I
(Acts whose publication is obligatory)
REGULATION(EC)No183/2005OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of12January2005
laying down requirements for feed hygiene
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-PEAN UNION,
Having regard to the Treaty establishing the European Commu-nity,and in particular Article37(2)and Article152(4)(b)thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article251 of the Treaty(2),
Whereas:
(1)Livestock production plays a very important part in the
agricultural sector of the Community.Satisfactory results
of this activity depend to a large extent on the use of safe
and good quality feed.
(2)The pursuit of a high level of protection of human and ani-
mal health is one of the fundamental objectives of food
law,as laid down in Regulation(EC)No178/2002of the
European Parliament and of the Council of28January
2002laying down the general principles and requirements
of food law,establishing the European Food Safety Author-
ity and laying down procedures in matters of food
safety(3).That Regulation also lays down other common
principles and definitions for national and Community
food law,including the aim of achieving free movement of
feed within the Community.(3)Council Directive95/69/EC(4)established the conditions
and arrangements applicable to certain categories of estab-
lishments and intermediaries in the animal feed sector,to
enable them to exercise their activities.Experience has
shown that these conditions and arrangements constitute
a sound basis for ensuring feed safety.That Directive also
established conditions for the approval of establishments
producing certain substances listed in Council
Directive82/471/EEC of30June1982concerning certain
products used in animal nutrition(5).
(4)Commission Directive98/51/EC of9July1998laying
down certain measures for implementing Council
Directive95/69/EC laying down the conditions and
arrangements for approving and registering certain estab-
lishments and intermediaries operating in the animal feedimported food
sector(6),established certain measures that included
arrangements for imports from third countries.
(5)Experience has also shown that it is necessary to ensure
that all feed businesses,including aquaculture,operate in
conformity with harmonised safety requirements and that
it is necessary to conduct a general review in order to take
into account the need to ensure a higher level of protec-
tion of human and animal health,and of the environment.
(6)The principal objective of the new hygiene rules set out in
this Regulation is to ensure a high level of consumer pro-
tection with regard to food and feed safety,taking particu-
lar account of the following principles:
(a)that primary responsibility for feed safety rests with
the feed business operator;
(1)OJ C32,5.2.2004,p.97.
(2)Opinion of the European Parliament of31March2004(not yet pub-
lished in the Official Journal)and Council Decision of21December 2004.
(3)OJ L31,1.2.2002,p.1.Regulation as amended by Regulation(EC)
No1642/2003(OJ L245,29.9.2003,p.4).(4)OJ L332,30.12.1995,p.15.Directive as last amended by Regulation
(EC)No806/2003(OJ L122,16.5.2003,p.1).
(5)OJ L213,21.7.1982,p.8.Directive as last amended by Regulation
(EC)No1882/2003of the European Parliament and of the Council (OJ L284,31.10.2003,p.1).
(6)OJ L208,24.7.1998,p.43.
(b)the need to ensure feed safety throughout the food
chain,starting with primary production of feed,up to
and including,the feeding of food-producing animals;
(c)the general implementation of procedures based on
the principles of hazard analysis and critical control
points(HACCP),which,together with the application
of good hygiene practice,should reinforce feed busi-
ness operators’responsibility;
(d)that guides to good practice are a valuable instrument
to help feed business operators at all levels of the feed
chain comply with feed hygiene rules and with the
application of HACCP principles;
(e)the establishment of microbiological criteria based on
scientific risk criteria;
(f)the need to ensure that imported feed attains a stan-
dard that is at least equivalent to that of feed produced
in the Community.
(7)In order to ensure the complete application of the registra-
tion and approval system to all the feed business operators
and,consequently,to guarantee full traceability,it is appro-
priate to ensure that they only source and use feed from
establishments which are registered and/or approved in
accordance with this Regulation.
(8)An integrated approach is necessary to ensure feed safety
from,and including,primary production of feed up to,and
including,its placing on the market or export.The primary
production of feed includes products which only undergo
simple physical treatment such as cleaning,packaging,
storage,natural drying or ensiling.
(9)In accordance with the principles of proportionality and
subsidiarity,Community rules should not apply to certain
cases of private domestic production of feed and feeding of
certain animals,nor to the direct supply of small quanti-
ties of primary production of feed at local level,nor to the
retailing of pet food.
(10)Feed hazards present at the level of primary production of
feed should be identified and adequately controlled,to
ensure that the objectives of this Regulation are met.The
fundamental principles of this Regulation should therefore
apply to farms which manufacture feed solely for the
requirements of their own production,as well as to farms
which place feed on the market.It should be taken into
consideration
that the risk is less if feed is produced and used for feeding
animals only used for domestic consumption,or for ani-
mals which are not used for food production.The trade of
small quantities of feed products at local level and the
retailing of pet food shall have particular treatment in the
framework of this Regulation.
(11)The application of HACCP principles to primary produc-
tion of feed is the medium-term objective of European
hygiene legislation.But guides to good practice should
already be encouraging the use of appropriate hygiene
requirements.
