Argentina Prohibits the use of three substances in personal care products

On 2 November 2023, the 90-day deadline set by the Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) for companies to make the required revisions and begin the process of changing formulations and labeling required under Provision 5978 / 2023 will expire.

The Provision was released by the ANMAT on 4 August 2023. The article prohibits the use of certain substances in cosmetics, personal hygiene, and perfume products, including 4-Amino-3-hydroxytoluene, 1,2,4-Trihydroxybenzene, and 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid.

The EU’s Scientific Committee on Consumer Safety (SCCS) has already issued opinions on the safety of these ingredients when used in hair and eyelash dyes. The SCCS found that 4-amino-3-hydroxytoluene and 1,2,4-Trihydroxybenzene are genotoxic, while 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid is mutagenic. According to the findings, the use of these chemicals in cosmetics is not safe. Based on the quality of the scientific evidence provided, the European Commission modified Annex II of Regulation No. 1223/2009 to include these compounds in the list of substances restricted for use in cosmetics. ANMAT cites the EU's findings as the proof required to ban the chemicals in Argentina.

Provision 5978 / 2023 also forbids the marketing of cosmetic products containing these chemicals. Companies that own, produce, or import cosmetic items affected by this clause have 90 calendar days (until 2 November 2023) to make required revisions and commence the process of changing formulations and labeling. Penalties for non-compliance will be imposed in accordance with Law 6.463 and Decree No. 341/92. The Provision entered into force on the day of its publication in the Official Gazette, and it must be filed with the National Directorate of the Official Registry, the Argentine Chamber of the Industry of Personal Hygiene, Cosmetics, and Perfumery Products, and other organizations.