We are the best regulatory path for your innovation.
Innovation in food and beverage needs a regulatory dossier with quality and experience.
Services
At Pura Consultoria, we conduct your food innovation process with technical competence, responsibility and efficiency. Our work is complete: it covers all preparation of information, dossier documentation, submission to Anvisa (Brazilian National Health Surveillance Agency), response to contingent requirements, and follow-up until publication on the Federal Official Gazette.
We are ready to offer the best regulatory path for your innovation.
Regularization of Novel Food Products and Ingredients
Preparation of dossier and conduction of process for regularization of Novel Food Products and Ingredients. In the universe of innovations there are a diversity of vegetal species and isolated structures, of animal and vegetal origin or synthetic ones, that need to be approved by Anvisa for commercialization and consumption in Brazil.
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Regularization of Enzymes as Food
As part of new ingredients or supplements, enzymes have the need for a specific dossier with particular requirements. These are regulatory processes with mandatory function claims. Scientific knowledge and systematic review methodology are required.
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Regularization of Function Claims for Food and Beverage
The approval of function claims by Anvisa is necessary to provide legal assurance in the use of information. Conventional food products and beverages can gain recognition by the consumer with proof of their functionality in health and nutrition.
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Regularization of Additives and Processing Aids
Process instruction for requesting permission to use food additive or processing aid with approval and inclusion in a positive list. Also indicated for cases of regularization of novel food products whose production process or formulation does not comply with the Brazilian health legislation.
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In-Company Regulatory Knowledge
Customized service according to the company’s needs in order to add regulatory knowledge in decision-making within new business or marketing. Indicated for companies that are taking their first steps in innovation and do not have knowledge in the regulatory area or even when they have a regulatory team, but feel insecure when it comes to innovation.
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Elaboration of Systematic Review
Scientific evidence resulting from systematic review for the purpose of proving safety and efficacy is a trend in the regulatory area of innovations, both in the requests made to Anvisa and in the definition of quality requirements for new regulations. The Systematic Review is the secondary study obtained through systematic methods previously established in the identification and selection of primary studies, data extraction and analysis of results.
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Gap Analysis
Technical and documental evaluation to identify gaps due to lack of relevant information for formalizing matters within Anvisa’s competence and that need to be submitted to its evaluation. It allows better planning and decision making to follow in the formalization of evaluation requests by Anvisa.
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Regularization of Probiotics as Food
Probiotics as a food supplement have the need for a specific dossier with particular requirements. These are regulatory processes with mandatory function claim. Scientific knowledge and systematic review methodology are required.
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Cases
Pura Consultoria brings a trajectory of regulatory cases having Ana Luiza Sauerbronn as its protagonist.
Get to know some brands attended and their success stories.
Approval of high oleic microalgae oil as a novel ingredient for Solazyme Bunge.
Approval of function property claim for micronized golden flaxseed flour.
Regularization of specific infant diet therapy formulas containing ingredients that demand proof of safety and efficacy.
Project feasibility studies for the Mitsubishi Corporation.
Regularization of lactase as a food product in various forms of presentation.
Project feasibility studies and regulatory solutions.
Regularization of aqueous mint extract as a novel food product (capsulated product by Catalent).
Regularization of coenzyme Q10 with vitamins and minerals in capsules as a novel food product, the first approved by Anvisa.
Defense of safety proof for l-carnitine l-tartrate by Lonza (post-market).
FAQ
Questions and Answers
Yes. Only Brazilian companies can, but the company does not need to be a food manufacturer. Brazilian companies representing a manufacturer or company interested in placing a novel ingredient in the Brazilian market may request regularization of novel ingredients. The Brazilian representative must make its registration with Anvisa and have from the manufacturer all the information and documents regarding the ingredient which are required in the dossier for the regularization request.
At the end of 2021, Anvisa created a specific evaluation request for novel foods and ingredients approved by foreign health authorities. The application for the evaluation of a novel food or ingredient that has EFSA or FDA approval, for example, can be made as “Assessment by leveraging analysis performed by foreign regulatory authorities” (Avaliação por aproveitamento de análise realizada por autoridades regulatórias estrangeiras). This order goes into a review queue for “Simplified Evaluation of Novel Foods and Novel Ingredients”. The complete copy of the risk assessment document published by the foreign authority is from the dossier items for this request.
No. In addition to companies that develop processing aids for food processing and need to have them approved by Anvisa, companies that use a processing aid in their ingredient processing should also be attentive. The description of the process for obtaining the ingredient, from its source to its final form, is part of the dossier for regularization of a novel food product or ingredient. If a processing aid not permitted by Anvisa is used, the companies’ request for regularization of the ingredient may be denied, and then they are advised to regularize the used processing aid and return their request for evaluation of the novel ingredient.
No. In order to make the ‘no added sugar’ claim, it is required that the reference food product is normally made with added sugars. If the reference food product does not exist, that complementary nutritional information cannot be used, as the established requirement would not be met. Thus, in that case, the company cannot place claims of ‘no added sugar’ on the labeling of its product, even if the other requirements are met. Nor can the ‘no added sugar’ claim be used if the identity and quality standard of the reference food product prohibits the addition of sugar. Having regulatory knowledge at the design or new business stage can prevent frustration in marketing and in the business itself.
Enzyme supplement and probiotic supplement have mandatory registration with Anvisa. The other supplements need the ingredient used in the formulation to have been approved by Anvisa through the request for evaluation of a novel ingredient. Those already approved can be consulted at the link below.
Consult approved food ingredients: https://bit.ly/3anXcrg
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