Date: 2020-02-07Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2020/172 of 6 February 2020 concerning the renewal of the authorisation of 3-phytase produced by Aspergillus niger (CBS 101.672) as a feed additive for piglets (weaned), pigs for fattening, sows, chickens for fattening, turkeys for fattening, laying hens, ducks and all other minor avian species, ornamental birds and the new authorisation for chickens reared for laying or for breeding purposes, turkeys reared for breeding or breeding hens and suckling piglets and repealing Regulations (EC) No 243/2007, (EC) No 1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 (holder of authorisation BASF SE) (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2020/172 renews the authorisation of 3-phytase produced by Aspergillus niger CBS 101.672 as a feed additive for various animal species. It also authorises its use for chickens reared for laying or breeding, turkeys reared for breeding, breeding hens, and suckling piglets. The regulation repeals Regulations EC No 243/2007, EC No 1142/2007, EC No 165/2008, EC No 505/2008 and EU No 327/2010 and came into force on 27 February 2020.
Key Points / Main Content:
* **Authorisation Renewal and Extension:**
* The authorisation of 3-phytase produced by Aspergillus niger CBS 101.672 is renewed as a zootechnical additive (digestibility enhancer).
* The authorisation is extended to include chickens reared for laying or breeding, turkeys reared for breeding or breeding hens, and suckling piglets.
* **Additive Specifications and Conditions:**
* Holder of authorisation: BASF SE.
* Minimum and maximum content of 3-phytase are specified for different animal categories (piglets, sows, pigs for fattening, chickens for fattening, laying hens, turkeys for fattening/breeding, ornamental birds, minor avian species and ducks) in FTU/kg of complete feedingstuff.
* The additive must comply with the specifications outlined in the Annex.
* **Safety and Handling Requirements:**
* The additive is a respiratory sensitiser and a potential skin sensitiser, requiring appropriate protective measures.
* Feed business operators must establish operational procedures and organisational measures to address potential risks.
* Personal protective equipment, including breathing and skin protection, is required if risks cannot be eliminated or minimised.
* Directions for use of the additive and premixes must include storage conditions and stability to heat treatment.
* **Repeal of Previous Regulations:**
* Regulations EC No 243/2007, EC No 1142/2007, EC No 165/2008, EC No 505/2008 and EU No 327/2010 are repealed.
Impact Analysis:
* **BASF SE (Holder of Authorisation):**
* *Impact:* Continued authorisation for existing uses and extension to new animal categories.
* *Action Required:* Ensure the additive complies with the specifications in the Annex and provide appropriate usage guidelines.
* **Feed Business Operators:**
* *Impact:* Use of an authorised feed additive for specified animal categories. Must manage potential safety risks associated with the additive.
* *Action Required:* Establish operational procedures and organisational measures to mitigate risks, provide appropriate personal protective equipment, and include storage and stability information in product directions.
* **Animal Producers (Pig, Poultry, Duck, Bird Farmers):**
* *Impact:* Access to an authorised feed additive to improve feed digestibility in animals.
* *Action Required:* Follow the usage guidelines and safety instructions provided by the additive supplier and feed business operators.
* **European Food Safety Authority (EFSA):**
* *Impact:* The EFSA's assessment of the additive's safety and efficacy formed the basis for the renewal and extension of the authorisation.
* *Action Required:* No specific action mentioned, but continued monitoring might be required.
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: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
Aspergillus niger CBS 101.672: A strain of fungus used to produce 3-phytase, a feed additive.
3-phytase: A feed additive used for piglets, pigs, sows, chickens, turkeys, laying hens, ducks, and other avian species to improve digestibility of feed.
BASF SE: The holder of the authorisation for 3-phytase as a feed additive.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Brussels: The city where the regulation was adopted.
