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 |
|---|---|---|---|---|
| 288 | HC Blue No 17CAS 16517-75-2 | 16517-75-2 | (b) 2,0% | |
| 289 | HC BLUE NO 15CAS 74578-10-2 | 74578-10-2 | (b) 0,2 % | |
| 29 | Calcium monofluorophosphateCAS 7789-74-4 | 7789-74-4 | 0,15 % | |
| 290 | ACID GREEN 25CAS 4403-90-1 | 4403-90-1 | 0,3 % | |
| 291 | ACID VIOLET 43CAS 4430-18-6 | 4430-18-6 | 0,5 % | |
| 292 | 2-METHOXYMETHYL-P-PHENYLENEDIAMINE /2-METHOXYMETHYL-P-PHENYLENEDIAMINE SULFATECAS 337906-36-2 ; 337906-37-3 | 337906-36-2 ; 337906-37-3 | — | |
| 293 | Hydroxyanthraquinone-aminopropyl Methyl Morpholinium MethosulfateCAS 38866-20-5 | 38866-20-5 | 0,5 % | |
| 294 | Disperse Red 17CAS 3179-89-3 | 3179-89-3 | (b) 0,2 % | |
| 295 | Acid Black 1CAS 1064-48-8 | 1064-48-8 | 0,5 % | |
| 296 | Pigment Red 57CAS 5858-81-1 | 5858-81-1 | 0,4 % | |
| 297 | ETHOXYDIGLYCOLCAS 111-90-0 | 111-90-0 | (a) 7% (b) 5% (c) 10% (d) 2,6% (e)2,6% | |
| 298 | HC RED NO 17CAS 1449471-67-3 | 1449471-67-3 | As from 3 September 2017: 0,5 % | |
| 299 | HC YELLOW NO 17CAS 1450801-55-4 | 1450801-55-4 | As from 3 September 2017: 0,5 % | |
| 2a | THIOGLYCOLIC ACIDCAS 68-11-1 | 68-11-1 | See conditions | |
| 2b | Thioglycolic acid esters | — | See conditions | |
| 3 | OXALIC ACIDCAS 144-62-7 | 144-62-7 | 5% | |
| 30 | Calcium fluorideCAS 7789-75-5 | 7789-75-5 | 0.15% | |
| 300 | 1-HEXYL 4,5-DIAMINO PYRAZOLE SULFATECAS 1361000-03-4 | 1361000-03-4 | — | |
| 301 | 2,5,6-TRIAMINO- 4-PYRIMIDINOL SULFATECAS 1603-02-7 | 1603-02-7 | — | |
| 302 | HYDROXYETHOXY AMINOPYRAZOLOPYRIDINE HCLCAS 1079221-49-0 | 1079221-49-0 | — | |
| 303 | 3-AMINO-2,6- DIMETHYLPHENOLCAS 6994-64-5 | 6994-64-5 | — | |
| 304 | BASIC BROWN 17CAS 68391-32-2 | 68391-32-2 | As from 3 September 2017: 2,0 % | |
| 305 | BASIC BLUE 124CAS 67846-56-4 | 67846-56-4 | As from 3 September 2017: 0,5 % | |
| 306 | ARACHIS HYPOGAEA OIL; ARACHIS HYPOGAEA SEEDCOAT EXTRACT; ARACHIS HYPOGAEA FLOUR; ARACHIS HYPOGAEA FRUIT EXTRACT; ARACHIS HYPOGAEA SPROUT EXTRACT; HYDROGENATED PEANUT OIL; PEANUT ACID; PEANUT GLYCERIDES; PEANUT OIL PEG-6 ESTERS; PEANUTAMIDE MEA; PEANUTAMIDE MIPA; POTASSIUM PEANUTATE; SODIUM PEANUTAMPHOACETATE; SODIUM PEANUTATE; SULFATED PEANUT OILCAS 8002-03-7; 68425-36; 91051; 91744-77-3; 68440-49-3; 93572-05-5; 61789-56-8; 61789-57-9; 73138-79-1 | 8002-03-7; 68425-36; 91051; 91744-77-3; 68440-49-3; 93572-05-5; 61789-56-8; 61789-57-9; 73138-79-1 | — | |
