Notifications for European Union (1104 notifications)

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(2).  Saponified paprika (Capsicum annuum) extract (capsanthin) was authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for poultry belonging to the group 'colourants, including pigments', under the heading'carotenoids and xanthophylls'. The 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 saponified paprika (Capsicum annuum) extract (capsanthin) as a feed additive for chickens for fattening, minor poultry species for fattening, laying hens and minor poultry species for laying. The applicant requested the additive to be classified in the additive category 'sensory additives' and in the functional group 'colourants: (ii) substances which, when fed to animals, add colours to food of animal origin'. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

The draft measure denies the existing authorisation of phosphoric acid 60% on silica carrier used as preservative antioxidant feed additive for all animal species, since the conditions for authorisation laid down by the relevant EU legislation are no longer met. According to the opinion of the European Food Safety Authority (EFSA) of 17 March 2020, considering the limited data provided in the dossier and in the absence of response from the applicant to its requests for additional information, EFSA could not conclude on the safety and efficacy of the additive. The draft denial act is accompanied by transitional measures in order to allow operators to adapt to the obligation to withdraw the products concerned from the market.

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 lanthanide citrate. 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 the preparation of lanthanide citrate as a feed additive for weaned piglets to be classified in the additive category 'zootechnical additives.

Regulation (EC) No 1831/2003 provides for the authorisation of additive 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 applications were submitted for the authorisation of L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534. These applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation. The applications concern the authorisation of L-tryptophan produced by Escherichia coli CGMCC 7.267, Escherichia coli CGMCC 11 674 or Escherichia coli KCCM 10 534 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'.

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 (2).The substances geraniol, citral, 3,7,11-trimethyldodeca-2,6,10-trien-1-ol, (Z)-nerol, geranyl acetate, geranyl butyrate, geranyl formate, geranyl propionate, neryl propionate, neryl formate, neryl acetate, neryl isobutyrate, geranyl isobutyrate and prenyl acetate ('the substances concerned') were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those additives substances 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 the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category 'sensory additives' and in the functional group 'flavouring compounds'. The 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 and renewing such authorisation.L-isoleucine produced by Escherichia coli FERM ABP-10641 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EU) No 348/2010 (2). In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-isoleucine produced by Escherichia coli FERM ABP-10641 as a feed additive for all animal species, requesting this additive to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'. This application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. Moreover, the application requested, in accordance with Article 7 of Regulation (EC) No 1831/2003, L-isoleucine produced by Escherichia coli FERM ABP-10641 to be authorised for use in water for drinking in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues' for all animal species, and for use in feed to be classified in the additive category 'sensory additives', functional group 'flavouring compounds'. The 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.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 80180 and Escherichia coli KCCM 80181. 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 80180 and Escherichia coli KCCM 80181 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category 'sensory additives'.

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or modifying such authorisation.The use of Lactococcus lactis NCIMB 30160 as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) No 1263/2011 (2). In accordance with Article 13(1) 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 Lactococcus lactis (NCIMB 30160) 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 formulation of the additive, consisting of the inclusion of polyethylene glycol (PEG 4000) in the list of cryoprotectants that can be used for the manufacture of the additive. The request was accompanied by the relevant supporting data.

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 zinc chelate of lysine and glutamic acid. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. That application concerns the authorisation of zinc chelate of lysine and glutamic acid as a feed additive for all animal species to be classified in the additive category 'nutritional additives'.

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.(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 applications were submitted for the authorisation of L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176. These applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation (EC). (3) The applications concern the authorisation of L-tryptophan produced by Escherichia coli KCCM 80135, Escherichia coli KCCM 80152, Escherichia coli CGMCC 7.248 or Corynebacterium glutamicum KCCM 80176 as a feed additive for all animal species, to be classified in the additive category 'nutritional additives'.

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 three applications were submitted for the authorisation of L-histidine monohydrochloride monohydrate. The applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation. The applications concern the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 as a feed additive for all animal species, to be classified in the additive category 'nutritional additives'. L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 and Corynebacterium glutamicum KCCM 80179 are also applied for the additive category 'sensory additives'.

