Official Journ alof the EuropeanUnion L 300/1
I 
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory) 
REGULATIONS  
  REGULATION (EC) No 1069/2009 OF  THE EUROPEAN PARLIAMENT AND  OF THE COUNCIL
of 21 October 2009
laying down health ru les 
as regards animal by- products 
and derived produ c
ts not intended for hu man 
consumption 
and repealing Regu lation 
(EC) No 1774/2002 (Animal by- produ
cts Regulation)
THE EUROPEAN PARLIAMENT AND THE  COUNCIL OF THE EURO­
PEAN 
UNION,
Having regard to the Treaty estab lishing the European Commu­
nity, 
and 
in 
particular Article 152(4)(b ) 
thereof,
Having 
regard 
to the proposal from the Commission ,
Having 
regard 
to the opin ion 
of the European 
Economic 
and 
Social 
Committee
(1) OJ C 100, 30.4.2009, p. 133. (1),
Having 
consulted 
the Committee of the Reg ions,
Acting 
in 
accordance 
with the procedure laid down  
in 
Article 251 
of the Treaty
(2) Opinion of the E uropean Parliamen t of 24 April 2009 (n ot yet pub­
l
ished in the Official Journ al)
 and
 Council
 Decision of 7 Septemb er
2009
. (2),
Whereas:
(1) Animal by-products not intended for human  consumption 
are 
a potential 
source of risk s 
to public 
and 
animal 
health. 
Past crises related to outb reaks 
of foot-an d-mouth 
disease, 
the spread of tran smissible
 spongiform
 encephalopathies
 
such as bovine 
spongiform 
encephalopathy 
(BSE) 
and 
the 
occurrence 
of dioxins 
in 
feedingstuffs 
have shown  
the con­
sequences
 of the improper use of certain an imal
 
by-products 
for public 
and 
animal 
health, the safety of the 
food and 
feed chain  
and 
consumer 
confidence. 
In 
addition, 
such 
crises may also have a wider adverse impact on  
soci­
ety as a whole, b y 
their impact on  
the socioecon omic 
situ­
ation 
of the farmers an d 
of the industrial 
sectors con cerned 
and 
on 
consumer 
confidence 
in 
the safety of products of 
animal 
origin. 
Disease outb reaks 
could also have n egative 
consequences 
for the environment, 
not 
only 
due to the dis­
posal prob lems 
posed, but 
also as reg ards 
biodiversity.(2) Animal by-products  arise main ly during the slaug hter of 
animals 
for human  
consumption, 
during 
the production  
of 
products of an imal
 origin
 such as dairy products, an d
 in 
the course of the disposal of dead an imals 
and 
during 
dis­
ease control 
measures. Reg ardless 
of their source, they 
pose a poten tial 
risk 
to public 
and 
animal 
health and 
the 
environment. 
This risk 
needs 
to be 
adequately con trolled, 
either
 by
 directing
 such products towards safe means of 
disposal or b y 
using 
them for differen t 
purposes, provided 
that strict con ditions 
are applied which min imise 
the health 
risks 
involved.
(3) The disposal of all an imal by-products  is not a realistic 
option, 
as it would lead to un sustainable 
costs and 
risks 
for 
the environment. 
Conversely, 
there is a clear in terest 
for all 
citizens 
that, provided the health risk s 
are minimised, 
a 
wide range 
of animal 
by-products 
are safely used for vari­
ous application s 
in 
a sustainable 
manner. 
A wide ran ge 
of 
animal 
by-products 
are indeed 
commonly 
used in 
impor­
tant
 productive sectors, such as the pharmaceutical, feed 
and 
leather industries.
(4) New techn ologies have widen ed the possib le use of animal 
by-products 
or derived products to a larg e 
number 
of pro­
ductive sectors, in  
particular for the g eneration 
of energy. 
However, 
the use of those n ew 
technologies 
might 
pose 
health risk s 
that must also b e 
minimised.
(5) Community health rules for collection , transport, handling, 
treatment, 
transformation, 
processing, 
storage, 
placing 
on 
the
 market,
 distribution,
 use or disposal of an imal
 
by-products 
should be 
laid down  
in 
a coheren t 
and 
com­
prehensive 
framework .
(6) Those general rules should b e proportion ate to the risk  to 
public 
and 
animal 
health which an imal 
by-products 
pose 
when 
they are dealt with b y 
operators at differen t 
stages 
ofN E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
 the chain 
from collection  
to their use or disposal. The rules 
should also tak e 
into 
account 
the risks 
for the environment 
posed
 during
 those operation s.
 The Commun ity
 frame­
work 
should in clude 
health rules on  
the placin g 
on 
the 
market,
 including
 intra-Community
 trade and
 import, of 
animal 
by-products, 
where appropriate.
(7) In Regulation (EC) No 1774/2002
(1) OJ L 273, 10.10.2002, p. 1. (1), the European Parlia­
ment 
and 
the Council 
laid down  
Community 
health rules 
concerning
 animal
 by-products
 not
 intended
 for human 
consumption. 
Based on 
scientific 
advice and 
as an 
action 
under
 the Commission White Paper of 12 January
 2000 
on Food Safety, that Reg ulation
 introduced
 a set of rules 
aimed at protectin g 
the safety of the food an d 
feed chain , 
which 
is complemen tary 
to Commun ity 
legislation 
on 
food 
and 
feed. Those rules have sig nificantly 
improved the 
level of protection  
in 
the Commun ity 
against 
the risks 
posed 
by 
animal 
by-products.
(8) Regulation (EC) No 1774/2002 in troduced the classifica­
tion 
of animal 
by-products 
into 
three categ ories 
according 
to 
the degree 
of risk 
involved. 
It 
requires operators to k eep 
animal
 by-products
 of differen t
 categories
 separate from 
each other if they wish to mak e 
use of animal 
by-products 
which 
do not 
pose a sig nificant 
risk 
to public 
or animal 
health, 
in 
particular if such products are derived from 
material fit for human  
consumption. 
That Regulation 
also 
introduced 
the principle 
that high-risk 
material should n ot 
be 
fed to farmed an imals, 
and 
that material derived from 
animals 
is not 
to be 
fed to animals 
of the species from 
which it is derived. Pursuan t 
to that Reg ulation, 
only 
mate­
rial from an imals 
which have un dergone 
veterinary 
inspec­
tion
 is to enter
 the feed chain .
 In
 addition,
 it lays down 
rules for processin g 
standards 
which ensure 
the reduction  
of 
risks.
(9) Under Article 35(2) of Reg ulation (EC) No 1774/2002, the 
Commission  
is to submit 
a report to the E uropean 
Parlia­
ment 
and 
to the Coun cil 
on 
the measures tak en 
by 
the 
Member 
States to en sure 
compliance 
with that Reg ulation. 
The 
report is to b e 
accompan ied, 
if appropriate, b y 
legis­
lative 
proposals. The report was sub mitted 
on 21 
October 
2005 
and
 emphasised that the prin ciples
 of Regulation
 
(EC) 
No 1774/2002 should b e 
maintained. 
In 
addition, 
it 
highlighted
 the areas where amen dments
 to that Reg ula
­
tion 
were considered 
necessary, 
in 
particular clarification s 
as
 regards
 the applicab ility
 of the rules to fin ished
 prod­
ucts, the relation ship
 with other Commun ity
 legislation
 
and 
the classification  
of certain 
material. The fin dings 
of a 
series of fact-fin ding
 missions
 carried out in the Member 
States by 
the Food an d 
Veterinary 
Office of the Commis­
sion 
(FVO) in 
2004 and 
2005 support those con clusions. 
According 
to the FVO, improvemen ts 
are necessary 
as 
regards 
the traceab ility 
of the flow of an imal 
by-products 
and
 the effectiven ess
 and
 harmon isation
 of official 
controls.(10) The Scien tific Steering Committee, which was superseded 
by
 the European
 Food Safety Authority (E FSA)
 in 2002, 
has adopted a n umber 
of opinions 
concerning 
animal 
by-products.
 Those opin ions
 demonstrate
 the need
 to 
maintain
 the main prin ciples
 of Reg ulation
 (EC)
 
No  1774/2002; in particular that an imal
 by-products
 
derived from an imals 
shown 
not 
to be 
fit for human  
con­
sumption  
as a result of a health in spection 
should not 
enter 
the 
feed chain . 
However, those an imal 
by-products 
may be 
recovered 
and 
used for the production  
of technical 
or 
industrial 
products un der 
specified health con ditions.
(11) The conclusions of the Presiden cy of the Coun cil on the 
Commission
 report of 21  Octob er
 2005 which were 
adopted in  
December 
2005, and 
the subsequent 
consulta­
tions 
carried out b y 
the Commission , 
have highlighted 
that 
the rules laid down  
in 
Regulation 
(EC) 
No  1774/2002 
should be
 improved. The chief ob jectives
 of the rules on 
animal 
by-products, 
namely 
the control 
of risks 
to public 
and 
animal 
health and 
the protection  
of the safety of the 
food and 
feed chain , 
should be 
clearly laid down . 
The pro­
visions 
of this Reg ulation 
should permit the achievemen t 
of 
those objectives.
(12) The rules on  animal by-products laid down  in this Regu­
lation 
should apply to products that may n ot 
be 
used for 
human 
consumption 
under 
Community 
legislation, 
in 
par­
ticular where they do n ot 
comply with food hyg iene 
legis­
lation 
or where they may n ot 
be 
placed on  
the market 
as 
food since
 they are un safe
 either because
 they are in juri
­
ous to health or un fit
 for human con sumption
 (animal
 
by-products
 ‘by
 law’). Those rules should, however, also 
apply to products of an imal 
origin 
which do comply with 
certain 
rules regarding 
their possib le 
use for human  
con­
sumption , 
or which are raw materials for the production  
of 
products for human  
consumption, 
even 
if they are even ­
tually 
destined 
for other purposes (an imal 
by-products ‘
by 
choice
’).
(13) In addition, in order to preven t risks arising from wild an i­
mals, 
bodies 
or parts of b odies 
of such an imals 
suspected 
of being
 infected
 with a tran smissible
 disease should b e
 
subject 
to the rules laid down  
in 
this Regulation. 
This 
inclusion 
should not 
imply an 
obligation 
to collect an d 
dis­
pose of bodies 
of wild an imals 
that have died or that are 
hunted
 in their n atural
 habitat.
 If
 good hun t
ing
 practices 
are observed, 
intestines 
and 
other body 
parts of wild g ame 
may
 be
 disposed of safely on site. Such practices for the 
mitigation
 of risks
 are well-estab lished
 in Memb er
 States 
and
 are in some cases b ased
 on cultural tradition s
 or on 
national 
legislation 
which reg ulates 
the activities of hun t­
ers.
 Commun ity
 legislation,
 in particular Reg ulation
 (EC)
 
No 853/2004 of the E uropean 
Parliamen t 
and 
of the Coun ­
cil 
of 29 April 2004 layin g 
down 
specific hyg iene 
rules for 
food of an imal 
origin
(2) OJ L 139, 30.4.2004, p. 55. (2), lays down  rules for han dling of 
meat 
and 
animal 
by-products 
from wild g ame. 
Those rulesN E 2 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/3
 also place the respon sibility 
for the preven tion 
of risks 
on 
trained
 persons
 such as hun ters.
 In view of the poten tial
 
risks
 for the food chain ,
 animal
 by
-products from k illed
 
wild game 
should on ly 
be 
subject 
to this Reg ulation 
in 
so 
far as food hyg iene 
legislation 
applies to the placin g 
on 
the 
market 
of such game 
and 
involves 
operation s 
carried out 
by
 game-handling
 establishments.
 In
 addition ,
 animal
 
by-products
 for the preparation of g ame
 trophies should 
be 
covered b y 
this Regulation 
in 
order to preven t 
animal 
health 
risks 
arising 
from such b y-products.
(14) The rules laid down  in this Regulation should apply to an i­
mal 
by-products 
derived from aquatic an imals, 
other than  
material
 from vessels operatin g
 under
 Commun ity
 food 
hygiene 
legislation. 
However, risk -proportionate 
measures 
should be 
adopted as reg ards 
the handling 
and 
disposal of 
material which arises on b oard
 fishing
 vessels from the 
evisceration  
of fish and 
which shows sig ns 
of disease. Such 
measures for the implemen tation 
of this Reg u
lation should 
be 
adopted on  
the basis 
of a risk 
assessmen t 
carried out b y 
the
 appropriate scien tific
 institution
 in view of the avail­
able
 evidence
 regarding
 the effectiven ess
 of certain mea­
sures to comb at
 the spread of diseases commun icable
 to 
humans, 
in 
particular of certain  
parasites.
(15) Due to the limited risk s arising from materials used as raw 
pet
 food on farm or supplied to en d
 users by
 food busi
­
nesses, 
certain 
activities related to such raw pet food should 
not 
be 
covered b y 
the rules laid down  
in 
this Regulation.
(16) It is appropriate to clarify in  this Regulation which animals 
are 
to be 
classified as pet an imals, 
so that b y-products 
derived 
from such an imals 
are not 
used in 
feed for farmed 
animals. 
In 
particular, an imals 
kept 
for purposes other 
than 
farming, 
such as for compan ionship, 
should be 
clas­
sified as pet an imals.
(17) For the sak e of consistency of Commun ity legislation, cer­
tain 
definitions 
set out in 
Regulation 
(EC) 
No 999/2001 of 
the European 
Parliamen t 
and 
of the Coun cil 
of 22 May 
2001 laying
 down rules for the preven tion,
 control
 and 
eradication of certain tran smissible
 spongiform
 encepha
­
lopathies
(1) OJ L 147, 31.5.2001, p. 1. (1) and in Directive 2008/98/E C of the European 
Parliamen t 
and 
of the Coun cil 
of 19 Novemb er 
2008 on 
waste
(2) OJ L 312, 22.11.2008, p. 3. (2) should b e used in this Regulation. The referen ce 
to
 Council
 Directive 86/609/E EC
 of 24 Novemb er
 1986 
on 
the approximation  
of laws, reg ulations 
and 
administra­
tive 
provisions 
of the Memb er 
States regarding 
the protec­
tion 
of animals 
used for experimen tal 
and 
other scien tific 
purposes
(3) OJ L 358, 18.12.1986, p. 1. (3) should b e clarified.(18) For the sak e of consistency of Commun ity legislation, the 
definition 
of ‘aquatic an imal
’ as laid down  
in 
Council 
Direc­
tive 2006/88/E C 
of 24 Octob er 
2006 on 
animal 
health 
requiremen ts
 for aquaculture an imals
 and
 products 
thereof, an d 
on 
the preven tion 
and 
control 
of certain 
dis­
eases in 
aquatic an imals
(4) OJ L 328, 24.11.2006, p. 14. (4) should b e used in this Regula­
tion. 
At the same time, aquatic in vertebrates 
which are n ot 
covered 
by 
that defin ition 
and 
which pose n o 
risk 
of dis­
ease transmission
 should b e
 subject
 to the same require­
ments 
as aquatic an imals.
(19) Council Directive 1999/31/E C of 26  April 1999  on the 
landfill 
of waste
(5) OJ L 182, 16.7.1999, p. 1. (5) specifies the con ditions for the issuin g 
of 
a permit for a lan dfill. 
This Regulation 
should provide 
for the disposal of an imal 
by-products 
on 
landfills 
for 
which such a permit has b een 
issued.
(20) The primary respon sibility for carryin g out operation s in 
accordance
 with this Reg ulation
 should rest with opera­
tors. At the same time, the pub lic
 interest
 in preven ting
 
risks 
to public 
and 
animal 
health requires that a collection  
and 
disposal system is in  
place to en s
ure the safe use or the 
safe disposal of an imal 
by-products 
which may n ot 
be 
used, 
or which are n ot 
used for econ omic 
reasons. 
The 
scope of the collection an d
 disposal system should tak e
 
