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GPC - Global Product Compliance

Brazil Proposes Changes in Active Ingredients and Personal Hygiene Products

2022-05-20 Reference source : ANVISA

Active ingredient Personal care Product registration/ notification


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:

Monograph Index

Substance/Organism

CAS #

B57

Bistrifluron

201593-84-2

M52

Mefentrifluconazole

1417782-03-6

A65

Ametoctradin

865318-97-4

P67

Pseudomonas fluorescens

-

B58

Burkholderia rinojensis

-

P66

Pseudomonas chlororaphis

-

P65

Pidiflumetofeno

1228284-64-7

P68

Phthorimaea operculella granulovirus

-

T79

Tiafenacil

1220411-29-9

E33

Spiropidion

1229023-00-0

 

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.



We acknowledge that the above information has been compiled from ANVISA.

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