(12)Feed safety depends on a number of factors.Legislation
should lay down minimum hygiene requirements.Official
controls should be in place to check feed business opera-
tors’compliance.In addition,feed business operators
should take measures or adopt procedures to achieve a
high level of feed safety.
(13)HACCP principles can help feed business operators attain
a higher standard of feed safety.HACCP principles should
not be regarded as a method of self-regulation and do not
replace official controls.
(14)The implementation of the HACCP principles requires the
full cooperation and commitment of feed businesses’
employees.
(15)HACCP principles in feed production should take into
account the principles contained in the Codex Alimenta-
rius,but should allow sufficient flexibility in all situations.
In certain feed business,it is not possible to identify criti-
cal control points and,in some cases,good practices can
replace the monitoring of critical control points.Similarly,
the requirement to establish‘critical limits’,as set out in the
Codex Alimentarius,does not require a numerical limit to
be fixed in every case.The requirement to retain docu-
ments as set out in the same Code needs to be flexible to
avoid undue burdens for very small businesses.It should be
ensured that operations carried out by a feed business at
the level of primary production of feed,including associ-
ated operations,as well as the mixing of feed with comple-
mentary feedingstuffs for the exclusive requirements of its
own holding,are not obliged to follow the HACCP
principles.
(16)Flexibility is also necessary to accommodate the needs of
feed businesses situated in regions suffering from special
geographical constraints or related to structural require-
ments.But such flexibility should not compromise feed
hygiene objectives.Provision should be made for discus-
sion within the Standing Committee on the Food Chain
and Animal Health,where appropriate.
(17)A system of registration and approval by the competent
authority of the Member State of all feed businesses is
appropriate to ensure traceability from manufacturer to
final user and to facilitate the implementation of effective
official controls.The existing systems for collection of data
concerning feed businesses may be used by the competent
authority of the Member States to start up and implement
the system provided for in this Regulation.
(18)It is appropriate that an approval system for feed busi-
nesses be maintained for activities which can present a
higher risk in the manufacture of feed.Provision should be
made for procedures to extend the current scope of the
approval system provided for in Directive95/69/EC.
(19)In order to be approved or registered,feed businesses
should meet several conditions relevant to their operations,
concerning facilities,equipment,personnel,production,
quality control,storage and documentation,in order to
ensure both feed safety and product traceability.Provision
should be made for these conditions to be varied,to ensure
that they are appropriate to the various types of feed busi-
ness.Member States should be allowed to grant condi-
tional approval of establishments,if it appears from the
on-site visit that the establishment meets all the infrastruc-
ture and equipment requirements.However,it is also
appropriate to set a maximum length of time for such con-
ditional approval.
(20)Provision should be made for temporarily suspending,
amending or revoking the registration or approval,where
establishments change or cease their activities or no longer
fulfil the conditions applicable to their activity.
(21)The traceability of feed and feed ingredients throughout
the feed chain is an essential element in ensuring feed
safety.Regulation(EC)No178/2002contains rules to
ensure the traceability of feed and feed ingredients and pro-
vides a procedure for the adoption of implementing rules
applicable to specific sectors.(22)Successive feed crises have shown that failures at any stage
in the feed chain can have important economic conse-
quences.The characteristics of feed production and the
complexity of the feed distribution chain mean that it is
difficult to withdraw feed from the market.The costs of
rectifying the economic damage along the feed and food
chain is often borne by public funds.The remedying of this
economic consequence at a low cost to society could be
improved if the operator whose activity causes economic
damage in the feed sector is held financially responsible.
However,establishing a general mandatory system of
financial liability and financial guarantees,for example
through insurance,which applies to all feed business
operators may not be feasible or appropriate.The Com-
mission should therefore consider this issue in greater
depth,taking into account provisions in existing legislation
with regard to liability in other spheres,as well as existing
systems and practices amongst the Member States.To this
end,the Commission should present a report,accompa-
nied where appropriate by legislative proposals.
(23)Feed imported into the Community must satisfy the general
requirements laid down in Regulation(EC)No178/2002
and the import conditions laid down in Regulation(EC)
No882/2004of the European Parliament and of the Coun-
cil of29April2004on official controls performed to
ensure the verification of compliance with feed and food
law,animal health and animal welfare rules(1).In order to
avoid trade disruptions it is appropriate that,pending the
completion of the implementing measures,imports con-
tinue to be authorised under the conditions laid down in
Directive98/51/EC.
(24)Community products exported to third countries have to
satisfy the general requirements laid down in Regulation
(EC)No178/2002.
(25)It is appropriate to broaden the scope of the rapid alert sys-
tem for food and feed laid down by Regulation(EC)
No178/2002to include risks to animal health or the envi-
ronment from feed used for animals not kept for food
production.
(26)Community legislation on feed hygiene has to be under-
pinned by scientific advice.To this end,the European Food
Safety Authority should be consulted whenever necessary.
