Notifications for European Union (1104 notifications)

The text revises the conditions of use and the EU specifications of the authorised food additives potassium nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E 251) and potassium nitrate (E 252). Nitrites and nitrates are food additives authorised in the European Union used as a preservative to secure, in conjunction with other factors, the microbiological safety of foods. At the same time, the presence of nitrites and nitrates in foods can give rise to the formation of nitrosamines some of which are carcinogenic. The European Food Safety Authority (EFSA) in its 2017 scientific opinions re-evaluating the safety of nitrites and nitrates as food additives concluded that their respective Acceptable Daily Intake values (ADIs) were not exceeded from food additive uses; however the ADIs would be exceeded if all sources of dietary exposure were to be considered together. In addition, EFSA considered that there was some concern for the overall exposure to nitrosamines present in food, which was also confirmed by the recent scientific opinion on the risks to public health related to the presence of nitrosamines in food (2023).Following the EFSA re-evaluation of nitrites and nitrates as food additives, it is appropriate to reduce the maximum amounts of nitrites and nitrates that may be added to foods to keep the level of nitrosamines potentially formed due to that use as low as possible, while ensuring microbiological safety. It is also appropriate to amend the specifications and lower the existing maximum permitted limits for lead, mercury and arsenic in nitrites and nitrates additives.In order to allow for a smooth transition, the text lays down transitional periods for food business operators to adapt to the new more stringent conditions of use and specifications.

The substance covered by the Act was authorised as feed additive for all animal species by Commission Implementing Regulation (EU) 2022/1493 for a 10-year period. Implementing Regulation (EU) 2023/584 corrects the maximum moisture content and the percentage of other amino acids contained in this additive identified as ‘3c305ii’.

The substances covered by the Act were authorised as feed additives for certain animal species by Commission Implementing Regulation (EU) 2022/1452 for a 10-year period. Implementing Regulation (EU) 2023/585 corrects the production methods for the additives Eugenol and 1-Methoxy4-(prop-1(trans)-enyl)benzene.

This draft Commission Implementing Regulation provides that the approval of the active substance clofentezine is not renewed in accordance with Regulation (EC) No 1107/2009. Member States shall withdraw authorisations for plant protection products containing clofentezine 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 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/994

This draft Commission Implementing Regulation provides that the approval of the active substance triflusulfuron-methyl is not renewed in accordance with Regulation (EC) No 1107/2009. Member States shall withdraw authorisations for plant protection products containing triflusulfuron-methyl 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 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/993

The substances covered by the Act were authorised as feed additives in the functional group of flavouring compounds. Applications were submitted for the reauthorisation of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. Further to the positive assessment by the European Food Safety Authority, these substances are reauthorised as feed additives for all animal species, under certain conditions. A transitional period is included for the interested parties to meet the new authorisation’s requirements.

The substances covered by the Act were authorised as feed additives in the functional group of flavouring compounds. Applications were submitted for the reauthorisation of these substances in accordance with article 10 of Regulation (EC) No 1831/2003. Further to the positive assessment by the European Food Safety Authority, these substances are reauthorised as feed additives for all animal species, under certain conditions. A transitional period is included for the interested parties to meet the new authorisation requirements.

The use of bitter orange extract as feed additive was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/652. Bitter orange extract is known to contain 10 to 20% neohesperidin, as detailed in the column "Composition, chemical formula, description, analytical method" in the Annex to Implementing Regulation (EU) 2022/652. An incorrect presumption of a relationship between neohesperidin, identified with CAS number 13241-33-3, and neohesperidin dihydrochalcone, identified with CAS number 20702-77-6, which has a similar name but is a distinct substance, resulted in point 3 of the column "Other provisions" in the Annex to Implementing Regulation (EU) 2022/652, which mistakenly provides for the exclusion of the use of bitter orange extract in combination with neohesperidin dihydrochalcone. Commission Implementing Regulation  (EU) 2023/54 corrects this mistake.

The preparations specified in this Act were initially authorised for a period of ten years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1263/2011. Several applications were submitted for the renewal of this authorisation. Further to the favorable assessment by the European Food Safety Authority, the authorisation of these preparations is renewed, subject to certain conditions. A transition period is laid down for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

The substances specified in this Act were initially entered in the Register of feed additives as existing products belonging to the functional group of flavouring compounds. Several applications were later submitted for the reauthorisation of these substances in accordance with Regulation (EC) No 1831/2003. Further to the favorable assessment by the European Food Safety Authority, these substances are reauthorised as feed additives for all animal species, subject to certain conditions. A transition period is laid down for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

