Regulatory and Safety Requirements for Food Cultures

Food cultures (micro-organisms) used directly in food production are considered food ingredients in the EU, a category of food ingredients with a very long history of use in a wide range of food products. FC, like other food ingredients, must comply with the requirements of the General Food Law, EU Regulation No. 178/2002 Article 14, which states: Food should not be placed on the market if it is unsafe and it is the responsibility of the food business operator to ensure food safety [3]. FC for food fermentation is not subject to EU rules on placing on the market, unless it is considered new to the EU market and its consumers. Since CF is used in food and beverages, the production of CF must comply with food safety standards. The implemented quality system combines Good Manufacturing Practices (GMP) for food and Critical Control Point Hazard Analysis (HACCP). The HACCP principles are based on: The 2020 version of the IFSP benchmarking requirements, published in February 2020, contains elements of food safety culture (“including, at a minimum: communication, training, employee feedback and performance measurement on food safety activities”). The FDA intends to work with GFSI and recognized standards to harmonize approaches to food safety culture. FDA Assistant Commissioner for Food Policy and Response Frank Yiannas has long identified food safety culture as a priority, tweeting about the new regulations, calling it an “important milestone.” We anticipate that the FDA`s focus on food safety culture will continue to grow as the agency works toward the goals of the new era of smarter food safety. As a result, the new EU regulation can be a useful resource for companies interested in assessing or improving their food safety culture, as it is the first authoritative source for defining key elements.

The Qualified Presumption List is EFSA`s fast-track tool used by EFSA`s Scientific Panels to assess products containing micro-organisms that need to be authorised before being placed on the market (e.g. feed additives, cell factories producing enzymes/additives/vitamins, novel micro-organisms, plant protection) [11]. It covers the entire risk assessment of microorganisms intended for use in humans, animals and the environment – “from farm to fork”. It harmonises the work of EFSA`s Panels, makes the approach more transparent, improves the consistency of assessments and makes better use of resources by focusing on organisms with the greatest risks or uncertainties. Microbial food cultures within the EU are regulated as an ingredient and their inclusion in food labelling is mandatory, but only if the culture is consumed in the final product. This is not the case for microbial food cultures used in certain technological processes such as fermentation or aging. The formation of ABs such as histamine, tyramine, putrescine, phenylethylamine and cadaverine is known to occur in various fermented foods such as fish, meat, wine and cheese [33]. A comprehensive review of the scientific literature and the risk of AB formation in fermented foods was carried out by EFSA`s Panel on Biological Hazards (BIOHAZ) and published in 2011 [34]. This article is a summary of a presentation by Christina Christensen, Global Food Cultures & Enzyms Regulatory Affairs Partner, at the Summer School in Food Regulatory Affairs 2019 at the University of Copenhagen. It is important to remember that foods are rich in microorganisms that are naturally present in and on foods.

Spontaneous fermentation was the beginning of fermented foods and is still an important contributor to nutrition. Even in ready-to-eat foods that are not considered fermented foods, fermentation hidden by native flora takes place during storage [5]. The International Dairy Federation and the European Food and Feed Crops Association coordinated a project on the safety of microbial food cultures, identifying species that would not be classified as new and having historical references for safe use in certain foods as a reference for food companies. The list contains evidence and documentation regarding the use of certain species in the EU that are traditionally used, as well as species traditionally used outside the EU. Leadership in the production of safe food and participation of all employees in food safety practices; Leslie Krasny is the President of Krasny Law Firm, which specializes in food law matters. Previously, she was Managing Partner of Keller and Heckman LLP`s San Francisco office and a member of Food Processing`s Editorial Advisory Board. All species used in food must have historical evidence of their use in food and safety. For example, penicillium, which may be on the QPS list, is used in some products as a traditional ingredient to make Camembert, but when penicillium contaminates grapes, it can produce a toxin that can be dangerous when consumed. Therefore, historical evidence is needed to prove that the food and species have been used safely in the food in which they are used as an ingredient. In the Russia-Kazakhstan-Belarus Customs Union, CF is considered food, and the Technical Regulation “On the Safety of Milk and Milk Products” (TR TS 033/2013) [56] is the main regulation governing standards and requirements for milk and dairy products, including the use of CF. Dairy producers must ensure the safety of an industrial plant and its manufacturing processes, as well as compliance with the requirements of the document. In the rest of the world, the way FC security is managed is sometimes very different.

For example, the US GRAS status is often not well understood in the EU and is confusing, especially when considering the purpose of the QPS list or IDF inventory. Another example is that, in several Asian countries, intentionally added industrial BCs are not considered food ingredients but food additives and therefore require registration, including safety assessment, before being placed on the market. In contrast, in the same countries, there is no regulation of CF used in food, which is considered traditional food production in each country. There are no requirements in UK food law that relate directly to the culture of food safety. However, the Food Standards Agency (FSA) developed a food safety culture diagnostic toolkit for its inspectors in 2012.