Notifications for European Union (1104 notifications)

The substances covered by the Act were authorized as feed additives in the functional group of flavouring compounds. Applications were submitted for the reauthorization 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 reauthorized as feed additives for all animal species (black pepper essential oil and black pepper oleoresin) and for cats and dogs (black pepper supercritical extract), under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The preparation specified in this Act was initially authorized for a period of ten years as feed additive for all animal species. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of this preparation is renewed, subject to certain conditions.

The substance covered by the Act was authorized as feed additive in the functional group ‘flavouring compounds’. The application was submitted for the reauthorization of this substance in accordance with article 10 of Regulation (EC) No 1831/2003. Further to the positive assessment by the European Food Safety Authority, this substance is reauthorized as feed additive for dogs, cats and horses, under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The Regulation amends model certificates and model declarations for the entry into the Union of consignments of certain categories of terrestrial animal and germinal products thereof in order to reflect new EU animal health requirements, update references to new EU legislation regarding residues requirements for the entry into the Union of animals, and clarify and make consistent the wording of certain requirements, notes and footnotes.

The proposal notified in G/SPS/N/EU/649 (29 June 2023) is now adopted by Commission Regulation (EU) 2024/341 of 22 January 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diethofencarb, fenoxycarb, flutriafol and pencycuron in or on certain products (Text with EEA relevance).The Regulation shall apply from 12 August 2024.

The proposal notified in G/SPS/N/EU/648 (28 June 2023) is now adopted by Commission Implementing Regulation (EU) 2023/2203 of 20 October 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance rafoxanide with respect to its maximum residue limit in foodstuffs of animal origin (Text with EEA relevance).The Regulation shall apply from 9 November 2023.

The following technical mistakes were highlighted in Implementing Regulation (EU) 2024/286 notified in G/SPS/N/EU/712 (18 January 2024):Several lines between the commodities were missing or wrongly inserted and created confusion in relation to groups of commodities for particular hazards and to which commodities belonged to which country of origin;The footnote for okra from India due to possible contamination by pesticide residues was wrongly indicated.These technical mistakes were corrected by Corrigenda 2024/90066 and 2024/90035 to Commission Implementing Regulation (EU) 2024/286 of 16 January 2024 amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council.

The proposal notified in G/SPS/N/EU/652 (6 July 2023) is now adopted by Commission Regulation (EU) 2024/398 of 29 January 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for haloxyfop in or on certain products (Text with EEA relevance).The Regulation shall apply from 19 August 2024.

The proposal notified in G/SPS/N/EU/646 (28 June 2023) is now adopted by Commission Regulation (EU) 2024/331 of 19 January 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for oxamyl in or on certain products (Text with EEA relevance).The Regulation shall apply from 11 May 2024.

The proposal notified in G/SPS/N/EU/647 (28 June 2023) is now adopted by Commission Implementing Regulation (EU) 2023/2194 of 19 October 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin (Text with EEA relevance).The Regulation shall apply from 9 November 2023.

The proposal notified in G/SPS/N/EU/653 (7 July 2023) is now adopted by Commission Regulation (EU) 2024/376 of 24 January 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for indoxacarb in or on certain products (Text with EEA relevance).The Regulation shall apply from 14 August 2024.

The proposal notified in G/SPS/N/EU/654 (7 July 2023) is now adopted by Commission Regulation (EU) 2024/345 of 22 January 2024 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 desmedipham, etridiazole, flurtamone, profoxydim, difenacoum and potassium permanganate in or on certain products (Text with EEA relevance).The Regulation shall apply from 12 August 2024.

The draft act concerns the withdrawal from the EU market of star anise terpenes from Illicium verum Hook.f. as a feed additive belonging to the functional group of ‘flavouring compounds’. That additive was allowed on the EU market under the previous legislation (Directive 70/524/EEC), as part of a generic entry within the group of ‘flavouring and appetising substances’ and was the subject of an application for re-authorization submitted under Article 10(2) of Regulation (EC) No 1831/2003. In its opinion of 26 September 2023, the European Food Safety Authority (‘EFSA’) concluded that the additive star anise terpenes contains up to 25% estragole by specification and is obtained by a manufacturing process which results in the enrichment of this genotoxic carcinogen. EFSA further stated that this does not comply with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives. Therefore, EFSA considered that it was inappropriate to perform an assessment of the safety and efficacy of star anise terpenes for its use as a feed additive. The applicant subsequently withdrew the application for re-authorization of that feed additive for all animal species. As a result of the withdrawal of the application, Article 10(5) of Regulation (EC) No 1831/2003 imposes the adoption of a measure requiring the withdrawal from the market of the additive concerned. It is proposed to provide a limited period of time – which is kept to a minimum due to the safety concerns raised in the relevant EFSA opinion - in order to allow operators to comply properly with the measure.

The proposal notified in G/SPS/N/EU/642 (13 June 2023) is now adopted by Commission Regulation (EU) 2024/352 of 22 January 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for (Z)-13-hexadecen-11-yn-1-yl acetate, (Z,Z,Z, Z)-7,13,16,19-docosatetraen-1-yl isobutyrate, acrinathrin, azimsulfuron, famoxadone, prochloraz and sodium hypochlorite in or on certain products (Text with EEA relevance).The Regulation shall apply from 12 August 2024.

The proposed draft Regulation concerns the review and update of existing MRLs for napropamide, pyridaben and tebufenpyrad in certain food products following the evaluation and/or the lack of confirmatory data.

Amending the lists of aquatic animal species which are susceptible to or vectors of the aquatic diseases which have been listed in accordance with Regulation (EU) 2016/429.

The proposed draft Regulation concerns the review and update of existing MRLs for cyproconazole and spirodiclofen in certain food commodities. MRLs for these substances in certain commodities are lowered. 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 as the approval of the use of the active substance has expired.

The proposal notified in G/SPS/N/EU/681 (27 September 2023) is now adopted by Commission Regulation (EU) 2024/238 of 15 January 2024 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the introduction of restrictions on the use of certain flavouring substances (Text with EEA relevance).The Regulation shall apply from 5 February 2024.

The proposal notified in G/SPS/N/EU/680 (27 September 2023) is now adopted by Commission Regulation (EU) 2024/234 of 15 January 2024 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of certain flavouring substances from the Union list (Text with EEA relevance).The Regulation shall apply from 5 February 2024.

The proposal notified in G/SPS/N/EU/650 (3 July 2023) is now adopted by Commission Implementing Regulation (EU) 2024/239 of 15 January 2024 correcting and amending Implementing Regulations (EU) 2022/1421, (EU) 2022/652, (EU) 2022/1490 and (EU) 2022/320 (Text with EEA relevance) [OJ L 68, 6 March 2023, p. 55].The Regulation shall apply from 5 February 2024.