On January 2023, The U.S. Food and Drug Administration (FDA) has issued a proposed rule to amend color additive regulations to increase fees for certification services.
The proposed rule will implement a 10% per pound increase in color certification fees. This increase in fees is necessary to cover operating costs to ensure that the color certification program continues to operate at the high level of quality and efficiency that the industry expects.
The FDA has issued regulations for issuing Color Additive Certifications when used in foods, drugs, cosmetics, and medical devices must analyze samples of each batch of color additive received from a manufacturer and verify that it meets the specifications for composition and purity. Certification is performed before color additives are allowed to be used in products marketed to US consumers. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.
Rules for Submission
- FDA reopened the comment period on January 24, 2023, for 45 days for the proposed rule.
- Deadline 60 days after publication in the Federal Register.
- Submit electronic (Federal eRulemaking Portal: https://www.regulations.gov) comments with docket number identification FDA-2022-N-1635.
- Confidential Submissions:To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission.
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico & Korea.
GRP helps many life science companies register their products in different countries in compliance with local regulations.