With regard to Chinese regulations, starting January 1, 2022, cosmetic registration applicants and filing parties must conduct safety assessments for cosmetics and submit simplified safety assessment reports according to Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition) (hereinafter referred to as the Guidelines).
However, starting May 1, 2024, registration applicants and filing parties must submit complete safety assessment reports.
Complete safety assessment reports have more stringent requirements than simplified reports. A key change is that applicants can no longer use "the applicant's historical use levels" and "ingredients' maximum historical use levels published by cosmetic competent authorities" as evidence for ingredient safety.
In addition, complete reports require appendices with physical/chemical testing, stability testing, product-packaging compatibility assessments, and preservative challenge tests. These are not mandatory for simplified reports at present.
The heightened requirements mean increased costs for brands entering China after May 1, 2024. Companies will face greater regulatory burdens for safety substantiation.
Therefore, cosmetic brands looking to enter the Chinese market should aim to do so before the 2024 deadline. This allows them to take advantage of the simplified reporting option. Entering sooner also provides more time to establish their brand and gain market share under the less strict pre-2024 regulations.
This article will explore key components that cosmetic exporters should be aware of when preparing simplified safety assessment reports for product registration or filing in China.
I.Permissible Evidence for Simplified Safety Assessment Reports
The Guidelines explain the permissible evidence for simplified cosmetic product safety assessment reports, which should choose at least one of the following evidence types in sequence:
1. Ingredients listed in the Safety and Technical Standards for Cosmetics (hereinafter referred to as the Standards) with restricted use, permitted preservatives, colorants, hair dyes, and sunscreens. They must meet the limit requirements as specified in the Standards.
2. Safety limits or assessment conclusions published by authoritative domestic and foreign organizations. The commonly cited international organizations are the Cosmetic Ingredient Review (CIR), Scientific Committee on Consumer Safety (SCCS), and International Fragrance Association (IFRA).
3. The applicant's historical use levels in their marketed products (at least 3 years) in the same application method.
4. The maximum historical use levels of ingredients published by cosmetic competent authorities. The inventory of Existing Cosmetic Ingredients in China (IECIC) is an important reference.
As for ingredients without any above evidence, they must undergo complete safety assessments per the Guidelines to ensure safe use.
II.Cosmetic Safety Assessor Qualifications
Assessors should have 5+ years of relevant experience and knowledge in medicine, pharmacy, biology, chemistry, toxicology, or other fields related to cosmetic quality and safety. They should understand cosmetic production processes, quality and safety controls, finished products, and ingredients.
III.Contents of Safety Assessment Reports
The reports usually contain a summary, product introduction, formula, design principles (for children's cosmetics), safety assessments of all ingredients, risk ingredient assessments, risk control recommendations, conclusion, assessor's signature and resume, references, appendices, etc.
In summary, China's impending regulatory changes create a sense of urgency for international cosmetic brands hoping to enter the Chinese market. By acting before the May 2024 deadline, companies can submit simplified safety assessment reports and avoid the more stringent and costly requirements for complete reports.
Don’t leave your market success to chance, and contact us today to start your cosmetic compliance journey to China: info@zmuni.com
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