A resolution published by the Brazilian health surveillance agency Anvisa significantly enlarging the registration validity period of personal care products, cosmetics and perfume from 5 to 10 years is now in force (Plenary Board Resolution – RDC – No. 312, published on October 16, 2019).
Personal care products, cosmetics and perfume are generally free from registration; prior communication to Anvisa suffices for these types of products. Although exempt from registration, personal care products, cosmetics and perfume must meet specific technical standards. In addition, a declaration of interest in continuing to market such products must be submitted 10 years after prior communication is made to Anvisa, and every 10 years thereafter. Failure to issue such a declaration will render the products not in compliance.
Despite the general rule being of a prior communication, some products are subject to registration. Products subject to registration are those defined and classified as Level 2 products.
Considering the increasing use of technology in the personal care products, cosmetics and perfume industry, the Level 2 product list, although comprehensive, may be subject to review.
Today, the level 2 product list is (Exhibit VIII of RDC No. 7, of February 10, 2015) as follows:
- Tanning products
- Sunscreen
- Kids sunscreen
- Antibacterial hand gel
- Hair straightening products
- Hair straightening and dying products
- Insect repellent
- Kids insect repellent
Submissions regarding personal care products, cosmetics and perfume which are exempt from registration are to be made on the Anvisa website. Anvisa will publish compliance of such products on the Anvisa website as well.
In turn, products subject to registration – which now are valid for 10 years – will have registration renewed every 10 years. Request for renewal is to be made during the first 6 months of the last validity year; otherwise, registration will be cancelled. Product compliance will be published in the official gazette DOU.
According to Anvisa’s personal care products, perfume, cosmetics and sanitizing products manager, the main purpose of the new registration validity rule is to make the process less bureaucratic, which will help Anvisa be more focused on reviewing requests involving products which have new ingredients and substances requiring a more careful risk analysis.
Under the new rule, registration periods for already registered products will be automatically extended for 10 years as from the registration effective date and taking into account any renewal that has already been granted. What is important here is that the company has to make a timely request for renewal, i.e., no earlier than 12 months and no later than 6 months from the registration validity expiration.
To avoid any doubt, another thing that is important to explain is that the registration validity period and the product validity period are not the same thing. For the public, no change was made to the requirements pertaining product safety. Product validity is the period of time defined by the manufacturer as the proper time to keep the product during its life cycle, provided that it is maintained in its original packaging and without any damage, under normal storage and usage conditions. Such a definition takes into account the product formulation and techniques used in production.
