Notifications for European Union (1104 notifications)

The draft Regulation amends Implementing Regulation (EU) 2020/1201.Major points to be highlighted:In Articles 28 and 29, replacement of 80% confidence level and 1% design prevalence for the description of the survey design and sampling scheme, by a sufficient level of confidence to detect a low level of presence of the specified pest;Addition to the list of plants for which specific inspections are required to be introduced into the Union territory the following species: Lavandula angustifolia Mill., Lavandula x intermedia Emeric ex Loisel., Lavandula latifolia Medik., Lavandula stoechas L.and Salvia rosmarinus Spenn;In Article 29 and Article 30, removal of the mention “under the rubric ‘place of origin’” when information is to be provided in the phytosanitary certificate;Update of the list of Xylella fastidiosa host plants, adding to Annex I the following species: Castanea sativa Mill.; Clinopodium nepeta (L.) Kuntze; Cornus sanguinea L.; Grevillea rosmarinifolia A. Cunn.; Lonicera periclymenum L.; Mentha suaveolens Ehrh.; Pyracantha coccinea M. Roem.; Senecio inaequidens DC;Addition of two new tests in part B of Annex IV.

Article 118 (1) of Regulation (EU) 2019/6 requires third country operators exporting animals or products of animal origin intended for human consumption 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)(a) of Delegated Regulation (EU) 2023/905 establishes that consignments of animals or products concerned entering the Union from third countries shall originate from a third country or region thereof included in the list of countries referred to in Article 5 of that Regulation.This draft Implementing Regulation lays down the list of approved third countries or regions thereof in accordance with Delegated Regulation (EU) 2023/905.

Commission Implementing Regulation (EU) 2024/1685 authorizes a preparation of glycosylated 1,25-dihydroxycholecalciferol from Solanum glaucophyllum extract as a feed additive for dairy cows in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, subject to certain conditions.

Commission Delegated Regulation (EU) 2019/934 supplements Regulation (EU) No 1308/2013 as regards rules that are necessary to ensure the proper functioning of the internal market for grapevine products. In particular, it defines in a clear and precise manner the permitted oenological practices including the methods for sweetening wines, the limits on the use of certain substances that may be used for wine-making and the conditions for using some of those substances for wine-making. It also aligns certain provisions with relevant international standards, namely the International Code of Oenological Practices and the International Oenological Codex of the International Organisation of Vine and Wine (OIV), as regards its Annex IA.The draft Commission Delegated Regulation amending Delegated Regulation (EU) 2019/934 introduces new oenological practices on the basis of resolutions adopted in 2022 and 2023 by the OIV. It also provides clarifications on, and improves consistency of, some of the existing provisions.Please note that elements pertaining to intellectual property rights, in particular to the application and/or implementation of Geographical Indications (GIs), are included in this notification as part of a legislative package but clearly fall outside the scope of the SPS Agreement.

This Regulation prohibits the use of bisphenol A (BPA) in the manufacture of those food contact materials and articles of which it may be a component, including adhesives, rubbers, ion-exchange resins, plastics, printing inks, silicones and varnishes and coatings. Additionally, it:allows the use of BPA in the manufacture of two specific food contact applications, by derogation and subject to a prohibition on the migration of BPA from the articles into food;prohibits the residual presence in food contact materials and articles that have been manufactured using bisphenols or bisphenol derivatives;prohibits the use of other bisphenols or bisphenol derivatives for which a harmonised classification of carcinogenic, mutagenic, reprotoxic category 1A or 1B or endocrine disrupting category 1, is listed in annex VI to Regulation (EC)M No 1272/2008 and applies, except where a derogation may be given;lays down rules concerning compliance and testing;sets out transitional periods for the application of the requirements.This draft Commission Regulation will also be notified under the TBT Agreement.

The proposed draft Regulation concerns the update of existing MRLs for zoxamide in certain food products.The European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the review of the existing MRLs for that active substance in accordance with Article 12(1) of Regulation (EC) No 396/2005 and setting of an import tolerance for onions, garlic and shallots.MRLs for zoxamide in certain commodities are changed based on this reasoned opinion. Codex MRLs are maintained and MRLs for certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorized any more in the European Union and for which a human health concern may not be excluded.

