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卫生部


化妆品卫生监督条例(附英文)

1989年11月13日，卫生部

第一章 总 则
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。
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。
第三条 国家实行化妆品卫生监督制度。国务院卫生行政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卫生行政部门主管本辖区内化妆品的卫生监督工作。
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。

第二章 化妆品生产的卫生监督
第五条 对化妆品生产企业的卫生监督实行卫生许可证制度。
《化妆品生产企业卫生许可证》由省、自治区、直辖市卫生行政部门批准并颁发。《化妆品生产企业卫生许可证》有效期四年，每二年复核一次。
未取得《化妆品生产企业卫生许可证》的单位，不得从事化妆品生产。
第六条 化妆品生产企业必须符合下列卫生要求：
（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。
（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。
（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。
（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。
（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。
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。
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。
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。
第九条 使用化妆品新原料生产化妆品，必须经国务院卫生行政部门批准。
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。
第十条 生产特殊用途的化妆品，必须经国务院卫生行政部门批准，取得批准文号后方可生产。
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。
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。
第十二条 化妆品标签上应当注明产品名称、厂名，并注明生产企业卫生许可证编号；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。
化妆品标签、小包装或者说明书上不得注有适应症，不得宣传疗效，不得使用医疗术语。

第三章 化妆品经营的卫生监督
第十三条 化妆品经营单位和个人不得销售下列化妆品：
（一）未取得《化妆品生产企业卫生许可证》的企业所生产的化妆品；
（二）无质量合格标记的化妆品；
（三）标签、小包装或者说明书不符合本条例第十二条规定的化妆品；
（四）未取得批准文号的特殊用途化妆品；
（五）超过使用期限的化妆品。
第十四条 化妆品的广告宣传不得有下列内容：
（一）化妆品名称、制法、效用或者性能有虚假夸大的；
（二）使用他人名义保证或以暗示方法使人误解其效用的；
（三）宣传医疗作用的。
第十五条 首次进口的化妆品，进口单位必须提供该化妆品的说明书、质量标准、检验方法等有关资料和样品以及出口国（地区）批准生产的证明文件，经国务院卫生行政部门批准，方可签定进口合同。
第十六条 进口的化妆品，必须经国家商检部门检验；检验合格的，方准进口。
个人自用进口的少量化妆品，按照海关规定办理进口手续。

第四章 化妆品卫生监督机构与职责
第十七条 各级卫生行政部门行使化妆品卫生监督职责，并指定化妆品卫生监督检验机构，负责本辖区内化妆品的监督检验工作。
第十八条 国务院卫生行政部门聘请科研、医疗、生产、卫生管理等有关专家组成化妆品安全性评审组，对进口化妆品、特殊用途的化妆品和化妆品新原料进行安全性评审，对化妆品引起的重大事故进行技术鉴定。
第十九条 各级卫生行政部门设化妆品监督员，对化妆品实施卫生监督。
化妆品卫生监督员，由省、自治区、直辖市卫生行政部门和国务院卫生行政部门，从符合条件的卫生专业人员中聘任，并发给其证章和证件。
第二十条 化妆品卫生监督员在实施化妆品卫生监督时，应当佩戴证章，出示证件。
化妆品卫生监督员对生产企业提供的技术资料应当负责保密。
第二十一条 化妆品卫生监督员有权按照国家规定向生产企业和经营单位抽检样品，索取与卫生监督有关的安全性资料，任何单位不得拒绝、隐瞒和提供假材料.
第二十二条 各级卫生行政部门和化妆品卫生监督员及卫生监督检验机构不得以技术咨询、技术服务等方式参与生产、销售化妆品，不得监制化妆品。
第二十三条 对因使用化妆品引起不良反应的病例，各医疗单位应当向地卫生行政部门报告。

第五章 罚 则
第二十四条 未取得《化妆品生产企业卫生许可证》的企业擅自生产化妆品的，责令该企业停产，没收产品及违法所得，并且可以处违法所得三到五倍的罚款。
第二十五条 生产未取得批准文号的特殊用途的化妆品，或者使用化妆品禁用原料和未经批准的化妆品新原料的，没收产品及违法所得，处违法所得三到五倍的罚款，并且可以责令该企业停产或者吊销《化妆品生产企业卫生许可证》。
第二十六条 进口或者销售未经批准或者检验的进口化妆品的，没收产品及违法所得，并且可以处违法所得三到五倍的罚款。
对已取得批准文号的生产特殊用途化妆品的企业，违反本条例规定，情节严重的，可以撤销产品的批准文号。
第二十七条 生产或者销售不符合国家《化妆品卫生标准》的化妆品的，没收产品及违法所得，并且可以处违法所得三到五倍的罚款。
二十八条 对违反本条例其他有关规定的，处以警告，责令限期改进；情节严重的，对生产企业，可以责令该企业停产或者吊销《化妆品生产企业卫生许可证》，对经营单位，可以责令其停止经营，没收违法所得，并且可以处违法所得二到三倍的罚款。
第二十九条 本条例规定的行政处罚，由县以上卫生行政部门决定。违反本条例第十四条有关广告管理的行政处罚，由工商行政管理部门决定。
吊销《化妆品生产企业卫生许可证》的处罚由省、自治区、直辖市卫生行政部门决定；撤销特殊用途化妆品批准文号的处罚由国务院卫生行政部门决定。
罚款及没收非法所得全部上交国库。没收的产品，由卫生行政部门监督处理。
第三十条 当事人对卫生行政部门的行政处罚决定不服的，可以在收到通知书次日起十五日内向上一级卫生行政部门申请复议。上一级卫生行政部门应当在三十日内给予答复。当事人对上一级卫生行政部门复议决定不服的，可以在收到复议通知书次日起十五日内向人民法院起诉。但对
卫生行政部门所作出的没收产品及责令停产的处罚决定必须立即执行。当事人对处罚决定不执行，逾期又不起诉的，卫生行政部门可以申请人民法院强制执行。
第三十一条 对违反本条例造成人体损伤或者发生中毒事故的，有直接的责任的生产企业和经营单位或者个人应负损害赔偿责任。
对造成严重后果，构成犯罪的，由司法机关依法追究刑事责任。
第三十二条 化妆品卫生监督员滥用职权，营私舞弊以及泄露企业提供的技术资料的，由卫生行政部门给予行政处分，造成严重后果，构成犯罪的，由司法机关依法追究刑事责任。

第六章 附 则
第三十三条 中国人民解放军所属单位生产的投放市场的化妆品的卫生监督，依照本条例执行。
第三十四条 本条例由国务院卫生行政部门负责解释；实施细则由国务院卫生行政部门制定。
第三十五条 本条例自一九九0年一月一日起施行。

REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS

Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)
REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS
(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)

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
shall 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.