Functional raw materials and third-country traditional foods entering the EU market need to pass EU approval and be authorized as novel foods to enter the EU market. For example, as early as the beginning of 2020, the chestnuts and monk fruit exported to Italy by China were "refused entry notice" because they were "unauthorized new foods". Therefore, the declaration of new food has also become a threshold for many manufacturers to enter the EU market.
The new food of the European Union, also known as the New Resource Food (Novel Food), mainly includes:
Foods and food ingredients containing GMOs;
Foods and food ingredients produced by GMOs;
The main structure is new or purposefully modified food and food ingredients;
food or food ingredients containing or isolated from microorganisms, fungi or algae;
Foods or ingredients that contain or are isolated from traditional animals or plants with a history of safe consumption.
It is stipulated that traditional foods that originally belonged to the consumption of specific ethnic groups outside Europe or new technologies and newly made foods currently circulating in the market can be called non-traditional/new resource foods (Non-traditional/Novel Food). The assessment shall be carried out by the member state's assessment body after an application to the competent authority of the Member State in accordance with the new EU Resource Food Regulation and the submission of safety assessment data before listing. It can only be listed in EU member states if it is assessed and approved by Member States.
Recently, three more have entered the EU new resource food list, marking that it can be officially sold in the EU market, namely Jianming's dried naked algae, nuliv Science's Sanqi and astragalus extract complex raw materials in the United States, and Skotan's selenium-rich yeast (lipolytic Jesse yeast) biomass in Skotan, Poland.
Dried naked algae
On December 2, 2020, EFSA issued Regulation (EU) No. 2020/1820, which authorizes BetaViaTM Complet as a new EU food as a new EU food as a new eu resource food in accordance with EU Parliament and Council Regulation (EU) 2015/2283.
On December 20, 2018, Jianming Company submitted an application to the European Commission pursuant to Article 10(1) of (EU) 2015/2283 for the use of dried whole cell ophthalmic worm algae (naked algae) as a new resource food. On 13 May 2019, pursuant to Article 10(3) of (EU) 2015/2283, the EFSA assessed the safety of this raw material as a new resource food ingredient and provided relevant scientific advice. On March 25, 2020, EFSA issued a safety opinion on the raw material as a new resource food, and the raw material is safe in terms of the proposed use and dosage.
BetaViaTM Complet, a dry naked algae raw material launched by Kemin, is a nutrient-rich naked algae ferment, containing more than 50% β-1,3-dextran, and rich in protein, as well as a variety of vitamins, minerals and other nutrients. Research conducted by Kemin has shown that it has a triple protection against immune health, can support immune health in all aspects, and is made from proprietary algae strains through a patented process.
Image source: Kemin official website
According to The revised European Commission Regulation (EU) 2017/2470, the parameters for raw materials for dry naked algae are specified as follows:
Naked algae is also a new food raw material in China (Announcement No. 10 of 2013), but the announcement only states that "the scope of use does not include infant food", and there is no corresponding product specifications, food types, dosage and other instructions.
Panax notoginseng & Astragalus extract compound raw material
On December 2, 2020, the European Food Safety Authority (EFSA) issued Regulation (EU) No. 2020/1821, which authorizes AstraGin® as a new EU food (Novel Food) to be officially placed on the EU market as a new EU food in accordance with Eu Parliament and Council Regulation (EU) 2015/2283.
On June 7, 2018, NuLiv Science submitted an application to the European Commission pursuant to Article 10(1) of (EU) 2015/2283 for AstraGin® as a new resource food. In accordance with Article 10(3) of (EU) 2015/2283, the EFSA evaluates the ingredients of this raw material as a new resource food ingredient and provides relevant scientific advice.
On May 24, 2020, the EFSA Research Assessment Panel issued an opinion on the safety of the release of this ingredient as a new resource food, stating that a daily intake of 0.5 milligrams (mg/kg bw) of AstraGin per kilogram of body weight is safe, which is equivalent to a maximum daily intake of 35 mg for adults (excluding pregnant women).
AstraGin is a standardized plant extract extracted from the roots of Panax notoginseng and Astragalus with a minimum total saponin content of 1.5%, astragalus methylphenidine content of 0.01%, and ginsenoside Rb1 content of as low as 0.1%. At the same time, AstraGin® is a patented natural compound with multiple patents in the United States, Chinese mainland, Taiwan and other places, which can promote a healthy intestinal environment and reduce inflammation.
