Following the release of the new Cosmetic Supervision and Administration Regulation (CSAR), the National Medical Products Administration has issued two more drafts for public comment “The Technical Guidelines for Safety Assessment of Cosmetics” and “The Classification Rules and Catalogue of Cosmetics”. These new guidelines provide more details regarding the technical requirements for cosmetics and raw materials as well as introduce a new classification method for cosmetics. As these are drafted guidelines, there is a window of time for companies to provide their feedback and comments on the measures.
The new drafts first provide clarity on the safety assessment requirements for cosmetic raw materials, cosmetic finished products, and personnel in charge of cosmetic safety assessment. The NMPA has also brought up a new classification method of cosmetics based on efficacy claims, usage application, dosage form, target group and usage method.
All the guidelines show us clearly that China is putting consumer safety at the center of their policies by further strengthening the requirements for product safety on both levels – raw materials and finished products.
There are no further developments on removing mandatory animal testing for imported cosmetics. Authorities are considering adding the requirement of a toxicology test in cases where the safety assessment report is not sufficient to assess the safety risks of the product.
“THE TECHNICAL GUIDELINES FOR SAFETY ASSESSMENT OF COSMETICS”
The purpose of issuing the “The Technical Guidelines for Safety Assessment of Cosmetics” is to implement the newly introduced CSAR, to further ensure the safety of cosmetics, to standardize the safety assessment of cosmetics, and to provide brands with relevant guidance regarding technical requirements for safety assessment of cosmetics.
The scope of the new draft technical guidelines not only includes finished cosmetic products, but also focuses on the cosmetic raw material safety. It details basic requirements for cosmetic raw materials and finished products safety assessment, requirements for cosmetic safety assessment personnel in charge, and guidelines for safety assessment reports and toxicology studies.
HIGHLIGHTS
1. Clarification of basic requirements for cosmetic raw materials and finished product safety.
- Safety of raw material is the foundation of the cosmetic safety. It is required to initiate the safety assessment of all of risky raw materials as well as potentially risky substances.
- Cosmetics safety assessment should be based on the existing scientific data and case analyses. It shall also follow the principles of science, justice and transparency.
- The reference materials for cosmetic safety assessment shall be from published technical reports, circulars, professional books or academic papers. Additionally, data or risk assessment materials published by international authoritative organizations maybe used. In cases that included unpublished research results, the authorization of the data owner shall be obtained and the science, accuracy and reliability of the results shall be analyzed.
- When carrying out safety assessments, cosmetic safety assessment personnel should use these guidelines as a reference basis, and analyze according to the specific conditions of raw materials and products.
- The resume of the assessor should be attached to the evaluation report. The content of the resume should include educational experience, cosmetics related work experience, professional training experience, etc.
- The evaluation materials shall be updated based on actual conditions. The materials shall be kept not less than ten years after the last batch of products on the market expires.
- If the conclusion of cosmetics safety assessment report is not sufficient to rule out the risk of the product safety, the toxicology test method shall be used for product safety evaluation.
2. Further details on the requirements for the safety assessment personnel in charge, based on this draft the personnel in charge shall:
- Have professional knowledge of cosmetics quality and safety with the relevant background in medicine, pharmacy, chemistry or toxicology.
- Understand the production process as well as quality and safety control requirements of cosmetics.
- Have more than five years of relevant professional experience.
- Have access to and be able to analyze, evaluate and interpret relevant literature information of chemistry and toxicology.
- Be able to analyze the safety of cosmetics fairly and objectively, and carry out safety assessments based on comprehensive analysis of all available data and exposure conditions.
- Receive corresponding professional training regularly, learn relevant knowledge of safety assessments, understand and master new safety assessment theory, technology and methods to apply these in practice.
3. Explanations regarding safety assessment procedures
- Details the points regarding the procedures on identification of risky or potentially harmful raw materials, substances and health hazard effects. This should include corresponding procedures for acute toxicity, irritation/corrosion, sensitization, phototoxicity, photoallergic reactions, mutagenicity, repeated dose toxicity, teratogenicity, reproductive and developmental toxicity, chronic toxicity/carcinogenicity and others.
4. Clarifications regarding risk assessment of cosmetic raw materials
- Specifies the principles of risk assessment and requirements regarding physical and chemical properties of cosmetic raw materials. This includes raw materials and fragrance derived from minerals, animals, plants, and biotechnology.
5. Clarifications regarding safety assessment of cosmetic products
- Defines evaluation principles of testing methods for the safety assessment of cosmetic products. The testing method is selected based on exposure time and product usage guideline.
