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《China Regulations on supervision and administration of cosmetics》Effective as of January 1, 2021

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《China Regulations on supervision and administration of cosmetics》Effective as of January 1, 2021.

On June 16, 2020, the regulations on the supervision and administration of cosmetics, which were adopted at the 77th executive meeting of the State Council on January 3, 2020, are hereby promulgated and shall come into force as of January 1, 2021.

supervision regulations

Chapter I General Provisions

Article 1 These Regulations are formulated for the purpose of strengthening the hygienic supervision of cosmetics, ensuring the hygienic quality and safe use of cosmetics, and ensuring the health of consumers.

Article 2 the term “cosmetics” as mentioned in these Regulations refers to the daily chemical industrial products that are spread on any part of the human body surface (skin, hair, nails, lips, etc.) by means of wiping, spraying or other similar methods, so as to achieve the purposes of cleaning, eliminating bad smell, skin care, beauty and decoration.

Article 3 the State shall implement a system of hygienic supervision over cosmetics. The administrative department of health under the State Council shall be in charge of the hygienic supervision of cosmetics throughout the country, and the administrative departments of health under the local people’s governments at or above the county level shall be in charge of the hygienic supervision of cosmetics within their jurisdiction.

Nail Polish

Nail polish is a cosmetic that is used to modify and increase the appearance of nails. It can form a layer of friction resistant film on the surface of nails, and protect and beautify nails.

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Article 4 all units and individuals engaged in the production and marketing of cosmetics must abide by these regulations.

Chapter II hygiene supervision over the production of cosmetics

Article 5 the system of hygiene license shall be applied to the hygiene supervision of cosmetic production enterprises.

The hygiene license for cosmetic production enterprises shall be approved and issued by the health administrative departments of provinces, autonomous regions and municipalities directly under the central government. The term of validity of the hygiene license for cosmetic production enterprises is four years, and it is reviewed once every two years.

Units that have not obtained the hygiene license for cosmetic production enterprises shall not engage in the production of cosmetics.

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Article 6 cosmetics production enterprises must meet the following hygiene requirements:

（1） The production enterprise shall be built in a clean area and keep a distance in line with the hygienic requirements from the toxic and harmful places.

（2） The building of the workshop of a production enterprise shall be solid and clean. The ceiling, wall and floor of the workshop shall be made of smooth and clean building materials, and shall have good daylighting (or lighting), and shall have facilities and measures to prevent and eliminate rodents and other harmful insects and their breeding conditions.

（3） The production enterprise shall set up workshops or places for raw materials, processing, packaging and storage of cosmetics corresponding to the variety and quantity of products.

（4） The production workshop shall have corresponding production facilities suitable for the characteristics of the products, and the technological procedures shall meet the hygiene requirements.

（5） The production enterprise must have the instruments, equipment and inspectors who can carry out microbiological test on the cosmetics it produces.

Article 7 persons directly engaged in the production of cosmetics must undergo annual health examination and obtain health certificates before they can engage in the production of cosmetics.

Personnel suffering from tinea manus, tinea fingernails, eczema on hands, psoriasis or scales on hands, exudative skin diseases, dysentery, typhoid fever, viral hepatitis, active tuberculosis and other infectious diseases shall not be directly engaged in the production of cosmetics.

Article 8 the raw materials, auxiliary materials, containers and packaging materials used in the production of cosmetics must meet the national health standards.

Article 9 the use of new cosmetic raw materials in the production of cosmetics must be approved by the administrative department of public health under the State Council.

New cosmetic raw materials refer to the natural or artificial raw materials used in the production of cosmetics for the first time in China.

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Article 10 the production of cosmetics for special purposes must be approved by the administrative department of public health under the State Council, and only after obtaining the approval number can they be produced.

Special purpose cosmetics refer to the cosmetics used for hair development, hair dyeing, perm, hair removal, breast care, bodybuilding, deodorization, freckle removal and sunscreen.

Article 11 before the cosmetics are put on the market, the production enterprises must inspect the hygienic quality of the products in accordance with the national hygienic standards for cosmetics, and the qualified products shall be attached with qualified marks. Products that have not been inspected or do not meet hygiene standards shall not leave the factory.

Article 12 the name of the product, the name of the factory and the hygiene license number of the manufacturer shall be indicated on the label of the cosmetics; the date of production and the period of effective use shall be indicated on the small package or instruction manual. For cosmetics for special purposes, the approval number shall also be indicated. For cosmetics that may cause adverse reactions, the instructions shall indicate the methods of use and precautions.

The label, small package or instruction manual of cosmetics shall not be marked with indications, shall not publicize curative effect, and shall not use medical terms.

Chapter III hygiene supervision over the operation of cosmetics

Article 13 cosmetics business units and individuals shall not sell the following cosmetics:

（1） Cosmetics produced by enterprises that have not obtained the hygiene license for cosmetics production enterprises;

（2） Cosmetics without quality mark;

（3） Cosmetics whose labels, small packages or instructions do not conform to the provisions of Article 12 of these regulations;

（4） Cosmetics for special purposes without approval number;

（5） Cosmetics beyond the service life.

Article 14 the advertising of cosmetics shall not contain the following contents:

（1） The name, preparation method, effectiveness or performance of cosmetics are falsely exaggerated;

（2） Using the name of another person to guarantee or to make people misunderstand its effectiveness by implication;

（3） It is necessary to publicize the role of medical treatment.

Article 15 for the cosmetics to be imported for the first time, the importing entity must provide the relevant materials and samples such as the instructions, quality standards and inspection methods of the cosmetics, as well as the certification documents of the exporting country (region) approving the production, and then sign the import contract with the approval of the administrative department of health under the State Council.