Article 118 (1) of Regulation (EU) 2019/6 requires third country operators exporting animals or products of animal origin to the European Union to respect the prohibition on the use of antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and on the use of antimicrobials that have been reserved for the treatment of certain infections in humans. Commission Delegated Regulation (EU) 2023/905 supplements Regulation (EU) 2019/6 as regards the conditions for the entry into the Union of consignments of food-producing animals and products derived therefrom intended for human consumption from third countries or regions thereof.Article 4 (1)(b) of Delegated Regulation (EU) 2023/905 establishes that consignments of animals or products concerned entering the Union from third countries shall be accompanied by an official certificate attesting compliance with the Union’s prohibition on the use of antimicrobial medicinal products.This draft Implementing Regulation amends the model certificates for the export to the Union of food-producing animals and products derived therefrom intended for human consumption to include the relevant attestations of compliance with the provisions set by Regulation (EU) 2019/6.

The draft act concerns the authorisation of guanidinoacetic acid, in the form of a substance and of a preparation, as a feed additive for chickens reared for breeding and chickens reared for laying (for use in feed and in water for drinking) and for chickens for fattening (for use in water for drinking). The draft act also corrects and amends the existing authorisation of that additive (for use in feed for chickens for fattening, pigs for fattening and weaned piglets) in order to re-allocate it to the category of ‘zootechnical additives’ instead of ‘nutritional additives’, on the basis of the EFSA opinions of 28 September 2022 and 27 January 2016. The draft act also specifies the composition of the additive in the form of a preparation.It is proposed to provide a transitional period in order to allow operators to adapt to the modifications of the existing authorisation, in particular the re-allocation of the additive to the category of ‘zootechnical additives’, triggering a holder-specific authorisation status. That transitional period would end on the expiry date of the existing authorisation (25 October 2026).

The proposed draft Regulation concerns the review of existing MRLs for desmedipham, etridiazole, flurtamone, profoxydim, difenacoum and potassium permanganate in certain food commodities following the non-approval of these substances in the European Union. Lower MRLs for etridiazole are set after deleting old uses which are not authorised any more in the European Union, and the values of the limits of determination specific to each product are updated in line with technical progress.

The proposed draft Regulation concerns the review of existing MRLs for indoxacarb in certain food commodities following the non-approval of indoxacarb in the European Union. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union. MRLs in certain commodities for which a human health concern may not be excluded are also lowered.

The proposed draft Regulation concerns the update of existing MRLs for thiacloprid in certain food commodities. The proposed changes are based upon reasoned opinions of the European Food Safety Authority (EFSA). 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 proposed draft Regulation concerns the update of existing MRLs for haloxyfop in certain food commodities. The proposed changes are based upon reasoned opinions of the European Food Safety Authority (EFSA). 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 use as feed additives of the following substances was authorized for ten years: expressed orange essential oil, distilled orange essential oil and folded orange oils from Citrus sinensis (L.) Osbeck by Commission Implementing Regulation (EU) 2022/1421; bitter orange extract by Implementing Regulation (EU) 2022/652; expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lemon essential oil (volatile fraction) and distilled lime essential oil by Implementing Regulation (EU) 2022/1490; and expressed mandarin essential oil by Implementing Regulation (EU) 2022/320. However, several aspects of these authorisations need to be corrected to accurately reflect the conclusions of the scientific opinions adopted by the European Food Safety Authority (EFSA) for each additive, mainly:- for expressed orange essential oil, distilled orange essential oil, folded orange oils, bitter orange extract, expressed lemon essential oil, residual fraction of expressed lemon oil distilled, distilled lime essential oil and expressed mandarin essential oil: addition in each corresponding table of the annexes to the above mentioned acts of a new entry to authorise the use for all animal species other than those already mentioned in the table, except dogs, cats, ornamental fish and ornamental birds;- for distilled lemon essential oil (volatile fraction): addition in the table of the annex of a new entry to authorise the use for all animal species other than those already mentioned in the table.

The proposed draft Regulation concerns the update of existing MRLs for diethofencarb, fenoxycarb, flutriafol and pencycuron in certain food products. MRLs for these substances in certain commodities are changed. Lower MRLs are set at the level of Codex MRLs or at the limit of determination, 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/606 (14 December 2022) is now adopted by Commission Regulation (EU) 2023/1029 of 25 May 2023 amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for phosmet in or on certain products (Text with EEA relevance) [OJ L 139, 6 May 2023, p. 15].The Regulation shall apply from 15 September 2023.

The proposed draft Regulation concerns the review of existing MRLs for oxamyl in certain food commodities following the non-approval of oxamyl in the European Union. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union. MRLs in certain commodities for which a human health concern may not be excluded are also lowered.