## 5 Commercialization, Regulation, and Technological Innovation
### Regulatory Issues and Standards  
Regulatory considerations are an important aspect to consider in the development and commercialization of functional food ingredients and nutraceuticals derived from coffee by-products [229]. The regulatory landscape for these products varies by region, and it is vital to comply with the relevant regulations in order to ensure market success and consumer safety [230,231]. In Europe, functional food ingredients and nutraceuticals are regulated under the European Union's novel food regulation. This regulation requires a safety assessment and authorization for any novel food or food ingredient that has not been consumed significantly in the EU prior to 1997. The authorization process can be lengthy and expensive, but it is necessary to ensure the safety and efficacy of these products [232]. In Asia, regulations for functional food ingredients and nutraceuticals vary by country. In Japan, for example, functional food ingredients are regulated under the Foods for Specified Health Uses (FOSHU) system, which requires a scientific review of the health claims made by these products [233]. In China, they are regulated under the Food Safety Law, which requires safety assessments and labeling requirements [234]. In Canada, functional food ingredients and nutraceuticals are classified as either foods or natural health products (NHPs) based on their intended use and claims. Functional food ingredients that make health claims are categorized as NHPs and require authorization from Health Canada before they can be legally marketed. The authorization process for NHPs involves a comprehensive review of safety, efficacy, and quality evidence submitted by manufacturers [235]. In the United States, these ingredients are regulated by the Food and Drug Administration (FDA) and are subject to safety and efficacy requirements. The FDA requires that these products be safe, effective, and labeled appropriately [236].  
Including coffee by-products in the European food sector and ensuring human health protection is essential to know if these are considered novel foods. The European specific legislation about novel food is contained in regulation (EU) No. 2015/2283 and (EU) No. 2017/2468 and No. 2017/2469 [232,237,238]. Dried coffee berries (husk or cascara) are considered novel. The term novel food included in this regulation is referred as \"a food is considered to be novel if it has not been regularly consumed by humans in the EU before 15 May 1997, when the first novel food Regulation came into force\" [239]. Moreover, there is another pathway for the approval of novel foods: a notification for a traditional food from a third country. The implementation of the dried cherry pulp and its infusion, specified in the regulation from the European Commission as traditional foods, has been recently published [240]. For the silverskin, a consultation request is currently determining its novel food status. The food products must be evaluated for safety and toxicological aspects during the approval procedure. Limitations on the utilization of coffee by-products are associated with their caffeine and acrylamide content (obtained after the roasting process). The caffeine content in foods formulated with coffee by-products should be below the European Food Safety Authority (EFSA) safety level for daily caffeine consumption of 400 mg for the general population and 200 mg for lactating women. The acrylamide limit established by the EFSA for coffee and instant coffee is 450 and 900 mg/kg, respectively [241]. The absence of pesticides and mycotoxins is a required determination that must also be carried out.  
In conclusion, navigating the regulatory landscape for functional food ingredients and nutraceuticals derived from coffee by-products can be complex, but it is essential to ensure compliance and safety. Companies need to work closely with regulatory agencies in their respective regions to ensure compliance and to stay up to date with evolving regulations.