Restricted Cosmetic Substances — Annex III
Annex III of EU Cosmetics Regulation 1223/2009 lists substances that may only be used under specific conditions. This grouped page currently contains 373 records with restriction logic, concentration limits, warnings or product-type conditions to review.
How this annex works
Annex III is the conditional list: 373 substances that may be used, but only within the limit, product type and warning the entry states. The condition attached to a number usually decides more cases than the number.
- 373 restricted substances; 211 carry a maximum concentration and 167 a mandatory warning.
- An entry is a package — concentration, product type and warning travel together and cannot be taken apart.
- Some limits are a pH range or a state after mixing rather than a percentage.
- Where a substance can both preserve and act, this annex covers the active use and Annex V the preservative one.
Reading an Annex III entry as a maximum concentration is the mistake this whole annex invites. The concentration is one term of a condition that also names the product types it applies to, often a pH range or a state after mixing, and usually a warning that has to appear on the label. A formula meeting the number in a product type the entry does not name has not met the entry.
The product-type conditions are lists rather than principles. Salicylic acid sits at 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant, and at 2.0% in other products; there is no category underneath that list to reason from, and a product either is one of the named things or is not. Kojic acid is permitted in face and hand products, which means a body serum has no entry to use regardless of concentration.
Several entries set limits that are not percentages at all. Thioglycolic acid carries a ready-for-use pH range alongside its concentration. Sodium and potassium hydroxide, used to adjust pH, are limited by the pH reached rather than by how much is added. Hydrogen peroxide is measured as 'present or released', which reaches materials that are not hydrogen peroxide but yield it.
Finally, purpose. A substance that can both preserve a product and act in it appears twice — here for the active use and in Annex V for the preservative one — with different limits. Climbazole is 0.5% as a preservative in rinse-off shampoo and 2.0% as an anti-dandruff active in the same format. Which entry governs is settled by what the product presents itself as doing, so the claim on the pack becomes part of the compliance answer.
Checked against
Annex III records
373 total| Entry | Substance | CAS | Max concentration | Flags |
|---|---|---|---|---|
| 245 | 2-AMINO-4-HYDROXYETHYLAMINOANISOLE / 2-AMINO-4-HYDROXYETHYLAMINOANISOLE SULFATECAS 83763-47-7 / 83763-48-8 | 83763-47-7 / 83763-48-8 | — | |
| 246 | HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCLCAS 94158-14-2 | 94158-14-2 | — | |
| 247 | HC BLUE NO 2CAS 33229-34-4 | 33229-34-4 | 2.8% | |
| 248 | 3-NITRO-P-HYDROXYETHYLAMINOPHENOLCAS 65235-31-6 | 65235-31-6 | (b) 1.85 % | |
| 249 | 4-NITROPHENYL AMINOETHYLUREACAS 27080-42-8 | 27080-42-8 | (b) 0.5% | |
| 25 | ZINC PHENOLSULFONATECAS 127-82-2 | 127-82-2 | 6% (as % of anhydrous substance) | |
| 250 | HC RED NO 10 + HC RED NO 11CAS 95576-89-9 - 95576-92-4 | 95576-89-9 - 95576-92-4 | (b) 1.0% | |
| 250 | HC Red No 10+ HC Red No 11CAS 9556-89-9 - 95576-92-4 | 9556-89-9 - 95576-92-4 | (b) 2,0% | |
| 251 | 2-CHLORO-6-ETHYLAMINO-4-NITROPHENOLCAS 131657-78-8 | 131657-78-8 | (a) 3.0% (b) 3.0% | |
| 251 | HC RED NO 7CAS 24905-87-1 | 24905-87-1 | 1,0% | |
