Article 1
Annex I to Directive 2008/38/EC is amended in accordance with...
Article 2
Feed included in the Annex to this Regulation and referred...
Article 3
This Regulation shall enter into force on the twentieth day...
ANNEX
Annex I to Directive 2008/38/EC is amended as follows:
In Part A, the following point is added: 10. When...
Commission Regulation (EU) No 5/2014
of 6 January 2014
amending Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes
(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 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC , and in particular Article 10(5) thereof,
Whereas:
(1)
In accordance with Article 32(2) of Regulation (EC) No 767/2009, several applications for authorisation were submitted to the Commission before 1 September 2010 for updating the list of intended uses as referred to in Article 10 of that Regulation.
(2)
Some of those applications concern changes of the conditions associated with the particular nutritional purposes ‘Nutritional restoration, convalescence’ as regards dogs and ‘Stabilisation of physiological digestion’ in respect of feed that may contain additives in concentrations higher than 100 times the relevant fixed maximum content in complete feed as referred to in Article 8(2) of Regulation (EC) No 767/2009. The other applications concern new particular nutritional purposes with respect to the requirement established in Article 8(2) of Regulation (EC) No 767/2009.
(3)
In addition, in accordance with Article 10 of Regulation (EC) No 767/2009, the Commission received an application to add the particular nutritional purpose ‘Reduction of iodine levels in feed in case of hyperthyroidism’ as regards cats.
(4)
A specific way of feeding is the administration of a bolus. In order to guarantee an appropriate and safe use of a bolus as feed for particular nutritional purposes, general requirements should be established for the conditions associated with certain intended uses.
(5)
The Commission made all applications, including the dossiers, available to the Member States.
(6)
The dossiers included in the applications demonstrate that the specific composition of the respective feeds fulfil the particular intended nutritional purposes ‘Nutritional restoration, convalescence‘ as regards dogs, ‘Stabilisation of physiological digestion’‘Reduction of iodine levels in feed in case of hyperthyroidism’ as regards cats, ‘Support the preparation for and recovery from sport effort’ as regards equidae, ‘Compensation for insufficient iron availability after birth’ as regards suckling piglets and calves, ‘Support the regeneration of hooves, trotters and skin’ as regards horses, ruminants and pigs, ‘Support the preparation for oestrus and reproduction’ as regards mammals and birds and ‘Long-term supply of grazing animals with trace elements and/or vitamins’ as regards ruminants with a functional rumen.
(7)
Furthermore, the evaluation showed that the feeds concerned have no adverse effects on animal health, human health, the environment or animal welfare. The evaluation of the dossiers included verification that the characterisation ‘high level of a certain feed additive’ implies an important level of the respective additive which is close to the relevant fixed maximum content in complete feed but not exceeding this content.
(8)
The applications are therefore valid and the particular nutritional purposes should be added to the list of intended uses and the conditions associated with the particular nutritional purposes ‘Nutritional restoration, convalescence’ and ‘Stabilisation of physiological digestion’ should be changed.
(9)
Directive 2008/38/EC should therefore be amended accordingly.
(10)
Since safety reasons do not require the immediate application of the modifications for the feed currently legally placed on the market, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements.
(11)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION:
OJ L 229, 1.9.2009, p. 1.