Contents
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 nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)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 an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECnote.
(2)The substances microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose were authorised without a time limit pursuant to Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products, in accordance with Article 10(1), point (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, applications were submitted for the re-evaluation of microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose as feed additives for all animal species. The applicants requested microcrystalline cellulose, methyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose to be classified in the additive category ‘technological additives’ and in the functional groups ‘emulsifiers’, ‘stabilisers’, ‘thickeners’ and ‘gelling agents’; ethyl cellulose in the additive category ‘technological additives’ and in the functional group ‘stabilisers’ and hydroxypropyl cellulose in the additive category ‘technological additives’ and in the functional groups ‘emulsifiers’, ‘stabilisers’, ‘thickeners’ and ‘gelling agents’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4)In addition, in accordance with Article 7 of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of microcrystalline cellulose, methyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose as feed additives for all animal species, requesting them to be classified in the additive category ‘technological additives’ and in the functional group ‘binders’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(5)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 July 2020note and 31 January 2024note that, under the proposed conditions of use, microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose, are safe for all animal species, the consumer and the environment. In the absence of data, it was not in the position to conclude on the safety for the user. No specific data on the efficacy of these additives in feedingstuffs were provided, but as they are all authorised for use as food additives, the Authority concluded that the effect seen when those substances are used in food could reasonably be expected to be seen when they are used as additives in feed. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6)In view of the above, the Commission considers that microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives.
(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, as far as they belong to the functional groups ‘emulsifiers’, ‘stabilisers’, ‘thickeners’ and ‘gelling agents’, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
The substances specified in the Annex, belonging to the additive category ‘technological additives’ and the functional groups ‘emulsifiers’, ‘stabilisers’, ‘thickeners’, ‘gelling agents’ or ‘binders’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Transitional measures#
1.The feed additives microcrystalline cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose, as authorised pursuant to Directive 70/524/EEC and premixtures containing these additives, which are produced and labelled before 19 August 2025 in accordance with the rules applicable before 19 February 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
2.Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 February 2026 in accordance with the rules applicable before 19 February 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.
3.Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 February 2027 in accordance with the rules applicable before 19 February 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
Article 3Entry 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.
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: emulsifiers | ||||||||
| 1c460i | Microcrystalline cellulose | Additive compositionMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis)Solid formCharacterisation of the active substanceMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis), manufactured from wood pulp partially depolymerised with a hydrolysation process obtained with heat and mineral acidCAS No: 9004-34-6Loss on drying: ≤ 7 %Water-soluble matters: ≤ 0,24 %Sulfated ash: ≤ 0,5 %Starch: not detectableCarboxyl groups ≤ 1 %Particle size: ≤ 10 % of particles of less than 5 μmAnalytical methodnoteFor the identification/characterisation of microcrystalline cellulose in the feed additive:Commission Regulation (EU) No 231/2012 for microcrystalline cellulose and the corresponding methods of the FAO JECFA microcrystalline cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: stabilisers | ||||||||
