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)

• CELEX: Implementing Regulation (EU) 2021/758
• Articles: 10

Article 1 Withdrawal from the market

The feed additives specified in Annex I shall be withdrawn from the market in respect of the animal species or categories of animals as specified in that Annex.

Article 2 Transitional measures for the feed additives to be withdrawn from the market

1.   Existing stocks of the feed additives listed in Chapters I.A and I.C of Annex I may continue to be placed on the market and used until 30 May 2022.

2.   Premixtures produced with the additives referred to in paragraph 1 may continue to be placed on the market and used until 30 August 2022.

3.   Compound feed and feed materials produced with the additives referred to in paragraph 1 or with the premixtures referred to in paragraph 2 may continue to be placed on the market and used until 30 May 2023.

4.   By way of derogation from paragraphs 1, 2 and 3, the feed additives sodium citrates, potassium citrates, sorbitol, mannitol and calcium hydroxide listed in Chapter I.A of Annex I, and feed produced with those additives, may continue to be placed on the market and used until 30 May 2028.

Article 3 Amendment to Regulation (EC) No 358/2005

In Annex II to Regulation (EC) No 358/2005, entry E 141 on chlorophyll copper complex is deleted.

Article 4 Repeals

Regulations (EC) No 880/2004 and (EC) No 775/2008 are repealed.

Article 5 Products not considered as feed additives within the scope of Regulation (EC) No 1831/2003

1.   The substances, micro-organisms or preparations (referred to as ‘products’) set out in Annex II are not feed additives within the scope of Regulation (EC) No 1831/2003.

2.   Products referred to in paragraph 1 which are lawfully on the market and are labelled as feed additives and premixtures before 30 May 2024 may continue to be placed on the market until stocks are exhausted. The same applies to feed materials or compound feed which refer to those products in their labelling as feed additives in accordance with Regulation (EC) No 767/2009.

Article 6 Products considered as feed additives within the scope of Regulation (EC) No 1831/2003

1.   The substances, micro-organisms or preparations (referred to as ‘products’) set out in Annex III are feed additives within the scope of Regulation (EC) No 1831/2003.

2.   Products referred to in paragraph 1 may continue to be placed on the market and used until 30 May 2028.

Article 7 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I Feed additives to be withdrawn from the market, as referred to in Article 1

ANNEX I

Feed additives to be withdrawn from the market, as referred to in Article 1

CHAPTER I.A.

Feed additives which were authorised without a time limit

Part 1

Feed additives to be withdrawn from the market for all species and categories of animals

Identification Number

Additive

Species or category of animals

Preservatives

E 331

Sodium citrates

All species

E 332

Potassium citrates

All species

E 325

Sodium lactate

All species

E 326

Potassium lactate

All species

Emulsifying and stabilising agents, thickeners and gelling agents

E 420

Sorbitol

All species

E 421

Mannitol

All species

Binders, anti-caking agents and coagulants

E 558

Bentonite-montmorillonite

All species

Vitamins, provitamins and chemically well-defined substances having similar effect

Riboflavin or Vitamin B 2 . All forms with the exception of :

—

Riboflavin solid form produced by Ashbya gossypii DSM 23096  ( 1 ) [3a825i];

—

Riboflavin solid form produced by Bacillus subtilis DSM 17339 and/or DSM 23984  ( 1 ) [3a825ii];

—

Riboflavin 5'-phosphate ester monosodium salt solid form produced after phosphorylation of riboflavin 98 % produced by Bacillus subtilis DSM 17339 and/or DSM 23984  ( 1 ) [3a826];

—

Riboflavin (80 %) produced by Bacillus subtilis KCCM-10445  ( 2 ) .

