Commission Implementing Regulation (EU) 2020/1399 of 5 October 2020 concerning the authorisation of butylated hydroxyanisole as a feed additive for all animal species except cats (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1399
• Articles: 4

Article 1 Authorisation

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

Article 2 Transitional measures

1.   The substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 26 April 2021 in accordance with the rules applicable before 26 October 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 26 October 2021 in accordance with the rules applicable before 26 October 2020 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 substances as specified in the Annex which are produced and labelled before 26 October 2022 in accordance with the rules applicable before 26 October 2020 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

Chemical formula, description, methods of analysis

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: Technological additives. Functional group: antioxidants

1b320

Butylated hydroxyanisole

Additive composition

Butylated hydroxyanisole (BHA)

(≥98,5%)

Waxy solid form

All animal species other than cats

-

-

150

1.

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

2.

BHA can be used in combination with butylated hydroxytoluene (BHT) up to 150 mg of the mixture/kg of complete feed.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its 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, safety glasses and gloves.

26.10.2030

Characterisation of the active substance

Mixture of:

—

2-tert-butyl-4-hydroxyanisole

—

3-tert-butyl-4-hydroxyanisole (≥85%)

CAS No: 25013-16-5

C 11 H 16 O 2

Analytical method

( 1 )

For the quantification of BHA in the feed additive :

—

Gas Chromatography coupled to Flame Ionization Detection (GC-FID) (FCC7 method)

For the quantification of BHA in premixtures and feedingstuffs:

—

Reversed Phase High Performance Liquid Chromatography coupled to UltraViolet-Diode-Array Detection (RP-HPLC-UV-DAD, 285 nm)

( 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