| 1c460i | Microcrystalline cellulose | Additive compositionMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis)Solid formCharacterisation of the active substanceMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis), manufactured from wood pulp partially depolymerised with a hydrolysation process obtained with heat and mineral acidCAS No: 9004-34-6Loss on drying: ≤ 7 %Water-soluble matters: ≤ 0,24 %Sulfated ash: ≤ 0,5 %Carboxyl groups ≤ 1 %Particle size: ≤ 10 % of particles of less than 5 μmAnalytical methodnoteFor the identification/characterisation of microcrystalline cellulose in the feed additive:Regulation (EU) No 231/2012 for microcrystalline cellulose and the corresponding methods of the FAO JECFA microcrystalline cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: thickeners | ||||||||
| 1c460i | Microcrystalline cellulose | Additive compositionMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis)Solid formCharacterisation of the active substanceMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis), manufactured from wood pulp partially depolymerised with a hydrolysation process obtained with heat and mineral acidCAS No: 9004-34-6Loss on drying: ≤ 7 %Water-soluble matters: ≤ 0,24 %Sulfated ash: ≤ 0,5 %Carboxyl groups ≤ 1 %Particle size: ≤ 10 % of particles of less than 5 μmAnalytical methodnoteFor the identification/characterisation of microcrystalline cellulose in the feed additive:Regulation (EU) No 231/2012 for microcrystalline cellulose and the corresponding methods of the FAO JECFA microcrystalline cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: gelling agents | ||||||||
| 1c460i | Microcrystalline cellulose | Additive compositionMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis)Solid formCharacterisation of the active substanceMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis), manufactured from wood pulp partially depolymerised with a hydrolysation process obtained with heat and mineral acidCAS No: 9004-34-6Loss on drying: ≤ 7 %Water-soluble matters: ≤ 0,24 %Sulfated ash: ≤ 0,5 %Carboxyl groups ≤ 1 %Particle size: ≤ 10 % of particles of less than 5 μmAnalytical methodnoteFor the identification/characterisation of microcrystalline cellulose in the feed additive:Regulation (EU) No 231/2012 for microcrystalline cellulose and the corresponding methods of the FAO JECFA microcrystalline cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: binders | ||||||||
| 1c460i | Microcrystalline cellulose | Additive compositionMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis)Solid formCharacterisation of the active substanceMicrocrystalline cellulose ≥ 97 % (calculated as cellulose on the anhydrous basis), manufactured from wood pulp partially depolymerised with a hydrolysation process obtained with heat and mineral acidCAS No: 9004-34-6Loss on drying: ≤ 7 %Water-soluble matters: ≤ 0,24 %Sulfated ash: ≤ 0,5 %Carboxyl groups ≤ 1 %Particle size: ≤ 10 % of particles of less than 5 μmAnalytical methodnoteFor the identification/characterisation of microcrystalline cellulose in the feed additive:Regulation (EU) No 231/2012 for microcrystalline cellulose and the corresponding methods of the FAO JECFA microcrystalline cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: emulsifiers | ||||||||
| 1c461 | Methyl cellulose | Additive compositionMethyl celluloseSolid formCharacterisation of the active substanceMethyl cellulose obtained from wood pulp or cotton by treatment with alkali and methylation of the alkali cellulose with methyl chlorideCAS No: 9004-67-5Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 %Analytical methodnoteFor the identification/characterisation of methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for methyl cellulose and the corresponding methods of the FAO JECFA Methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0345 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: stabilisers | ||||||||
| 1c461 | Methyl cellulose | Additive compositionMethyl celluloseSolid formCharacterisation of the active substanceMethyl cellulose obtained from wood pulp or cotton by treatment with alkali and methylation of the alkali cellulose with methyl chlorideCAS No: 9004-67-5Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 %Analytical methodnoteFor the identification/characterisation of methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for methyl cellulose and the corresponding methods of the FAO JECFA Methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0345 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: thickeners | ||||||||
