COMMISSION IMPLEMENTING REGULATION (EU) 2019/ 12 - of 3 January 2019 - concerning the authorisation of L-arginine as a feed additive for all animal species

COMMISSION IMPLEMENTING REGULATION (EU) 2019/12

of 3 January 2019

concerning the authorisation of L-arginine as a feed additive for all animal species

(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 (

), 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.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 two applications were submitted for the

authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 10741P and by Escherichia coli NITE

BP-02186 as a feed additive for use in feed and in water for drinking for all animal species. Those applications

were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC)

No 1831/2003.

(3) The applications concern the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 10741P

as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’ and of

L-arginine produced by Escherichia coli NITE BP-02186 as a feed additive for all animal species to be classified in

the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the

additive category ‘sensory additives’, functional group ‘flavouring compounds’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 April 2018 (

) and

19 April 2018 (

) that, under the proposed conditions of use, L-arginine produced by Escherichia coli NITE

BP-02186 and by Corynebacterium glutamicum KCCM 10741P does not have an adverse effect on animal health,

consumer health or the environment and that no safety concerns for users would arise provided that appropriate

protective measures are taken.

(5) The Authority also concluded that the additive is an effective source of the amino acid arginine for all animal

species and that for the supplemental L-arginine to be fully efficacious in ruminants, it should be protected

against degradation in the rumen. The Authority expressed in its opinions a concern over potential nutritional

imbalances of when L-arginine is administered as amino acid via water for drinking. However, no maximum

content for L-arginine is proposed by the Authority. Moreover, the Authority recommends supplementation with

L-arginine in appropriate amounts. Thus, in the case of supplementation with L-arginine as amino acid via

drinking water it is appropriate to alert the user to take into account the dietary supply with all the essential and

conditionally essential amino acids.

(6) As regards the use as flavouring, the Authority states that no further demonstration of efficacy is necessary when

used at the recommended dose. The use of L-arginine as flavouring compound is not authorised in water for

drinking. At the recommended dose, L-arginine as flavouring compound is unlikely to pose any concern for the

dietary supply with all the essential and conditionally essential amino acids.

(7) The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also

verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory

set up by Regulation (EC) No 1831/2003.

(8) The assessment of L-arginine shows that the conditions for authorisation, as provided for in Article 5 of

Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as

specified in the Annex to this Regulation.

(9) The fact that the use of the L-arginine is not authorised as flavouring in water for drinking does not preclude its

use in compound feed which is administered via water.

4.1.2019 L 2/21 Official Journal of the European Union

(

) OJ L 268, 18.10.2003, p. 29.

(

) EFSA Journal 2018;16(5):5276

(

) EFSA Journal 2018;16(5):5277

(10) 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

1. The substances L-arginine produced by Corynebacterium glutamicum KCCM 10741P and L-arginine produced by

Escherichia coli NITE BP-02186 specified in the Annex, belonging to the additive category ‘nutritional additives’ and to

the functional group ‘amino acids, their salts and analogues’ are authorised as a feed additive in animal nutrition subject

to the conditions laid down in that Annex.

2. The substance L-arginine produced by Escherichia coli NITE BP-02186 specified in the Annex, belonging to the

additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as a feed additive

in animal nutrition subject to the conditions laid down in that Annex.

Article 2

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.

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

Done at Brussels, 3 January 2019.

For the Commission

The President

Jean-Claude JUNCKER

4.1.2019 L 2/22 Official Journal of the European Union

ANNEX

Identifica

tion

number of

the additive

Name of

the holder

of author

isation

Additive

Composition, chemical formula, description,

analytical method.

Species or

category of

animal

Maximum

age

Minimum

content

Maximum

content

Other provisions

End of

period

of author

isation

mg/kg of complete feed

with a moisture content of

12 %

Category of nutritional additives. Functional group: amino acids, their salts and analogues.

3c363 — L-arginine Additive composition

Powder with a minimum content of

L-arginine of 98 % (on a dry matter

basis) and a maximum content of

1,5 % water

Characterisation of the active substance

L-arginine ((S)-2-amino-5-guanidino

pentanoic acid) produced by fer

mentation with Escherichia coli NITE

BP-02186.

Chemical formula: C

CAS number: 74-79-3

Analytical method (

)

For the identification of L-arginine in

the feed additive:

— Food Chemical Codex ‘L-arginine

monograph’

For the quantification of arginine in

the feed additive and water:

— ion exchange chromatography

coupled with post-column derivat

isation and photometric detection

(IEC-VIS)

All animal

species

1. L-arginine may be placed on

the market and used as an ad

ditive consisting of a prepara

tion.

2. The additive can be also used

via water for drinking.

3. In the directions for use of the

additive and premixture, the

storage conditions, the stability

to heat treatment and the sta

bility in water for drinking

shall be indicated.

4. The moisture content shall be

indicated on the label of the

additive.

5. Declaration to be made on the

label of the additive and

premixture: ‘The supplementa

tion with L-arginine, in par

ticular via water for drinking,

should take into account all es

sential and conditional essen

tial amino acids in order to

avoid imbalances.’

24 January

2029

4.1.2019 L 2/23 Official Journal of the European Union

Identifica

tion

number of

the additive

Name of

the holder

of author

isation

Additive

Composition, chemical formula, description,

analytical method.

