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The recap of key EU regulatory updates consists of the following parts: legal acts from the official journal of the European Union and the notification of WTO notification; consultation progress on novel food; scientific opinions from European Food Safety Authority (EFSA), and open consultations released by EFSA.
Click the title of each sector for more details.
In May 2022, quite a few regulatory updates happened in EU, including 5 regulations related to the rejection of health claims, 5 related to epidemiological situation and 2 regarding monitoring plan. Revisions about the approval and non-approval active substances can be found in EU’s official journal. (Notes: Active substances are the substances, including micro-organisms, that have general or specific action against harmful organisms or on plants, parts of plants or plant products.)
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. Rejected health claims on foods
Pursuant to Regulation (EC) No 1924/2006, health claims made on foods are prohibited unless they are authorised by the European Commission in accordance with that Regulation and included in a list of permitted claims.
The below are the rejected health claims on foods this month.
Official link | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
Nutrimune (a pasteurised cow’s skimmed milk fermented with Lactobacillus paracasei CBA L74) | Nutrimune supports the immune system in defence against pathogens in the upper respiratory and gastrointestinal tracts of young children | ||
Anxiofit-1, a food ingredient that contains an Echinacea angustifolia hydro-alcoholic root dry extract standardised for the specific alkamide profile | Anxiofit-1 ameliorates subthreshold and mild anxiety. Subthreshold and mild anxiety are risk factors in the development of anxiety disorders and depression. | ||
GlycoLite™ – A proprietary standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) | GlycoLite™ helps to reduce body weight. | ||
Lozenges with two Lactobacillus reuteri strains: Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289, approximately equal amount of each strain (total minimum amount of 1 × 108 CFU/lozenge of each bacterial strain) | Lozenges containing Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 support normal gum function. | ||
Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) | Bifidobacterium animalis subsp. lactis Bi-07 contributes to the improvement of lactose digestion in individuals who have difficulty in digesting lactose. | ||
Coffee C21, a blend of pure Arabica roast coffees (Coffea arabica L.) without any non-coffee ingredients | Regular consumption of Coffee C21 contributes to the maintenance of DNA integrity in cells of the body. | ||
MenaQ7®, vitamin K2 as menaquinone-7 | MenaQ7®, vitamin K2 as menaquinone-7, improves arterial stiffness. | ||
‘Symbiosal®’, a food supplement containing sea salt (97 %) plus chitosan (3 %) | ‘Symbiosal®’ lowers the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for high blood pressure (hypertension). |
2. Regulatory changes related to epidemiological situation
Laying down special control measures for African swine fever (Release date: May 16, 2022)
Recently, African swine fever in wild porcine animals is outbreaking in Germany, Slovakia and Poland. Taking into account the current African swine fever epidemiological situation in the Union, zoning in those Member States as well as the risk management measures in place have been reassessed and updated. These changes are reflected in Annex I to Implementing Regulation (EU) 2021/605. It shall take effect on the promulgation date.
Concerning certain emergency measures relating to African swine fever in Italy (Release date: May 16, 2022)
Italy shall ensure that consignments of porcine animals kept in the infected zone in the Annex and products thereof are not authorised for movements to other Member States or to third countries. This Decision shall apply until 31 August 2022.
Amending the entries of poultry and poultry products from Canada, the United Kingdom and the United States (Release date: May 20, 2022)
Taking into account the current highly pathogenic avian influenza (HPAI) 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.
Amending emergency measures in relation to outbreaks of highly pathogenic avian influenza in certain Member States (Release date: May 25, 2022)
Given the urgency of the HPAI epidemiological situation in the Union, amendments are made to update the protection and surveillance zones as well as the duration of the measures applicable in accordance with Delegated Regulation (EU) 2020/687.
Amending the entries of poultry and poultry products from the United Kingdom and the United States (Release date: May 31, 2022)
Taking into account the current HPAI epidemic in 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.
3. Monitoring plan
A coordinated control programme for 2023, 2024 and 2025 to ensure compliance with maximum pesticide residue and to assess the consumer exposure to pesticide residues in food of plant and animal origin (Release date: May 16, 2022)
Member States shall, during the years 2023, 2024 and 2025, take and analyse samples of the pesticide/product combinations as set out in Annex I, including fruits, vegetable, grain, dairy, etc. The number of samples of each product to be taken and analysed shall be as set out in Annex II.
Commission recommendation on monitoring the presence of inorganic arsenic in feed (Release date: May 23, 2022)
Currently only limited occurrence data on the presence of inorganic arsenic in feed are available in the EFSA database. It is therefore appropriate to monitor the presence of inorganic arsenic in feed across the Union before considering setting maximum levels of inorganic arsenic in certain feed or any other risk management measures needed to ensure a high level of animal and human health protection.