| 1c461 | Methyl cellulose | Additive compositionMethyl celluloseSolid formCharacterisation of the active substanceMethyl cellulose obtained from wood pulp or cotton by treatment with alkali and methylation of the alkali cellulose with methyl chlorideCAS No: 9004-67-5Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 %Analytical methodnoteFor the identification/characterisation of methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for methyl cellulose and the corresponding methods of the FAO JECFA Methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0345 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: gelling agents | ||||||||
| 1c461 | Methyl cellulose | Additive compositionMethyl celluloseSolid formCharacterisation of the active substanceMethyl cellulose obtained from wood pulp or cotton by treatment with alkali and methylation of the alkali cellulose with methyl chlorideCAS No: 9004-67-5Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 %Analytical methodnoteFor the identification/characterisation of methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for methyl cellulose and the corresponding methods of the FAO JECFA Methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0345 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: binders | ||||||||
| 1c461 | Methyl cellulose | Additive compositionMethyl celluloseSolid formCharacterisation of the active substanceMethyl cellulose obtained from wood pulp or cotton by treatment with alkali and methylation of the alkali cellulose with methyl chlorideCAS No: 9004-67-5Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 %Analytical methodnoteFor the identification/characterisation of methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for methyl cellulose and the corresponding methods of the FAO JECFA Methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0345 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: stabilisers | ||||||||
| 1d462 | Ethyl cellulose | Additive compositionEthyl celluloseSolid formCharacterisation of the active substanceEthyl cellulose, obtained by reaction of partially depolymerised cellulose with ethyl chlorideEthoxyl groups (-OC2H5): > 44 % and < 50 % on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)CAS No: 9004-57-3Loss on drying: ≤ 3%Sulfated ash: ≤ 0,4 %Analytical methodnoteFor the identification/characterisation of ethyl cellulose in the feed additive:Regulation (EU) No 231/2012 for ethyl cellulose and the corresponding methods described in the FAO JECFA Ethyl cellulose monograph and the European Pharmacopoeia monograph 0822 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: emulsifiers | ||||||||
| 1c463 | Hydroxypropyl cellulose | Additive compositionHydroxypropyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl cellulose, obtained by partial etherification of cellulose from fibrous plant material with hydroxypropyl groupsHydroxypropoxyl groups (-OCH2CHOHCH3): ≤ 80,5 % equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basisCAS No: 9004-64-2Loss on drying: ≤ 10 %Sulfated ash: ≤ 0,5 %Propylene chlorohydrins ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl cellulose and the corresponding methods of FAO JECFA hydroxypropyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopeia monograph 0337 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: stabilisers | ||||||||
| 1c463 | Hydroxypropyl cellulose | Additive compositionHydroxypropyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl cellulose, obtained by partial etherification of cellulose from fibrous plant material with hydroxypropyl groupsHydroxypropoxyl groups (-OCH2CHOHCH3): ≤ 80,5 % equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basisCAS No: 9004-64-2Loss on drying: ≤ 10 %Sulfated ash: ≤ 0,5 %Propylene chlorohydrins ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl cellulose and the corresponding methods of FAO JECFA hydroxypropyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopeia monograph 0337 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: thickeners | ||||||||
| 1c463 | Hydroxypropyl cellulose | Additive compositionHydroxypropyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl cellulose, obtained by partial etherification of cellulose from fibrous plant material with hydroxypropyl groupsHydroxypropoxyl groups (-OCH2CHOHCH3): ≤ 80,5 % equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basisCAS No: 9004-64-2Loss on drying: ≤ 10 %Sulfated ash: ≤ 0,5 %Propylene chlorohydrins ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl cellulose and the corresponding methods of FAO JECFA hydroxypropyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopeia monograph 0337 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: gelling agents | ||||||||
