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化妆品卫生监督条例 REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS

2006-05-18 00:21   我要纠错 | 打印 | 收藏 | | |

卫生部令第三号
(Approved by the State Council on September 26, 1989, and issued by Decree No. 3 of the Ministry of Public Health on November 13, 1989)
颁布日期:19891113  实施日期:19900101  颁布单位:卫生部

  Chapter I General Provisions

  Article 1 These Regulations are formulated to strengthen hygiene supervision over cosmetics so as to ensure hygiene quality and safety use of cosmetics and to safeguard the consumers' health.

  Article 2 The term “Cosmetics” referred to in these Regulations means those daily used chemical products applied on the surface of any part of the human body (such as skin, hair, nails and lips) by way of smearing, spraying or other similar methods to keep the body clean, to get rid of undesirable smell, to protect the skin, to make up the face and to increase the beauty of the appearance.

  Article 3 The State shall enforce hygiene supervision over cosmetics. The health administrative department under the State Council is in charge of the nationwide hygiene supervisory work on cosmetics while the health administration departments at or above county government level are in charge of the hygiene supervisory work on cosmetics within their respective jurisdiction.

  Article 4 All units or persons who are engaged in the production and business of cosmetics must abide by these Regulations.

  Chapter II Hygiene Supervision over the Production of Cosmetics

  Article 5 The State shall exercise hygiene supervision over the enterprises engaged in the production of cosmetics by means of Hygiene License system. Hygiene License for the Production Enterprise of Cosmetics shall be approved and issued by the hygiene administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level.

  The term of validity of a Hygiene License for the Production Enterprise of Cosmetics is four years and it must be verified after two years.

  No enterprise shall be allowed to engage in the production of cosmetics without a Hygiene License.

  Article 6 A production enterprise of cosmetics must meet the following hygiene requirements:

  (1) it must be built in a clean area and away from areas contaminated with poisonous or other harmful matters at a certain distance as required by the relevant hygiene regulations;

  (2) the production building must be strong and clean. The ceiling, walls and floors inside the workshop must be built with smooth and glazed material. The workshop must be well-lit and have necessary facilities and equipment to kill rats and insects and to prevent them from causing harm to the products and from multiplying;

  (3) it must have adequate depository for materials and finished products and workshops of appropriate capacity for processing and packing purposes;

  (4) the workshops must be equipped with the necessary facilities to meet the specific requirements of the products, and the technological process must meet the hygiene standard;

  (5) it must have testing instruments and qualified technical personnel to carry out microbiological test on its cosmetic products.

  Article 7 The staff and workers directly involved in the production of cosmetics are required to have a physical check-up every year. Only those who hold a health certificate shall be allowed to engage in the production.

  Any worker who suffers from ringworm of fingers, ringworm of finger-nails, hand eczema, hand scale, effusive dermatosis, dysentery, typhoid, virus hepatitis, and active tuberculosis shall not allowed to be directly engaged in the production of cosmetics.

  Article 8 The materials and additives needed in the making of cosmetics and the immediate containers and packing materials of cosmetics must meet the State hygiene standards.

  Article 9 Before a new kind of material is used to make cosmetics, an application must be made to the health administrative department under the State Council for approval. “New kind of material” refers to natural or synthetic materials that are used to make cosmetics for the first time in China.

  Article 10 The production of special cosmetics must be approved by the health administrative department under the State Council. Only after an approval document is obtained from this department can the factory start the production.

  “Special Cosmetics” refer to those substance used for hair nourishment, hair-dye, hair perm, hair removing, breast massage, deodorant, fading cream and antisunburn lotion.

  Article 11 Before putting its cosmetic products onto the market, the producer is required to conduct hygiene quality examination in accordance with the Hygiene Standard for Cosmetics formulated by the State and mark the qualified products. The products that are not examined or are not up to the required hygiene standard are not allowed to be shipped out of the factory.

  Article 12 On the label of a cosmetic product, the name of the product, the name of the producer and the serial number of the hygiene license for the production enterprise must be clearly stated; on the smaller package or the specification sheet, the date of production and expiry must be stated. In the case of special cosmetic products, the approval document number must also be printed. In the case of cosmetics that may cause undesirable reactions, warnings and instructions on the use of the product must be stated in the specification sheet. No indications, curative effect and medical terms are allowed to be written on the label, on the inner packing or on the specification sheet of cosmetic products.

  Chapter III Hygiene Supervision over Cosmetics Sales

  Article 13 No unit or person in the cosmetics business shall be allowed to sell cosmetics of the following kinds:

  (1) the cosmetics produced by an enterprise without a Hygiene License for the Production Enterprise of Cosmetics;

  (2) the cosmetics without a quality tag;

  (3) the cosmetics of which the label, the smaller package or the specification sheet does not conform to the rules stipulated in Article 12 of these Regulations;

  (4) the special cosmetics without an approval document;

  (5) the cosmetics that has expired.

  Article 14 The following content shall not be allowed to be included in cosmetic advertising:

  (1) exaggerating the effectiveness of the cosmetic product through its chosen name and the description of its production method, its properties and efficacy;

  (2) giving a guarantee in the name of other people or giving a hint to lure consumers into misunderstanding the efficacy of the product;(3) advertising the medical efficacy of the cosmetic product.

  Article 15 When a cosmetic product is imported for the first time, the importing unit is required to submit to the health administrative department under the State Council the relevant information such as the specifications, the quality standard, and the method of testing, and a sample of that cosmetics together with a production license issued by the official department of the exporting country (or region)。 Only after an approval by the health administrative department under the State Council is obtained can the importing unit sign the import contract.

