Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/431 (15 October 2020) is now adopted by Commission Implementing Regulation (EU) 2021/505 of 23 March 2021 concerning the denial of authorisation of phosphoric acid 60% on silica carrier as a feed additive belonging to the functional group of preservatives (Text with EEA relevance) [OJ L 102, 23 March 2020, pp. 1]. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Regulation (EC) No 1831/2003 provides for the authorization of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorization. Pyridoxine hydrochloride (vitamin B6) was authorized for 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 515/2011(2). In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorization of pyridoxine hydrochloride as a feed additive for all animal species, requesting the additive to be classified in the additive category "nutritional additives". That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation. The European Food Safety Authority ("the Authority") concluded in its opinion of 30 September 2020(3) that the applicant has provided evidence that the additive complies with the existing conditions of authorization. The Authority concluded that pyridoxine hydrochloride under the current authorized conditions of use does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is non-irritant to skin and eyes and is not a skin sensitiser but it may cause photosensitisation and in the absence of inhalation toxicity studies, adverse effects in the respiratory tract could not be fully excluded. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to the users of the additive. The Authority also concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorization. The assessment of pyridoxine hydrochloride shows that the conditions for authorization, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorization of that additive should be renewed.

The proposed draft Regulation concerns the review of existing MRLs for amisulbrom, flubendiamide, meptyldinocap, metaflumizone and propineb in certain food commodities. MRLs for these substances in certain commodities are changed: either increased or lowered. Lower MRLs are set after updating the limits of determination and/or deleting old uses which are not authorised any more in the European Union or for which a human health concern may not be excluded. The residue definition for some substances has also been updated.

The proposed draft Regulation concerns the review of the existing maximum residue levels (MRLs) for the substances flupyradifurone and difluoroacetic acid. MRLs for these substances are either increased, maintained or lowered. Lower MRLs are set after updating the limits of determination and/or deleting old uses which are not authorised any more in the European Union or for which a human health concern may not be excluded.

This draft Commission Implementing Regulation provides that the approval of the active substance famoxadone is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing famoxadone 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 EU under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC. 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/783.

The proposal notified in G/SPS/N/EU/391 (8 July 2020) was adopted as Commission Regulation (EU) 2021/382 of 3 March 2021 amending the Annexes to Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs as regards food allergen management, redistribution of food and food safety culture (Text with EEA relevance) [OJ L 74, 4 March 2020, p.3]. This Regulation shall enter into force on 24 March 2021.

The proposed draft Regulation concerns the review of existing MRLs for 6-benzyladenine, aminopyralid and chlorantraniliprole in certain food commodities. MRLs for these substances in certain commodities are changed: either increased or lowered. Lower MRLs are set after updating the limits of determination and/or deleting old uses which are not authorised any more in the European Union or for which a human health concern may not be excluded. The residue definition for some substances has also been updated.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The application concerns the authorisation of a tincture derived from Artemisia vulgaris L. (mugwort tincture) as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category "sensory additives". The European Food Safety Authority ("the Authority") concluded in its opinions of 4 October 2019 and 1 July 2020 that, under the proposed conditions of use the tincture derived from Artemisia vulgaris L. (mugwort tincture) does not have adverse effects on animal health, consumer health or the environment. The Authority indicated that no conclusions can be drawn on the additive's potential to be a dermal/eye irritant or a skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC and Article 4 for the authorisation of a new use of an additive. Lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta were authorised by Commission Implementing Regulation (EU) 2020/1097 concerning the authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying. The European Food Safety Authority ("the Authority") concluded in its opinion of 3 April 2019 that the maximum proposed use level of 80 mg total carotenoids/kg of complete feed for lutein-rich and lutein/zeaxanthin extracts is safe for poultry for fattening (except turkeys), minor poultry for fattening, poultry for laying (except turkeys) and minor poultry for laying. By mistake, the heading of the sixth and seventh columns of the Annex to Implementing Regulation (EU) 2020/1097 refers to "mg of active substance of kg of complete feeding stuff with a moisture content of 12 %". That reference is not correct as the EFSA opinion refers to the "total carotenoids". It is therefore appropriate to correct the heading of the sixth and seventh columns of the table in the Annex to that Implementing Regulation to reflect the wording appearing in the EFSA opinion of 3 April 2019. The references to "poultry for fattening (except turkeys)" and "poultry for laying, (except turkeys)" have been modified to "chickens for fattening" and "laying hens". This change does not affect or modify the categories of animals currently authorised, as the term "poultry" covers turkeys for laying and fattening, chickens for fattening and laying hens. Therefore, it is more appropriate to refer directly to chickens for fattening and laying hens.

The use of the preparation of Lactococcus lactis NCIMB 30160 as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) No 1263/2011 for a 10- year period. The authorisation was subsequently modified by Commission Implementing Regulation (EU) 2020/1092 in accordance with Article 13(2) of Regulation (EC) No 1831/2003, as regards the formulation of the additive. The intended modification did not concern the period of authorisation laid down in Implementing Regulation (EU) No 1263/2011, which was to run until 26 December 2021. However, in the Annex to Implementing Regulation (EU) 2020/1092, it was mistakenly indicated that the period of authorisation for Lactococcus lactis NCIMB 30160 was to run until 16 August 2030. That error was therefore inserted in Implementing Regulation (EU) No 1263/2011 through Implementing Regulation (EU) 2020/1092. For reasons of clarity and legal certainty, it is therefore necessary to correct Implementing Regulation (EU) No 1263/2011 as regards the end of period of authorisation for Lactococcus lactis NCIMB 30160. Implementing Regulation (EU) 2020/1092 provided that the modification to be brought to the terms of the authorisation of the additive Lactococcus lactis NCIMB 30160 only concerned the formulation of the additive. No reference was made to the need to modify the period of authorisation of that additive. In addition, Article 9(8) of Regulation (EC) No 1831/2003 prescribes that authorisations are granted for a period of 10 years and such rule may not be derogated from through a modification to the terms of an authorisation. Moreover, the Register of feed additives continued to mention the date of 26 December 2021 as the expiry date of the authorisation of the additive Lactococcus lactis NCIMB 30160, even after the adoption of Implementing Regulation (EU) 2020/1092. The absence of retroactive effect of the proposed correction would lead to a breach of the principle of non- discrimination between operators, as the granting of an extended period of authorisation from the date of entry.

