Background
Mercosur (Mercado Común del Sur), also known as the Southern Common Market, is a South American trade bloc originally comprising Brazil, Argentina, Uruguay, and Paraguay. Mercosur cosmetics legislation is based on the resolutions proposed by Mercosur’s executive body-Grupo Mercado Común (GMC). These resolutions shall be incorporated into the internal legal system of each member states. 1
Mercosur has its own cosmetic ingredient lists, which closely resembles the ingredient lists from the EU Cosmetic Regulation No 1223/2009, including prohibited ingredients, restricted ingredients, authorized hair dyes, etc. Mercosur Resolution No 44/2015 sets out a list of ultraviolet (UV) filters permitted for use in personal hygiene products, cosmetics, and perfumes in the Mercosur member countries.
Brazilian Positive List of UV Filters
On February 16, 2022, the Brazilian Health Regulatory Agency (ANVISA) issued Resolution RDC No. 600, which was adopted on February 9 and took effect upon issuance. The Resolution internalizes Mercosur Resolution No 44/2015 (as amended by Mercosur Resolution No 14/2021) and establishes a list of 36 allowed UV filters for personal hygiene products, cosmetics, and perfumes in Brazil. 2
On February 18, 2022, Brazil notified the WTO Committee on Technical Barriers to Trade (TBT) of its Resolution RDC No. 600. 3
Details of the 36 allowed UV filters are given below (The text in red indicates the difference from the EU Cosmetic Regulation No 1223/2009):
No. |
INCI Name |
CAS No. |
Maximum Authorized Concentration |
Other Limitations and Requirements |
Comparison with EU Cosmetic Regulation No 1223/2009 |
1 |
Camphor Benzalkonium Methosulfate |
52793-97-2 |
6% |
||
2 |
Terephthalylidene Dicamphor Sulfonic Acid |
92761-26-7 / 90457-82-2 |
10% (as acid) |
||
3 |
Butyl Methoxydibenzoylmethane |
70356-09-1 |
5% |
||
4 |
Benzylidene Camphor Sulfonic Acid |
56039-58-8 |
6% (as acid) |
||
5 |
Octocrylene |
6197-30-4 |
10% (as acid) |
||
6 |
Cinoxate |
104-28-9 |
3% |
Functions as a UV absorber* but is not on the EU’s positive list of UV filters |
|
7 |
Benzophenone-8 |
131-53-3 |
3% |
Functions as a UV absorber* but is not on the EU’s positive list of UV filters |
|
8 |
Menthyl Anthranilate |
134-09-8 |
5% |
Functions as a UV absorber* but is not on the EU’s positive list of UV filters |
|
9 |
TEA-Salicylate |
2174-16-5 |
12% |
Functions as a UV filter* but is not on the EU’s positive list of UV filters |
|
10 |
Phenylbenzimidazole Sulfonic Acid |
27503-81-7 |
8% (as acid) |
||
11 |
Ethylhexyl Methoxycinnamate |
5466-77-3 |
10% |
||
12 |
Benzophenone-3 |
131-57-7 |
10% |
Products with the concentration greater than 0.5% must include a warning on the label: "Contains Benzophenone-3". |
The maximum authorized concentration in the EU is 6%. |
13 |
Benzophenone-4 |
4065-45-6 |
10% (as acid) |
|
|
14 |
Benzophenone-5 |
6628-37-1 |
5% (as acid) |
The benzophenone-4 and benzophenone-5 entries are not separated under the EU regulation. |
|
15 |
PABA |
150-13-0 |
15% |
Prohibited cosmetic ingredient in EU |
|
16 |
Homosalate |
118-56-9 |
15% |
The maximum authorized concentration in the EU is 10%. |
|
17 |
Polyacrylamidomethyl Benzylidene Camphor |
113783-61-2 |
6% |
||
18 |
Titanium Dioxide |
13463-67-7 / 1317-70-0 / 1317-80-2 |
25% |
||
19 |
PEG-25 PABA |
116242-27-4 |
10% |
||
20 |
Ethylhexyl Dimethyl PABA |
21245-02-3 |
8% |
||
21 |
Ethylhexyl Salicylate |
118-60-5 |
5% |
||
22 |
Isoamyl p-Methoxycinnamate |
71617-10-2 |
10% |
||
23 |
4-Methylbenzylidene Camphor |
38102-62-4 / 36861-47-9 |
4% |
||
24 |
3-Benzylidene Camphor |
15087-24-8 |
2% |
Prohibited cosmetic ingredient in EU |
|
25 |
Ethylhexyl Triazone |
88122-99-0 |
5% |
||
26 |
Zinc Oxide |
1314-13-2 |
25% |
||
27 |
Drometrizole Trisiloxane |
155633-54-8 |
15% |
||
28 |
Diethylhexyl Butamido Triazone |
154702-15-5 |
10% |
||
29 |
Methylene Bis-Benzotriazolyl Tetramethylbutylphenol |
103597-45-1 |
10% |
||
30 |
Disodium Phenyl Dibenzimidazole Tetrasulfonate |
180898-37-7 |
10% (as acid) |
||
31 |
Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine |
187393-00-6 |
10% |
||
32 |
Polysilicone-15 |
207574-74-1 |
10% |
||
33 |
Diethylamino Hydroxybenzoyl Hexyl Benzoate |
302776-68-7 |
10% |
||
34 |
Tris-Biphenyl Triazine |
31274-51-8 |
10% |
-Median primary particle size > 80nm; -Purity ≥ 98% and uncoated |
|
35 |
Phenylene Bis-Diphenyltriazine |
55514-22-2 |
5% |
|
EU only has the first limitation requirement. |
36 |
Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate |
1419401-88-9 |
3% |
|
|
*: The ingredient's function is based on the information from Cosing. |
Comparison with EU Cosmetic Regulation No 1223/2009
It is worth noting that among the 36 UV filters, 25 ingredients have the same use restrictions as those in the EU cosmetic regulation. Five ingredients have slightly different usage conditions. Four ingredients can be functioned as a UV absorber or UV filter but are not included in the EU’s positive list. Two ingredients, PABA and 3-Benzylidene Camphor, are banned from being used in cosmetics in the EU. In addition, Brazil's positive list does not cover ingredients in the nano form, such as nano-Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, nano-Titanium Dioxide, and nano-Zinc Oxide.