The Brazilian Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency; ANVISA) has released Resolution – RDC No. 650 (11 April 2022) that contains provisions on criteria for inclusion, exclusion and updating of sanitizing products which have a lower potential risk, provided they are produced within the scope of MERCOSUR, and specifically including MERCOSUR No. 51/2006 “MERCOSUR Technical Regulation On Criteria For Inclusion, Exclusion And Updating Of Household Products With Lower Potential Risk Manufactured in the MERCOSUR Scope”.
RDC No. 650 has the manifest goal of protecting human health and safety, primarily through encouraging the development and use of low-risk sanitizing products. Such products, provided they comply with RDC No. 50, would receive less regulatory scrutiny by ANVISA, and potentially a faster path to market.
RDC No. 650 encompasses sanitizing products intended for general cleaning and the like, intended for use on objects, fabrics, inanimate surfaces and environments, in homes, vehicles, industries and in public or private places or establishments, as provided in Annex I of the Resolution. Per Article 3, those items listed in Annex I must comply with the following criteria:
1. Products formulated with substances that have no demonstrable mutagenic, teratogenic or carcinogenic effects;
2. Products whose pH value, in a 1% p/p solution at a temperature of 25°C, is greater than 2 and less than 11.5; and
3. Products that have a cleaning purpose and the like.
Articles 4 and 5 list the exclusions to RDC No., 650, specifically those with antimicrobial action, disinfectants, biological products based on bacteria, oxidants and reducing agents. In addition, products that have “unwanted effects” or have been associated with any health problem(s).
Annex I includes the following products:
1. Fabric softeners;
2. Waxes and polishes;
3. Air fresheners (without bacteriostatic action);
4. Odor neutralizers;
5. Detergents;
6. Furniture polish;
7. Floor cleaners;
8. Plastic cleaners;
9. Tire cleaners;
10. Wipes for windows;
11. General purpose cleaners
12. “Ironing facilitators”;
13. Carpet and rug cleaners
14. Shoe cleaning products;
15. Polishers;
16. Soaps; and
17. Rinse aids.
If passed into National law, entry into force would occur on 02 May 2022.
