Brazil updates the list of prohibited substances in cosmetics
On August 4, 2021, Brazil's national health supervision agency (Anvisa) issued RDC resolution 529, which officially entered into force on August 11, 2021.
The amendments related to cosmetics in this resolution are as follows:
1. the resolution stipulates that a list of substances that can not be used for personal care products, cosmetics and perfumes should be provided.
2. in addition to substances listed in the annex, it is prohibited to use hazardous substances in personal care products, cosmetics and fragrances under the following circumstances:
1) Substances classified as category 1 according to the international classification of the international agency for research on cancer (IARC);
2) According to EU CLP regulation (EC) no 1272 / 2008, it is classified as CMR substances (i.e. carcinogenic, mutagenic and reproductive toxic substances), belonging to categories 1a, 1b and 2
3. Of course, the above substances do not always have health risks. If the scientific and technical documents are submitted for analysis and approval by Anvisa that the above substances are safe, CMR substances listed as class I by IARC or belonging to classes 1a, 1b and 2 can be used.
1) The scientific and technical documents shall take into account the requirements set out in Decree No. 295 of 16 April 1998 and its updates, and may include references such as foreign regulations, scientific research prepared internationally or scientific research prepared by the scientific community of the States parties to Mercosur.
2) scientific and technical documentation should take into account the health risks of consumers, the maximum allowable concentration, controllable range, frequency of use and exposure time when using personal care products, cosmetics and fragrances under normal conditions.
Relevant Brazilian enterprises must ensure that their products do not contain these prohibited substances after August 11, 2024, that is, enterprises are given a transition period of 36 months.
In this revision, five prohibited substances for cosmetics are added, namely isobutyl hydroxybenzene, isopropyl hydroxybenzene, quaternary ammonium salt-15, chloroacetamide and benzyl chlorophenol.
The five cosmetics prohibited substances updated in Brazil have been listed in the catalogue of prohibited cosmetics raw materials in China (2021). Isobutyl hydroxybenzene, isopropyl hydroxybenzene, quaternary ammonium salt-15 and chloroacetamide were included in the list of prohibited raw materials for cosmetics as early as 2015. Although benzylchlorophenol is listed in the latest catalogue of prohibited raw materials, it also exists in the list of approved preservatives for cosmetics (2015). Nmpa has been revising the list of approved preservatives for cosmetics, but the official version has not been released yet. When registering cosmetics, enterprises should pay attention to the provisions of the catalogue of prohibited raw materials for cosmetics in China (2021).
In addition, the EU banned the use of isobutyl hydroxybenzene and isopropyl hydroxybenzene in cosmetics in 2014. Quaternary ammonium salt-15, chloroacetamide and benzylchlorophenol were included in the list of prohibited components in Annex II of (EC) No. 1223 / 2009 in amendment (EU) 2019 / 831 issued by the European Commission on May 22, 2019.