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Regulations related to health care products
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Regulations on the Hygienic Supervision of Cosmetics
(Approved by the State Council on September 26, 1989 and issued by the Ministry of Health Decree No. 3 on November 13, 1989)
Chapter I General Provisions
Article I In order to strengthen the hygiene supervision of cosmetics, to ensure the hygienic quality of cosmetics and the use of safety, to protect the health of consumers, the formulation of these regulations.
Second Article The cosmetics referred to in these regulations, refers to the rubbing, spraying or other similar methods, dispersed on any part of the human body's surface (skin, hair, nails, lips, etc.), in order to achieve the purpose of cleaning, eliminating bad odors, skincare, cosmetic and modification of the daily use of chemical industrial products.
Article III of the national implementation of cosmetics health supervision system. The State Council administrative department of health in charge of the national cosmetics health supervision, the local people's governments at or above the county level of the health administrative department in charge of cosmetics within the jurisdiction of the health supervision.
Article 4 All units and individuals engaged in the production and operation of cosmetics must comply with these regulations.
Chapter II of the cosmetics production health supervision Article 5 of the cosmetics manufacturer of health supervision of the implementation of health license system.
"Cosmetics production enterprise health license" by the province, autonomous region, municipality directly under the Central Government health administrative department for approval and issuance. Cosmetics production enterprise health license" is valid for four years, every two years, a review.
Not obtain "cosmetic production enterprise health license" of the unit, shall not engage in the production of cosmetics.
Article VI of the cosmetics production enterprises must meet the following health requirements:
(a) the production enterprise should be built in a clean area, and toxic, hazardous places to maintain a distance in line with health requirements.
(b) the production enterprise plant building should be strong, clean. Workshop ceilings, walls, floors should be clean building materials, should have good lighting (or lighting), and should have the prevention and elimination of rodents and other harmful insects and their breeding conditions of the facilities and measures.
(C) the manufacturer should have with the product variety, quantity appropriate to the cosmetic raw materials, processing, packaging, storage and other plants or premises.
(d) the production plant should be suitable for the product characteristics of the corresponding production facilities, process procedures should be in line with health requirements.
(E) the production of cosmetics must have the ability to produce microbiological testing of instruments and equipment and inspectors.
Article VII directly engaged in the production of cosmetics, must be annual health checks, obtain a health certificate before engaging in the production of cosmetics.
Anyone who suffers from ringworm, ringworm of the fingernails, hand eczema, psoriasis or scaly, exudative skin diseases occurring on the hands, as well as dysentery, typhoid fever, viral hepatitis, active tuberculosis and other infectious diseases shall not be directly engaged in cosmetic production activities.
Article VIII of the raw materials required for the production of cosmetics, auxiliary materials and direct contact with cosmetic containers and packaging materials must comply with national health standards.
Article IX of the use of new cosmetic raw materials for the production of cosmetics, must be approved by the State Council administrative department of health.
New cosmetic raw materials is the first time in the domestic production of natural or artificial raw materials used in cosmetics.
Article X of the production of special-purpose cosmetics, must be approved by the State Council administrative department of health, to obtain approval number before production.
Special-purpose cosmetics are used for hair breeding, hair coloring, perming, hair removal, breast beauty, bodybuilding, deodorant, spots, sunscreen cosmetics.
Article XI of the manufacturers of cosmetics on the market before, must be in accordance with the national "hygiene standards for cosmetics" on the product health quality inspection, the quality of qualified products should be accompanied by qualified mark. Without inspection or does not meet the health standards of the product shall not be shipped
Article XII of the cosmetic label should indicate the product name, factory name, and indicate the number of health permits for manufacturing enterprises; small packages or manuals should indicate the date of production and effective period of use. Special use cosmetics, should also indicate the approval number. May cause adverse reactions to cosmetics, instructions should indicate the use of methods, precautions.
Cosmetic labels, small packages or instructions shall not be noted on the indications, shall not publicize the efficacy, shall not use medical terminology.
