대한화장품협회

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)		The maximum authorized concentration in the EU is 5%. The benzophenone-4 and benzophenone-5 entries are not separated under the EU regulation.
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%	Its use in spray systems (which disperse particles in the air) is prohibited. The nanomaterial must have the following characteristics: -Median primary particle size > 80nm; -Purity ≥ 98% and uncoated
35	Phenylene Bis-Diphenyltriazine	55514-22-2	5%	Prohibited in products that may lead to inhalation exposure. The concentration of the methyl pyrrolidone and hydrazine impurities should be kept at a trace level.	EU only has the first limitation requirement.
36	Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate	1419401-88-9	3%	Prohibited in products that may lead to inhalation exposure. Do not use with nitrosating agents. Maximum content of nitrosamines: 50mg/kg. Pack/keep in nitrite-free containers.
*: 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.