Amending the specifications of the novel food trans-resveratrol (Release date: May 4, 2022)
The Implementing Regulation (EU) 2022/672 authorizes the removal of the particle size requirement in the specifications of trans-resveratrol produced from microbial sources, aiming to align its specifications with the synthetic trans-resveratrol. (Final date for comments: Not applicable)
Amending the conditions of approval of the active substance penflufen (Release date: May 5, 2022)
The Commission has concluded that it is necessary and appropriate to restrict the approval of penflufen and prohibit the treatment of seed potato tubers before or during planting. However, it is possible to maintain the use of penflufen to treat cereal seeds, since safe uses have been demonstrated. Member States will be provided with sufficient time to amend or withdraw authorisations for plant protection products containing penflufen which are not complying with the restricted conditions of approval. (Final date for comments: 60 days from notification)
Amending maximum levels of arsenic in certain food (Release date: May 13, 2022)
The draft Regulation lowers the existing maximum level for inorganic arsenic in non-parboiled milled rice (polished or white rice). It also establishes new maximum levels for inorganic arsenic in rice flour, rice-based drinks, fish, crustaceans, bivalve molluscs, food for infants and young children, fruit juices, concentrated fruit juices, as well as nectars and salt. (Final date for comments: July 12, 2022)
Amending the lipid and magnesium requirements for total diet replacement for weight control (Release date: May 18, 2022)
Taking into account EFSA’s scientific opinion, the Commission concluded that it is appropriate
to lower the minimum alpha-linolenic acid content required under Delegated Regulation (EU) 2017/1798 for total diet replacement for weight control to 0.8 g/total daily ration;
to increase the maximum magnesium content permitted for those products to 350 mg/total daily ration; and
to delete the provision on the minimum content of linoleic acid.
(Final date for comments: 60 days from notification)
Amending the use of ascorbic acid (E300), sodium ascorbate (E301) and calcium ascorbate (E302) in tuna (Release date: May 23, 2022)
The use of above food additives incanned tuna in high amounts to artificially restore the colour of fresh tuna flesh does not comply with the general conditions for inclusion and use of food additives in the Union and with the quantum satis principle. On the basis of the information provided by the industry to the EFSA in view of the re-evaluation of the food additives safety and official controls carried out by some competent authorities, a maximum level of 300 mg/kg is considered appropriate. The maximum level allows to maintain the current levels of legitimate use following good manufacturing practice. (Final date for comments: July 22, 2022)
Lupin sprouts (powdered) enriched with iron is produced by germinating disinfected seeds of Lupinus angustifolius in the iron sulphate (FeSO4) solution. The production process includes not-in-common-used production practices/process technologies used before 15th May 1997 and gives rise to significant changes in the food, affecting its nutritional value. Hence, it is considered as novel food.
European Food Safety Authority gave scientific opinions on the requests from the European Commission in its journal released in May (Volume 20, Issue 5). The below lists the major content.
Topic | Notes |
1. Food ingredients | |
Safety of the extension of use of 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) as novel foods in food supplements for infants | The authorised novel foods (NFs) are produced by fermentation with genetically modified strains of Escherichia coli K-12 and already included in the EU list of NFs. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2’-FL in FS intended for infants (< 1 year old), at a maximum use level of 1.2 g/day. The applicant also proposes an extension of use of LNnT in FS intended for infants, at a maximum use level of 0.6 g/day, etc. The Panel concludes that the use of the NFs containing 2’-FL or LNnT in FS for infants is safe under the proposed conditions of use. |
Safety evaluation of the food enzyme pectin lyase from the genetically modified Aspergillus luchuensis strain FLOSC | The food enzyme is intended to be used in fruit and vegetable processing for juice production. 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 dextranase from the Collariella gracilis strain AE-DX | The Panel considers that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the occurrence rate is considered to be low. 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 of bovine milk osteopontin as a Novel food | The NF concerns osteopontin OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L in infant formula (IF), follow-on formula (FoF) and ready-to-eat dairy-based meals for children up to 35 months of age. Considering the source of the NF, that neither the toxicological studies nor the provided infant studies do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use. |
Safety of partially defatted house cricket (Acheta domesticus) powder as a novel food | The NF is proposed as dry powder. The main components of the NF are protein, fat and fibre (chitin). The applicant proposed to use the NF as food ingredient in a number of food products. The Panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins and may cause allergic reactions in subjects allergic to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. That aside, the Panel concludes that the NF is safe under the proposed uses and use levels. |
Safety of the proposed amendment of the specifications for enzymatically produced steviol glycosides (E 960c): Rebaudioside D produced via enzymatic bioconversion of purified stevia leaf extract | The Panel concludes that there is no toxicological concern. However, based on the available data, the Panel cannot exclude the possibility that some residual amount of DNA coding for the kanamycin resistance gene remains in the final product. Therefore, the Panel concludes that the safety of Rebaudioside D produced via this enzymatic bioconversion has not been sufficiently demonstrated with the available data given that the absence of recombinant DNA has not been shown. |
Safety of lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food | The applicant intends to add the NF to a variety of foods, including infant and follow-on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The Panel concludes that the NF is safe under the proposed conditions of use. |
Safety of 3’-sialyllactose (3’-SL) sodium salt produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food | |
Safety of 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli BL21 (DE3) as a Novel Food | |
2. Food additive | |
Follow-up of the re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive | The Panel concludes that the maximum limits in the EU specifications for the 4 toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on the actual levels in the commercial food additive E 475. The Panel also concludes that the maximum limits for erucic acid, 3-monochloropropanediol and glycidyl esters should be included in the EU specifications for E 475. Alternatively, the Panel recommends an amendment of the definition of E 475, etc. |
Follow-up of the re-evaluation of polyglycerol polyricinoleate (E 476) as a food additive | The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury, cadmium) should be lowered based on actual levels in the commercial food additive E 476. The Panel also concluded that maximum limits for glycidyl esters and 3-monochloropropanediol should be included in the EU specifications for E 476. Alternatively, the Panel recommends an amendment of the definition of E 476, etc.. |
Scientific opinion on Prosmoke BW 01 | Prosmoke BW 01 contains furan-2(5H)-one (formerly [FL-no: 10.066]), for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for this component are above the TTC of 0.0025 μg/kg bw per day (or 0.15 μg/person per day) for DNA-reactive mutagens and/or carcinogens, the Panel concludes that Prosmoke BW 01 raises concern with respect to genotoxicity.