Chapter III of the cosmetics business health supervision
Article XIII of the cosmetics business units and individuals shall not sell the following cosmetics:
(a) did not obtain the "Cosmetics Manufacturing Enterprises Health License" of the enterprise production of cosmetics;
(b) no quality mark of the cosmetic;
(c) labels, packages or instructions do not comply with the provisions of Article XII of these Regulations. Instructions do not meet the provisions of Article XII of these Regulations cosmetics;
(D) did not obtain approval of special-use cosmetics;
(E) more than the use of cosmetics. Article XIV of cosmetics advertising shall not have the following content:
(a) cosmetics name, method of production, utility or performance of false exaggeration;
(b) the use of other people's names to ensure that or by implication to mislead people about its effectiveness;
(c) the promotion of medical effects.
Article XV of the first imported cosmetics, the importing unit must provide the cosmetic instructions, quality standards, test methods and other relevant information and samples as well as the exporting country (region) to approve the production of documents approved by the State Council administrative department of health, before signing the import contract.
Article XVI of the imported cosmetics, must be inspected by the State Commodity Inspection Departments; qualified, before being allowed to import.
Individuals imported for personal use in small quantities of cosmetics, in accordance with the provisions of the Customs and Excise Department for import procedures.
Chapter IV cosmetic health supervision and responsibility
Article XVII of the health administrative departments at all levels to exercise health supervision of cosmetics, and designated cosmetic health supervision and inspection agencies, responsible for the supervision and inspection of cosmetics within the jurisdiction.
Article XVIII of the State Council administrative department of health to hire scientific research, medical, production, health management and other relevant experts to form a cosmetic safety assessment group, imported cosmetics, cosmetics for special purposes and new cosmetic raw materials for the safety assessment of cosmetic products caused by major accidents in technical appraisal. Article 19 of the health administrative departments at all levels of cosmetics health supervisor, the implementation of health supervision of cosmetics.
Cosmetic health supervisor, by the provinces, autonomous regions and municipalities directly under the Central Health Administration and the State Council administrative department of health, from the qualified health professionals in the appointment, and issued its seal and documents.
Article 20 of the cosmetic health inspectors in the implementation of cosmetic health supervision, shall wear a badge, show your credentials.
Cosmetic hygiene supervisor of the production of technical information provided by the enterprise shall be responsible for confidentiality.
Article 21 of the cosmetic health inspectors have the right to the production enterprises and business units in accordance with state regulations for sampling, and health supervision of security information, any unit shall not be refused, concealment and the provision of false materials.
Article 22 of the health administrative departments at all levels and cosmetic health inspectors and health supervision and inspection agencies shall not be technical advice, technical services and other ways to participate in the production and sale of cosmetics, cosmetics shall not be supervised.
Article 23 of the cases of adverse reactions caused by the use of cosmetics, each medical unit shall report to the local health administrative department.
Chapter V Penalties
Article 24 If an enterprise does not obtain the "Cosmetic Manufacturer Health License" for the unauthorized production of cosmetics, the enterprise shall be ordered to stop production, confiscate the products and the illegal income, and may impose a fine of three to five times the illegal income.
Article 25 The production of cosmetics for special purposes without obtaining the approval number, or the use of cosmetics prohibited raw materials and unapproved new cosmetic raw materials, confiscate the product and the illegal income, and impose a fine of three to five times the amount of illegal income, and can be ordered to stop production or revocation of the "Cosmetics Manufacturing Enterprises Hygiene License".
Article 26 The import or sale of imported cosmetics without approval or inspection, confiscate the product and the illegal income, and may impose a fine of three to five times the illegal income.
The enterprises that have obtained the approval number for the production of special-use cosmetics, violation of the provisions of these Regulations, the circumstances are serious, the approval number of the product can be withdrawn.
Article 27 The production or sale of cosmetics that do not comply with the national "Hygienic Standard for Cosmetics", the confiscation of the product and the illegal income, and may impose a fine of three to five times the illegal income.
Article 28 of the violation of other relevant provisions of these Regulations, a warning, ordered to improve within a certain period of time; the circumstances are serious, the production of enterprises, may be ordered to suspend production or revocation of the "Cosmetics Manufacturer Health License", the business unit, may be ordered to stop operations, confiscate the illegal income, and may impose a fine of two to three times the illegal income.
