第一章 总 则
第五章 罚 则
第六章 附 则
REGULATIONS CONCERNING THE HYGIENE SUPERVISION OVER COSMETICS
Important Notice: (注意事项)
This English document is coming from the "LAWS AND REGULATIONS OF THEPEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)which is compiled by the Brueau of Legislative Affairs of the StateCouncil of the People's Republic of China, and is published by the ChinaLegal 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 issuedby Decree No. 3 of the Ministry of Public Health on November 13, 1989)
Chapter I General Provisions
These Regulations are formulated to strengthen hygiene supervision overcosmetics so as to ensure hygiene quality and safety use of cosmetics andto safeguard the consumers' health.
The term "Cosmetics" referred to in these Regulations means those dailyused chemical products applied on the surface of any part of the humanbody (such as skin, hair, nails and lips) by way of smearing, spraying orother similar methods to keep the body clean, to get rid of undesirablesmell, to protect the skin, to make up the face and to increase the beautyof the appearance.
The State shall enforce hygiene supervision over cosmetics. The healthadministrative department under the State Council is in charge of thenationwide hygiene supervisory work on cosmetics while the healthadministration departments at or above county government level are incharge of the hygiene supervisory work on cosmetics within theirrespective jurisdiction.
All units or persons who are engaged in the production and business ofcosmetics must abide by these Regulations.
Chapter II Hygiene Supervision over the Production of Cosmetics
The State shall exercise hygiene supervision over the enterprises engagedin the production of cosmetics by means of Hygiene License system. HygieneLicense for the Production Enterprise of Cosmetics shall be approved andissued 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 ofCosmetics is four years and it must be verified after two years.No enterprise shall be allowed to engage in the production of cosmeticswithout a Hygiene License.
A production enterprise of cosmetics must meet the following hygienerequirements:
(1) it must be built in a clean area and away from areas contaminated withpoisonous or other harmful matters at a certain distance as required bythe relevant hygiene regulations;
(2) the production building must be strong and clean. The ceiling, wallsand floors inside the workshop must be built with smooth and glazedmaterial. The workshop must be well-lit and have necessary facilities andequipment to kill rats and insects and to prevent them from causing harmto the products and from multiplying;
(3) it must have adequate depository for materials and finished productsand workshops of appropriate capacity for processing and packing purposes;
(4) the workshops must be equipped with the necessary facilities to meetthe specific requirements of the products, and the technological processmust meet the hygiene standard;
(5) it must have testing instruments and qualified technical personnel tocarry out microbiological test on its cosmetic products.
The staff and workers directly involved in the production of cosmetics arerequired to have a physical check-up every year. Only those who hold ahealth 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, virushepatitis, and active tuberculosis shall not allowed to be directlyengaged in the production of cosmetics.
The materials and additives needed in the making of cosmetics and theimmediate containers and packing materials of cosmetics must meet theState hygiene standards.
Before a new kind of material is used to make cosmetics, an applicationmust be made to the health administrative department under the StateCouncil for approval. "New kind of material" refers to natural orsynthetic materials that are used to make cosmetics for the first time inChina.
The production of special cosmetics must be approved by the healthadministrative department under the State Council. Only after an approvaldocument is obtained from this department can the factory start theproduction.
"Special Cosmetics" refer to those substance used for hair nourishment,
hair-dye, hair perm, hair removing, breast massage, deodorant, fadingcream and antisunburn lotion.
Before putting its cosmetic products onto the market, the producer isrequired to conduct hygiene quality examination in accordance with theHygiene Standard for Cosmetics formulated by the State and mark thequalified products. The products that are not examined or are not up tothe required hygiene standard are not allowed to be shipped out of thefactory.
On the label of a cosmetic product, the name of the product, the name ofthe producer and the serial number of the hygiene license for theproduction enterprise must be clearly stated; on the smaller package orthe specification sheet, the date of production and expiry must be stated.In the case of special cosmetic products, the approval document numbermust also be printed. In the case of cosmetics that may cause undesirablereactions, warnings and instructions on the use of the product must bestated in the specification sheet. No indications, curative effect andmedical terms are allowed to be written on the label, on the inner packingor on the specification sheet of cosmetic products.
Chapter III Hygiene Supervision over Cosmetics Sales
No unit or person in the cosmetics business shall be allowed to sellcosmetics 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 12of these Regulations;
(4) the special cosmetics without an approval document;
(5) the cosmetics that has expired.
The following content shall not be allowed to be included in cosmeticadvertising:
(1) exaggerating the effectiveness of the cosmetic product through itschosen name and the description of its production method, its propertiesand efficacy;
(2) giving a guarantee in the name of other people or giving a hint tolure consumers into misunderstanding the efficacy of the product;
(3) advertising the medical efficacy of the cosmetic product.
When a cosmetic product is imported for the first time, the importing unitis required to submit to the health administrative department under theState Council the relevant information such as the specifications, thequality standard, and the method of testing, and a sample of thatcosmetics together with a production license issued by the officialdepartment of the exporting country (or region). Only after an approval bythe health administrative department under the State Council is obtainedcan the importing unit sign the import contract.
All imported cosmetics are subject to inspection by the State Bureau ofImport and Export Commodities Inspection. Only those qualified cosmeticsare allowed to be imported. Cosmetics imported in small quantity forpersonal use shall follow the import formalities in accordance withCustoms regulations.
