16.3.2012 EN Official Journal of the European Union L 77/1
COMMISSION REGULATION (EU) No 225/2012
of 15 March 2012
amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of the Council as regards the approval of establishments placing on the market, for feed use, products derived from vegetable oils and blended fats and as regards the specific requirements for production, storage, transport and dioxin testing of oils, fats and products derived thereof
(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 183/2005 of the European Parliament and the Council of 12 January 2005 laying down requirements for feed hygiene (1), and in particular Article 27(b) and (f) thereof,
Whereas:
(1) Regulation (EC) No 183/2005 lays down general rules on feed hygiene, conditions and arrangements to ensure that processing conditions to minimise and control potential hazards are respected. Feed business establishments are to be registered with or approved by the competent authority. Additionally, feed business operators lower down the feed chain have the obligation to source feed only from establishments which are registered or approved.
(2) 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 (2) requires feed placed on the market to be safe and explicitly labelled with the respective type of feed. Additionally, Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (3) lists detailed descriptions for specific feed materials to be used for labelling purposes.
(3) The interplay of these requirements should ensure traceability and a high level of consumer protection throughout the feed and food chain.
(4) Official controls and controls carried out by feed business operators have shown that certain oils and fats and products derived thereof not intended for feed use have been used as feed materials resulting in feed exceeding the maximum dioxin levels laid down in Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (4). As a consequence, food derived from animals fed with contaminated feed may pose a public health risk. In addition, financial losses may result from the withdrawal of contaminated feed and food from the market.
(5) To enhance feed hygiene and without prejudice to the competence of the Member States as laid down in Article 10(2) of Regulation (EC) No 183/2005, establishments further processing crude vegetable oils, manufacturing products derived from oils of vegetable origin and blending fats should be subject to approval in accordance with that Regulation if these products are intended for use in feed.
(6) Specific requirements for the production, labelling, storage and transport of those feed materials should be provided for to take into account the experience gained from the application of hazard analysis and critical control points (HACCP)-based systems.
(7) A reinforced dioxin monitoring would facilitate the detection of non-compliances and the enforcement of feed law. It is necessary to provide for an obligation for feed business operators to test fats, oils and products derived thereof for dioxin and dioxin-like PCBs in order to reduce the risk that contaminated products enter the food chain and, therefore, support the strategy to reduce the exposure to dioxin of EU citizens. The risk of dioxin contamination should be the basis for the establishment of the monitoring plan. The responsibility to place safe feed on the market is with the feed business operators. Thus the costs for the analysis should be fully borne by them. Detailed provisions on sampling and analysis not contained in this Regulation should remain within the competence of the Member States. Furthermore, Member States are encouraged to focus on the controls of feed business operators that are not under the scope of the dioxin monitoring but that obtain the products mentioned above.
(8) The mandatory risk-based monitoring system must not affect the feed business operator’s duty to comply with the requirements of Union legislation on feed hygiene. It should be integrated into good hygiene practices and the HACCP-based system. This should be verified by the competent authority in the context of the approval of the feed business operator. The operator’s regular review of his own risk assessment should consider the findings of the dioxin monitoring.
(9) Laboratories performing dioxin analyses should be obliged to report results exceeding the maximum permitted limits provided for in Directive 2002/32/EC not only to the feed business operator but also to the competent authority in order to improve transparency; this obligation does not exempt the feed business operator from his obligation to inform the competent authority.
(10) In order to verify the effectiveness of the provisions concerning the mandatory dioxin monitoring and its integration in the feed business operators HACCP system, a review after two years should be provided for.
(11) Sufficient time should be allowed to give competent authorities and feed business operators the possibility to adapt to the provisions of this Regulation.
(12) 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,
Annex II to Regulation (EC) No 183/2005 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 16 September 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.