The Technical Guidelines for Cosmetic Safety Assessment (2021 edition) were promulgated

                                                                                              SGS cosmetics experts comb four major concerns

                                                                                                             The Chinese version of safety assessment is officially launched

On April 9, 2021, the "Technical Guidelines for Cosmetic Safety Assessment (2021 version)" organized and drafted by the State Food and Drug Administration was officially promulgated and implemented from May 1, 2021. The guidelines are one of the important supporting documents for the implementation of the Regulations on the Supervision and Administration of Cosmetics, and help regulate and guide the safety assessment of cosmetics.

SGS Cosmetics experts collate the four major concerns of the Technical Guidelines for Cosmetic Safety Assessment (2021 edition) to help you quickly and efficiently understand the new regulations.

One or three stages

In order to give enterprises a reasonable time to prepare to comply with the requirements of the new regulations, the implementation of the cosmetic safety assessment report system adopts a three-step plan, that is, from May 1, 2021 to December 31, 2021, cosmetics registration or filing accept the current version of the cosmetic risk assessment report, but also accept the simplified version or full version of the safety assessment report that meets the requirements of the guidelines; From January 1, 2022, cosmetics registrants or registrants must carry out cosmetic safety assessments in accordance with the guidelines and submit simplified or complete product safety assessment reports; From May 1, 2024, all cosmetic products must provide a full cosmetic safety assessment report.

Two, two versions

Within three years of the implementation of the guidelines, cosmetic safety assessment reports will be available in simplified and complete versions. Both simplified and full cosmetic safety assessment reports must include a summary, product description, product formulation, formulation design principles (for children's cosmetics only), safety assessment of each ingredient in the formulation, assessment of possible risk substances, risk control measures or recommendations, safety assessment conclusions, safety evaluator signatures, safety evaluator resumes, references, appendices (including The main difference between the two is that the simplified version of the report does not clearly propose the requirements of providing anti-corrosion challenge testing and product stability test reports.

3. Test method

Physical and chemical stability and microbiological testing of products are necessary tests to ensure product safety, but the current guidelines do not specify methods. Due to the large number of cosmetic products and the large difference in formula characteristics, there is no unified test method at present. Enterprises can develop stability solutions suitable for their own products, and refer to the COLIPA test guide on stability when necessary. According to the guidelines, the effectiveness of its anti-corrosion system can be evaluated with reference to international standards or methods.

4. Reassess

The guidelines also make detailed provisions on the safety monitoring of products after marketing. If there are new toxicological findings of raw materials used in listed products that affect the existing evaluation results, the quality specifications of raw materials occur enough to cause changes in the existing safety evaluation results, and the adverse reaction rate caused by normal use shows a significant increase trend, etc., the safety of products needs to be re-evaluated. The new findings in the toxicology of raw materials suggest that attention should be paid to the relevant assessment opinions issued by the European Scientific Committee for Consumer Safety SCCS and the updated information on the toxicology classification of substances under the EU CLP regulation.