The Regulations concerning the Supervision and Administration over Cosmetics (Version of revised draft for review) (the "Draft for Review") drafted by China Food and Drug Administration was published on 20th July 2015 for public comments.
This version of the draft represents a second revision of the original Regulations Concerning the Hygiene Supervision over Cosmetics (the "Current Regulation") produced in 1989, and initially revised in 2014. Experts from REACH24H Consulting Group made a full transition to this revision in the first place.
The highlights in the Draft for Review include the following:
1.1 General Provisions- Expand the Product Range
In accordance with the first revision, the Draft for Review classifies oral care products such as toothpaste as cosmetic products subject to regulation. Despite the opposition of some industrial associations and enterprises, the revised draft expressly specifies that oral care products should be included in the category of cosmetics aligning with U.S., European and Japanese frameworks. In the draft regulation the CFDA doesn't explicitly state how to deal with certain commonly used medical terms such as "anti-cavity" and "anti-bacteria". The draft does not clarify if usage of claims relating to medicinal functionality will classify a product as a medicine or a cosmetic.
1.2 Ingredients and Products
1.2.1Modification of Cosmetic Ingredient Inventories
The CFDA is responsible for the formulation and publication of the inventories of prohibited cosmetic ingredients, restricted cosmetic ingredient and permitted cosmetic ingredients. The inventory of permitted cosmetic ingredients includes preservatives, sunscreens, colorants, hair dyes, whitening agents and other high risk ingredients. The CFDA republishes the updated inventories at the end of each year. In the new draft the "Inventory of Existing Ingredients" proposed in the last version doesn't exist. Experts from REACH24H speculate that, the "Inventory of Permitted cosmetic Ingredients" represents a more simplified version of the existing "Inventory of Existing Ingredients".
1.2.2 Relaxed Requirements for New Ingredients
Raw materials that pose heighten adverse reaction risks such as antiseptic, sun screens, colorants, hair colorants and skin whitening agents are subject to review and approval whereas other inherently safer ingredients are only subject to record filing with the CFDA at least 30 working prior to market release.
Manufacturer shall provide regular reports on the use and safety of new ingredients semiannually for the first 3 years after the approval or notification of the new ingredients. Only domestic manufacturers or agents designated by the importer are eligible to make a new ingredient application to the CFDA. However this poses a major problem as information about new ingredient is usually confidential and manufacturers or brand owner are typically extremely hesitant to divulge finished product information.
1.2.3 Revised Cosmetic Classifications
The draft revises the classification of "cosmetics for special purpose" and "cosmetics for non-special purpose" in the Current Regulation to "special cosmetics' and "general cosmetics'. "Special cosmetics" have been consolidated from a total of nine categories to just five categories which include hair dyes products, hair perming products, whitening products, sunscreens and other special cosmetics. The CFDA may adjust the scope of special cosmetics according to risk assessment results.
1.2.4 Strengthened Safety Assessment
The Draft for Review adds requirements for safety assessment. Cosmetic registration applicants and record filing applicants shall appoint a specific staff member or designate an independent third-party institute to conduct a safety assessment in accordance with the requirements prescribed by CFDA. The draft gives more detailed requirements for the qualifications of safety evaluation staff, (i.e., they should have relevant professional knowledge of medicine, pharmacy, chemical, toxicology, etc. and over 5 years of working experience in those fields.). Experts from REACH24H Consulting Group have are extremely experienced in toxicological evaluation, and our fully qualified cosmetic safety assessors have made full preparation for the pending implementation of this new policy.
1.2.5 Emphasis on Agent Responsibilities
The Draft for Review defines the responsibilities of agents. Agents designated by brand owners, manufacturers, importers/exports are responsible for the authenticity, scientific accuracy and compliance of the information submitted to CFDA. Agents shall also cooperate with overseas enterprise to monitor undesirable effects of cosmetics, recalls of defective products, and must also bear legal liability for quality and safety issues.
Additional responsibilities are consistent with international frameworks (especially the European practices).
