ANVISA Regulates Different Label Variations for the Same Product

The National Health Regulatory Agency (ANVISA) of Brazil, on 22 November 2018, published a new standard - Resolution RDC 250/2018 related to the Official Gazette of the Union. The new resolution, related to Cosmetics labeling, was passed to enhance the agility of the cosmetics sector in Brazil and reduce the cost of labeling processes to the organizations.

In brief, at present, it is required to submit every label change of cosmetic product (including changes to non-sanitary features such as promotional slogans and colors) to the Agency. And the ANVISA did not allow different labels of the same product to coexist at any given time. Hence, the Resolution RDC 250/2018 allows cosmetics and personal care product organizations/manufacturers to regulate different labeling variations for the same product.

With the new standard in effect, only changes that are related to safety and benefits of products will demand the submission of labeling or new art of labeling to the agency. It is also expected to eliminate the need for submission of labeling changes that do not pose a health risk, such as:

  • data from customer service
  • social name and
  • addresses of the holder

In addition, to clear doubts and to give a clarity on the update especially for the cosmetics manufacturers and to the National Health Surveillance System, the Management of Hygiene, Cosmetics, Perfumes, and Sanitation Products (GHCOS) will soon be publishing a question and answer document for guidance.

As the new resolution permitting the regularization of even simple changes, it’s time for cosmetics manufacturers to critically look into every set of label variations before submissions. To be compliant, consult an expert to keep abreast with latest regulatory information. Be Informed. Be Compliant.