All species

E 160 a

Beta-carotene. All forms with the exception of beta-carotene authorised by Commission Implementing Regulation (EU) 2015/1103  ( 3 ) [3a160(a)]

All species

Silage additives

Microorganisms

Enterococcus faecium CNCM I-3236/ATCC 19434

All species

Bacillus subtilis MBS-BS-01

All species

Lactobacillus plantarum DSM 11520

All species

Colourants, including pigments

Other colourants

E 153

Carbon black as a colouring agent authorised for colouring foodstuffs by Community rules

All species

Flavouring and appetising substances

Natural products – botanically defined

Allium cepa L.: Onion concentrate CoE 24

All species

Allium sativum L.: Garlic extract (water-based)

All species

Amyris balsamifera L.: Amyris oil CoE 33

All species

Anacardium occidentale L.: Cashew oil CoE 34

All species

Anethum graveolens L.: Dill seed extract CAS 8006-75-5 CoE 42 Einecs 289-790-8

All species

Apium graveolens L.: Celery seed extract CAS 89997-35-3 FEMA 2270 CoE 52 Einecs 289-668-4

All species

Artemisia absinthium L.: Wormwood oil CAS 8008-93-3 FEMA 3116 CoE 61 Einecs 284-503-2

All species

Artemisia annua L.: Annual mugwort extract (water-based)/Annual mugwort oil

All species

Artemisia pallens Wall.: Davana oil CAS 8016-03-3 FEMA 2359 CoE 69 Einecs 295-155-6

All species

Bacopa monnieri (L.) Pennell: Thyme leaved gratiola tincture

All species

Carum carvi L. = Apium carvi L.: Caraway seed extract/Caraway oleoresin CAS 8000-42-8 CoE 112 Einecs 288-921-6

All species

Cimicifuga simplex (Wormsk. ex DC.) Ledeb.

= C. racemosa (L.) Nutt.: Sarashina shoma extract

All species

Cinnamomum aromaticum Nees, C. cassia Nees ex Blume: Cassia bark extract CAS 84961-46-6 FEMA 2257 CoE 131 Einecs 284-635-0

All species

Cinnamomum zeylanicum Bl., C. verum J.S. Presl: Cinnamon bark oleoresin CAS 84961-46-6 FEMA 2290 CoE 133 Einecs 283-479-0

All species

Citrus aurantium L.: Neroli bigarade oil CAS 8016-38-4 FEMA 2771 CoE 136 Einecs 277-143-2/Petitgrain bigarade absolute CAS 8014-17-3 CoE 136 Einecs 283-881-6

All species

Citrus reticulata Blanco: Mandarin, Tangerine terpenes CoE 142

All species

Citrus x paradisi Macfad.: Grapefruit oil expressed CAS 8016-20-4 FEMA 2530 CoE 140 Einecs 289-904-6/Grapefruit extract CoE 140

All species

Glycyrrhiza glabra L.: Licorice extract (solvent-based) CAS 97676-23-8 FEMA 2628 CoE 218 Einecs 272-837-1

All species

Juniperus communis L.: Juniper berry extract CAS 84603-69-0 CoE 249 Einecs 283-268-3

All species

Laurus nobilis L.: Laurel leaves extract/Laurel leaves oleoresin CAS 84603-73-6 FEMA 2613 CoE 255 Einecs 283-272-5

All species

Lavandula latifolia Medik.: Spike lavender oil CoE 256

All species

Lepidium meyenii Walp.: Maca extract

All species

Leptospermum scoparium J. R. et G. Forst.: Broom teatree oil

All species

Macleaya cordata (Willd.) R. Br.: Plume poppy absolute/Plume poppy extract/Plume poppy oil/Plume poppy tincture

All species

Mallotus philippinensis (Lam.) Muell. Arg.: Kamala extract CoE 535

All species

Malpighia glabra L.: Acerola extract

All species

Malus sylvestris Mill.: Apple concentrate CoE 386

All species

Medicago sativa L.: Alfalfa tincture CoE 274

All species

Melissa officinalis L.: Melissa oil CoE 280

All species

Mentha pulegium L.: Pennyroyal oil CAS 8013-99-8 FEMA 2839 CoE 283 Einecs 290-061-1

All species

Myristica fragrans Houtt.: Mace oil CAS 8007-12-3 FEMA 2653 CoE 296 Einecs 282-013-3/Nutmeg oleoresin CAS 8408268-8 CoE 296 Einecs 282-013-3

All species

Myroxylon balsamum (L.) Harms: Tolu balsam extract (solvent-based) CAS 9000-64-0 FEMA 3069 CoE 297 Einecs 232-550-4