into 
account 
the actual amoun t 
of animal 
by-products 
which 
accrue in 
the particular Memb er 
State. It 
should also 
reflect, on  
a precaution ary 
basis, 
the need 
for extended 
dis­
posal capacities in  
the event 
of major outb reaks 
of trans­
missible
 diseases or of temporary techn ical
 failures in an 
existing 
disposal facility. Memb er 
States should b e 
permit­
ted to cooperate with each other an d 
third coun tries 
pro­
vided that the ob jectives 
of this Reg ulation 
are met.
(21) It is importan t to determin e the startin g point in the life 
cycle 
of animal 
by-products 
from which the requiremen ts 
of
 this Reg ulation
 should apply. On ce
 a product has 
become
 an animal
 by-product,
 it should n ot
 re-enter
 the 
food chain . 
Special circumstan ces 
apply for the han dling 
of 
certain 
raw materials, such as hides, han dled 
in 
establish­
ments 
or plants 
integrated 
at the same time in to 
the food 
chain 
and 
the animal 
by-products 
chain. 
In 
those cases, the 
necessary 
measures should b e 
taken 
by 
means 
of segrega­
tion 
to mitigate 
potential 
risks 
for the food chain  
which 
can arise from cross-con tamination.
 For other establish­
ments, 
risk-based 
conditions 
should be 
determined 
to pre­
vent 
cross-contamination, 
in 
particular throug h 
separation  
between 
the animal 
by-products 
chain 
and 
the food chain .
(22) For reason s of legal certainty and proper con trol of poten­
tial 
risks, 
an 
end 
point 
in 
the manufacturing 
chain 
should 
be
 determin ed
 for products which n o
 longer
 have directN E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
 relevance 
for the safety of the feed chain . 
For certain  
prod­
ucts regulated 
under 
other Commun ity 
legis
lation, such an  
end 
point 
should be 
determined 
at the stag e 
of manufac­
turing. 
Products which have reached this en d 
point 
should 
be 
exempt from con trols 
under 
this Regulation. 
In 
particu­
lar, products b eyond 
the end 
point 
should be 
allowed to b e 
placed 
on 
the market 
without restriction  
under 
this Regu­
lation 
and 
to be 
handled 
and 
transported 
by 
operators 
which have n ot 
been 
approved or reg istered 
in 
accordance 
with 
this Regulation.
(23) However, it should b e possible to modify such an  end 
point, 
particularly in  
the case of n ewly 
emerging 
risks. 
Regulation 
(EC) 
No 1774/2002 exempts certain  
products, 
notably 
guano, 
certain 
hides to which particular forms of 
treatment 
such as tan ning 
have been 
applied, an d 
certain 
game 
trophies from its requiremen ts. 
Similar exemption s 
should
 be
 provided for in the implemen ti
ng measures to 
be 
adopted un der 
this Regulation 
for products such as ole­
ochemical products an d
 the end
 products resultin g
 from 
the production  
of biodiesel, 
under 
appropriate con ditions.
(24) In order to en sure a high level of protection  of public and 
animal 
health, Memb er 
States should con tinue 
to take 
the 
necessary
 measures to preven t
 the dispatch of an imal
 
by-products 
from restricted areas or estab lishments, 
in 
par­
ticular in the even t
 of an outb reak
 of a disease listed in 
Council
 Directive 92/119/E EC
 of 17  Decemb er
 1992 
introducing 
general 
Community 
measures for the con trol 
of 
certain 
animal 
diseases an d 
specific measures relatin g 
to 
swine 
vesicular disease
(1) OJ L 62, 15.3.1993, p. 69. (1).
(25) Operation s with animal by-products  which give rise to a 
considerable
 degree
 of risk to pub lic
 and
 animal
 health 
should on ly 
be 
carried out in  
establishments 
or plants 
which 
have been 
approved in  
advance 
for such operation s 
by 
the competen t 
authority. That con dition 
should apply 
in 
particular to processin g 
establishments 
or plants 
and 
other 
establishments 
or plants 
which han dle 
or store an i­
mal
 by-products
 with a direct relevance for the safety of 
the feed chain .
 It
 should b e
 permitted for an imal
 
by-products
 of more than on e
 category
 to be
 handled
 in 
the same estab lishment
 or plan t
 provided cross-
contamination 
is prevented. 
It 
should further b e 
permitted 
to amend
 those con ditions
 if the amoun t
 of material for 
disposal an d
 processin g
 rises due to a major outb reak
 of 
disease, provided it is en sured 
that the temporary use un der 
such 
amended 
conditions 
does not 
lead to the propag ation 
of 
disease risk s.
(26) However, such approvals should n ot be necessary for 
establishments
 or plants
 which process or han dle
 certain 
safe materials, such as products processed to such an  
extent 
that 
they no 
longer 
pose a risk  
to public 
and 
animal 
health. Such estab lishments 
or plants 
should be 
registered 
so as to 
permit official con trol 
over the flow of material an d 
ensure 
their
 traceability.
 That reg istration
 requiremen t
 should 
apply also to operators who tran sport 
animal 
by-products 
or
 derived products, un less
 they are n o
 longer
 subject
 to 
any 
control 
since 
an 
end 
point 
in 
the chain  
has been 
determined.
(27) Establishments or plants should be approved followin g the 
submission 
of information 
to the competen t 
authority an d 
following
 a visit carried out on site which demon strates
 
that the requiremen ts 
of this Reg ulation 
for the infrastruc­
ture 
and 
equipmen t 
of the estab lishment 
or plant 
will be 
met, 
so that an y 
risks 
to public 
and 
animal 
health arisin g 
from 
the process used will b e 
adequately con tained. 
It 
should 
be 
possible 
to grant 
the approvals con ditionally 
in 
order 
to allow operators to rectify deficien cies 
before 
the 
establishment 
or plant 
obtains 
full approval.
(28) Establishments  or plants whose operation s have already 
been 
approved in  
accordance 
with Commun ity 
legislation 
on 
food hygiene 
should not 
be 
required to b e 
approved or 
registered 
under 
this Regulation, 
as approvals or reg istra­
tions
 under
 that Commun ity
 legislation
 already take into 
account 
the objectives 
of this Reg ulation. 
However, estab ­
lishments
 or plants
 which have b een
 approved or reg is
­
tered under
 hygiene
 legislation
 should b e
 obliged
 to 
comply with the requiremen ts 
of this Reg ulation 
and 
sub­
ject 
to official con trols 
carried out for the purposes of veri­
fying 
compliance 
with the requiremen ts 
of this Reg ulation.
(29) Animal by-products and derived products should b e clas­
sified 
into 
three categ ories 
which reflect the deg ree 
of risk 
that 
they pose to pub lic 
and 
animal 
health, on  
the basis 
of 
risk assessmen ts.
 While an imal
 by-products
 and
 derived 
products posin g 
a high 
risk 
should on ly 
be 
used for pur­
poses outside the feed chain , 
their use posin g 
a lower risk  
should 
be 
permitted un der 
safe conditions.
(30) Progress in science and technology may lead to the devel­
opment 
of processes which elimin ate 
or minimise 
the risks 
to
 public
 and
 animal
 health. Amen dments
 to the lists of 
animal
 by-products
 set out in this Reg ulation
 should b e
 
possible, 
in 
order to tak e 
account 
of such prog ress. 
Prior to 
any 
such amen dments, 
and 
in 
accordance 
with the g eneral 
principles
 of Commun ity
 legislation
 aimed at en suring
 a 
high 
level of protection  
of public 
and 
animal 
health, a risk  
assessmen t 
should be 
carried out b y 
the appropriate scien ­
tific 
institution, 
such as E FSA, 
the European 
Medicines 
Agency
 or the Scien tific
 Committee for Con sumer
 Prod­
ucts, depen ding 
on 
the type of an imal 
by-products 
for 
which risk s 
are to be 
assessed. However, it should b e 
clear 
that once
 animal
 by-products
 of differen t
 categories
 are 
mixed, the mixture should b e 
handled 
in 
accordance 
with 
the standards 
laid down  
for the proportion  
of the mixture 
belonging 
to the hig hest 
risk 
category.N E 4 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/5
(31) Due to the hig h risk to public health, an imal by-products 
giving 
rise to a risk  
of transmissible 
spongiform 
encepha­
lopathy
 (TSE)
 should, in particular, n ot
 be
 used for feed. 
This restriction  
should also apply to wild an imals 
through 
which
 a commun icable
 disease may b e
 transmitted.
 The 
restriction  
on 
the feedin g 
of animal 
by-products 
giving 
rise 
to a TSE 
risk 
should be 
without prejudice to the feedin g 
rules 
laid down  
in 
Regulation 
(EC) 
No 999/2001.
(32) Animal by-products from animals used for experimen ts as 
defined 
in 
Directive 86/609/E EC 
should also b e 
excluded 
from use in feed, due to the poten tial
 risks
 arising
 from 
those animal
 by-products.
 However, Memb er
 States may 
allow the use of an imal 
by-products 
from animals 
which 
have been 
used for experimen ts 
to test new 
feed additives, 
in 
accordance 
with Regulation 
(EC) 
No 1831/2003 of the 
European 
Parliamen t 
and 
of the Coun cil 
of 22 Septemb er 
2003
 on 
additives for use in  
animal 
nutrition
(1) OJ L 268, 18.10.2003, p. 29. (1).
(33) The use of certain sub stances and products is un lawful 
under 
Council 
Regulation 
(EEC) 
No 2377/90 of 26 June 
1990
 laying 
down 
a Commun ity 
procedure for the estab ­
lishment 
of maximum residue limits of veterin ary 
medici­
nal 
products in  
food stuffs of an imal 
origin
(2) OJ L 224, 18.8.1990, p. 1. (2) and Council 
Directive 
96/22/EC 
of 29 April 1996 con cerning 
the pro­
hibition 
on 
the use in  
stockfarming 
of certain  
substances 
having 
a hormon al 
or thyrostatic action  
and 
of ß ago­
nists
(3) OJ L 125, 23.5.1996, p. 3. (3). In addition , Council Directive 96/23/E C of
29 
April 1996 on  
measures to mon itor 
certain 
substances 
and 
residues thereof in  
live animals 
and 
animal 
products
(4) OJ L 125, 23.5.1996, p. 10. (4) 
lays down  
further rules on  
the monitoring 
of certain 
sub­
stances
 and
 residues thereof in live an imals
 and
 animal
 
products. Directive 96/23/E C 
also lays down  
rules which 
apply where the presen ce
 of residues of authorised sub­
stances
 or contaminants
 exceeding
 certain permitted lev­
els has been 
established. 
In 
order to en sure 
the coheren ce 
of
 Commun ity
 legislation,
 products of an imal
 origin
 in 
which sub stances 
are detected in  
breach 
of Regulation 
(EEC) 
No 2377/90 an d 
Directives 96/22/E C 
and 
96/23/EC 
should 
be 
classified as Categ ory 
1 or Categ ory 
2 material, 
as appropriate, in view of the risk they pose to the food 
and 
feed chain .
(34) Manure and digestive tract content should not need to be 
disposed
 of, provided that proper treatmen t
 ensures
 that 
diseases are n ot 
transmitted 
during 
their application  
to 
land.
 Animal
 by-products
 from animals
 that die on farm 
and
 animals
 killed
 for the eradication of diseases should 
not 
be 
used in 
the feed chain . 
This restriction  
should also 
apply to imported an imal 
by-products 
which are allowed 
into
 the Commun ity,
 where they do n ot
 comply with Community 
legislation 
upon 
inspection 
at the Commun ity 
border
 post, and
 to products which do n ot
 comply with 
the applicab le
 requiremen ts
 during
 checks
 carried out 
within the Commun ity.
 Non-compliance
 with Directive 
2000/13/E C 
of the European 
Parliamen t 
and 
of the Coun ­
cil 
of 20 March 2000 on  
the approximation  
of the laws of 
the Memb er
 States relatin g
 to the lab ellin
g, present
ation 
and 
advertisin g 
of foodstuffs
(5) OJ L 109, 6.5.2000, p. 29. (5) and with Regulation (EC) 
No 
767/2009 of the E uropean 
Parliamen t 
and 
of the Coun ­
cil 
of 13 July 2009 on  
the placin g 
on 
the market 
and 
use 
of feed
(6) OJ L 229, 1.9.2009, p. 1. (6) should n ot result in the exclusion  from the feed 
chain 
of products presen ted 
for border 
inspection.
(35) Since the date of en try into force of Reg ulation (EC) 
No
  1774/2002, the classification of certain an imal
 
by-products 
by 
default as Categ ory 
2 material limits their 
possible 
uses severely, while n ot 
necessarily 
being 
propor­
tionate 
to the risk s 
involved. 
Accordingly 
those animal 
by-products 
should be 
reclassified as Categ ory 
3 material, 
so as to allow their use for certain feedin g
 purposes. For 
any
 other animal
 by-products
 which are n ot
 listed under
 
one 
of the three categ ories, 
the categorisation 
by 
default as 
Category 
2 material should b e 
maintained 
for precaution ­
ary 
reasons, 
in 
particular to rein force 
the general 
exclusion 
of 
such material from the feed chain  
for farmed an imals, 
other 
than 
fur animals.
(36) Other leg islation which has en tered into force followin g 
the 
adoption 
of Regulation 
(EC) 
No 178/2002 of the E uro­
pean 
Parliamen t 
and 
of the Coun cil 
of 28 January 
2002 
laying
 down the g eneral
 principles
 and
 requiremen ts
 of 
food law, estab lishing 
the European 
Food Safety Authority 
and 
laying 
down 
procedures in  
matters of food safety
(7) OJ L 31, 1.2.2002, p. 1. (7), 
namely 
Regulation 
(EC) 
No 852/2004 of the European Par­
liament 
and 
of the Coun cil 
of 29  April 2004 on  
the 
hygiene
 of foodstuffs
(8) OJ L 139, 30.4.2004, p. 1. (8), Regulation (EC) No 853/2004 
and 
Regulation 
(EC) 
No 183/2005 of the E uropean 
Parlia­
ment 
and 
of the Coun cil 
of 12 January 
2005 layin g 
down 
requiremen ts 
for feed hyg iene
(9) OJ L 35, 8.2.2005, p. 1. (9), and to which Reg ulation 
(EC) 
No 1774/2002 is complemen tary, 
places the primary 
duty of complyin g 
with Commun ity 
legislation, 
aimed at 
protecting 
public 
and 
animal 
health, on  
the food an d 
feed 
business 
operators. I n 
line 
with that leg islation, 
operators 
carrying 
out activities un der 
this Regulation 
should also b e 
primarily
 responsible
 for ensuring
 complian ce
 with this 
Regulation. 
That obligation 
should be 
further clarified an d 
specified 
as regards 
the mean s 
by 
which traceab ility 
is 
ensured, 
such as separate collection  
and 
channelling 
of ani­
mal 
by-products. 
Established 
systems en suring 
traceability 
for
 products exclusively circulatin g
 at national
 level byN E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
 other mean s 
should con tinue 
to operate, if they provide 
equivalent
 information.
 Every
 effort should b e
 made to 
promote the use of electron ic
 and
 other mean s
 of docu­
mentation 
which do n ot 
involve 
paper records, as lon g 
as 
they ensure 
full traceab ility.
(37) A system of own  checks is necessary to ensure that, within  
an 
establishment 
or plant, 
the requiremen ts 
of this Reg u­
lation 
are fulfilled. Durin g 
official con trols 
the competen t 
authorities
 should tak e
 into
 account
 the performan c
e of 
own 
checks. 
In 
certain 
establishments 
or plants 
own 
checks 
should 
be 
carried out throug h 
a system b ased 
on 
the haz­
ard analysis 
and 
critical con trol 
points 
(HACCP) prin ciples. 
The 
HACCP prin ciples 
should be 
based 
on 
the experien ce 
of 
their implemen tation 
under 
Community 
legislation 
on 
food
 and
 feed hygiene.
 In
 this respect, n ation
al guides to 
good 
practice could serve as a useful tool to facilitate the 
practical implemen tation 
of the HACCP prin ciples, 
and 
of 
other aspects of this Reg ulation.
(38) Animal by-products  should on ly be used if the risk s to 
public
 and
 animal
 health are min imised
 in the course of 
their processin g 
and 
the placin g 
on 
the market 
of derived 
products man ufactured 
on 
the basis 
of animal
 by-products. 
If 
this option  
is not 
available, 
the animal 
by-products 
should 
be 
disposed of un der 
safe conditions. 
The option s 
available 
for the use of an imal 
by-products 
of the differen t 
categories
 should b e
 clarified in coheren ce
 with other 
Community 
legislation. 
In 
general, 
the option s 
for a higher 
risk 
category 
should be 
available 
for the lower risk  
catego­
ries 
as well, un less 
special con siderations 
apply in 
view of 
the risk 
attached to certain  
animal 
by-products.
(39) Disposal of an imal by-products  and derived products 
should 
take 
place in 
accordance 
with environmental 
legis­
lation 
regarding 
landfilling 
and 
waste incineration. 
In 
order 
to ensure
 consistency,
 incineration
 should tak e
 place in 
accordance
 with Directive 2000/76/E C
 of the European
 
Parliamen t 
and 
of the Coun cil 
of 4 Decemb er 
2000 on 
the 
incineration 
of waste
(1) OJ L 332, 28.12.2000, p. 91. (1). Co-incineration of waste – either 
as 
a recovery or disposal operation  
– is subject 
to similar 
conditions
 regarding
 approval an d
 operation to those 
regarding
 waste incineration,
 in particular as to air emis­
sion 
limit values, waste water an d 
residue discharg e, 
con­
trol
 and
 monitoring
 and
 measuremen t
 requiremen ts.
 
Consequently,
 direct co-in cineration,
 without prior pro­
cessing, 
of all three categ ories 
of materials should b e 
per­
mitted. In 
addition, 
specific provision s 
should be 
enacted 
for 
the approval of low an d 
high-capacity 
incineration 
plants.
(40) The use of an imal by-products or derived products as a fuel 
in
 the comb ustion
 process should b e
 authorised an d
 should not
 be
 considered
 as a waste disposal operation .
 