(27)To take account of technical and scientific progress,there
should be close and effective cooperation between the
Commission and the Member States within the Standing
Committee on the Food Chain and Animal Health. (1)OJ L165,30.4.2004,p.1(Corrigendum:OJ L191,28.5.2004,p.1).
(28)This Regulation takes account of international obligations
laid down in the WTO Sanitary and Phytosanitary Agree-
ment and the international food safety standards contained
in the Codex Alimentarius.
(29)The Member States should lay down rules on penalties
applicable to infringements of the provisions of this Regu-
lation and ensure that they are implemented.Those penal-
ties have to be effective,proportionate and dissuasive.
(30)The measures necessary for the implementation of this
Regulation should be adopted in accordance with Council
Decision1999/468/EC of28June1999laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission(1).
(31)It is appropriate to provide for a deferred date of applica-
tion of the Regulation,in order to allow the feed businesses
affected by it time to adapt.
(32)For the above reasons,Directives95/69/EC and98/51/EC
should be repealed,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER,SCOPE AND DEFINITIONS
Article1
Subject matter
This Regulation lays down:
(a)general rules on feed hygiene;
(b)conditions and arrangements ensuring traceability of feed;
(c)conditions and arrangements for registration and approval of
establishments.
Article2
Scope
1.This Regulation shall apply to:
(a)the activities of feed business operators at all stages,from and
including primary production of feed,up to and including, the placing of feed on the market;(b)the feeding of food-producing animals;
(c)imports and exports of feed from and to third countries.
2.This Regulation shall not apply to:
(a)the private domestic production of feed:
(i)for food-producing animals kept for private domestic
consumption;
and
(ii)for animals not kept for food production;
(b)the feeding of food-producing animals kept for private
domestic consumption or for the activities mentioned in Article1(2)(c)of Regulation(EC)No852/2004of the Euro-pean Parliament and of the Council of29April2004on the hygiene of foodstuffs(2);
(c)the feeding of animals not kept for food production;
(d)the direct supply of small quantities of primary production of
feed at local level by the producer to local farms for use on those farms;
(e)the retailing of pet food.
3.Member States may establish rules and guidance governing the activities referred to in paragraph2.Such national rules and guidance shall ensure the achievement of the objectives of this Regulation.
Article3
Definitions
For the purposes of this Regulation,the definitions in Regulation (EC)No178/2002shall apply,subject to the following specific definitions:
(a)‘feed hygiene’means the measures and conditions necessary
to control hazards and to ensure fitness for animal consump-tion of a feed,taking into account its intended use;
(1)OJ L184,17.7.1999,p.23.(2)OJ L139,30.4.2004,p.1.(Corrigendum:OJ L226,25.6.2004,p.3).
(b)‘feed business operator’means the natural or legal person
responsible for ensuring that the requirements of the present Regulation are met within the feed business under their control;
(c)‘feed additives’means substances or micro-organisms autho-
rised under Regulation(EC)No1831/2003of the European Parliament and of the Council of22September2003on additives for use in animal nutrition(1);
(d)‘establishment’means any unit of a feed business;
(e)‘competent authority’means the authority of a Member State
or of a third country designated to carry out official controls;
(f)‘primary production of feed’means the production of agri-
cultural products,including in particular growing,harvest-ing,milking,rearing of animals(prior to their slaughter)or fishing resulting exclusively in products which do not undergo any other operation following their harvest,collec-tion or capture,apart from simple physical treatment.
CHAPTER II
OBLIGATIONS
Article4
General obligations
1.Feed business operators shall ensure that all stages of pro-duction,processing and distribution under their control are car-ried out in accordance with Community legislation,national law compatible therewith,and good practice.They shall ensure in par-ticular that they satisfy the relevant hygiene requirements laid down in this Regulation.
2.When feeding food-producing animals,farmers shall take measures and adopt procedures to keep the risk of biological, chemical and physical contamination of feed,animals and animal products as low as reasonably achievable.
Article5
Specific obligations
1.For operations at the level of primary production of feed and the following associated operations:
(a)transport,storage and handling of primary products at the
place of production;
(b)transport operations to deliver primary products from the
place of production to an establishment;
(c)mixing of feed for the exclusive requirements of their own
holdings without using additives or premixtures of additives with the exception of silage additives,
feed business operators shall comply with the provisions in Annex I,where relevant for the operations carried out.
2.For operations other than those referred to in paragraph1, including mixing of feed for the exclusive requirements of their own holdings when using additives or premixtures of additives with the exception of silage additives,feed business operators shall comply with the provisions in Annex II,where relevant for the operations carried out.
3.Feed business operators shall:
(a)comply with specific microbiological criteria;
(b)take measures or adopt procedures necessary to meet specific
targets.
The criteria and targets referred to in points(a)and(b)shall be adopted in accordance with the procedure referred to in Article31(2).
4.Feed business operators may use the guides provided for in Chapter III to help them comply with their obligations under this Regulation.
5.Farmers shall comply with the provisions set out in Annex III when feeding food-producing animals.
(1)OJ L268,18.10.2003,p.29.

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