Tag: Color Additives

Lead Acetate in Cosmetics

Since 1980 lead acetate has been considered a safe color additive for use in cosmetics for hair coloring. In 2017, a color additive petition requesting repeal of regulation that allows for the use of lead acetate in cosmetics was submitted. After carefully reviewing the submission and other relevant information, FDA concluded that there is no reasonable certainty of no harm from this use of lead acetate. On October 30, 2018, FDA published a final rule banning the use of Lead Acetate in cosmetic products intended for hair coloring. The rule is effective from December 03, 2018 and the industry has 12 months to make the transition and reformulate their products. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements.

Hair dye products containing Lead Acetate are required to bear such a warning statement:

CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.

Manufacturers and labelers of cosmetic products must comply with FDA labeling requirements otherwise their products are considered misbranded and are subject to detention.

Liberty Management Group Ltd. can help companies with labeling compliance. Our label experts check your labels against current labeling regulations and help you avoid detention and import refusals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 25, 2019

Color Additives in Cosmetics

FDA regulates cosmetic products and its ingredients. Color additives are added to cosmetic products to improve their appearance. Color additives are subject to strict system of approval under the FD&C Act. Failure to meet US color additive requirements may cause a cosmetic to be adulterated and make it subject to detention at the port of entry.

The FDA requirements for color additives that are added to cosmetics are as follows:

  1. All Color additives must be approved by FDA. There must be a regulation specifically addressing a substance use as a color additive, specifications and restrictions.
  2. Along with approval, many color additives are also required to be batch certified by FDA if they are to be used in cosmetics marketed in the US. This means that FDA chemists have analyzed a sample from the batch and have found that it meets the requirements for composition and purity stated in the regulation—called a “listing regulation”—for that color additive. FDA determines the need for batch certification based on whether the color additive needs this level of control to protect the public health. Some color additives, in their uncertified forms, might contain impurities at levels that pose a health concern.
  3. Color additives may only be used as stated in the regulations pertaining them including maximum permissible concentration in the finished product.

FD&C Act categorizes color additives into two main types:

  1. Those subject to certification – Petroleum based color additives aka coal tar dyes or synthetic organic colors. Such colors usually have 3-part names e.g.; FD&C Yellow No. 5
  2. Those exempt from certification – Obtained primarily from mineral, plant or animal sources.

A list of color additives approved for use in cosmetics can be found here https://www.fda.gov/industry/color-additives-cosmetics/color-additives-listed-use-cosmetics-code-federal-regulations

Some color additives are approved for use for one use and excluded for use in another.

To ensure that the cosmetic products do not contain any unapproved color additive or other unapproved ingredients, a manufacturer can avail LMG’s label and ingredient review service.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: July 03, 2019