  Article 16 All imported cosmetics are subject to inspection by the State Bureau of Import and Export Commodities Inspection. Only those qualified cosmetics are allowed to be imported. Cosmetics imported in small quantity for personal use shall follow the import formalities in accordance with Customs regulations.

  Chapter IV The Organ for Hygiene Supervision over Cosmetics and Its Duties

  Article 17 The health administration departments at all government levels shall exercise hygiene supervision over cosmetics. They shall entrust an inspection organ to carry out the specific hygiene supervisory work within their jurisdiction.

  Article 18 The health administrative department under the State Council shall invite research specialists and experts from medical units, production enterprises and health administration organs to form an appraisal group for the safety of cosmetics. They shall make appraisal of the safety of imported cosmetics, special cosmetics and the new ingredients of cosmetics. Besides, they make technical investigation in the hazardous results of cosmetics of poor quality.

  Article 19 The health administration departments at all levels shall appoint cosmetic hygiene supervisors to exercise hygiene supervision over cosmetics.

  Cosmetics hygiene supervisors shall be selected by the health administrative department under the State Council, at the provincial, autonomous regional or municipal (directly under the Central Government) level from among qualified hygiene personnel and shall be issued with badges and identity cards.

  Article 20 When carrying out their duties, the cosmetic hygiene supervisors are required to wear their badges and show their identity cards. They must keep confidential the technical data presented by the production enterprises.

  Article 21 Cosmetic hygiene supervisors are vested with the right to conduct sample testing of the cosmetics of any production or business unit. They may ask for information of cosmetic safety that is related to their hygiene supervisory work. No unit shall refuse to provide or withhold the facts, or to present false material.

  Article 22 The health administration departments, the cosmetic hygiene supervisors or the hygiene supervision and inspection organs at all levels are not allowed to have a hand in the production, sale or supervision of the making of cosmetics in the form of technical consultancy, technical service and under any other pretences.

  Article 23 If any medical treatment unit finds out any cases who suffer from undesirable effect after using a certain cosmetics, it is required to make a report to the local health administration department.

  Chapter V Penalty Provisions

  Article 24 If any production enterprise without a Hygiene License for the Production Enterprise of Cosmetics is found to have made cosmetics without authorization, it shall be ordered to stop production and its products and illegal earnings shall be confiscated and a fine 3 to 5 times the illegal profits shall be imposed on it.

  Article 25 If any production enterprise without holding an approval document is found to have produced special cosmetics or have used prohibited materials or any new ingredients that had not been previously approved, its products and illegal earnings shall be confiscated and a fine 3 to 5 times their illegal profits shall be imposed on it. It may be ordered to stop production or to have its Hygiene License for the Production Enterprise of Cosmetics revoked.

  Article 26 Those who import or sell imported cosmetics that have not been approved or examined shall be punished by having their goods and illegal earnings confiscated and by a fine 3 to 5 times their illegal profits.

  As for those enterprises holding an approval document for the production of special cosmetics, if they violate these provisions and the case is serious enough, their approval document shall be revoked.

  Article 27 Those who produce or sell any cosmetics that are not up to the State Hygiene Standard for Cosmetics shall be punished by having their products and illegal earnings confiscated and by a fine 3 to 5 times their illegal profits.

  Article 28 If any production enterprise or business enterprise violates other rules of these Regulations, they shall be given a warning and be ordered to correct their wrong doings within a prescribed period of time; if the case is serious enough, in the case of a production enterprise, it shall be ordered to stop production or to have its Hygiene License for the Production Enterprise of Cosmetics revoked; and, in the case of a business enterprise, it shall be ordered to stop business, have its illegal earnings confiscated and be punished by a fine 2 to 3 times their illegal profits.

  Article 29 Disciplinary sanctions for violation of these Regulations shall be decided by the health administration departments at or above the county level.

  Disciplinary sanctions for violation of Article 14 of these Regulations hall be decided by the administration department for industry and commerce.

  The punishment by revocation of the Hygiene License for the Production Enterprise of Cosmetics shall be decided by the health administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level. The punishment by revocation of the approval document for the production of special cosmetics shall be decided by the health administrative department under the State Council. The fine and confiscation shall all be turned over to the State treasury and the products confiscated shall be disposed under the supervision of the health administration department.

  Article 30 If the party concerned does not accept the disciplinary sanction imposed by the health administration department, it may appeal to the health administration department at a higher level for a review of the case within 15 days after receiving the notification of the sanction. The higher health administration department is required to give a reply within 30 days. If it is still not satisfied with the decision made by the health administration at the higher level, it may bring a suit to the people's court within 15 days after receiving the notification of the reconsideration, but it must carry out at once the order of the health administration department about confiscation of their products and suspension of production. If, upon the expiration of this period, the party has neither applied for reconsideration nor complied with the sanction, the health administration department may request the people's court to take enforcement at law.

  Article 31 In the case that the consumer is harmed physically or poisoned as a result of violation of these Regulations, the production enterprise, the business enterprise or the persons who are directly responsible for the consequences must compensate for the loss. If the case has produced serious consequences, the party responsible shall be prosecuted for criminal responsibility by the judicial organs in accordance with the law.

  Article 32 Any cosmetic hygiene supervisor who abuses his power or engages in malpractices for personal gains or discloses the technical data provided by the enterprise shall be subject to disciplinary sanctions; and if the case is serious enough to constitute a crime, he shall be prosecuted for criminal responsibility according to law.

  Chapter VI Supplementary Provisions

  Article 33 Hygiene supervision work over the cosmetics produced and put to sale on the market by any units in the People's Liberation Army shall be conducted in accordance with these Regulations.

  Article 34 The right to interpret these Regulations resides in the health administration department under the State Council and the rules for the implementation of these Regulations shall be formulated by the health administration department under the State Council.

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

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