Date: 2015-07-01Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2015/1043 of 30 June 2015 concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 (holder of authorisation Huvepharma NV) (Text with EEA relevance)
Executive Summary:
This regulation authorises the use of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma citrinoviride Bisset IM SD135 as a zootechnical feed additive for various poultry and pig species. It amends Regulations EC No 2148/2004, EC No 828/2007, and EC No 322/2009, and includes transitional measures allowing the continued use of products produced and labelled before January 21, 2016, until existing stocks are exhausted, provided they comply with the rules applicable before July 21, 2015. The authorisation is valid until July 21, 2025.
Key Points / Main Content:
Authorisation of Feed Additive:
* The preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma citrinoviride Bisset IM SD135 is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening, and minor poultry species for fattening and laying.
* The additive is classified under the category of zootechnical additives, functional group digestibility enhancers.
* The authorisation is granted to Huvepharma NV.
* Specific minimum and maximum content levels are defined for each animal category.
Amendments to Existing Regulations:
* Regulation EC No 2148/2004 is amended by deleting the entry on E 1617, endo-1,4-beta-xylanase EC 3.2.1.8 in Annex IV.
* Regulation EC No 828/2007 is amended by deleting Article 2 and Annex II.
* Regulation EC No 322/2009 is amended by deleting Article 2 and Annex II.
Transitional Measures:
* Products produced and labelled before January 21, 2016, according to the rules applicable before July 21, 2015, may continue to be placed on the market and used until existing stocks are exhausted.
Safety and Usage:
* The directions for use of the additive and premixture must indicate storage conditions and stability to pelleting.
* The additive is intended for use in feed rich in starch and non-starch polysaccharides, mainly beta-arabinoxylans.
* Safety precautions, including breathing protection, glasses, and gloves, shall be used during handling.
* For use in weaned piglets until approximately 35 kg.
Validity:
* The authorisation is valid until 21 July 2025.
Impact Analysis:
Huvepharma NV (Holder of Authorisation):
* Impact: Authorised to market and sell the specified feed additive under the conditions outlined in the Annex.
* Action Required: Ensure compliance with the specifications regarding composition, identification, and usage levels, and include the required information in the directions for use.
Feed Manufacturers:
* Impact: Can legally incorporate the additive into feed for the specified animal categories within the defined limits.
* Action Required: Adjust feed formulations to include the additive within the authorised levels and ensure proper labelling. Comply with transitional measures for existing stock.
Farmers/Animal Producers:
* Impact: Able to use feed containing the authorised additive for their animals, potentially improving digestibility and performance.
* Action Required: Ensure that feed purchased contains the additive within the specified limits and follow the usage instructions.
Member States:
* Impact: Must ensure the regulation is applied and enforced within their jurisdiction.
* Action Required: Implement the necessary measures to monitor and enforce compliance with the regulation.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EC No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Council Directive 70/524/EEC: A Council Directive concerning additives in feedingstuffs.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on risks associated with the food chain.
Trichoderma citrinoviride Bisset IM SD135: A strain of microorganism used to produce endo-1,4-beta-xylanase, an enzyme used as a feed additive.
Huvepharma NV: The holder of the authorisation for the feed additive.
Brussels: The city where the regulation was adopted.
1.7.2015 EN Official Journal of the European Union L 167/63
COMMISSION IMPLEMENTING REGULATION (EU) 2015/1043
of 30 June 2015
concerning the authorisation of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by
Trichoderma citrinoviride Bisset (IM SD135) as a feed additive for chickens for fattening, turkeys for
fattening, laying hens, weaned piglets, pigs for fattening and minor poultry species for fattening
and for laying, and amending Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC)
No 322/2009 (holder of authorisation Huvepharma NV)
(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 preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135)
(formerly Trichoderma longibrachiatum) was authorised in accordance with Directive 70/524/EEC without a time
limit as a feed additive for chickens for fattening by Commission Regulation (EC) No 2148/2004 (3), for turkeys
for fattening by Commission Regulation (EC) No 828/2007 (4) and for laying hens and weaned piglets by
Commission Regulation (EC) No 322/2009 (5). That preparation was subsequently entered in the Register of feed
additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that
Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,4-beta-xylanase
(EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) (formerly Trichoderma longibrachiatum) as a
feed additive for chickens for fattening, turkeys for fattening, laying hens, weaned piglets, pigs for fattening and
minor poultry species for fattening and for laying. The applicant requested that additive to be classified in the
additive category ‘zootechnical 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 opinions of 31 January 2013 (6) and
10 December 2014 (7) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase
(EC 3.2.1.8) produced by Trichoderma citrinoviride Bisset (IM SD135) (formerly Trichoderma longibrachiatum) does
not have an adverse effect on animal health, human health or the environment.