Chapter IV The Organ for Hygiene Supervision over Cosmetics and Its Duties
The health administration departments at all government levels shallexercise hygiene supervision over cosmetics. They shall entrust aninspection organ to carry out the specific hygiene supervisory work withintheir jurisdiction.
The health administrative department under the State Council shall inviteresearch specialists and experts from medical units, productionenterprises and health administration organs to form an appraisal groupfor the safety of cosmetics. They shall make appraisal of the safety ofimported cosmetics, special cosmetics and the new ingredients ofcosmetics. Besides, they make technical investigation in the hazardousresults of cosmetics of poor quality.
The health administration departments at all levels shall appoint cosmetichygiene supervisors to exercise hygiene supervision over cosmetics.Cosmetics hygiene supervisors shall be selected by the healthadministrative 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 withbadges and identity cards.
When carrying out their duties, the cosmetic hygiene supervisors arerequired to wear their badges and show their identity cards. They mustkeep confidential the technical data presented by the productionenterprises.
Cosmetic hygiene supervisors are vested with the right to conduct sampletesting of the cosmetics of any production or business unit. They may askfor information of cosmetic safety that is related to their hygienesupervisory work. No unit shall refuse to provide or withhold the facts,or to present false material.
The health administration departments, the cosmetic hygiene supervisors orthe hygiene supervision and inspection organs at all levels are notallowed to have a hand in the production, sale or supervision of themaking of cosmetics in the form of technical consultancy, technicalservice and under any other pretences.
If any medical treatment unit finds out any cases who suffer fromundesirable effect after using a certain cosmetics, it is required to makea report to the local health administration department.
Chapter V Penalty Provisions
If any production enterprise without a Hygiene License for the ProductionEnterprise of Cosmetics is found to have made cosmetics withoutauthorization, it shall be ordered to stop production and its products andillegal earnings shall be confiscated and a fine 3 to 5 times the illegalprofits shall be imposed on it.
If any production enterprise without holding an approval document is foundto have produced special cosmetics or have used prohibited materials orany new ingredients that had not been previously approved, its productsand illegal earnings shall be confiscated and a fine 3 to 5 times theirillegal profits shall be imposed on it. It may be ordered to stopproduction or to have its Hygiene License for the Production Enterprise ofCosmetics revoked.
Those who import or sell imported cosmetics that have not been approved orexamined shall be punished by having their goods and illegal earningsconfiscated and by a fine 3 to 5 times their illegal profits.As for those enterprises holding an approval document for the productionof special cosmetics, if they violate these provisions and the case isserious enough, their approval document shall be revoked.
Those who produce or sell any cosmetics that are not up to the StateHygiene Standard for Cosmetics shall be punished by having their productsand illegal earnings confiscated and by a fine 3 to 5 times their illegalprofits.
If any production enterprise or business enterprise violates other rulesof these Regulations, they shall be given a warning and be ordered tocorrect their wrong doings within a prescribed period of time; if the caseis serious enough, in the case of a production enterprise, it shall beordered to stop production or to have its Hygiene License for theProduction Enterprise of Cosmetics revoked; and, in the case of a businessenterprise, it shall be ordered to stop business, have its illegalearnings confiscated and be punished by a fine 2 to 3 times their illegalprofits.
Disciplinary sanctions for violation of these Regulations shall be decidedby the health administration departments at or above the county level.Disciplinary sanctions for violation of Article 14 of these Regulationsshall be decided by the administration department for industry andcommerce.
The punishment by revocation of the Hygiene License for the ProductionEnterprise of Cosmetics shall be decided by the health administrationdepartment at the provincial, autonomous regional or municipal (directlyunder the Central Government) level. The punishment by revocation of theapproval document for the production of special cosmetics shall be decidedby the health administrative department under the State Council. The fineand confiscation shall all be turned over to the State treasury and theproducts confiscated shall be disposed under the supervision of the healthadministration department.
If the party concerned does not accept the disciplinary sanction imposedby the health administration department, it may appeal to the healthadministration department at a higher level for a review of the casewithin 15 days after receiving the notification of the sanction. Thehigher health administration department is required to give a reply within30 days. If it is still not satisfied with the decision made by the healthadministration at the higher level, it may bring a suit to the people'scourt within 15 days after receiving the notification of thereconsideration, but it must carry out at once the order of the healthadministration department about confiscation of their products andsuspension of production. If, upon the expiration of this period, theparty has neither applied for reconsideration nor complied with thesanction, the health administration department may request the people'scourt to take enforcement at law.
In the case that the consumer is harmed physically or poisoned as a resultof violation of these Regulations, the production enterprise, the businessenterprise or the persons who are directly responsible for theconsequences must compensate for the loss. If the case has producedserious consequences, the party responsible shall be prosecuted forcriminal responsibility by the judicial organs in accordance with the law.
Any cosmetic hygiene supervisor who abuses his power or engages inmalpractices for personal gains or discloses the technical data providedby the enterprise shall be subject to disciplinary sanctions; and if thecase is serious enough to constitute a crime, he shall be prosecuted forcriminal responsibility according to law.
Chapter VI Supplementary Provisions
Hygiene supervision work over the cosmetics produced and put to sale onthe market by any units in the People's Liberation Army shall be conductedin accordance with these Regulations.
The right to interpret these Regulations resides in the healthadministration department under the State Council and the rules for theimplementation of these Regulations shall be formulated by the healthadministration department under the State Council.
These Regulations shall come into force as of January 1, 1990.