The regulatory framework of plant-based food in Brazil

Renata Fialho de Oliveira

Veirano Advogados, São Paulo

renata.oliveira@veirano.com.br

Beatriz Goncalves Marconi

Veirano Advogados, São Paulo

beatriz.marconi@veirano.com.br

Luisa Allodi Rossit

Veirano Advogados, São Paulo

luisa.rossit@veirano.com.br

Introduction

According to the Brazilian Federal Constitution, the Unified Health System (SUS) has authority to ‘inspect and oversee food, including the control of its nutritional content, as well as beverages and water for human consumption’ (Art 200, VI). Within the SUS, authority for food oversight is incumbent to ANVISA.[1] Such authority, however, is not exclusive, since there are pieces of federal legislation which assign competence over foods and beverages to entities outside the Unified Health System, in particular to the Ministry of Agriculture, Livestock, and Supply (MAPA).[2]

The legal and infra-legal framework associated with ANVISA’s and MAPA’s scope of authority with respect to the entire food supply chain is quite scattered and complex. In general, agricultural authorities are responsible for the initial stages of food production, including inspecting and registering establishments that process animal-derived products (such as meat, milk, eggs), inspecting fresh vegetable products, and registering beverages (such as soft drinks, juices, and alcoholic beverages). Health surveillance agencies, on the other hand, are responsible for controlling food processing and distribution stages, including packed food, beverages, packaged water, food additives, and limits of organic contaminants. The responsibilities are shared between the agriculture and health authorities, divided according to the type of product.

As a result, in many cases, regulations issued by both authorities apply to certain products. For example, packaged meat must comply with regulations issued by MAPA regarding identity, quality and safety, as well as resolutions issued by ANVISA regarding packaged food and nutritional labelling. Furthermore, agricultural agencies are responsible for sanitary inspections in slaughter and meat processing establishments, while health agencies inspect the wholesale and retail establishments selling the meat.

The regulation of plant-based products

Brazil does not yet have specific regulations focused solely on them plant-based products. However, this does not prevent ANVISA and MAPA from inspecting and supervising this type of product, as the general framework already allows for such scrutiny.

In the past, ANVISA has taken the position that the claim of the lack of regulation and non-isonomic treatment regarding the inspection of plant-based products is inaccurate,[3] as existing rules should be sufficient to cover plant-based products. Nevertheless, the Agency and MAPA are working to identify and analyse possible regulatory problems, their causes, and consequences, while also mapping the affected agents.

Consequently, even if there is no legal definition of plant-based products, authorities recognise that they are ‘processed foods formulated based on ingredients of plant origin and that seek a similarity in appearance, texture, flavour, and other attributes to traditional products of animal origin, such as meat and meat products, fish, eggs, milk, and dairy products.’[4]

Applicable regulation

Despite the lack of specific regulation applicable to plant-based products there are some ANVISA and MAPA regulation initiatives, This is mainly due to innovations in the food market arising from new technologies, which have allowed the creation of new sources of protein (of plant origin, by cell culture or fermentation) and which has generated demands regarding the framework, labelling and procedure for the regularisation of these products.

In this sense, ANVISA held virtual workshops in October and December 2021, as the agency’s initial activities for the preparation of the Regulatory Impact Analysis on plant-based products. These workshops were to gather information on the likely effects of such products, in order to subsidise decision-making and the issuing of normative acts related to this issue.

Following the workshops, ANVISA concluded that the regulatory problem that best explained the difficulties pointed out related to its task is the irregularity of information in the plant-based food market. This problem is also related to the guarantee of consumers’ fundamental right to clear information on the different products and services, specifying their characteristics, composition and risks.

ANVISA identified that the use of legal designations applicable to products of animal origin in the labelling of plant-based products, as well as the similarity between packaging, the use of images related to food of animal origin, and also plant-based products being placed near animal origin products in shops can cause confusion to consumers regarding the real identity and composition of food. Additionally, the fact that plant-based products use generic, unsubstantiated and difficult to prove health and sustainability claims also offers high potential for consumer confusion or deception.

