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On December 31, 2024, Brazil launched two separate public consultations to review draft amendments to the lists of prohibited and restricted ingredients. Public input is accepted from January 7 to March 7, 2025.1-2
1. List of Prohibited Ingredients
Currently, cosmetics intended for the Brazilian market shall not contain ingredients listed in the annex to Resolution RDC No. 529/2021. The draft outlines 13 additions, 2 revisions, and 5 deletions to this annex.
Status | Ref. No. | Substances (Excerpt) | CAS No. | EC No. |
Addition | 1405 | Diboron trioxide; boric oxide | 1303-86-2 | 215-125-8 |
1406 | Boric acid | 10043-35-3 / 11113-50-1 | 233-139-2 / 234-343-4 | |
1409 | POLYURETHANE-18 | / | / | |
1410 | POLYURETHANE-19 | / | / | |
1411 | Dibutyltin hydrogen borate | 75113-37-0 | 401-040-5 | |
Revision | 178 | 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphene | 103-16-2 / 150-76-5 / 622-62-8 | 203-083-3 / 205-769-8 / 210-748-1 |
221 | Mercury and its compounds, except those special cases mentioned in other ingredient lists | 7439-97-6 | 231-106-7 | |
Deletion | 382 | Benzoyl peroxide | 94-36-0 | 202-327-6 |
1339 | Hydroquinone | 123-31-9 | 204-617-8 | |
1373 | Azelaic acid | 123-99-9 | 204-669-1 | |
Notes: 2. The detailed amendments to this list are available here. | ||||
2. List of Restricted Ingredients
The annex to Resolution RDC No. 530/2021 compiles 132 ingredients permitted for use in cosmetics under specific conditions. This includes 26 fragrance allergens, which shall be indicated by their INCI names on product labels if their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. The draft introduces 115 new ingredients, removes 7, and makes comprehensive revisions to existing entries by adding INCI names and CAS numbers, and updating use conditions to reflect the latest scientific research. As a result, the updated restricted ingredients list will contain 246 ingredients in total, with the number of regulated fragrance allergens increasing to 77.
Amendments to the List of Ingredients Restricted (Excerpt) | ||||||||
Status | Ref. No. | Chemical Name | INCI Name | CAS No. | Application Scope | Maximum concentration | Others | Labelling of Use Conditions and Warnings |
Addition | 151 | 3-Carene; 3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) | 3-Carene | 13466-78-9 | / | / | Peroxide value less than 10 mmoles/L (This limit applies to the substance and not to the finished cosmetic product.) | / |
162 | Allyl butyrate; 2-Propenyl Butanoate | Allyl butyrate | 2051-78-7 | / | / | Level of free allyl alcohol in the ester shall be less than 0.1% | / | |
181 | Amylcyclopentenone; 2-Pentylcyclopent-2-en-1-one | Amylcyclopentenone | 25564-22-1 | / | 0.1% | / | / | |
Revision | 33 | Bis(8-hydroxyquinolinium)sulphate | Oxyquinoline sulphate | 134-31-6 | (a) Stabilizer for hydrogen peroxide in rinse-off hair products | (a) 0.3% (as base) | / | / |
38 | Talc: Hydrated magnesium silicate | Talc | 14807-96-6 | (a) Powdery products intended to be used for children under 3 years of age | / | Shall guarantee the substance is asbestos-free | (a) Keep powder away from children's nose and mouth | |
Sodium perborate | Sodium perborate | 15120-21-5 / 7632-04-4 / 11138-47-9 | (a) Oral hygiene products | (a) 0.1% | (a) Not to be used in preparations for children under 3 years of age. | a) | ||
| Deletion | 45 | Undecylenic acid and its zinc salts, amides, monoethanolamides and sulfosuccinates | / | / | Antidandruff products | 2% | / | / |
46 | Ketoconazole | / | / | Antidandruff products | 1% | / | / | |
/ | 2-(4-tert-Butylbenzyl)propionaldehyde | Butylphenyl methylpropional | 80-54-6 | / | / | The presence of the substance shall be indicated in the list of ingredients using the INCI nomenclature, when its concentration exceeds: | / | |
Notes: | ||||||||
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