Personal Hygiene Products, Cosmetics and Fragrances
Personal hygiene products, cosmetics and fragrances are preparations made from natural or synthetic substances, for external use in various parts of the human body, skin, hair, nails, lips, external genitals, teeth and mucous membranes of the oral cavity, with the sole or principal purpose of cleaning, perfuming, altering and correcting bodily odors and / or protecting or keeping them in good condition.
Market authorizations
The general regulation applicable to market authorization for personal hygiene products, cosmetics and fragrances is Resolution RDC 07/2015 (amended by Resolution RDC 237/2018). Only those products listed in Annex VIII are subject to the pre-market approval procedures (sunscreen and suntan, hair strengtheners, topical insect repellents and antiseptic gels for hands).
Products that are not included in Annex VIII of Resolution RDC 07/2015 are considered exempt from pre-market approval by Anvisa. These products are subject to a notification procedure, aiming at informing Anvisa about the intention to market a product exempted from pre-market approval. The notification procedure is carried out online, via the SGAS System, by the Brazilian company responsible for the product in Brazil.
Pre-market approvals are valid for five years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods. Notifications are valid for five years from the date when the online protocol is finalized, and may be renewed for equal and successive periods.
Applicable regulations
These are the main regulations applicable relating to the market authorization (pre-market approval and notification) of personal hygiene products, cosmetics and fragrances exported to Brazil:
- Resolution RDC 237/2018: Amends RDC 07/2015
- Resolution RDC 142/2017: Disposable personal hygiene products for body hygiene, which include toothbrush and dental hygiene rods, dental wires and tapes, disposable sanitary napkins, menstrual pads and flexible rods.
- Resolution RDC 178/2017: Amends RDC 142/2017.
- Resolution RDC 15/ 2015: Technical requirements for the pre-market approval of personal hygiene products, cosmetics and fragrances for children
- Resolution RDC 30/2012: Technical Regulation on Sunscreens in Cosmetics.
- Resolution RDC 19/2013: Technical requirements for pre-market approval of topical insect repellent.
- Resolution RDC 481/1999: Microbiological parameters for personal hygiene products, cosmetics and fragrances.
- Resolution RDC 83/2016: List of substances that cannot be used in personal hygiene products, cosmetics and fragrances.
- Resolution RDC 3/2012: Lists of substances which personal hygiene products, cosmetics and fragrances should not contain except under specific conditions and with specific restrictions.
- Resolution RDC 15/2013: Approves the use of lead acetate, pyrogalol, formaldehyde, and paraformaldehyde in cosmetics.
- Resolution RDC 29/2012: Preservatives permitted for personal hygiene products, cosmetics and fragrances.
- Resolution RDC 44/2012: Colorants permitted for personal hygiene products, cosmetics and fragrances.
- Resolution RDC 69/2016: UV-filters permitted for personal hygiene products, cosmetics and fragrances.