All species

Myroxylon balsamum (L.) Harms var. Pereirae : Balsam peru extract (solvent-based) CAS 8007-00-9 FEMA 2117, 2116 CoE 298 Einecs 232-352-8

All species

Ocimum basilicum L.: Basil oil CAS 801573-4 FEMA 2119 CoE 308 Einecs 283-900-8

All species

Opopanax chironium (L.) Koch, Commiphora erythrea Engler: Opoponax oil CAS 8021- 36-1 CoE 313 Einecs 232-558-8

All species

Passiflora edulis Sims. = P. incarnata L.: Passionfruit extract (water-based) CoE 321

All species

Pelargonium asperum Her. ex Spreng.: Geranium oil

All species

Peumus boldus Mol.: Boldo extract CoE 328/Boldo tincture CoE 328

All species

Pinus pinaster Soland.: Pine oil

All species

Pimenta racemosa (Mill.) J.W.Moore: Bay oil CAS 8006-78-8 CoE 334

All species

Piper methysticum G. Forst.: Kawa-kawa tincture

All species

Quillaja saponaria Molina: Quillaia extract (solvent-based) CoE 391/Quillaia concentrate

All species

Ribes nigrum L.: Black currant extract CoE 399

All species

Satureja hortensis L.: Savory summer oil CAS 8016-68-0 FEMA 3013 CoE 425 Einecs 283-922-8

All species

Sophora japonica L.: Pagoda tree oil

All species

Styrax benzoin Dryand., S. tonkinensis (Pierre) Craib ex Hartwich: Benzoin resinoid CAS 9000 -05-9 FEMA 2133 CoE 439 Einecs 232-523-7

All species

Tagetes erecta L., T. glandulifera Schrank., T. minuta L. e.a.: Tagetes oil CAS 8016- 84-0 FEMA 3040 CoE 443/494 Einecs 294-862-7

All species

Thea sinensis L. = Camellia thea Link. = Camellia sinensis (L.) O. Kuntze: Tea tincture CoE 451

All species

Uncaria tomentosa L. = Ourouparia guianensis Aubl.: Cat’s claw extract

All species

Valeriana officinalis L.: Valerian root tincture CoE 473

All species

Vetiveria zizanoides (L.) Nash.: Vetiver oil CAS 8016-96-4 CoE 479 Einecs 282-490-8

All species

Vitis vinifera L.: Cognac oil green CAS 8016-21-5 FEMA 2331 CoE 485 Einecs 232-403-4/Cognac oil white CAS 801621-5 FEMA 2332 CoE 485 Einecs 232-403-4

All species

Vitis vinifera L.: Grape seed extract CoE 485

All species

Yucca mohavensis Sarg. = Y. schidigera Roezl ex Ortgies: Mojave yucca extract (solvent-based) CAS 90147-57-2 FEMA 3121 Einecs 290-449-0/Yucca concentrate/Yucca residuals

All species

Zingiber officinale Rosc.: Ginger extract CAS 84696-15-1 FEMA 2521 CoE 489 Einecs 283-634-2

All species

Natural products and corresponding synthetic products

CAS No 1128 -08-1/3-Methyl-2-pentylcyclopent-2-en-1-one/Flavis No 07.140

All species

CAS No 352195-40-5/Disodium Inosine-5-Mono-phosphate (IMP)

All species

Part 2

Feed additives to be withdrawn from the market for certain species or categories of animals

Identification Number

Additive

Species and category of animals

Trace elements

E 7

Molybdenum – Mo, Sodium molybdate

All animal species and categories with the exception of sheep

Acidity regulators

E 503 (i)

Ammonium carbonate

Cats; Dogs

E 503 (ii)

Ammonium hydrogen carbonate

Cats; Dogs

E 525

Potassium hydroxide

Cats; Dogs

E 526

Calcium hydroxide

Cats; Dogs

Colourants, including pigments

Carotenoids and xanthophylls

E 160 a

Beta-carotene

Canaries

Other colourants

E 141

Chlorophyllin copper complex as a colouring agent authorised for colouring foodstuffs by Community rules

