Notifications for European Union (1104 notifications)

Expressed orange essential oil, distilled orange essential oil and folded orange 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 of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck for all animal species. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’.  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 September 2021 that, under the proposed conditions of use, expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck do not have adverse effects on animal health, consumer health or the environment. 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 additives. Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

The proposal notified in G/SPS/N/EU/464 (15 March 2021) is now adopted by Regulation (EU) 2021/1756 of the European Parliament and of the Council of 6 October 2021 amending Regulation (EU) 2017/625 as regards official controls on animals and products of animal origin exported from third countries to the Union in order to ensure compliance with the prohibition of certain uses of antimicrobials and Regulation (EC) No 853/2004 as regards the direct supply of meat from poultry and lagomorphs (Text with EEA relevance) [OJ L 357, 8 October 2021, p. 27].The Regulation shall apply from 28 October 2021.

The proposal notified in G/SPS/N/EU/547 (9 March 2022) is now adopted by Commission Regulation (EU) 2022/1370 of 5 August 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of ochratoxin A in certain foodstuffs (Text with EEA relevance) [OJ L 206, 8 August 2022, p. 11].The Regulation shall apply from 1 January 2023.

The proposal notified in G/SPS/N/EU/554 (14 April 2022) is now adopted by Commission Implementing Regulation (EU) 2022/1322 of 25 July 2022 amending Implementing Regulation (EU) 2021/632 as regards the lists of products of animal origin, animal by-products and composite products subject to official controls at border control posts (Text with EEA relevance) [OJ L 13, 20 January 2022, p. 5].The Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

The draft Regulation:-        establishes maximum levels for dioxins and for the sum of dioxins and dioxin-like PCBs in meat and meat products from caprine animals, horse, rabbit, wild boar, game birds and venison and liver of caprine animals, horse and game birds (foodstuffs for which no maximum level for dioxins and dioxin-like PCBs has been established in the European Union);-        extends the existing maximum level for dioxins and the sum of dioxins and dioxin-like PCBs in hen eggs to all poultry eggs (except goose eggs);-        changes the part of crabs and crablike crustaceans to which the maximum level for dioxins and the sum of dioxins and dioxin-like PCBs applies; and-        lowers the maximum levels for dioxins and the sum of dioxins and dioxin-like PCBs in milk and dairy products.

The proposal notified in G/SPS/N/EU/525 (13 December 2021) is now adopted by Commission Regulation (EU) 2022/1321 of 25 July 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 fluoride ion, oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride in or on certain products (Text with EEA relevance) [OJ L 200, 29 July 2022, p. 1].The Regulation shall apply from 21 February 2023.

The proposal notified in G/SPS/N/EU/557 (21 April 2022) is now adopted by Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance) [OJ L 191, 20 July 2022, p. 58].The Regulation shall apply from 9 February 2023.

Import requirements and internal measures are put in place in relation to Meloidogyne graminicola (Golden & Birchfield).

The authorisation of ethoxyquin used as an antioxidant feed additive for all animal species had been suspended by Commission Implementing Regulation (EU) 2017/962 of 7 June 2017, as amended by Commission Implementing Regulation (EU) 2021/412, on the basis of the opinion of the European Food Safety Authority (EFSA) of 21 October 2015 (cf notification G/SPS/N/EU/190). The authorisation of the additive was suspended pending the submission and assessment of supplementary data to be produced by the applicant for authorisation, in accordance with a time schedule listing the necessary studies to be carried out. Implementing Regulation (EU) 2017/962 provided for a review of the suspension measure by 31 December 2022 at the latest and in any event after the adoption by EFSA of a non-favourable opinion on the safety and efficacy of the additive ethoxyquin.After assessment of the submitted supplementary data, EFSA adopted on 27 January 2022 a new opinion, which was not favourable as regards the safety of the additive, in particular for long-living and reproductive animals, for consumers and for the environment. Therefore, since the conditions for authorisation of the additive laid down by the relevant EU legislation are still not met, the authorisation of ethoxyquin had to be denied, which is the subject matter of Commission Implementing Regulation (EU) 2022/1375. The notified measure therefore confirms the withdrawal from the EU market of the feed additive ethoxyquin for use for all animal species.

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. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC. Olibanum extract 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 olibanum extract from Boswellia serrata Roxb. ex Colebr. for horses and dogs. 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 European Food Safety Authority ('the Authority') concluded in its opinion of 27 January 2022 that, under the proposed conditions of use, olibanum extract from Boswellia serrata Roxb. ex Colebr. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that olibanum extract from Boswellia serrata Roxb. ex Colebr. should be considered as a non-irritant to skin and eyes, but in the absence of data, no conclusion could be drawn on its potential to be a dermal and respiratory 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.

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(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM12856. 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 preparation of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2022 that, under the proposed conditions of use, the preparation of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM 12856 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is not irritant for eyes and skin but should be considered a respiratory sensitiser and no conclusions could be drawn on the skin sensitisation potential of the additive. 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 preparation concerned has the potential to improve the preservation of nutrients in silage prepared with easy and moderately difficult to ensile material. 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 assessment of the preparation of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri DSM12856 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied. Accordingly, the use of the preparation should be authorised as specified in the Annex to this Regulation.

Essential oil from Origanum vulgare 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 essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. 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 European Food Safety Authority ('the Authority') concluded in its opinion of 12 November 2019 that, under the proposed conditions of use, essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. should be considered as an irritant to skin and eyes, and as a potential skin and respiratory sensitizer. 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 essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. 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 assessment of essential oil from Origanum vulgare ssp. hirtum (Link) Ietsw. 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.