| 307 | HYDROLYZED WHEAT PROTEINCAS 94350-06-8 / 222400-28-4 / 70084-87-6 / 100209- 50-5 | 94350-06-8 / 222400-28-4 / 70084-87-6 / 100209- 50-5 | — | |
| 308 | Tagetes minuta flower extract; Tagetes minuta flower oilCAS 91770-75-1; 91770-75-1/8016-84-0 | 91770-75-1; 91770-75-1/8016-84-0 | (a) 0,01 % (b) 0,1 % | |
| 309 | Tagetes patula flower extract; Tagetes patula flower oilCAS 91722-29-1; 91722-29-1/8016-84-0 | 91722-29-1; 91722-29-1/8016-84-0 | (a) 0,01 % (b) 0,1 % | |
| 31 | Sodium fluorideCAS 7681-49-4 | 7681-49-4 | 0,15 % | |
| 310 | CLIMBAZOLECAS 38083-17-9; | 38083-17-9; | 2,0 % | |
| 312 | FURFURALCAS 98-01-1 | 98-01-1 | 0,001 % | CMR |
| 313 | HEMACAS 868-77-9 | 868-77-9 | — | |
| 314 | DI-HEMA TRIMETHYLHEXYL DICARBAMATECAS 41137-60-4 / 72869-86-4 | 41137-60-4 / 72869-86-4 | — | |
| 315 | DIMETHYLPIPERAZINIUM AMINOPYRAZOLOPYRIDINE HCLCAS 1256553-33-9 | 1256553-33-9 | — | |
| 316 | METHYLIMIDAZOLIUMPROPYL P-PHENYLENEDIAMINE HCLCAS 220158-86-1 | 220158-86-1 | — | |
| 317 | HC Orange No. 6CAS 1449653-83-1 | 1449653-83-1 | As from 3 June 2021: 0,5 % | |
| 318 | ACID ORANGE 7CAS 633-96-5 | 633-96-5 | As from 3 June 2021: 0,5 %. | |
| 319 | TETRABROMOPHENOL BLUECAS 4430-25-5 | 4430-25-5 | (b) As from 3 June 2021: 0,2 % | |
| 32 | POTASSIUM FLUORIDECAS 7789-23-3 | 7789-23-3 | 0,15 % | |
| 320 | INDIGOFERA TINCTORIA LEAF; INDIGOFERA TINCTORIA LEAF POWDER; INDIGOFERA TINCTORIA LEAF EXTRACT; INDIGOFERA TINCTORIA EXTRACTCAS 84775-63-3 | 84775-63-3 | As from 3 June 2021: 25 %. | |
| 321 | TITANIUM DIOXIDECAS 13463-67-7/ 1317-70-0/ 1317-80-2 | 13463-67-7/ 1317-70-0/ 1317-80-2 | See conditions | |
| 322 | DIHYDROXYACETONECAS 96-26-4 | 96-26-4 | (a) 6,25 % (b) 10 % | |
| 323 | METHYL N-METHYLANTHRANILATECAS 85-91-6 | 85-91-6 | (a) 0,1 % (b) 0,2 % | |
| 324 | METHYL SALICYLATECAS 119-36-8 | 119-36-8 | See conditions | CMR |
| 325 | Butylated HydroxytolueneCAS 128-37-0 | 128-37-0 | a) 0,001 % b) 0,1 % c) 0,8 % | |
| 326 | Acid Yellow 3CAS 8004-92-0 | 8004-92-0 | 0,5 % | |
| 327 | Acetyl CedreneCAS 32388-55-9 | 32388-55-9 | — | |
| 328 | Amyl SalicylateCAS 2050-08-0 | 2050-08-0 | — | |
| 329 | AnetholeCAS 104-46-1/ 4180-23-8 | 104-46-1/ 4180-23-8 | — | |
| 33 | AMMONIUM FLUORIDECAS 12125-01-8 | 12125-01-8 | 0,15 % | |
| 330 | BenzaldehydeCAS 100-52-7 | 100-52-7 | — |
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.