Notifications for European Union (1104 notifications)

There is a correction to notification G/SPS/N/EU/612, dated 30 January 2023:A mistake has occurred during the publication phase in all languages of Commission Implementing Regulation (EU) 2023/174 amending Commission Implementing Regulation (EU) 2019/1793.On page 44, Article 1, the text of point (1) is replaced as follows:‘(1) Article 14 is replaced by the following:“Article 14Transitional periodConsignments of groundnuts and products produced from groundnuts from Bolivia, curry leaves (BergeraMurrava koenigii) from India, turnips (Brassica rapa ssp. rapa) from Lebanon, Sesamum seeds from Nigeria, vanilla extract from the United States and okra from Vietnam, which have been dispatched from the country of origin, or from another third country if that country is different from the country of origin, before the date of entry into force of Commission Implementing Regulation (EU) 2023/174 (*), may enter the Union until 16 April 2023 without being accompanied by the results of sampling and analyses and the official certificate provided for in Articles 10 and 11.(*) Commission Implementing Regulation (EU) 2023/174 of 26 January 2023 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 (OJ L 25, 27.1.2023, p. 36).";'

This draft Commission Implementing Regulation provides that the approval of the active substance oxamyl is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing oxamyl 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 oxamyl, a number of concerns and areas that could not be finalised finalized were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA) and reported here after: The operators' exposure is unacceptable (min 112% of the AEOL and min 389% of the AAOEL) even when the use of PPE is considered; The preliminary consumer dietary risk assessment did indicate a large exceedance of the acute reference dose (ARfD) for all the representative uses: 1,538% (potatoes, children), 1,223% (watermelons, children), 656% (cucumbers, children) and 581% (tomatoes, children) even when oxamyl residues at the LOQ of 0.01mg/kg were considered. These concerns and areas that could not be finalised mean that oxamyl does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and its approval cannot be renewed. Existing authorisations will need to be withdrawn. EU member States must withdraw existing plant protection products containing oxamyl at the latest by six months from the date of entry into force. A period of grace in line with Article 46 of Regulation No 1107/2009 is allowed for and shall expire at the latest 12 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 Maximum Residue Limits 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/945.

The proposal notified in G/SPS/N/EU/578 (12 July 2022) is now adopted by Commission Regulation (EU) 2023/198 of 30 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin in or on certain products (Text with EEA relevance) [OJ L 27, 31 January 2023, p. 7].The Regulation shall apply from 20 August 2023.