The available toxicity studies are not adequate to support the safety assessment of the whole mixture, due to limitations in the studies and the fact that they were performed with a batch which may not be representative for the material of commerce. |
3. FCM | |
Safety assessment of the process PET Verpackungen Deutschland, based on the EREMA basic and Polymetrix SSP leaN technology, used to recycle post-consumer PET into food contact materials | The Panel concludes that the recycled PET obtained from the mentioned process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature, with or without hotfill. |
Safety assessment of the process RCS Plastics, based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process Indorama Ventures Recycling Verdun (IVRV), based on the NGR technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process Roxane Nord, based on VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process rPET InWaste, based on the NGR technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process World PET Plastic, based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process Société Générale de Recyclage (SGR), based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process Wellman Neufchâteau Recyclage (WNR), based on the NGR technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process NAN YA PLASTICS, based on the EREMA Basic technology, used to recycle post-consumer PET into food contact materials | The Panel concludes that the recycled PET obtained from the mentioned process is not considered of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature. |
Safety assessment of the process Utsumi, based on the EREMA Basic technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process Zibo Containers, based on the EREMA Basic technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process INTCO MALAYSIA, based on the EREMA Basic technology, used to recycle post-consumer PET into food contact materials | |
Safety assessment of the process 3R, based on NGR technology, used to recycle post-consumer PET into food contact materials | |
4. Feed additive | |
Safety and efficacy of a feed additive consisting of butylated hydroxytoluene (BHT) for all animal species | The additive BHT is considered safe for chickens for fattening and weaning piglets at the maximum proposed concentration of 150 mg/kg in complete feed. In the absence of data, no conclusion on the safety for the other target species could be drawn. In the absence of data, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) also cannot conclude on the safety of BHT for the environment. |
Safety and efficacy of a feed additive consisting of Sunset Yellow FCF for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents | Sunset Yellow FCF is considered safe for the target species at the following concentrations in complete feed: 165 mg/kg for cats, 198 mg/kg for dogs, 733 mg/kg for ornamental fish, etc. In the absence of adequate information, the FEEDAP Panel cannot conclude neither on the eyes and skin irritation potential of Sunset yellow FCF, nor on its skin sensitisation potential. Exposure by inhalation is considered to be unlikely. The FEEDAP Panel cannot conclude on the efficacy of the additive. |
Draft opinion on review of existing health based guidance values for copper (Consultation starts from May 24, 2022 to August 1, 2022)
EFSA's Methodology and Scientific Support (MESE) Unit has launched an open consultation on the draft Scientific Opinion (SC) on an Acceptable Daily Intake (ADI) for exposure to copper. The SC concludes that no retention of copper is expected to occur with the intake of 5 mg/day. It also established an ADI of 0.07 mg/kg bw, which is considered conservative and sufficiently protective for all age groups. The previous ADI is 0.15 mg/kg bw.
Draft protocol for the hazard assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food (Consultation starts from May 25, 2022 to July 5, 2022)
EFSA was requested by the European Commission to re-evaluate the risks to public health related to the presence of plasticisers such as phthalates, structurally similar substances and replacement substances, as a consequence of migration from food contact materials (FCMs). The protocol describes how hazard identification and hazard characterisation will be addressed. This draft protocol describes the strategy for retrieving, selecting, and extracting the data; appraising the relevant evidence; as well as summarizing, analysing and integrating scientific evidence in order to perform hazard assessments.
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