Commission Implementing Regulation (EU) 2015/861 of 3 June 2015 concerning the authorisation of potassium iodide, calcium iodate anhydrous and coated granulated calcium iodate anhydrous as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/861
• Articles: 5

Article 1 Authorisation

The substances and preparations specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Amendment to Regulation (EC) No 1459/2005

In the Annex to Commission Regulation (EC) No 1459/2005, the entries ‘Potassium iodide’ and ‘calcium iodate anhydrous’, related to the element E 2 Iodine-I, are deleted.

Article 3 Transitional measures

1.   Potassium iodide and calcium iodate anhydrous which were authorised by Directive 70/524/EEC and premixtures containing them, which are produced and labelled before 24 December 2015 in accordance with the rules applicable before 24 June 2015 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 specified in paragraph 1 which are produced and labelled before 24 June 2016 in accordance with the rules applicable before 24 June 2015 may continue to be placed on the market and used until the existing stocks are exhausted. As regards feed intended for non-food producing animals, the time period for production and labelling referred to in the first sentence shall end 24 June 2017.

Article 4 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.

Schedules & Appendices

ANNEX

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

Element (I) in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b201

—

Potassium iodide

Additive composition

Potassium iodide and calcium stearate, as powder, with a minimum content of 69 % iodine

Characterisation of the active substance

Potassium iodide

Chemical formula: KI

CAS number: 7681-11-0

Analytical methods

( 1 )

For the determination of Potassium iodide in the feed additive:

—

Titrimetry — Food Chemicals Codex monograph; or

—

Titrimetry — European Pharmacopoeia monograph (Eur.Ph. 6 01/2008:0186).

For the quantification of total potassium in the feed additive:

—

Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or

—

Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN 15510:2007).

For the quantification of total iodine in premixtures, feed materials and compound feed:

—

Inductively Coupled Plasma Mass Spectrometry, ICP-MS (EN 15111:2007).

All species

—

—

Equines: 4 (total)

Ruminants for milk production and laying hens: 5 (total)

Fish: 20 (total)

Other species or categories of animals: 10 (total)

1.

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

2.

Potassium iodide may be placed on the market and used as an additive consisting of a preparation.

3.

Protective measures shall be taken according to national regulations implementing Union legislation on health and safety at work including Council Directives 89/391/EEC  ( 2 ) , 89/656/EEC  ( 3 ) , 92/85/EEC  ( 4 ) and 98/24/EC  ( 5 ) . Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC  ( 6 ) shall be worn during handling.

4.

In the directions for use of the additive and premixture indicate the storage and stability conditions.

5.

The recommended maximum content of total iodine in complete feed for:

—

equines is 3 mg/kg,

—

dogs is 4 mg/kg,

—

cats is 5 mg/kg,

—

ruminants for milk production is 2 mg/kg and

—

laying hens 3 mg/kg.

24 June 2025

3b202

—

Calcium iodate anhydrous

Additive composition

Calcium iodate anhydrous, as powder, with a minimum content of 63,5 % iodine

Characterisation of the active substances

Chemical formula: Ca(IO 3 ) 2

CAS number: 7789-80-2

Analytical methods

( 1 )

For the determination of Calcium iodate in the feed additive:

—

Titrimetry — Food Chemicals Codex monograph; or

—

Titrimetry — European Pharmacopoeia monograph (Eur.Ph. 6 01/2008:20504).

For the quantification of total calcium in the feed additive:

—

Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or

—

Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN 15510:2007).

For the quantification of total iodine in premixtures, feed materials and compound feed:

—

Inductively Coupled Plasma Mass Spectrometry, ICP-MS (EN 15111:2007).

All species

—

—

Equines: 4 (total)

Ruminants for milk production and laying hens: 5 (total)

Fish: 20 (total)

Other species or categories of animals: 10 (total)

1.

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

2.

Calcium iodate anhydrous may be placed on the market and used as an additive consisting of a preparation.

3.

Protective measures shall be taken according to national regulations implementing Union legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.

4.

The recommended maximum content of total iodine in complete feed for:

—

equines is 3 mg/kg,

—

dogs is 4 mg/kg,

—

cats is 5 mg/kg,

—

ruminants for milk production is 2 mg/kg and

—

laying hens 3 mg/kg.

24 June 2025

3b203

—

Coated granulated calcium iodate anhydrous

Additive composition

Coated granulated preparation of calcium iodate anhydrous with an iodine content of 1 — 10 %

Coating agents and dispersants (choice of polyoxyethylene (20) sorbitan monolaurate (E432), glycerol polyethyleneglycol ricinoleate (E484), polyethyleneglycol 300, sorbitol (E420ii), and maltodextrin): < 5 %.

Feed materials (calcium magnesium carbonate, calcium carbonate, corn cobs) as granulating agents.

Particles < 50 μm: < 1,5 %

Characterisation of the active substance

Chemical formula: Ca(IO 3 ) 2

CAS number: 7789-80-2

Analytical methods

( 1 )

For the determination of Calcium iodate in the feed additive:

—

Titrimetry — Food Chemicals Codex monograph; or

—

Titrimetry — European Pharmacopoeia monograph (Eur.Ph. 6 01/2008:20504).

For the quantification of total calcium in the feed additive:

—

Atomic Absorption Spectrometry, AAS (EN ISO 6869:2000); or

—

Inductively Coupled Plasma Atomic Emission Spectrometry, ICP-AES (EN 15510:2007).

For the quantification of total iodine in premixtures, feed materials and compound feed:

—

Inductively Coupled Plasma Mass Spectrometry, ICP-MS (EN 15111:2007).

All species

—

—

Equines: 4 (total)

Ruminants for milk production and laying hens: 5 (total)

Fish: 20 (total)

Other species or categories of animals: 10 (total)

1.

For user safety: breathing protection, safety glasses and gloves shall be worn during handling.

2.

The recommended maximum content of total iodine in complete feed for:

—

equines is 3 mg/kg,

—

dogs is 4 mg/kg,

—

cats is 5 mg/kg,

—

ruminants for milk production is 2 mg/kg and

—

laying hens 3 mg/kg.

24 June 2025

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

( 2 )   Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( OJ L 183, 29.6.1989, p. 1 ).

( 3 )   Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace ( OJ L 393, 30.12.1989, p. 18 ).

( 4 )   Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding ( OJ L 348, 28.11.1992, p. 1 ).

( 5 )   Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work ( OJ L 131, 5.5.1998, p. 11 ).

( 6 )   Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment ( OJ L 399, 30.12.1989, p. 18 ).