Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/407 (19 August 2020) is now amended by Commission Implementing Regulation (EU) No 2021/74 of 26 January 2021 amending Implementing Regulation (EU) 2020/1191 on measures to prevent the introduction into and the spread within the Union of Tomato brown rugose fruit virus (ToBRFV) [OJ L 27, 27 January 2021, pp. 15]. The Regulation will enter into force on 30 January 2021.

This draft Commission Implementing Regulation provides that the approval of the active substance alpha-cypermethrin is withdrawn in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing alpha-cypermethrin as an active substance. This decision only concerns the placing on the market of this substance and plant protection products containing it. Following withdrawal 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/770.

The measure changes the conditions of use of the novel food 'trans-resveratrol' by removing the specific delivery formats, capsule or tablet form, as the only allowed forms of the food supplements containing the novel food 'trans-resveratrol' as listed in the Union list. Thus, the novel food will be authorised for use in any form of food supplements at the previously authorised maximum level.

The use of a preparation of montmorillonite-illite as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) 2016/1964. In accordance with Article 13 of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority ('the Authority') to issue an opinion on whether the authorisation of a preparation of montmorillonite-illite as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, considering a modification of the terms of that authorisation. The modification relates to the current authorisation for the use of the additive as anticaking agent in complementary feedingstuffs. The request was accompanied by the relevant supporting data. The Authority concluded in its opinions of 30 October 2014, 10 September 2015 and 20 March 2020 that the proposed modification to the terms of authorisation of the preparation of montmorillonite-illite does not modify the previous conclusions that the additive does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that dust generated during normal handling of the additive has the potential to expose the whole of the respiratory tract of users to harmful substances (crystalline silica) for which no safe levels of exposure have been identified and that in the absence of data on the effects on skin and eyes, must be considered as irritant to skin and eyes and as a potential 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 has also concluded that the additive is efficacious as an anti-caking agent. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of the proposed modification to the authorisation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Implementing Regulation (EU) 2016/1964 should therefore be amended accordingly.

Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 900/2009. In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 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 of Regulation (EC) No 1831/2003. It results from the opinion of the European Food Safety Authority ('the Authority') of 7 May 2020 that, under the proposed conditions of use, selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 does not have an adverse effect on animal health, consumer safety or the environment. The Authority also concluded that the additive is a potential dermal and respiratory 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. Finally, the Authority recommended changing the denomination of the additive. 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 selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 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 selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 as feed additive, Regulation (EC) No 900/2009 should be repealed. Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 was authorised for 10 years as a feed additive for salmonids by Commission Regulation (EC) No 244/2007. In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids. The application included a request to change the strain designation to Escherichia coli NITE SD 00268 and was accompanied by the particulars and documents required under Article 14 of that Regulation. In addition, in accordance with Article 7 of that Regulation, the application requested an extension of use to other finfish. The application was accompanied by the particulars and documents required under Article 7 of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its opinion of 18 March 2020 that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE SD 00268, when supplemented at levels appropriate to the requirements of the target species, does not have an adverse effect on animal health, consumer health or the environment. The Authority also concluded that while the additive in question is not a skin irritant, it was not possible to conclude on the potential for the additive to be toxic if inhaled, an irritant to eyes 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. The Authority also concluded that the additive is an efficacious source of the amino acid histidine for fish species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports 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-histidine monohydrochloride monohydrate produced by Escherichia coli NITE SD 00268 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. As a consequence of the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 244/2007 should be repealed.

Pediococcus pentosaceus DSM 16244 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 514/2010. In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of Pediococcus pentosaceus DSM 16244 as a feed additive for all animal species, requesting the additive to be classified in the additive category 'technological additives'. That application was accompanied by the particulars and documents required under Article 14 of that Regulation. The European Food Safety Authority ('the Authority') concluded in its opinion of 25 May 2020 that the applicant has provided evidence that the additive complies with the existing conditions of authorisation. The Authority concluded that Pediococcus pentosaceus DSM 16244 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that is not irritant to skin and eyes but considered a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. The assessment of Pediococcus pentosaceus DSM 16244 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation. As a consequence of the renewal of the authorisation of Pediococcus pentosaceus DSM 16244 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EU) No 514/2010 should be repealed.