| 1c463 | Hydroxypropyl cellulose | Additive compositionHydroxypropyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl cellulose, obtained by partial etherification of cellulose from fibrous plant material with hydroxypropyl groupsHydroxypropoxyl groups (-OCH2CHOHCH3): ≤ 80,5 % equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basisCAS No: 9004-64-2Loss on drying: ≤ 10 %Sulfated ash: ≤ 0,5 %Propylene chlorohydrins ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl cellulose and the corresponding methods of FAO JECFA hydroxypropyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopeia monograph 0337 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: emulsifiers | ||||||||
| 1c464 | Hydroxypropyl methyl cellulose | Additive compositionHydroxypropyl methyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl methyl cellulose manufactured reacting partially depolymerised cellulose with methyl groups and containing a small degree of hydroxypropyl substitutionCAS No: 9004-65-3Methoxyl groups: (-OCH3) 19-30 %Hydroxypropoxyl groups (-OCH2CHOHCH3): 3-12 %Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 % (for products with viscosity of 50 mPa.s or above); ≤ 3 % (for products with viscosity below 50 mPa.s)Propylene chlorohydrins: ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl methyl cellulose and the corresponding methods of the FAO JECFA Hydroxypropyl methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0348 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: stabilisers | ||||||||
| 1c464 | Hydroxypropyl methyl cellulose | Additive compositionHydroxypropyl methyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl methyl cellulose manufactured reacting partially depolymerised cellulose with methyl groups and containing a small degree of hydroxypropyl substitutionCAS No: 9004-65-3Methoxyl groups (-OCH3): 19-30 %Hydroxypropoxyl groups (-OCH2CHOHCH3): 3-12 %Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 % (for products with viscosity of 50 mPa.s or above); ≤ 3 % (for products with viscosity below 50 mPa.s)Propylene chlorohydrins: ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl methyl cellulose and the corresponding methods of the FAO JECFA Hydroxypropyl methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0348 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: thickeners | ||||||||
| 1c464 | Hydroxypropyl methyl cellulose | Additive compositionHydroxypropyl methyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl methyl cellulose manufactured reacting partially depolymerised cellulose with methyl groups and containing a small degree of hydroxypropyl substitutionCAS No: 9004-65-3Methoxyl groups (-OCH3): 19-30 %Hydroxypropoxyl groups (-OCH2CHOHCH3): 3-12 %Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 % (for products with viscosity of 50 mPa.s or above); ≤ 3 % (for products with viscosity below 50 mPa.s)Propylene chlorohydrins: ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl methyl cellulose and the corresponding methods of the FAO JECFA Hydroxypropyl methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0348 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: gelling agents | ||||||||
| 1c464 | Hydroxypropyl methyl cellulose | Additive compositionHydroxypropyl methyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl methyl cellulose manufactured reacting partially depolymerised cellulose with methyl groups and containing a small degree of hydroxypropyl substitutionCAS No: 9004-65-3Methoxyl groups (-OCH3): 19-30 %Hydroxypropoxyl groups (-OCH2CHOHCH3): 3-12 %Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 % (for products with viscosity of 50 mPa.s or above); ≤ 3 % (for products with viscosity below 50 mPa.s)Propylene chlorohydrins: ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl methyl cellulose and the corresponding methods of the FAO JECFA Hydroxypropyl methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0348 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: binders | ||||||||
| 1c464 | Hydroxypropyl methyl cellulose | Additive compositionHydroxypropyl methyl celluloseSolid formCharacterisation of the active substanceHydroxypropyl methyl cellulose manufactured reacting partially depolymerised cellulose with methyl groups and containing a small degree of hydroxypropyl substitutionCAS No: 9004-65-3Methoxyl groups (-OCH3): 19-30 %Hydroxypropoxyl groups (-OCH2CHOHCH3): 3-12 %Loss on drying: ≤ 10 %Sulfated ash: ≤ 1,5 % (for products with viscosity of 50 mPa.s or above); ≤ 3 % (for products with viscosity below 50 mPa.s)Propylene chlorohydrins: ≤ 0,1 mg/kgAnalytical methodnoteFor the identification/characterisation of hydroxypropyl methyl cellulose in the feed additive:Regulation (EU) No 231/2012 for hydroxypropyl methyl cellulose and the corresponding methods of the FAO JECFA Hydroxypropyl methyl cellulose monograph, the Volume 4 of FAO JECFA combined compendium for food additives specifications and the European Pharmacopoeia monograph 0348 | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: emulsifiers | ||||||||
