Notifications for European Union (1104 notifications)

The proposed draft Regulation concerns the review of the existing maximum residue levels (MRLs) for the substance chlordecone. MRLs for this substance are lowered. Lower MRLs are set to reflect the current monitoring data on the occurrence of chlordecone in the European Union due to the use of this persistent compound in the past.

Please note that the document G/SPS/N/EU/398/Add.1 dated 27 April 2021 was distributed erroneously and therefore should be considered null and void.

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-valine. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. The application concerns the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.358 as a feed additive for all animal species, to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'.  The European Food Safety Authority ('the Authority') concluded in its opinion of 30 September 2020 that, under the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 7.358, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer health or the environment. With respect to the safety of the user of L-valine produced by Corynebacterium glutamicum CGMCC 7.358, the Authority could neither exclude a risk by inhalation, nor that the substance it is irritant to skin or eyes, or a dermal sensitiser. Therefore, appropriate protective measures should be taken for this additive to prevent adverse effects on human health, in particular as regards the users of the additive. Furthermore, the Authority concluded that the substance is considered an efficacious source of the essential amino acid L-valine for animal nutrition and that, in order to be efficacious in ruminants, it should 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 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-valine produced by Corynebacterium glutamicum CGMCC 7.358 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 substance 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 such authorisation. Article 4(1) of that Regulation provides for the authorisation of additives. In accordance with Article 4(1) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of essential oil from Origanum vulgare L. subsp. hirtum (Link) letsw. Var. Vulkan (DOS 00001) as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category 'sensory additives'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its opinions of 29 November 2017 and 4 July 2019 that, under the proposed conditions of use, the essential oil from Origanum vulgare L. subsp. hirtum (Link) letsw. Var. Vulkan (DOS 00001) does not have an adverse effect on animal health, consumer health or the environment. It also concluded that the additive is considered as a potential irritant to skin and eye and a potential respiratory and skin sensitiser in susceptible individuals. 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 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.

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(1) of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of liquid L-lysine base and technically pure L-lysine monohydrochloride as nutritional feed additives for use in feed and in water for drinking for all animal species. These applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The applications concern the authorisation of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP as feed additives for all animal species to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'. The European Food Safety Authority ('the Authority') concluded in its opinions of 30 September 2020(2)and 18 November 2020(3)(4)that, under the proposed conditions of use, L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP do not have an adverse effect on animal health, consumer health or the environment. The Authority could conclude on the safety for the user of the L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum KCCM 80216 and Corynebacterium glutamicum KCTC 12307BP. It stated that of L-lysine monohydrochloride, technically pure, and L-lysine base, liquid, produced by Corynebacterium casei KCCM 80190 are considered hazardous by inhalation and that L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 is a mild eye irritant. 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 concluded that L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP, are effective sources of the essential amino acid L-lysine for all animal species. For the supplemental L-lysine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. In its opinions, the Authority referred to a previous statement concerning potential nutritional imbalances for amino acids and hygienic concerns, when they are administered via water for drinking. However, the Authority did not propose a maximum content for the supplementation with L-lysine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-lysine as amino acid via water for drinking.

The proposal notified in G/SPS/N/EU/396 (15 July 2020) is now adopted by Commission Regulation (EU) N° 2021/644 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 fluxapyroxad, hymexazol, metamitron, penflufen and spirotetramat in or on certain products [OJ L 133, 20 April 2021, p. 9]. The Regulation shall apply from 10 November 2021.

Regulation (EU) 2017/625 empowers the Commission to adopt, by way of implementing acts, model official certificates which accompany animals and goods entering the Union, and rules for the issuance of such certificates. Regulation (EU) 2016/429 empowers the Commission to lay down, by way of implementing acts, rules concerning animal health provisions to be contained in those official certificates.The purpose of this Regulation is to amend certain certificates of Implementing Regulations (EU) 2020/2235 and (EU) 2020/2236 in order to ensure coherence between public and animal health requirements for the entry into the Union of certain live aquatic animals and products of animal origin intended for human consumption in accordance with Regulation (EC) No 853/2004. This Regulation clarifies certain provisions related to public health and animal health requirements in order to align with the already applicable Regulation (EC) No 853/2004.

The purpose of this Regulation is to facilitate the transition to the use of the new animal health certificates and animal health/official certificates for movements of consignments within the Union and between Member States and in the interest of legal certainty, clarify transitional provisions during transitional period for certificates for entry into the Union. The act does not change transitional requirements for consignments entering the Union established but provide more clarity for transitional provisions. The date of application of this Regulation is 21 April 2021.

In accordance with Regulation (EU) 2017/625, certain categories of animals and goods from third countries should always be presented for official controls at the border control post of entry into the Union.This Implementing Regulation establishes the lists of the different animals and products of animal origin, germinal products, animal by-products and derived products, hay and straw and composite products to be presented for official controls at border control posts with the indication of their respective Combined Nomenclature (CN) code provided for in Council Regulation (EEC) No 2658/87.As new conditions for the entry into the Union of composite products start to apply from 21 April 2021 in accordance with Commission Delegated Regulation (EU) 2019/625 it is necessary to repeal Decision 2007/275/EC and include CN codes of composite products into this single list. This Implementing Regulation does not lay down new CN codes subject to checks at border control posts, but rather integrates CN codes of composite products into a single list due to repealed Decision 2007/275.

