What are MAPA exempt from registration products?November 04, 2019
Products exempt from registration in MAPA – Ministry of Agriculture, Livestock and Supply are products with simpler regulation that do not need registration.
In this blog post you will learn about what MAPA’s exempt products are and how Licempre can help your company have less regulatory bureaucracy and more results in a safe, transparent and agile manner.
What is MAPA?
MAPA is the body responsible for evaluating agribusiness-related products such as fertilizers, animal products, veterinary products, among others, in order to ensure greater quality and safety for consumers, as well as the development of agribusiness activities. What is MAPA’s product exemption?
The exemption of products in MAPA includes products that are characterized by being simpler, that is, products that according to the regulator present less risk to the consumer.
However, all products need MAPA evaluation and documentation, as we will follow.
What is the difference between registration and product registration?
To better understand what product registration exemption is, let’s first understand the difference between register and registration.
All of these nomenclatures are part of product regularization. The difference between them is their classification in relation to the risk of the presented product.
See it below:
- Register – present an intermediate risk and only need registration.
- Registration – considered high-risk products, as this class requires registration of the product.
As stated earlier, products exempt from registration with the Ministry of Agriculture are considered simpler products, which provide for wealthier minors and have less complexity than other products.
There are many categories of products exempt from registration and MAPA aims to establish the criteria and evaluate the protocols for the procedures for manufacturing, fractionation, importation and marketing of products exempt from registration are made to comply with the requirements established by the regulatory agency.
Thus, we can conclude that while products are exempt from registration they need an evaluation and documentation to be marketable.
What products are exempt from MAPA registration?
Registration exemption applies to a number of products. There is a very large list of exempt products that varies according to the category of each product.
Among the categories, we can mention the products like pet food, ruminant supplement, Premix, cosmetics.
Imported product exempt from registration must also be approved by MAPA.
How does MAPA product exemption work?
Exemption from registration does not eliminate the need for regulatory review, but it varies by product and category.
For example, animal feed products such as feed or snacks are exempt from registration, but the company needs a license for EP (producing establishment) or EI (importing establishment) and the product needs to be registered with the agency and given a control number.
Thus, the company must be aware of the procedures required by the agency.
Licempre is a company that specializes in regulatory affairs and takes care of the entire process, clarifying doubts and conducting all information gathering so that your company and product are in accordance with the requirements of the agency.
Normative Instruction No. 38 of 27 October 2015
According to Normative Instruction No. 38, of October 27, 2015, become effective with the following wording:
Article 1 – Establish the criteria and procedures for the manufacture, fractionation, importation and sale of products exempt from registration dealt with in this Normative Instruction.
Article 2 – Approve the form templates and product lists to be exempted from registration contained in Annexes I, II, III, IV and V.
Article 3 – To exempt from registration under this Normative Instruction the following products:
I – the product intended for animal feed classified as a ruminant supplement, pig supplement, poultry supplement, premix, core, concentrate, feed.
II – the grains and seeds in nature and hay referred to in item II of article 20 of the Regulation approved by Decree No. 6,296, of December 11, 2007, which only undergo the grinding process and maintain their nutritional characteristics;
III – the ingredients used in human food and susceptible to use in animal feed listed in Annex IV of this Normative Instruction;
IV – the additives listed in Annex V of this Normative Instruction, which may be mixed together.
Article 4 – The exemption of registration of ingredients, additives, supplements for ruminants,pig supplements, poultry supplements, premix, kernels, concentrates and feed for feed does not exempt the establishment and the persons responsible for compliance with the requirements laid down in specific normative acts (NR).
Article 5 – The classifications, identity and quality standards, labeling rules, and other requirements other than registration set forth in product-specific standards covered by this Normative Instruction must be met.
Should my company have a MAPA license?
Every company that has activities related to agribusiness must have the Company License with MAPA, as it is mandatory for the commercialization of the products.
This determination also applies to all activities related to production, storage, importation, exportation and distribution.
According to MAPA – Ministry of Agriculture, Livestock and Development, the request for documents may vary depending on the activity of home business.
See the licenses companies must have, established by MAPA.
- Distributor Establishment (ED)
- Commercial Establishment (EC)
- Exporting Establishment (EE)
- Importer Establishment (EI)
Still in this scenario, it is necessary to be aware of the Import Certificate, which is necessary for companies that carry out goods import activities.
Licempre carries out the entire bureaucratic process in regulatory licensing issues according to the activity and requirement of the responsible body.
The great advantage of having a regulatory product advisory firm is safety, practicality and agility, reducing bureaucratization and emphasizing results for companies requiring MAPA licenses.
How can Licempre help you?
All products exempt from MAPA registration must follow good manufacturing practices as well as regulatory and regulatory requirements.
It is important to remember that any activity involving the marketing, manufacture or importation of products that do not comply with MAPA approval is prohibited.
This way your company should be able to perform the activities.
Thus, Licempre can assist your company in both licensing the establishment and registering exempt products.
You can talk to one of our experts and answer all your questions.