Cosmetics in Mercosur: technical requirements updated

Published: 25 June 2019

The internalization of Mercosur Technical Requirement related to the update of technical requirements for the regularization of personal hygiene products, cosmetics, and perfumes at Mercosur level was approved in the 13th Regular Public Meeting of Anvisa’s Collegiate Board (Dicol), held on 28 May 2019.

The update aims at streamlining analysis and ensuring safety and efficacy of personal hygiene products, cosmetics, and perfumes, in addition to improving the activities of monitoring and supervision of such products.

The alteration of technical requirements needed for the products at issue was the subject discussed at Mercosur SGT-11 Cosmetics Sub-commission meetings, held in 2017 and 2018. On 8 November 2018, the analysis was completed, and Resolution Mercosur/GMC/RES 44/18 was published.

Alterations

The new resolution updates the technical requirements established by RDC 07/2015 to regularize personal hygiene products, cosmetics, and perfumes, so only health-relevant documents are mandatory requirements for such regularization. The elimination of documents that do not contribute towards the products’ safety and efficacy assessment allows the regulated sector and Anvisa to focus their efforts on analyzing what is relevant.

One of the alterations was the exclusion of the Notarized Certificate of Free Sale (CVL, in Portuguese), simplifying the regularization, without altering the product’s health safety. It was verified that several countries do not require the CVL for imported cosmetics. In addition to that, in many countries that document is not issued by health authorities, but by chambers of commerce.

Other important health improvements in the resolution were the inclusions of:

1 – the content of active ingredients in products categorized as repellents, sunscreens, and smoothing products, or – when provided for in a specific regulation – in the organoleptic and physical-chemical technical specifications of the finished product.   

2 – the determination of the main functional substances or groups of substances in the case of insect repellents and sunscreens, or – when provided for in a specific regulation – in stability studies.