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.(2) L-arginine produced by Corynebacterium glutamicum ATCC 13870 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 1139/2007 (2).(3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 as feed additive for all animal species, requesting this additive to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'. This application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003 and included a request to change the strain designation to Corynebacterium glutamicum NITE SD 00285. (4) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as a feed additive for use in feed and in water for drinking for all animal species. The application concerns the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 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' and additive category 'sensory additives', functional group 'flavouring compounds'. This 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 Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).(2) Erythrosine was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for ornamental fish belonging to the group ‘colourants, including pigments', under the heading ‘other colourants'. It was also authorised without a time limit as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments', under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules'. The 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. (3) 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 erythrosine as a feed additive for ornamental fish and for dogs and cats. The applicant requested the additive to be classified in the additive category ‘sensory additive' and in the functional group ‘colourants'. In accordance with Article 7 of Regulation (EC) No 1831/2003, the applicant also requested the authorisation of erythrosine as a feed additive for a new use in reptiles, to be classified in the additive category ‘sensory additive' and in the functional group ‘colourants'. Lately, the applicant withdrew the application for ornamental fish and for reptiles. The 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.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 11473 as a feed additive for use in feed for all animal species. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. This application concerns the authorisation of L-threonine produced by Escherichia coli CGMCC 11473 as a feed additive for all animal species to be classified in the additive category 'nutritional additives'.

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 sodium formate. 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 sodium formate as a feed additive for all animal species to be classified in the category ‘technological additives'.

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 (2).Ponceau 4R was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for ornamental fish belonging to the group 'colourants, including pigments', under the heading 'other colourants'. It was also authorised without a time limit as a feed additive for dogs and cats belonging to the group 'colourants, including pigments', under the heading 'colouring agents authorised for colouring foodstuffs by Community rules'. The 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 ponceau 4R as a feed additive for ornamental fish and for dogs and cats. The applicant requested the additive to be classified in the additive category 'sensory additive' and in the functional group 'colourants'. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

Description of content: 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 (2):(2) Allura red AC was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments' under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules'. The 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. (3) 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 allura red AC as a feed additive for dogs and cats. The applicant requested the additive to be classified in the additive category ‘sensory additive' and in the functional group ‘colourants'. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

The revision aims at addressing a number of requests from Member States and stakeholders to provide more clarity on certain legal provisions related to official controls.As regards official controls in meat, only clarifications, better consistency of wordings and a return to inspection practices applicable before the entry into force of the Regulation (December 2019) were aimed at.As regards official controls in bivalve molluscs,  the detection of Paralytic Shellfish Poison (PSP) toxins will be permitted only using alternative methods not entailing the use of animals (the use of the mouse bioassay shall be forbidden); moreover taking into account that EFSA has concluded that there are no reports on adverse effects in humans associated with Pectenotoxins (PTX) group toxins, those toxins will be removed from the list of toxins to be tested during official controls. As regards official controls in fishery products, taking into account that fishery products derived from aquaculture are tested to establish compliance as regards contaminants and pesticides, also wild caught fishery products should be tested to establish the compliance as regards contaminants.

The revision aims at adapting the Delegated Regulation (EC) No 2019/625 with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption to introduce import conditions for live snails that are intended for human consumption as for processed snails. To ensure the protection of the health of European consumers there is a need to list authorised third countries exporting live snails in the European Union. An official certificate shall accompany such consignments The amendment also adds Harmonized System codes for composite products, clarifies the categories of composite products accompanied by a certificate, and adapts the import conditions for casings with regard to the raw materials they are derived from.

The revision aims at addressing a number of requests from EU countries and stakeholders, while maintaining a high level of food safety.As regards hygiene rules on meat, the amendments introduce certain targeted  flexibility, hence facilitating trade or alignments with the Regulations related to meat inspection, applicable since December 2019 and notified earlier to the World Trade Organisation.As regards bivalve molluscs, the amendment removes pectenotoxins from the list of marine biotoxins to be analysed in live bivalve molluscs based on a scientific opinion; establishes a specific model of the registration document that must accompany movements of live bivalve molluscs after harvesting and until their placing on the market and aligns the rules for echinoderms harvested outside classified production areas fixed in Delegated Regulation (EU) 2019/624 to the limitations in derogation established by the Parliament and the Council in Regulation (EU) 2017/625. As regards fishery products, the amendments fix specific hygiene requirements for reefer vessels as regards transport temperature and cold store maintenance, and the obligation on board vessels that containers used for storing and or freezing fishery products be not used for other purposes.