In accordance with Article 7(1) of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80187. 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 monosodium glutamate 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 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 monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80187 in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinion of 10 November 2021 that, under the proposed conditions of use, monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80187 does not have adverse effects on animal health, human health or the environment. The Authority concluded in the opinion that the additive is not toxic by inhalation, is not irritant to skin or eyes and is not adermal sensitiser. The Authority further concluded, that monosodium glutamate is efficacious for contributing 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 monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80187 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. Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures. The fact that monosodium glutamate produced by fermentation with Corynebacterium glutamicum KCCM 80187 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.

In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of Allura Red AC. 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 Allura Red AC as a feed additive for small non-food producing mammals and ornamental birds, to be classified in the category 'sensory additives' and in the functional group 'colourants'. The European Food Safety Authority ('the Authority') concluded in its opinion of 11 November 2021 that, under the proposed conditions of use, Allura Red AC does not have adverse effects on animal health, consumer safety or the environment. The Authority could not conclude on the efficacy of Allura Red AC when used in feed for small non-food producing mammals and ornamental birds, considering the wide variety of feeding stuffs used in complete and complementary feed for small non-food producing mammals and ornamental birds, and the uncertainty of which concentration of Allura Red AC would result in a visible effect. However, the Authority also stated that for this additive, which is authorised in food and, where the function for feed is the same as that for food, no further demonstration of efficacy might be necessary. 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. Moreover, Allura red AC is already authorised in feed for cats and dogs by Commission Implementing Regulation (EU) 2020/197 and the Authority concluded, in its opinion of 24 April 2012, that Allura Red AC is effective in colouring a typical feed for dogs at a minimum dose of 50 mg/kg, which is similar to the minimum levels proposed by the Authority for this use in small non-food producing mammals and ornamental birds. In view of the above, the Commission therefore considers that there is sufficient evidence of the efficacy of this substance. The assessment of Allura Red AC 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.

The substances ethyl acrylate, pentyl isovalerate, butyl 2-methyl butyrate, 2-methylundecanal, (2E)-methylcrotonic acid, ethyl (E,Z)-deca-2,4-dienoate, butan-2-one, cyclohexyl acetate, 3,4-dimethylcyclopentan-1,2-dione, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one, phenethyl butyrate, hexyl phenylacetate, 4-methylacetophenone4-methoxyacetophenone, 3-methylphenol, 3,4-dimethylphenol, 1-methoxy-4-methylbenzene, trimethyloxazole and 4,5-dihydrothiophen-3(2H)-one were authorised without a time limit in accordance with Directive 70/524/EEC as a feed additives for all animal species. Those substances 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, several applications were submitted for the re-evaluation of those additives for all animal species. The applicant requested the additives 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 these additives in water for drinking should not be allowed. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

The application concerns the authorisation of great mullein tincture 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 great mullein tincture 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 great mullein tincture in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinions of 12 November 2019 and 24 June 2021 that, under the proposed conditions of use, great mullein tincture does not have adverse effects on animal health, consumer health or the environment.

The proposed draft Regulation concerns the update of existing MRLs for benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, metazachlor, nicotine, profenofos, quizalofop-P, sodium aluminium silicate, thiabendazole and triadimenol in certain food commodities. MRLs for these substances in certain commodities are changed. 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. Some temporary MRLs are lowered based on monitoring data.

The proposed draft Regulation concerns the update of existing MRLs for calcium phosphide, cyromazine, topramezone and triflumizole in certain food commodities. MRLs for these substances in certain commodities are changed. 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. Some MRLs are kept based on veterinary uses.

Article 12 of Implementing Regulation (EU) 2019/1793 requires the Commission to review the lists set out in the Annexes on a regular basis, and not exceeding six months, in light of new information related to risks and non-compliance. In addition, in case of an emerging risk, or where there is evidence of a widespread serious non-compliance with the Union agri-food chain legislation, a safeguard measure ranging from special import conditions (listing of the commodity in Annex I or Annex II) to suspension of entry into the Union (listing in Annex IIa).Commission notice on information related to risks and non-compliance in the context of periodic reviews of Commission Implementing Regulation (EU) 2019/1793 explains the relevant criteria and considerations, in the context of periodic reviews under Article 12 of Commission Implementing Regulation (EU) 2019/1793. The purpose of this Notice is to make the process transparent for citizens, business operators, and national competent authorities, both in the Union and in territories and third countries from where food and feed of non-animal origin subject to Implementing Regulation (EU) 2019/1793 are imported into the Union. This Notice is intended to assist business operators and national competent authorities to better understand the application of Article 12 of Implementing Regulation (EU) 2019/1793.

The proposal notified in G/SPS/N/EU/509 (27 September 2021) is now adopted by Commission Delegated Regulation (EU) 2022/887 of 28 March 2022 amending Delegated Regulation (EU) 2019/625 as regards Combined Nomenclature and Harmonised System codes and import conditions of certain composite products, amending Delegated Regulation (EU) 2019/2122 as regards certain goods and pet birds exempted from official controls at border control posts and amending Delegated Regulation (EU) 2021/630 as regards requirements for composite products exempted from official controls at border control posts (Text with EEA relevance) [OJ L 154, 7 June 2022, p. 23].This Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.