Species or

category of

animal

Maximum

age

Minimum

content

Maximum

content

Other provisions

End of

period

of author

isation

mg/kg of complete feed

with a moisture content of

12 %

For the quantification of arginine in

premixtures, compound feed and feed

materials:

— ion exchange chromatography

coupled with post-column derivat

isation and photometric detection

(IEC-VIS) – Commission Regulation

(EC) No 152/2009

6. For users of the additive and

premixture, feed business oper

ators shall establish operational

procedures and organisational

measures to address potential

risks by inhalation. Where

those risks cannot be elimin

ated or reduced to a minimum

by such procedures and meas

ures, the additive and premix

ture shall be used with per

sonal protective equipment,

including breathing protection.

3c362 — L-arginine Additive composition

Powder with a minimum content of

L-arginine of 98 % (on a dry matter

basis) and a maximum content of

0,5 % water

Characterisation of the active substance

L-arginine ((S)-2-amino-5-guanidino

pentanoic acid) produced by fermen

tation with Corynebacterium glutamicum

KCCM10741P

Chemical formula: C

CAS number: 74-79-3

Analytical method (

)

For the identification of L-arginine in

the feed additive:

— Food Chemical Codex ‘L-arginine

monograph’

All animal

species

1. L-arginine may be placed on

the market and used as an ad

ditive consisting of a prepara

tion.

2. The additive can be also used

via water for drinking.

3. In the directions for use of the

additive and premixture, the

storage conditions, the stability

to heat treatment and the sta

bility in water for drinking

shall be indicated.

4. Declaration to be made on the

label of the additive and

premixture: ‘The supplementa

tion with L-arginine, in par

ticular via water for drinking,

should take into account all es

sential and conditional essen

tial amino acids in order to

avoid imbalances.’

24 January

2029

4.1.2019 L 2/24 Official Journal of the European Union

Identifica

tion

number of

the additive

Name of

the holder

of author

isation

Additive

Composition, chemical formula, description,

analytical method.

Species or

category of

animal

Maximum

age

Minimum

content

Maximum

content

Other provisions

End of

period

of author

isation

mg/kg of complete feed

with a moisture content of

12 %

For the quantification of arginine in

the feed additive and water:

— ion exchange chromatography

coupled with post-column derivat

isation and photometric detection

(IEC-VIS)

For the quantification of arginine in

premixtures, compound feed and feed

materials:

— ion exchange chromatography

coupled with post-column derivat

isation and photometric detection

(IEC-VIS) – Commission Regulation

(EC) No 152/2009

5. For users of the additive and

premixture, feed business oper



ators shall establish operational

procedures and organisational

measures to address potential

risks by inhalation. Where

those risks cannot be elimin

ated or reduced to a minimum

by such procedures and meas

ures, the additive and premix

ture shall be used with per

sonal protective equipment,

including breathing protection.

Category: Sensory additives. Functional group: Flavouring compounds

3c363 — L-Arginine Additive composition

Powder with a minimum content of

L-arginine of 98 % (on a dry matter

basis) and a maximum content of

1,5 % water

Characterisation of the active substance

L-arginine ((S)-2-amino-5-guanidino

pentanoic acid) produced by fer

mentation with

— Escherichia coli NITE BP-02186

Chemical formula: C

CAS number 74-79-3

FLAVIS No 17.003

All animal

species

— — — 1. L-arginine may be placed on

the market and used as an ad

ditive consisting of a prepara

tion

2. The additive shall be incorpor

ated into the feed in the form

of a premixture.

3. In the directions for use of the

additive and premixture, the

storage conditions and the

stability to heat treatment shall

be indicated.

4. The moisture content shall be

indicated on the label of the

additive.

24 January

2029

4.1.2019 L 2/25 Official Journal of the European Union

Identifica

tion

number of

the additive

Name of

the holder

of author

isation

Additive

Composition, chemical formula, description,

analytical method.

Species or

category of

animal

Maximum

age

Minimum

content

Maximum

content

Other provisions

End of

period

of author

isation

mg/kg of complete feed

with a moisture content of

12 %

Method of analysis (

)

For the identification of L-arginine in

the feed additive:

— Food Chemical Codex ‘L-arginine

monograph’

For the quantification of arginine in

the feed additive

— ion exchange chromatography

coupled with post-column derivat

isation and photometric detection

(IEC-VIS)

For the quantification of arginine in

premixtures, compound feed and feed

materials:

— ion exchange chromatography

coupled with post-column derivat

isation and photometric detection

(IEC-VIS) – Commission Regulation

(EC) No 152/2009

5. On the label of the additive

and premixture the following

shall be indicated:

‘Recommended maximum con

tent of the active substance

of complete feedingstuff with

a moisture content of 12 %:

25 mg/kg.’

6. For users of the additive and

premixture, feed business oper

ators shall establish operational

procedures and organisational

measures to address potential

risks by inhalation. Where

those risks cannot be elimin

ated or reduced to a minimum

by such procedures and meas

ures, the additive and premix

ture shall be used with per

sonal protective equipment,

including breathing protection.

(

) 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

4.1.2019 L 2/26 Official Journal of the European Union