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EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
In view of Regulation (EU) 2015/2283 of the European Parliament and of the Council, of November 25, 2015, regarding novel foods, which modifies Regulation (EU) no. 1169/2011 of the European Parliament and of the Council and repeals Regulation (EC) no. 258/97 of the European Parliament and of the Council and Regulation (CE) n. 1852/2001 of the Commission (1), including in particular on article 12,
Considering the following:
- (1) Regulation (EU) 2015/2283 provides that only new foodstuffs authorized and included in the Union list may be marketed in the Union.
- (2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) established a Union list of authorized novel foods.
- (3) The list of the Unit that appeared in the annex to the Implementing Regulation (EU) 2017/2470 includes baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation as an authorized novel food.
- (4) Through Commission Execution Decision 2014/396/EU (3), in accordance with Regulation (EC) no. 258/97 of the European Parliament and of the Council (4) and following the opinion of the European Food Safety Authority (5), the trade of baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation as a new food ingredient was authorized to be used in the production of leavened bread, rolls and fine bakery products, such as in food supplements, as defined in Directive 2002/46/EC of the European Parliament and of the Council (6) .
- (5) Commission Implementing Regulation (EU) 2018/1018 (7) authorization, in accordance with Regulation (EU) 2015/2283, an extension of the use and levels of use of baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation. In particular, the use of UV-treated baker's yeast (Saccharomyces cerevisiae) is extended to additional food categories, namely fresh or dried, packaged, home baking yeast and food supplements, with no indication of maximum levels permitted, and the vitamin D2 content of the Leavedura concentrate was modified.
- (6) On May 15, 2020, the company Lallemand Bio-Ingredients Division (the applicant) submitted to the Commission, pursuant to Article 10(1) of Regulation (EU) 2015/2283, an application for an extension of the use as novel food of baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation. The applicant requested that the use of baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation be extended with various additional foods intended for the general population. The applicant requested the result that the novel food could be used in foods intended for infants and young children.
- (7) Pursuant to Article 10(3) of Regulation (EU) 2015/2283, on 20 July 2020 the Commission consulted the European Food Safety Authority (the Authority) and asked it to issue a scientific opinion Previous evaluation of the safety of the extension of the use as novel food of baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation.
- (8) On 28 April 2021, the Authority adopted its scientific opinion Safety of extended uses of UV-treated baker's yeast as a Novel Food in accordance with Regulation (EU) 2015/2283 (8) . Said scientific opinion meets the requirements established in article 11 of Regulation (EU) 2015/2283.
- (9) In its own words, the Authority concludes that UV-treated baker's yeast (Saccharomyces cerevisiae) is safe under the proposed conditions of use. Therefore, the Authority's opinion provides the necessary grounds to establish that baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation, under these specific conditions of use, meets the requirements for placing on the market in accordance with Article 12(1), of Regulation (EU) 2015/2283.
- (10) According to Commission Directive 2006/125/EC (9), vitamin D must not be added to baby food. Due to the fact that it may have contained vitamin D2, the use of baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation should not be authorized in baby foods. In addition, in accordance with Regulation (EC) no. 1925/2006 of the European Parliament and of the Council (10), vitamins cannot be added to unprocessed foods. Therefore, UV-treated baker's yeast (Saccharomyces cerevisiae) should not be licensed for its proposed use on amphibians, reptiles, snails, insects, algae, or prokaryotes, nor on fungi, mosses, or lichens.
- (11) According to the opinion of the Authority, baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation should be inactivated for use in infant formula and follow-on formula, processed cereal-based foods and foods for special medical purposes, such as as defined in Regulation (EU) n. 609/2013 of the European Parliament and of the Council (11); for this reason, it is advisable to modify the specifications of the novel food.
- (12) The information provided in the application and in the opinion of the Authority sufficient grounds to establish that the changes in the specifications and the conditions of use of the novel food meet the requirements for its marketing in accordance with Article 12 of the Regulation (EU ) 2015/2283.
- (13) Process, therefore, amend the annex to Implementing Regulation (EU) 2017/2470 accordingly.
