The Legislative Affairs Office of the State Council Consulting for Public Comments on the Draft Version of Regulations Concerning the Supervision and Administration of Cosmetics

Regulations Concerning the Hygiene Supervision of Cosmetics (RHSC, Decree No.3) was issued on 13 November 1989 by the Ministry of Health (MOH) of China and came into effect on 1 January 1990. With the rapid development of cosmetics industry, Decree No.3 is not available to meet the need to ensure the health of consumers such as the use of nano materials in cosmetics at present. The RHSC has the weak crackdown to illegal behaviors. Moreover, there is no risk management system established on the condition that the enterprise is acted as the main body and the control of cosmetic ingredients and efficacy claims, GMP requirements and traceability of business process are the core factors. The purposes of revising RHSC are:

Reducing pre-market approval appropriately and strengthening the supervision during the event or afterwards;
Building the sort management system of cosmetic ingredients, finished products and enterprises according to the degree of risk;
Highlighting the responsibility of enterprises as the main body
Proposing the social participation

20 Jul 2015, the Legislative Affairs Office of the State Council issued a notice to invite public comments on the draft version of Regulations Concerning the Supervision and Administration of Cosmetics (RSAC). Any opinions can be sent to the feedback system of draft regulations in the China Legislative Information Network or to the email address hzp@chinalaw.gov.cn before 20 Aug 2015.

Main changes

1. General information

Chapter	RHSC (old)	RSAC (new)
I	General principles (Article 1-4)	General principles (Article 1-7)
II	Hygienic supervision of cosmetics production (Article 5-12)	Raw materials and products (Article 8-21)
III	Hygienic supervision of cosmetics business (Article 13-16)	Production and management (Article 22-40)
IV	Hygienic supervision institution and responsibility of cosmetics(Article 17-23)	Labelling and advertisement (Article 41-45)
V	Penalty (Article 24-32)	Supervision and administration (Article 46-59)
VI	Supplementary provisions (Article 33-35)	Legal liability (Article 60-76)
VII	-	Supplementary provisions (Article 77-79)

2. Management of cosmetic products

Item	RHSC (old)	RSAC (new)
Definition	Cosmetics are defined as daily used industrial chemicals which can be spread on the outer surface of human body (e.g. skin, hairs, nails. lips etc) for the purpose of cleaning, deodorizing, providing skin care, beauty and make – up, by way of smearing, spraying or other similar means.	Cosmetics are defined as the products which can be spread on the outer surface of human body (e.g. skin, hairs, nails. lips etc), the teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, deodorizing and keeping in good condition, by way of smearing, spraying or other similar means.
Competent authority	Ministry of Health	China Food and Drug Administration
Category	1. Non special use cosmetics 2. Special use cosmetics: hair growth, hair dye, hair perm, deodorization, depilation, anti-freckle, breast shaping, fitness and sun block	1. Non special use cosmetics 2. Special use cosmetics*: hair dye, hair perm, whitening, sun block and others
Product management	Special use cosmetics: pre-market approval in MOH Imported cosmetics: pre-market approval in MOH	Special use cosmetics: pre-market approval in CFDA； Imported non special use cosmetics**: record-keeping in CFDA within 10 working days prior to import; Domestic non special use cosmetics: record-keeping in provincial/municipal FDA within 10 working days prior to production;
Dossier requirements	Instruction sheet, quality standard, testing method, testing samples and others	Name, address and contact of applicant or filer; Name, address and contact of manufacturer; Product name, full ingredient list, GB or QB standard, testing report, safety assessment report and certificate of assessor, sample of label and instructions and other required docs***.
Requirements of safety assessor	-	More than 5 years of working experience in the field of medical science, pharmacy, chemistry or toxicology
Valid period of approval license****	-	5 years for special use cosmetics
The Chinese responsible person	-	Not only responsible for the registration or record keeping of cosmetics but also for the safety of cosmetics.
Labeling	Requirements: -	Requirements: required for the outer and inner package. A statement added to the registration dossiers when choosing to use a sticker as the Chinese label for imported cosmetics.
	Contents: product name, plant name, sanitary certificate number of manufacturer, production date and effective lifespan indicated on a pouch pack or instructions, application methods and precautions	Contents: product name, name and address of manufacturer and contract manufacturer, number of production certificate, registration or record keeping number of products, standard number, full ingredient list, net weight.
	Efficacy claims: -	Efficacy claims: efficacy literature or research data available to public in CFDA designated website for social supervision. (Note: cosmetic manufacturers are responsible for the truth of efficacy claims)
E-commerce business	-	Real-name registration of cosmetics operators required for the third-party platform which undertakes the responsibility of management.
Adverse effect monitoring	Medical institutions should notify to MOH when having the case of adverse effect caused by cosmetics	Cosmetics manufacturers should monitor the adverse effect of market cosmetics actively and submit the report to adverse reactions monitoring organization. Urging the social organization and individuals to report the adverse reactions to FDA or monitoring institution.
Emergency control measures	-	The cosmetics causing serious or bulk adverse reactions have to be stopped producing, importing and selling. Cancelling the approval license of cosmetics with safety issue. The monitoring results available to social public
Emergency disposal	-	Drawing up cosmetics quality and safety emergency plans. Determining the accident classification, disposal organization and direction system and responsibility, precaution and warning mechanism, disposal procedure and emergency safeguard measures.
Overseas inspection	-	CFDA can carry out the on-site inspection to overseas cosmetics manufacturers regarding the production quality and management standard.
Credit supervision	-	Increasing the frequency of supervision inspection and sampling to the production operators having the adverse credit record.
Complaint and report	-	The email address or phone number available to handle public enquiries and complaints.

