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The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the last month, ANVISA has proposed modifications to active ingredients employed in agrochemicals and revised provisions for personal hygiene products.

Through Normative Instructions (IN), ANVISA proposes to include the following active ingredients in the ingredient list used in Agrochemicals, Sanitizing Disinfectants and Wood Condoms, which is regulated by IN 103/2021:

In addition, proposal 1085 aims to modify substances present in IN 103/2021 annexes, i.e., the frequent need for toxicological assessment or reassessment of referred active ingredients. Proposal 1089 also intends to revise further 15 active ingredients with a public consultation open until June 5, 2022.

In a resolution published in May 2022, ANVISA also targeted disposable personal hygiene products. Among the list, brushes and sticks for oral hygiene, dental floss and tape, disposable sanitary pads, menstrual cups and swabs went under new regularization rules. RDC 640/2022 also defines the classification, technical requirements, and labeling instructions for such products to be marketable in Brazil.

Among the directives, ANVISA requires that product owners submit a notification via the online portal containing product technical information. Product owners can look up which detailed data is mandatory in RDC 640/2022 Annex I, to know to which extent they should be present.

Furthermore, ingredients that may migrate to the skin and/or mucous membranes must comply with the requirements set out in the respective lists of substances for personal care products, cosmetics and perfumes, according to their classification.

Latin American countries have been constantly improving their chemical management instruments in the last few years. Among several meetings and discussions, countries are motivated to pursue the implementation of their national chemical policy.

The Latin American Regulatory Cooperation Forum (LARCF) has been front running with events and cooperation partnerships in the region, bringing together more than 100 regional industry members. The most recent meeting (April 2022) once again shed light on the risk approach to chemical management, highlighting the importance of national chemical inventories.

In the published document, Risk Approach in the Management of Industrial Chemical Substances and Products – Inventories, the Forum explains the importance of chemical inventories in driving chemical policies forward. However, it recognizes that inventories need to be accompanied by mechanisms to identify substances and mixtures offering unreasonable risks to health and the environment, i.e., substance prioritization, risk assessment, and measures for risk management.

The report also insists that governments develop inventories open to data exchange as individual and isolated inventories often bring duplication of data, delay trades, and increased expenses. The OECD Mutual Acceptance of Data (MAD) is pointed out as a solution in this case.

LARCF has already published a Roadmap for Sound Management of Industrial Chemicals in September 2020 and seeks future publications and guidelines related to substance prioritization, risk assessment, and risk management.

From a regional perspective, only Chile and Colombia have implemented their national chemical inventories. In contrast, other countries still have to figure out their implementing regulations and/or ways to drive the process forward in the political scenario.