Notifications for European Union (1104 notifications)

To establish an MRL for rafoxanide in bovine and ovine, in relation to milk, and to extrapolate the MRL for rafoxanide to all ruminants except ovine.

To establish MRL for ketoprofen in chicken tissues and to extrapolate it to other poultry species, but not to poultry eggs.

The text removes the authorisation to use stearyl tartrate (E 483) in foods based on the recent scientific opinion from the European Food Safety Authority (EFSA) concluding that the safety of stearyl tartrate (E 483) could not be assessed.In order to allow for a smooth transition, the text lays down that foods that contain stearyl tartrate (E 483) used in accordance with the rules applicable before the date of application of the Regulation may continue to be marketed until their date of minimum durability or ‘use-by date’.

Emergency import requirements are put in place in relation to Spodoptera frugiperda (Smith).

The proposed draft Regulation concerns the update of existing MRLs for (Z)-13-hexadecen-11-yn-1-yl acetate, (Z,Z,Z,Z)-7,13,16,19-docosatetraen-1-yl isoburyrate, acrinathrin, azimsulfuron, famoxadone, methyl nonyl ketone, prochloraz and sodium hypochlorite in certain food commodities. 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.

Import requirements and internal measures are put in place in relation to theTomato brown rugose fruit virus.

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:Modification of measures/ new measures:Inclusion in Annex I of sugar apple (Annonna squamosa) from Egypt, green papaya (Carica papaya) from Mexico, cumin seeds from India due to risk of contamination by pesticide residues and tahini and halva from Sesamum seeds from Syria due to risk of contamination by SalmonellaDelisting from Annex I (and thus, from the Regulation) of watermelon (Egusi, Citrullus spp.) seeds and derived products from Nigeria, groundnuts and products produced from groundnuts from Senegal, 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 Malaysia and dried apricots and apricots, otherwise prepared or preserved from Uzbekistan;Removal from Annex II and inclusion in Annex I of sweet peppers (Capsicum annuum) and peppers of the genus Capsicum (other than sweet) from Dominican Republic, peppers of the genus Capsicum (other than sweet) from Pakistan, due to risk of contamination by pesticide residues, groundnuts and produced from groundnuts from Gambia, peppers of the genus Capsicum (sweet or other than sweet) from India, groundnuts and products produced from groundnuts from Sudan due to risk of contamination by aflatoxins, 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 and guar gum from India, instant noodles containing spices/seasonings or sauces from South Korea, 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, instant noodles containing spices/seasonings or sauces from Vietnam due to risk of contamination by residues of Ethylene Oxide and guar gum from India due to risk of contamination by pentachlorophenol and dioxins;Increase in the frequency of identity and physical checks laid down in Annex I for sweet peppers (Capsicum annuum), peppers of the genus Capsicum (other than sweet) and oranges from Egypt (from 20% to 30%), drumsticks (Moringa oleifera) (from 10% to 20%), rice (from 5% to 10%) and guava (Psidium guajava) (from 20% to 30%) from India, gotukola (Centella asiatica) and mukunuwenna (Alternanthera sessilis) from Sri Lanka (from 30% to 50%), pomegranates from Türkiye (from 20% to 30%) due to risk of contamination by pesticide residues;Removal from Annex I and inclusion in Annex II of unprocessed apricot kernels from Türkiye due to risk of contamination by cyanide;Increase in the frequency of identity and physical checks laid down in Annex II for groundnuts and products produced from groundnuts from Egypt (from 20% to 30%) due to risk of contamination by aflatoxins and for oranges from Türkiye (from 20% to 30%) due to risk of contamination by pesticide residues; Inclusion in Annex II of pistachios and derived products originating in the United States and dispatched from Türkiye (50%) due to risk of contamination by aflatoxins.2. Technical adjustments to existing measures:To include ’including mixtures’ and the corresponding CN codes to the entry of groundnuts and derived products from Bolivia in table 1 of Annex II in the rows referring to groundnuts (peanuts), otherwise prepared or preserved;To delete the category ‘feed’ from the entry of Sesamum seeds from India in relation to Salmonella in table 1 of Annex II;Corrections and subdivisions added to CN codes for calcium carbonate from India in Table 1 of Annex II.