*the scope will be adjusted by CFDA in line with the development of scientific research, monitoring of adverse effect and safety risk assessment of cosmetics.

**CFDA will issue the detailed measures of record-keeping

***For cosmetics produced for China market specially, relevant research and testing data conducted for Chinese consumers are required

****Can be transferred to another party in view of CFDA approval

3. Management of new cosmetic ingredients

Item	RHSC (old)	RSAC (new)
Definition	The natural or artificial raw materials have never been used in cosmetics in China	The natural or artificial raw materials have never been used in cosmetics in China
Inventory of cosmetic ingredients**	-	Banned, restricted and approval ingredients list*
Competent authority	Ministry of Health	China Food and Drug Administration
Management system	Pre-market approval in MOH	Pre-market approval available for new preservatives, colorants, sunscreen agents, hair dye agents, whitening agents and other high safety risk ingredients. Record-keeping required within 30 working days before use for other new cosmetic ingredients in terms of the technical requirements issued by CFDA.
Post-market supervision	-	Reporting the situation of use and safety to CFDA every half year within 3 years after approval.

*containing approval preservatives, colorants, sun screen agents, hair dye agents, whitening agents and other high safety risk ingredients.

** CFDA will update the revised inventory before the end of each year if needed

4. Penalty

4.1 Producing cosmetics without having the sanitary permit of cosmetics manufacturers

Item	RHSC (old)	RSAC (new)
Stopping production and sale	√	√
Confiscating the illegal income	√	√
Fine	3-5 times of illegal income	5-10 times when the value of illegal cosmetics is less than 10,000 yuan. Or 10-20 times of illegal cosmetics value
Cancelling approval license of cosmetics	-	√
Others	-	a) Not accepting the application of cosmetic approval within 10 years; b) Fining 20,000-100,000 yuan to the owner, responsible person of quality and safety, safety assessor of illegal enterprise separately; c) The illegal company can’t engage in the cosmetics business within 10 years.

Note: The punishment of illegal behavior below is same as above in terms of RSAC. Producing cosmetics by forging or using production certificate or approval license of special use cosmetics illegally

4.2 Producing unapproved special use cosmetics & Using banned or new cosmetic ingredients in cosmetics

Item	RHSC (old)	RSAC (new)
Stopping production and sale	√	√
Confiscating the illegal income	√	√
Fine	3-5 times of illegal income	5-10 times when the value of illegal cosmetics is less than 10,000 yuan. Or 10-20 times of the illegal cosmetics value
Cancelling sanitary certificate of cosmetics manufacturer	-	√
Others	-	a) Not accepting the application of cosmetic approval within 10 years; b) Fining 20,000-100,000 yuan to the owner, responsible person of quality and safety, safety assessor of illegal enterprise separately; c) The illegal company can’t engage in the cosmetics business within 10 years.

4.3 Importing or selling unapproved imported cosmetics & Producing or selling cosmetics not compliant with the Hygienic Standard for Cosmetics

Item	RHSC (old)	RSAC (new)
Stopping importation and sale	-	√
Confiscating the illegal income	√	√
Fine	3-5 times of illegal income	2-5 times when the value of illegal cosmetics is less than 10,000 yuan. Or 5-10 times of the illegal cosmetics value
Others	-	a) Not accepting the application of cosmetic approval within 5 years; b) Fining 10,000-50,000 yuan to the owner, responsible person of quality and safety, safety assessor of illegal enterprise separately; c) The illegal company can’t engage in the cosmetics business within 5 years.

Note: The punishment of illegal behavior below is same as above in terms of RSAC

Selling cosmetics produced by illegal manufacturer
Changing the period of use illegally or marketing overdue cosmetics
The affixed procedure of Chinese label for imported cosmetics is not compliant with the rules
Not handling the cosmetics quality and safety incidents or taking actions of recall actively
Appointing unqualified contract manufacturers or not managing the production behavior of contract manufacturers and the quality and safety of cosmetics.

Summary and CIRS Comments

Registration or record-keeping procedure of cosmetics

Cosmetics are divided into non special use and special use cosmetics in China. Special use cosmetics consist of hair dye, hair perm, whitening, sun block and others.

CIRS Comments

It is possible that the type of special use cosmetics for hair growth, depilation, breast shaping, fitness and deodorization are cancelled, or classified as drug or common use cosmetics.

CFDA will issue the specific record-keeping requirements for imported non special use cosmetics. The pre-market record-keeping process and time will be easier and shorter than current management system. The government will strengthen the post-market supervision of cosmetics. In that case, the responsibility of cosmetics quality and safety is transferred from the government to the cosmetic enterprises or the Chinese responsible agent.
The Chinese sticker is available to imported cosmetics as well
CFDA will issue a separate regulation for the management of toothpastes.
The safety assessment report should be prepared and signed by qualified assessor or third-party.

Registration or record-keeping procedure of new cosmetic ingredients

New cosmetic ingredients are divided into high safety risk ingredients such as preservatives, colorants, sunscreen agents, hair dye agents, whitening agents and other ingredients with low safety risk.

CIRS Comments

So far, it is almost only one new cosmetic ingredient can be approved each year. However, CFDA will carry out the sort management to the new cosmetic ingredients in terms of the safety risk so as to urge the development of cosmetics industry. It is the great news for ingredient suppliers because many new cosmetic ingredients with low safety risk can be placed into China market earlier. CFDA will issue separate requirements for the record-keeping of new cosmetic ingredients with low safety risk.

Source: http://www.sda.gov.cn/WS01/CL0781/124701.html

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