Notifications for European Union (1104 notifications)

The proposal notified in G/SPS/N/EU/478 (6 April 2021) is now adopted by Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans (Text with EEA relevance) [OJ L 353, 6 October 2021, p. 1]. The Regulation shall apply from 28 January 2022.

The proposed draft Regulation is a new legislative act which updates the list of invasive alien species of Union concern in implementation of the Regulation (EU) No 1143/2014 of the European Parliament and of the Council on the prevention and management of the introduction and spread of invasive alien species. The list was established by Commission Implementing Regulation (EU) No 2016/1141, and was updated by Commission Implementing Regulation (EU) No 2017/1263 and by Commission Implementing Regulation (EU) No 2019/1262. The notified proposal for a draft Regulation adds further species to the list.

The proposal notified in G/SPS/N/EU/470 (17 March 2021) is now adopted by Commission Regulation (EU) 2021/1841 of 20 October 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 6-benzyladenine and aminopyralid in or on certain products (Text with EEA relevance) [OJ L 373/63, 21 October 2021].Chlorantraniliprole was taken out of the Regulation due to an objection by the European Parliament on a maximum residue level measure and the resulting delays, subsequent measures that build on that first one were affected and reviewed to ensure that proposed Maximum residue levels could be consistently established. The Regulation shall apply from 10 May 2022.

This draft Commission Regulation concerns the inclusion of green tea catechins in Annex III of Regulation (EC) No 1925/2006 ('the Regulation').In its opinion, adopted on 14 March 2018, EFSA concluded that while catechins from green tea infusions prepared in a traditional way were considered safe for use, catechins taken as a food supplement, at and above 800mg of (-)-epigallocatechin-3-gallate, had been shown to cause elevated serum transaminases, which is indicative of liver injury. 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 green tea catechins, 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 Annex III to the Regulation). >

The text removes the authorisation to use titanium dioxide (E 171) in foods based on the recent scientific opinion of the European Food Safety Authority (EFSA) concluding that titanium dioxide can no longer be considered as safe when used as a food additive. The text also includes a commitment to review the necessity to maintain titanium dioxide (E 171) or otherwise delete it from the Union list of food additives for exclusive use as a colour in medicinal products within three years after the date of entering into force of this Regulation. In order to allow for a smooth transition, the text lays down that foods that contain titanium dioxide (E 171) used in accordance with the rules applicable before the date of entry into force of the Regulation may be placed on the market until six months after that date. Those foods may then continue to be marketed until their date of minimum durability or 'use by' date.

The Regulation corrects and amends Regulation (EU) 2021/404 to address certain inconsistencies between the lists of third countries, territories or zones thereof authorised for the entry into the Union under the Animal Health Law, and applicable from 21 April 2021, and the lists of third countries authorised for imports into the Union laid down in a number of EU legal acts which were repealed as from that date.

The proposal notified in G/SPS/N/EU/416 (6 October 2020) is now adopted by Commission Implementing Regulation (EU) 2021/1709 of 23 September 2021 amending Implementing Regulation (EU) 2019/627 as regards uniform practical arrangements for the performance of official controls on products of animal origin (Text with EEA relevance) [OJ L 339, 24 September 2021, p. 84]. 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/490 (21 May 2021) is now adopted by Commission Regulation (EU) 2021/1532 of 17 September 2021 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 (Text with EEA relevance) [OJ L 330, 20 September 2021, p. 69]. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

The revision has the main purpose to align the import conditions for shelf-stable composite products containing colostrum-based products, to the requirements proposed in Commission Delegated Regulation (EU) 2020/692 on animal health grounds, considering the animal health risks related to those processed products of animal origin and the absence of effective treatments to mitigate them. Therefore, shelf-stable composite products containing colostrum-based products shall no longer benefit from the possibility to be accompanied by a private attestation, and will have to be officially certified.The opportunity is taken: - to correct some structural and writing errors in some articles that might create unintentional confusion as regards the combined nomenclature and harmonised system codes of the products covered by the import conditions; - to include a CN code for pollen flour which represents a residue risk and should only be imported in accordance with the import conditions for other apiculture products; it also includes a CN code for Vitamin D3 derived from lanolin to ensure imports can continue under the relevant import conditions; - to amend Delegated Regulation (EU) 2019/2122 in respect of the provisions for pet birds to make minor updates to certain references to acts mentioned in that Delegated Regulation; - to provide new legal references in Delegated Regulation (EU) 2021/630 as a consequence of changes in Article 12(2) of Delegated Regulation (EU) 2019/625 and to clarify that only shelf-stable composite products not containing colostrum-based products or any processed meat other than gelatine, collagen or highly refined products may be exempted from official controls at border control posts.

On the basis of an underpinning opinion of the European Food Safety Authority (EFSA) https://www.efsa.europa.eu/en/efsajournal/pub/5993, the measure authorises the use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae in food supplements that are intended for the general population above the age of 14 years.

