Filing of Color Additive Petition from International Association of Color Manufacturers; Request to Amend Regulations to Remove Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
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The U.S. Food and Drug Administration (FDA) has filed a color additive petition from the International Association of Color Manufacturers (IACM). The petition proposes amending the color additive regulations to remove provisions allowing the use of three specific solvents—methylene chloride, trichloroethylene, and ethylene dichloride—in preparing certain color additives. These solvents will no longer be permitted because their uses have been permanently abandoned by industry. This action follows the IACM's voluntary decision to discontinue these solvents due to safety concerns and regulatory pressures. The FDA is now seeking public comments on the proposed rule, which would update 21 CFR to reflect the abandonment and eliminate these outdated allowances. If finalized, the amendment would streamline regulations by removing references to these hazardous chemicals, aligning rules with current manufacturing practices. No economic impact is anticipated since the uses are already abandoned.
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Key Changes
- Amend color additive regulations to remove provisions for methylene chloride use
- Amend to remove provisions for trichloroethylene use
- Amend to remove provisions for ethylene dichloride use
+ 3 more changes with Pro
Obligations
What this law requires
Remove provisions in 21 CFR allowing the use of methylene chloride as a solvent in preparing color additives
Remove provisions in 21 CFR allowing the use of trichloroethylene as a solvent in preparing color additives
Remove provisions in 21 CFR allowing the use of ethylene dichloride as a solvent in preparing color additives
Cease using methylene chloride, trichloroethylene, and ethylene dichloride in the preparation of color additives
Submit public comments to the FDA during the comment period on the proposed rule amending color additive regulations