All animal species and categories with the exception of dogs and cats

E 141

Chlorophyll copper complex as a colouring agent

[functional group 2 a (iii)]

Grain-eating ornamental birds; Small rodents; Ornamental fish

E 153

Carbon black as a colouring agent

[functional group 2 a (iii)]

Ornamental fish

E 172

Iron Oxide Red, Black & Yellow as colouring agent authorised for colouring foodstuffs by Community rules

Horses

Flavouring and appetising substances

Natural products – botanically defined

Helianthus annuus L.: Sunflower extract

Cats; Dogs

Hyssopus officinalis L. = H. decumbens Jord. & Fourr.: Hyssop Oil CAS 8006-83-5 FEMA 2591 CoE 235 Einecs 283-266-3

Cats; Dogs

Sus scrofa (extract from defatted porcine pancreatic glands)

Cats and dogs and other carnivorous and omnivorous companion animals such as ferrets

Amino acids, their salts and analogues

3.2.7.

Mixtures of:

(a)

L-lysine-monohydrochloride, technically pure and,

(b)

DL-methionine, technically pure

protected with copolymer vinyl-pyridine/styrene

Dairy cows

CHAPTER I.B.

Feed additives which were authorised for a limited period

Identification Number

Additive

Species or category of animals

Coccidiostats and other medicinal substances

E 758

Robenidine hydrochloride 66 g/kg (holder of the authorisation Zoetis Belgium SA)

Turkeys

E 770

Maduramicin ammonium alpha 1 g/100 g (holder of the authorisation Zoetis Belgium SA)

Turkeys

CHAPTER I.C.

Feed additives for which a notification referred to in Article 10(1)(a) of Regulation (EC) No 1831/2003 was not submitted

Identification Number

Additive

Species or category of animals

Amino acids, their salts and analogues

3.2.6.

L-lysine phosphate and its by-products produced by fermentation with Brevibacterium lactofermentum NRRL B-11470

Poultry; Pigs

( 1 )   Those forms of riboflavin have been authorised by Commission Implementing Regulation (EU) 2019/901 of 29 May 2019 concerning the authorisation of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) (sources of vitamin B2) as feed additives for all animal species ( OJ L 144, 3.6.2019, p. 41 ).

( 2 )   This form of riboflavin has been the subject of a denial of authorisation by Commission Implementing Regulation (EU) 2018/1254 of 19 September 2018 concerning the denial of authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect ( OJ L 237, 20.9.2018, p. 5 ).

( 3 )   Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed additive for all animal species ( OJ L 181, 9.7.2015, p. 57 ).

ANNEX II Products which are not feed additives within the scope of Regulation (EC) No 1831/2003, as referred to in Article 5(1)

ANNEX II

Products which are not feed additives within the scope of Regulation (EC) No 1831/2003, as referred to in Article 5(1)

1.

Tamarind seed flour

2.

Potassium dihydrogen orthophosphate

3.

Dipotassium hydrogen orthophosphate

4.

Tripotassium orthophosphate

5.

Ammonium dihydrogen orthophosphate

6.

Diammonium hydrogen orthophosphate

7.

Disodium dihydrogen diphosphate

8.

Tetrapotassium diphosphate

9.

Pentapotassium triphosphate

10.

Sodium sesquicarbonate

11.

Potassium hydrogen carbonate

12.

Calcium oxide

13.

Sucrose esters of fatty acids (esters of saccharose and edible fatty acids)

14.

Sucroglycerides (mixture of esters of saccharose and mono- and di-glycerides of edible fatty acids)

15.

Polyglycerol esters of non-polymerised edible fatty acids

16.

Mono-esters of propane-1,2-diol (propyleneglycol) and edible fatty acids, alone or in mixtures with diesters

17.

Merluccius capensis , Galeorhinus australis e.a.,/Cartilage

ANNEX III Products which are feed additives within the scope of Regulation (EC) No 1831/2003, as referred to in Article 6(1)

ANNEX III

Products which are feed additives within the scope of Regulation (EC) No 1831/2003, as referred to in Article 6(1)

1.

Xylitol

2.

Ammonium lactate

3.

Ammonium acetate