ANVISA identified insufficient, subjective and outdated regulations and guidelines on plant-based food. There is even a lack of harmonised international guidelines on these products. The Codex Alimentarius, for example, which is the main international regulatory reference in food, does not have guidelines which specifically address plant-based foods.

With the same objective as ANVISA, in 2021 the Secretariat of Agricultural Defence (SDA) of MAPA formalised a Public Call for Subsidies, through Ordinance No 327/2021, to allow wide dissemination and the participation of various stakeholders in discussion on the regulation of plant-based products. At the end of the public consultation, it was concluded that there is a lack of clarity and transparency for consumers regarding the sustainability, health benefits and nutritional equivalence of such products compared to animal protein.

Considering the analyses and conclusions of both institutions aimed at solving plant-based product-related issues, it seems necessary to issue normative acts to regulate them.

On 3 July 2023, the SDA submitted to public consultation for a period of 75 days, that is, until 16 September 2023. The consultation related to the Proposal for Ordinance SDA/MAPA No. 831/2023, which establishes minimum identity and quality requirements for equivalent plant-based products, as well as information on the visual identity and labelling rules for such products. However, the rules of the proposed Ordinance do not apply to ready-to-eat gastronomic preparations, even if formulated solely with raw materials of plant origin.

The proposed Ordinance establishes the minimum quality requirements for plant-based products and rules on marking and labelling, such as that the sales description of the product must contain the phrase ‘plant equivalent of’ followed by the sales description of the product of animal origin regulated by MAPA. This point is innovative, considering the discussions in other jurisdictions and the Bills of Law No 508/2022 and 10,556/2018.[5] These relate to it not being possible for plant-based products to be labelled with such words as ‘hamburger’, ‘sausage’, ‘milk’ or make any reference to products of animal origin. In addition, to avoid any confusion, the products should contain the following wording: ‘this product is not a substitute for its animal equivalent in nutritional or functional terms’.

Accordingly, to ensure fair competition, which is one of the concerns of the food sectors which manufacture products of animal origin, the Proposal established that the labelling of plant-based products may not use terms or images which may depreciate the product of animal origin or the animal production system.

If accepted, the Ordinance from SDA/MAPA will come into effect 180 calendar days after its publication.

Meanwhile, while legislative initiatives are not progressing, the private sector has been acting independently. For example, on 17 July 2023, ‘Base Planta’ – an association of plant-based product companies was created to help develop the sector. Base Planta’s initial objective is to demand that plant-based products have the same tax treatment as those of animal origin. In this way, in addition to having a more competitive participation in the market, plant-based products will be more accessible to consumers.

The importance of developing the legislation

The absence of regulation and irregularity of information in the plant-based food market can lead to such direct consequences as legal uncertainty, unfair competition and confusion or difficulty in understanding product characteristics. This is in addition to indirect, longer-term consequences such as judicialisation by consumers, damage to consumer health of, increasing consumer prices, discouragement of innovation and investment, etc.

Therefore, to avoid such consequences, regulation of the sector is essential as it will define minimum identity and quality requirements for products equivalent to animal products which are already regulated, but which are plant-based. The regulation will also allow information to be made available to consumers in an accurate and precise way and, consequently, ensure fair competition between food products.

Although innovations in plant-based products are still being developed and, therefore, the regulation currently under discussion is only initial and may be subject of future discussion, minimum parameters to be observed by the industry and clear standards differentiating both the animal and plant sectors, are necessary to protect consumers.

Conclusion

The same general food regulations which govern other food products also apply to plant-based items, and compliance with these rules is mandatory.

Nevertheless, with the significant growth of the plant-based market in Brazil and the recognition of specific needs of ensuring fair competition between these products and traditional animal-derived ones, regulatory authorities are actively working on establishing a comprehensive framework for the plant-based industry. It is expected that the necessary standards will be enacted in the near future.

With the introduction of this initial regulatory framework, the minimum identity and quality requirements for plant-based products will be clear to the entire sector, as will guidelines regarding the wording which can or cannot be used on the labelling of such products.

This evolving regulatory landscape aims to safeguard consumer interests, foster fair competition between the plant- and animal-derived food sectors, and ensure the proper functioning and growth of the plant-based industry in Brazil.