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:1.    Modification of measures/new measures:-         Inclusion in Annex I of palm oil from Côte d'Ivoire due to risk of contamination by Sudan dyes; granadilla, passion fruit (Passiflora ligularispassiflora edulis) from Colombia, basil (Ocimum basilicum) and mint (Mentha) from Israel, peppers of the genus Capsicum (other than sweet) from Kenya and Rwanda, black eyed beans (Vigna unguiculata) from Madagascar due to risk of contamination by pesticide residues; Sesamum seeds from Türkiye due to risk of contamination by Salmonella-         Delisting from Annex I (and thus, from the Regulation) of groundnuts and products produced from groundnuts from Argentina and Brazil (aflatoxins), Galia melons (C. melo var. reticulatus) from Honduras, chinese celery (Apium graveolens) and yardlong beans (Vigna unguiculata ssp. sesquipedalisVigna unguiculata ssp. unguiculata) from Cambodia, locust beans (carob), mucilages and thickeners, whether or not modified, derived from locust beans seeds from Morocco, groundnuts and products produced from groundnuts from Madagascar, tomato ketchup and other tomato sauces from Mexico, watermelon (Egusi, Citrullus spp.) seeds and derived products from Sierra Leone, turnips (Brassica rapa ssp. rapa) from Syria and coriander leaves, basil, mint and parsley from Viet Nam;-         Removal from Annex I and inclusion in Annex II of groundnuts and products produced from groundnuts from Bolivia, curry leaves (Bergera/Murrava koenigii) from India, turnips (Brassica rapa ssp. rapa) from Lebanon, Sesamum seeds from Nigeria and okra from Viet Nam;-         Increase in the frequency of identity and physical checks laid down in Annex I for groundnuts and products produced from groundnuts from Brazil (pesticide residues – 30%) gotukola (Centella asiatica) and mukunuwenna (Alternanthera sessilis) from Sri Lanka (30%), rice from Pakistan (aflatoxins and Ochratoxin A – 10%), lemons (Citrus limonCitrus limonum) and grapefruits from Türkiye (30%) and cumin seeds and dried oregano from Türkiye (20%);-         Inclusion in Annex II of vanilla extract from the United States, due to contamination risk by ethylene oxide;-         Removal from Annex II and inclusion in Annex I of Brazil nuts in shell and mixtures of Brazil nuts or dried fruits containing Brazil nuts in shell from Brazil , betel leaves (Piper betle L.) from India, food supplements containing botanicals from South Korea, locust beans (carob), mucilages and thickeners, whether or not modified, derived from locust beans seeds from Malaysia, watermelon (Egusi, Citrullus spp.) seeds and derived products from Nigeria;-         Increase in the frequency of identity and physical checks laid down in Annex II for calcium carbonate from India (30%) and dried figs and products derived from dried figs from Türkiye (30%);-         Decrease in the frequency of identity and physical checks laid down in Annex II for yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata) from the Dominican Republic (30%) and Peppers of the genus Capsicum from India (aflatoxins - 10%).2.    Technical adjustments to existing measures:-         To allow for a more precise identification of commodities subject to increased official controls, the TARIC sub-division for CN code ex 1211 90 86 is corrected in the entry on gotukola (Centella asiatica) from Sri Lanka in Annex I;-         To allow for a better evaluation of the data from official controls performed by the member States, it is appropriate to divide the entry on spices from India by commodities and CN codes;-         To allow for a more precise identification of goods subject to temporary increase of official controls or to special conditions at their entry into the Union, it is appropriate to include a footnote related to food supplements containing botanicals from South Korea in Annex I and from India in Annex II;-         The limits of Sudan dyes and Rhodamine B is added in footnotes of Annex I and Annex II.In addition, this Implementing Regulation amends official certificate laid down in Annex IV to Implementing Regulation (EU) 2019/1793 to allow certify compliance with the Union requirements regarding Sudan dyes and Rhodamine B and Article 14 of that Regulation regarding the transitional period.

The proposal notified in G/SPS/N/EU/573 (22 June 2022) is now adopted by Commission Regulation (EU) 2023/173 of 26 January 2023 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 1-methyl-3-(trifluoromethyl)-1H-pyrazole-4- carboxamide, cycloxydim, cyflumetofen, cyfluthrin, metobromuron and penthiopyrad in or on certain products (Text with EEA relevance) [OJ L 25, 27 January 2023, p. 1].The Regulation shall apply from 16 August 2023.

The aim of this Regulation is to amend Regulation (EU) No 10/2011 to address new opinions of the European Food Safety Authority, either to authorize substance following applications for authorization by business operators, or to address existing substance authorizations based on mandates provided by the European Commission.

Animal health requirements for entry into the European Union of live animals, germinal products and products of animal origin for human consumption.

The proposed draft Regulation concerns the update of existing MRLs for bifenazate in certain food commodities. MRLs in certain commodities are changed. The consumer risk assessment for edible crops could not be finalised, as relevant information needed to ensure consumer safety was not provided and the toxicity of a relevant metabolite could not be determined. Therefore bifenazate is approved only to use in non-edible crops in permanent greenhouses and lower MRLs are set.

This draft Commission Implementing Regulation provides that the approval of the active substance ipconazole is withdrawn in accordance with Regulation (EC) No 1107/2009.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.Active substances may be reviewed at any time where in the light of new scientific and technical knowledge there are indications that the substance no longer satisfies the approval criteria laid down in Article 4 of Regulation (EC) No 1107/2009.Substances that are or have to be classified as toxic for reproduction category 1B (R1B) according to Regulation (EC) No 1272/2008 cannot be approved unless exposure to humans is demonstrated to be negligible under realistic conditions of use.Commission Delegated Regulation (EU) 2020/1182 amended Annex VI to Regulation (EC) No 1272/2008 and classified ipconazole as toxic for reproduction category 1B.Negligible exposure to ipconazole for humans could not be concluded due to limitations with the available data.Furthermore, a high long-term risk to birds from the representative uses of ipconazole was concluded by the European Food Safety Authority.This means that ipconazole no longer fulfils the approval criteria as outlined in Regulation (EC) No 1107/2009 and the approval should therefore be withdrawn.Existing authorizations will need to be withdrawn; EU member States must withdraw existing plant protection products containing ipconazole 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.This decision only concerns the placing on the market of this substance and plant protection products containing it. Following withdrawal of approval and the expiry of all grace periods for stocks of products containing this substance, separate action may be taken on MRLs in which case 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/944.