The draft Regulation lowers existing maximum levels for lead or establishes new maximum levels for cadmium in infant formulae marketed as powder, processed cereal-based foods and baby foods for infants and young children, foods for special medical purposes intended for infants and young children marketed as powder, drinks for infants and young children labelled and sold as such, offal, wild fungi, fresh turmeric, fresh ginger, wine, aromatised wine, aromatised wine-based drinks and aromatised wine-product cocktails, liqueur wine made from grapes, dried spices, salt.

The draft Regulation lowers existing maximum levels for cadmium or establishes new maximum levels for cadmium in citrus fruits, pome fruits, stone fruits, table olives, kiwi fruits, bananas, mangoes papayas and pineapples, berries and small fruits, tree nuts, radishes, tropical roots and tubers, parsley roots, turnips, beetroots, celeriac, bulb vegetables (except garlic), fruiting vegetables, brassica vegetables, leafy vegetables (except spinaches and similar leaves, mustard seedlings and fresh herbs), legume vegetables, stem vegetables, fungi, pulses, oilseeds (except soy beans), rye, barley, rice, quinoa, wheat bran, wheat gluten, durum wheat, young child formula, drinks for infants and young children labelled and sold as such and salt.

Controls on the prohibition of certain uses of antimicrobial veterinary medicinal products with respect to animals and products of animal origin exported to the European Union are included into the scope of Regulation (EU) 2017/625 on official controls (notified in notice G/SPS/N/EU/43/Add.2).

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159. That application was accompanied by the particulars and documents required under Article 7 of Regulation (EC) No 1831/2003.  The application concerns the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 as a feed additive for all animal species, to be classified in the additive category "technological additives". The European Food Safety Authority ("the Authority") concluded in its opinion of 1 July 2020 that, under the proposed conditions of use, the preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is not toxic by inhalation and the respiratory exposure is likely to be low but a risk of sensitisation via the respiratory route could not be excluded. The additive is non-irritant to skin and eyes and is not considered a as a dermal sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation concerned has the capability to degrade fumonisins in fermenting feed (with a fumonisin content within the limits operating in the Union) but only in silages, not in other fermenting feeds. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of the preparation of fumonisin esterase produced by Komagataella phaffii DSM 32159 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised.

Animal health measures for movement of consignments of salamanders between EU member States and for the entry of such consignments into the Union to ensure that the fungus Batrachochytrium salamandrivorans (Bsal) is not spread by those animals. The relevant current Commission Implementing Decision (EU) 2018/320 applies until 21 April 2021. The new measures by Commission Implementing Decision (EU) 2021/361 will apply from 21 April 2021. They take into account risk mitigation measures referred to in an EFSA Technical Assistance and in an EFSA Scientific Opinion (see below under point 9), and experience with the application of Implementing Decision (EU) 2018/320. They provide for appropriate quarantine, diagnostic testing and treatment of salamanders as well as for certification of their health status. These measures are of temporary nature. Most risk-mitigating measures, in particular the quarantining in an appropriate establishment, testing and treatment of traded and introduced salamanders are to be done by competent veterinary authorities, operators and laboratories located within the Union. All consignments of salamanders destined for intra-Union trade or entry into the Union are subject to risk mitigation measures.

The proposal notified in G/SPS/N/EU/394 (15 July 2020) was adopted as Commission Regulation (EU) 2021/155 of 9 February 2021 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 carbon tetrachloride, chlorothalonil, chlorpropham, dimethoate, ethoprophos, fenamidone, methiocarb, omethoate, propiconazole and pymetrozine in or on certain products (Text with EEA relevance) [OJ L 46, 10 February 2021, p.5]. This Regulation shall apply from 2 September 2021.

The European Union wishes to inform trade partners that the proposal notified in G/SPS/N/EU/388 (2 June 2020) as draft Commission Regulation (EU) amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for titanium dioxide (E 171) was withdrawn.

The European Union wishes to inform trade partners that the proposal notified in G/SPS/N/EU/405 (6 August 2020) as draft Commission Regulation (EU) amending Regulation (EC) No 1881/2006 as regards maximum levels of acrylamide in certain food stuffs for infants and young children was withdrawn.

The proposal notified in G/SPS/N/EU/380 (1 April 2020) is now amended by Commission Implementing Regulation (EU) No 2021/83 of 27 January 2021 amending Implementing Regulation (EU) 2020/466 as regards the performance of official controls and other official activities by specifically authorised natural persons and the period of application of temporary measures (Text with EEA relevance) [OJ L 29, 28 February 2021, pp. 23-24]. The Regulation will enter into force on 31 January 2021; it will be applicable from 2 February 2021.