- The safety assessment of cosmetic products should be carried out in conjunction with these guidelines. In addition to exposure level, product evaluations assess usage method, application, dosage, location, residue, etc., to ensure product safety compliance.
- Details the evaluation of product physical and chemical stability.
- Describes product’s microbiological evaluation.
- Clarifies the evaluation requirements for children’s cosmetics.
6. Post-market safety monitoring
- Requires that companies shall monitor, record and archive the products safety information while on the market. Including adverse reactions during normal use and improper use, consumer complaints and follow-up, etc.
- If any of the following situations occur with the products sold on the market, the safety of the product needs to be reassessed:
- The raw materials used in the marketed product have new discoveries related to toxicology, and will affect the existing risk assessment results;
- The adverse reaction of the marketed product has been continuously and significantly increasing, or a serious adverse reaction has occurred; or
- Other conditions that affect product quality and safety.
7. Detailed requirements for safety assessment report
- Risk assessment report of cosmetic raw materials.
- Safety assessment report of cosmetic product.
- The standard format of safety assessment report and formula evaluation.
- Example of safety assessment report.
- Evaluation method of cosmetic preservative efficacy.
“THE CLASSIFICATION RULES AND CATALOGUE OF COSMETICS”
The purpose of issuing the catalogue is to implement the newly introduced CSAR guidelines, to further standardize the production and operation of cosmetics, to ensure the quality and safety of cosmetics, to strengthen supervision and management of cosmetic products, and to clarify the cosmetic classification determination. This includes cosmetic efficacy claims category coding catalog, classification and coding catalogue of cosmetic usage location, classification and coding catalogue of cosmetic target group, classification and coding catalogue of cosmetic product dosage forms, classification and coding catalogue of cosmetic use methods.
The authorities introduced a new codification system that adopts hierarchical code. The code is divided into five levels: efficacy claims, usage application, product dosage forms, target group and usage method.
HIGHLIGHTS
1. Classification System Determination
- Includes cosmetic efficacy claims category coding catalog, classification and coding catalogue of cosmetic application parts, classification and coding catalogue of cosmetic target group, classification and coding catalogue of cosmetic product dosage forms, classification and coding catalogue of cosmetic use methods
- Efficacy claim definitions and classifications were introduced:
- Special use cosmetics may include the following claims: hair dying, hair perm, freckle and whitening, sunscreen, and anti-hair loss.
- All of the other 23 claims mentioned in the cosmetic efficacy claims list belong to the general cosmetics group.
- Any other claims will be classified as new claims and regulated as special use cosmetics. These cosmetics will need to provide additional documentation to prove the efficacy claims. These new claims are coded as “A” on the list.
- Product usage location shall strictly follow the classification guidelines and applicable definitions. For example, for hair dying and hair perm, the usage location can only be hair. If it’s beyond the defined location scope of hair, then it is required to choose the “other” classification. This is code “C” on the list.
- Target group classification was introduced:
- The cosmetics targeted at pregnant women and breast-feeding women shall be regulated as special use cosmetics.
- The cosmetics targeted at babies from 0-3 years old, the claims of cleaning, moisturizing, hydrating, soothing and refreshing will be classified as general cosmetics. All the other claims for baby cosmetics will be regulated as special use cosmetics.
- The cosmetics targeted at children from 3 – 12 years old, the claims of cleaning, make-up remover, moisturizing, hydrating, cosmetology, hair styling, perfume, hair protection, refreshing, oil control, soothing, exfoliation, prevent hair breakage and hair repair will be regulated as general cosmetics. Any other claims for this target group will be regulated as special use cosmetics.
2. New Codification System
- The authorities introduced a new codification system that adopts hierarchical code. The code is divided into five levels: efficacy claims (L1), usage location (L2), product dosage form (L3), target group (L4) and usage method (L5).
- The coding format in the online filing system shall be as follows“L1 + L2+L3+L4+L5”.
Please note that the above measures are drafts and have been issued for public opinion. The authorities may amend, add, delete, or abolish the measures based on industry feedback. Public opinions can be submitted until August 30, 2020 via e-mail: huazhuangpinchu@163.com
Knudsen&CRC is happy to assist with compiling, translating and submitting suggestions to the authorities on your behalf. Please feel free to contact us via e-mail: info@knudsenchina.com
Knudsen&CRC will follow the development of further implementation guidelines and share the updates as well as prepare a webinar on the implications of the new laws once they are finalized.
Knudsen&CRC supports foreign companies in overcoming regulatory barriers by providing regulatory compliance advisory services within a number of highly regulated industries: cosmetics, skincare, food, beverage, dietary supplements, medical devices, and pharmaceutical. For more information on the new cosmetics regulations, please contact us at info@knudsenchina.com