Brazil regulation change: new rules for sanitising products
03 Nov 2025
Brazil regulation change: new rules for sanitising products
On August 20, 2025, Anvisa published RDC 989/2025 and IN 394/2025, introducing updated requirements for sanitizing products and repealing RDC 59/2010. These changes aim to harmonize Brazilian legislation with Mercosur standards while maintaining national provisions for analytical tolerances and shelf life.
Key highlights
- Risk classification
- Risk 1 = Notification; Risk 2 = Registration.
- Risk 1 products must be notified through the electronic platform provided via Anvisa prior to being placed on the market.
- Risk 2 products can only be placed on the market after registration is granted and published in the Federal Official Gazette (DOU).
- LD50 testing now specifies conditions for pure products (OTC) and diluted forms (professional use).
- Risk 1 = Notification; Risk 2 = Registration.
- Safety requirements:
- Ban on carcinogenic, mutagenic, and teratogenic substances.
- Mandatory biodegradability for anionic surfactants.
- Labelling and packaging:
- Harmonized warnings and mandatory info, including the telephone number of at least one Toxicological Information and Assistance Center (CIAT);
- Prohibition on misleading claims and reuse of food packaging.
- Volume limits:
- Risk 1 over-the-counter products may have a maximum net content of up to 10 kg/L and must have packaging that facilitates safe use.
- National specifics (IN 394/2025):
- Analytical tolerances, shelf-life proof, and stability test conditions.
These updates enhance consumer safety, improve transparency and align Brazil with Mercosur standards, boosting trade competitiveness while modernising the regulatory framework.
Implications for businesses
Businesses placing sanitising products on the market in Brazil should review product portfolios to ensure compliance risks are minimised. Understanding which risk classification your products fall into will detail any compliance actions required.
How can Ricardo help?
Ricardo can provide consultancy support to help your organisation to navigate these requirements in Brazil, including registration requirements, labelling and packaging and Safety Data Sheets (SDS).
