US to Ban the Sales of Cosmetics Containing Formaldehyde and Formaldehyde Releasers

On February 11, 2025, the United States notified a cosmetic-related measure (G/TBT/N/USA/2187) restricting the intentional addition of formaldehyde and formaldehyde releasers in cosmetics. The deadline for public comments is April 11, 2025. If approved, the restriction will take effect on January 1, 2027.

US,Cosmetic,Formaldehyde,Ingredient,Requirements

Intentionally Added Formaldehyde and Formaldehyde Releasers

(1) Methods of Adding Formaldehyde and Its Functions

The Washington Administrative Code (WAC 173-339-020) specifically defines the methods of intentional addition of formaldehyde in cosmetics and its functions.

Methods of Addition:

Direct addition of formaldehyde to cosmetics or their ingredients.
Addition of formaldehyde releasers, which are chemicals that gradually release formaldehyde over time.

Formaldehyde is considered "intentionally added" in cosmetics when used for the following purposes:

Antimicrobial;
Preservative;
Denaturant;
Cross-linker; and/or
Other purposes.

(2) Formaldehyde Releasers

The Washington Administrative Code (WAC 173-339-015(2)) specifies 28 formaldehyde releasers that are considered to be intentionally added formaldehyde in cosmetics.

SN	Chemical Name	CAS No.
1	DMDM Hydantoin	6440-58-0
2	Diazolidinyl Urea	78491-02-8
3	Imidiazolidinyl Urea	39236-46-9
4	Quaternium-15	4080-31-3; 51229-78-8
5	Tosylamide/Formaldehyde Resin (PTSAF)	25035-71-6
6	2-Bromo-2-Nitropropane-1,3-Diol (Bronopol)	52-51-7
7	Sodium Hydroxymethyl-glycinate	70161-44-3
8	Polyoxymethylene Urea	9011-05-6; 68611-64-3
9	Glyoxal	107-22-2
10	Polyoxymethylene Melamine	9003-08-1
11	5-Bromo-5-Nitro-1,3-Dioxane (Bronidox)	30007-47-7
12	7-Ethylbicyclo-oxazolidine (Bioban CS1246)	7747-35-5
13	Benzylhemiformal	14548-60-8
14	Dimethylhydantoin formaldehyde (DMHF)	26811-08-5; 9065-13-8
15	Dimethylol Glycol	3586-55-8
16	Dimethylol Urea	140-95-4
17	Dimethyl Oxazolidine	51200-87-4
18	Glyoxylic Acid (when used in heat-activated hair straighteners)	298-12-4
19	Glyoxylol Carbocysteine (when used in heat-activated hair straighteners)	1268868-51-4
20	MDM Hydantoin	116-25-6; 27636-82-4; 16228-00-5
21	Methenamine	100-97-0
22	Methylal	109-87-5
23	Paraformaldehyde	30525-89-4
24	Polyoxymethylene	9002-81-7
25	Tetramethylol-glycoluril	5395-50-6
26	Timonacic (when used in heat-activated hair straighteners)	444-27-9
27	Tris (hydroxymethyl) nitromethane	126-11-4
28	Urea, polymer with formaldehyde, isobutylated	68002-18-6

Toxic-Free Cosmetics Act (TFCA)

In 2023, the Washington State Legislature passed the Toxic-Free Cosmetics Act (TFCA) to enhance the safety of cosmetics and personal care products while protecting the health of Washington State residents and the environment from exposure to toxic chemicals.

Transition Period: Starting January 1, 2025, the manufacture, distribution, and sale of cosmetics containing the following nine categories of substances will be prohibited in Washington State. Existing products containing these substances may continue to be sold until January 1, 2026.

Serial No.	Prohibited Substances	CAS No.	Restriction
1	Ortho-phthalates	/	Must not be intentionally added
2	Perfluoroalkyl and polyfluoroalkyl substances	/	Must not be intentionally added
3	Formaldehyde and chemicals determined by the department to release formaldehyde	50-00-0	Must not be intentionally added
4	Methylene glycol	463-57-0	Must not be intentionally added
5	Mercury and mercury compounds	7439-97-6	Must not be intentionally added
6	Triclosan	3380-34-5	Must not be intentionally added
7	m-phenylenediamine and its salts	108-45-2	Must not be intentionally added
8	o-phenylenediamine and its salts	95-54-5	Must not be intentionally added
9	Lead and lead compounds	7439-92-1	Must not contain intentionally added lead or lead compounds, or exceed a concentration of 1 ppm

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in the United States:

FDA Color Additive Batch Certification;
FDA Cosmetic Product Facility Registration in the United States;
FDA Cosmetic Product Listing in the United States;
FDA OTC Drug Registration in the United States;
Cosmetic/OTC drug label review in the United States;
Application for INCI name of cosmetic ingredients; and
US Agency Service.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

https://members.wto.org/crnattachments/2025/TBT/USA/25_01289_00_e.pdf

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