This draft Commission Implementing Regulation provides that the approval of the active substance S-metolachlor is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing S-metolachlor 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.In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.During the evaluation and peer-review of S-metolachlor, a number of concerns and areas that could not be finalised were identified. These are detailed in the statement of the European Food Safety Authority (EFSA).The decision is based on a risk assessment carried out by a rapporteur EU member State and peer reviewed by the European Food Safety Authority together with all EU member States, taking into account other factors legitimate to the matter.In the case of S-metolachlor, the outcome of the risk assessment, as documented in the EFSA conclusion, is not favourable and identifies critical areas of concern.These critical areas of concern have been identified: 1) the representative uses are shown to contaminate groundwater (by both the active substance and the groundwater relevant metabolites); and 2) all the representative uses are shown to pose risk for mammals, since high risk to earthworm-eating mammals via secondary poisoning was concluded.Moreover, part of the risk assessment could not be finalised by EFSA, thus precluding the renewal, such as an issue not finalised for the risk assessment of two human metabolites, the consumer dietary risk assessment (and the consequent livestock exposure assessment), and the consumer risk assessment regarding the treatment of surface water. For the environmental compartment, the risk assessment for aquatic and the one for non-target terrestrial plants could not be finalised.Therefore, the outcome of the risk assessment is not favourable to the renewal given that it can be concluded that several application scenarios are not acceptable. These concerns mean that S-metolachlor does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009.Existing authorisations will need to be withdrawn; EU member States must withdraw existing plant protection products containing S-metolachlor at the latest by three months from the date of entry into force. A period of grace in line with Article 46 of Regulation 1107/2009 is allowed for and shall expire at the latest six months from the entry into force (allowing for a final season of use).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/982.

New MRL for new target tissue as regards the substance praziquantel and rewording for the entry "animal species" already existing.

The measure authorises a production process using acetone washes of the pig kidneys to obtain the protein extract and the use of Ultra High Performance Liquid Chromatography linked with Fluorescent Detection (UHPLC-FLD) as an additional method to the currently authorised one for the determination of the enzymatic activity of Diamine Oxidase (DAO) contained in the extracted protein.

The measure authorizes the change in the conditions of use of 2’-Fucosyllactose to remove the obligatory condition that, when 2’-Fucosyllactose is used in combination with Lacto-N-neotetraose in infant formula and follow-on formula and in milk-based drinks and similar products intended for young children, at the currently authorized levels of up to 1,2 g/l, they should be used only at a 2:1 ratio (two parts 2’-Fucosyllactose to one part Lacto-N-neotetraose).

The measure authorizes the change in the conditions of use of Lacto-N-neotetraose to be used in infant formula and follow-on formula at the currently authorized levels of up to 0,6 g/l, without the obligatory use in combination with 2′-Fucosyllactose at a 1:2 use ratio (one part Lacto-N-neotetraose with two parts 2′-Fucosyllactose). Also, the measure removes the obligatory use of Lacto-N-neotetraose in combination with 2′-Fucosyllactose at a 1:2 use ratio in milk-based drinks and similar products intended for young children without when the two novel foods are added separately.

Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in food has been amended many times. To improve the readability and clarity of this Regulation, this Regulation replaces Regulation (EC) No 1881/2006, including all subsequent amendments.  All the provisions provided for in this Regulation have already been previously notified to the WTO for comments. This draft Regulation does not change in substance these previously notified comments and is therefore mainly notified for information.

On 9 January 2023, the European Food Safety Authority updated the database of host plants susceptible to Xylella fastidiosa (Wells et al.). Annexes I and II to Implementing Regulation (EU) 2020/1201 are therefore amended accordingly.

The main purposes of the revision are to:•          introduce specific requirements for dry-ageing of beef, subject to a transitional period;•          amend the transport conditions of carcases and certain cuts of domestic ungulates and harmonise the testing of the surface temperature of such meat;•          allow the transport of farmed game slaughtered on the farm, to be transported to a game handing establishment;•          introduce alternative options to demonstrate the effectiveness of heat treatments of milk;•          allow the flavouring of eggs under certain conditions;•          introduce provisions to slightly decrease the temperature for slicing fresh or processed fishery products or to increase the temperature of frozen fishery products and the prohibition to store or transport fishery products at that temporarily technologically-required temperature.

The text revises the EU specifications of the authorised food additives mono- and diglycerides of fatty acids (E 471) based on the recent scientific opinion from the European Food Safety Authority (EFSA). The current specifications are adapted by reducing the maximum limits for toxic elements, by including maximum limits for the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD), glycidyl fatty acid esters (expressed as glycidol) and erucic acid and by modifying the definition of mono- and diglycerides of fatty acids (E 471).In order to allow for a smooth transition, the text lays down that the use of the food additives mono- and diglycerides of fatty acids (E 471), lawfully placed on the market before the date of the entry into force of this Regulation is allowed during a transitional period of six months. Foods containing such food additives may continue to be placed on the market during the same transitional period and may remain on the market until their date of minimum durability or 'use-by-date'. However, in light of the vulnerability of infants and young children, the food additive mono- and diglycerides of fatty acids (E 471) not complying with the maximum level for glycidyl fatty acid ester set out in this Regulation for use in foods for infants and young children should not allowed to be added to such foods after the date of entry into force of this Regulation and the marketing of those foods should be allowed only if they were lawfully placed on the market already before that date.The food additive mono- and diglycerides of fatty acids (E 471) legally placed on the market after the date of entry into force of this Regulation and complying with the reduced intermediate maximum level for glycidyl fatty acid esters (expressed as glycidol) is allowed to be used until the exhaustion of stocks and foods, except food for infants and young children, containing such food additive should be allowed to be placed on the market and to remain on the market until their date of minimum durability or 'use-by-date'.