- (14) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THESE REGULATIONS:
Article 1
1. In the list of the Authorized Novel Foods Unit in the annex to Implementing Regulation (EU) 2017/2470, the entry for baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation is amended in accordance with the annex to this Regulation.
2. In the list of Unions referred to in paragraph 1, the entry shall include the conditions of use and the labeling requirements set out in the annex.
LE0000611806_20220203
Article 2
This Regulation will enter into force twenty days after its publication in the Official Journal of the European Union.
This Regulation shall be binding in all its elements and directly applicable in each Member State.
Done in Brussels, on February 11, 2022.
For the Commission
the president
Ursula VON DER LEYEN
ANNEXED
The Annex of the Execution Regulation (EU) 2017/2470 is modified as follows:
- 1) The entry in Table 1 (Authorized Novel Foods) for UV-treated Baker's Yeast (Saccharomyces cerevisiae) is replaced by the following: Authorized Novel Food Conditions under which the Novel Baker's Food (Saccharomyces cerevisiae) may be used treated with ultraviolet radiation Specific food category Maximum content of vitamin D2 Yeast-leavened bread rolls5 μg/100 gFine yeast-leavened bakery products5 μg/100 gFood supplements as defined in Directive 2002/46/EC
45 μg/100 g, in case of fresh yeast
200 μg/100 g, in case of yeast
1.-The name of the new food on the labeling of food products will be "yeast with vitamin D" or "yeast with vitamin D2".
2.-In the labeling of the new food it is indicated that the food product is intended only to be cooked and that it should not be consumed raw.
3.- The labeling of the new food will vary the instructions for use intended for the final consumer, so that the maximum concentration of 5 μg/100 g of vitamin D2 is superimposed on the final homemade product.
dishes, including ready-to-eat dishes (except soups and salads) 3 μg/100 g /100 g ) n 609/2013 In accordance with Regulation (EU) n. 609/2013 Foods made from cereals, as defined in Regulation (EU) no. 609/2013 In accordance with Regulation (EU) no. 609/2013 Processed fruit-based products 1,5 μg/100g Processed vegetables 2 μg/100g Bread and similar products 5 μg/100g Breakfast cereals 4 μg/100g Pasta, dough and similar products 5 μg/100g Other cereal-based products 3 μg/100g, condiments, ingredients for sauces sauces or dessert toppings10 μg/100 gProtein products10 μg/100 gCheese2 μg/100 gDairy desserts and similar products2 μg/100 gFermented milk or fermented cream1,5 μg/100 gDairy dairy products and their concentrate /100 gDairy products, whey and cream0,5 μg/100 gMeat and dairy substitutes2,5 μg/100 gSubstitutes of the complete diet for weight control, as defined in Regulation (EU) n. 609/20135 μg/100 gMeal replacements for weight control5 μg/100 gFoods for special medical purposes, as defined in Regulation (EU) n. 609/2013 Meets the particular nutritional requirements of people as intended for products
- 2) The entry in Table 2 relating to Baker's yeast (Saccharomyces cerevisiae) treated with ultraviolet radiation is constituted by the following text:
Description/definition:
Baker's yeast (Saccharomyces cerevisiae) is treated with ultraviolet radiation to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). The content of vitamin D2 in the yeast concentrate varies between 800.000 and 3.500.000 IU of vitamin D/100 g (200-875 μg/g).
The yeast must be inactivated for use in infant formulas and follow-on formulas, foods made from cereals and foods for special medical purposes, as defined in Regulation (EU) n. 609/2013; for use in other foods, the yeast must be inactivated or not.
The yeast concentrate is mixed with ordinary baker's yeast, so as not to exceed the maximum level in packaged fresh or dry baker's yeast for home baking.
Tan-colored granules with good fluidity.
Vitamin D2:
Denominación química: (5Z,7E,22E)-(3S),-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
Synonym: ergocalciferol
CAS No.: 50-14-6
Molecular weight: 396,65g/mol
Microbiological criteria for yeast concentrate:
Coliforms: ≤ 103/g
Escherichia coli: ≤ 10/g
Salmonella: Absence in 25g