On 23 June 2021, 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. For reasons of transparency and clarity, it is indicated, for each of the tests listed in Annex IV to Implementing Regulation (EU) 2020/1201, the Digital Object Identifier (DOI) that allows direct access to the scientific articles describing those tests.

This Implementing Regulation amends existing regulations to specify precise reference to the relevant list of third countries or regions thereof provided in regulations (EU) 2021/404 and (EU) 2021/405; approved national measures designed to limit the impact of certain diseases of aquatic animals laid down in Decision (EU) 2021/260 and rectify written mistakes or unintentional omissions were spotted in the texts after publication of Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 on 30 December 2020 in the Official Journal of the European Union. As well taking into account changes in specific legislations on animals health an public health areas.

The proposal notified in G/SPS/N/EU/480 (15 April 2021) is now adopted by Commission Regulation (EU) 2021/1408 of 27 August 2021 amending Regulation (EC) No 1881/2006 as regards maximum levels of tropane alkaloids in certain foodstuffs (Text with EEA relevance) [OJ L 304, 30 August 2021, p. 1]. 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/479 (14 April 2021) is now adopted by Commission Regulation (EU) 2021/1399 of 24 August 2021 amending Regulation (EC) No 1881/2006 as regards maximum levels of ergot sclerotia and ergot alkaloids in certain foodstuffs (Text with EEA relevance) [OJ L 301, 25 August 2021, p. 1].The Regulation shall apply from 1 January 2022.

The proposal notified in G/SPS/N/EU/489 (21 May 2021) has been revised after the closure of the initial consultation period.The amendments concern the following:- removing the proposal which withdrew the authorisation of DL tartaric acid. This implies reintroducing line item 6.9 into Table 2 of Part A of Annex I to the draft Delegated Regulation, deleting point (c) of paragraph (1) of Annex I to the draft Delegated Regulation initially notified, and deleting the recital which justified withdrawing the authorisation of DL tartaric acid (i.e. Recital (30) of the initially notified draft);- adding the vine varieties Garnacha Roja and Mazuela allowed for the production of liqueur wines with the traditional terms 'vino dulce natural', 'vino dolce naturale', 'vinho doce natural' and 'οινος γλυκυς φυσικος' (appendix 3 to Annex III to the revised draft Delegated Regulation); - adding the relevant 2021 resolutions of the International Organisation of Vine and Wine into the draft Regulation (line items 6.14 (fumaric acid) and 7.12 (aspergillopepsin I)).

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 manganese chelate of lysine and glutamic acid. The 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 the preparation of manganese chelate of lysine and glutamic acid as a feed additive for all animal species to be classified in the additive category 'nutritional additives' and the functional group 'compounds of trace elements'. The European Food Safety Authority ('the Authority') concluded in its opinions of 10 January 2020 and 27 January 2021 that, under the proposed conditions of use, manganese chelate of lysine and glutamic acid does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that the handling of the additive poses a risk to users by inhalation and that it should be considered as an eye irritant, 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 the users of the additive. The Authority concluded that the additive is efficacious in chickens for fattening; this conclusion can be extended to all other animal species. 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 manganese chelate of lysine and glutamic acid 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 as specified in the Annex to this Regulation.

The proposal notified in G/SPS/N/EU/414 (1 October 2020) is now adopted by Commission Delegated Regulation (EU) No 2021/1374 of 12 April 2021 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council on specific hygiene requirements for food of animal origin (Text with EEA relevance) [OJ L 297, 20 August 2021, p. 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 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 phytomenadione. That 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 phytomenadione as a feed additive for horses. The applicant requested this additive to be classified in the additive category 'nutritional additives'. The European Food Safety Authority ('the Authority') concluded in its opinion of 17 March 2021 that, under the proposed conditions of use, phytomenadione does not have adverse effects on animal health, consumer safety or the environment. The Authority concluded that users will not be exposed by inhalation when the additive is presented in solid form or viscous liquid. Data from the Scientific Committee on Consumer Safety indicates that vitamin K1 can be categorised as a dermal sensitiser. For preparations, the Authority could not conclude on their potential to be toxic by inhalation or on their potential as skin/eye irritant. 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 and its preparations. The Authority concluded that phytomenadione is considered as an efficacious source of vitamin K1 for horses, when added to feed. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of phytomenadione shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of phytomenadione should be authorised. The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.

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

This draft Commission Implementing Regulation provides that the approval of the active substance indoxacarb is not renewed in accordance with Regulation (EC) No 1107/2009. EU Member States shall withdraw authorisations for plant protection products containing indoxacarb 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. 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. uring the evaluation and peer-review of indoxacarb, 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). The EFSA identified a critical concern in relation to the high long-term risk to wild mammals for all representative uses and, additionally, a high risk to consumers and workers for the representative use in lettuce and a high risk to bees for the representative use in maize, sweet corn and lettuce for seed production. Furthermore, there are several areas of the risk assessment not finalised due to lack of data in the dossier. These concerns mean that indoxacarb does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently. Existing authorisations will need to be withdrawn; EU member States must withdraw existing plant protection products containing indoxacarb 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 6 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 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/827.