Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/629 (24 March 2023) is now adopted by Commission Regulation (EU 2023/1329 of 29 June 2023 amending Annex II to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council as regards the use of polyglycerol polyricinoleate (E 476) and the Annex to Commission Regulation (EU) No. 231/2012 as regards specifications for glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol polyricinoleate (E 476) (Text with EEA relevance) [OJ L 166, 30 June 2023, p. 66].The Regulation shall apply from 20 July 2023.

This proposal aims at correcting Commission Implementing Regulation 2022/415 notified in G/SPS/N/EU/552 on 5 April 2022 [OJ L 68, 6.3.2023, p. 55]. Namely, it corrects the title of Commission Implementing Regulation 2022/415 (that erroneously refers to “all animal species”), excludes ruminants with a non-functional rumen from the animal categories covered by the authorisation of lactic acid and calcium lactate and deletes the entry related to iron wrongly added for calcium acetate under “Characterisation of the active substance”.

The proposal notified in G/SPS/N/EU/632 (24 April 2023) is now adopted by Commission Regulation (EU) 2023/1428 of 7 July 2023 amending the Annex to Regulation (EU) No 231/2012 as regards mono- and diglycerides of fatty acids (E 471) (Text with EEA relevance) [OJ L 175, 10.7.2023, p. 6].The Regulation shall apply from 30 July 2023.

The proposal notified in G/SPS/N/EU/611 (23 January 2023) is now adopted by Commission Regulation (EU) 2023/1442 of 11 July 2023 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and addition of new substances (Text with EEA relevance) [OJ L 177, 12 July 2023, p. 45]. The Regulation shall apply from 1 August 2023.

The proposal notified in G/SPS/N/EU/614 (16 February 2023) is now adopted by Commission Delegated Regulation (EU) 2023/1674 of 19 June 2023 amending Delegated Regulation (EU) 2021/630 as regards the inclusion of certain spreads and preparations for making beverages containing cocoa, certain prepared foods obtained from cereals or cereal products, certain prepared foods obtained from rice and other cereals, certain chips and crisps, and certain sauces and condiments in the list of composite products exempted from official controls at border control posts and amending Annexes I and III to Delegated Regulation (EU) 2019/2122 (Text with EEA relevance) [OJ L 216, 1.9.2023, p. 1]. The Regulation shall apply from 21 September 2023.

The draft act concerns the authorisation as “flavouring compound” of a tincture from the plant Gentiana Lutea L. within the scope of the European Union legislation on feed additives, i.e. Regulation (EC) No. 1831/2003. The measure aims at authorising this additive for all species, but only for categories of animals intended for fattening, and to withdraw the placing on the market of the additive for the rest of the animals. It is proposed to provide transitional periods for the different types of feeds: 12 months for existing stocks of the additive, 15 months for stocks of premixtures produced with the additives mentioned before and 24 months for compound feed produced with the feed additives and premixtures mentioned before.

The proposal notified in G/SPS/N/EU/634 (4 May 2023) is now adopted by Commission Implementing Regulation (EU) 2023/1706 of 7 September 2023 amending Implementing Regulation (EU) 2020/1201 as regards the lists of plants known to be susceptible to Xylella fastidiosa [OJ L 221, 8 September 2023, p. 14]. The Regulation shall apply from 28 September 2023.

The proposed draft Regulation concerns the update of existing MRLs for 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl in certain food products following the evaluation and/or the lack of confirmatory data.

The proposal notified in G/SPS/N/EU/630 (14 April 2023) is now adopted by Commission Implementing Regulation (EU) 2023/1699 of 6 September 2023 on the status of attapulgite as a feed additive within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (Text with EEA relevance) [OJ L 220, 7 September 2023, p. 9]. The Regulation shall apply from 26 September 2023.

The preparation covered by this Act was authorised by Commission Implementing Regulation (EU) No 1065/2012 for a period of 10 years as feed additive for all animal species. An application was submitted for the renewal of this authorisation. Further to the favorable assessment by the European Food Safety Authority, the authorisation of this preparation is renewed, subject to certain conditions. A transitional period is laid down for the interested parties to prepare themselves to meet the new requirements resulting from this renewal.

The preparation covered by this Act was authorised by Commission Implementing Regulation (EU) No 93/2012 for a period of 10 years as feed additive for all animal species. An application was submitted for the renewal of this authorisation. Further to the favorable assessment by the European Food Safety Authority, the authorisation of this preparation is renewed, subject to certain conditions. A transitional period is laid down for the interested parties to prepare themselves to meet the new requirements resulting from this renewal.

The act concerns the withdrawal from the EU market of a series of feed additives for administrative reasons, due to the lack of application for re-authorisation of those products submitted before the deadline laid down in Article 10(2) of Regulation (EC) No 1831/2003 – or the withdrawal by the applicant of a submitted application for re-authorisation. Transitional periods are laid down for the interested parties to prepare themselves to meet the requirement concerning the withdrawal from the market of the products concerned.

Commission Implementing Regulation (EU) 2023/1405 authorises a preparation of Lactiplantibacillus plantarum ATCC 55058 and a preparation of Lactiplantibacillus plantarum ATCC 55942 for all animal species as feed additives belonging to the additive category ‘technological additives’ and the functional group ‘silage additives’.

This draft Commission Implementing Regulation provides that the approval of the active substance Benthiavalicarb is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing Benthiavalicarb as an active substance. The non-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. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, 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/997.

This draft Commission Implementing Regulation provides that the approval of the active substance Metiram is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing Metiram as an active substance. The non-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. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, 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/996.

The preparation covered by this Act was authorised by Commission Implementing Regulation (EU) No 349/2010 for a period of ten years as feed additive for all animal species. An application was submitted for the renewal of this authorisation. Further to the favorable assessment by the European Food Safety Authority, the authorisation of this preparation is renewed, subject to certain conditions. A transitional period is laid down for the interested parties to prepare themselves to meet the new requirements resulting from this renewal.

Commission Implementing Regulation (EU) 2023/649 authorises L-arginine produced by Corynebacterium glutamicum CGMCC 20516, for all animal species, as a feed additive belonging to the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’.

The use of ylang ylang essential oil as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) 2022/1412 for a 10-year period.Commission Implementing Regulation (EU) 2023/257 corrects a date indicated in the transitional measure for non-food-producing animals set out in Article 2, paragraph 3.

Commission Implementing Regulation (EU) 2023/1163 authorises L-Lysine monohydrochloride and L-Lysine sulphate produced by Corynebacterium glutamicum CGMCC 17927 for all animal species as feed additives belonging to the additive category ‘nutritional additives’ and the functional group ‘amino acids, their salts and analogues’.

Commission Implementing Regulation (EU) 2023/651 authorises riboflavin (vitamin B2) produced by Bacillus subtilis KCCM 10445 and a preparation of riboflavin produced by Bacillus subtilis KCCM 10445 as feed additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, for all animal species.