Article 29 The administrative penalties provided for in these Regulations shall be decided by the health administrative departments at or above the county level. Violation of Article 14 of these Regulations on the management of advertising administrative penalties shall be decided by the administrative department for industry and commerce.
Revocation of "cosmetics manufacturer health license" by the provincial, autonomous regions and municipalities directly under the Central Health Administration to decide on the penalties; revoke the approval number of special-use cosmetics by the State Council, the State Council administrative department of health to decide on the penalties.
Fines and confiscation of all illegal income to the state treasury. Confiscated products, the administrative department of health to supervise the disposal.
Article 30 of the parties to the administrative department of health administrative department of the administrative penalty decision is not satisfied, you can within 15 days from the next day after receipt of the notice to the higher level of health administration department to apply for reconsideration. The higher level of health administration department shall give a reply within 30 days. If the party concerned is not satisfied with the decision of the higher-level health administrative department for reconsideration, the party concerned may file a lawsuit to the people's court within 15 days from the next day after the receipt of the notice of reconsideration. However, the sanitary administrative department of the confiscation of products and ordered the suspension of production of the penalty decision must be immediately implemented. The parties to the penalty decision is not enforced, and overdue prosecution, the administrative department of health may apply to the people's court for compulsory execution.
Article 31 For violation of these regulations caused by human injury or poisoning accidents, have direct responsibility for the production enterprises and business units or individuals shall be liable for damages.
The serious consequences, constituting a crime, by the judicial organs shall be investigated for criminal responsibility.
Article 32 of the cosmetic health supervisor abuse of power, malpractice and leakage of technical information provided by the enterprise, by the administrative department of health to give administrative sanctions, resulting in serious consequences, constituting a crime, by the judicial organs shall be held criminally responsible.
Chapter VI Supplementary Provisions Article 33 The People's Liberation Army units produced by the health supervision of cosmetics placed on the market, in accordance with the implementation of these Regulations.
Article 34 These Regulations shall be interpreted by the health administrative department of the State Council; the implementing rules shall be formulated by the health administrative department of the State Council.
Article 35 These Regulations shall January 1, 1990 shall come into force.
Measures for the Administration of Health Food
(Issued by the Ministry of Health of the People's Republic of China on March 15, 1996, No. 46)
Chapter I. General Provisions
Article 1 In order to strengthen the supervision and management of health food products, to ensure the quality of health food products, according to the "People's Republic of China *** and the State of food hygiene law" (hereinafter referred to as the "food hygiene law"), the formulation of these measures.
Second Article The health food referred to in these measures refers to the indication of food with specific health functions. That is, suitable for consumption by a particular group of people, with the regulation of body functions, not for the purpose of treating disease food.
Article 3 The State Council administrative department of health (hereinafter referred to as the Ministry of Health) on health food, health food instructions for the implementation of the approval system.
Chapter II Approval of Health Food
Article 4 Health food must meet the following requirements:
(1) It has been proved to have a clear and stable health care effect through the necessary functional tests on animals and the population;
(2) All kinds of raw materials and their products must comply with the requirements of food hygiene, and they do not produce any acute, subacute or chronic hazards to the human body;< /p>
(c) The composition and dosage of the formula must have a scientific basis, with a clear efficacy of the ingredients. If the efficacy of the ingredients can not be clear under the existing technical conditions, the name of the main raw materials related to health care functions should be identified:
(d) labels, instructions and advertising shall not promote the role of therapeutic effects.
Article 5 Where the claim that the health function of food must be examined and confirmed by the Ministry of Health. The developer shall apply to the local provincial health administrative department. After the initial examination and approval, reported to the Ministry of Health for approval. The Ministry of Health on the review of qualified health food issued "Health Food Approval Certificate", the approval number for the "health food health word () No." to obtain "Health Food Approval Certificate" of the food permitted to use the Ministry of Health health food logo (logo pattern see Annex).
