Product Compliance
Test/Filing/Registration
Foreword: In accordance with Provisions on the Management for Cosmetics Registration and Filing Materials, Technical Guidelines for the Cosmetic Safety Assessment 2021 , Classification Rules and Catalog of Cosmetics, as well as of the FDA training and review of the rejection opinions, the official review of domestic common cosmetics is more strict after the new laws and regulations. It gives more specific details than previously. Zoop summarizes the latest common problems of archival materials and make corresponding suggestions. We carried out a detailed analysis of the common problems in each module, including the filing application form, product name naming basis, product formula, product label, product safety assessment data. There are several key and difficult points, especially the product formula, product implementation standards and product safety assessment data, we can read and discuss more. For example, when extracts of animal organs and blood products are used as raw materials in product formulation, it should be noted to provide the source, ingredients and preparation process. We also need to provide the relevant documents permitted by the producing country of the raw material, such as the qualifications of safety assessors. There should be qualification requirements for safety assessors as follows : 1.Safety assessors should have professional knowledge related to cosmetic quality and safety such as medicine, pharmacy, biology, chemistry or toxicology; 2.Safety assessors shall comprehend the finished cosmetic or raw material production process and quality and safety control requirements, and have more than five years of relevant professional working experience; 3.Safety assessors shall have professional training record of cosmetic safety assessment. It should be reminded that after the product filing is passed, there will be later technical verification. Therefore, the standardization of data is particularly important. The following are suggestions for reference. Ultimately, it needs to be applied flexibly according to local conditions. |