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,
Whereas:
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of potassium alginate.
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.
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.
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.
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 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 2Transitional 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 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.
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
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 compositionSodium alginate Powder form Characterisation of the active substanceSodium alginate (≥ 90,8 %) (C6H7NaO6)n Analytical method4For 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. 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. 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 compositionPotassium alginate Powder form Characterisation of the active substancePotassium alginate (≥ 89,2 %) (C6H7KO6)n CAS No: 9005-36-1 Analytical method4For 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. 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. | 4 November 2028 |
Technological additives: thickeners | ||||||||
1d401 | Sodium alginate | Additive compositionSodium alginate Powder form Characterisation of the active substanceSodium alginate (≥ 90,8 %) (C6H7NaO6)n Analytical method4For 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. 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. 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 compositionPotassium alginate Powder form Characterisation of the active substancePotassium alginate (≥ 89,2 %) (C6H7KO6)n CAS No: 9005-36-1 Analytical method4For 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. 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. | 4 November 2028 |
Technological additives: gelling agents | ||||||||
1d401 | Sodium alginate | Additive compositionSodium alginate Powder form Characterisation of the active substanceSodium alginate (≥ 90,8 %) (C6H7NaO6)n Analytical method4For 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. 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. 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 compositionPotassium alginate Powder form Characterisation of the active substancePotassium alginate (≥ 89,2 %) (C6H7KO6)n CAS No: 9005-36-1 Analytical method4For 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. 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. | 4 November 2028 |
Technological additives: binders | ||||||||
1d401 | Sodium alginate | Additive compositionSodium alginate Powder form Characterisation of the active substanceSodium alginate (≥ 90,8 %) (C6H7NaO6)n Analytical method4For 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. 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. 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 compositionPotassium alginate Powder form Characterisation of the active substancePotassium alginate (≥ 89,2 %) (C6H7KO6)n CAS No: 9005-36-1 Analytical method4For 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. 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. | 4 November 2028 |