Commission Implementing Regulation (EU) 2021/344 of 25 February 2021 concerning the authorisation of sorbitan monolaurate as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/344
• Articles: 4

Article 1 Authorisation

The additive specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘emulsifiers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The additive specified in the Annex and premixtures containing this additive, which are produced and labelled before 18 September 2021 in accordance with the rules applicable before 18 March 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the additive as specified in the Annex which are produced and labelled before 18 March 2022 in accordance with the rules applicable before 18 March 2021 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.   Compound feed and feed materials containing the additive as specified in the Annex which are produced and labelled before 18 March 2023 in accordance with the rules applicable before 18 March 2021 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 .

Schedules & Appendices

ANNEX

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 %

Category of technological additives. Functional group: emulsifiers

1c493

Sorbitan monolaurate

Additive composition

A preparation of sorbitan monolaurate containing ≥ 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters, esterified with fatty acids derived from coconut oil.

Liquid form

All animal species

-

-

85

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.

18 March 2031

Characterisation of the active substance

Sorbitan monolaurate

CAS number: 1338-39-2

C 18 H 34 O 6

Analytical method

( 1 )

For the characterisation of sorbitan monolaurate in the feed additive:

—

FAO JECFA Monograph ‘Sorbitan Monolaurate’

( 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