Article 6 When applying for the Certificate of Approval for Health Food, the following information must be submitted:
(1) application form for health food;
(2) formula, production process and quality standard of the health food;
(2) toxicological safety evaluation report;
(4) evaluation report of health care function;
(5) The list of efficacy ingredients of the health food, as well as the qualitative and/or quantitative test methods of the efficacy ingredients, and stability test report. If the efficacy of the ingredients cannot be clarified under the existing technical conditions, a list of the main raw materials related to the health care function of the food shall be submitted.
(F) samples of the product and its hygienic test report;
(G) labeling and instructions (sample for review);
(H) domestic and foreign information;
(I) according to the relevant provisions or product characteristics should be submitted to other materials.
Article VII The Ministry of Health and the provincial health administrative departments shall respectively become the evaluation committee to undertake the technical evaluation work, the committee shall be composed of experts in food hygiene, nutrition, toxicology, medicine and other related professions.
Article VIII of the Ministry of Health Review Committee held four times a year, generally held in the last month of each quarter. All materials qualified by the initial review must be sent to the Ministry of Health by the end of the first month of each quarter. The Ministry of Health will make a decision on whether to approve or not within 30 working days after the review based on the review comments.
If the evaluation committee of the Ministry of Health considers it necessary to re-examine the declared health food, the inspection organization designated by the Ministry of Health will conduct the re-examination. The cost of re-examination shall be borne by the applicant of the health food product.
Article IX by two or more collaborators *** with the same application for the same health food, "Health Food Approval Certificate" *** with the signature, but the certificate will only be issued to all the collaborators *** with the determination of the responsible person, the application, in addition to submitting the information listed in these measures, should be submitted by all the collaborators signed by the responsible person recommendation.
Article X "Health Food Approval Certificate" holders can use this certificate to transfer technology or cooperation with other parties *** with the production, transfer, should be transferred to the Ministry of Health with the transferee *** with the Ministry of Health to apply for a copy of the "Health Food Approval Certificate". When applying, you should hold the "Health Food Approval Certificate" and provide a valid technology transfer contract.
The copy of the Health Food Approval Certificate is issued to the transferee, who is not entitled to further technology transfer.
Article 11 Drugs which have been approved by the relevant state departments for production and operation shall not apply for the Certificate of Approval for Health Food.
Article XII When importing health food, the importer or agent must submit an application to the Ministry of Health. Application, in addition to providing the materials required under Article 6, but also to provide the country (region) or international organization of the relevant standards, as well as production, sale of the country (region) of the relevant health institutions to allow the production or sale of the certificate.
Article XIII of the Ministry of Health on the examination of imported health food issued by the "Certificate of Approval of Imported Health Food", the "Certificate of Approval of Imported Health Food" of the product must be marked on the package with the approval number and the Ministry of Health regulations on the health food logo.
Ports of imported food hygiene supervision and inspection agencies with the "Certificate of Approval of Imported Health Food" for inspection, release after passing.
Chapter III Production and Operation of Health Food
Article XIV in the production of health food, food manufacturers must be located at the provincial health administrative department to apply for the provincial health administrative departments to review and approve the applicant and the applicant's health license on the addition of "X health food" license items before production. The production can be carried out.
Article 15 When applying for the production of health food, the following information must be submitted:
(1) Valid food production and operation license issued by the administrative department of health with direct jurisdiction;
(2) Original or copy of the Certificate of Approval for Health Food;
(3) Enterprise standard for health food formulated by the manufacturing enterprise, hygienic norms of the manufacturing enterprise
(4) technology transfer or cooperative production, should be submitted to the holder of the "health food approval certificate" signed with the technology transfer or cooperative production of a valid contract;
(5) production conditions, production of technical personnel, quality assurance system of the situation;
(6) three batches of product quality and health inspection reports.
Article XVI without the Ministry of Health review and approval of the food, shall not be in the name of health food production and operation; without the provincial health administrative department review and approval of the enterprise, shall not produce health food.
Article XVII of the health food producers must be in accordance with the approved content of the organization of production, shall not change the product formula, production process, product quality standards of the enterprise, as well as the product name, labeling, instructions and so on.
