New opportunities and challenges for novel protein authorisations

New opportunities and challenges for novel protein authorisations

In today’s world, animal-based products are eagerly consumed all around the globe. Every year, the global meat consumption keeps increasing, which is a trend that is nowadays, to a great degree, mainly observed in developing and emerging economies. Animal protein production contributes to severe environmental footprints and increased long-term consumption of meat products can potentially lead to additional risks for human health. Moreover, animal welfare issues have raised over the past years. These specific concerns have led to a growing industry and consumer interest in sustainable alternatives protein sources to conventional animal products.

Alternative protein sources are generally understood as foods with a high protein content that can be served as an alternative to animal protein foods, such as meat, fish, dairy, and eggs. Considering the novelty of alternative protein, several regulatory unclarities might be a hurdle to bring these products on the market.

Alternative proteins have the potential to fall under the legal definition of a novel food in the European Union. Novel foods are subject to Regulation (EU) 2015/2283. All novel foods or food ingredients require a safety assessment and a pre-market authorisation before they are included in the Union list and can be sold in the EU.

Regulatory challenges related to different types of alternative protein

Plant proteins can be used to mimic meat, seafood, and dairy products, and are often referred to as ‘plant-based meat’. If the protein from conventional plant sources is extracted in a way that may alter the nutritional content and/or novel methods are used in the production process of plant-based protein, then the final product would be considered a novel food and requires an authorisation before marketing in the EU.

Single-cell protein (SCP) are alternative proteins that are produced by the cultivation of single-celled organisms. In the EU, only micro-organisms with a long history of safe use would not require a novel food authorisation. The advantage of using microbes as a protein source is the great variety of substrates that can be used to grow them, including side streams and waste from the agri-food industry, which makes them a sustainable source of protein. Moreover, several micro-organisms use substrates like CO2 or methane, providing a high efficiency for protein production.

Insect protein provides a sustainable alternative source of protein as they require less resources in comparison to traditional animal protein. Before Regulation (EU) 2015/2283 became applicable in the EU in the beginning of 2018, some Member States have allowed insects as food and created national rules. When Regulation (EU) 2015/2283 became applicable in 2018, whole insects, insect parts, insect flour, and insect extracts became subject to that Regulation and need an authorisation according to that regulation to be marketed in the EU.

Cell-based meat or cultured meat refers to meat developed from animal cell culture. The process to produce cultured meat involves growing the selected cell lines, or stem cells, in a bioreactor. The cells are grown in a suitable growth medium and may subsequently be assembled on a scaffold to produce products resembling meat muscle. In the EU, cultured animal tissue is considered a novel food, due to the novel production process. However, in the case specific techniques in the production process of the cultured meat are used that would be considered techniques resulting in a genetic modification in the EU, then the product would fall under the scope of Regulation (EC) 1829/2003 on genetically modified food and feed, and would be regulated as such.

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If you are interested in learning more on this topic, we invite you to join Pen & Tec’s round table discussion on “New opportunities and challenges for novel protein authorisations” hosted by Pen & Tec’s Senior Regulatory Affairs Manager and novel food expert Ing. Justyna Pałasińska at Future Food-Tech Seminar, an event dedicated to alternative protein taking place in New York on June 21-22. The round table will be taking place on June 22 at 10.15 AM. Are you interested in bringing your alternative protein product into the EU? You might want to check our regulatory guidelines on “Regulatory approval for alternative proteins in the EU – steps to success” – its free!

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