Date: 2016-05-28Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2016/842 of 27 May 2016 amending Regulation (EC) No 167/2008 as regards the name of the holder of the authorisation and the trade name of a coccidiostat (Text with EEA relevance)
Executive Summary:
Commission Implementing Regulation (EU) 2016/842 amends Regulation (EC) No 167/2008, addressing a change in the authorisation holder and trade name for the coccidiostat Kokcisan 120G. The marketing rights have been transferred to Huvepharma EOOD, with a subsequent request to change the trade name. Existing stocks may be used up during a transitional period. This regulation entered into force on June 17, 2016.
Key Points / Main Content:
* **Amendment of Authorisation:**
* The holder of the authorisation for the coccidiostat is changed from KRKA, d.d Novo mesto, Slovenia to Huvepharma EOOD, Bulgaria.
* The trade name of the coccidiostat is changed from Kokcisan 120G to Huvesal 120 G.
* **Transitional Period:**
* Existing stocks of the additive, premixtures, and compound feed containing the additive that comply with regulations prior to the entry into force of this Regulation can continue to be placed on the market and used until exhausted.
* **Entry into Force:**
* This Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union (June 17, 2016).
Impact Analysis:
* **Huvepharma EOOD:**
* Impact: Becomes the new holder of the authorisation for the coccidiostat and can market the product under the new trade name.
* Action Required: Market the product under the new trade name Huvesal 120 G.
* **Feed Additive Manufacturers and Distributors:**
* Impact: Need to be aware of the change in authorisation holder and trade name. Can continue to use existing stocks of the additive, premixtures and compound feed containing the additive, which are in conformity with the provisions applying before the date of entry into force of this Regulation until they are exhausted.
* Action Required: Update product labels and documentation to reflect the new authorisation holder and trade name for new production batches. Use up existing stock in alignment with the regulation.
* **Member States:**
* Impact: Must ensure the regulation is directly applicable within their jurisdiction.
* Action Required: Implement and enforce the changes to the authorisation of the coccidiostat.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
COMMISSION IMPLEMENTING REGULATION EU 2016/842: A regulation amending Regulation EC No 167/2008 regarding the authorisation and trade name of a coccidiostat.
Regulation EC No 167/2008: A Commission Regulation concerning the authorisation of a coccidiostat.
Regulation EC No 1831/2003: Regulation of the European Parliament and of the Council on additives for use in animal nutrition.
KRKA d.d.: Original holder of the authorisation for the coccidiostat, located in Novo mesto, Slovenia.
Huvepharma EOOD: New holder of the marketing rights for the feed additive, located in Bulgaria.
Kokcisan 120G: The original trade name of the coccidiostat feed additive.
Huvesal 120 G: The new trade name of the coccidiostat feed additive.
28.5.2016 EN Official Journal of the European Union L 141/47
COMMISSION IMPLEMENTING REGULATION (EU) 2016/842
of 27 May 2016
amending Regulation (EC) No 167/2008 as regards the name of the holder of the authorisation and
the trade name of a coccidiostat
(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 13(3) thereof,
Whereas:
(1) KRKA d.d. has submitted an application in accordance with Article 13(3) of Regulation (EC) No 1831/2003
proposing to change the name of the holder of the authorisation as regards Commission Regulation (EC)
No 167/2008 (2) concerning the authorisation of a coccidiostat (Kokcisan 120G).
(2) The applicant claims that, with effect from 5 February 2016, it has transferred the marketing rights of the feed
additive Kokcisan 120G to Huvepharma EOOD. Furthermore, Huvepharma EOOD, as the new owner of the
marketing rights of the feed additive requests to change the trade name of the feed additive. The applicant has
submitted relevant data supporting its request.
(3) The proposed changes of the terms of the authorisation are purely administrative in nature and do not entail a
fresh assessment of the additive concerned. The European Food Safety Authority was informed of the application.
(4) To allow that feed additive to be marketed under the name of Huvepharma EOOD and under the new trade
name, it is necessary to change the terms of the authorisation.
(5) Regulation (EC) No 167/2008 should therefore be amended accordingly.
(6) Since safety reasons do not require the immediate application of the amendments made by this Regulation to
Regulation (EC) No 167/2008, it is appropriate to provide for a transitional period during which existing stocks
of the additive, premixtures and compound feed containing the additive may be used up.
(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 Annex to Commission Regulation (EC) No 167/2008 is amended as follows:
(1) in the second column, the words ‘KRKA, d.d Novo mesto, Slovenia’ are replaced by ‘Huvepharma EOOD, Bulgaria’;
(2) in the third column, the words ‘Kokcisan 120G’ are replaced by ‘Huvesal 120 G’.
(1) OJ L 268, 18.10.2003, p. 29.
(2) Commission Regulation (EC) No 167/2008 of 22 February 2008 concerning a new authorisation for ten years of a coccidiostat as an
additive in feedingstuffs (OJ L 50, 23.2.2008, p. 14).L 141/48 EN Official Journal of the European Union 28.5.2016
Article 2
Existing stocks of the additive, premixtures and compound feed containing the additive, which are in conformity with
the provisions applying before the date of entry into force of this Regulation may continue to be placed on the market
and used until they are exhausted.
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, 27 May 2016.
For the Commission
The President
Jean-Claude JUNCKER