Article XVIII of the health food production process, production conditions must be consistent with the corresponding food production enterprise health norms or other relevant N health requirements, the choice of technology should be able to maintain the stability of the efficacy of the product components, the efficacy of the ingredients in the process of processing is not a loss, not destroyed, not transformed and does not produce harmful intermediates.
Article 19 should be used in stereotyped packaging. Direct contact with health food packaging materials or containers must meet the relevant health standards or health requirements. Packaging materials or containers and their packaging methods should be conducive to maintaining the stability of the efficacy of health food ingredients.
Article 20 When purchasing health food, health food operators must obtain a copy of the "Health Food Approval Certificate" issued by the Ministry of Health and the product inspection certificate.
Procurement of imported health food should ask for "imported health food approval certificate" copy and port imported food hygiene supervision and inspection agency inspection certificate.
Chapter IV health food labeling, instructions and advertising
Article 21 of the health food labels and instructions must comply with the relevant state standards and requirements, and indicate the following:
(a) health effects and suitable for the population;
(b) methods of consumption and the appropriate amount to consume;
(c) storage methods;
(d) the name and content of the efficacy of the ingredients, because in the existing technical conditions, can not be clear efficacy of the ingredients, then the name of the raw materials related to health care functions must be indicated;
(e) health food approval number;
(f) health food logo;
(g) the relevant standards or requirements of other labeling content of the current set.
Article 22 The name of the health food should be accurate, scientific shall not use personal names, geographical names, code names and exaggerated or easily misunderstood name, shall not use the product is not the name of the main efficacy of the ingredients.
Article 23 of the health food labels, instructions and advertising content must be true, in line with the quality of its products do not. There shall be no publicity suggesting that the disease can be cured.
Article 24 is strictly prohibited the use of feudal superstitions for the promotion of health food.
Article 25 without the Ministry of Health in accordance with the review and approval of the food, shall not be publicized in the name of health food.
Chapter V Supervision and Management of Health Food Products
Article 26 According to the Food Sanitation Law and the relevant regulations and standards of the Ministry of Health, the administrative departments of health at all levels shall strengthen the supervision, monitoring and management of health food products. The Ministry of Health may organize supervisory sampling tests on health food products that have been approved for production, and announce the results of the sampling tests to the society.
Article 27 The Ministry of Health may determine the re-examination of the approved health food in accordance with the following circumstances;
(1) scientific development, there is a change in the understanding of the function of the originally approved health food;
(2) the formula, production process, and health care function of the product are questioned by the possible change;
(3) the need for supervision and monitoring of the health food. Supervision and monitoring work needs.
Those who fail to pass the examination or those who do not accept the re-examination, the Ministry of Health shall revoke their "Health Food Approval Certificate". Qualified, the original certificate is still valid.
Article 28 The general health supervision and management of health food manufacturers and operators, in accordance with the "Food Sanitation Law" and related regulations.
Chapter VI Penalties
Article 29 Anyone who has one of the following circumstances, by the local people's government at or above the county level of the health administrative department in accordance with the "Food Sanitation Law," Article 45 of the penalties.
(A) without the Ministry of Health in accordance with the review and approval of these measures, and in the name of health food production, business;
(B) not in accordance with the approval of health food imports, and in the name of health food business;
(C) the name of the health food, labeling, manuals are not used in accordance with the approved content.
Article 30 of the health food advertisements to promote the efficacy or the use of feudal superstitions for health food propaganda, in accordance with the State Administration for Industry and Commerce and the Ministry of Health, "Food Advertisement Management Measures" of the relevant provisions of the penalties.
Article 31 Violation of the Food Sanitation Law or other relevant health requirements, shall be punished in accordance with the corresponding provisions.
Chapter VII Supplementary Provisions
Article 32 The standards and functional evaluation methods of health food shall be formulated and approved for promulgation by the Ministry of Health.
Article 33 The functional evaluation and testing of health food, safety and toxicological evaluation by the Ministry of Health recognized testing organizations.
Article 34 These Measures shall be interpreted by the Ministry of Health.
Article 35 These Measures shall come into force on June 1, 1996, other health management methods inconsistent with these Measures, these Measures shall prevail.