Notifications for European Union (1104 notifications)

The measure concerns the authorisation of fresh plants of Wolffia arrhiza and/or Wolffia globosa as a traditional food from a third country under Regulation (EU) 2015/2283 and amending Commission Implementing Regulation (EU) 2017/2470.

The measure concerns an authorisation of the placing on the Union market of calcium fructoborate as a novel food.

The measure concerns an authorisation of the placing on the Union market of vitamin D2 mushroom powder as a novel food.

The measure concerns an authorisation of the placing on the Union market of Schizochytrium sp. (FCC-3204) oil as a novel food.

The draft Regulation lowers existing maximum levels for mercury in cephalopods, marine gastropods and muscle meat of certain fish species, for which EU MLs are currently established under Regulation (EC) No 629/2008 and Regulation (EU) No 420/2011, and it establishes a new maximum level for mercury in salt.

The proposed draft Regulation concerns the review of existing MRLs for fluoride ion, oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride in certain food commodities. MRLs for these substances in certain commodities are changed: either increased or lowered. Lower MRLs are set after updating the limits of determination and/or deleting old uses which are not authorised any more in the European Union or for which a human health concern may not be excluded. Some residue definitions have been updated.

The regulation concerns the placing on the market of plastic materials and articles with recycled/secondary plastic content intended for use in contact with food. It sets out rules for the manufacture thereof, suitable recycling technologies, recycling processes, recycling installations, plastic waste, collection and sorting of plastic input and the decontamination thereof, and the use of the plastic output, quality control, registration of business operators and enforcement, with the purpose to ensure that the recycled content in the final plastic materials and articles intended for contact with food do not cause harm to the consumers of those foods, or change their quality or organoleptic properties. The Regulation repeals Regulation (EC) No 282/2008, which it will replace.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of disodium 5'-guanylate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The application concerns the authorisation of disodium 5'-guanylate as a feed additive for all animal species, to be classified in the category 'sensory additives' and in the functional group 'flavouring compounds'. The applicant requested disodium 5'‑guanylate to be authorised also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of 'flavouring compounds' for use in water for drinking. Therefore, the use of disodium 5'-guanylate in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, disodium 5'-guanylate does not have adverse effects on animal health, human health or the environment. The Authority further concluded that disodium 5'-guanylate is efficacious to contribute to the flavour of feed. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of disodium 5'-guanylate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. The application concerns the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 as a feed additive for all animal species, to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'. The European Food Safety Authority ('the Authority') concluded in its opinion of 17 March 2021 that, under the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 7.366, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer safety or the environment. With respect to the safety of the user of that additive, the Authority could neither exclude a risk by inhalation, nor that L-valine might be irritant to skin or eyes, or a dermal sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Further, the Authority concluded that it is considered an efficacious source of the essential amino acid L-valine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the extension of use of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive from finfish to all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The application concerns the authorisation of the extension of use of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive from finfish to all animal species to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues', and in the additive category 'sensory additives', functional group 'flavouring compounds'. The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, L‑histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 does not have an adverse effect on animal health, consumers safety or the environment. The Authority also concluded for the additive in question that it was not possible to conclude on the potential for the additive to be toxic if inhaled, an irritant to eyes or a skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of the essential amino acid histidine and efficacious as a flavouring compound.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-tryptophan produced by Escherichia coli KCCM 80210. The application was accompanied by the particulars and documents required under Article 7 of that Regulation. The application concerns the authorisation of L‑tryptophan produced by Escherichia coli KCCM 80210 as a feed additive for all animal species, to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'. The European Food Safety Authority ('the Authority') concluded in its opinion of 27 January 2021 that, under the proposed conditions of use, L-tryptophan produced by Escherichia coli KCCM 80210 does not have an adverse effect on the health of non-ruminant animals, consumer safety or the environment. To be safe for ruminants, the L-tryptophan should be protected against degradation in the rumen. The Authority stated that the additive under assessment is considered a mild eye irritant. The endotoxin activity of the additive and its dusting potential indicate a risk by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC. Titanium dioxide was authorised without a time limit by Directive 70/524/EEC as a colourant additive (colouring agents authorised for colouring foodstuffs by Community rules) for cats and dogs. It was also authorised without a time limit for all animal species, with the exception of cats and dogs, for animal feedingstuffs under certain conditions. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of titanium dioxide as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category 'sensory additives' and the functional group 'colourants: substances that add or restore colour in feedingstuffs'. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') noted in its opinion of 5 May 2021 that it could not conclude on the safety of titanium dioxide for the target species, consumers and environment, given the absence of specific data related to its use as a feed additive and considering that the genotoxicity of particles of titanium dioxide could not be ruled out, raising potential concerns on the safety of the additive for the target species (especially for long-living animals and reproductive animals), consumers and users. In the absence of studies with titanium dioxide, the Authority could not conclude on the assessment of the effects of the additive on eyes and skin. The Authority further noted that titanium dioxide is potentially carcinogenic to workers if inhaled and that, as the genotoxicity of particles of titanium dioxide cannot be ruled out, it should be considered as an additional potential concern to users handling the additive. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium diformate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The application concerns the authorisation of potassium diformate as a feed additive for pigs for fattening and weaned piglets, to be classified in the category 'technological additives'. The European Food Safety Authority ('the Authority') concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, potassium diformate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the substance does not raise concerns regarding the effects on the respiratory system and the skin but is an eye irritant. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the substance has the potential to be efficacious as a technological additive in feedingstuffs. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

