# L_2018257EN.01001301.xml

| 15.10.2018 | EN | Official Journal of the European Union | L 257/13 |
| --- | --- | --- | --- |

15.10.2018

EN

Official Journal of the European Union

L 257/13

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1533

of 12 October 2018

concerning the authorisation of sodium alginate as a feed additive for cats, dogs, other non-food-producing animals and fish and potassium alginate as a feed additive for cats and dogs

(Text with EEA relevance)

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 nutrition (1), 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 authorisation. |
| --- | --- |

(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 authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium alginate. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium alginate.

| (3) | Article 10 of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). Sodium alginate was authorised without a time limit by Directive 70/524/EEC as feed additive for fish, pets and other non-food-producing animals. The additive was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

Article 10 of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). Sodium alginate was authorised without a time limit by Directive 70/524/EEC as feed additive for fish, pets and other non-food-producing animals. The additive was subsequently entered in the Register of feed additives as existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (4) | 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 sodium alginate as feed additive for pets and other non-food-producing animals and fish. |
| --- | --- |

(4)

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 sodium alginate as feed additive for pets and other non-food-producing animals and fish.

| (5) | The applications concern the authorisation of potassium alginate as a feed additive for cats and dogs, and sodium alginate as a feed additive for cats, dogs, other non-food-producing animals and fish, to be classified in the additive category ‘technological additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The applications concern the authorisation of potassium alginate as a feed additive for cats and dogs, and sodium alginate as a feed additive for cats, dogs, other non-food-producing animals and fish, to be classified in the additive category ‘technological additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (6) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2017 (3) that, under the proposed conditions of use, potassium alginate and sodium alginate do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the potassium alginate and sodium alginate concerned are effective as stabilisers, thickeners, gelling agents and binders. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(6)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2017 (3) that, under the proposed conditions of use, potassium alginate and sodium alginate do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the potassium alginate and sodium alginate concerned are effective as stabilisers, thickeners, gelling agents and binders. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (7) | The assessment of the additives concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of additives should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(7)

The assessment of the additives concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of additives should be authorised as specified in the Annex to this Regulation.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(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 1

Authorisation

The additives specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘stabilisers’, ‘thickeners’, ‘gelling agents’ and ‘binders’ are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

Sodium alginate specified in the Annex and premixtures containing that additive, which are produced and labelled before 4 May 2019 in accordance with the rules applicable before 4 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted.

Feed materials and compound feed containing sodium alginate specified in the Annex which are produced and labelled before 4 November 2019 in accordance with the rules applicable before 4 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food producing animals.

Feed materials and compound feed containing sodium alginate specified in the Annex which are produced and labelled before 4 November 2020 in accordance with the rules applicable before 4 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 October 2018.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2017; 15(7):4945.

3

EFSA Journal

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ANNEX

| Identification number of the 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 % |
| Technological additives: stabilisers |
| 1d401 | Sodium alginate | Additive composition

  Sodium alginate
  Powder form

  Characterisation of the active substance

  Sodium alginate (≥ 90,8 %)
  (C6H7NaO6)n

  Analytical method
   (1)

  For the identification of sodium alginate in the feed additive: — The sodium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006) | Cats and dogs | — | — | 35 200 | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |

Identification number of the 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 %

Technological additives: stabilisers

1d401

Sodium alginate

Additive composition

Sodium alginate

Powder form

Characterisation of the active substance

Sodium alginate (≥ 90,8 %)

(C6H7NaO6)n

Analytical method
   (1)

For the identification of sodium alginate in the feed additive: — The sodium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Other non-food-producing animals

Fish

—

—

—

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

1d402

Potassium alginate

Additive composition

Potassium alginate

Powder form

Characterisation of the active substance

Potassium alginate (≥ 89,2 %)

(C6H7KO6)n

CAS No: 9005-36-1

Analytical method
   (1)

For the identification of potassium alginate in the feed additive: The potassium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Technological additives: thickeners

1d401

Sodium alginate

Additive composition

Sodium alginate

Powder form

Characterisation of the active substance

Sodium alginate (≥ 90,8 %)

(C6H7NaO6)n

Analytical method
   (1)

For the identification of sodium alginate in the feed additive: — The sodium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Other non-food-producing animals

Fish

—

—

—

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

1d402

Potassium alginate

Additive composition

Potassium alginate

Powder form

Characterisation of the active substance

Potassium alginate (≥ 89,2 %)

(C6H7KO6)n

CAS No: 9005-36-1

Analytical method
   (1)

For the identification of potassium alginate in the feed additive: The potassium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Technological additives: gelling agents

1d401

Sodium alginate

Additive composition

Sodium alginate

Powder form

Characterisation of the active substance

Sodium alginate (≥ 90,8 %)

(C6H7NaO6)n

Analytical method
   (1)

For the identification of sodium alginate in the feed additive: — The sodium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications – Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Other non-food-producing animals

Fish

—

—

—

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

1d402

Potassium alginate

Additive composition

Potassium alginate

Powder form

Characterisation of the active substance

Potassium alginate (≥ 89,2 %)

(C6H7KO6)n

CAS No: 9005-36-1

Analytical method
   (1)

For the identification of potassium alginate in the feed additive: The potassium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Technological additives: binders

1d401

Sodium alginate

Additive composition

Sodium alginate

Powder form

Characterisation of the active substance

Sodium alginate (≥ 90,8 %)

(C6H7NaO6)n

Analytical method
   (1)

For the identification of sodium alginate in the feed additive: — The sodium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

Other non-food-producing animals

Fish

—

—

—

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

1d402

Potassium alginate

Additive composition

Potassium alginate

Powder form

Characterisation of the active substance

Potassium alginate (≥ 89,2 %)

(C6H7KO6)n

CAS No: 9005-36-1

Analytical method
   (1)

For the identification of potassium alginate in the feed additive: The potassium alginate monograph, FAO JECFA Combined Compendium of Food Additive Specifications — Monograph No 1 (2006)

Cats and dogs

—

—

35 200

| 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs. |
| --- | --- |

2.

The mixture of different sources of alginates shall not exceed the permitted maximum content in complete feedingstuffs.

| 3. | 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

4 November 2028

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(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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