When we are dealing with products exempt from registration on the MAPA it does not mean that they should not be regulated in any way. They are simpler products, of low complexity and that offer lower risks, that is, that present an intermediate risk. In this case, registration of these products is necessary, even if they are exempt.
In the case of MAPA, the classification of products is divided into two categories: cadastre and registration. The cadastre, as we saw above, are for products exempt from MAPA registration in Brazil, those that are classified as high risk consumer products must be registered. Both need to undergo an assessment by the regulatory body.
MAPA (Ministry of Agriculture, Livestock and Supply) is the Brazilian body responsible for regulating products related to: Planting, care and animal feeding, among others.
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Does my establishment need a registration with MAPA?
Before regularizing these products exempted from MAPA registration in Brazil, there is a need to establish a physical location in Brazil, after that it will be possible to regularize the establishment according to its activity, that is, obtain the Company License from MAPA, being mandatory for marketing of products, be it:
- Distributor Establishment (DE)
- Commercial Establishment (CE)
- Exporting Establishment (EE)
- Importer Establishment (IE), Import Certificate also needed
- Producer Establishment (PE)
Every establishment that manufactures, fractionates, distributes, imports, exports and markets must be registered with the MAPA. The Establishment and the product must pass evaluation criteria in compliance with the MAPA guidelines, standards and requirements, also following good manufacturing practices. The documentation may vary according to the activity, and if the establishment and the products exempted from registration in the MAPA are not properly regulated, any operation is prohibited. Learn more: Company License.
What is needed to regularize products exempt from MAPA registration in Brazil?
The regularization process is based on the classification of the product and the verification of it in the list of products exempt from registration with MAPA.
The fact that these products are exempt from MAPA registration in Brazil does not exempt the establishment and the technical responsible from their obligations regarding the approval of formulas, labels and packaging, in addition to filling out the RTPI (Technical Report and Exempt Product).
As stated before, after the regulated establishment, we will start the assembly of the technical dossier and the filling out of the forms for the regularization of products exempt from map registration in Brazil. Both must obey quality standards and follow labeling criteria and other established requirements so that their composition contains only ingredients or additives approved by MAPA. The establishment must do all of this process before it even starts manufacturing.
All documentation must be auditable, being available to MAPA when requested. The establishment must keep the records of the internal controls of the activities, dated and signed for one year, thus allowing the traceability of the products. In the case of an importing establishment, other documentation is required in addition to the cadastre of each of the products exempt from MAPA registration to be imported.
There is a list of exempt products for both human and animal feed, among others. Don't waste any more time! Avoid infractions, cancellation of cadastre or registration and interdiction of your establishment. Talk to those who understand! Fill out the form below and speak to one of our consultants about Regularization of products exempt from MAPA registration in Brazil! Or if you prefer, contact Stone Okamont!