However, such use should tak e 
place under 
conditions 
which 
ensure 
the protection  
of public 
and 
animal 
health, 
as well as the appropriate en vironmental 
standards.
(41) This Regulation should provide for the possib ility to lay 
down 
parameters for processin g 
methods reg arding 
time, 
temperature an d 
pressure for an imal 
by-products, 
in 
par­
ticular for the methods curren tly 
referred to as methods 2 
to 7 under 
Regulation 
(EC) 
No 1774/2002.
(42) Shells from shellfish from which the soft tissue or flesh 
have been 
removed, should b e 
excluded from the scope of 
the Regulation.
 Due to the various practices in the Com­
munity 
regarding 
the removal of such soft tissue or flesh 
from shells, it should b e 
possible 
to use shells from which 
the entire 
soft tissue or flesh has n ot 
been 
removed, pro­
vided such use does n ot 
lead to a risk  
arising 
to public 
and 
animal 
health. Nation al 
guides 
to good 
practice could assist 
in 
the dissemin ation 
of knowledge 
regarding 
proper con ­
ditions 
under 
which such use would b e 
possible.
(43) In view of the limited risk  to public or animal health aris­
ing
 from such products, the competen t
 authority should 
be
 able
 to authorise the preparation an d
 application to 
land 
of biodynamic 
preparation s, 
on 
the basis 
of Cat­
egory 
2 and 
Category 
3 materials, as referred to in  
Council 
Regulation 
(EC) 
No 834/2007 of 28 June 
2007 on 
organic 
production  
and 
labelling 
of organic 
products
(2) OJ L 189, 20.7.2007, p. 1. (2).
(44) Novel techn ologies which are b eing developed offer advan ­
tageous 
ways of g enerating 
energy 
on 
the basis 
of animal 
by-products
 or of providin g
 for the safe disposal of such 
products. Safe disposal may tak e
 place throug h
 a combi
­
nation 
of methods for the safe con tainment 
of animal 
by-products 
on 
site with estab lished 
disposal methods, an d 
through
 a combination
 of authorised processin g
 param­
eters with n ew
 standards
 which have b een
 favourab ly
 
assessed. I n 
order to tak e 
account 
of the related progress in  
science
 and
 technology,
 such techn ologies
 should b e
 
authorised as altern ative 
methods for the disposal or use of 
animal 
by-products 
throughout 
the Commun ity. 
If 
a tech­
nological 
process has b een 
developed b y 
an 
individual, 
an 
application  
checked 
by 
the competen t 
authority should b e 
examined 
by 
EFSA 
before 
such authorisation  
is granted, 
in 
order 
to ensure 
that an 
assessmen t 
of the risk  
reduction 
potential 
of the process is carried out an d 
that the rig hts 
of 
individuals, 
including 
the confidentiality 
of business 
infor­
mation,
 is preserved. I n
 order to provide advice to appli­
cants 
a standard 
format for application  
should be 
adopted. 
Since
 that documen t
 is intended
 only
 to be
 indicative
 it 
should be 
adopted in  
accordance 
with the advisory proce­
dure in 
collaboration 
with EFSA.
(45) It is appropriate to clarify the requiremen ts applicable to 
the
 placing
 on the mark et
 of animal
 by-products
 andN E 6 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/7
 derived products in tended 
for feedin g 
purposes an d 
of 
organic
 fertilisers an d
 soil improvers, so as to en sure
 the 
protection of the food an d
 feed chain .
 Only
 Category
 3 
material should b e 
used for feedin g 
farmed an imals 
other 
than 
fur animals. 
Fertilisers produced on  
the basis 
of ani­
mal 
by-products 
may affect the safety of the feed an d 
food 
chain. 
Where they have b een 
manufactured 
from meat-
and-bone 
meal derived from Categ ory 
2 material or from 
processed an imal 
protein, 
a compon ent, 
such as an  
inor­
ganic 
or an 
indigestible 
substance, 
should be 
added in 
order 
to prevent 
their direct use for feedin g
 purposes. Such 
mixing 
should not 
be 
required if the composition  
or pack­
aging
 of products, in particular of products destin ed
 for 
use by 
the final 
consumer, 
prevents 
the misuse of the prod­
uct for feedin g
 purposes. When determin ing
 the compo­
nents,
 different
 circumstan ces
 regarding
 climate an d
 soil 
and 
the objective 
for the use of particular fertilisers should 
be 
taken 
into 
account.
(46) Regulation (EC) No 1523/2007 of the European Parlia­
ment
 and
 of the Coun cil
 of 11 Decemb er
 2007 banning
 
the placin g
 on the mark et
 and
 the import to, or export 
from, the Commun ity 
of cat and 
dog 
fur, and 
products 
containing 
such fur
(1) OJ L 343, 27.12.2007, p. 1. (1) lays down  a general prohibition on 
the 
placing 
on 
the market 
and 
the import an d 
export of cat 
and
 dog fur an d
 products con taining
 such fur. However, 
that prohib ition 
should not 
affect the ob liga
tion 
under this 
Regulation 
to dispose of an imal 
by-products 
from cats an d 
dogs, 
including 
fur.
(47) The promotion  of science and research, an d artistic activi­
ties 
may require the use of an imal 
by-products 
or derived 
products of all categ ories,
 sometimes in quantities b elow
 
the scale of commercial exchan ges. 
In 
order to facilitate the 
import an d 
use of such an imal 
by-products 
or derived 
products, the competen t 
authority should b e 
able 
to fix the 
conditions 
for such operation s 
on 
a case-specific b asis. 
Harmonised 
conditions 
should be 
laid down  
where action  
at 
a Commun ity 
level is necessary.
(48) Regulation (EC) No 1774/2002 con tains detailed provi­
sions
 which allow, b y
 way of derog ation,
 the feedin g
 of 
Category 
2 and 
Category 
3 materials to zoo an imals. 
Simi­
lar provision s 
should be 
laid down  
in 
this Regulation 
and 
the
 feeding
 of certain Categ ory
  1 material should b e
 
allowed an d 
complemen ted 
by 
the possib ility 
to lay down  
detailed 
rules to con trol 
any 
possible 
risks 
arising 
to pub­
lic 
or animal 
health.
(49) Regulation (EC) No 1774/2002 allows for the feedin g of 
Category 
1 material to en dangered 
or protected species of 
necrophagous 
birds 
and 
other species livin g 
in 
their natu­
ral 
habitat, 
for the promotion  
of biodiversity. 
In 
order to 
provide an  
adequate tool for the preservation  
of those spe­
cies, that feedin g 
practice should con tinue 
to be 
permitted under 
this Regulation, 
in 
accordance 
with conditions 
laid 
down 
to prevent 
the spread of diseases. At the same time, 
health con ditions 
should be 
laid down  
in 
the implemen t­
ing 
measures permittin g 
the use of such Categ ory 
1 mate­
rial for feedin g 
purposes in  
extensive 
grazing 
systems an d 
for 
feeding 
to other carn ivore 
species, such as b ears 
and 
wolves. 
It 
is importan t 
that such health con ditions 
take 
into 
account 
the natural 
consumption 
patterns 
of the spe­
cies concerned
 as well as Commun ity
 objectives
 for the 
promotion  
of biodiversity 
as referred to in  
the Commun i­
cation 
from the Commission  
of 22 May 2006 en titled
‘
Halting 
the loss of b iodiversity 
by 
2010 – an d 
beyond
’.
(50) Burial and burning of animal by-products, in particular of 
dead 
animals 
may be 
justified in  
specific situation s, 
in 
par­
ticular in 
remote areas, or in  
disease con trol 
situations 
requiring 
the emerg ency 
disposal of the an imals 
killed 
as a 
measure to con trol 
an 
outbreak 
of a serious tran smissible 
disease.
 In
 particular, disposal on site should b e
 allowed 
under 
special circumstan ces, 
since 
the availab le 
rendering 
or 
incinerator 
capacity within  
a region 
or a Memb er 
State 
could otherwise b e 
a limiting 
factor in 
the control 
of a 
disease.
(51) The curren t derogation concerning burial and burning of 
animal 
by-products 
should be 
extended 
to areas where 
access is n ot
 practically possib le
 or presen ts
 a risk to the 
health and
 safety of the collection personn e
l. Experien ce
 
gained
 with the application of Reg ulation
 (EC)
 
No 1774/2002 an d
 with natural
 disasters such as forest 
fires and 
floods in 
certain 
Member 
States has shown  
that 
under
 such exception al
 circumstan ces,
 disposal b y
 burial
 
or burning 
on 
site can 
be 
justified so as to en sure 
the swift 
disposal of an imals
 and
 to avoid the propag ation
 of dis­
ease risks. 
The overall size of remote areas in  
a Member 
State 
should be 
limited, on  
the basis 
of the experien ce 
gained
 with the application of Reg ulation
 (EC)
 
No 999/2001 so as to en sure 
that the gene
ral obligation 
to 
have in place a proper disposal system which complies 
with the rules laid down  
in 
this Regulation 
is fulfilled.
(52) Certain establishments or plants which han dle only small 
quantities 
of animal 
by-products 
which do n ot 
pose a risk  
to 
public 
and 
animal 
health should b e 
allowed to dispose 
of such by-products 
by 
means 
other than  
disposal in  
accor­
dance
 with this Reg ulation,
 under
 official supervision .
 
However, the criteria for such exception al
 circumstan ces
 
should be 
laid down  
at Commun ity 
level, so as to en sure 
their 
uniform 
application , 
based 
on 
the actual situation  
of 
certain sectors an d
 the availab ility
 of other disposal sys­
tems in 
certain 
Member 
States.
(53) The possib le courses of action which the competen t 
authority
 can take
 when carryin g
 out official controls 
should be
 specified in order to en sure
 legal
 certainty,
 in 
particular reg arding
 the suspen sion
 or perman entN E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
 prohibition 
of operation s 
or the imposition  
of conditions 
to 
ensure 
the proper application  
of this Reg ulation. 
These 
official con trols 
should be 
carried out in  
the framework  
of 
multi-annual
 control
 plans
 under
 Regulation
 (EC
) 
No 882/2004 of the E uropean 
Parliamen t 
and 
of the Coun ­
cil 
of 29 April 2004 on  
official con trols 
performed to 
ensure
 the verification of complian ce
 with feed an d
 food 
law, animal 
health and 
animal 
welfare rules
(1) OJ L 165, 30.4.2004, p. 1. (1).
(54) In order to en sure that Memb er States may con trol the 
quantity 
of material which is in troduced 
for disposal in to 
their
 territory, the competen t
 authority should authorise 
the receipt of such material to its territory.
(55) Pressure sterilisation  and auxiliary tran sport conditions 
may
 be
 imposed so as to en sure
 the control
 of possib le
 
risks.
 In
 order to en sure
 traceability
 and
 cooperation 
between 
the competen t 
authorities of Memb er 
States con ­
trolling 
the dispatch of an imal 
by-products 
or derived 
products, the Traces system in troduced
 by
 Commission 
Decision 
2004/292/E C
(2) OJ L 94, 31.3.2004, p. 63. (2) should b e used to provide in for­
mation 
on 
the dispatch of Categ ory 
1 and 
Category 
2 
materials an d 
meat-and-bone 
meal or an imal 
fat derived 
from Categ ory 
1 and 
Category 
2 materials, an d 
processed 
animal
 protein derived from Categ ory
  3 material. For 
materials typically sen t
 in small quan tities
 for research, 
education al,
 artistic or diag nostic
 use, special con ditions
 
should be
 laid down to facilitate the movemen t
 of such 
materials within the Commun ity.
 Bilateral arran gements
 
facilitating
 the control
 of materials moved b et
ween the 
Member
 States sharin g
 a common b order
 should b e
 per­
mitted un der 
special circumstan ces.
(56) In order to facilitate the tran sport of consignments through 
third 
countries 
neighbouring 
more than  
one 
Member State, 
a special reg ime 
for the dispatch of con si
gnm
ents from the 
territory of on e 
Member 
State to an other 
through 
the ter­
ritory of a third coun try 
should be 
introduced 
in 
order to 
ensure, 
in 
particular, that con signments 
re-entering 
Com­
munity 
territory are sub ject 
to veterin ary 
checks 
in 
accor­
dance 
with Coun cil 
Directive 89/662/E EC 
of 11 Decemb er 
1989 
concerning
 veterinary
 checks
 in intra-Community
 
trade with a view to the completion of the in ternal
 
market
(3) OJ L 395, 30.12.1989, p. 13. (3).
(57) For the sak e of coheren ce of Commun ity legislation, it is 
necessary 
to clarify the relation ship 
between 
the rules laid 
down in this Reg ulation
 and
 Commun ity
 legislation
 on waste. In
 particular, con sistency
 should b e
 ensured with 
the prohib itions 
on 
waste exports laid down  
in 
Regulation 
(EC) 
No 1013/2006 of the E uropean 
Parliamen t 
and 
of the 
Council
 of 14 June
 2006 on shipmen ts
 of waste
(4) OJ L 190, 12.7.2006, p. 1. (4). In 
order 
to preven t 
potentially 
detrimental 
effects for the 
environment, 
the export of an imal 
by-products 
and 
derived 
products destin ed 
for disposal b y 
incineration 
and 
by 
land­
fill 
should be 
prohibited. 
The export of an imal 
by-products 
and 
derived products should also b e 
prevented 
where the 
objective 
is to use them in  
a biogas 
or compostin g 
plant 
to 
third coun tries 
which are n ot 
members 
of the Org anisation 
for
 Economic
 Cooperation an d
 Developmen t
 (OECD),
 in 
order to preven t
 potentially
 adverse en vironmental
 
impacts an d
 risks
 to public
 and
 animal
 health. When 
applying 
the provision s 
to derogate 
from the export b an, 
the 
Commission  
is obliged 
to fully respect in  
its decision s 
the 
Basel Con vention 
on 
the control 
of transboundary 
movemen ts 
of hazardous waste an d 
their disposal, as con ­
cluded, 
on 
behalf 
of the Commun ity, 
by 
Council 
Decision 
93/98/EEC
(5) OJ L 39, 16.2.1993, p. 1. (5), and the amendment to this Con vention laid 
down 
in 
Decision 
III/1 
of the Con ference 
of the Parties, as 
approved, on  
behalf 
of the Commun ity, 
by 
Council 
Deci­
sion 97/640/E C
(6) OJ L 272, 4.10.1997, p. 45. (6), and implemen ted by Regulation (EC) 
No 
1013/2006.
(58) In addition, it should b e ensured that animal by-products 
mixed 
or contaminated 
with hazardous waste, as listed in  
Commission
 Decision 2000/532/E C
 of 3  May 2000  
replacing
 Decision 94/3/E C
 establishing
 a list of wastes 
pursuant 
to Article 1(a) of Coun cil 
Directive 75/442/E EC 
on
 waste an d
 Council
 Decision 94/904/E C
 establishin g
 a 
list of hazardous waste pursuan t 
to Article 1(4) of Coun cil 
Directive
 91/689/E EC
 on hazardous waste
(7) OJ L 226, 6.9.2000, p. 3. (7) are only 
imported, 
exported or dispatched b etween 
Member 
States 
in 
accordance 
with Regulation 
(EC) 
No 1013/2006. I t 
is 
also necessary 
to lay down  
rules concerning 
the dispatch 
of such material within  
a Member 
State.
(59) The Commission should b e able to carry out con trols in 
Member 
States. Commun ity 
controls 
in 
third coun tries 
should 
be 
carried out in  
accordance 
with Regulation 
(EC) 
No 
882/2004.
(60) The import of an imal by-products  and derived products 
into 
the Commun ity 
and 
the transit 
of such material should 
take 
place in 
accordance 
with rules which are at least as 
strict as those applicab le 
within 
the Commun ity. 
Alterna­
tively,
 the rules applicab le
 to animal
 by
-products an d
 
derived products in  
third coun tries 
may be 
recognised 
to 
be 
equivalent 
to the rules laid down  
in 
Community 
legis­
lation. 
Due to the poten tial 
risk 
arising 
from them, a sim­
plified set of import rules should b e 
applicable 
to products 
which are destin ed 
for uses outside the feed chain .N E 8 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/9
(61) Community legislation on the man ufacture of derived 
products 
intended 
for use as cosmetic products, medicin al 
products
 or medical devices comprises a comprehen sive
 
framework  
for the placin g 
on 
the market 
of such products: 
Council 
Directive 76/768/E EC 
of 27  July 1976 on  
the 
approximation of laws of the Memb er
 States relatin g
 to 
cosmetic products
(1) OJ L 262, 27.9.1976, p. 169. (1), Directive 2001/83/E C of the Euro­
pean 
Parliamen t 
and 
of the Coun cil 
of 6 Novemb er 
2001 
on 
the Commun ity 
code relatin g 
to medicinal products for 
human 
use
(2) OJ L 311, 28.11.2001, p. 67. (2), Directive 2001/82/E C of the European Par­
liament
 and
 of the Coun cil
 of 6 Novemb er
 2001 on the 
Community
 code relatin g
 to veterin ary
 medicinal
 prod­
ucts
(3) OJ L 311, 28.11.2001, p. 1. (3), Council Directive 90/385/E EC of 20  June 1990 on 
the 
approximation  
of the laws of the Memb er 
States relat­
ing
 to active implan table
 medical devices
(4) OJ L 189, 20.7.1990, p. 17. (4), Council 
Directive 
93/42/EEC 
of 14 June 
1993 con cerning 
medical 
devices
(5) OJ L 169, 12.7.1993, p. 1. (5) and Directive 98/79/E C of the European Parlia­
ment 
and 
of the Coun cil 
of 27 Octob er 
1998 on 
in 
vitro 
diagnostic
 medical devices
(6) OJ L 331, 7.12.1998, p. 1. (6) (the specific Directives). 
However, the specific Directives on  
cosmetic products an d 
medical 
devices do n ot 
provide for protection  
against 
risks 
to 
animal 
health. In 
such cases, this Reg ulation 
should 
apply to those risk s 
and 
recourse to safeg uard 
measures in  
accordance 
with Regulation 
(EC) 
No 178/2002 should b e 
possible.
(62) Animal by-products or derived products that are supplied 
as 
material or in gredients 
for the man ufacture 
of such 
derived products should also b e 
subject 
to the require­
ments 
of the specific Directives, in  
so far as they lay down  
rules 
controlling 
risks 
to public 
and 
animal 
health. Those 
specific Directives already reg ulate 
starting 
material of an i­
mal 
origin 
which may b e 
used for the man ufacture 
of the 
derived products referred to an d 
impose certain  
conditions 
to 
ensure 
the protection  
of public 
or animal 
health. In 
par­
ticular, Directive 76/768/E EC 
excludes Categ ory 
1 and 
Cat­
egory 
2 materials as part of the composition  
of a cosmetic 
product an d
 obliges
 manufacturers
 to apply good manu­
facturing 
practices. Commission  
Directive 2003/32/E C
(7) OJ L 105, 26.4.2003, p. 18. (7) 
introduces
 detailed specification s
 with respect to medical 
devices man ufactured 
utilising 
tissues of an imal 
origin.
(63) However, where those con ditions have not yet b een laid 
down 
in 
the specific Directives or where they do n ot 
cover 
certain risk s
 to public
 and
 animal
 health, this Reg ulation
 
should apply, an d 
recourse to safeg uard 
measures in  
accor­
dance
 with Reg ulation
 (EC)
 No  178/2002 should b e
 
possible.
(64) Certain derived products do n ot enter the feed chain  or are 
not 
applied to lan d 
which is g razed 
by 
farmed an imals 
or 
from which herb age 
for feed is cut. Such derived products include
 products for techn ical
 uses, such as treated hides 
for leather production ,
 processed wool for the textile 
industry,
 bone
 products for g lue
 and
 processed material 
destined
 for petfood. Operators should b e
 permitted to 
place such products on  
the market 
provided that they are 
either derived from raw material requirin g 
no 
treatment 
or 
the treatmen t 
or the end 
use of the treated material en sures 
adequate 
risk 
control.
(65) Certain failures to comply with the rules laid down  in 
Regulation
 (EC)
 No 1774/2002 have b een
 revealed in a 
number 
of Member 
States. Accordin gly, 
in 
addition 
to the 
strict enforcement 
of those rules, crimin al 
and 
other sanc­
tions
 against
 operators which do n ot
 comply with those 
rules are n eeded.
 Therefore, it is n ecessary
 that Memb er
 
States lay down rules on pen alties
 applicable to in fringe
­
ments 
of this Reg ulation.
(66) Since the objective of this Reg ulation, namely to lay down  
public 
and 
animal 
health rules for an imal 
by-products 
and 
derived 
products in  
order to preven t 
and 
minimise 
risks 
to 
public 
and 
animal 
health arisin g 
from those products an d, 
in 
particular, to protect the safety of the food an d 
feed 
chain,
 cannot
 be
 sufficien tly
 achieved b y
 the Memb er
 
States and 
can 
therefore b e 
better 
achieved at Commun ity 
level, 
the Commun ity 
may adopt measures, in  
accordance 
with 
the principle 
of subsidiarity 
as set out in  
Article 5 of 
the Treaty. I n 
accordance 
with the prin ciple 
of proportion ­
ality, 
as set out in  
that Article, this Reg ulation 
does not 
go 
beyond 
what is necessary 
in 
order to achieve that ob jective.
(67) In order to en hance legal certainty and in the light of the 
Commission ’s
 general
 objective
 to simplify Commun ity
 
legislation,
 a coheren t
 framework of rules should b e
 laid 
down 
in 
this Regulation, 
taking 
into 
account 
the rules laid 
down 
in 
Regulation 
(EC) 
No 1774/2002, as well as the 
experience 
gained 
and 
progress 
made since 
the date of 
entry
 into
 force of that Reg ulation.
 Regulation
 (EC)
 
No 1774/2002 should therefore b e 
repealed an d 
replaced 
by 
this Regulation.
(68) The measures n ecessary for the implemen tation of this 
Regulation 
should be 
adopted in  
accordance 
with Coun cil 
Decision 
1999/468/E C 
of 28 June 
1999 layin g 
down 
the 
procedures for the exercise of implemen ting 
powers con ­
ferred 
on 
the Commission
(8) OJ L 184, 17.7.1999, p. 23. (8).
(69) In order to improve coheren ce and clarity of Commun ity 
legislation,
 the techn ical
 rules con cerning
 specific opera­
tions
 involving
 animal
 by-products,
 which are curren tlyN E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
 laid down in the An nexes
 to Reg ulation
 (EC)
 
No  1774/2002, as well as in implemen ting
 measures 
adopted b y
 the Commission on the b asis
 of that Reg ula
­
tion
(1) Regulation (EC) No 811/2003 on  the intra-species recycling ban for
fish, and
 the burial
 and
 burning
 of certain an im
al by-products
(
OJ L 117, 13.5.2003, p. 14); Decision  
2003/322/E C 
on 
the feedin g
of
 certain n ecrophagous
 birds
 with certain Categ or
y  1 materials
(OJ L 117, 13.5.2003, p. 32); Decision  
2003/324/E C 
on 
a derogation
from
 the intra-species
 recycling
 ban
 for fur an i
mals (OJ  L  117,
13.5.2003, p. 37); Reg ulation 
(EC) 
No 92/2005 on  
means 
of disposal
or uses (OJ L 19, 21.1.2005, p. 27); Reg ulation 
(EC) 
No 181/2006 on
organic 
fertilisers an d 
soil improvers other than  
manure 
(OJ L 29,
2.2.2006, p. 31); Reg ulation 
(EC) 
No 1192/2006 on  
lists of approved
plants 
(OJ L 215, 5.8.2006, p. 10); Reg ulation 
(EC) 
No 2007/2006 on
the importation an d
 transit
 of certain in termediate
 products derived
from Categ ory 
3 material (OJ L 379, 28.12.2006, p. 98). (1), should b e laid down  in separate implemen ting 
acts.
 Consultation
 and
 information
 of consumers
 and
 
socio-profession al 
circles con cerned 
with issues related to 
this Regulation
 should b e
 carried out in accordan ce
 with 
Commission  
Decision 
2004/613/E C 
of 6  August 
2004 
concerning 
the creation  
of an 
advisory g roup 
on 
the food 
chain 
and 
animal 
and 
plant 
health
(2) OJ L 275, 25.8.2004, p. 17. (2).
(70) In particular, the Commission  should be empowered to 
adopt 
rules modifyin g 
the end 
point 
in 
the manufacturing 
chain 
of certain 
derived products an d 
establishing 
such an 
end 
point 
for certain  
other derived products, rules in  
regard 
to 
serious tran smissible 
diseases in  
the presen ce 
of which 
the dispatch of an imal
 by-products
 and
 derived products 
should not 
be 
allowed an d/or 
the conditions 
allowing
 such 
a dispatch, measures chan ging 
the categorisation 
of animal 
by-products
 and
 derived products, measures regardin g
 
restriction s 
on 
the use an d 
disposal of an imal 
by-products 
and
 derived products, measures layin g
 down con ditions
 
for the application  
of certain 
derogations 
regarding the use, 
collection  
and 
disposal of an imal 
by-products 
and 
derived 
products an d 
measures authorisin g 
or rejectin g 
a particu­
lar alternative 
method for the use an d 
disposal of an imal 
by-products 
and 
derived products.
(71) In addition, the Commission  should be empowered to 
adopt 
more specific rules con cerning 
collection  
and 
trans­
port 
of animal 
by-products 
and 
derived products, the in fra­
structure,
 equipmen t
 and
 hygiene
 requiremen ts
 for 
establishments 
or plants 
handling 
animal 
by-products 
and 
derived 
products, the con ditions 
and 
technical 
require­
ments 
for the han dling 
of animal 
by-products 
and 
derived 
products, in cluding
 the eviden ce
 to be
 presented
 for the 
purpose of validation  
of such treatmen t, 
conditions 
for the 
placing 
on 
the market 
of animal 
by-products 
and 
derived 
products, requiremen ts 
related to safe sourcin g, 
safe treat­
ment 
and 
safe end 
uses, conditions 
for the import, tran sit 
and
 export of an imal
 by-products
 and
 derived products, 
detailed arran gements
 for implemen ting
 official con trols
 including
 rules con cerning
 the referen ce
 methods for 
microbiological 
analyses 
as well as con ditions 
for the con ­
trol 
of the dispatch of certain  
animal 
by-products 
and 
derived 
products b etween 
Member 
States. Sin ce 
those mea­
sures are of g eneral 
scope and 
are designed 
to amend 
non-
essential
 elements
 of this Reg ulation,
 inter
 alia, by
 
supplemen ting
 it with n ew
 non-essential
 elements,
 they 
must be 
adopted in  
accordance 
with the reg ulatory 
proce­
dure with scrutin y 
provided for in  
Article 5a of Decision  
1999/468/E C.
(72) On grounds of efficien cy, the normal time-limits for the 
regulatory 
procedure with scrutin y 
should be 
curtailed for 
the adoption  
of measures specifyin g 
the conditions 
for the 
dispatch of an imal
 by-products
 from restricted holdin gs,
 
plants 
or zones. 
On 
grounds 
of urgency, 
it is necessary 
to 
apply the urg ency 
procedure provided for in  
Article 5a(6) 
of Decision  
1999/468/E C 
for the adoption  
of measures 
modifying
 the end
 point
 in the manufacturing chain for 
certain 
products,
HAVE ADOPTED THIS REGULATION:
TITLE 
I
GENERAL PROVISIONS
CHAPTER I
Common provisions
Section  1
Subject
 matter, scope and definitions
Article 1
Subject 
matter
This Regulation 
lays down  
public 
health and 
animal 
health rules 
for animal 
by-products 
and 
derived products, in  
order to preven t 
and 
minimise 
risks 
to public 
and 
animal 
health arisin g 
from those 
products, an d 
in 
particular to protect the safety of the food an d 
feed 
chain.
Article 
2
Scope
1. This Regulation 
shall apply to: 
(a) animal 
by-products 
and 
derived products which are excluded 
from human  
consumption 
under 
Community 
legislation; 
andN E 0 1 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/11
(b) the  followin g  products which pursuan t  to a decision b y  an 
operator, which shall b e 
irreversible, 
are destin ed 
for pur­
poses other than  
human 
consumption:
(i) products 
of animal 
origin 
which may b e 
destined 
for 
human 
consumption 
under 
Community 
legislation;
(ii) raw 
materials for the production  
of products of an imal 
origin.
2. This 
Regulation 
shall not 
apply to the followin g 
animal 
by-products: 
(a) entire 
bodies 
or parts of wild an imals, 
other than  
wild game, 
which 
are not 
suspected of b eing 
infected 
or affected with a 
disease commun icable 
to human s 
or animals, 
except for 
aquatic an imals 
landed 
for commercial purposes;
(b) entire 
bodies 
or parts of wild g ame 
which are n ot 
collected 
after killing, 
in 
accordance 
with good 
hunting 
practice, with­
out prejudice to Reg ulation 
(EC) 
No 853/2004;
(c) animal
 by-products
 from wild g ame
 and
 from wild g ame
 
meat referred to in Article  1(3)(e) of Reg ulation
 (EC)
 
No 853/2004;
(d) oocytes, emb ryos 
and 
semen 
destined 
for breeding 
purposes;
(e) raw milk, 
colostrum an d 
products derived therefrom which 
are obtained, 
kept, 
disposed of or used on  
the farm of orig in;
(f) shells 
from shellfish with the soft tissue an d 
flesh removed;
(g) catering 
waste, except if it:
(i) originates
 from mean s
 of tran sport
 operatin g
 
internationally;
(ii) is 
destined 
for feedin g 
purposes;
(iii) is destined 
for processin g 
by 
pressure sterilisation  
or for 
processing 
by 
methods referred to in  
point 
(b) 
of the first 
subparagraph 
of Article 15(1) or for tran sformation 
into 
biogas 
or for compostin g;
(h) without 
prejudice to Commun ity 
environmental 
legislation, 
material
 from vessels complyin g
 with Reg ulations
 (EC)
 
No 852/2004 an d 
(EC) 
No 853/2004, which has arisen  
in 
the
 course of their fishin g
 operation s
 and is disposed of at 
sea, except material derived from on -board
 evisceration of 
fish showin g 
signs 
of disease, in cluding 
parasites, that are 
communicable 
to human s;
(i) raw 
pet food orig inating 
from retail shops, where the cuttin g 
and 
storage 
are performed solely for the purpose of supply­
ing 
the consumer 
directly on  
the spot;
(j) raw pet food derived from an imals 
which are slaug htered 
on 
the 
farm of orig in 
for private domestic con sumption; 
and(k) excremen t and urine other than  manure and non-mineralised 
guano.
3.
 This Regulation
 shall be
 without prejudice to Commun ity
 
veterinary 
legislation 
having 
as its objective 
the control 
and 
eradi­
cation 
of animal 
diseases.
Article 3
Definitions
For 
the purposes of this Reg ulation, 
the followin g 
definitions 
shall 
apply:
1. ‘animal 
by-products
’ means 
entire 
bodies 
or parts of an imals, 
products
 of animal
 origin
 or other products ob tained
 from 
animals,
 which are n ot
 intended
 for human con sumption,
 
including 
oocytes, emb ryos 
and 
semen;
2. ‘
derived products’ mean s 
products ob tained 
from one 
or 
more treatmen ts,
 transformations
 or steps of processin g
 of 
animal 
by-products;
3. ‘
products of an imal 
origin
’ means 
products of an imal 
origin 
as
 defined
 in point
  8.1 of An nex
  I to Reg ulation
 (EC)
 
No 853/2004;
4. ‘carcase’ mean s 
carcase as defin ed 
in 
point 
1.9 of An nex 
I 
to 
Regulation 
(EC) 
No 853/2004;
5. ‘animal
’ means 
any 
invertebrate 
or vertebrate 
animal;
6. ‘
farmed an imal
’ means:
(a) any 
animal 
that is kept, 
fattened 
or bred 
by 
humans 
and 
used 
for the production  
of food, wool, fur, feathers, hides 
and 
skins 
or any 
other product ob tained 
from animals 
or 
for other farmin g 
purposes;
(b) equidae;
7. ‘
wild animal
’ means 
any 
animal 
not 
kept 
by 
humans;
8. ‘
pet animal
’ means 
any 
animal 
belonging 
to species n ormally 
nourished 
and 
kept 
but 
not 
consumed, 
by 
humans 
for pur­
poses other than  
farming;
9.
 ‘aquatic an imals
’ means
 aquatic an imals
 as defin ed
 in 
Article 3(1)(e) of Directive 2006/88/E C;
10. ‘
competen t 
authority’ mean s 
the central 
authority of a Mem­
ber 
State competen t 
to ensure 
compliance 
with the require­
ments 
of this Reg ulation 
or any 
authority to which that 
competen ce
 has been
 delegated;
 it also in cludes,
 where 
appropriate, the correspon ding 
authority of a third coun try;
11. ‘
operator’ mean s 
the natural 
or legal 
persons 
having 
an 
ani­
mal 
by-product 
or derived product un der 
their actual con trol, 
including 
carriers, traders an d 
users;N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
12. ‘user’ means  the natural  or legal  persons  using  animal  
by-products
 and
 derived products for special feedin g
 pur­
poses, for research or for other specific purposes;
13. ‘establishment
’ or ‘plant
’ means 
any 
place where an y 
opera­
tion 
involving 
the handling 
of animal 
by-products 
or derived 
products is carried out, other than  
a fishing 
vessel;
14. ‘placing 
on 
the market
’ means 
any 
operation  
the purpose of 
which is to sell an imal 
by-products 
or derived products to a 
third party in the Commun ity
 or any
 other form of supply 
against 
payment 
or free of charg e 
to such a third party or 
storage 
with a view to supply to such a third party;
15. ‘transit
’ means 
movemen t 
through 
the Commun ity 
from the 
territory of a third coun try 
to the territory of an other 
third 
country, 
other than  
by 
sea or by 
air;
16. ‘export’ means
 movemen t
 from the Commun ity
 to a third 
country;
17. ‘
transmissible 
spongiform 
encephalopathies 
(TSEs)
’ means 
all 
transmissible
 spongiform
 encephalopathies
 as defin ed
 in 
Article 3(1)(a) of Reg ulation 
(EC) 
No 999/2001;
18. ‘specified risk material’  means
 specified risk material as 
defined 
in 
Article 3(1)(g ) 
of Regulation 
(EC) 
No 999/2001;
19. ‘pressure sterilisation ’ means
 the processin g
 of animal
 