| 1c466 | Sodium carboxymethyl cellulose | Additive compositionSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis)Solid formCharacterisation of the active substanceSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis), obtained by etherification reaction between the alkali-cellulose complex and monochloroacetic acidCAS No: 9000-32-4Carboxymethyl groups (-CH2COOH): 0,2-1,5 per anhydroglucose unitLoss on drying: ≤ 12 %Total glycolate: ≤ 0,4 % (as sodium glycolate on the anhydrous basis)Sodium: ≤ 12,4 % (on the anhydrous basis)Analytical methodnoteFor the identification/characterisation of sodium carboxymethyl cellulose in the feed additive:Regulation (EU) No 231/2012 for sodium carboxymethyl cellulose and the corresponding methods of FAO JECFA sodium carboxymethyl cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications. | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: stabilisers | ||||||||
| 1c466 | Sodium carboxymethyl cellulose | Additive compositionSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis)Solid formCharacterisation of the active substanceSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis), obtained by etherification reaction between the alkali-cellulose complex and monochloroacetic acidCAS No: 9000-32-4Carboxymethyl groups (-CH2COOH): 0,2-1,5 per anydroglucose unitLoss on drying: ≤ 12 %Total glycolate: ≤ 0,4 % (as sodium glycolate on the anhydrous basis)Sodium: ≤ 12,4 % (on the anhydrous basis)Analytical methodnoteFor the identification/characterisation of sodium carboxymethyl cellulose in the feed additive:Regulation (EU) No 231/2012 for sodium carboxymethyl cellulose and the corresponding methods of FAO JECFA sodium carboxymethyl cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications. | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: thickeners | ||||||||
| 1c466 | Sodium carboxymethyl cellulose | Additive compositionSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis)Solid formCharacterisation of the active substanceSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis), obtained by etherification reaction between the alkali-cellulose complex and monochloroacetic acidCAS No: 9000-32-4Carboxymethyl groups (-CH2COOH): 0,2-1,5 per anydroglucose unitLoss on drying: ≤ 12 %Total glycolate: ≤ 0,4 % (as sodium glycolate on the anhydrous basis)Sodium: ≤ 12,4 % (on the anhydrous basis)Analytical methodnoteFor the identification/characterisation of sodium carboxymethyl cellulose in the feed additive:Regulation (EU) No 231/2012 for sodium carboxymethyl cellulose and the corresponding methods of FAO JECFA sodium carboxymethyl cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications. | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: gelling agents | ||||||||
| 1c466 | Sodium carboxymethyl cellulose | Additive compositionSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis)Solid formCharacterisation of the active substanceSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis), obtained by etherification reaction between the alkali-cellulose complex and monochloroacetic acidCAS No: 9000-32-4Carboxymethyl groups (-CH2COOH): 0,2-1,5 per anydroglucose unitLoss on drying: ≤ 12 %Total glycolate: ≤ 0,4 % (as sodium glycolate on the anhydrous basis)Sodium: ≤ 12,4 % (on the anhydrous basis)Analytical methodnoteFor the identification/characterisation of sodium carboxymethyl cellulose in the feed additive:Regulation (EU) No 231/2012 for sodium carboxymethyl cellulose and the corresponding methods of FAO JECFA sodium carboxymethyl cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications. | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | ||||||||
| Category: technological additives. Functional group: binders | ||||||||
| 1c466 | Sodium carboxymethyl cellulose | Additive compositionSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis)Solid formCharacterisation of the active substanceSodium carboxymethyl cellulose ≥ 99,5 % (on the anhydrous basis), obtained by etherification reaction between the alkali-cellulose complex and monochloroacetic acidCAS No: 9000-32-4Carboxymethyl groups (-CH2COOH): 0,2-1,5 per anydroglucose unitLoss on drying: ≤ 12 %Total glycolate: ≤ 0,4 % (as sodium glycolate on the anhydrous basis)Sodium: ≤ 12,4 % (on the anhydrous basis)Analytical methodnoteFor the identification/characterisation of sodium carboxymethyl cellulose in the feed additive:Regulation (EU) No 231/2012 for sodium carboxymethyl cellulose and the corresponding methods of FAO JECFA sodium carboxymethyl cellulose monograph and the Volume 4 of FAO JECFA combined compendium for food additives specifications. | All animal species | - | - | - | 1. In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. | 19 February 2035 |
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