Article 16 imported cosmetics must be inspected by the State commodity inspection department, and only those that pass the inspection can be imported.

A small amount of cosmetics imported for personal use shall go through the import procedures in accordance with the customs regulations.

Chapter IV cosmetics hygiene supervision institutions and responsibilities

Article 17 the administrative departments of health at all levels shall exercise the duties of hygienic supervision over cosmetics, and appoint the hygienic supervision and inspection institutions for cosmetics to be responsible for the supervision and inspection of cosmetics within their jurisdiction.

Article 18 the administrative department of health under the State Council shall employ experts in scientific research, medical treatment, production, health management, etc. to form a cosmetics safety assessment group to conduct safety assessment on imported cosmetics, cosmetics for special purposes and new cosmetics raw materials, and conduct technical identification on major accidents caused by cosmetics.

Article 19 the administrative departments of public health at all levels shall set up cosmetics hygiene supervisors to supervise the hygiene of cosmetics.

Cosmetics hygiene supervisors shall be appointed by the health administrative departments of provinces, autonomous regions and municipalities directly under the central government and the health administrative departments of the State Council from qualified health professionals and issued with their badges and certificates.

Article 20 when carrying out cosmetic hygiene supervision, cosmetic hygiene supervisors shall wear badges and produce certificates.

The cosmetic hygiene supervisor shall be responsible for keeping the technical data provided by the manufacturer confidential.

Article 21 the health supervisor of cosmetics shall have the right to sample from the production enterprises and business units in accordance with the provisions of the state to obtain the safety information related to health supervision. No unit shall refuse, conceal or provide false materials.

Article 22 the administrative departments of health at all levels, the health supervisors of cosmetics and the health supervision and inspection institutions shall not participate in the production and sale of cosmetics or supervise the production of cosmetics by means of technical consultation and technical services.

Article 23 for the cases of adverse reactions caused by the use of cosmetics, each medical unit shall report to the local health administrative department.

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Chapter V penalties

Article 24 If an enterprise produces cosmetics without obtaining the hygiene license for cosmetic production enterprise, it shall be ordered to stop production, confiscate its products and illegal income, and may be fined 3 to 5 times of the illegal income.

Article 25 those who produce cosmetics for special purposes without approval number, or use prohibited raw materials for cosmetics or new raw materials for cosmetics without approval, shall have their products and illegal income confiscated and be fined three to five times of the illegal income, and may be ordered to stop production or suspend the hygiene license for cosmetics production enterprises.

Article 26 Whoever imports or sells imported cosmetics that have not been approved or inspected shall have their products and illegal income confiscated and may be fined three to five times the illegal income.

If an enterprise that has obtained the approval number for the production of cosmetics for special purposes violates the provisions of these regulations and the circumstances are serious, the approval number of the product may be revoked.

Article 27 Anyone who produces or sells cosmetics that do not conform to the national hygienic standards for cosmetics shall have the products and illegal income confiscated and may be fined 3 to 5 times of the illegal income.

Article 28 those who violate other relevant provisions of these Regulations shall be given a warning and ordered to make improvement within a time limit; if the circumstances are serious, the production enterprise may be ordered to stop production or its hygiene license for cosmetic production enterprise may be revoked, and the business entity may be ordered to stop operation, its illegal income may be confiscated, and a fine of two to three times the illegal income may be imposed.

Article 29 the administrative penalty stipulated in these Regulations shall be decided by the administrative department of public health at or above the county level. The administrative penalty for violation of Article 14 of these regulations concerning advertising administration shall be decided by the administrative department for Industry and commerce.

The penalty of revoking the hygiene license of cosmetic production enterprise shall be decided by the health administrative department of the province, autonomous region and municipality directly under the central government; the penalty of revoking the approval number of cosmetics for special purposes shall be decided by the health administrative department of the State Council.

All fines and confiscated illegal income shall be handed over to the state treasury. The confiscated products shall be supervised and handled by the administrative department of public health.

Article 30 If a party refuses to accept the decision of the administrative department for health on administrative penalty, he may apply to the administrative department for health at the next higher level for reconsideration within 15 days from the day after receiving the notice. The health administrative department at the next higher level shall give a reply within 30 days. If the party concerned is not satisfied with the reconsideration decision of the health administrative department at the next higher level, he may bring a suit in the people’s court within 15 days from the day after receiving the reconsideration notice. However, the penalty decisions of confiscating the products and ordering the production to stop must be implemented immediately. If the party concerned fails to enforce the penalty decision or fails to bring a suit within the time limit, the administrative department of public health may apply to the people’s court for compulsory execution.

Article 31 in case of human body injury or poisoning accident caused by violation of these regulations, the production enterprise, business operation entity or individual who is directly responsible shall be liable for damages.

If serious consequences are caused and a crime is constituted, the judicial organ shall investigate the criminal responsibility according to law.

Article 32 If a cosmetic health supervisor abuses his power, engages in malpractice or divulges the technical data provided by the enterprise, he shall be given administrative sanctions by the administrative department of health. If serious consequences are caused and a crime is constituted, the judicial organ shall investigate the criminal responsibility according to law.

Chapter VI supplementary provisions

Article 33 the hygiene supervision of cosmetics produced and put on the market by units affiliated to the Chinese people’s Liberation Army shall be carried out in accordance with these regulations.

Article 34 The administrative department of health under the State Council shall be responsible for the interpretation of these regulations, and the detailed rules for their implementation shall be formulated by the administrative department of health under the State Council.

Article 35 these Regulations shall come into force as of January 1, 1990

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