Commission Delegated Regulation (EU) 2022/2292 lays down import conditions for food-producing animals and certain food. The draft makes the listing of establishments entering into the EU honey and apiculture products mandatory, subject to a transitional period. A number of other amendments are made facilitating trade of several products of animal origin.

The draft act concerns the determination of the legal status of the substance attapulgite as a feed additive within the scope of the EU legislation on feed additives, i.e. Regulation (EC) No. 1831/2003. The measure aims at bringing legal certainty and consistency as regards the conditions of placing on the market and use of attapulgite under the relevant applicable legislation.It is proposed to provide a transitional period of seven years in order to allow operators to adapt to the new status of attapulgite as a feed additive.

The proposal notified in G/SPS/N/EU/527 (15 December 2021) is now adopted Commission Regulation (EU) 2023/710 of 30 March 2023 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 bromopropylate, chloridazon, fenpropimorph, imazaquin and tralkoxydim in or on certain products (Text with EEA relevance) [OJ L 93, 31 March 2023, p. 57–83].The MRLs for the active substance bifenthrin, which was initially included in the draft Regulation notified in G/SPS/N/EU/527, will be reviewed in a separated Regulation taking into account a recent assessment from the European Food Safety Authority (EFSA Journal 2023;21(3):7864). The proposal will be notified to the Committee on Sanitary and Phytosanitary Measures.The MRLs for the active substance fenpropimorph for barley, oat, rye, wheat, sugar beet roots, all tissues from mammals and milk, which were initially lowered to the limit of quantification in the draft Regulation notified in G/SPS/N/EU/527, are maintained at the level proposed by Codex Alimentarius in the adopted Commission Regulation (EU) 2023/710.The adopted Commission Regulation (EU) 2023/710 includes a provision to allow the marketing of products which have been produced in the Union or imported into the Union before the modified MRLs start applying.The Regulation shall apply from 21 October 2023.

The text revises the EU specifications of the authorised food additives glycerol (E 422), polyglycerol esters of fatty acids (E 475) and, polyglycerol polyricinoleate (E 476) and authorises an extension of use of polyglycerol polyricinoleate (E 476) based on the recent scientific opinions from the European Food Safety Authority (EFS). For glycerol (E 422), the current specifications are adapted by reducing the maximum limits for toxic elements (arsenic, lead, mercury and cadmium), by deleting the identification method based on acrolein formation during heating, by deleting the test for the presence of acrolein, by including a maximum limit for acrolein and by modifying the definition of glycerol (E 422). For polyglycerol esters of fatty acids (E 475), the current specifications are adapted by reducing the maximum limits for toxic elements, by including maximum limits for the sum of 3-monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD), glycidyl fatty acid esters (expressed as glycidol) and erucic acid and by modifying the definition of polyglycerol esters of fatty acids (E 475). For polyglycerol polyricinoleate (E 476), the current specifications are adapted by reducing the maximum limits for toxic elements, by including maximum limits for the sum of 3‑monochloropropanediol (3-MCPD) and 3-MCPD fatty acid esters (expressed as 3-MCPD) and glycidyl fatty acid esters (expressed as glycidol) and by modifying the definition of polyglycerol polyricinoleate (E 476).The text also authorises the use of polyglycerol polyricinolate (E 476) in food category 03 'Edible ices' at a maximum level of 4,000 mg/kg and in food category 12.6 'Sauces' at an increased maximum level of 8,000 mg/kg for emulsified sauces with a fat content of 20% or more.In order to allow for a smooth transition, the text lays down that the use of the food additives glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol polyricinolate (E 476) lawfully placed on the market before the date of the entry into force of this Regulation is allowed during a transitional period of six months. Foods containing such food additives may continue to be placed on the market during the same transitional period and may remain on the market until their date of minimum durability or 'use-by-date'. The food additive polyglycerol esters of fatty acids (E 475) legally placed on the market after the date of entry into force of this Regulation and complying with the reduced intermediate maximum level for glycidyl fatty acid esters (expressed as glycidol) is allowed to be used until the exhaustion of stocks and foods containing such food additive should be allowed to be placed on the market and to remain on the market until their date of minimum durability or 'use-by-date'.