G/SPS/N/EU/772 contains a typo. In Item 6, "yearlong beans" should read "yardlong beans".6.Description of content: Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country).               This Implementing Regulation amends Annexes I and II to Implementing Regulation (EU) 2019/1793 by introducing the following changes:•     Inclusion in Annex I of eggplants (Solanum aethiopicum) from Burkina Faso due to risk of contamination by pesticide residues;•     Delisting from Annex I (and thus, from the Regulation) of Brazil nuts in shell and mixtures of Brazil nuts or dried fruits containing Brazil nuts in Shell from Brazil, groundnuts and products produced from groundnuts from Brazil, groundnuts and products produced from groundnuts from The Gambia, locust beans (carob), locust beans seeds, not decorticated, crushed or ground and mucilages and thickeners, whether or not modified, derived from locust beans or locust beans seeds from India and guar gum from India, instant noodles containing spices/seasonings or sauces from South Korea, peppers of genus Capsicum (other than sweet) from Pakistan, groundnuts and products produced from groundnuts from Sudan, locust beans (carob), locust beans seeds, not decorticated, crushed or ground and mucilages and thickeners, whether or not modified, derived from locust beans or locust beans seeds from Türkiye and instant noodles containing spices/seasonings or sauces from Viet Nam;•     Decrease in the frequency of identity and physical checks laid down in Annex I for hazelnuts and products produced from hazelnuts from Georgia (aflatoxins – 20%), spice mixes from Pakistan (aflatoxins – 30%) and grapefruits from Türkiye pesticide residues – 20%);•     Increase in the frequency of identity and physical checks laid down in Annex I for betel leaves (Piper betle L.) from India (Salmonella – 50%) and drumsticks (Moringa oleifera) from India (pesticide residues – 30%);•     Removal from Annex I and inclusion in Annex II of Gotukola (Centella asiatica) from Sri Lanka (pesticide residues – 50%) and peppers of the genus Capsicum (other than sweet) from Viet Nam (pesticide residues – 50%);•     Removal from Annex II and inclusion in Annex I of yardlong beans from Dominican Republic (pesticide residues – 30%), groundnuts and products produced from groundnuts from Ghana (aflatoxins – 50%), mixtures of food additives containing locust bean gum or guar gum, vanilla and cloves (whole fruit, cloves and stems) from India (ethylene oxide – 20%), mixtures of food additives containing locust bean gum from Malaysia (ethylene oxide – 30%) and mixtures of food additives containing locyst bean gum from Türkiye (ethylene oxide – 30%);•     Increase in the frequency of identity and physical checks laid down in Annex II for nutmeg (Myristica fragrans) from Indonesia (aflatoxins – 50%), nutmeg, mace and cardamon from India (ethylene oxide – 30%), sesamum seeds from Uganda (Salmonella – 30%) and pitahaya (dragon fruit) from Viet Nam (pesticide residues – 30%);•          Decrease in the frequency of identity and physical checks laid down in Annex II for pepper of the genus Piper, dried or crushed or ground fruit of the Capsicum or of the genus Pimenta and ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices from Ethiopia (aflatoxins – 30%), dried figs and products produced from dried figs from Türkiye (aflatoxins – 20%), pistachios and products produced from pistachios from Türkiye (aflatoxins – 30%) and pistachios and derived products originating in the United States and dispatched to the Union from Türkiye (aflatoxins – 30%).

The proposal notified in G/SPS/N/EU/729 (23 February 2024) is now adopted by Commission Implementing Regulation (EU) 2024/1727 of 20 June 2024 withdrawing from the market certain feed additives (Text with EEA relevance).This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

The text revises the EU specifications of the authorized food additives sorbic acid (E 200), potassium sorbate (E 202) and propyl gallate (E 310) and authorizes an extension of use of sorbic acid (E 200) and potassium sorbate (E 202) as preservatives in fruit-flavoured water-based gelatine desserts based on the recent scientific opinions from the European Food Safety Authority (EFSA). For sorbic acid (E 200) and potassium sorbate (E 202), the current specifications are adapted by reducing the maximum limits for toxic elements (arsenic, lead and mercury) and by establishing a maximum limit for zinc. Furthermore, the description of potassium sorbate (E 202) is amended by including the granular form.For propyl gallate (E 310), the current specifications are adapted by reducing the maximum limits for toxic elements and by restricting the use of catalysts in the manufacturing process of the food additive. The text also authorizes the use of sorbic acid (E 200) and potassium sorbate (E 202) in food category 16 ‘Desserts excluding products covered in categories 1, 3 and 4’ at a maximum level of 1000 mg/kg for fruit-flavoured water-based gelatine desserts.In order to allow for a smooth transition, the application of the new purity specifications for the food additives sorbic acid (E 200), potassium sorbate (E 202) and propyl gallate (E 310), and the definition of propyl gallate (E 310) is deferred and a transitional period is provided for food additives placed on the market before the date of application. Also, for foods containing sorbic acid (E 200), potassium sorbate (E 202) or propyl gallate (E 310) that have been lawfully placed on the market before the date of application, a transitional period is provided.