(5) The Authority also concluded that the use of that preparation has the potential to be efficacious in turkeys for
fattening, chickens for fattening, laying hens, weaned piglets and pigs for fattening. The Authority further
considered that the conclusions on the efficacy can be extrapolated to minor poultry species for fattening and for
laying. 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 additive in feed submitted by the Reference
Laboratory set up by Regulation (EC) No 1831/2003.
(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) Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisations of certain
additives and the authorisation of new uses of an additive already authorised in feedingstuffs (OJ L 370, 17.12.2004, p. 24).
(4) Commission Regulation (EC) No 828/2007 of 13 July 2007 concerning the permanent and provisional authorisation of certain additives
in feedingstuffs (OJ L 184, 14.7.2007, p. 12).
(5) Commission Regulation (EC) No 322/2009 of 20 April 2009 concerning the permanent authorisations of certain additives in feeding
stuffs (OJ L 101, 21.4.2009, p. 9).
(6) EFSA Journal 2013; 11(2):3105.
(7) EFSA Journal 2015; 13(1):3969.L 167/64 EN Official Journal of the European Union 1.7.2015
(6) The assessment of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma citrinoviride
Bisset (IM SD135) (formerly Trichoderma longibrachiatum) shows that the conditions for authorisation, as provided
for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should
be authorised as specified in the Annex to this Regulation.
(7) Regulations (EC) No 2148/2004, (EC) No 828/2007 and (EC) No 322/2009 should therefore be amended
accordingly.
(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authori
sation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new
requirements resulting from the authorisation.
(9) 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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional
group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in
that Annex.
Article 2
Amendment to Regulation (EC) No 2148/2004
In Annex IV to Regulation (EC) No 2148/2004 the entry on E 1617, endo-1,4-beta-xylanase EC 3.2.1.8, is deleted.
Article 3
Amendment to Regulation (EC) No 828/2007
Regulation (EC) No 828/2007 is amended as follows:
(1) Article 2 is deleted;
(2) Annex II is deleted.
Article 4
Amendment to Regulation (EC) No 322/2009
Regulation (EC) No 322/2009 is amended as follows:
(1) Article 2 is deleted;
(2) Annex II is deleted.
Article 5
Transitional measures
The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before
21 January 2016 in accordance with the rules applicable before 21 July 2015 may continue to be placed on the market
and used until the existing stocks are exhausted.1.7.2015 EN Official Journal of the European Union L 167/65
Article 6
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, 30 June 2015.
For the Commission
The President
Jean-Claude JUNCKERANNEX
Minimum Maximum
content content
Identification Name of the End of period
Composition, chemical formula, description, analytical Species or cat Maximum
number of holder of Additive Units of activity/kg of Other provisions of authorisa
method egory of animal age
the additive authorisation complete feedingstuff tion
with a moisture
content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a1617 Huve Endo-1,4- Additive composition Turkeys for — 1 050 — 1. In the directions for 21 July
pharma NV beta-xyla fattening and EPU use of the additive and 2025
Preparation of endo-1,4-beta-xylanase (EC
nase minor poultry premixture, indicate
3.2.1.8) produced by Trichoderma citrinoviride Bis
species for fat the storage conditions
EC 3.2.1.8 set (IM SD135) with a minimum activity of
tening and stability to pellet
6 000 EPU(1)/g
ing.
(solid and liquid form) Chickens for 1 500
2. For use in feed rich in
fattening EPU
starch and non-starch
Characterisation of the active substance
Laying hens polysaccharides
endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Minor poultry (mainly beta- arabi
Trichoderma citrinoviride Bisset (IM SD135) species for noxylans).
laying 3. For safety: breathing
Analytical method(2)
Weaned pig protection, glasses and
For characterisation of endo-1,4-beta-xylanase lets gloves shall be used
activity: during handling.
Pigs for fat
colorimetric method measuring water soluble tening 4. For use in weaned pig
dye released by action of endo-1,4-β-xylanase lets until approxi
from azurine cross-linked wheat arabinoxylan mately 35 kg.
substrates.
(1) 1 EPU is the amount of enzyme which releases 0,0083 μmol of reducing sugars (xylose equivalent) per minute from oat spelt xylan at pH 4,7 and 50 °C.
(2) 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
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