Coconut oil, as it contains a high content of fatty acids, is a healthy food and rich in vitamins. Its use in cooking made it better known, but today we can see several cosmetic products with coconut oil, it is used as a pre -workout, anti-inflammatory, antiviral and antibacterial.
The forms of presentation, claim, application and use will determine in which agency the registration should be made. To make the coconut oil regularization process, it is necessary to know the legislation. If you have difficulties, get in touch with us and make your budget to regularize coconut oil.
There is a new IN that will come into effect on March 17, 2022, which establishes sanitary requirements, analyzes and physical-chemical tests for the regularization of coconut oil.
In the case of coconut oil for human use, it must be registered at the National Health Surveillance Agency. First, your company needs to be duly registered at ANVISA, and only then you can request the product registration.
Following the following steps:
The Operating License, issued by the Health Surveillance Agency (VISA), authorizes the operation of your company's activities, after verifying compliance with all the rules established by the RDC corresponding to the activity performed. It is the most judicious phase of the whole process.
In this process, it is up to the institution to adapt its physical structure to receive the inspection of a VISA’s inspection agent, who will evaluate the technical and operational conditions of the place, so that your establishment can function and lead you to the next step, which is the Company Operation Authorization.
The Company Operation Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it is necessary to have specialized technical support.
The Company Operating Authorization, better known as “AFE”, is an ANVISA’s permission for the company to carry out its activities. The document, which will be published in the Official Gazette (DOU), must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing or exporting.
In this phase, petitions, documents verification, payment of fees, among others, take place. Each category requires specific documentation and it is very important to pay attention to the base documents, as the lack of these can result in instant rejection.
Obtaining the AFE indicates that the company operates in accordance with brazilian legislation and is able to operate throughout the national territory.
If the application of coconut oil is for animal use, remembering that it is a plant origin product, and products of this origin go directly through the Ministry of Agriculture, if the final destination of this product is for animal use, it will remain in MAPA.
Before regularizing coconut oil at MAPA, your company needs to be registered according to its activity, see below:
All agribusiness-related companies and goods must have the Establishment Registration at MAPA, even if produce, store, distribute, fractionate, commercialize, import or export. The Establishment Registration must occur before the Product Registration for commercialization.
Below are the establishments that must be regularized:
Distributor Establishment (ED)
Commercial Establishment (EC), which resells products in bulk;
Exporting Establishment (EE)
Importing Establishment (EI)
Production Establishment (EP)
Storage Establishment (EA)
Finally, whether any of the agencies to which you are going to regularize, it is important that you have a minimum of product documentation, that is, the basic tests of ingestion, application and the initial documentary part of tests, reports and studies.
It is important that you already have these documents at hand to start the process.
If you have encountered any difficulty in regularizing coconut oil, count on Stone Okamont. We have a team of trained professionals ready to meet your company and product needs.
Request your quote below and talk to one of our attendants.