Regulation (EU) 2019/1793 lays down rules concerning the temporary increase of official controls upon entry into the Union on certain food and feed of non-animal origin from certain third countries (in Annex I); special import conditions for certain food and feed from certain third countries due to the contamination risk by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins and microbiological contamination (in Annex II - increased official border controls and official certificate accompanied by the results of sampling and analysis in the third country). This Implementing Regulation amends Annexes I and II to Implementing Regulation (EU) 2019/1793 by introducing the following changes:Inclusion in Annex I of eggplants (Solanum aethiopicum) from Burkina Faso due to risk of contamination by pesticide residues;Delisting from Annex I (and thus, from the Regulation) of Brazil nuts in shell and mixtures of Brazil nuts or dried fruits containing Brazil nuts in Shell from Brazil, groundnuts and products produced from groundnuts from Brazil, groundnuts and products produced from groundnuts from The Gambia, locust beans (carob), locust beans seeds, not decorticated, crushed or ground and mucilages and thickeners, whether or not modified, derived from locust beans or locust beans seeds from India and guar gum from India, instant noodles containing spices/seasonings or sauces from South Korea, peppers of genus Capsicum (other than sweet) from Pakistan, groundnuts and products produced from groundnuts from Sudan, locust beans (carob), locust beans seeds, not decorticated, crushed or ground and mucilages and thickeners, whether or not modified, derived from locust beans or locust beans seeds from Türkiye and instant noodles containing spices/seasonings or sauces from Viet Nam;Decrease in the frequency of identity and physical checks laid down in Annex I for hazelnuts and products produced from hazelnuts from Georgia (aflatoxins – 20%), spice mixes from Pakistan (aflatoxins – 30%) and grapefruits from Türkiye pesticide residues – 20%);Increase in the frequency of identity and physical checks laid down in Annex I for betel leaves (Piper betle L.) from India (Salmonella – 50%) and drumsticks (Moringa oleifera) from India (pesticide residues – 30%);Removal from Annex I and inclusion in Annex II of Gotukola (Centella asiatica) from Sri Lanka (pesticide residues – 50%) and peppers of the genus Capsicum (other than sweet) from Vietnam (pesticide residues – 50%);Removal from Annex II and inclusion in Annex I of yearlong beans from Dominican Republic (pesticide residues – 30%), groundnuts and products produced from groundnuts from Ghana (aflatoxins – 50%), mixtures of food additives containing locust bean gum or guar gum, vanilla and cloves (whole fruit, cloves and stems) from India (ethylene oxide – 20%), mixtures of food additives containing locust bean gum from Malaysia (ethylene oxide – 30%) and mixtures of food additives containing locyst bean gum from Türkiye (ethylene oxide – 30%);Increase in the frequency of identity and physical checks laid down in Annex II for nutmeg (Myristica fragrans) from Indonesia (aflatoxins – 50%), nutmeg, mace and cardamon from India (ethylene oxide – 30%), sesamum seeds from Uganda (Salmonella – 30%) and pitahaya (dragon fruit) from Vietnam (pesticide residues – 30%);Decrease in the frequency of identity and physical checks laid down in Annex II for pepper of the genus Piper, dried or crushed or ground fruit of the Capsicum or of the genus Pimenta and ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices from Ethiopia (aflatoxins – 30%), dried figs and products produced from dried figs from Türkiye (aflatoxins – 20%), pistachios and products produced from pistachios from Türkiye (aflatoxins – 30%) and pistachios and derived products originating in the United States and dispatched to the Union from Türkiye (aflatoxins – 30%).

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 proposal notified in G/SPS/N/EU/733 (1 March 2024) is now adopted by Commission Regulation (EU) 2024/1451 of 24 May 2024 amending Annex II and Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additives tartaric acid (L(+)-) (E 334), sodium tartrates (E 335), potassium tartrates (E 336), sodium potassium tartrate (E 337) and calcium tartrate (E 354) (Text with EEA relevance).The Regulation shall apply from 16 December 2024.

The substances specified in this Act were initially authorized for a period of ten years as feed additives for all animal species in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. An application was submitted for the renewal of this authorization. Further to the favourable assessment by the European Food Safety Authority, the authorization of these substances is renewed, subject to certain conditions.

Commission Implementing Regulation (EU) 2024/1325 authorizes cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299 as a feed additive in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, subject to certain conditions (Text with EEA relevance).

The substance specified in this Act was initially authorized for a period of ten years as a feed additive for all animal species in the category ‘technological additives’ and in the functional group ‘silage additives’. 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 substance is renewed, subject to certain conditions.

The substance specified in this Act was initially authorized for a period of ten years as a feed additive for cats, dogs and ornamental fish in the category ‘technological additives’ and in the functional group ‘acidity regulators’. 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 substance is renewed, subject to certain conditions.

The substance specified in this Act was initially authorized for a period of ten years as a feed additive for all animal species in the category ‘technological additives’ and in the functional group ‘preservatives’. 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 substance is renewed, subject to certain conditions.

The preparation specified in this Act was initially authorized for a period of ten years as a feed additive for all animal species in the category ‘technological additives’ and in the functional group ‘silage additives’. 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 foreseen dates of adoption and publication for the draft Commission Regulation (EU) amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the removal of the flavouring substance Benzene-1,2-diol (FL No. 04.029) from the Union list (Text with EEA relevance) should read fourth quarter 2024 instead of June 2024.

The proposal notified in G/SPS/N/EU/686 (30 October 2023) is now adopted by Commission Regulation (EU) 2024/1314 of 15 May 2024 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon in or on certain products (Text with EEA relevance).The Regulation shall apply from 5 December 2024.