Notifications for European Union (1104 notifications)

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

The measure concerns a change in the specifications of the novel food Coriander seed oil from Coriandrum sativum and amending Implementing Regulation (EU) 2017/2470.

The proposal notified in G/SPS/N/EU/465 (15 March 2021) is now adopted by Commission Regulation (EU) 2021/1317 of 9 August 2021 amending Regulation (EC) No 1881/2006 as regards maximum levels of lead in certain foodstuffs (Text with EEA relevance) [OJ L 286, 10 August 2021, p. 1]. The Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/466 (15 March 2021) is now adopted by Commission Regulation (EU) 2021/1323 of 10 August 2021 amending Regulation (EC) No 1881/2006 as regards maximum levels of cadmium in certain foodstuffs (Text with EEA relevance) [OJ L 288, 11 August 2021, p. 13]. The Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Implementing Regulation 2019/2072 contains the list of Union Quarantine pests, Protected Zone Quarantine Pests and Regulated Non-Quarantine Pests (RNQPs). Furthermore, it lays down phytosanitary import and internal movement requirements for plants, plant products and other objects that may pose a phytosanitary risk to the European Union.The draft amendment of Implementing Regulation 2019/2072 stipulates: Addition of new pests in the list of Union quarantine pests (Annex II); Revision of the pests that are currently regulated as groups of pests (Annex II); Changes in scientific names of pests (Annex II); Addition of new pests in the list of RNQPs (Annex IV); Revisions of the prohibited commodities (Annex VI); Addition of new import requirements (Annexes V and VII); Revision of existing import requirements (Annexes V, VII and X); Addition/Revision of CN codes (Annexes VI, VII, X and XI); Revision of regulated commodities (Annexes XI and XII); Repeal of Decisions 98/109/EC and 2002/757/EC and Implementing Regulations (EU) 2020/885 and (EU) 2020/1292. In addition, the draft Regulation contains additions/revisions of internal movement requirements of regulated commodities in the European Union. These revisions are provided for information and clarity purposes.

This draft Commission Implementing Regulation provides that the approval of the active substance cypermethrin is renewed in accordance with Regulation (EC) No 1107/2009. It is however, necessary to include certain conditions and restrictions for spray applications outdoors to ensure the required protection level for aquatic organisms and non-targeted arthropods including bees is met.Existing authorised plant protection products containing cypermethrin will be reviewed in accordance with the conditions and restrictions set in this act. The conditions and restrictions are 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 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 cypermethrin, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA). In its Statement on risk mitigation measures on cypermethrin published on 4 October 2019, EFSA presented the levels of the necessary drift reduction and the measures that would be needed to demonstrate low risk to the non-target organisms, in particular aquatic organisms and non-target arthropods, including bees.This means that cypermethrin meets the approval criteria as outlined in Regulation (EC) No 1107/2009 only if appropriate mitigation measures to ensure the required protection level for aquatic organisms, non-targeted arthropods including bees are put in place for spray applications outdoors.Existing authorisations will need to be amended or withdrawn following renewal of authorisation in accordance with Article 43 of Regulation (EC) No 1107/2009.This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned active substance. Any action on MRLs will be subject to notification under the SPS procedure. This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/825.

The text aims at updating the current authorisation of the food additive steviol glycosides (E 960) and to authorise rebaudioside M produced via enzyme modification of steviol glycosides from Stevia in the European Union. The Annex to Regulation No 231/2012 (specifications for food additives) is amended accordingly, in line with the conclusion of the evaluation of the safety of this food additive by the European Food Safety Authority (EFSA), which concluded that the new additive does not raise safety concern at the same proposed uses and use levels as steviol glycosides (E 960). In the interest of clarity and coherence, the currently authorised food additive 'steviol glycosides (E 960)' is renamed as 'Steviol glycosides from Stevia (E 960a)'and 'rebaudioside M produced via enzyme modification of steviol glycosides from Stevia' is assigned E 960c(i) as an E-number. As those food additives may be regulated combined, a new group for steviol glycosides, including both of them, is inserted in Part C of Annex II to Regulation (EC) No 1333/2008, and all entries for steviol glycosides (E 960) in Part E of Annex II to that Regulation are replaced accordingly, while maintaining the currently applicable uses and maximum level for authorised uses and use levels.

The proposal notified in G/SPS/N/EU/444 (18 November 2020) is now adopted by Commission Regulation (EU) No 2021/1176 of 16 July 2021 amending Annexes III, V, VII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards genotyping of positive TSE cases in goats, the determination of age in ovine and caprine animals, the measures applicable in a herd or flock with atypical scrapie and the conditions for imports of products of bovine, ovine and caprine origin (Text with EEA relevance) [OJ L 256, 19 July 2021, p. 56]. The Regulation shall apply from 8 August 2021.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation. Manganese chelate of hydroxy analogue of methionine was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 350/2010. In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of manganese chelate of hydroxy analogue of methionine as feed additive for all animal species in the additive category 'nutritional additives'. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. It results from the opinion of the European Food Safety Authority ('the Authority') of 30 September 2020 that, under the proposed conditions of use, manganese chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, consumer safety or the environment. The Authority also concluded for the additive a risk for the user by inhalation and that it is a skin sensitizer. 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 proof of the efficacy of the additive, on which the initial authorisation was based, withstands in a renewal procedure. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of manganese chelate of hydroxy analogue of methionine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of this additive should be renewed. As a consequence of the renewal of the authorisation of manganese chelate of hydroxy analogue of methionine as feed additive, Regulation (EU) No 350/2010 should be repealed.