The proposal notified in G/SPS/N/EU/400 (21 July 2020) is now adopted by Commission Implementing Regulation (EU) 2023/60 of 5 January 2023 concerning the authorisation of conjugated linoleic acid (t10, c12)-methylester as a feed additive for pigs for fattening and dairy cows (holder of authorisation: BASF SE) (Text with EEA relevance) [OJ L 5, 6 January 2023, p. 19].The additive belongs to a category linked to an authorisation holder, therefore the name of the authorisation holder needs to be included in the authorisation. Only the authorisation holder or a person authorised by him can place the additive in the EU market.This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

The measure concerns an amendment of the Union list of novel foods in order to correct some errors identified in the Union list of novel foods (Implementing Regulation (EU) 2017/2470).

The proposal notified in G/SPS/N/EU/576 (4 July 2022) is now adopted by Commission Regulation (EU) 2022/2388 of 7 December 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of perfluoroalkyl substances in certain foodstuffs (Text with EEA relevance) [OJ L 316, 8 December 2022, p. 38].The Regulation shall apply from 1 January 2023.

The proposed draft Regulation concerns the review of existing MRLs for phosmet in certain food commodities. MRLs for these substances in certain commodities are lowered. Lower MRLs are set after deleting old uses which are not authorised any more in the European Union and for which a human health concern may not be excluded.

The proposal notified in G/SPS/N/EU/511 (13 October 2021) is now adopted by Commission Regulation (EU) 2022/2340 of 30 November 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards green tea extracts containing (-)-epigallocatechin-3-gallate (Text with EEA relevance) [OJ L 310, 1 December 2022, p. 7].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

This draft Commission Delegated Regulation develops the requirements to be met by animals and products of animal origin, intended for human consumption, exported from third countries to the Union in connection with the ban on the use of antimicrobials for growth promotion and yield increase and the ban on the use of certain antimicrobials reserved for treatment of infections in humans (Commission Implementing Regulation (EU) 2022/1255) set out in Regulation (EU) 2019/6.

The proposal notified in G/SPS/N/EU/577 (7 July 2022) is now adopted by Commission Delegated Regulation (EU) 2022/2292 of 6 September 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption (Text with EEA relevance) [OJ L 304, 24 November 2022, p. 1].This Regulation shall apply from 15 December 2022.

Regulation (EU) 2022/1265 provides for a prohibition for the introduction of the Rose Rosette Virus in the Union territory, for an immediate submission of information on the suspected presence of the specified pest and of its specified vector in the Union and for rules for surveys for its presence in the Union territory. The Regulation also provides requirements for the introduction into the Union territory of Rosa spp. plants other than seeds, originating in third countries, as well as for official checks to be conducted at their introduction into the Union.

The proposal notified in G/SPS/N/EU/536 (6 January 2022) is now adopted by Commission Regulation (EU) 2022/2246 of 15 November 2022 amending Annexes VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards chronic wasting disease in live cervids (Text with EEA relevance) [OJ L 295, 16 November 2022, p. 1].The Regulation shall apply from 1 January 2023.

The proposal notified in G/SPS/N/EU/567 (18 May 2022) is now adopted by Commission Implementing Regulation (EU) 2022/2095 of 28 October 2022 establishing measures to prevent the introduction into, establishment and spread within the Union territory of Anoplophora chinensis (Forster) and repealing Decision 2012/138/EU [OJ L 281, 31 October 2022, p. 53].This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union and shall apply until 31 December 2029.

The proposal notified in G/SPS/N/EU/592 (24 August 2022) is now adopted by Commission Regulation (EU) 2022/2002 of 21 October 2022 amending Regulation (EC) No 1881/2006 as regards maximum levels of dioxins and dioxin-like PCBs in certain foodstuffs (Text with EEA relevance) [OJ L 274, 24 October 2022, p. 64].The Regulation shall apply from 1 January 2023.