Notifications for European Union (1104 notifications)

Commission Implementing Regulation (EU) 2024/1055 authorises iron(II) – betaine complex as a feed additive in the category ‘nutritional additives’, functional group ‘compounds of trace elements’, subject to certain conditions.

The proposal notified in G/SPS/N/EU/678 (13 September 2023) is now adopted by Commission Regulation (EU) 2024/1077 of 15 April 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2,4-DB, iodosulfuron-methyl, mesotrione and pyraflufen-ethyl in or on certain products (Text with EEA relevance).The Regulation shall apply from 6 November 2024.

The proposal notified in G/SPS/N/EU/708 (4 January 2024) is now adopted by Commission Regulation (EU) 2024/1022 of 8 April 2024 amending Regulation (EU) 2023/915 as regards maximum levels of deoxynivalenol in food (Text with EEA relevance).The Regulation shall apply from 1 July 2024.

Commission Implementing Regulation (EU) 2024/997 authorizes L-valine produced by Corynebacterium glutamicum CGMCC 18932 as feed additive in the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’, subject to certain conditions.

The proposal notified in G/SPS/N/EU/707 (4 January 2024) is now adopted by Commission Regulation (EU) 2024/1038 of 9 April 2024 amending Regulation (EU) 2023/915 as regards maximum levels of T-2 and HT-2 toxins in food (Text with EEA relevance).The Regulation shall apply from 1 July 2024.

The proposal notified in G/SPS/N/EU/709 (4 January 2024) is now adopted by Commission Regulation (EU) ) 2024/1003 of 4 April 2024 amending Regulation (EU) 2023/915 as regards maximum levels for the sum of 3-monochlorpropanediol (3-MCPD) and 3-MCPD fatty acid esters in infant formulae, follow-on formulae and food for special medical purposes intended for infants and young children and young child formulae (Text with EEA relevance).The Regulation shall apply from 1 January 2025.

The measure concerns an extension of the conditions of use of the novel food lactitol to the generic reference to food supplements and their forms defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the member States relating to food supplements.

The measure concerns an amendment of several parameters (astaxanthin monoesters, astaxanthin diesters, astaxanthin 9-cis stereoisomer, and the protein content) in the specifications of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae.

The measure concerns the removal of galactose from the specifications of the novel food galacto-oligosaccharide, which currently include galactose at levels greater than 0.8% of the dry matter.

The proposal notified in G/SPS/N/EU/609 (17 January 2023) is now adopted by Commission Regulation (EU) 2024/891 of 22 March 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 bifenazate in or on certain products (Text with EEA relevance).The Regulation shall apply from 14 October 2024.

The measure updates the definition of ‘engineered nanomaterials’ of Regulation (EU) 2015/2263 on novel foods in line with technical and scientific progress. The measure transposes the main elements of the general nanomaterial definition of Commission Recommendation 2022/C 229/01 which is in turn underpinned by extensive technical and scientific elements and developments. The act maintains the current definition size limit (In addition, the Regulation includes elements specifically aimed to address the subjectivity elements in interpreting the ‘intentionally produced’ notion of the current definition which have hampered its implementation.

The substance covered by the Act was originally authorized as feed additive for all animal species. An 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 certain animal species in the category of sensory additives and the functional group of flavouring compounds, under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The substance covered by the Act was authorized as feed additive for all animal species. An 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 all animal species, in the category ‘technological additives’ and the functional group ‘binders’, under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The substance covered by the Act was originally authorized as feed additive for all animal species. An 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 certain animal species in the category of sensory additives and the functional group of flavouring compounds, under certain conditions. A transitional period is included for the interested parties to meet the new authorization’s requirements.

The substances covered by the Act were authorized as feed additives for some animal species by Commission Implementing Regulation (EU) 2022/415 for a 10-year period. Implementing Regulation (EU) 2024/762 corrects Implementing Regulation (EU) 2022/415 as follows:the title of Implementing Regulation (EU) 2022/415, which erroneously refers to ‘all animal species’, is adjusted to refer to ‘some animal species’;the entries 1a270 on lactic acid and 1a327 on calcium lactate are corrected to exclude ruminants with a non-functional rumen from the scope of the authorisation;concerning the entry 1a263 on calcium acetate, the text under the heading ‘Characterisation of the active substance’ is corrected to delete an erroneous entry related to iron.

Commission Implementing Regulation (EU) 2024/777 authorizes L-lysine base, liquid, L-lysine monohydrochloride, liquid, and L-lysine monohydrochloride produced by Escherichia coli NITE BP-02917 as feed additives in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and in the category ‘sensory additives’, functional group ‘flavouring compounds’, subject to certain conditions.

This Regulation aims to increase quality control under Regulation (EU) No 10/2011 on plastic food contact materials by:ensuring alignment with Regulation (EU) 2022/1616 on recycled plastics and Regulation (EU) No 528/2012 on biocidal products;introducing purity requirements for substances obtained from waste and natural materials; andadapting migration testing of multi-layer materials and repeat testing.It also adds quality control rules to Regulation (EC) No 2023/2006 on good manufacturing practice.

Commission Implementing Regulation (EU) 2024/764 authorizes a preparation of Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 as a feed additive belonging to the additive category ‘technological additives’ and in the functional group ‘hygiene condition enhancers’, subject to certain conditions.

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

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.