Do you know the difference between deodorant and antiperspirant registration?

Some differences in the deodorant or antiperspirant regularization process are the specific analyzes that must be presented.

For the regularization of the antiperspirant, it is necessary to prove that the product is safe and effective for human use, therefore, without the presentation of this study, it will not be possible to proceed with the regularization.

In the regularization of the deodorant, it is not necessary to present the safety and efficacy study, but this does not exclude proof of stability and the presentation of physical-chemical data.

As mentioned, there are different processes and requirements for each of these products. The antiperspirant is a product risk level II, which means it has specific indications, whose characteristics require proof of safety and/or efficacy, as well as information and care, mode and restrictions on use.

The deodorant is classified as risk level I, which is characterized by having basic or elementary properties, the regularization of this product is more simple compared to the regularization of a cosmetic of risk level II.

Before regularizing deodorant or antiperspirant, you will need to regularize your company with the ANVISA (National Health Surveillance Agency) following these steps:

The first step is to obtain the Operating License for your establishment, a document issued by the VISA (Sanitary Surveillance), legalizing the operation of your company's activities and respecting all the rules established by the RDC corresponding to the activity that will be performed. This is the most careful phase of the deodorant or antiperspirant regularization process.

In this process, it is up to the institution to adapt its physical structure to receive the inspection from a VISA inspector. The agent will evaluate the technical and operational conditions of the place, so that your establishment can operate, moving on to the next step, which is the Authorization for the operation of the company.

The Authorization for Business Operation (AFE) is one of the most important regulatory steps for the success of your business, so it is necessary to count on specialized technical support.

The Authorization for Business Operation, better known as "AFE", is an authorization from ANVISA for the company to carry out its activities; the document will be published in the Official Gazette of the Union (DOU). The AFE must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing, or exporting.

At this stage, the petition must be filed, then the responsible body will verify the documents submitted, and collect the fees. Each type of category requires specific documentation, it is very important to pay attention to the base documents, as the lack of these can result in instant rejection.

Obtaining the AFE demonstrates that the company acts in accordance with the Brazilian legislation and is able to act throughout the national territory, thus moving on to the next phase, which is to regularize the deodorant or antiperspirant.

Stone Okamont has a personalized service system, in which each case is analyzed in a unique way and the best solutions are proposed.

With a team of highly qualified and updated professionals in the most diverse demands, we find in ANVISA the best method for regularization of deodorant or antiperspirant.

Get in touch with us, learn about our smart solutions and bring your company closer to success!