by-products, 
after reduction  
in 
particle size to n ot 
more than  
50 
mm, to a core temperature of more than  
133 °C 
for at 
least 20 min utes 
without in terruption 
at an abs
olute pressure 
of at least 3 b ar;
20.
 ‘manure
’ means
 any
 excremen t
 and/or
 urine
 of farmed an i
­
mals other than  
farmed fish, with or without litter;
21. ‘authorised lan dfill
’ means
 a landfill
 for which a permit has 
been 
issued in 
accordance 
with Directive 1999/31/E C;
22. ‘
organic 
fertiliser’ an d ‘
soil improver’ mean s 
materials of an i­
mal 
origin 
used to main tain 
or improve plan t 
nutrition 
and 
the 
physical an d 
chemical properties an d 
biological 
activities 
of soils, either separately or tog ether;
 they may in clude
 
manure,
 non-mineralised
 guano,
 digestive
 tract con tent,
 
compost an d 
digestion 
residues;
23. ‘remote area’ mean s 
an 
area where the an imal 
population  
is 
so small, an d 
where disposal estab lishments 
or plants 
are so 
far away that the arran gements 
necessary 
for the collection  
and 
transport 
of animal 
by-products 
would be 
unacceptably 
onerous 
compared to local disposal;
24. ‘food’ or ‘foodstuff’ mean s 
food or foodstuff as defin ed 
in 
Article 
2 of Regulation 
(EC) 
No 178/2002;
25. ‘feed’ or ‘feedingstuff
’ means 
feed or feedin gstuff 
as defined 
in 
Article 
3(4) of Reg ulation 
(EC) 
No 178/2002;26. ‘centrifuge or separator sludg e ’ means material collected as a 
by-product
 after purification of raw milk and separation of 
skimmed 
milk 
and 
cream from raw milk ;
27.
 ‘waste’ means
 waste as defin ed
 in point
 1 of Article 3 of 
Directive 2008/98/E C.
Section
  2
Obligations
Article 4
Starting point in the manu facturing 
chain and obligations
1. As soon as operators g enerate
 animal
 by-products
 or 
derived products fallin g 
within 
the scope of this Reg ulation, 
they 
shall iden tify 
them and 
ensure 
that they are dealt with in  
accor­
dance 
with this Reg ulation 
(starting 
point).
2. Operators 
shall ensure 
at all stages 
of collection , 
transport, 
handling, 
treatment, 
transformation, 
processing, 
storage, 
placing 
on
 the mark et,
 distribution,
 use and
 disposal within the b usi
­
nesses
 under
 their con trol
 that animal
 by
-products an d
 derived 
products satisfy the requiremen ts 
of this Reg ulation 
which are rel­
evant 
to their activities.
3. Member
 States shall mon itor
 and
 verify that the relevan t
 
requiremen ts
 of this Reg ulation
 are fulfilled b y
 operators alon g
 
the entire
 chain of an imal
 by-products
 and
 derived products as 
referred to in  
paragraph 
2. For that purpose, they shall main tain 
a 
system of official con trols 
in 
accordance 
with relevan t 
Commu­
nity 
legislation.
4.
 Member
 States shall en sure
 that an adequate system is in 
place on 
their territory en suring 
that animal 
by-products 
are: 
(a) collected, iden tified
 and
 transported
 without un due
 delay; 
and
(b)
 treated, used or disposed of in accordan ce
 with this 
Regulation.
5.
 Member
 States may fulfil their ob ligations
 under
 para­
graph
  4 in cooperation with other Memb er
 States or third 
countries.
Article 
5
End point in the manu facturing 
chain
1. Derived products referred to in Article  33 which have 
reached the stag e 
of manufacturing 
regulated 
by 
the Commun ity 
legislation 
referred to in  
that Article shall b e 
regarded 
as having 
reached 
the end 
point 
in 
the manufacturing 
chain, 
beyond 
which 
they are n o 
longer 
subject 
to the requiremen ts 
of this Reg ulation. N E 2 1 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/13
Those derived products may sub sequently be placed on  the mar­
ket 
without restriction s 
under 
this Regulation 
and 
shall no 
longer 
be 
subject 
to official con trols 
in 
accordance 
with this Reg ulation. 
The 
end 
point 
in 
the manufacturing 
chain 
may be 
modified: 
(a) for products referred to in  
Article 33(a) to (d), in  
case of risk s 
to 
animal 
health;
(b) for 
products referred to in  
Article 33(e) an d 
(f), in 
case of risk s 
to 
public 
or animal 
health.
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation,
 shall be
 adopted in accordan ce
 with the reg ulatory
 
procedure with scrutin y 
referred to in  
Article 52(6).
2. For derived products referred to in  
Articles 35 an d 
36 which 
no 
longer 
pose any 
significant 
risk 
to public 
or animal 
health, an  
end 
point 
in 
the manufacturing 
chain 
may be 
determined, 
beyond 
which 
they are n o 
longer 
subject 
to the requiremen ts 
of this 
Regulation. 
Those 
derived products may sub sequently 
be 
placed on  
the mar­
ket 
without restriction s 
under 
this Regulation 
and 
shall no 
longer 
be 
subject 
to official con trols 
in 
accordance 
with this Reg ulation. 
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(5). 
3. In 
the event 
of risks 
to public 
or animal 
health, Articles 53 
and 
54 of Reg ulation 
(EC) 
No 178/2002 con cerning 
emergency 
measures 
shall apply mutatis mutan dis 
to the derived products 
referred to in  
Articles 33 an d 
36 of this Reg ulation.
Section
  3
Animal health restrictions
Article 6
General animal health restrictions
1. Animal 
by-products 
and 
derived products from susceptib le 
species
 shall not
 be
 dispatched from holdin gs,
 establishments,
 
plants 
or zones 
which are sub ject 
to restriction s: 
(a) pursuant 
to Commun ity 
veterinary 
legislation; 
or
(b) due 
to the presen ce 
of a serious tran smissible 
disease:
(i) listed in 
Annex 
I 
to Directive 92/119/E EC; 
or
(ii) laid down  
in 
accordance 
with the secon d 
subparagraph.
The 
measures referred to in  
point 
(b)(ii) 
of the first sub paragraph, 
designed 
to amend 
non-essential 
elements 
of this Reg ulation 
by 
supplemen ting 
it, shall be 
adopted in  
accordance 
with the reg u­
latory 
procedure with scrutin y 
referred to in  
Article 52(4).2. Paragraph  1 shall not apply where an imal by-products and 
derived 
products are dispatched un der 
conditions 
designed 
to pre­
vent 
the spread of diseases tran smissible 
to human s 
or animals. 
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(5). 
Section  4
Categorisation
Article 7
Categorisation of animal by- products 
and derived produ cts
1.
 Animal
 by-products
 shall be
 categorised
 into
 specific cat­
egories 
which reflect the level of risk  
to public 
and 
animal 
health 
arising
 from those an imal
 by-products,
 in accordance with the 
lists laid down  
in 
Articles 8, 9 an d 
10.
2. Derived products shall b e
 subject
 to the rules for the spe­
cific categ ory 
of animal 
by-products 
from which they have b een 
derived, 
unless 
otherwise specified in  
this Regulation, 
or provided 
for in 
measures for the implemen tation 
of this Reg ulation 
which 
may specify the con ditions 
under 
which derived products are n ot 
subject 
to those rules adopted b y 
the Commission .
3. Articles 
8, 9 and 
10 may b e 
amended 
in 
order to tak e 
into 
account 
scientific 
progress 
as regards 
the assessmen t 
of the level 
of risk, 
provided such prog ress 
can 
be 
identified 
on 
the basis 
of a 
risk assessmen t
 carried out b y
 the appropriate scien tific
 institu
­
tion. 
However, n o 
animal 
by-products 
listed in 
those Articles may 
be
 removed from those lists, on ly
 changes
 of categorisation
 or 
additions 
may be 
made.
4. The measures referred to in  
paragraphs 
2 and 
3, designed 
to 
amend
 non-essential
 elements
 of this Reg ula
tion, inter alia, b y
 
supplemen ting 
it, shall be 
adopted in  
accordance 
with the reg u­
latory 
procedure with scrutin y 
referred to in  
Article 52(4).
Article 8
Category 1 material
Category
  1 material shall comprise the followin g
 animal
 
by-products:
(a) entire 
bodies 
and 
all body 
parts, including 
hides and 
skins, 
of 
the followin g 
animals:
(i)
 animals
 suspected of b eing
 infected
 by
 a TSE in accor­
dance
 with Reg ulation
 (EC)
 No 999/2001 or in which 
the presen ce 
of a TSE 
has been 
officially con firmed;
(ii)
 animals
 killed
 in the con text
 of TSE eradication 
measures;
(iii) animals 
other than  
farmed an d 
wild animals, 
including 
in 
particular pet an imals, 
zoo animals 
and 
circus animals;N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
(iv) animals used for experimen ts as defined by Article 2(d) 
of Directive 86/609/E EC
 without prejudice to 
Article 3(2) of Reg ulation 
(EC) 
No 1831/2003;
(v) wild animals, 
when 
suspected of b eing 
infected 
with dis­
eases commun icable 
to human s 
or animals;
(b) the 
following 
material:
(i) specified risk  
material;
(ii) entire 
bodies 
or parts of dead an imals 
containing 
speci­
fied risk 
material at the time of disposal;
(c) animal
 by-products
 derived from an imals
 which have b een
 
submitted 
to illegal 
treatment 
as defined 
in 
Article 1(2)(d) of 
Directive 96/22/E C 
or Article 2(b ) 
of Directive 96/23/E C;
(d) animal 
by-products 
containing 
residues of other sub stances 
and 
environmental 
contaminants 
listed in 
Group B(3) of 
Annex
 I to Directive 96/23/E C,
 if such residues exceed the 
permitted level laid down  
by 
Community 
legislation 
or, in 
the 
absence 
thereof, b y 
national 
legislation;
(e) animal 
by-products 
collected durin g 
the treatmen t 
of waste 
water required b y 
implemen ting 
rules adopted un der 
point 
(c) 
of the first parag raph 
of Article 27:
(i) from estab lishments 
or plants 
processing 
Category 
1 
material; or
(ii) from other estab lishments 
or plants 
where specified risk  
material 
is being 
removed;
(f) catering
 waste from mean s
 of tran sport
 operatin g
 
internationally;
(g) mixtures 
of Category 
1 material with either Categ ory 
2 mate­
rial or Categ ory 
3 material or b oth.
Article 
9
Category 2 material
Category
  2 material shall comprise the followin g
 animal
 
by-products:
(a) manure, 
non-mineralised 
guano 
and 
digestive 
tract content;
(b) animal 
by-products 
collected durin g 
the treatmen t 
of waste 
water required b y 
implemen ting 
rules adopted un der 
point 
(c) 
of the first parag raph 
of Article 27:
(i) from estab lishments 
or plants 
processing 
Category 
2 
material; or(ii) from slaug hterhouses  other than those covered b y  
Article 8(e);
(c) animal
 by-products
 containing
 residues of authorised sub­
stances 
or contaminants 
exceeding 
the permitted levels as 
referred to in  
Article 15(3) of Directive 96/23/E C;
(d) products 
of animal 
origin 
which have b een 
declared un fit 
for 
human 
consumption 
due to the presen ce 
of foreign 
bodies 
in 
those 
products;
(e) products of an imal 
origin, 
other than  
Category 
1 material, 
that are:
(i) imported or in troduced 
from a third coun try 
and 
fail to 
comply with Commun ity 
veterinary 
legislation 
for their 
import or in troduction
 into
 the Commun ity
 except 
where Commun ity 
legislation 
allows their import or 
introduction
 subject
 to specific restriction s
 or their 
return 
to the third coun try; 
or
(ii) dispatched to an other 
Member 
State and 
fail to comply 
with requiremen ts 
laid down  
or authorised b y 
Commu­
nity 
legislation 
except where they are return ed 
with the 
authorisation of the competen t
 authority of the Mem­
ber 
State of orig in;
(f) animals 
and 
parts of an imals, 
other than  
those referred to in  
Article 
8 or Article 10,
(i) that died other than b y
 being
 slaughtered
 or killed
 for 
human con sumption,
 including
 animals
 killed
 for dis­
ease control 
purposes;
(ii) foetuses;
(iii) oocytes, emb ryos 
and 
semen 
which are n ot 
destined 
for 
breeding 
purposes; an d
(iv) dead-in-shell 
poultry;
(g) mixtures 
of Category 
2 material with Categ ory 
3 material;
(h) animal
 by-products
 other than Categ ory
 1 material or Cat­
egory 
3 material.
Article 10
Category 3 material
Category
  3 material shall comprise the followin g
 animal
 
by-products:
(a)
 carcases an d
 parts of an imals
 slaughtered
 or, in the case of 
game, 
bodies 
or parts of an imals 
killed, 
and 
which are fit for 
human con sumption
 in accordan ce
 with Commun ity
 legi
s­
lation, 
but 
are not 
intended 
for human  
consumption 
for 
commercial reason s;N E 4 1 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/15
(b) carcases and the followin g parts orig inating either from an i­
mals 
that have b een 
slaughtered 
in 
a slaugh
terhouse an d 
were 
considered 
fit for slaug hter 
for human  
consumption 
follow­
ing 
an 
ante-mortem 
inspection 
or bodies 
and 
the followin g 
parts 
of animals 
from game 
killed 
for human  
consumption 
in 
accordance 
with Commun ity 
legislation:
(i)
 carcases or b odies
 and
 parts of an imals
 which are 
rejected as un fit 
for human  
consumption 
in 
accordance 
with 
Community 
legislation, 
but 
which did n ot 
show 
any
 signs
 of disease commun icable
 to human s
 or 
animals;
(ii) heads 
of poultry;
(iii) hides and
 skins,
 including
 trimmin gs
 and
 splitting
 
thereof, horn s 
and 
feet, including 
the phalan ges 
and 
the 
carpus an d 
metacarpus b ones, 
tarsus and 
metatarsus 
bones, 
of:
—animals,
 other than rumin ants
 requiring
 TSE test­
ing, 
and
 
—ruminants
 which have b een
 tested with a negative 
result in 
accordance 
with Article 6(1) of Reg ulation 
(EC) 
No 999/2001;
(iv) pig 
bristles;
(v) feathers;
(c)
 animal
 by-products
 from poultry an d
 lagomorphs
 slaugh
­
tered on 
the farm as referred to in  
Article 1(3)(d) of Reg ula­
tion
 (EC)
 No 853/2004, which did n ot
 show an y
 signs
 of 
disease commun icable 
to human s 
or animals;
(d) blood 
of animals 
which did n ot 
show any 
signs 
of disease 
communicable
 through
 blood
 to human s
 or animals
 
obtained 
from the followin g 
animals 
that have b een 
slaugh­
tered 
in 
a slaughterhouse 
after havin g 
been 
considered 
fit for 
slaughter 
for human  
consumption 
following 
an 
ante-mortem 
inspection 
in 
accordance 
with Commun ity 
legislation:
(i) animals 
other than  
ruminants 
requiring 
TSE 
testing; 
and
(ii) ruminants 
which have b een 
tested with a n egative 
result 
in accordan ce
 with Article  6(1) of Reg ulation
 (EC)
 
No 999/2001;
(e) animal 
by-products 
arising 
from the production  
of products 
intended
 for human con sumption,
 including
 degreased 
bones, 
greaves 
and 
centrifuge 
or separator sludg e 
from milk  
processing;
(f) products 
of animal 
origin, 
or foodstuffs con taining 
products 
of animal 
origin, 
which are n o 
longer 
intended 
for human  
consumption 
for commercial reason s 
or due to prob lems 
of 
manufacturing 
or packaging 
defects or other defects from 
which no 
risk 
to public 
or animal 
health arise;(g)  petfood an d  feedingstuffs  of animal  origin , or feedin gstuffs  
containing
 animal
 by-products
 or derived products, which 
are no 
longer 
intended 
for feeding 
for commercial reason s 
or 
due to prob lems
 of manufacturing
 or packaging
 defects or 
other defects from which n o 
risk 
to public 
or animal 
health 
arises;
(h) blood,
 placenta,
 wool, feathers, hair, horn s,
 hoof cuts an d
 
raw milk 
originating 
from live an imals 
that did not 
show any 
signs
 of disease commun icable
 through
 that product to 
humans 
or animals;
(i) aquatic 
animals, 
and 
parts of such an imals, 
except sea mam­
mals, which did n ot 
show any 
signs 
of disease commun icable 
to 
humans 
or animals;
(j)
 animal
 by-products
 from aquatic an imals
 originating
 from 
establishments 
or plants 
manufacturing 
products for human  
consumption;
(k)
 the followin g
 material orig inating
 from animals
 which did 
not
 show any
 signs
 of disease commun icable
 through
 that 
material to human s 
or animals:
(i) shells 
from shellfish with soft tissue or flesh;
(ii) the followin g 
originating 
from terrestrial an imals:
—hatchery 
by-products,
 
