FDA certification 1 페이지 | 스카이월드씨앤에어

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FDA certification 목록
번호	제목	글쓴이	조회	날짜
01 MoCRA Key Contents 1) Report adverse events and maintain records 2) FDA Facilities and Product Registration 3) Cosmetic Safety Proof 4) Revised labelling requirements 5) Authorize FDA to suspend facilities, access records, and force recovery 6) Revise GMP requirements and strengthen compliance obligations 7) New rules on talc to be established
02 Facility Registration Requirements 1) Due date – Although the extension of the deadline does not force registration until July 1, 2024, the FDA recommends compliance with the deadline below. – Owner/operator of facilities involved in manufacturing/processing cosmetics for U.S. distribution purposes before December 29, 2023 – Owners/operators of facilities involved in the manufacture/processing of cosmetics for U.S. distribution purposes for the first time since 12.29 : Within 60 days from the date of first involvement in the activity or within 60 days from December 29, 2023 2) Update: every two years 3) Details of registration – Owner and/or Operator Name – Name, location, and contact information of the facility – US agent contact information for non-US facilities overseas – Facility Registration Number (FEI) – All commercial brands manufactured/processed at the facility – Facility manufactured/processed product categories and their responsibilities – Type of submission (first, modified, periodic, abbreviated) – Additional information that may be requested: Parent company name, facility DUNS number, additional contact information
03 Product Registration Requirements 1) Due date – Although the extension of the deadline does not force registration until July 1, 2024, the FDA recommends compliance with the deadline below. – Products on the market in the U.S. before December 29, 2023 – U.S. Market Start Products After 12.29: Within 120 Days From Market Date or Within 120 Days From 2023.12.29 2) Update: every year 3) Details of registration – Facility registration number of each facility where cosmetics are manufactured/processed (multiple) – Name of person in charge, contact information, and cosmetic name displayed on the label * Director: Manufacturers, packers, and distributors of cosmetics whose names are marked on cosmetic labels – Cosmetics category – Cosmetic ingredient list (including fragrances, flavoring agents, and pigments) – Product listing number (if previously assigned) – Type of submission (first, periodic, abbreviated) – Additional information that may be requested: Parent company name, type (manufacturing/packaging/distributing), label design, product web link, professional – Whether, the person responsible for the location stated on the label DUNS number, unique ingredient identifier (UNII)
04 Relaxation of regulations on small businesses Contact/infusion of the eye mucous membrane (e.g., tattoo) / internal use (e.g., mouthwash) / Except for products and manufacturing facilities that alter appearance for more than 24 hours under normal use conditions, companies with an average annual gross of less than $1,000,000 in cosmetic sales in the U.S. are defined as small businesses, exempt from facility registration and product listing, and GMP and hazard record management systems are relaxed. However, even for small businesses, we recommend facility and product registration because the actual export process may result in cumbersome procedures such as registration data (e.g., registration number) or justification for exemption from registration (e.g., proof of sales).
05 Service and Quote Guidance 1) We check the latest FDA notice to provide information so that we can accurately identify what is needed to register MoCRA and cosmetics and prepare for the upcoming deadline. 2) Provides ingredient and label review based on FDA cosmetic requirements and our experience and expertise. 3) We provide a toxicological evaluation certificate issuance service in accordance with the demand for cosmetic safety verification. 4) Provides a U.S. Agent contract for facility registration. 5) It provides a DUNS number issuing agency service. ※ For U.S. FDA cosmetic approval and reporting inquiries, please contact the information in the contact information.

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