Regulation (EU) 2017/625 of the European Parliament and of the Council on Official Controls ('Official Controls Regulation') establishes the framework for official controls and other official activities to verify the correct application of Union agri-food chain legislation. This includes official controls performed on animals and goods entering the Union from third countries. Article 48(h) of the Official Controls Regulation provides that certain categories of animals and goods referred to in Article 47(1) of the same Regulation coming from third countries may be exempted from official controls at border control posts. According to Article 77(1)(k) of the Official Controls Regulation, arrangements for specific official controls may be laid down in delegated acts for those animals and goods exempted from official controls at border control posts.The purpose of this Regulation is to lay down cases and conditions under which certain lower risk shelf-stable composite products not containing processed meat are exempted from official controls at border control posts. EU member states' competent authorities should perform official controls on such composite products regularly, on a risk basis and with appropriate frequency, at the place of destination, the point of release for free circulation in the Union, or the warehouses or the premises of the operator responsible for the consignment. The Regulation establishes a new list of certain shelf-stable composite products not containing processed meat exempted from official controls at border control posts and lays down rules concerning official controls on those products.

The proposal notified in G/SPS/N/EU/443 (13 November 2020) 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.

The proposal notified in G/SPS/N/EU/395 (15 July 2020) is now adopted by Commission Regulation (EU) No 2021/616 of 13 April 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 benalaxyl, benalaxyl-M, dichlobenil, fluopicolide, proquinazid and pyridalyl in or on certain products (Text with EEA relevance) [OJ L 131, 16 April 2021, p. 4]. The Regulation shall apply from 6 November 2021.

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); and, suspension of entry into the Union for certain food and feed from certain third countries (in Annex IIa). This Implementing Regulation amends Annexes I, II and IIa to Implementing Regulation (EU) 2019/1793 by introducing the following changes: - deletion from Annex I of goji berries from China, and of dried grapes from Turkey; - increase in the frequency of identity and physical checks laid down in Annex I for pepper of the Capsicum species (other than sweet) from Thailand, and for black pepper from Brazil; - deletion from Annex II and inclusion in Annex I of groundnuts (peanuts) from Brazil, of groundnuts (peanuts) from China, and of hazelnuts from Turkey; - increase in the frequency of identity and physical checks laid down in Annex II of groundnuts (peanuts) from India; - deletion from Annex IIa and inclusion in Annex II of foodstuffs containing or consisting of betel leaves (Piper betle) from Bangladesh; - all the entries concerning Sesamum seeds in Annexes I and II to Implementing Regulation (EU) 2019/1793 are amended to include the Combined Nomenclature (CN) code for roasted Sesamum seeds; - the entry concerning sweet peppers (Capsicum annuum) from Turkey in Annex I is amended to cover all peppers of the Capsicum species. In addition, this Implementing Regulation confirms the provisions of Commission Implementing Regulation (EU) 2020/1540 of 22 October 2020 amending Implementing Regulation (EU) 2019/1793 as regards Sesamum seeds from India due to possible contamination with ethylene oxide and other pesticide residues. Furthermore, Part II of the model official certificate in Annex IV to Implementing Regulation (EU) 2019/1793 was amended to allow for more than one certification, where such certification is mandatory.

The draft Regulation establishes a maximum level for:- atropine and scopolamine in processed cereal based foods and baby foods for infants and young children containing maize and their derived products in addition to the already established levels in processed cereal based foods and baby foods for infants and young children containing millet, sorghum, buckwheat and their derived products; - the sum of atropine and scopolamine in millet, sorghum, buckwheat, maize and their milling products and in herbal infusions.

The draft Regulation revises the maximum levels set for ergot sclerotia in cereal grains with the exception of maize and rice and establishes maximum levels for ergot alkaloids in milling products of barley, wheat, spelt, rye and oats, wheat gluten, processed cereal based foods for infants and young children.

The proposal notified in G/SPS/N/EU/415 (2 October 2020) is now adopted by Commission Delegated Regulation (EU) No 2021/573 of 1 February 2021 amending Delegated Regulation (EU) 2019/625 as regards import conditions for live snails, for composite products and for casings placed on the market for human consumption (Text with EEA relevance) [OJ L 120, 8 April 2021, page 6].This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 1(5), (7)(b) and (8) shall apply from 21 April 2021.

The proposal notified in G/SPS/N/EU/402 (28 July 2020) is now adopted by Commission Implementing Regulation (EU) No 2021/403 of 24 March 2021 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 and model animal health/official certificates, for the entry into the Union and movements between member states of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (Text with EEA relevance) [OJ L 113, 31 March 2021, p. 1]. The Implementing Regulation shall apply from 21 April 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 such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC. Ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of ginger essential oil from Zingiber officinale Roscoe for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, laying hens, turkeys for fattening, piglets, pigs for fattening, sows, dairy cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from Zingiber officinale Roscoe for horses and dogs. The applicant requested ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe 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 ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe in water for drinking should not be allowed. The applicant requested the additives to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

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 that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC. Methanethiol was authorised without a time limit, in accordance with Directive 70/524/EEC, as a feed additive for all animal species. This additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of methanethiol as a feed additive for all animal species. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. The European Food Safety Authority ('the Authority') concluded in its opinions of 17 April 2013 and 30 September 2020 that, under the proposed conditions of use, methanethiol does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive should be considered as irritant to skin and eyes and to the respiratory tract and no conclusions could be drawn on skin sensitisation. 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 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 methanethiol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of methanethiol should be authorised as specified in the Annex to this Regulation.

This draft Commission Delegated Regulation aims to define criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans. It will serve as a basis for a forthcoming Commission Implementing Regulation establishing a list of antimicrobials to be reserved for the treatment of certain infections in humans. Such antimicrobials shall not be used in animals or products of animal origin to be imported into the European Union, in accordance with Article 118 of Regulation (EU) 2019/6.