September 2, 2021
by Raissa Havens, regulatory specialist, UL’s Supply Chain department
The Brazilian Health Regulatory Agency (ANVISA) updated the List of Prohibited Substances in Personal Hygiene, Cosmetics and Perfume Products, published on June 17, 2016, under Resolution 82/2016, to include new substances, such as parabens and other preservatives already banned under the EU Cosmetics Regulation.
The updated list was published under the Ministry of Health through Resolution RDC 529 of Aug. 4, 2021, incorporating the modifications adopted by GMC MERCOSUR Resolution 37/20.
The substances that are now prohibited and their Chemical Abstracts Service (CAS) numbers are listed below:
- Isobutylparaben (4247-02-3)
- Isopropylparaben (4191-73-5)
- Quaternium-15 (51229-78-8)
- Chloroacetamide (79-07-2)
- Chlorophene (120-32-1)
In addition to the list of items noted in the regulation’s annex, the ban also applies to substances in:
- Category 1: according to the international classification of the International Agency for Research on Cancer (IARC)
- Categories 1A, 1B and 2: carcinogenic, mutagenic or toxic properties for reproduction (CMR substances), according to Part 3 of Annex VI of Regulation (EC) No 1272/2008
However, these substances may be used if considered safe by ANVISA.
This Resolution entered into force on Aug. 11, 2021, its publication date in the Official Gazette. Companies have 36 months from this date to adapt any products accordingly.
UL’s ChemADVISOR® Regulatory Database will reflect the changes in the October 2021 release (Q4).
Recommended action items
- Review your company’s cosmetic products sold in Brazil and determine if they contain any ingredients banned by this regulation.
- Seek alternative ingredient(s) for products that do not comply with the new restrictions.