Anvisa, the Brazilian agency responsible for overseeing the safety of drugs and cosmetics, has just published a technical note (Nota Técnica (NT) 5/2021 [1]) specifying the procedures for labelling in Portuguese the ingredients of perfumes and hygiene and cosmetic products sold in the country.
The note complements the rules laid down in the resolution (RDC) 432/2020 of November 4, 2020, which provides that personal hygiene products, cosmetics and perfumes marketed in Brazil must be labelled with the list of their ingredients in Portuguese.
INCI labelling remains mandatory
"The International Nomenclature of Cosmetic Ingredients (INCI) remains mandatory in the labelling of personal hygiene products, cosmetics and perfumes," Anvisa first emphasizes in its note.
In practical, as the November text already mentioned, the translation into Portuguese appears to be a complement to the INCI list, the two pieces of information will thus have to coexist on the label, whether on the original product label or thanks to an additional label sufficiently resistant so that the information cannot be removed or erased, even partially.
Regarding the translation of INCI terms, operators will have to refer to the official Brazilian pharmacopoeia (Denominação Comum Brasileira - DCB).
In the absence of a translation available in the DCB, the Agency advises companies to translate the INCI terms in accordance with the method provided in Article 7 of DRC 63/2012, namely:
a) the translation must respect the usual spelling and phonetics of the Portuguese language of Brazil;
(b) the translation must be distinct phonetically and by its spelling from other existing translations and be spelled as simply as possible;
(c) the use of a trade name, trademark or other fanciful name in the translation is prohibited; and
d) translations which, due to their spelling or phonetics, would induce a reference to anatomical, physiological, pathological or therapeutic effects or which could lead to confusion with other names, should be avoided.
Clarity and ease of reading
The technical note also details the rules to be followed so that the information be clear for consumers:
a) the translation of the ingredients into Portuguese must appear in parentheses or after a bar, next to the corresponding terms in the INCI list, which must be introduced by the terms Composição or Ingredientes; or in a separate list preceded by the terms Composição (português) or Ingredientes (português);
b) ingredients in Portuguese will be in the same order as in the INCI list of ingredients;
c) the terms “e o corante”, “e os corantes” or “Pode conter os corantes”: must precede the list of colour additives in Portuguese;
d) knowing that these different terms may or may not be in upper case.
The entire Technical Note (NT) 5/2021 is available (in Portuguese) here below or on the Brazilian government website www.gov.br
