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Regulations Concerning the Hygiene Supervision over Cosmetics (2019 Revision PKULAW Version) [Effective]
化妆品卫生监督条例(2019修订) [现行有效]

Regulations Concerning the Hygiene Supervision over Cosmetics 


(Approved by the State Council on September 26, 1989; issued by the Order No. 3 of the Ministry of Health of the People's Republic of China on November 13, 1989; and revised in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) (1989年9月26日国务院批准,1989年11月13日卫生部令第3号发布 根据2019年3月2日《国务院关于修改部分行政法规的决定》修订)

Chapter I General Provisions 

第一章 总 则

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.   第一条 为加强化妆品的卫生监督,保证化妆品的卫生质量和使用安全,保障消费者健康,制定本条例。
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.   第二条 本条例所称的化妆品,是指以涂擦、喷洒或者其他类似的方法,散布于人体表面任何部位(皮肤、毛发、指甲、口唇等),以达到清洁、消除不良气味、护肤、美容和修饰目的的日用化学工业产品。
Article 3 The State shall enforce hygiene supervision over cosmetics. The cosmetics supervision and administration department under the State Council is in charge of the nationwide hygiene supervisory work on cosmetics while the cosmetics supervision and administration department at or above county government level are in charge of the hygiene supervisory work on cosmetics within their respective jurisdiction.   第三条 国家实行化妆品卫生监督制度。国务院化妆品监督管理部门主管全国化妆品的卫生监督工作,县以上地方各级人民政府的化妆品监督管理部门主管本辖区内化妆品的卫生监督工作。
Article 4 All units or persons who are engaged in the production and business of cosmetics must abide by these Regulations.   第四条 凡从事化妆品生产、经营的单位和个人都必须遵守本条例。
Chapter II Hygiene Supervision over the Production of Cosmetics 

第二章 化妆品生产的卫生监督

Article 5 Cosmetics production enterprises shall be subject to the production permit system.   第五条 对化妆品生产企业实行化妆品生产许可证制度。
Cosmetics production permits shall be approved and issued by the cosmetics supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government. A cosmetics production permit shall be valid for five years. 化妆品生产许可证由省、自治区、直辖市化妆品监督管理部门批准并颁发。化妆品生产许可证有效期五年。
No entity may engage in the production of cosmetics without a cosmetics production permit. 未取得化妆品生产许可证的单位,不得从事化妆品生产。
Article 6 A production enterprise of cosmetics must meet the following hygiene requirements:   第六条 化妆品生产企业必须符合下列卫生要求:
(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; (一)生产企业应当建在清洁区域内,与有毒、有害场所保持符合卫生要求的间距。
(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; (二)生产企业厂房的建筑应当坚固、清洁。车间内天花板、墙壁、地面应当采用光洁建筑材料,应当具有良好的采光(或照明),并应当具有防止和消除鼠害和其他有害昆虫及其孳生条件的设施和措施。
(3) it must have adequate depository for materials and finished products and workshops of appropriate capacity for processing and packing purposes; (三)生产企业应当设有与产品品种、数量相适应的化妆品原料、加工、包装、贮存等厂房或场所。
(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; (四)生产车间应当有适合产品特点的相应的生产设施,工艺规程应当符合卫生要求。
(5) it must have testing instruments and qualified technical personnel to carry out microbiological test on its cosmetic products. (五)生产企业必须具有能对所生产的化妆品进行微生物检验的仪器设备和检验人员。
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.   第七条 直接从事化妆品生产的人员,必须每年进行健康检查,取得健康证后方可从事化妆品的生产活动。
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. 凡患有手癣、指甲癣、手部湿疹、发生于手部的银屑病或者鳞屑、渗出性皮肤病以及患有痢疾、伤寒、病毒性肝炎、活动性肺结核等传染病的人员,不得直接从事化妆品生产活动。
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.   第八条 生产化妆品所需的原料、辅料以及直接接触化妆品的容器和包装材料必须符合国家卫生标准。
Article 9 Before a new kind of material is used to make cosmetics, an application must be made to the cosmetics supervision and administration department under the State Council for approval.   第九条 使用化妆品新原料生产化妆品,必须经国务院化妆品监督管理部门批准。
"New kind of material" refers to natural or synthetic materials that are used to make cosmetics for the first time in China. 化妆品新原料是指在国内首次使用于化妆品生产的天然或人工原料。
Article 10 The production of special cosmetics must be approved by the cosmetics supervision and administration department under the State Council. Only after an approval document is obtained from this department can the factory start the production.   第十条老婆觉得我剪头发浪费钱 生产特殊用途的化妆品,必须经国务院化妆品监督管理部门批准,取得批准文号后方可生产。
"Special Cosmetics" refer to those substance used for hair nourishment, hair-dye, hair perm, hair removing, breast massage, deodorant, fading cream and anti-sunburn lotion. 特殊用途化妆品是指用于育发、染发、烫发、脱毛、美乳、健美、除臭、祛斑、防晒的化妆品。
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.   第十一条 生产企业在化妆品投放市场前,必须按照国家《化妆品卫生标准》对产品进行卫生质量检验,对质量合格的产品应当附有合格标记。未经检验或者不符合卫生标准的产品不得出厂。
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 cosmetics production permit 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.
   第十二条 化妆品标签上应当注明产品名称、厂名,并注明生产企业化妆品生产许可证编号;小包装或者说明书上应当注明生产日期和有效使用期限。特殊用途的化妆品,还应当注明批准文号。对可能引起不良反应的化妆品,说明书上应当注明使用方法、注意事项。

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