—eggs,
 
—egg 
by-products, 
including 
egg 
shells,
(iii) day-old chick s 
killed 
for commercial reason s;
(l) aquatic 
and 
terrestrial in vertebrates 
other than  
species patho­
genic 
to human s 
or animals;
(m) animals 
and 
parts thereof of the zoolog ical 
orders of Roden ­
tia 
and 
Lagomorpha, 
except Categ ory 
1 material as referred 
to in 
Article 8(a)(iii), (iv) an d 
(v) and 
Category 
2 material as 
referred to in  
Article 9(a) to (g );
(n) hides 
and 
skins, 
hooves, feathers, wool, horn s, 
hair and 
fur 
originating 
from dead an imals 
that did not 
show any 
signs 
of 
disease commun icable 
through 
that product to human s 
or 
animals, 
other than  
those referred to in  
point 
(b) 
of this 
Article;
(o) adipose tissue from an imals 
which did n ot 
show any 
signs 
of 
disease commun icable
 through
 that material to humans or 
animals, 
which were slaug htered 
in 
a slaughterhouse 
and 
which 
were considered 
fit for slaug hter 
for human  
consump­
tion 
following 
an 
ante-mortem 
inspection 
in 
accordance 
with 
Community 
legislation;
(p) catering 
waste other than  
as referred to in  
Article 8(f).N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
CHAPTER II
Disposal and use of animal by-products and derived products
Section  1
Restrictions on u se
Article 
11
Restrictions on u se
1. The 
following 
uses of an imal 
by-products 
and 
derived prod­
ucts shall b e 
prohibited: 
(a) the 
feeding 
of terrestrial an imals 
of a given 
species other than  
fur 
animals 
with processed an imal 
protein 
derived from the 
bodies 
or parts of b odies 
of animals 
of the same species;
(b) the 
feeding 
of farmed an imals 
other than  
fur animals 
with 
catering
 waste or feed material con taining
 or derived from 
catering 
waste;
(c) the feedin g 
of farmed an imals 
with herbage, 
either directly b y 
grazing 
or by 
feeding 
with cut herb age, 
from land 
to which 
organic 
fertilisers or soil improvers, other than  
manure, 
have 
been
 applied un less
 the cuttin g
 or grazing
 takes
 place after 
the expiry of a waitin g 
period which en sures 
adequate con ­
trol 
of risks 
to public 
and 
animal 
health and 
is at least 21 
days; and
(d)
 the feedin g
 of farmed fish with processed an imal
 protein 
derived from the b odies 
or parts of b odies 
of farmed fish of 
the same species.
2. Measures relatin g 
to the followin g 
may be 
laid down : 
(a) the 
checks 
and 
controls 
to be 
carried out to en sure 
the appli­
cation 
of the prohib itions 
referred to in  
paragraph 
1, includ­
ing 
detection 
methods an d 
tests to b e 
used to verify the 
presence 
of materials orig inating 
from certain  
species an d 
thresholds 
for insignificant 
amounts 
of processed an imal 
proteins 
referred to in  
points 
(a) and 
(d) of parag raph 
1 which 
are caused b y
 adventitious
 and
 technically
 unavoidable
 
contamination;
(b) the 
conditions 
for the feedin g 
of fur animals 
with processed 
animal 
protein 
derived from b odies 
or parts of b odies 
of ani­
mals 
of the same species; an d
(c) the 
conditions 
for the feedin g 
of farmed an imals 
with herb ­
age 
from land 
to which org anic 
fertilisers or soil improvers 
have been
 applied, in particular a modification of the wait­
ing 
period as referred to in  
paragraph 
1(c).Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory  procedure with scrutin y  referred to in 
Article 52(4).
Section  2
Disposal
 and u se
Article 
12
Disposal 
and use 
of Category 1 material
Category 
1 material shall b e:
(a) disposed 
of as waste b y 
incineration:
(i) directly 
without prior processin g; 
or
(ii) following
 processin g,
 by
 pressure sterilisation if the 
competen t 
authority so requires, an d 
permanent 
mark­
ing 
of the resultin g 
material;
(b) recovered 
or disposed of b y 
co-incineration, 
if the Categ ory 
1 
material is waste:
(i) directly without prior processin g; 
or
(ii) following
 processin g,
 by
 pressure sterilisation if the 
competen t 
authority so requires, an d 
permanent 
mark­
ing 
of the resultin g 
material;
(c) in 
the case of Categ ory 
1 material other than  
material referred 
to in 
Article 8(a)(i) an d 
(ii), disposed of b y 
processing 
by 
pres­
sure sterilisation , 
permanent 
marking 
of the resultin g 
mate­
rial and 
burial 
in 
an 
authorised lan dfill;
(d) in 
the case of Categ ory 
1 material referred to in  
Article 8(f), 
disposed of b y 
burial 
in 
an 
authorised lan dfill;
(e) used 
as a fuel for comb ustion 
with or without prior process­
ing; 
or
(f) used for the man ufacture 
of derived products referred to in  
Articles
 33, 34 an d
 36 and
 placed on the mark et
 in accor­
dance 
with those Articles.
Article 13
Disposal 
and use 
of Category 2 material
Category 
2 material shall b e:
(a) disposed 
of as waste b y 
incineration:
(i) directly 
without prior processin g; 
or
(ii) following
 processin g,
 by
 pressure sterilisation if the 
competen t 
authority so requires, an d 
permanent 
mark­
ing 
of the resultin g 
material;N E 6 1 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/17
(b) recovered or disposed of b y co-incineration, if the Categ ory  2 
material is waste:
(i) directly without prior processin g; 
or
(ii) following
 processin g,
 by
 pressure sterilisation if the 
competen t 
authority so requires, an d 
permanent 
mark­
ing 
of the resultin g 
material;
(c) disposed of in  
an 
authorised lan dfill, 
following 
processing 
by 
pressure
 sterilisation an d
 permanent
 marking
 of the result­
ing 
material;
(d) used for the man ufacturing
 of organic
 fertilisers or soil 
improvers to b e
 placed on the mark et
 in accordan ce
 with 
Article  32 followin g
 processin g
 by
 pressure sterilisation ,
 
when applicab le,
 and
 permanent
 marking
 of the resultin g
 
material;
(e) composted or tran sformed 
into 
biogas:
(i)
 following
 processin g
 by
 pressure sterilisation an d
 per­
manent 
marking 
of the resultin g 
material; or
(ii) in the case of man ure,
 digestive
 tract and
 its content,
 
milk,
 milk-based
 products, colostrum, eg gs
 and
 egg
 
products which the competen t 
authority does n ot 
con­
sider 
to present 
a risk 
for the spread of an y 
serious tran s­
missible 
disease, followin g 
or without prior processin g;
(f)
 applied to lan d
 without processin g,
 in the case of man ure,
 
digestive 
tract content 
separated from the dig estive 
tract, 
milk, 
milk-based 
products an d 
colostrum which the compe­
tent
 authority does n ot
 consider
 to presen t
 a risk for the 
spread of an y 
serious tran smissible 
disease;
(g) in 
the case of material orig inating 
from aquatic an imals, 
ensiled, 
composted or tran sformed 
into 
biogas;
(h) used 
as a fuel for comb ustion 
with or without prior process­
ing; 
or
(i) used for the man ufacture 
of derived products referred to in  
Articles
 33, 34 an d
 36 and
 placed on the mark et
 in accor­
dance 
with those Articles.
Article 14
Disposal 
and use 
of Category 3 material
Category 
3 material shall b e:
(a) disposed 
of as waste b y 
incineration, 
with or without prior 
processing;
(b) recovered 
or disposed of b y 
co-incineration, 
with or without 
prior processin g, 
if the Categ ory 
3 material is waste;
(c) disposed of in  
an 
authorised lan dfill, 
following 
processing;(d)  processed, except in the case of Categ ory  3 material which 
has changed 
through 
decomposition  
or spoilag e 
so as to 
present 
an 
unacceptable 
risk 
to public 
or animal 
health, 
through 
that product, an d 
used:
(i) for the man ufacturing 
of feed for farmed an imals 
other 
than fur an imals,
 to be
 placed on the mark et
 in accor­
dance
 with Article 31, except in the case of material 
referred to in  
Article 10(n ), 
(o) and 
(p);
(ii) for the man ufacturing 
of feed for fur an imals, 
to be 
placed 
on 
the market 
in 
accordance 
with Article 36;
(iii) for the man ufacturing 
of pet food, to b e 
placed on  
the 
market 
in 
accordance 
with Article 35; or
(iv) for the man ufacturing
 of organic
 fertilisers or soil 
improvers, to b e 
placed on  
the market 
in 
accordance 
with 
Article 32;
(e) used for the production  
of raw petfood, to b e 
placed on  
the 
market 
in 
accordance 
with Article 35;
(f) composted or tran sformed 
into 
biogas;
(g) in 
the case of material orig inating 
from aquatic an imals, 
ensiled, 
composted or tran sformed 
into 
biogas;
(h) in 
the case of shells from shellfish, other than  
those referred 
to in Article 2(2)(f), an d
 egg
 shells, used un der
 conditions
 
determined 
by 
the competen t 
authority which preven t 
risks 
arising 
to public 
and 
animal 
health;
(i) used as a fuel for comb ustion
 with or without prior 
processing;
(j) used 
for the man ufacture 
of derived products referred to in  
Articles
 33, 34 an d
 36 and
 placed on the mark et
 in accor­
dance 
with those Articles;
(k) in 
the case of caterin g 
waste referred to in  
Article 10(p) pro­
cessed by
 pressure sterilisation or b y
 processin g
 methods 
referred to in poin t
  (b)
 of the first sub paragraph
 of 
Article 15(1) or composted or tran sformed 
into 
biogas; 
or
(l) applied to lan d 
without processin g, 
in 
the case of raw milk , 
colostrum 
and 
products derived therefrom, which the com­
petent
 authority does n ot
 consider
 to presen t
 a risk of an y
 
disease commun icable 
through 
those products to human s 
or 
animals.
Article 
15
Implementing measu res
1. Measures 
for the implemen tation 
of this Section  
may be 
laid 
down 
relating 
to the followin g: 
(a) special 
conditions 
for the on -board 
handlin
g and the disposal 
of material derived from on -board 
evisceration  
of fish show­
ing
 signs
 of disease, in cluding
 parasites, that are commun i
­
cable 
to human s;N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
(b) processing methods for an imal by-products other than  pres­
sure sterilisation , 
in 
particular as reg ards 
the parameters to b e 
applied 
for those processin g 
methods, in  
particular the time, 
temperature, pressure an d 
size of particles;
(c) parameters for the tran sformation
 of animal
 by-products,
 
including 
catering 
waste, into 
biogas 
or compost;
(d) conditions 
for the incineration 
and 
co-incineration 
of animal 
by-products 
and 
derived products;
(e) conditions 
for the comb ustion 
of animal 
by-products 
and 
derived 
products;
(f) conditions
 for the g eneration
 and
 handling of an imal
 
by-products 
referred to in  
Article 10(c);
(g) ensilage 
of material orig inating 
from aquatic an imals;
(h) permanent 
marking 
of animal 
by-products;
(i) the 
application  
to land 
of certain 
animal
 by-p
roducts, org anic 
fertilisers 
and 
soil improvers;
(j) the use of certain  
animal 
by-products 
for feedin g 
to farmed 
animals; 
and
(k) the 
level of risk  
to public 
or animal 
health with respect to cer­
tain 
material which is con sidered 
as unacceptable 
as referred 
to in 
Article 14(d).
Those measures desig ned 
to amend 
non-essential 
elements 
of this 
Regulation, 
by 
supplemen ting 
it, shall be 
adopted in  
accordance 
with
 the regulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
2. Pending 
the adoption  
of rules referred to: 
(a) in 
points 
(c), (f) and 
(g) 
of the first sub paragraph 
of para­
graph 
1, Member 
States may adopt or main tain 
national 
rules 
for:(i) the g
eneration
 and
 handling
 of animal
 by-products
 
referred to in  
Article 10(c);
(ii) the transformation 
of animal 
by-products 
referred to in  
Article 
10(p); and
(iii) for 
the ensilage 
of material orig inating 
from aquatic 
animals;
(b) in 
point 
(a) of the first sub paragraph 
of paragraph 
1, animal 
by-products
 referred to therein may b e
 disposed of at sea, 
without prejudice to Commun ity 
environmental 
legislation.Section   3
Derogations
Article 
16
Derogations
By
 way of derog ation
 from Articles  12, 13 an d
  14, animal
 
by-products 
may be:
(a) in 
the case of an imal 
by-products 
referred to in  
point 
(a) of 
the first sub paragraph 
of Article 15(1), han dled 
and 
disposed 
of in 
accordance 
with special con ditions 
laid down  
pursuant 
to 
that point;
(b) used 
for research an d 
other specific purposes in  
accordance 
with 
Article 17;
(c) in the case of an imal
 by-products
 referred to in Article 18, 
used for special feedin g
 purposes in accordan ce
 with that 
Article;
(d) in the case of an imal
 by-products
 referred to in Article 19, 
disposed of in  
accordance 
with that Article;
(e) disposed of or used in  
accordance 
with altern ative 
methods 
which have b een
 authorised in accordan ce
 with Article 20, 
based 
on 
parameters which may in clude 
pressure sterilisation  
or 
other requiremen ts 
of this Reg ulation 
or the implemen t­
ing 
measures thereof;
(f) in the case of Categ ory
 2 and
 Category
 3 materials an d
 if 
authorised b y
 the competen t
 authority, used for the prepa­
ration 
and 
application  
to land 
of bio-dynamic 
preparation s 
as 
referred to in Article  12(1)(c) of Reg ulation
 (EC)
 
No 834/2007;
(g) in 
the case of Categ ory 
3 material an d, 
if authorised b y 
the 
competen t 
authority, used for feedin g 
to pet animals;
(h) in 
the case of an imal 
by-products, 
except for Categ ory 
1 
material, which arise in  
the course of surg ical 
intervention 
on 
live 
animals 
or during 
birth 
of animals 
on 
farm and, 
if autho­
rised by 
the competen t 
authority, disposed of on  
that farm.
Article 17
Research and other specific pu rposes
1. The 
competen t 
authority may, b y 
way of derog ation 
from 
Articles 12, 13 an d 
14, authorise the use of an imal 
by-products 
and
 derived products for exhib itions,
 artistic activities, an d
 for 
diagnostic,
 education al
 or research purposes un d
er condition s
 
which ensure 
the control 
of risks 
to public 
and 
animal 
health. 
Such conditions 
shall include: 
(a)
 the prohib ition
 of any
 subsequent
 use of the an imal
 
by-products 
or derived products for other purposes; an dN E 8 1 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/19
(b) the ob ligation to dispose of the an imal by-products or derived 
products safely, or to re-dispatch them to their place of ori­
gin, 
if appropriate.
2. In 
the case of risk s 
to public 
and 
animal 
health which require 
the adoption  
of measures for the whole territory of the Commu­
nity,
 in particular in the case of n ewly
 emerging
 risks,
 harmon­
ised conditions 
for the import an d 
use of the an imal 
by-products 
and 
derived products referred to in  
paragraph 
1 may be 
laid down . 
Such 
conditions 
may include 
requiremen ts 
regarding 
storage, 
packaging, 
identification, 
transport 
and 
disposal. 
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4). 
Article 18
Special feeding pu rposes
1. The 
competen t 
authority may, b y 
way of derog ation 
from 
Articles 13 an d 
14, authorise, un der 
conditions 
which ensure 
the 
control 
of risks 
to public 
and 
animal 
health, the collection  
and 
use 
of Category 
2 material, provided that it comes from an imals 
which 
were not 
killed 
or did not 
die as a result of the presen ce 
or 
suspected presen ce 
of a disease commun icable 
to human s 
or ani­
mals, 
and 
of Category 
3 material for feedin g 
to: 
(a) zoo animals;
(b) circus 
animals;
(c) reptiles 
and 
birds 
of prey other than  
zoo or circus an imals;
(d) fur 
animals;
(e) wild 
animals;
(f) dogs 
from recog nised 
kennels 
or packs 
of hounds;
(g) dogs 
and 
cats in 
shelters;
(h) maggots 
and 
worms for fishin g 
bait.
2. The 
competen t 
authority may authorise, b y 
way of derog a­
tion 
from Article 12, an d 
in 
accordance 
with the con ditions 
laid 
down 
pursuant 
to paragraph 
3 of this Article: 
(a) the feedin g
 of the Categ ory
  1 material referred to in 
Article 8(b )(ii) 
and 
of material derived from zoo an imals 
for 
feeding 
to zoo an imals; 
and
(b)
 the feedin g
 of the Categ ory
  1 material referred to in 
Article  8(b )(ii)
 to endangered
 or protected species of 
necrophagous 
birds 
and 
other species livin g 
in 
their natural 
habitat, 
for the promotion  
of biodiversity.3. Measures for the implemen tation of this Article may b e laid 
down 
relating 
to the followin g: 
(a) conditions 
under 
which the collection  
and 
use as referred to 
in 
paragraph 
1 may be 
authorised with respect to the move­
ment, 
storage 
and 
use of Categ ory 
2 material an d 
of Cat­
egory 
3 material for feedin g, 
including 
in 
the case of n ewly 
emerging 
risks; 
and
(b) conditions 
under 
which, in 
certain 
cases by 
way of derog a­
tion 
from the ob ligation 
laid down  
in 
Article 21(1), the feed­
ing
 of Category
 1 material as referred to in parag raph
 2 of 
this Article may b e 
authorised, in cluding:
(i)
 the endangered
 or protected species of n ecrophagous
 
