Administrative Measures for Product Formula Registration of Infants and Young Children Formula Milk Powder
Chapter I General Principles
Article 1 In order to carry out strictly administration over the product formula registration of infants and young children formula milk powder and ensure the quality of infants and young children formula milk powder safe, the Measures are hereby formulated in accordance with such laws and regulations as Food Safety Law of the People¡¯s Republic of China.
Article 2 The Measures apply to the administration over the product formula registration of the infants and young children formula milk powder produced, sold and imported within the territory of the People¡¯s Republic of China.
Article 3 Product formula registration of infants and young children formula milk powder refers to the approval process that CFDA performs a review on the product formula of the infants and young children formula milk powder applying for registration in accordance with the procedures and provisions of the Measures, and then decides whether to approve the registration.
Article 4 The administration over the product formula registration of infants and young children formula milk powder shall follow the principles of scientificity, strictness, openness, justice, and fairness.
Article 5 CFDA is responsible for the administration over the product formula registration of infants and young children formula milk powder.
The administrative licensing acceptance institutions under CFDA (hereafter referred to as acceptance institution) are responsible for the acceptance of product formula registration of infants and young children formula milk powder.
The food review institutions under CFDA (hereafter referred to as review institution) are responsible for the review of product formula registration of infants and young children formula milk powder.
The examination and verification institutions under CFDA (hereafter referred to as examination and verification institution) are responsible for the on-site verification of product formula registration of infants and young children formula milk powder.
The food and drug administration departments of province, autonomous region and municipality directly under the central government shall take responsibilities to coordinate with CFDA to carry out on-site verification on product formula registration of infants and young children formula milk powder in their respective administrative areas.
Article 6 The applicant shall be responsible for the authenticity, integrity and legitimacy of the materials submitted thereby and bear legal liability.
The applicant shall assist food and drug administration departments to carry out on-site verification and sampling inspection related to registration.
Chapter II Application and Registration
Article 7 The applicant shall be the manufacturing enterprises which plan to product and sell infants and young children formula milk powder within the territory of People¡¯s Republic of China or overseas manufacturing enterprises which plan to import infants and young children formula milk powder to People¡¯s Republic of China.
The applicant shall possess research & development ability, production ability and test ability corresponding with produced infants and young children formula milk powder, conform to the requirements of good manufacturing practices (GMPs) for powdered formula foods for infants and young children, carry out the hazard analysis and critical control point system and perform lot by lot inspection of outgoing products according to relevant laws and regulations and items specified by national food safety standard on infants and young children formula milk powder.
Article 8 The application for product formula registration shall comply with requirements of relevant laws and regulations and national food safety standards, and research & development and demonstration report
as well as sufficient evidence which can prove the scientificity and safety of product formula shall be provided.
In case of application for product formula registration of infants and young children formula milk powder, the following materials shall be submitted to CFDA:
(I) Application for product formula registration of infants and young children formula milk powder;
(II) Qualification certificates of applicant subject;
(III) Quality safety standards for raw and auxiliary materials;
(IV) Development and research report on product formula;
(V) Descriptions on production technology;
(VI) Product test report;
(VII) Evidentiary materials proving the development & research, production and test ability;
(VIII) Other materials proving the scientificity and safety of the product formula.
Article 9 There shall be distinct differences among more than two product formulas designed for the same age group applying for registration by the same enterprise, which shall be confirmed by scientific basis. Each enterprise shall hold no more than 9 product formulas of 3 formula series, each of which includes infant formula (0~6 months, stage 1), older infant formula (6~12 months, stage 2) and young children formula (12~36 months, stage 3).
Article 10 The wholly-owned subsidiary, which has obtained the product formula registration and production license of infants and young children formula milk powder, may use the registered product formula of infants and young children formula milk powder of another wholly-owned subsidiary within the same group company. The group company shall submit written report to CFDA before organizing production.
Article 11 For the application for product formula registration of infants and young children formula milk powder proposed by applicant, the acceptance institution shall handle respectively based on the following circumstances:
(I) Where the applying items is not necessary to register by law, the acceptance institution shall immediately inform the applicant of refusal on application;
(II) Where the applying items are not under the jurisdiction of CFDA by law, the acceptance institution shall immediately make a decision on refusal of application and inform the applicant that it shall file the application to relevant administrations;
(III) Where the mistakes of application materials can be corrected on the spot, it shall be allowed to correct on the spot;
(IV) Where the application materials are incomplete or fail to comply with statutory form, CFDA shall notify the applicant about all the contents necessary to be supplemented at one time on the spot or within 5 workdays; it is deemed to have accepted the application since the date of receiving the application materials if the applicant is not notified within the prescribed time limit;
(V) Where the application materials are complete and in compliance with statutory form, or the applicant submits all the corrected application materials as requested, the registration application shall be accepted.
For acceptance or refusal of the registration application, the acceptance institution shall issue dated written certificates with special seal of administrative licensing acceptance stamped by CFDA.
Article 12 The acceptance institution shall deliver the application materials to review institution within 3 workdays after acceptance.
Article 13 The review institution shall review the conformance between the application materials as well as product formula claim and product formula registration content, notify examination and verification institution to carry out on-site verification on the applicant based on actual requirements, organize inspection institution to carry out sampling inspection, organize professors to demonstrate professional matters, and complete the review within 60 workdays from receiving the accepted materials.
In particular cases where the review time shall be prolonged, it can be extended for another 30 workdays with the consent of director of review institution. The decision on extension shall be informed to the applicant in written form.
Article 14 The examination and verification institution shall make on-site verification on research & development ability, production ability and test ability of applicant within 20 workdays from the date of accepting notice of review institution and issue on-site verification report.
The examination and verification institution shall notify the provincial food and drug administration department where the applicant is located to participate in the on-site verification, and the above mentioned department shall dispatch staff in verification.
Article 15 The review institution shall entrust the qualified food inspection institutes to carry out the sampling inspection.
The inspection institution shall complete sampling inspection work within 30 workdays from the acceptance date and issue product inspection report.
Article 16 It shall be determined according to actual conditions for the working time limit of on-site verification and sampling inspection on overseas manufacturing enterprise.
Article 17 The review institution shall carry out review on the basis of application materials, on-site verification report and product inspection report and make a review conclusion.
Article 18 The review institution shall issue a written notice on refusal of registration to the applicant in case of making a decision on refusal of registration. The applicant shall propose a written re-examination application and explain re-examination reason within 20 workdays from acceptance date where he/she is objectionable to the notice. The re-examination content is limited to original application items and materials.
The review institution shall make a decision on the re-examination within 30 workdays from accepting re-examination application and notify the applicant in written form.
Article 19 The review institution shall notify all the contents need to be supplemented and corrected once where it considers necessary to supplement and correct materials. The applicant shall supplement materials once in accordance with the notice on supplementation and correction within 3 months. The time of supplementing and correcting materials is not counted in review time. Failure to supplement and correct in due time, it shall be regarded as not providing materials any more.
Article 20 CFDA shall make a decision on approval or refusal of registration within 20 workdays from the date of acceptance.
The acceptance institution shall issue Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder or notify the applicant of a decision on refusal of registration within 10 workdays from the date of making decision by CFDA.
Article 21 The time necessary for on-site verification, sampling inspection and re-examination is not counted in time limit of technical review and registration decision. The review time is not counted in time limit of registration decision.
Article 22 The applicant may propose administration review application in written form towards CFDA or propose administrative lawsuit towards People¡¯s Court where he/she is objectionable to the decision on refusal of registration made by CFDA.
Article 23 The content of Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder and attachments shall include the following items:
(I) Product name;
(II) Enterprise name, legal representative and production address;
(III) Registration number, approval date and validity period;
(IV) Production technology;
(V) Product formula.
The format of registration number for Product Formula of Infants and young children formula milk powder is: GSZZ YP+four-digital year number+4-digital serial number, among which YP stands for product formula of infants and young children formula milk powder.
The validity period of Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder is 5 years.
Article 24 Within the validity period of Product Formula Registration of Infants and Young Children Formula Milk Powder, where the Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder is lost or damaged, the applicant shall propose application in written form towards acceptance institution and explain reasons. He/she shall publish lost declaration on the websites of food and drug administration department of province, autonomous region and municipality directly under the central government in case of applying for reissuance because of losing; and return the original Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder in case of applying for reissuance because of damage.
CFDA shall grant for its reissuance within 20 workdays from the date of acceptance. The reissued Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder shall sign original registration date and indicate the word ¡°Reissued¡±.
Article 25 Within the validity period of Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder, the applicant shall propose change application for registration towards CFDA and submit the following materials where it is necessary to alternate registration certificate and contents specified on attachments:
(I) Change Application for Product Formula Registration of Infants and Young Children Formula Milk Powder;
(II) Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder and attachments;
(III) Materials relevant to change items.
Article 26 The review institution shall organize and carry out review according to the provisions of Article
13 in the Measures based on actual requirements and make review conclusions where applying for changing product formula by the applicant may influence the scientificity and safety of product formula.
The review institution shall verify and make a conclusion within 10 workdays from the acceptance date where applying for changing enterprise name and production address by the applicant may not influence the scientificity and safety of product formula. Where the name of applicant has been changed, it shall be applied for changing by applicant after changing.
CFDA shall make a decision on approval or disapproval according to the conclusions of the review within 10 workdays from accepting the review conclusion. In case of complying with requirements, CFDA shall handle registration change procedures by law, and the issue date of registration certificate is subject to approval date of change, the original registration number and validity period of certificate remain the same. In case of disapproving the change of registration, CFDA shall make a decision on disapproval of registration change.