L 35/6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 7.2.2020
COMMISSION IMPLEMENTING REGULATION (EU) 2020/172
of 6 February 2020
concerning the renewal of the authorisation of 3-phytase produced by Aspergillus niger (CBS
101.672) as a feed additive for piglets (weaned), pigs for fattening, sows, chickens for fattening,
turkeys for fattening, laying hens, ducks and all other minor avian species, ornamental birds and the
new authorisation for chickens reared for laying or for breeding purposes, turkeys reared for
breeding or breeding hens and suckling piglets and repealing Regulations (EC) No 243/2007, (EC) No
1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 (holder of authorisation
BASF SE)
(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) 3-phytase produced by Aspergillus niger (CBS 101.672) was authorised for 10 years as a feed additive for piglets
(weaned), pigs for fattening and chickens for fattening by Commission Regulation (EC) No 243/2007(2), for laying
hens and turkeys for fattening by Commission Regulation (EC) No 1142/2007(3), for ducks by Commission
Regulation (EC) No 165/2008(4), for sows by Commission Regulation (EC) No 505/2008(5), and for minor avian
species, other than ducks, and for ornamental birds by Commission Regulation (EU) No 327/2010(6).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an
application was submitted by the holder of the authorisation for the renewal of the authorisation of 3-phytase
produced by Aspergillus niger (CBS 101.672) as a feed additive for piglets (weaned), pigs for fattening, sows, chickens
for fattening, laying hens, turkeys for fattening, ducks and other minor avian species and ornamental birds, and for a
new use for chickens reared for laying or for breeding purposes, turkeys reared for breeding or breeding hens and
suckling piglets requesting that additive to be classified in the additive category ‘zootechnical additives’ That
application was accompanied by the particulars and documents required under Articles 7(3) and 14(2) of that
Regulation.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 February 2019(7) that the
applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The
Authority also concluded that the additive does not have adverse effect on animal health and the environment. It
was also concluded that the additive is a respiratory sensitiser and should be considered as a potential skin
sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent
adverse effect on human health, in particular as regards the users of feed additives. The Authority also concluded
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Regulation (EC) No 243/2007 of 6 March 2007 concerning the authorisation of 3-phytase (Natuphos) as a feed additive
(OJ L 73, 13.3.2007, p. 4).
(3) Commission Regulation (EC) No 1142/2007 of 1 October 2007 concerning the authorisation of a new use of 3-phytase (Natuphos) as
a feed additive (OJ L 256, 2.10.2007, p. 20).
(4) Commission Regulation (EC) No 165/2008 of 22 February 2008 concerning the authorisation of a new use of 3-phytase (Natuphos) as
a feed additive (OJ L 50, 23.2.2008, p. 8).
(5) Commission Regulation (EC) No 505/2008 of 6 June 2008 concerning the authorisation of a new use of 3-phytase (Natuphos) as a
feed additive (OJ L 149, 7.6.2008, p. 33).
(6) Commission Regulation (EU) No 327/2010 of 21 April 2010 concerning the authorisation of a new use of 3-phytase as a feed additive
for all minor avian species, other than ducks, and for ornamental birds (holder of authorisation BASF SE), (OJ L 100, 22.4.2010, p. 3).
(7) EFSA Journal 2019;17(3):5640.7.2.2020 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 35/7
that the additive is efficacious in improving digestibility of feed for chickens reared for laying or for breeding
purposes, turkeys reared for breeding or breeding hens and suckling piglets. 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.
(5) The assessment of 3-phytase produced by Aspergillus niger (CBS 101.672) 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 3-phytase produced by Aspergillus niger (CBS 101.672) as a
feed additive under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 243/2007, (EC)
No 1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 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 1
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional
group ‘digestibility enhancers’ is authorised and renewed as an additive in animal nutrition, subject to the conditions laid
down in that Annex.
Article 2
Regulations (EC) No 243/2007, (EC) No 1142/2007, (EC) No 165/2008, (EC) No 505/2008 and (EU) No 327/2010 are
repealed.
Article 3
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, 6 February 2020.
For the Commission
The President
Ursula VON DER LEYENANNEX
Minimum Maximum
content content
Identification Name of the Maxi-
Composition, chemical formula, description, Species or category End of period of
number of the holder of Additive mum Other provisions
analytical method of animal Unit of activity/kg of authorisation
additive authorisation age
complete feedingstuff with a
moisture content of 12 %
Category of zootechnical additives. Functional group: digestibility enhancers
4a1600 BASF SE 3-phytase Additive composition Piglets - 500 FTU 1. In the directions for use of 27.2.2030
EC 3.1.3.8 3-phytase produced (suckling and the additive and premix
by Aspergillus niger (CBS 101.672) weaned) tures, the storage condi
having a minimum activity of: Sows tions and stability to heat
Solid form: 5 000 FTU (1)/g treatment shall be indi
Pigs for fattening - 100 FTU
Liquid form: 5 000 FTU/ml cated.
Characterisation of the active substance 2. For users of the additive
Chickens for fat - 375 FTU
3-phytase produced and premixtures, feed
tening by Aspergillus niger (CBS 101.672) business operators shall Chickens reared
Analytical method (2) establish operational pro
for laying/breed
Colorimetric method measuring inor cedures and organisa
ing
ganic phosphate released by the enzyme tional measures to ad
from phytate substrate. Laying hens - 250 FTU dress potential risks
Turkeys for fat resulting from its use.
tening Where those risks cannot
Turkeys reared be eliminated or reduced
for breeding and to a minimum by such
breeding hens procedures and mea
Ornamental sures, the additive and
birds and all min premixtures shall be used
or avian species, with personal protective
other than ducks equipment, including
breathing and skin pro
Ducks - 300 FTU tection.
(1) 1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °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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