birds 
and 
other species in  
certain 
Member 
States to 
which such material may b e 
fed;
(ii) measures to preven t 
risks 
to public 
and 
animal 
health.
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Article 19
Collection, transport and disposal
1. The competen t 
authority may, b y 
way of derog ation 
from 
Articles 12, 13, 14 an d 
21, authorise the disposal: 
(a) by 
burial 
of dead pet an imals 
and 
equidae;
(b) by 
burning 
or burial 
on 
site or by 
other mean s 
under 
official 
supervision  
which preven t 
the transmission 
of risks 
to pub­
lic 
and 
animal 
health of Categ ory 
1 material referred to in  
Article 
8(a)(v) and 
(b)(ii), 
Category 
2 and 
Category 
3 materi­
als in 
remote areas;
(c) by 
burning 
or burial 
on 
site or by 
other mean s 
under 
official 
supervision  
which preven t 
the transmission 
of risks 
to pub­
lic 
and 
animal 
health of Categ ory 
1 material referred to in  
Article 
8(b)(ii), 
Category 
2 and 
Category 
3 materials in  
areas 
where access is practically impossib le 
or where access would 
only 
be 
possible 
under 
circumstan ces, 
related to g eographi­
cal
 or climatic reason s
 or due to a n atural
 disaster, which 
would pose a risk  
to the health an d 
safety of the person nel 
carrying 
out the collection  
or where access would n ecessitate 
the 
use of disproportion ate 
means 
of collection ;
(d) by 
means 
other than  
burning 
or burial 
on 
site, under 
official 
supervision , 
in 
the case of Categ ory 
2 and 
Category 
3 mate­
rials which do n ot
 pose a risk to pub lic
 and
 animal
 health, 
when the amoun ts
 of materials do n ot
 exceed a particular 
volume per week , 
this volume b eing 
determined 
in 
relation 
to 
the nature 
of the activities carried out an d 
the species of 
origin 
of the animal 
by-products 
concerned;N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
(e) by burning or burial on site, under conditions which preven t 
the 
transmission 
of risks 
to public 
and 
animal 
health, of an i­
mal 
by-products 
other than  
Category 
1 material referred to 
in Article 8(a)(i) in the even t
 of an outb reak
 of a notifiable
 
disease, if tran sport 
to the nearest 
plant 
approved for pro­
cessing 
or disposal of the an imal 
by-products 
would increase 
the
 danger
 of propag ation
 of health risks or, in case of a 
widespread outb reak 
of an 
epizootic disease, would mean  
that 
the disposal capacities of such plan ts 
were exceeded; an d
(f) by 
burning 
or burial 
on 
site, under 
conditions 
which preven t 
the 
transmission 
of risks 
to public 
and 
animal 
health, of b ees 
and 
apiculture b y-products.
2. The 
animal 
population  
of a particular species in  
the remote 
areas referred to in  
paragraph 
1(b) 
shall not 
exceed a maximum 
percentage 
of the animal 
population  
of this species in  
the Mem­
ber 
State concerned.
3. Member 
States shall mak e 
available 
to the Commission  
information 
on: 
(a) the 
areas that they categ orise 
as remote areas for the purpose 
of applyin g 
paragraph 
1(b) 
and 
the reason s 
for that categ ori­
sation,
 and
 updated in formation
 concerning
 any
 change
 to 
such categ orisation; 
and
(b) the 
use they mak e 
of the authorisation s 
provided for in  
points 
(c) and 
(d) of parag raph 
1 with respect to Categ ory 
1 
and 
Category 
2 materials.
4. Measures for the implemen tation 
of this Article shall b e 
laid 
down 
relating 
to the followin g: 
(a) conditions 
aimed at en suring 
control 
of risks 
to public 
and 
animal 
health in 
the event 
of burning 
and 
burial 
on 
site;
(b)
 the maximum percen tage
 of the an imal
 population as 
referred to in  
paragraph 
2;
(c) the volume of an imal 
by-products, 
in 
relation 
to the nature 
of 
activities an d 
the species of orig in, 
as referred to in  
para­
graph 
1(d); and
(d) the 
list of diseases referred to in  
paragraph 
1(e).
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Section  4
Alternative methods
Article 20
Authorisation 
of alternative methods
1. The procedure for authorisation  
of an 
alternative 
method of 
use or disposal of an imal 
by-products 
or derived products may b e 
initiated 
either by 
the Commission  
or, followin g 
an 
application , 
by
 a Member
 State or b y
 an interested
 party, which may repre­
sent 
several interested 
parties.2. Interested parties shall sen d their application s to the com­
petent 
authority of the Memb er 
State where they in tend 
to use the 
alternative 
method. 
The competen t
 authority shall evaluate, within a period of two 
months 
following 
receipt of a complete application , 
whether the 
application complies with the stan dard
 format for application s
 
referred to in  
paragraph 
10. 
3. The competen t
 authority shall commun icate
 the applica­
tions 
of the Memb er 
States and 
interested 
parties, tog ether 
with a 
report on its evaluation to the E uropean
 Food Safety Authority 
(EFSA) 
and 
inform 
the Commission  
thereof.
4. When 
the Commission  
initiates 
the procedure for authori­
sation, 
it shall sen d 
a report on  
its evaluation  
to EFSA.
5. EFSA 
shall assess, within  
six months 
following 
receipt of a 
complete application , 
whether the method sub mi
tted ensures that 
risks 
to public 
or animal 
health are: 
(a) controlled
 in a man ner
 which preven ts
 their proliferation 
before
 disposal in accordan ce
 with this Reg u
lation or the 
implemen ting 
measures thereof; or
(b) reduced 
to a degree 
which is at least equivalen t, 
for the rel­
evant
 category
 of animal
 by-products,
 to the processing 
methods laid down  
pursuant 
to point 
(b) 
of the first sub para­
graph 
of Article 15(1).
EFSA 
shall issue an  
opinion 
on 
the application  
submitted.
6. In 
duly justified cases where E FSA 
requests addition al 
infor­
mation
 from applican ts,
 the period provided for in para­
graph 
5 may be 
extended. 
After
 consulting
 the Commission or the applican t,
 EFSA
 shall 
decide on a period within which that in formation
 shall be
 pro­
vided to it an d 
inform 
the Commission  
and 
the applican t 
as 
appropriate of the addition al 
period needed. 
7. Where 
applicants 
wish to sub mit 
additional 
information 
on 
their 
own 
initiative, 
they shall sen d 
it directly to E FSA. 
In 
that case the period provided for in  
paragraph 
5 shall not 
be 
extended 
by 
an 
additional 
period. 
8. EFSA 
shall forward its opin ion 
to the Commission , 
the 
applicant
 and
 the competen t
 authority of the Memb er
 State 
concerned.
9.
 Within three mon ths
 following
 receipt of the opin ion
 of 
EFSA 
and 
taking 
account 
of that opin ion, 
the Commission  
shall 
inform 
the applican t 
of the proposed measure to b e 
adopted in  
accordance 
with parag raph 
11.
10. A standard
 format for application s
 for altern ative
 meth­
ods shall b e 
adopted in  
accordance 
with the advisory procedure 
referred to in  
Article 52(2).N E 0 2 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/21
11. Following  receipt of the opin ion  of EFSA,  the following 
shall be 
adopted: 
(a) either a measure authorisin g 
an 
alternative 
method of use or 
disposal of an imal 
by-products 
or derived products; or
(b) a 
measure rejectin g 
the authorisation  
of such an  
alternative 
method.
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
TITLE II
OBLIGATIONS 
OF 
OPERATORS
CHAPTER I
General obligations
Section  1
Collection, transport and traceability
Article 21
Collection and identification as regards category and 
transport
1. Operators shall collect, iden tify
 and
 transport
 animal
 
by-products 
without un due 
delay under 
conditions 
which preven t 
risks 
arising 
to public 
and 
animal 
health.
2. Operators shall en sure 
that animal 
by-products 
and 
derived 
products are accompan ied 
during 
transport 
by 
a commercial 
document 
or, when 
required b y 
this Regulation 
or by 
a measure 
adopted in  
accordance 
with parag raph 
6, by 
a health certificate. 
By way of derog ation 
from the first sub paragraph, 
the competen t 
authority
 may authorise the tran sport
 of manure b etween
 two 
points 
located on  
the same farm or b etween 
farms and 
users of 
manure
 within the same Memb er
 State without a commercial 
document 
or health certificate. 
3. Commercial documen ts 
and 
health certificates accompan y­
ing 
animal 
by-products 
or derived products durin g 
transport 
shall 
at least include 
information 
on 
the origin, 
the destin ation 
and 
the 
quantity
 of such products, an d
 a description of the an imal
 
by-products
 or derived products an d
 their markin g,
 when such 
marking 
is required b y 
this Regulation. 
However, 
for animal 
by-products 
and 
derived products tran s­
ported
 within the territory of a Memb er
 State, the competen t
 
authority of the Memb er 
State concerned 
may authorise tran smis­
sion
 of the in formation
 referred to in the first sub paragraph
 by
 
way of an  
alternative 
system. 4. Operators shall collect, tran sport 
and 
dispose of Categ ory 
3 
catering 
waste, in 
accordance 
with national 
measures foreseen  
in 
Article 
13 of Directive 2008/98/E C.
5. The 
following 
shall be 
adopted in  
accordance 
with the reg u­
latory 
procedure referred to in  
Article 52(3): 
(a) models for commercial documen ts 
which are required to 
accompan y 
animal 
by-products 
during 
transport; 
and
(b)
 models for health certificates an d
 the condition s
 go
verni
ng 
the way they must accompan y
 animal
 by-products
 and
 
derived products durin g 
transport.
6. Measures 
for the implemen tation 
of this Article may b e 
laid 
down 
relating 
to the followin g: 
(a) cases 
where a health certificate is required, havin g 
regard 
to 
the level of risk  
to public 
and 
animal 
health arisin g 
from cer­
tain 
derived products;
(b)
 cases where, b y
 way of derog ation
 from the first sub para
­
graph 
of paragraph 
2 and 
having 
regard 
to the low level of 
risk 
to public 
and 
animal 
health arisin g 
from certain  
animal 
by-products 
or derived products, tran sport 
of derived prod­
ucts may tak e
 place without the documen ts
 or certificates 
referred to in  
that parag raph;
(c)
 requiremen ts
 for the iden tification,
 including
 labelling,
 and
 
for the separation of differen t
 categories
 of animal
 
by-products 
during 
transport; 
and
(d) conditions 
to prevent 
risks 
to public 
and 
animal 
health aris­
ing
 during
 the collection an d
 transport
 of animal
 
by-products,
 including
 conditions
 for the safe tran sport
 of 
those products with respect to con tainers, 
vehicles an d 
pack­
aging 
material.
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Article 22
Traceability
1. Operators con signing,
 transporting
 or receivin g
 animal
 
by-products 
or derived products shall k eep 
a record of con sign­
ments 
and 
related commercial documen ts 
or health certificates. 
However, the first sub paragraph 
shall not 
apply when  
an 
autho­
risation 
to transport 
animal 
by-products 
or derived products 
without commercial documen ts 
or health certificates has b een 
granted
 in accordan ce
 with the secon d
 subparagraph
 of 
Article  21(2) or in accordan ce
 with implemen ting
 measures 
adopted un der 
Article 21(6)(b ). N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
2. The operators referred to in  paragraph  1 shall have in  place 
systems an d 
procedures to iden tify: 
(a)
 the other operators to which their an imal
 by-products
 or 
derived products have b een 
supplied; an d
(b) the 
operators from whom they have b een 
supplied.
This information
 shall be
 made availab le
 to the competen t
 
authorities on  
request.
3. Measures for the implemen tation 
of this Article may b e 
adopted 
in 
accordance 
with the reg ulatory 
procedure referred to 
in 
Article 52(3), in  
particular on : 
(a)
 the information
 to be
 made availab le
 to the competen t
 
authorities;
(b)
 the period of time durin g
 which this information must b e
 
kept.
Section
  2
Registration and approval
Article 23
Registration of operators, establishments or plants
1. With a view to reg istration, 
operators shall: 
(a) before
 commen cing
 operation s,
 notify
 the competen t
 
authority of an y 
establishments 
or plants 
under 
their control 
which
 are active at an y
 stage
 of the generation,
 transport,
 
handling, 
processing, 
storage, 
placing 
on 
the market, 
distri­
bution,
 use or disposal of an imal
 by-products
 and
 derived 
products;
(b) provide 
the competen t 
authority with in formation 
on:
(i) the 
category 
of animal 
by-products 
or derived products 
under 
their control;
(ii)
 the nature
 of the operation s
 performed using an imal
 
by-products 
or derived products as startin g 
material.
2. Operators shall provide the competen t 
authority with up-to-
date information 
on 
any 
establishments 
or plants 
under 
their con­
trol 
as referred to in  
point 
(a) of parag raph 
1, including 
any 
significant 
change 
in 
activities such as an y 
closure of an  
existing 
establishment 
or plant.
3. Detailed 
rules regarding 
registration 
as referred to in  
para­
graph 
1 may be 
adopted in  
accordance 
with the reg ulatory 
pro­
cedure referred to in  
Article 52(3).
4. By way of derog ation
 from parag raph
 1, no
 notification 
with a view to reg istration
 shall be
 required for activities with 
respect to which estab lishments
 generating
 animal
 by-products
 
have already b een 
approved or reg istered 
in 
accordance 
with 
Regulation 
(EC) 
No 852/2004 or Reg ulation 
(EC) 
No 853/2004; 
and 
for activities with respect to which estab lishments 
or plants 
have 
already been 
approved in  
accordance 
with Article 24 of this 
Regulation. The  same derog ation  shall apply for the activities in volving  the 
generation 
of animal 
by-products 
on 
site only, 
which are carried 
out on 
farms or other premises where an imals 
are kept, 
bred 
or 
taken 
care of. 
Article 24
Approval of establishments or plants
1. Operators shall en sure 
that estab lishments 
or plants 
under 
their
 control
 are approved b y
 the competen t
 authority, where 
such estab lishments
 or plants
 carry out on e
 or more of the fol­
lowing 
activities: 
(a) processing 
of animal 
by-products 
by 
pressure sterilisation , 
by 
processing 
methods referred to in  
point 
(b) 
of the first sub ­
paragraph 
of Article 15(1) or b y 
alternative 
methods autho­
rised in 
accordance 
with Article 20;
(b) disposal, 
as waste, b y 
incineration 
of animal 
by-products 
and 
derived 
products, excludin g 
establishments 
or plants 
which 
have a permit to operate in accordan ce
 with Directive 
2000/76/E C;
(c) disposal 
or recovery of an imal 
by-products and derived prod­
ucts, if they are waste, b y
 co-incineration,
 excluding
 estab­
lishments
 or plants
 which have a permit to operate in 
accordance 
with Directive 2000/76/E C;
(d)
 use of animal
 by-products
 and
 derived products as fuel for 
combustion;
(e) manufacturing 
of pet food;
(f) manufacturing 
of organic 
fertilisers an d 
soil improvers;
(g) transformation 
of animal 
by-products 
and/or 
derived prod­
ucts into 
biogas 
or compost;
(h) handling 
of animal 
by-products 
after their collection , 
by 
way 
of operation s 
such as sortin g, 
cutting, 
chilling, 
freezing, 
salt­
ing, 
removal of hides an d 
skins 
or of specified risk  
material;
(i) storage 
of animal 
by-products;
(j) storage 
of derived products in tended 
to be:
(i) disposed 
of by 
landfill 
or incineration 
or intended 
to be 
recovered 
or disposed of b y 
co-incineration;
(ii) used 
as fuel for comb ustion;
(iii)
 used as feed, excludin g
 establishments
 or plan ts
 
approved or reg istered
 in accordan ce
 with Reg ulati
on 
(EC) 
No 183/2005;
(iv) used as org anic 
fertilisers an d 
soil improvers, excludin g 
storage 
at a place of direct application .N E 2 2 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/23
2. The approval referred to in  paragraph  1 shall specify if the 
establishment
 or plant
 is approved for operations with an imal
 
by-products 
and/or 
derived products of: 
(a) a particular categ ory 
referred to in  
Articles 8, 9 or 10; or
(b) more 
than 
one 
category 
referred to in  
Articles 8, 9 or 10, 
indicating 
if such operation s 
are carried out:
(i) permanently 
under 
conditions 
of strict separation  
which 
prevent 
any 
risk 
to public 
and 
animal 
health; or
(ii) temporarily un der 
conditions 
which preven t 
contamina­
tion, 
in 
response 
to a shortag e 
of capacity for such prod­
ucts arisin g 
due to:
—a widespread outb reak 
of an 
epizootic disease, or 
—other extraordin ary 
and 
unforeseen 
circumstan ces.
Article 
25
General hygiene requ irements
1. Operators 
shall ensure 
that estab lishments 
or plants 
under 
their
 control
 carrying
 out the activities referred to in 
Article 24(1)(a) an d 
(h): 
(a) are constructed
 in a way permittin g
 their effective clean ing
 
and 
disinfection 
and 
where appropriate the con struction 
of 
floors facilitates the drain ing 
of liquids;
(b) have 
access to adequate facilities for person al 
hygiene 
such as 
lavatories, chan ging 
rooms an d 
washbasins 
for staff;
(c) have appropriate arran gements 
for protection  
against 
pests, 
such as in sects, 
rodents 
and 
birds;
(d) keep 
installations 
and 
equipmen t 
in 
good 
condition 
and 
ensure 
that measurin g 
equipmen t 
is calibrated 
regularly; 
and
(e) have 
appropriate arran gements 
for the clean ing 
and 
the dis­
infection 
of containers 
and 
vehicles in  
place to avoid risk s 
of 
contamination.
2. Any 
person 
working 
in 
the establishment 
or plant 
referred 
to in 
paragraph 
1 shall wear suitab le, 
clean 
and, 
where necessary, 
protective 
clothing. 
Where 
appropriate in  
a particular estab lishment 
or plant: 
(a) persons 
working 
in 
the unclean 
sector shall n ot 
enter 
the 
clean sector without first chan ging
 their work clothes an d
 
shoes or without havin g 
disinfected 
them;(b) equipmen t and machinery shall not be moved from the 
unclean
 to the clean sector without first b eing
 cleaned
 and
 
disinfected; 
and
(c) the 
operator shall estab lish 
a procedure relatin g 
to the move­
ments 
of person s 
in 
order to mon itor 
their movemen ts 
and 
describe 
the correct use of footb aths 
and 
wheel baths.
3.
 In
 establishments
 or plants
 carrying
 out the activities 
referred to in  
Article 24(1)(a): 
(a) animal
 by-products
 shall be
 handled
 in such a way as to 
avoid risk s 
of contamination;
(b)
 animal
 by-products
 shall be
 processed as soon as possib le.
 
