Notifications for European Union (1104 notifications)

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof, Whereas 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'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. This application concerns the authorisation of disodium 5'-inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category '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 disodium 5'‐inosinate produced by fermentation with Corynebacterium stationis KCCM 80161 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 measure concerns an amendment of Implementing Regulation (EU) 2017/2469 to take into account the requirements of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.

The measure concerns an amendment of Implementing Regulation (EU) 2017/2468 to take into account the requirements of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.

The proposal notified in G/SPS/N/EU/404 (6 August 2020) was adopted as Commission Regulation (EU) 2020/1158 of 5 August 2020 on the conditions governing imports of food and feed originating in third countries following the accident at the Chernobyl nuclear power station (Text with EEA relevance) [OJ L 257, 6 August 2020, p.1]. This Regulation entered into force on 9 August

The proposal notified in G/SPS/N/EU/399 (21 July 2020) was adopted as Commission Regulation (EU) 2020/1681 of 12 November 2020 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (Text with EEA relevance) [OJ L 379, 13 November 2020, p.27]. This Regulation shall apply from 3 December 2020.

The proposed amendment in Annex IX to Regulation (EC) No 999/2001 is the only part of the text with a possible impact on international trade. The proposal will ensure full consistency of the EU import conditions of products derived from ruminants originating from a country with undetermined BSE risk, whether the products are imported directly from this country or from a country with negligible or controlled BSE risk. To this aim, two additional conditions will become applicable to these products imported from a controlled BSE risk country:- the animals have not been fed with meat-and-bone meal or greaves, - the products were produced and handled in a manner which ensures that they did not contain and were not contaminated with nervous and lymphatic tissues exposed during the deboning process.

The proposed draft Regulation concerns the review of existing MRLs for ametoctradin, bixafen, fenazaquin, spinetoram, tefluthrin and thiencarbazone-methyl 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. The residue definition for some substances has also been updated.

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. Article 10(2) of that Regulation provides for the re- evaluation of additives authorised pursuant to Council Directive 70/524/EEC(2). The substances cinnamyl alcohol, 3-phenylpropan-1-ol, 2-phenylpropanal, 3-(p-cumenyl)-2-methylpropionalde- hyde, alpha-methylcinnamaldehyde, 3-phenylpropanal, cinnamic acid, cinnamyl acetate, cinnamyl butyrate, 3- phenylpropyl isobutyrate, cinnamyl isovalerate, cinnamyl isobutyrate, ethyl cinnamate, methyl cinnamate and isopentyl cinnamate (‘substances concerned') were authorised without a time limit in accordance with Directive 70/ 524/EEC as feed additives for all animal species. Those 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 the substances concerned as feed additives for all animal species. The applicant requested those additives 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 proposal notified in G/SPS/N/EU/372 (5 March 2020) was adopted as Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance) [OJ L 288, 3 September 2020, p.1]. This Regulation entered into force on 23 September 2020.

The proposal notified in G/SPS/N/EU/340 (7 August 2019) was adopted as Commission Regulation (EU) 2020/1255 of 7 September 2020 amending Regulation (EC) No 1881/2006 as regards maximum levels of polycyclic aromatic hydrocarbons (PAHs) in traditionally smoked meat and smoked meat products and traditionally smoked fish and smoked fishery products and establishing a maximum level of PAHs in powders of food of plant origin used for the preparation of beverages (Text with EEA relevance) [OJ L 293, 8 September 2020, p.1]. This Regulation entered into force on 28 September 2020.

The proposal notified in G/SPS/N/EU/368 (24 February 2020) was adopted as Commission Regulation (EU) 2020/1322 of 23 September 2020 amending Regulation (EC) No 1881/2006 as regards maximum levels of 3‐monochloropropanediol (3-MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid esters in certain foods (Text with EEA relevance) [OJ L 310, 24 September 2020, p.2]. This Regulation entered into force on 14 October 2020.

The proposal notified in G/SPS/N/EU/379 (23 March 2020) was adopted as Commission Regulation (EU) 2020/1566 of 27 October 2020 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 bupirimate, carfentrazone-ethyl, ethirimol, and pyriofenone in or on certain products (Text with EEA relevance) [OJ L 358, 28 October 2020, p.30]. This Regulation shall apply from 17 May 2021.

The proposed draft Regulation concerns the review of existing MRLs for clethodim, dazomet, hexythiazox, metam and sethoxydim 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. The residue definition for some substances has also been updated.

The notified Regulation supplements rules that are already laid down in the EU Animal Health Law (Regulation (EU) 2016/429), concerning movements of aquatic animals and certain products from aquatic animals, within the EU. In that regard, it lays down the rules concerning:1. the obligations on operators, including transporters, for the transport of aquatic animals;2. supplementary animal health requirements for movements of aquatic animals intended for specific uses or purposes, including certification and notification requirements;3. the production, processing and distribution of products of animal origin from aquaculture animals, other than live aquaculture animals.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition. 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 80 184 and Escherichia coli KCCM 80 096 as a feed additive for use in feed for 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 L-methionine produced by Corynebacterium glutamicum KCCM 80 184 and Escherichia coli KCCM 80 096 as a feed additive for all animal species to be classified in the additive category 'nutritional additives'. The European Food Safety Authority ('the Authority') concluded in its opinion of 12 November 2019(2) that, under the proposed conditions of use, L-methionine produced by Corynebacterium glutamicum KCCM 80 184 and Escherichia coli KCCM 80 096 does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that L-methionine produced by Corynebacterium glutamicum KCCM 80 184 and Escherichia coli KCCM 80 096 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 additive should be protected against degradation in the rumen. >

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council, either on the initiative of the Commission or following an application. Pursuant to Annex II to Regulation (EC) No 1333/2008, ascorbic acid (E 300) and citric acid (E 330) are currently authorised for use as food additives in a wide variety of foods.

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-cystine produced by Pantoea ananatis NITE BP-02525 as a feed additive in feed and water for drinking for all animal species. That application was accompanied by the particulars and documents required under Article 7 of Regulation (EC) No 1831/2003. The application concerns the authorisation of L-cystine produced by Pantoea ananatis NITE BP-02525 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', and in the additive category 'sensory additives', functional group 'f lavouring compounds'.

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. Article 10(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Article 4 of the same Regulation for the authorisation of a new use of an additive.Ethyl ester of β-apo-8'-carotenoic acid was authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for poultry belonging to the functional group ‘colourants, including pigments', under the heading 'carotenoids and xanthophylls'. 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 Articles 4 and 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of ethyl ester of β-apo-8'-carotenoic acid in water for drinking and the re-evaluation of ethyl ester of β-apo-8'-carotenoic acid as feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'colourants'. The application was accompanied by the particulars and documents required under Article 7(3) of 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 authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of copper chelate of lysine and glutamic acid. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. That application concerns the authorisation of copper chelate of lysine and glutamic acid as a feed additive for all animal species to be classified in the additive category ‘nutritional additives.

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. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger CBS 109.713 and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger DSM 18 404 as a feed additive for lactating sows to be classified in the additive category 'zootechnical additives' and in the functional group 'digestibility enhancers'.