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 L-threonine produced by Escherichia coli CGMCC 13325 as a feed additive for use in feed for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. The application concerns the authorisation of L-threonine produced by Escherichia coli CGMCC 13325 as a feed additive for all animal species to be classified in the additive category 'nutritional additives'. The European Food Safety Authority ('the Authority') concluded in its opinion of 18 November 2020 that, under the proposed conditions of use, L-threonine produced by Escherichia coli CGMCC 13325 does not have an adverse effect on animal health, consumer health or the environment. It could not conclude on the potential of L-threonine produced by Escherichia coli CGMCC 13325 to be a skin sensitiser and irritant to the skin and eyes, and stated an inhalation risk to endotoxins for the users of the additive. Therefore, 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 additive is an efficacious source of the amino acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive needs to be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post- market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of L-threonine produced by Escherichia coli CGMCC 13325 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation. Zinc chelate of hydroxy analogue of methionine was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 335/2010. In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of zinc chelate of hydroxy analogue of methionine as feed additive for all animal species in the additive category 'nutritional additives'. The application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. It results from the opinion of the European Food Safety Authority ('the Authority') of 18 November 2020 that, under the proposed conditions of use, zinc chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, consumer safety or the environment. The Authority also concluded for the additive a risk for the user by inhalation and that it is a skin sensitizer. 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 proof of the efficacy of the additive, on which the initial authorisation was based, withstands in a renewal procedure. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of zinc chelate of hydroxy analogue of methionine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of this additive should be renewed.

This draft Commission Implementing Regulation provides that the approval of the active substance phosmet is not renewed in accordance with Regulation (EC) No 1107/2009. Member states shall withdraw authorisations for plant protection products containing phosmet 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.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 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/790.

The existing emergency import requirements in relation to Spodoptera frugiperda (Smith), (stipulated in Commission Implementing Decision (EU) 2018/638), are prolonged until 30 June 2023. The prolongation of the existing measures is due to the continuing fast spread of the pest worldwide and towards the Union territory.

The proposal notified in G/SPS/N/EU/397/Rev.1 (7 May 2021) is now adopted by Commission Regulation (EU) No 2021/618 of 15 April 2021 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 diclofop, fluopyram, ipconazole and terbuthylazine in or on certain products (Text with EEA relevance) [OJ L 131, 16 April 2021, p. 55]. The Regulation shall apply from 6 November 2021.

This draft Commission Regulation concerns the inclusion of monacolins from red yeast rice (RYR) in Annex III of Regulation (EC) No 1925/2006 ('the Regulation').EFSA, in its scientific opinion adopted on 28 June 2018, considered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolemia in the European Union. EFSA concluded that monacolins in RYR when used as food supplements were of significant safety concern at the use level of 10 mg/day, and that individual cases of severe adverse reactions had been reported at intake levels as low as 3 mg/day. Furthermore, EFSA noted that the profile of adverse effects to RYR was similar to that of lovastatin. Therefore, pursuant to the procedure of Article 8 of the Regulation, this substance should be included in Annex III (Part B) to the Regulation. Furthermore, as EFSA could not identify a safe dietary intake of monacolins from RYR, and therefore, there is still the possibility of harmful effects on health but scientific uncertainty persists in this regard, this substance should be placed under Union scrutiny (Part C of the 'Regulation').

The Union list of flavourings and source materials is laid down in Annex I to Regulation (EC) No 1334/3008. It was established by Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances notified in G/SPS/N/EU/13/Add.1 (12 October 2012). This list is now amended by 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 inclusion of 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione in the Union list of flavouring substances".This addendum concerns the addition of the substance mentioned above, with FL n 16.127, to the list of authorised flavouring substances in the European Union.This inclusion follows an application and the European Food Safety Authority (EFSA) evaluation evaluated this substance. The substance mentioned is included with certain conditions of use. The substance complies with the general requirements for flavourings set out in Article 4 of Regulation (EC) No 1334/2008.

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 2019 and 2020 by the OIV. It also provides clarifications on, and improves consistency of, some of the existing provisions. Lastly, it withdraws the authorisation of DL tartaric acid in the light of its observed nephrotoxic effects. 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.

The proposal notified in G/SPS/N/EU/455 (16 December 2020) is now adopted by Commission Implementing Regulation (EU) 2021/758 of 7 May 2021 on the status of certain products as feed additives within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council and on the withdrawal from the market of certain feed additives (Text with EEA relevance) [OJ L 162, 10 May 2021, p. 5]. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The proposal notified in G/SPS/N/EU/398 (16 July 2020) is now adopted by Commission Regulation (EU) 2021/663 of 22 April 2021 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlordecone in or on certain products (Text with EEA relevance) [OJ L 139, 23 April 2021, p. 148].The Regulation shall apply from 13 November 2021.

The proposed draft Regulation concerns the review of existing MRLs for acequinocyl, cycloxydim, diclofop, fluopyram, ipconazole and terbuthylazine 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.