Cosmetics FDA registration application process and the new version of cosmetics FDA certification requirements.
With the continuous expansion of the global cosmetics market, the safety and effectiveness requirements of cosmetics in various countries** are also getting higher and higher. The U.S. Food and Drug Administration (FDA), as the world's leading cosmetics regulatory agency, is constantly updating and improving the registration application process and certification requirements for cosmetics. In this article, BSON Testing will introduce in detail the cosmetics FDA registration application process and the new version of the cosmetics FDA certification requirements to help relevant enterprises and individuals better understand and comply with relevant regulations.
2. Application process for FDA registration of cosmetics.
Understand the regulations and requirementsBefore starting the FDA registration application for cosmetics, companies need to understand the FDA's regulations and requirements for cosmetics, including product classification, ingredient requirements, labeling requirements, safety assessment, etc. At the same time, it is also necessary to understand the FDA's registration application process and associated fees.
Preparation of application materialsAccording to the requirements of the FDA, enterprises need to prepare the following application materials:
1) Product ingredient list: list the name, concentration and use of all ingredients in the product;
2) Product labeling: provide a draft label of the product, including product name, manufacturer information, usage method, etc.;
3) Safety assessment report: conduct a comprehensive safety assessment of the product, including ingredient safety, use safety, etc.;
4) Manufacturer information: provide the name, address, ** and other information of the manufacturer;
5) Other relevant documents: such as product research and development reports, quality management system documents, etc.
Enterprises that submit application materials need to submit the above application materials to FDA, and can choose to submit **. **Submissions can shorten the approval time, but there is an additional fee. Mail-in submissions are relatively slow, but the fees are lower.
Review and ApprovalFDA will review the submitted application materials and issue a Certificate of Registration if the materials are complete and meet regulatory requirements. If the materials are incomplete or do not meet the regulatory requirements, the business needs to revise and resubmit in accordance with FDA requirements.
3. The new version of the FDA certification requirements for cosmetics.
Ingredient requirementsThe new version of the FDA certification requirements for cosmetics has made stricter regulations on the ingredients of cosmetics. All cosmetic ingredients must comply with FDA regulations, including banned ingredients, restricted ingredients, etc. At the same time, for some specific types of cosmetics, such as sunscreens, hair dyes, etc., additional ingredient requirements must also be met.
Safety assessment requirementsThe new version of the FDA certification requirements for cosmetics has made stricter provisions on the safety assessment of cosmetics. Enterprises need to conduct a comprehensive safety assessment of their products, including ingredient safety, safety of use, etc. Scientific methods and procedures need to be followed in the assessment process to ensure the accuracy and reliability of the assessment results.
Labeling requirementsThe new version of the FDA certification requirements for cosmetics has made the labeling of cosmetics more stringent. Labels must be clear, accurate, and easy to understand, including product name, manufacturer information, how to use it, ingredient list, and more. At the same time, the label must also comply with FDA label specifications, such as font size, color, etc.
Manufacturer RequirementsThe new version of the FDA certification requirements for cosmetics has made stricter regulations for manufacturers of cosmetics. Manufacturers must have the corresponding production capacity and quality management system to ensure the quality and safety of products. At the same time, manufacturers must also comply with FDA regulations and requirements, such as reporting systems, record-keeping systems, etc.