Search Legislation

Commission Implementing Regulation (EU) 2020/1398Show full title

Commission Implementing Regulation (EU) 2020/1398 of 5 October 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses and repealing Regulation (EC) No 886/2009 (holder of authorisation All-Technology Ireland Ltd) (Text with EEA relevance)

 Help about what version

What Version

 Help about advanced features

Advanced Features

 Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

This item of legislation originated from the EU

Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).

Changes to legislation:

This version of this Regulation was derived from EUR-Lex on IP completion day (31 December 2020 11:00 p.m.). It has not been amended by the UK since then. Find out more about legislation originating from the EU as published on legislation.gov.uk. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

Commission Implementing Regulation (EU) 2020/1398

of 5 October 2020

concerning the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses and repealing Regulation (EC) No 886/2009 (holder of authorisation All-Technology Ireland Ltd)

(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 and renewing such authorisation.

(2) The preparation of Saccharomyces cerevisiae CBS 493.94 was authorised for 10 years as a feed additive for horses by Commission Regulation (EC) No 886/2009(2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 November 2019(3) that, Saccharomyces cerevisiae CBS 493.94 does not have an adverse effect under the authorised conditions of use for the animal health, consumer health or the environment. It also concluded that the additive should be considered as a moderate eye irritant and a potential skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Since the Authority was unable to conclude on the new proposed minimum dose, the previous doses should be maintained.

(5) The assessment of Saccharomyces cerevisiae CBS 493.94 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

(6) As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae CBS 493.94 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 886/2009 should be repealed.

(7) 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 1U.K.

The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.

Article 2U.K.

Regulation (EC) No 886/2009 is repealed.

Article 3U.K.

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, 5 October 2020.

For the Commission

The President

Ursula von der Leyen

ANNEXU.K.

a

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

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
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancer.
4a1704All-Technology Ireland Ltd.

Saccharomyces cerevisae

CBS 493.94

Additive composition

Preparation of Saccharomyces cerevisae CBS 493.94 containing a minimum of:

1 × 109 CFU/g additive

Powder and granulated form

Horses-1,6 × 109-

1.In the directions for use of the additive and premixture, 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, including eyes, skin and breathing protection.

26.10.2030

Characterisation of active substance

Viable cells of Saccharomyces cerevisae CBS 493.94

Analytical method a

Enumeration: pour plate method

using chloramphenicol glucose yeast

extract agar (EN 15789:2009).

Identification: polymerase chain

reaction (PCR) method (CEN/TS 15790:2008)

(2)

Commission Regulation (EC) No 886/2009 of 25 September 2009 concerning the authorisation of the preparation of Saccharomyces cerevisiae CBS 493.94 as a feed additive for horses (holder of authorisation Alltech France) (OJ L 254, 26.9.2009, p. 66).

(3)

EFSA Journal 2019; 17(12):5918.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources