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16.3.2012 Official
Journal
of
the
European
Union
L
77/1
II
(Non-legislative acts)
REGULATIONS
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,
(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
Having regard to the Treaty on the Functioning of the European
been used as feed materials resulting in feed exceeding
Union,
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
Having regard to Regulation (EC) No 183/2005 of the European
animal feed ( 4 ). As a consequence, food derived from
Parliament and the Council of 12 January 2005 laying down
animals fed with contaminated feed may pose a public
requirements for feed hygiene ( 1 ), and in particular Article 27(b)
health risk. In addition, financial losses may result from
and (f) thereof,
the withdrawal of contaminated feed and food from the
market.
Whereas:
(5) To
enhance
feed
hygiene
and
without
prejudice
to
the
competence of the Member States as laid down in
(1) Regulation
(EC)
No
183/2005
lays
down
general
rules
on
Article 10(2) of Regulation (EC) No 183/2005, estab
feed hygiene, conditions and arrangements to ensure that
lishments further processing crude vegetable oils, manu
processing conditions to minimise and control potential
facturing products derived from oils of vegetable origin
hazards are respected. Feed business establishments are to
and blending fats should be subject to approval in
be registered with or approved by the competent auth
accordance with that Regulation if these products are
ority. Additionally, feed business operators lower down
intended for use in feed.
the feed chain have the obligation to source feed only
from establishments which are registered or approved.
(6) Specific
requirements
for
the
production,
labelling,
storage and transport of those feed materials should be
(2) Regulation
(EC)
No
767/2009
of
the
European
provided for to take into account the experience gained
Parliament and of the Council of 13 July 2009 on the
from the application of hazard analysis and critical
placing on the market and use of feed ( 2 ) requires feed
control points (HACCP)-based systems.
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
(7) A
reinforced
dioxin
monitoring
would
facilitate
the
descriptions for specific feed materials to be used for
detection of non-compliances and the enforcement of
labelling purposes.
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
(3)
The interplay of these requirements should ensure tracea
PCBs in order to reduce the risk that contaminated
bility and a high level of consumer protection
products enter the food chain and, therefore, support
throughout the feed and food chain.
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.
( 1 ) OJ L 35, 8.2.2005, p. 1.
( 2 ) OJ L 229, 1.9.2009, p. 1.
( 3 ) OJ L 159, 17.6.2011, p. 25.
( 4 ) OJ L 140, 30.5.2002, p. 10.

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L 77/2
EN
Official Journal of the European Union
16.3.2012
The responsibility to place safe feed on the market is
integration in the feed business operators HACCP system,
with the feed business operators. Thus the costs for the
a review after two years should be provided for.
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
(11) Sufficient
time
should
be
allowed
to
give
competent
encouraged to focus on the controls of feed business
authorities and feed business operators the possibility
operators that are not under the scope of the dioxin
to adapt to the provisions of this Regulation.
monitoring but that obtain the products mentioned
above.
(12) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(8) The
mandatory
risk-based
monitoring
system
must
not
Committee on the Food Chain and Animal Health and
affect the feed business operator’s duty to comply with
neither the European Parliament nor the Council has
the requirements of Union legislation on feed hygiene. It
opposed them,
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
HAS ADOPTED THIS REGULATION:
of his own risk assessment should consider the findings
of the dioxin monitoring.
Article 1
(9) Laboratories
performing
dioxin
analyses
should
be Annex II to Regulation (EC) No 183/2005 is amended in
obliged to report results exceeding the maximum
accordance with the Annex to this Regulation.
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
Article 2
operator from his obligation to inform the competent
This Regulation shall enter into force on the 20th day following
authority.
its publication in the Official Journal of the European Union.
(10) In
order
to
verify
the
effectiveness
of
the
provisions
concerning the mandatory dioxin monitoring and its
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

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EN
16.3.2012 Official
Journal
of
the
European
Union
L
77/3
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:
‘DEFINITIONS
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.’;
(2) the following point is added in the section headed ‘FACILITIES AND EQUIPMENT’:
‘10. Establishments carrying out one or more of the following activities to place on the market products for use in
feed shall be subject to approval in accordance with Article 10(3):
(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.’;
(3) the following points are added in the section headed ‘PRODUCTION’:
‘7. Fat blending establishments placing products intended for feed on the market shall keep all products intended for
feed physically separated from products intended for other purposes unless the latter products comply:
— 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.
___________
(*) OJ L 140, 30.5.2002, p. 10.’;
(4) the following section is added after the section headed ‘QUALITY CONTROL’:
‘DIOXIN MONITORING
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. To supplement the feed business operator’s HACCP system, the analyses referred to in point 1 shall be carried out
with at least the following frequencies:
(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.

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L 77/4
EN
Official Journal of the European Union
16.3.2012
(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.

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EN
16.3.2012 Official
Journal
of
the
European
Union
L
77/5
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 to perform an analysis, as referred to in point 1 he shall
instruct the laboratory to communicate the results of that analysis to the competent authority in case the dioxin
limits set out in points 1 and 2 of Section V of Annex I to Directive 2002/32/EC are exceeded.
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.
___________
(*) OJ L 54, 26.2.2009, p. 1.
(**) OJ L 300, 14.11.2009, p. 1.’;
(5) the following point is added in the section headed ‘STORAGE AND TRANSPORT’:
‘7. Containers which are to serve for storage or transport of blended fats, oils of vegetable origin or products derived
thereof intended for use in feed shall not be used for the transport or storage of products other than these unless
the products comply with the requirements of:
— 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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