Image source: Photo Network
According to Regulation (EU) 2017/2470 of the revised Commission, the parameters for the raw materials of Panax notoginseng and astragalus complexes are as follows:
At present, in China, panax notoginseng flowers, three seven stems and leaves are also ordinary food, as a local specialty food management, specific can refer to the "DBS53/024-2017 food safety local standards dry three seven stems and leaves", "DBS53/ 023-2017 food safety local standards dry three seven flowers".
On January 6, 2020, the Health Commission issued the "Notice on the Pilot Work on the Substance Management pilot work of 9 substances such as party ginseng that are both food and Chinese medicinal materials in accordance with tradition", according to the provisions of the Food Safety Law, after safety assessment and wide public solicitation of opinions, the party ginseng, cistanche, dendrobium officinale, American ginseng, astragalus, Ganoderma lucidum, dogwood, tianma, Eucommia leaves and other nine substances to carry out the pilot work of production and operation of substances that are both food and Chinese medicinal materials (hereinafter referred to as food and medicine substances) in accordance with tradition. After the pilot is passed, astragalus can be included in the medicinal and food homology.
Selenium-rich yeast (lipolytic yelleria saccharomyces cerevisiae) biomass
On December 4, 2020, the European Food Safety Authority (EFSA) issued Regulation (EU) No. 2020/1993, which authorizes selenium-rich yeast (Yarrowia lipolytica) biomass to be officially launched into the EU market as a new eu resource food (Novel Food) in accordance with Eu Parliament and Council Regulation (EU) 2015/2283.
On 21 September 2018, the Polish company Skotan submitted an application to the European Commission pursuant to Article 10(1) of (EU) 2015/2283 for the use of selenium-rich yeast Yarrowia lipolytica biomass as a new resource food. On 18 February 2019, in accordance with Article 10(3) of Regulation (EU) 2015/2283, the EFSA assessed its safety as a new resource food and provided scientific advice.
On December 18, 2019, EFSA issued a safety opinion on the raw material. There are no safety issues with the selenium-rich yeast Yarouia lipolytica biomass at the proposed level of use, and the selenium provided by this feedstock is also considered to be as safe as selenium provided by other dietary sources. At the same time, the applicable population of this raw material is over four years old, and the intake dose is 50mg to 800mg per day.
Yarrowia lipolytica is isolated from the environment (i.e., soil and water) and high-fat, high-protein foods (such as cooked meats and cheeses, etc.), the main components are protein (about 45-55 g/100 g), dietary fiber (about 25 g/100 g), which is mainly composed of β-dextran, which is the complex polysaccharide that makes up the cell wall of yeast and grain. The fat content in yeast is about 7 to 10g/100g, mainly monounsaturated fatty acids and polyunsaturated fatty acids.
According to Regulation (EU) 2017/2470 of the Revised European Commission, the parameters for selenium-rich yeast (lipolytic yeast) biomass are specified as follows:
Selenium-rich yeast in China is a food nutrition enhancer, the Health Commission announced in 2016 No. 9 that selenium-rich yeast expanded the scope of use, can be used to modulate milk powder and rice noodle products. The implementation standard can refer to the "GB 1903.21-2016 National Standard for Food Safety Food Nutrition Enhancer Selenium-rich Yeast".
In November 2015, the European Union approved new regulations on new food products in order to improve the conditions to speed up the entry of new and innovative foods into the market while ensuring a high level of food safety, providing more food options for European consumers and creating a more favorable environment for the European agri-food industry. Major changes to the new rules include improving the efficiency of the ratification process and removing unnecessary barriers to trade. New food labels should not only meet the requirements of general labeling, but also include warning signs that are not recommended for certain vulnerable groups.
In 2018 the European Commission published Implementing Regulation (EU) 2017/2470 establishing the EU List of New Food Products in accordance with EU Regulation (EU) 2015/2283 of the European Parliament and the Council on New Food Products. The list includes 127 new resource foods, and in the past two years, a variety of raw materials have entered the list, and as of December 2020, the EU new resource food list has reached more than 150.
Source of the article: This article is based on the official website of EFSA