The proposal notified in G/SPS/N/EU/401 (28 July 2020) was adopted as Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (Text with EEA relevance) [OJ L 442, 30 December 2020, p.1]. This Regulation shall apply from 21 April 2021. The text of the legislation is available in English, French and Spanish: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX%3A32020R2235&qid=1609929445609.

The proposal notified in G/SPS/N/EU/403 (28 July 2020) was adopted as Commission Implementing Regulation (EU) 2020/2236 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates for the entry into the Union and movements within the Union of consignments of aquatic animals and of certain products of animal origin from aquatic animals, official certification regarding such certificates and repealing Regulation (EC) No 1251/2008 (Text with EEA relevance) [OJ L 442, 30 December 2020, p.410]. This Implementing Regulation shall apply from 21 April 2021.

The proposal notified in G/SPS/N/EU/371 (2 March 2020) was adopted as Commission Regulation (EU) 2020/1633 of 27 October 2020 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azinphos-methyl, bentazone, dimethomorph, fludioxonil, flufenoxuron, oxadiazon, phosalone, pyraclostrobin, repellants: tall oil and teflubenzuron in or on certain products (Text with EEA relevance) [OJ L 367, 5 November 2020, p.1]. This Regulation shall apply from 25 May 2021.

The European Union wishes to inform trade partners that the proposal notified in G/SPS/N/EU/407 (19 August 2020) will be amended to update the requirements for internal movements and import.For practical reasons, seeds that have been harvested before 15 August 2020 cannot fulfil the requirement for their mother plants to be produced in a production site where the specified pest is known not to occur, on the basis of official inspections carried out at the appropriate time to detect the specified pest. Therefore, such seeds should be exempted from the condition under Article 7(1)(a) and from the requirement under point (a) (i) of Article 9(1) of Implementing Regulation (EU) 2020/1191.The specified seeds originating from third countries should be tested using the sampling and testing methods as referred in the Annex of Implementing Regulation (EU) 2020/1191. To take into account that some specified seeds may have been tested months before they are actually certified for export, it is proportionate from 1 April 2021 onwards to require carrying out of mandatory molecular testing, and give third countries time to adapt to this requirement. A new addendum will be published as soon as the draft Commission Implementing Regulation is adopted and published in the Official Journal of the European Union.

The draft act concerns both the withdrawal from the EU market of a series of feed additives for administrative reasons and the clarification of the legal status of a series of products as feed additives or not, according to the EU legislation on feed additives. This notification concerns specifically the envisaged decision on the status of three products (listed in Annex III of the draft act) to be considered as feed additives within the meaning of Regulation (EC) No 1831/2003. For those products, it is proposed to provide a transitional period of seven years in order to allow operators to adapt to the new status as feed additives.

The proposal notified in G/SPS/N/EU/406 (6 August 2020) was adopted as Commission Regulation (EU) 2020/2040 of 11 December 2020 amending Regulation (EC) No 1881/2006 as regards maximum levels of pyrrolizidine alkaloids in certain foodstuffs (Text with EEA relevance) [OJ L 420, 14 December 2020, p.1]. This Regulation shall apply from 1 July 2022.

The measure concerns authorising the placing on the market of chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food for use in food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children.

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

The measure concerns authorising the placing on the market of selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food for use in food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and children under four years of age.

The measure concerns an amendment of the Union list of novel foods in order to include 8 novel foods, which were authorised between the publications of Implementing Regulation (EU) 2017/2470 and of Implementing Regulation (EU) 2018/1023.

The measure concerns the authorisation of sugars obtained from cocoa (Theobroma cacao L.) pulp as a novel food.

The European Commission, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof, Whereas: 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-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003 This application concerns the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category 'sensory additives'. The applicant requested the feed additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of 'flavouring compounds' for use in water for drinking. Therefore, the use of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 in water for drinking should not be allowed. The fact that of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed administered via water.