Overview of Regulatory Updates in EU | April 2022

The recap of EU regulatory updates consists of three parts:

EU legal acts, where readers can find the major regulatory updates in the EU;
Consultation progress on novel food status, which summarized the progress for the review of novel foods;
and EFSA journal. EFSA mainly gives scientific opinions on the requests from the European Commission, which is also valuable for stakeholders to know.

Click the title of each sector for more details.

EU Legal Acts

In April 2022, quite a few regulatory updates happened in EU, including 5 regulations related to the authorization of substances, 5 concerning the amendment to maximum residue levels, specification and condition of the use of substances, 2 related to epidemiological situation, 2 regarding monitoring plan and 1 related to geographical indications. These regulations shall enter into force on the twentieth day following its publication date in the Official Journal of the European Union, unless otherwise specified.

1. Authorisation of substances

Authorising the placing on the market of mung bean (Vigna radiata) protein as a novel food and amending Commission Implementing Regulation (EU) 2017/2470 (Release date: April 25)

During 5 years from the effective date of this Regulation, only the initial applicant (Company: Eat Just, Inc.) is authorised to place this novel food on the market within the Union, unless a subsequent applicant obtains authorisation for that novel food or is with the agreement of the applicant. This novel food can be used in protein products, etc. Use condition and specification for this novel food is specified in this regulation.

Authorisation of substances as a feed additive

Release date	Substance	Species or category of animal	Additive category and functional group	Notes
April 5	A preparation of lemon extract	All animal species	Belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”	Transitional measures and other requirements can be found in corresponding regulations.
April 21	A preparation of the leaves extract of Melissa officinalis L.	All animal species
April 21	Bitter orange extract	Chickens for fattening, piglets, dairy cow, calves, cats, dogs, etc.
April 21	Butylated hydroxyanisole	Cats	Belonging to the additive category “technological additives” and to the functional group “antioxidants”

2. Amendment to maximum residue levels, specification and condition of the use of substances

Amending maximum residue levels of flutianil in or on certain products (Release date: April 8)

Maximum residue levels of flutianil in fruits, vegetables, milk, etc., are updated.

Amending maximum levels of mercury in fish and salt (Release date: April 13)

Maximum levels of mercury in fish, food supplement, salt, etc., are revised. Foods impacted by this regulation can remain on the market until the date of minimum durability or use-by-date.

Amending specifications for sodium diacetate (E 262(ii)) (Release date: April 21)

The specification for sodium diacetate in the Annex to Regulation (EU) No 231/2012 is changed from containing “39 to 41% of free acetic acid and 58 to 60% of sodium acetate” to “39 to 43% of free acetic acid and 57 to 60% of sodium acetate”.

Amending the specifications of the novel food trans-resveratrol (from microbial source) (Release date: April 25)

An applicant requested to change the specifications of trans-resveratrol from a microbial source, which is to remove the requirement that “100% of the particles of the novel food produced by S. cerevisiae should be of a size less than 62,23 micrometres (< 62,23μm)”. After evaluation, the Commission amended the Annex to Implementing Regulation (EU) 2017/2470 accordingly.

Amending the conditions of use of the novel food galacto-oligosaccharide (Release date: April 29)

An applicant requested to extend the use of galacto-oligosaccharide to dairy confectionary, cheese and processed cheese, as well as butter and spreads intended for the general population. After evaluation, European Food Safety Authority concluded that the novel food that is composed of ≥ 57% galacto-oligosaccharide dry matter, lactose and related saccharides, is safe under the proposed extension of use in dairy confectionary, cheese and processed cheese, as well as butter and spreads, and therefore it is appropriate to amend the conditions of use of galacto-oligosaccharide. Hence, the Annex to Implementing Regulation (EU) 2017/2470 is amended accordingly.

3. Regulatory changes related to epidemiological situation

Amending special control measures for African swine fever (Release date: April 11)

Considering the urgency of the epidemiological situation in the Union as regards the spread of African swine fever, EU revised the Annex I “Restricted zones” to Implementing Regulation (EU) 2021/605, which took effect on the promulgation date.

Amending the entries of fresh meat of poultry from Canada, the United Kingdom and the United States (Release date: April 27)

Taking into account the current highly pathogenic avian influenza epidemic in Canada, the United Kingdom and the United States and the serious risk of its introduction into the EU, the amendments to Implementing Regulation (EU) 2021/404 shall take effect on the promulgation date.

4. Monitoring plan

Commission recommendation on monitoring the presence of Alternaria toxins in food (Release date: April 6)

It is said member States in close cooperation with the food business operators should monitor the Alternaria toxins alternariol, alternariol monomethyl ether and tenuazonic acid in food, in particular in processed tomato products, paprika powder, sesame seeds, sunflower seeds, sunflower oil, tree nuts, dried figs and cereal-based foods for infants and young children. For the determination of alternariol and alternariol monomethyl ether, the limit of quantification (LOQ) should not be higher than 2 μg/kg in cereal-based foods for infants and young children and 4 μg/kg in other foods. For the determination of tenuazonic acid, the LOQ should not be higher than 20 μg/kg in all foods.

Commission recommendation on monitoring the presence of glycoalkaloids in potatoes and potato-derived products (Release date: April 7)

It is said that member States with active involvement of food business operators should monitor glycoalkaloids α-solanine and α-chaconine in potatoes and potato products. Member States, with active involvement of food business operators, should carry out investigations to identify the factors leading to levels above the indicative level of 100 mg/kg as sum of α-solanine and α-chaconine in potatoes and processed potato products.

