13/12/2018

How to regulate perfume with ANVISA

The perfume market is resilient in the midst of the economic crisis. With this opportunity, Stone Okamont will teach you how to regulate perfume with ANVISA.

Brazil dominates the perfume market in Latin America, according to a Euromonitor survey. However, it is necessary to regulate your perfume at the Brazilian Health Regulatory Agency before marketing it.

Stone Okamont has more than 30 years of experience and expert consultants to regulate perfume at ANVISA with excellence and extraordinary results. Check out!

 

 What is a perfume according to ANVISA?

Perfumes are preparations, formed by natural or synthetic substances, for external use in the human body for the purpose of perfuming.

 

Local Operating Licence to regulate perfume at ANVISA

Before starting the process to regulate perfume with ANVISA, the regulatory agency requires you to obtain the Operating License.

The License comes from a survey carried out by VISA, the Local Sanitary Surveillance.

If the establishment complies with the requirements, a report is issued that proves the technical and operational conditions for the manufacture of perfume.

 

Do I need AFE to regulate perfume with ANVISA?

The AFE, Operation Permits, is mandatory to regulate perfume with ANVISA.

The petition must be sent to the Brazilian Health Regulatory Agency, and, after its approval, authorization is published in the Official Gazette.

The AFE proves that the company is regularized in ANVISA and acts in accordance with Brazilian legislation.

 

Risk Class in the perfume regulation with ANVISA

The Brazilian Health Regulatory Agency includes perfumes in the category of cosmetics, which are classified in Class I and Class II.

In the case of the perfume product, its Risk Class is I.

 This means that to regulate perfume with ANVISA, only one notification will be necessary.

The process is as important as registration but requires less evidence of efficacy and safety due to its usage and purpose specifications.

 

Is the Certificate of Good Practices required to register perfume with ANVISA?

The Certificate of Good Manufacturing Practices is required only when the products are classified as Risk Class III or IV.

As perfume is in risk class I, certification is not required to regulate perfume with ANVISA.

 

Procedure to regulate perfume with ANVISA

Although the notification process is simpler than registration, it is important to pay attention to the requirements imposed by the Brazilian Health Regulatory Agency when regulating perfume.

Some of them are:

  • State the purpose of the product;
  • Present the labeling project containing the perfume warning data according to current legislation;
  • The function of each component of the perfume formula should be presented.

The process for regulating perfume at ANVISA can be a little tricky, but Stone Okamont has smart solutions that bring quick results at reduced costs!

 

 How to regulate perfume with ANVISA with ease?

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

With a team of professionals highly trained and updated in the most diverse demands, we find the best method to regulate your perfume with ANVISA.

Contact us, know our smart solutions and let your company closer to success! Click here!

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