Article 27 In case the validity period of Product Formula Registration of Infants and Young Children Formula Milk Powder is expired and needs to be renewed, the applicant shall propose renewal application towards CFDA 6 months before expiration date and submit the following materials:
(I) Renewal Application for Product Formula Registration of Infants and Young Children Formula Milk Powder;
(II) Qualification certificates of applicant subject;
(III) Research & development ability, production ability and test ability of enterprise;
(IV) Self-inspection report of quality management system of enterprise production;
(V) Tracking assessment of nutrition and safety of products;
(VI) Opinions on renewal of registration issued by food and drug administration departments in the province, autonomous region and municipality directly under the central government where the production enterprise is located;
(VII) Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder and attachments.
The review institution shall organize and carry out review on the renewal application for registration on the basis of article 13 in the Measures based on actual requirements and make review conclusions.
CFDA shall make a decision on approval or disapproval according to the conclusions of the review within 20 workdays from the acceptance date. The registration certificate shall be renewed for applicant in case of approving the renewal of registration, and the registration number will remain the same and the period of validity will be recounted as of the day of approval; a decision on disapproval of registration renewal shall be provided to applicant in case of disapproving the renewal of registration. In case the decisions are not made overdue, it shall be deemed approval.
Article 28 In case of any of the following circumstances, the registration renewal shall be refused:
(I) Where the renewal application for registration is not proposed within the prescribed time limit;
(II) Where the enterprise does not organize production in accordance with registered formula within 5 years after registering product formula;
(III) Where the enterprise fails to maintain the research & development ability, production ability and test ability at registration;
(IV) Other circumstances failing to comply with relevant provisions.
Article 29 Where there are no provisions on the procedures for change and renewal of product formula registration of infants and young children formula milk powder, the relevant provisions on product formula registration of infants and young children specified by the Measures shall apply.
Chapter III Label and Specification
Article 30 Where applying for product formula registration of infants and young children formula milk powder, the applicant shall submit sample manuscript of label and specification and explanatory and evidentiary materials declared in the label and specification.
Where the label and specification involves product formula of the infants and young children formula milk powder, it shall be consistent with that in the registered product formula and the registration number shall be marked.
Article 31 Where the product name contains animal origin, the animal origin of dairy raw materials used, such as raw milk, milk powder, and whey (protein) powder, shall be indicated in the List of Ingredients based on product formula. In case the dairy raw materials used have more than two animal origins, the proportion of raw materials with different animal origins shall be indicated.
The specific name of edible vegetable oil shall be indicated in the List of Ingredients according to the descending order of addition amount.
Nutrition Facts shall be indicated in accordance with the nutrients order stipulated by the national food safety standard for infants and young children formula milk powder and according to the categories such as energy, protein, fat, carbohydrates, vitamins, minerals and optional components, etc.
Article 32 Where the source of raw materials, such as raw milk or raw material powder, is declared, the specific place of origin or country of origin shall be truthfully indicated, and the fuzzy information such as ¡°imported milk source¡±, ¡°originate from foreign pasture¡±, ¡°ecological pasture¡± and ¡°imported raw materials¡± shall not be used.
Article 33 The suitable month age of infants and young children formula milk powder shall be indicated in the claims, with simultaneous use of ¡°Stage1, Stage 2, Stage 3¡±.
Article 34 The label and specification shall not contain the following contents:
(I) The contents concerning function of disease prevention and disease treatment;
(II) The contents explicitly or implicitly declaring the function of health care;
(III) The contents explicitly or implicitly declaring the functions such as ¡°be beneficial to intellectual development¡±, ¡°increase the resistance or immunity¡± and ¡°protect the intestinal function¡±, etc.;
(IV) The words such as ¡°no adding¡±, ¡°no containing¡± and ¡°additive free¡±, etc. used to emphasize no use or no containing of a certain substance that shall not be used or contained in the product formula according to the food safety standard;
(V) False, exaggerated and absolute contents and those in violation of scientific principle;
(VI) Claims inconsistent with the content of product formula registration.
Chapter IV Supervision and Management
Article 35 Institutions and personnel that take charge of technical review, on-site verification, sampling inspection, expert argumentation for the product formula registration of infants and young children formula milk powder shall be responsible for the issued review conclusion, on-site verification report, product test report and expert opinion, etc.
Institutions and personnel that take charge of technical review, on-site verification, sampling inspection, expert argumentation for the product formula registration of infants and young children formula milk powder shall abide by professional ethics according to the provision of relevant laws, regulations and rules, and carry out the technical review, on-site verification and sampling inspection according to the national food safety standard and technical specification, so as to ensure the scientificity, objectivity and fairness of relevant works.
