
Article 1 
Annex II to Regulation (EC) No 183/2005 is amended in accordance with the Annex to this Regulation.
Article 2 
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.Done at Brussels, 15 March 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX

Annex II to Regulation (EC) No 183/2005 is amended as follows:

((1)) the following section is inserted after the title of Annex II:
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For the purposes of this Annex, the following definitions shall apply:


((a)) “batch” means an identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together;
((b)) “products derived from vegetable oils” means any product derived from crude or recovered vegetable oils by oleochemical or biodiesel processing or distillation, chemical or physical refining, other than the refined oil;
((c)) “fat blending” means the mixing of crude oils, refined oils, animal fats, oils recovered from the food industry and/or products derived thereof to produce a blended oil or fat, with the exception of solely the storage of consecutive batches.
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((2)) the following point is added in the section headed ‘FACILITIES AND EQUIPMENT’:
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10. 

((a)) processing of crude vegetable oil except those under the scope of Regulation (EC) No 852/2004;
((b)) oleochemical manufacturing of fatty acids;
((c)) manufacturing of biodiesel;
((d)) fat blending.
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((3)) the following points are added in the section headed ‘PRODUCTION’:
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7. 

— with the requirements of this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and
— with Annex I to Directive 2002/32/EC of the European Parliament and the Council.

8. The labelling of the products shall clearly indicate whether they are intended for feed or other purposes. If the producer declares that a certain batch of a product is not intended for feed or food use, this declaration shall not be subsequently altered by an operator at a later stage of the chain.
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((4)) the following section is added after the section headed ‘QUALITY CONTROL’:
' 1. Feed business operators placing on the market fats, oils or products derived thereof intended for use in feed, including compound feed, shall analyse those products in accredited laboratories for the sum of dioxins and dioxin-like PCBs in accordance with Commission Regulation (EC) No 152/2009.
 2. 

((a)) processors of crude vegetable oils:

((i)) 100 % of the batches of crude coconut oils shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;
((ii)) 100 % of the batches of the products derived from vegetable oils except glycerol, lecithin and gums intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products.
((b)) producers of animal fat:
one representative analysis per 2 000 tonnes of animal fat and products derived thereof belonging to category 3, as laid down in Article 10 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council.
((c)) operators of fish oil:

((i)) 100 % of the batches of fish oil shall be analysed if it is produced from:

— products derived from crude fish oil other than refined fish oil,
— fisheries with no monitoring history, of unspecified origin or from the Baltic Sea,
— fish by-products from establishments manufacturing fish for human consumption that are not EU approved,
— blue whiting or menhaden,
a batch may comprise at the maximum 1 000 tonnes of fish oil;
((ii)) 100 % of the outgoing batches of products derived from crude fish oil other than refined fish oil shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;
((iii)) one representative analysis per 2 000 tonnes shall be carried out, as regards fish oil not referred to in (i);
((iv)) fish oil decontaminated by an officially approved treatment shall be analysed according to the HACCP principles in compliance with Article 6.
((d)) oleochemical and biodiesel industry:

((i)) 100 % of the incoming batches of crude coconut oils and products derived from vegetable oils except glycerol, lecithin and gums, animal fats not covered by (b), fish oil not covered by (c), oils recovered from the food industry and blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;
((ii)) 100 % of the batches of products derived from the processing of the products mentioned in (i) except glycerol, lecithin and gums shall be analysed.
((e)) fat blending establishments:

((i)) 100 % of the incoming batches of crude coconut oils and products derived from vegetable oils except glycerol, lecithin and gums, animal fats not covered by (b), fish oil not covered by (c), oils recovered from the food industry and blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;
or
((ii)) 100 % of the batches of blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products.
The feed business operator shall declare to the competent authority in the context of his risk assessment which alternative he chooses.
((f)) producers of compound feed for food producing animals other than those mentioned in (e):

((i)) 100 % of the incoming batches of crude coconut oils and products derived from vegetable oils except glycerol, lecithin and gums, animal fats not covered by (b), fish oil not covered by (c), oils recovered from the food industry and blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;
((ii)) a sampling frequency of 1 % of the batches shall be carried out as regards manufactured compound feed containing products referred to in (i).
 3. If it can be demonstrated that a homogenous consignment is bigger than the maximum batch size according to point 2 and that it has been sampled in a representative way, then the results of the analysis of the appropriately drawn and sealed sample will be considered acceptable.
 4. Where a feed business operator proves that a batch of a product or all components of a batch as referred to under point 2 entering his operation has already been analysed at an earlier stage of production, processing or distribution, or are in compliance with the requirements of points 2(b) or (c)(iii) the feed business operator shall be released from the obligation to analyse this batch and shall analyse it according to the general HACCP principles in compliance with Article 6.
 5. Any delivery of products as referred to under points 2(d)(i), (e)(i) and (f)(i) shall be accompanied by a proof that these products or all components thereof have been analysed or are in compliance with the requirements of points 2(b) or (c)(iii).
 6. If all incoming batches of products mentioned in points 2(d)(i), (e)(i) and (f)(i) entering a production process have been analysed in line with the requirements of this Regulation and if it can be assured that the production process, handling and storage does not increase the dioxin contamination, the feed business operator shall be released from the obligation to analyse the final product and shall analyse it according to the general HACCP principles in compliance with Article 6.
 7. 
Where a feed business operator mandates a laboratory which is located in a Member State other than the feed business operator ordering the analysis he shall instruct the laboratory to report to its competent authority, which shall inform the competent authority of the Member State where the feed business operator is located.

Feed business operators shall inform the competent authority of the Member State where they are located if they mandate a laboratory located in a third country. Evidence must be provided that the laboratory performs the analysis in accordance with Regulation (EC) No 152/2009.
 8. The dioxin testing requirements shall be reviewed by 16 March 2014.
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((5)) the following point is added in the section headed ‘STORAGE AND TRANSPORT’:
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7. 

— this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and
— Annex I to Directive 2002/32/EC.

They shall be kept separate from any other cargo where there is a risk of contamination.

Where this separate use is not possible, the containers shall be efficiently cleaned so as to remove any trace of product if those containers were previously used for products not meeting the requirements of:


— this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and
— Annex I to Directive 2002/32/EC.

Animal fats of category 3, as laid down in Article 10 of Regulation (EC) No 1069/2009, intended for use in feed shall be stored and transported in line with that Regulation.
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