FDA COLOUR CERTIFICATION

FDA Color Certification

As per US FDA Chapter VII, section 721, colour additives, except coal tar hair dyes, are subject to FDA approval before they used in food, drugs, or cosmetics, or medical devices.
US FDA insists manufactures of above should batch certify the colour additives before selling the product in USA for the purpose of using in human beings and animals.

Colour certificate is issued after FDA chemists analysed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation

Colour Additives for Use in the United States

We consultants helps companies by providing guidance in

  • Identifying the colour code and relevant requirements
  • Help in filling the application
  • Selection of batches/lot for testing
  • Answering to concerns raised by FDA if any in consultation with company team.

The guidance Fees starts from 1500 USD. The fee for color batch certification is based on the weight of the batch

To know about FDA Fees – Click here
More information please write to enquiry@i3cglobal.com

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