This draft Commission Implementing Regulation provides that the approval of the active substance isopyrazam is withdrawn in accordance with Regulation (EC) No 1107/2009.Member States shall withdraw authorisations for plant protection products containing isopyrazam as an active substance.In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.Active substances may be reviewed at any time where in the light of new scientific and technical knowledge there are indications that the substance no longer satisfies the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009.Substances that are or have to be classified as toxic for reproduction category 1B (R1B) according to Regulation (EC) No 1272/2008 cannot be approved unless exposure to humans is demonstrated to be negligible under realistic conditions of use.In December 2020, the ECHA Committee for Risk Assessment concluded that isopyrazam meets the criteria to be classified as R1B. Negligible exposure is not demonstrated since residues are expected in crops (therefore there is no negligible exposure demonstrated for consumers).This means that isopyrazam no longer fulfils the approval criteria as outlined in Regulation (EC) No 1107/2009 and the approval should therefore be withdrawn.Existing authorisations will need to be withdrawn; Member States must withdraw existing plant protection products containing isopyrazam at the latest by three months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest six months from the entry into force.This decision only concerns the placing on the market of this substance and plant protection products containing it. Following withdrawal of approval and the expiry of all grace periods for stocks of products containing this substance, separate action may be taken on MRLs and a separate notification will be made in accordance with SPS procedures. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/857.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of L-lysine base, L-lysine monohydrochloride and L-lysine sulphate. The applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation. The applications concern the authorisation of L-lysine base and L-lysine monohydrochloride produced by Corynebacterium glutamicum KCCM 80183, L-lysine monohydrochloride and L-lysine sulphate produced by Corynebacterium glutamicum CCTCC M 2015595 and L-lysine sulphate produced by Corynebacterium glutamicum KCCM 80227 as feed additives for all animal species, to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'.

This draft Commission Implementing Regulation provides that the approval conditions of the active substance sulfoxaflor are amended in accordance with Regulation (EC) No 1107/2009 based on the evaluation of confirmatory data as required in Regulation (EU) 2015/1295 of 27 July 2015 approving the active substance sulfoxaflor for use in the European Union. Existing authorised plant protection products containing sulfoxaflor will be reviewed in accordance with the restriction set in this act. This decision however only concerns the placing on the market of this substance. Following restriction of the approval and the consequent expiry of all grace periods for stocks of products, separate legal action will likely be taken on Maximum Residue Levels and a separate notification will be made in accordance with SPS procedures in due time. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/853.

The proposal notified in G/SPS/N/EU/474 (31 March 2021) is now adopted by Commission Regulation (EU) 2021/1881 of 26 October 2021 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for imidacloprid in or on certain products (Text with EEA relevance) [OJ L 380, 27 October 2021, p. 5].The Regulation shall apply from 16 May 2022.

The proposal notified in G/SPS/N/EU/473 (31 March 2021) is now adopted by Commission Regulation (EU) 2021/1864 of 22 October 2021 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for amisulbrom, flubendiamide, meptyldinocap, metaflumizone and propineb in or on certain products (Text with EEA relevance) [OJ L 377, 25 October 2021, p. 3]. The Regulation shall apply from 14 May 2022.

The proposal notified in G/SPS/N/EU/472 (19 March 2021) is now adopted by Commission Regulation (EU) 2021/1842 of 20 October 2021 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for flupyradifurone and difluoroacetic acid in or on certain products (Text with EEA relevance) [OJ L 373, 21 October 2021, p. 76]. The Regulation shall apply from 10 May 2022 as regards the MRLs for flupyradifurone in grape leaves and difluoroacetic acid in maize, cocoa beans and swine liver.

Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country); and, suspension of entry into the Union for certain food and feed from certain third countries (in Annex IIa).This Implementing Regulation amends Annexes I and II to Implementing Regulation (EU) 2019/1793, in particular for the for commodities from Argentina, Brazil, Egypt, Ethiopia, Gambia, Georgia, Ghana, India, Malaysia, Sri Lanka, Sudan, Turkey, Uganda, United States, by introducing the following changes: - Inclusion in Annex I of lemons from Turkey, and of groundnuts from Brazil; - Deletion from Annex I of pistachios from the United States; - Increase in the frequency of identity and physical checks laid down in Annex I for oranges, mandarins, clementines, wilkings and similar citrus hybrids, and sweet peppers and peppers of the Capsicum species (other than sweet) from Turkey, for jackfruit from Malaysia, for peppers (other than sweet) from Uganda, and for groundnuts from the United States; - Increase in the frequency of identity and physical checks laid down in Annex I and addition of ethylene oxide to the analysis performed on okra from India; - Decrease in the frequency of identity and physical checks laid down in Annex I for hazelnuts and derived products from Georgia; - Amendment to the entry concerning hazelnuts from Georgia to ensure consistency with other similar entries concerning the same products; - Deletion from Annex I and inclusion in Annex II of Sesamum seeds from Ethiopia and of peppers of the Capsicum species (sweet or other than sweet) from Sri Lanka; - Increase in the frequency of identity and physical checks laid down in Annex II for Sesamum seeds from Sudan and for vine leaves from Turkey. >In addition, this Implementing Regulation amends several Articles of Implementing Regulation (EU) 2019/1793, in particular concerning the definition of country of origin, the replacement of 'compound food' by 'food consisting of two or more ingredients', and the transitional period. Furthermore, Annex IV to Implementing Regulation (EU) 2019/1793 was amended to ensure consistency with other import certificates.