Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/568 (23 May 2022) is now adopted by Commission Regulation (EU) 2022/1923 of 10 October 2022 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) in tuna (Text with EEA relevance) [OJ L 264, 11 October 2022, p. 8].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/572 (20 June 2022) is now adopted by Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (Text with EEA relevance) [OJ L 248, 26 September 2022, p. 32].This Regulation shall apply from 15 December 2022.

The proposal notified in G/SPS/N/EU/571 (20 June 2022) is now adopted by Commission Delegated Regulation (EU) 2022/1644 of 7 July 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with specific requirements for the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof (Text with EEA relevance) [OJ L 248, 26 September 2022, p. 3].This Regulation shall apply from 15 December 2022.

This draft Commission Implementing Regulation provides that the approval of the active substance captan is renewed with restriction to uses in greenhouses, in accordance with Regulation (EC) No 1107/2009. Member States shall amend/withdraw authorisations for plant protection products containing captan as an active substance. The restricted renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the European Union under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/EEC.This decision only concerns the placing on the market of this substance and plant protection products containing it. Separate action will likely 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/928.

The proposal notified in G/SPS/N/EU/524 (7 December 2021) is now adopted by Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (Text with EEA relevance) [OJ L243, 20 September 2022, p. 3].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10 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 expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil for all animal species. The Authority concluded, that expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil are recognised to flavour food and their function in feed would be essentially the same as that in food, and therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398. The application concerns the authorisation of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 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 assessment of L-lysine sulphate produced by Escherichia coli CGMCC 7.398 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.

Expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) 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 expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil for all animal species. The Authority concluded that expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil are recognised to flavour food and their function in feed would be essentially the same as that in food, and therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

The proposal notified in G/SPS/N/EU/491 (26 May 2021) is now adopted by Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance) [OJ L 151, 2 June 2022, p. 37].This Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/532 (15 December 2021) is now adopted by Commission Regulation (EU) 2022/1406 of 3 August 2022 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 methoxyfenozide, propoxur, spinosad and thiram in or on certain products (Text with EEA relevance) [OJ L 215, 18 August 2022, p. 1].The Regulation shall apply from 28 February 2023.

The proposal notified in G/SPS/N/EU/534 (20 December 2021) is now adopted by Commission Regulation (EU) 2022/1346 of 1 August 2022 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 1,4-dimethylnaphthalene, 8-hydroxyquinoline, pinoxaden and valifenalate in or on certain products (Text with EEA relevance) [OJ L 202, 2 August 2022, p. 31].The Regulation shall apply from 22 February 2023.

The proposal notified in G/SPS/N/EU/533 (20 December 2021) is now adopted by Commission Regulation (EU) 2022/1363 of 3 August 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2,4-D, azoxystrobin, cyhalofop-butyl, cymoxanil, fenhexamid, flazasulfuron, florasulam, fluroxypyr, iprovalicarb and silthiofam in or on certain products (Text with EEA relevance) [OJ L 205, 5 August 2022, p. 207].The Regulation shall apply from 25 February 2023.

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine produced by Escherichia coli CCTCC M2020321 as a feed additive for all animal species. The application concerns the authorisation of L-valine produced by Escherichia coli CCTCC M2020321 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'. in view of the Authority’s opinion, the Commission therefore 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 assessment of L-valine produced by Escherichia coli CCTCC M2020321 shows that the conditions for authorisation set out in Article 5 of Regulation (EC) No 1831/2003, are fulfilled.

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246. That application was accompanied by the particulars and documents required under Article 7 of that Regulation. The application concerns the authorisation of L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 as feed additives for all animal species to be classified in the additive category 'nutritional additives'. The Authority further concluded that L-methionine produced by Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 is an effective source of methionine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the substance 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 report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

The proposed draft Regulation concerns the review of existing MRLs for isoxaben, novaluron and tetraconazole in certain food commodities. MRLs for these substances in certain commodities are lowered or raised. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union or for which a human health concern may not be excluded

The proposal notified in G/SPS/N/EU/548 (9 March 2022) is now adopted by Commission Regulation (EU) 2022/1393 of 11 August 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of delta-9-tetrahydrocannabinol (Δ9-THC) in hemp seeds and products derived therefrom (Text with EEA relevance) [OJ L 211, 12 August 2022, p. 83].The Regulation shall apply from 1 January 2023.

Buchu leaves oil was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) 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 an essential oil from the leaves of Agathosma betulina (P.J. Bergius) Pillans (buchu leaf essential oil) for all animal species. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant requested the additive 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 buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans in water for drinking should not be allowed. The Authority further concluded, that buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans is recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. 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.

The proposal notified in G/SPS/N/EU/546 (8 March 2022) is now adopted by Commission Regulation (EU) 2022/1364 of 4 August 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of hydrocyanic acid in certain foodstuffs (Text with EEA relevance) [OJ L 205, 5 August 2022, p. 227].The Regulation shall apply from 1 January 2023.

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681. 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 L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681 as feed additives for all animal species, to be classified in the categories ‘nutritional additives’ and ‘sensory additives’. The applicant requested the feed additive to be authorised for use also 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 monosodium glutamate produced by Corynebacterium glutamicum KCCM 80188 in water for drinking should not be allowed. The fact that the additive is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed administered via water.The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2022 that, under the proposed conditions of use, L-glutamic acid and monosodium glutamate produced by Corynebacterium glutamicum NITE BP-01681 do not have adverse effects on animal health, consumer safety or the environment. It also concluded that these substances are neither considered irritant to skin or eyes, nor dermal sensitisers, but are considered 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. The Authority also concluded that these substances have the potential to be efficacious as nutritional additives and as flavouring compounds in feeding stuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. 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.

Ylang ylang oil was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) 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 ylang ylang essential oil from the flowers of Cananga odorata (Lam) Hook f. & Thomson for all animal species. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applicant requested the additive 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 ylang ylang essential oil from Cananga odorata (Lam) Hook f. & Thomson in water for drinking should not be allowed.The fact that ylang ylang essential oil from Cananga odorata (Lam) Hook f. & Thomson is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water. The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annnex.