5. Others

Establishing a list of geographical indications [Commission Implementing Decision (EU) 2022/540 and 2022/541] (Release date: April 5)

The following geographical indications are to be filed as applications for international registration:

Country	Item
Bulgaria	Стралджанска Мускатова ракия/Мускатова ракия от Стралджа/Straldjanska Muscatova rakya/ Muscatova rakya from Straldja (GI) Ямболска гроздова ракия/Гроздова ракия от Ямбол/Yambolska grozdova rakya/ Grozdova rakya ot Yambol (GI)
Greece	Τσίπουρο Τυρνάβου/Tsipouro of Tyrnavos (GI) Σαντορίνη (protected designation of origin—PDO)
France	Val de Loire (protected geographical indications—PGI) Pays d’Oc (PGI)
Italy	Bolgheri (PDO)

Consultation Progress on Novel Food Status

EFSA Journal

European Food Safety Authority (EFSA) gave scientific opinions on the requests from the European Commission in its journal released in April. The below listed the major content.

Topic	Notes
1. Front-of-pack nutrition labeling
Scientific advice related to nutrient profiling for the development of harmonized mandatory front-of-pack nutrition labelling and the setting of nutrient profiles	The Panel concludes that dietary intakes of saturated fatty acids (SFA), sodium and added/free sugars are above, and intakes of dietary fibre and potassium below, the current dietary recommendations in a majority of European populations. The items mentioned above could be included in nutrient profiling models. Energy could be included. In food group/category-based nutrient profiling models, total fat could replace energy in most food groups owing to its high-energy density, while the energy density of food groups with low or no fat content may be well accounted for by the inclusion of (added/free) sugars. Some nutrients could be included in nutrient profiling models.
2. Novel food
Safety of pea and rice protein fermented by Shiitake (Lentinula edodes) mycelia as a novel food	The Panel considers that the novel food is safe at the proposed conditions of use.
Safety of Beta-lactoglobulin as a novel food
3. Food enzyme
Safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase from genetically modified Aspergillus niger strain NZYM-NM	Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
Safety evaluation of the food enzyme α-glucosidase from Aspergillus niger strain AE-TGU
Safety evaluation of the food enzyme endo-polygalacturonase from genetically modified Aspergillus luchuensis strain FLYSC
4. Feed additives
Safety and efficacy of a feed additive consisting of carrageenan for pets and other non-food-producing animals	The FEEDAP Panel concludes that the additive is efficacious as a gelling agent and thickener, and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder and emulsifier.
Safety and efficacy of a feed additive consisting of agar for pets and non-food-producing animals	The FEEDAP Panel concludes that the additive is efficacious as a gelling agent and thickener, and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder.
Safety and efficacy of the feed additive consisting of ammonium chloride (Ammonium Chloride AF) for all ruminants, dogs and cats for the renewal of its authorisation	In 2012, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive. Subsequently, the additive was authorised in the EU. The evidence provided by the applicant indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence has been found that will make the FEEDAP Panel reconsider its previous conclusions on the safety for target species, consumers and environment.
Safety of feed additives consisting of β-damascone [07.083] and (E)-β-damascone [07.224] belonging to chemical group 8, when used as flavoring in feed for all animal species	The use of β-damascone [07.083] and (E)-β-damascone [07.224] as feed additives is considered safe for the terrestrial and freshwater environment.
Safety of 37 feed additives consisting of flavouring compounds belonging to different chemical groups for use in all animal species	The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) gives a maximum proposed use level for certain feed additives.
Safety and efficacy of a feed additive consisting of l-lysine sulfate produced by Escherichia coli CGMCC 7.398 for all animal species	The additive does not pose any safety concerns associated with the production strain The additive is considered safe for the target species The additive is safe for the consumers and for the environment In the absence of data, the FEEDAP Panel cannot conclude the potential of the additive under assessment to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive represents a risk by inhalation for users handling the additive. The additive l-lysine sulfate is considered as an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, this would require protection against degradation in the rumen.
Safety and efficacy of a feed additive consisting of l-methionine produced by the combined activities of Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 for all animal species	The additive does not pose any safety concern associated with the genetic modification of the production strains The additive is safe for the target species The FEEDAP Panel has concerns about the use of amino acids in water for drinking for hygienic reasons The additive is safe for the consumers and for the environment The additive is not an irritant to skin/eyes and not a dermal sensitiser. It shows no toxicity by inhalation l-methionine ≥ 90% is a risk for the user For the supplemental l-methionine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.
Safety and efficacy of a feed additive consisting of sepiolite for all animal species	The FEEDAP Panel concludes that sepiolite was efficacious as a thickener-suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use.
Safety and efficacy of a feed additive consisting of acacia gum (gum Arabic) for all animal species	The use of the additive in animal nutrition is considered safe for the consumers. Acacia gum is a potential dermal and respiratory sensitiser. No conclusion can be reached on its irritating potential to skin or eyes. The use of acacia gum in animal nutrition is considered safe for the environment.
Safety and efficacy of a feed additive consisting of lactic acid produced by Weizmannia coagulans (synonym Bacillus coagulans) DSM 32789 for all animal species except for fish (Jungbunzlauer SA)	The use of the additive under assessment in animal nutrition is considered safe for the consumers and for the environment. It is considered corrosive to skin, eyes and mucous membranes. Lactic acid is used in food as a preservative. It is reasonable to expect that the effect seen in food will be observed in feed when it is used at comparable concentrations and conditions. However, the FEEDAP Panel has reservations about its effectiveness as a preservative in complete feed with a moisture content of ≤ 12%.
Safety and efficacy of a feed additive consisting of guar gum for all animal species	The use of the additive in animal nutrition is considered safe for the consumer and the environment. In the absence of data, no conclusions could be drawn on the safety of the additive for the user. Guar gum is efficacious as a gelling agent and thickener, and contributes to stabilise canned pet feed. No conclusion can be drawn on the additive as an emulsifier.