An Analysis of the Regulatory Framework Applicable to Products Obtained from Mushroom and Mycelium
84 Pages Posted: 18 Nov 2021
Date Written: November 3, 2021
This report concerns food law provisions applicable to mushroom and mycelium products (MMP) produced or marketed in the EU. The objective of the report is to map the regulatory environment governing mushrooms and mycelium products, highlighting gaps in EU law and pinpointing to areas of further research. Our findings show that the sector is still in the developing phase, and the application of the regulatory framework to MMP includes several legal uncertainties. The classification of MMP as foods or medicines depends on the intended use. Innovative MMP could be considered medicinal products. This classification excludes food law provisions. Food business operators working with borderline (food/medicine) products should consider their claims and accompanying materials. Mushrooms and mycelia, as well as products derived from them, can be subject to the rules of the common agricultural policy. The classification of products derived from mushrooms and mycelium as novel foods is challenging. Despite a long history of consumption of some fruiting bodies, products obtained from mycelium of the same species may be subject to Regulation (EU) 2015/2283 on novel foods. This is equally the case of species not commonly consumed. The Novel Food Regulation places significant regulatory requirements on applicants applying for novel food authorisations. This entails the proof of safety via solid and robust scientific evidence, for example numerous toxicity studies or animal models or human data. In the MMP market segment, the authorisation of biomass fermentation with the use of various fungi mycelia is particularly relevant. The pioneering phase of the MMP sector mainly relies on start-ups often with little capitalisation. High regulatory requirements set by the Novel Food Regulation can seriously hamper innovation in the sector. Food business operators already opt for solutions which escape the Novel Food Regulation, thus placing regulatory requirements above other business or societal considerations in their business models. Moreover, the use of food and agricultural by-products as substrates for fermentation could increase the sustainability of the industry but it is limited by food safety provisions. The use of food additives in the MMP does not raise regulatory concerns. The use of MMP to produce food additives might open more opportunities for the future of this sector. Companies must also pay attention to a correct labelling of MMP. The first issue to consider is the wording to be used in the name of the food and the list of ingredients of processed products to indicate mushrooms, mycelia as well as products derived from them (e.g. protein powders). Descriptive names are probably the most suitable to not mislead consumers. In the second place, novel foods may require mandatory information that are specified in novel food authorizations. As for voluntary labelling information, nutrition and health claims can be added, if they do not mislead consumers, and specific conditions are met. Organic certification is provided for in EU law. Food business operators producing, or the marketing of organic products may acquire respective certification by accredited bodies. Finally, MMP are commonly classified as “vegan” or “vegetarian” and bear sustainability claims. In the absence of specific EU or national provisions, private schemes can be used to provide costumers and consumers with indications of which products are vegan or vegetarian. The same is valid for sustainability indications: private labels are the most used solutions. The regulatory landscape applicable to MMP presents some room for improvement that could be addressed by the legislator. Food business operators are uncertain about the novel food status of their products and using food and agricultural by-products as a suitable substrate for the growth of mushrooms and mycelia. Legal requirements applicable to end products, in particular their labelling, might also bring legal uncertainty. Our research represents an instrument to navigate the regulatory framework applicable to MMP in the food sector. However, every situation needs to be assessed on a case-by-case basis. Following the report’s publication, we expect to stir academic and policy discussion on the regulation of MMP.
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