kind of food in the province have been set up in the region for more than 30 years as a stereotypical or non-shaped packing food production and trading history, and is not contained in the People's Republic of China pharmacopoeia. 23rd new food ingredients in these measures do not include genetically modified food, functional food, food additive varieties.

    Genetically modified food, health food, new varieties of food additive management in accordance with the relevant laws and regulations of the State. 24th article this way come into force October 1, 2013. Originally released on December 1, 2007, the Ministry of health of the novel foods regulation repealed simultaneously.

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