Commission Implementing Regulation (EU) 2018/250 of 15 February 2018 concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives for all animal species (Text with EEA relevance. )
Date: 2018-02-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, flavouring, market approval




L_2018053EN.01016601.xml










23.2.2018   


EN


Official Journal of the European Union


L 53/166








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/250
of 15 February 2018
         
concerning the authorisation of methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate as feed additives 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 (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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).












(2)


The substances methyl 2-furoate, bis-(2-methyl-3-furyl) disulfide, furfural, furfuryl alcohol, 2-furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide, methyl 2-methyl-3-furyl disulfide and furfuryl acetate (‘substances concerned’) were authorised without a time limit by Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) 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, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested that those additives be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 January 2016 (3) that under the proposed conditions of use the substances concerned do not have adverse effects on animal health, human health or the environment. These substances increase the food smell or palatability. The Authority has concluded that since the substances concerned are used in food as flavourings and their function in feed is essentially the same as in food no further demonstration of efficacy is necessary. Therefore, that conclusion can be extrapolated for feed. The applicant withdrew the application for use of the substances concerned in water for drinking.












(5)


The Authority further noted that for the substances concerned hazards for the skin, eye contact and respiratory exposure are recognised. Most substances are classified as irritating to the respiratory system. Consequently, appropriate protective measures should be taken. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.












(6)


The assessment of the substances 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 those substances should be authorised as specified in the Annex to this Regulation.












(7)


The applicant proposed use levels for the substances concerned to the Authority. Having regard to that proposal, the Authority considered that certain use levels are safe (‘levels considered by the Authority’). For the purpose of official controls along the food chain, certain labelling requirements should be provided for. In particular, where the use levels exceed the levels considered by the Authority, it is appropriate to require that the label of premixtures and the labelling of feed materials and compound feed containing the substances concerned include certain information including reference to the levels considered by the Authority.












(8)


The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water.












(9)


Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.












(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

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.


Article 2

Transitional measures


1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 15 September 2018 in accordance with the rules applicable before 15 March 2018 may continue to be placed on the market and used until the existing stocks are exhausted.


2.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2019 in accordance with the rules applicable before 15 March 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.


3.   Feed materials and compound feed containing the substances as specified in the Annex which are produced and labelled before 15 March 2020 in accordance with the rules applicable before 15 March 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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 February 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





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

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

(3)  
            EFSA Journal 2016;14(2):4389.




ANNEX














Identification number of the additive


Name of the holder of authorisation


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 active substance/kg of complete feedingstuff with a moisture content of 12 %





Category: Sensory additives. Functional group: Flavouring compounds






2b13002


—


Methyl 2-furoate



Additive composition

Methyl 2-furoate

Characterisation of the active substance

Methyl 2-furoate
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C6H6O3

CAS number: 611-13-2
FLAVIS No: 13.002

Method of analysis
 (1)

For the determination of methyl 2-furoate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,5 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13016


—


Bis-(2-methyl-3-furyl) disulfide



Additive composition

Bis-(2-methyl-3-furyl) disulfide

Characterisation of the active substance

Bis-(2-methyl-3-furyl) disulfide
Produced by chemical synthesis
Purity: min. 98 % assay
Chemical formula: C10H10O2 S2

CAS number: 28588-75-2
FLAVIS No: 13.016

Method of analysis
 (1)

For the determination of bis-(2-methyl-3-furyl) disulfide in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13018


—


Furfural



Additive composition

Furfural

Characterisation of the active substance

Furfural
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C5H4O2

CAS number: 98-01-1
FLAVIS No: 13.018

Method of analysis
 (1)

For the determination of furfural in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13019


—


Furfuryl alcohol



Additive composition

Furfuryl alcohol

Characterisation of the active substance

Furfuryl alcohol
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C5H6O2

CAS number: 98-00-0
FLAVIS No: 13.019

Method of analysis
 (1)

For the determination of furfuryl alcohol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 5 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13026


—


2-Furanmethanethiol



Additive composition

2-Furanmethanethiol

Characterisation of the active substance

2-Furanmethanethiol
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C5H6OS
CAS number: 98-02-2
FLAVIS No: 13.026

Method of analysis
 (1)

For the determination of 2-furanmethanethiol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13033


—


S-Furfuryl acetothioate



Additive composition

S-furfuryl acetothioate

Characterisation of the active substance

S-furfuryl acetothioate
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C7H8O2S
CAS number: 13678-68-7
FLAVIS No: 13.033

Method of analysis
 (1)

For the determination of S-furfuryl acetothioate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13050


—


Difurfuryl disulfide



Additive composition

Difurfuryl disulfide

Characterisation of the active substance

Difurfuryl disulfide
Produced by chemical synthesis
Purity: min. 96 % assay
Chemical formula: C10H10O2S2

CAS number: 4437-20-1
FLAVIS No: 13.050

Method of analysis
 (1)

For the determination of difurfuryl disulfide in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13053


—


Methyl furfuryl sulfide



Additive composition

Methyl furfuryl sulfide

Characterisation of the active substance

Methyl furfuryl sulfide
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C6H8OS
CAS number: 1438-91-1
FLAVIS No: 13.053

Method of analysis
 (1)

For the determination of methyl furfuryl sulfide in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13055


—


2-Methylfuran-3-thiol



Additive composition

2-Methylfuran-3-thiol

Characterisation of the active substance

2-Methylfuran-3-thiol
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C5H6OS
CAS number: 28588-74-1
FLAVIS No: 13.055

Method of analysis
 (1)

For the determination of 2-methylfuran-3-thiol in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13064


—


Methyl furfuryl disulfide



Additive composition

Methyl furfuryl disulfide

Characterisation of the active substance

Methyl furfuryl disulfide
Produced by chemical synthesis
Purity: min. 95 % assay
Chemical formula: C6H8OS2

CAS number: 57500-00-2
FLAVIS No: 13.064

Method of analysis
 (1)

For the determination of methyl furfuryl disulfide in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13079


—


Methyl 2-methyl-3-furyl disulfide



Additive composition

Methyl 2-methyl-3-furyl disulfide

Characterisation of the active substance

Methyl 2-methyl-3-furyl disulfide
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C6H8OS2

CAS number: 65505-17-1
FLAVIS No: 13.079

Method of analysis
 (1)

For the determination of methyl 2-methyl-3-furyl disulfide in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,05 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,05 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028




2b13128


—


Furfuryl acetate



Additive composition

Furfuryl acetate

Characterisation of the active substance

Furfuryl acetate
Produced by chemical synthesis
Purity: min. 97 % assay
Chemical formula: C7H8O3

CAS number: 623-17-6
FLAVIS No: 13.128

Method of analysis
 (1)

For the determination of furfuryl acetate in the feed additive and in feed flavouring premixtures:
Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.


All animal species


—


—


—








1.


The additive shall be incorporated into the feed in the form of a premixture.










2.


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










3.


On the label of the additive the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 0,5 mg/kg.’










4.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures where the use level suggested on the label of the premixture would result in exceeding the level referred to in point 3.










5.


The functional group, the identification number, the name and the added amount of the active substance shall be indicated in the labelling of feed materials and compound feedingstuffs where the content of the active substance in the complete feedingstuff with a moisture content of 12 % exceeds: 0,5 mg/kg.










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves.






15.3.2028






(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