| 252 | 2-AMINO-6-CHLORO-4-NITROPHENOLCAS 6358-09-4 | 6358-09-4 | (b) 2.0% | |
| 253 | HC Yellow No. 4CAS 59820-43-8 | 59820-43-8 | 1,5 % | |
| 253 | HC Yellow No 4CAS 59820-43-8 | 59820-43-8 | 1,5% | |
| 254 | ACID RED 33CAS 3567-66-6 | 3567-66-6 | 0.5 % | |
| 255 | HC Yellow No 2CAS 4926-55-0 | 4926-55-0 | (b) 1,0% | |
| 256 | HC Orange No 1CAS 54381-08-7 | 54381-08-7 | 1.0% | |
| 257 | LAURETH-9CAS 3055-99-0 | 3055-99-0 | (a) 3,0 % (b) 4,0 % | |
| 258 | HC Red No 1CAS 2784-89-6 | 2784-89-6 | 1,0% | |
| 259 | HC Yellow No 9CAS 86419-69-4 | 86419-69-4 | 0,5% (calculated as hydrochloride) | |
| 26 | AMMONIUM MONOFLUOROPHOSPHATECAS 20859-38-5 -- 66115-19-3 | 20859-38-5 -- 66115-19-3 | 0,15 % | |
| 260 | HC Yellow No 7CAS 104226-21-3 | 104226-21-3 | 0,25% | |
| 261 | HC Yellow No 13CAS 10442-83-8 | 10442-83-8 | — | |
| 262 | BASIC YELLOW 57CAS 68391-31-1 | 68391-31-1 | 2,0% | |
| 263 | Disperse Black 9CAS 20721-50-0 | 20721-50-0 | 0,3% | |
| 264 | HC Blue No 14CAS 99788-75-7 | 99788-75-7 | 0,3% | |
| 265 | DISPERSE VIOLET 1CAS 128-95-0 | 128-95-0 | 0.5% | |
| 266 | HC RED No 3CAS 2871-01-4 | 2871-01-4 | (b) 3,0% | |
| 267 | BASIC RED 76CAS 68391-30-0 | 68391-30-0 | 2,0 % | |
| 269 | 2-Amino-5- Ethylphenol HCl | — | — | |
| 269 | BASIC RED 51CAS 77061-58-6 | 77061-58-6 | (b) 1,0 % | |
| 27 | Sodium monofluorophosphateCAS 10163-15-2 -- 7631-97-2 | 10163-15-2 -- 7631-97-2 | 0.15% | |
| 270 | ACID RED 92CAS 18472-87-2 | 18472-87-2 | (b) 0,4 % | |
| 271 | Disperse Blue 377 is a mixture of three dyes:(1) 1,4-bis[(2-hydroxyethyl)amino]anthra-9,10-quinone/(2) 1-[(2-hydroxyethyl)amino]-4-[(3- hydroxypropyl)amino]anthra- 9,10-quinone/(3) 1,4-bis[(3- hydroxypropyl)amino]anthra- 9,10-quinoneCAS (1) 4471-41-4/(2) 67674-26-4/(3) 67701-36-4 | (1) 4471-41-4/(2) 67674-26-4/(3) 67701-36-4 | 2,0 % | |
| 272 | P-AMINOPHENOLCAS 123-30-8 | 123-30-8 | — | |
| 273 | 1-Hydroxyethyl-4,5- Diamino Pyrazole SulfateCAS 155601-30-2 | 155601-30-2 | — | |
| 274 | 4-Formyl-1-Methylquinolinium-p-ToluenesulfonateCAS 223398-02-5 | 223398-02-5 | — | |
| 275 | Basic Yellow 87CAS 68259-00-7 | 68259-00-7 | (b) 1,0 % | |
| 276 | BASIC ORANGE 31CAS 97404-02-9 | 97404-02-9 | (b) 1,0 % | |
| 277 | 2,6-Diamino-3- ((Pyridine-3-yl)azo)PyridineCAS 28365-08-4 | 28365-08-4 | (b) 0.25 % | |
| 278 | BASIC VIOLET 2CAS 3245-91-7 | 3245-91-7 | 0.5 % | |
| 279 | 2,3-Diaminodihydropyrazolopyrazolone DimethosulfonateCAS 857035-95-1 | 857035-95-1 | — | |
| 28 | Potassium monofluorophosphateCAS 14104-28-0 | 14104-28-0 | 0.15% | |
| 280 | Picramic Acid and Sodium PicramateCAS 96-91-3 / 831-52-7 | 96-91-3 / 831-52-7 | (b) 0.6 % | |
| 281 | 2-Nitro-5-Glyceryl MethylanilineCAS 80062-31-3 | 80062-31-3 | (b) 1.0 % | |
| 282 | HC Blue 16CAS 502453-61-4 | 502453-61-4 | 3,0 % | |
| 283 | 5-Amino-6-Chloro-o- Cresol / 5-Amino-6-Chloro-o- Cresol HClCAS 84540-50-1 / 80419-48-3 | 84540-50-1 / 80419-48-3 | (b) 0.5 % | |
| 284 | 2,2'-METHYLENEBIS 4-AMINOPHENOL HCLCAS 27311-52-0 / 63969-46-0 | 27311-52-0 / 63969-46-0 | (b) 1.0 % | |
| 285 | 2,6-DiaminopyridineCAS 141-86-6 | 141-86-6 | — | |
| 286 | CETRIMONIUM CHLORIDE (1) / STRARTRIMONIUM CHLORIDE (1)CAS 112-02-7 | 112-02-7 | See conditions | |
| 287 | BEHENTRIMONIUM CHLORIDE (1)CAS 17301-53-0 | 17301-53-0 | See conditions |
How to use this grouped view
Annex III lists substances permitted only under defined conditions. This grouped view is built for quickly triaging 373 restricted-substance records before you open the full entry and check concentration limits, product scope and warnings.
Open individual records to review the full set of conditions, concentration limits, label warnings and applicable product categories.