1.3 Manufacturing and Operation: Production Quality Management Standards
Although "Good Manufacturing Practice Guidance" for Cosmetics is still in the drafting process, the Draft for Review states that manufacturers of cosmetics shall comply with good manufacturing practices. Cosmetics manufacturers shall comply with requirements of "Manufacture Quality Management Standards for Cosmetics" to organize production, establish and implement administration systems to manage selection of suppliers, raw materials testing, the process of production and quality control, equipment administration, products testing and reserved sample, recall of unqualified products administration, etc.
1.4 Labeling and Advertisement -Stricter Regulation of Functional Claims, Labels and Advertisement of Cosmetics
The Draft for Review prohibits cosmetics labels which indicate or suggest medicinal effects, exaggerate functions, could potentially confuse or mislead consumers or violate relevant laws and regulations. The claimed efficacy of cosmetics shall be based on sufficient scientific evidence. Advertisement of cosmetics shall be authentic and legitimate. Such advertisements shall indicate unsubstantiated efficacy through use of a trademark, images or other methods and shall not declare or suggest any medicinal effects. For imported cosmetics use of "over-labels" is allowed, and shall comply with related requirements of production quality control in the process of affixing this Chinese language over-label. The over-label must be accompanied by an explanation in the documents used during product registration and filing.
1.5 Supervision and Management
1.5.1 Establishment of an adverse reaction monitoring system
Cosmetics manufacturers shall proactively monitor adverse effects of commercially distributed cosmetics and report the adverse effects of cosmetics. If any cosmetics operators and medical institutes find any adverse effects with respect to the use of cosmetics, such operators and institutes shall report to the monitoring organization of such adverse effects and notify the cosmetics manufacturers. Social organizations and individuals are encouraged to report any possible adverse effects with respect to the use of cosmetics.
1.5.2 Increased Penalties for Illegal Activities
The penalties for regulatory violations under the current regulatory framework have been an ineffective deterrent for violators. The Draft for Review increases the penalties for violations. The scope of legal responsibility covers all kinds of violations, and the punitive measures used to punish offenders have also been standardized.
2. Potential Impact on the Cosmetics Industry
The Draft for Review indicates the CFDA's resolve to regulate China's cosmetic supply chain. Oral care products such as toothpaste and mouthwash have been clearly classified with accompanying new regulatory requirements. The Draft for Review standardized industry practices relating to registration and filing, advertisement, promotion and distribution.
The reduced scope of the administrative permission for ingredients and special products shows a more prudent attitude by regulatory authorities towards special use products, as well as a trend towards administrative simplification which may help spur innovation and promote the development of the whole industry.
Defining "high risk ingredients" is still an issue, as in the draft the CFDA has not included the current "Inventory of Existing Cosmetic Ingredient in China" which is used as the primary basis for assessing risk of ingredients. Specific details to define new ingredients in the actual application process are not prescribed.
Protection of R&D and confidential business information between the various links in the compliance information and documentation chain need to be addressed. In this regards, the practices adopted by China's Ministry of Environmental Protection (MEP) can be used as a reference. The MEP established chemical registration centers for chemical material suppliers to submit information in a confidential manner.
According to the Draft for Review, manufacturers of cosmetics shall comply with Production Quality Management Standards and use good manufacturing practices. In addition, the Draft strengthens safety assessment requirements and the responsibility of agents in addition to strictly stipulating requirements for use of functional claims, labels, and advertisements of cosmetics.
The draft establishes an adverse reaction monitoring system and increases penalties for illegal activities, indicates a tougher stance by regulators towards illegal behaviors.
The Draft for Review is consistent with the surpervisory goal set by the CFDA in the Explanations on Revising Regulations concerning the Supervision and Administration over Cosmetics, which are "Government supervision, industry self-regulation, internal control and public supervision". However, the Draft for Review goes into too much technical detail for an overarching cosmetic law which could limit the development of the industry. Experts from REACH24H suggest relevant industrial associations and enterprises pay close attention to the status of the revision to stay abreast of any future changes and to be ready for future promulgation.
3. Feed Back Channels
Please feel free to email us on cosmetics@reach24h.cn for any comments or questions before 20th Aug 2015, we will collect feedback opinion, and hand it to the Legal Affairs Office of the State Council.
Or you can give feedback directly via the official comments collecting system（http://www.chinalaw.gov.cn）, letter, or e-mail（hzp@chinalaw.gov.cn）.
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