Article 36 The food and drug administration department shall verify and handle the problem timely after receiving the report from relevant units or individuals about violations of laws and regulations in the works related to product formula registration of infants and young children formula milk powder, such as acceptance, technical review, on-site verification, sampling inspection, expert argumentation and approval, etc.
Article 37 CFAD shall publish catalog information of product formula registration of infants and young children formula milk powder within 30 days from the date of approval.
Article 38 Institutions and personnel participating in the application acceptance, technical review, on-site verification, sampling inspection and expert argumentation for the formula registration of the infants and young children formula milk powder shall keep business secrets known during the registration.
The applicant shall mark the business secret in the application materials and indicate the basis according to relevant national provisions.
Article 39 Where the applicant refuses the on-site verification and sampling inspection, CFDA shall disapprove the product formula registration of infants and young children formula milk powder.
Article 40 CFDA shall revoke the product formula registration of infants and young children formula milk powder according to their authority and request from the interested party, in case of any of the following circumstances:
(I) Where the staffs abuse powder and neglect of duty to make the decision on approval of registration;
(II) Where the decision on approval of registration is made by exceeding legitimate authority;
(III) Where the decision on approval of registration is made in violation of legal procedures;
(IV) Where the applicant having no qualification for application or failing to meet the statutory conditions has been approved for registration;
(V) Other circumstances under which the registration may be revoked in accordance with the law.
Article 41 CFDA shall cancel the product formula registration of infants and young children formula milk powder according to law, in case of any of the following circumstances:
(I) Where the enterprise applies for cancellation;
(II) Where the enterprise terminates according to law;
(III) Where the certificate expires and the enterprise has not applied for extension;
(IV) Where the registration is revoked or withdrawn according to law, or the registration certificate is revoked according to law;
(V) Other circumstances that shall be cancelled as stipulated in laws and regulations.
Chapter V Legal Responsibilities
Article 42 Where Food Safety Standard and other relevant laws and regulations stipulate the provisions on the unlawful acts related to product formula registration of infants and young children formula milk powder, the aforesaid provisions shall prevail.
Article 43 Where the applicant conceals relevant information or provides false materials and samples during the application for product formula registration of infants and young children formula milk powder, CFDA shall refuse the acceptance of application or approval of the registration, give the applicant warning and announce to the public. The applicant shall not apply for product formula registration of infants and young children formula milk powder again within a year; for suspected criminal cases, it shall be transferred to the public security organization, and the criminal liability shall be prosecuted.
Where the applicant acquires the Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder by the improper means such as deception and bribery, etc., or in the manners such as concealing the true situation and submitting false materials, etc., CFDA shall revoke the certificate according to law and impose a fine of not less than 10000 yuan and not more than 30000 yuan. The licensed applicant shall not apply for registration again within three years; for suspected criminal cases, it shall be transferred to the public security organization, and the criminal liability shall be prosecuted.
Article 44 Where the applicant change matters having no effect on the scientificity and safety of product formula but do not apply for change according to law, it shall be instructed to correct and given a warning by the food and drug administration departments above county level; where the applicant refuses to correct, a fine of not less than 10000 yuan and not more than 30000 yuan shall be imposed.
Where the applicant change matters having effect on the scientificity and safety of product formula but do not apply for change according to law, it shall be punished by the food and drug administration departments above county level according to the provisions of Article 124 in Food Safety Law.
Article 45 Where the Product Formula Registration Certificate of Infants and Young Children Formula Milk Powder is forged, altered, sold, leased, lend, transferred, it shall be instructed to correct and given a warning by the food and drug administration departments above county level and a fine of not more than 10000 yuan shall be imposed; for serious violations, a fine of not less than 10000 yuan and not more than 30000 yuan shall be imposed; for suspected criminal cases, it shall be transferred to the public security organization, and the criminal liability shall be prosecuted.
Article 46 Where the producers and distributors of infants and young children formula milk powder violate the provisions of Article 30 ~ 34 in the Measures, it shall be instructed to correct and given a warning by the food and drug administration departments, and a fine of not less than 10000 yuan and not more than 30000 yuan shall be imposed according to the law.
Article 47 Where the food and drug administration departments and the staffs thereof approve the registration of applicant failing to meet the conditions or approve the registration by exceeding legitimate authority, it shall be published according to the provisions of Article 144 in Food Safety Law.
Where the food and drug administration departments and the staffs thereof abuse powder, neglect duty and play favoritism or fraud in the process of the registration, it shall be published according to provisions of Article 145 in Food Safety Law.
Chapter VI Supplementary Provisions
Article 48 The product formula of infants and young children formula milk powder referred in the Measures refers to the food raw materials and food additives used for production of infants and young children formula milk powder and their usage amount as well as the nutrition content of the product.
Article 49 The Measures shall enter into force from October 1, 2016.
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