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.
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