After processin g,
 derived products shall b e
 handled
 and
 
stored in 
such a way as to avoid risk s 
of contamination;
(c) where 
appropriate, durin g 
any 
processing 
applied to an imal 
by-products
 and
 derived products every part of the an imal
 
by-product 
and 
derived products shall b e 
treated to a g iven 
temperature
 for a g iven
 period of time an d
 risks
 of 
re-contamination 
shall be 
prevented;
(d) the 
operators shall check  
regularly 
the applicab le 
parameters, 
particularly temperature, pressure, time, size of particles, 
where appropriate b y 
automatic devices;
(e) cleaning 
procedures shall b e 
established 
and 
documented 
for 
all parts of the estab lishments 
or plants.
Article 
26
Handling of animal by- products 
within food bu sinesses
1. The 
treatment, 
processing 
or storage 
of animal 
by-products 
in 
establishments 
or plants 
approved or reg istered 
in 
accordance 
with 
Article 4 of Reg ulation 
(EC) 
No 853/2004 or in  
accordance 
with
 Article 6 of Reg ulation
 (EC)
 No 852/2004 shall b e
 carried 
out under
 conditions
 which preven t
 cross-con tamination
 and
 if 
appropriate in  
a dedicated part of the estab lishment 
or plant.
2.
 Raw materials for the production of g elatine
 and
 collagen
 
not 
intended 
for human  
consumption 
may be 
stored, treated or 
processed in  
the establishments 
specifically authorised in  
accor­
dance 
with Regulation 
(EC) 
No 853/2004, An nex 
III, Section  
XIV, 
Chapter 
I, 
point 
5, and 
Section 
XV, Chapter I , 
point 
5, provided 
the transmission 
of disease risk  
is prevented 
by 
segregation 
of 
such raw materials from the raw materials for the production  
of 
products of an imal 
origin.
3. Paragraphs 
1 and 
2 shall apply without prejudice to more 
specific requiremen ts
 laid down in Commun ity
 veterinary
 
legislation.
Article 
27
Implementing measu res
Measures 
for the implemen tation 
of this Section  
and 
Section 
1 of 
this Chapter shall b e 
laid down  
relating 
to the followin g:
(a) infrastructure 
and 
equipmen t 
requiremen ts 
applicable 
within 
establishments 
or plants;N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
(b) hygiene  requiremen ts  applicable  to all types of han dling  of 
animal 
by-products 
and 
derived products, in cluding 
mea­
sures modifyin g 
hygiene 
requiremen ts 
for establishments 
or 
plants 
referred to in  
Article 25(1);
(c) conditions 
and 
technical 
requiremen ts 
for the handling, treat­
ment,
 transformation,
 processin g
 and
 storage
 of animal
 
by-products
 or derived products an d
 conditions
 for treat­
ment 
of waste water;
(d) evidence 
to be 
presented 
by 
the operator for the purpose of 
validation  
of the treatmen t, 
transformation 
and 
processing 
of 
animal
 by-products
 or derived products, on their ab ility
 to 
prevent 
public 
and 
animal 
health risk s;
(e) conditions 
for the han dling 
of animal 
by-products 
or derived 
products of more than  
one 
category 
referred to in  
Articles 8, 
9 or 10 in  
the same estab lishment 
or plant:
(i) where 
such operation s 
are carried out separately;
(ii) where such operation s
 are carried out temporarily in 
certain 
circumstan ces;
(f) conditions 
for the preven tion 
of cross-con tamination 
when 
animal 
by-products 
are stored, treated or processed in  
a dedi­
cated part of an estab lishment
 or plant
 referred to in 
Article 26;
(g) standard 
transformation 
parameters for b iogas 
and 
compost­
ing 
plants;
(h)
 requiremen ts
 applicab le
 to the in cineration
 or 
co-incineration 
in 
plants 
of high 
and 
low capacity as referred 
to in 
Article 24(1)(b ) 
and 
(c); and
(i)
 requiremen ts
 applicab le
 to the comb ustion
 of animal
 
by-products
 and
 derived products as referred to in 
Article 24(1)(d).
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Section  3
Own checks and hazard analysis and 
critical control points
Article 28
Own checks
Operators shall put in  
place, implemen t 
and maintain  
own 
checks 
in 
their estab lishments 
or plants 
in 
order to mon itor 
compliance 
with 
this Regulation. 
They shall en sure 
that no 
animal 
by-products 
or 
derived products suspected or discovered n ot 
to comply with 
this Regulation 
leave the estab lishment 
or plant, 
unless 
destined 
for 
disposal.Article 29
Hazard analysis and critical control points
1. Operators carryin g 
out one 
of the followin g 
activities shall 
put in 
place, implemen t 
and 
maintain 
a permanent 
written 
pro­
cedure or procedures b ased
 on the hazard an alysis
 and
 critical 
control 
points 
(HACCP) prin ciples 
for the: 
(a) processing 
of animal 
by-products;
(b)
 transformation
 of animal
 by-products
 into
 biogas
 and
 
compost;
(c) handling
 and
 storage
 of more than on e
 category
 of animal
 
by-products 
or derived products in  
the same establishmen t 
or 
plant;
(d) manufacturing 
of pet food.
2. Operators as specified in  
paragraph 
1 shall in 
particular: 
(a) identify
 any
 hazards that must b e
 prevented,
 eliminated
 or 
reduced to acceptab le 
levels;
(b) identify 
the critical con trol 
points 
at the step or steps at which 
control 
is essential 
to prevent 
or eliminate 
a hazard or reduce 
it to acceptab le 
levels;
(c) establish 
critical limits at critical con trol 
points 
which sepa­
rate acceptab ility
 from unacceptability,
 for the preven tion,
 
elimination 
or reduction  
of identified 
hazards;
(d) establish 
and 
implemen t 
effective mon itoring 
procedures at 
critical con trol 
points;
(e) establish 
corrective action  
when 
monitoring 
indicates 
that a 
critical con trol 
point 
is not 
under 
control;
(f) establish 
procedures to verify that the measures outlin ed 
in 
points 
(a) to (e) are complete an d 
working 
effectively. Verifi­
cation 
procedures shall b e 
carried out reg ularly;
(g) establish 
documents 
and 
records commen surate 
with the 
nature 
and 
size of the b usinesses 
to demon strate 
the effective 
application  
of the measures set out in  
points 
(a) to (f).
3. When any
 modification is made to a product, process or 
any
 stage
 of production ,
 processin g,
 storage
 or distrib ution,
 
operators shall review their procedures an d
 make
 the necessary
 
changes.
4. Measures 
to facilitate the implemen tation 
of this Article 
may be 
adopted in  
accordance 
with the reg ulatory 
procedure 
referred to in  
Article 52(3).N E 4 2 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/25
Article 30
National gu ides 
to good practice
1. Where necessary, 
competen t 
authorities shall en cour
age 
the 
developmen t, 
dissemination 
and 
voluntary 
use of national 
guides 
to 
good 
practice in  
particular for the application  
of HACCP prin ­
ciples 
as referred to in  
Article 29. Operators may use such g uides 
on 
a voluntary 
basis.
2. The 
competen t 
authority shall assess n ational 
guides 
to 
ensure 
that: 
(a) they have b een
 developed in con sultation
 with representa­
tives of parties whose in terests 
may be 
substantially 
affected, 
and 
have been 
disseminated 
by 
sectors of operators; an d
(b)
 their contents
 are practicab le
 for the sectors to which they 
refer.
CHAPTER II
Placing on the market
Section  1
Animal by- products
 and derived produ cts
 
for feeding to farmed animals exclu ding
 
fur
 animals
Article 31
Placing on the market
1. Animal 
by-products 
and 
derived products destin ed 
for feed­
ing 
to farmed an imals, 
excluding 
fur animals, 
may only 
be 
placed 
on 
the market 
provided: 
(a) they are or they are derived from Categ ory 
3 material other 
than 
material referred to in  
Article 10(n ), 
(o) and 
(p);
(b) they 
have been 
collected or processed, as applicab le, 
in 
accor­
dance 
with the con ditions 
for pressure sterilisation  
or other 
conditions 
to preven t 
risks 
arising 
to public 
and 
animal 
health 
in 
accordance 
with measures adopted pursuan t 
to 
Article 15 an d 
any 
measures which have b een 
laid down  
in 
accordance 
with parag raph 
2 of this Article; an d
(c)
 they come from approved or reg istered
 establishments
 or 
plants, 
as applicab le 
for the an imal 
by-product 
or derived 
product con cerned.
2. Measures 
for the implemen tation 
of this Article may b e 
laid 
down 
relating 
to the pub lic 
and 
animal 
health con ditions 
for the 
collection ,
 processin g
 and
 treatmen t
 of animal
 by-products and 
derived products referred to in  
paragraph 
1. 
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordance 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4). Section  2
Organic fertilisers and soil improvers
Article 32
Placing on the market and u se
1. Organic 
fertilisers an d 
soil improvers may b e 
placed on  
the 
market 
and 
used provided: 
(a) they are derived from Categ ory 
2 or Categ ory 
3 material;
(b) they 
have been 
produced in  
accordance 
with the con ditions 
for 
pressure sterilisation  
or with other con ditions 
to prevent 
risks 
arising 
to public 
and 
animal 
health, in 
accordance 
with 
the requiremen ts 
laid down  
pursuant 
to Article 15 an d 
any 
measures
 which have b een
 laid down in accordan ce
 with 
paragraph 
3 of this Article;
(c) they come from approved or reg istered
 establishments
 or 
plants, as applicab le; and
(d) in 
the case of meat-an d-bone 
meal derived from Categ ory 
2 
material an d 
processed an imal 
proteins 
intended 
to be 
used 
as or in 
organic 
fertilisers an d 
soil improvers, they have b een 
mixed
 with a compon ent
 to exclude the sub sequent
 use of 
the mixture for feedin g 
purposes an d 
marked 
when 
required 
by 
measures adopted un der 
paragraph 
3.
In 
addition, 
digestion 
residues from tran sformation 
into 
bio
gas or 
compost may b e 
placed on  
the market 
and 
used as org anic 
ferti­
lisers or soil improvers.
Member 
States may adopt or main tain 
national 
rules imposin g 
additional 
conditions 
for or restrictin g 
the use of org anic 
fertilis­
ers and
 soil improvers, provided that such rules are justified on 
grounds 
of the protection  
of public 
and 
animal 
health.
2. By way of derog ation 
from poin t 
(d) of parag raph 
1, mix­
ing 
shall not 
be 
required for materials whose use for feedin g 
pur­
poses is excluded due to their composition  
or packaging.
3. Measures 
for the implemen tation 
of this Article may b e 
laid 
down 
relating 
to the followin g: 
(a) public 
and 
animal 
health con ditions 
for the production  
and 
use 
of organic 
fertilisers an d 
soil improvers;
(b) components 
or substances 
for the mark ing 
of organic 
fertil­
isers or soil improvers;
(c) components
 to be
 mixed with org anic
 fertilisers or soil 
improvers;
(d) supplemen tary
 conditions,
 such as the methods to b e
 used 
for marking
 and
 the minimum
 proportion s
 to be observed 
when 
preparing 
the mixture, in  
order to exclude the use of 
such fertilisers or soil improvers for feedin g 
purposes; an dN E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
(e) cases where the composition  or packaging allows the mate­
rials to be 
exempted from the mixin g 
requiremen t.
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Section  3
Derived
 produ cts
 regulated
 by certain 
other Commu nity
 legislation
Article 33
Placing on the market
Operators may place on the mark et
 the followin g
 derived 
products:
(a) cosmetic products as defin ed 
in 
Article  1(1) of Directive 
76/768/EEC;
(b)
 active implan table
 medical devices as defin ed
 in 
Article 1(2)(c) of Directive 90/385/E EC;
(c) medical 
devices as defin ed 
in 
Article  1(2)(a) of Directive 
93/42/EEC;
(d)
 in vitro diag nostic
 medical devices as defin ed
 in 
Article 1(2)(b ) 
of Directive 98/79/E C;
(e)
 veterinary
 medicinal
 products as defin ed
 in Article 1(2) of 
Directive 2001/82/E C;
(f)
 medicinal
 products as defin ed
 in Article 1(2) of Directive 
2001/83/E C.
Article 
34
Manufacture
1.
 The import, collection an d
 movemen t
 of animal 
by-products 
and 
derived products destin ed 
for establishments 
or 
plants 
for the man ufacture 
of the derived products referred to in  
Article 
33 and 
the manufacture 
of those derived products shall b e 
carried 
out in 
accordance 
with the Commun ity 
legislation 
referred 
to in 
that Article. 
Unused 
material from such estab lishments 
or plants 
shall be 
dis­
posed of in  
accordance 
with that leg islation. 
2. However, 
this Regulation 
shall apply where the Commun ity 
legislation
 referred to in Article 33 does n ot
 provide for con di
­
tions
 controlling
 potential
 risks
 to public
 and animal health in 
accordance 
with the ob jectives 
of this Reg ulation.Section   4
Other derived produ cts
Article 
35
Placing on the market of pet food
Operators may place pet food on  
the market 
provided:
(a) the products are derived:
(i) from Categ ory 
3 material, other than  
material referred to 
in 
Article 10(n ), 
(o) and 
(p);
(ii) in 
the case of imported pet food or of pet food produced 
from imported materials, from Categ ory
  1 material 
referred to in  
Article  8(c), sub ject 
to conditions 
laid 
down 
pursuant 
to point 
(a) of the first parag raph 
of 
Article 40; or
(iii) in 
the case of raw petfood, from material referred to in  
Article 
10(a) and 
(b)(i) 
and 
(ii); and
(b) they 
ensure 
the control 
of risks 
to public 
and 
animal 
health 
by 
safe treatmen t 
in 
accordance 
with Article 38, where safe 
sourcing 
in 
accordance 
with Article 37 does n ot 
ensure 
suf­
ficient 
control.
Article 
36
Placing on the market of other derived produ cts
Operators 
may place on  
the market 
derived products, other than  
the 
products referred to in  
Articles 31, 32, 33 an d 
35, provided:
(a) those products are:(i) n
ot 
intended 
for use for the feedin g 
to farmed an imals 
or 
for application  
to land 
from which such an imals 
are 
to be 
fed; or
(ii) intended 
for feedin g 
to fur animals; 
and
(b) they 
ensure 
the control 
of risks 
to public 
and 
animal 
health 
by:
(i) safe 
sourcing 
in 
accordance 
with Article 37;
(ii) safe treatmen t 
in 
accordance 
with Article 38, where safe 
sourcing 
does not 
ensure 
sufficient 
control; 
or
(iii) verifying
 that the products are on ly
 used for safe en d
 
uses in 
accordance 
with Article 39 where safe treatmen t 
does 
not 
ensure 
sufficient 
control.N E 6 2 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/27
Article 37
Safe sourcing
1. Safe 
sourcing 
shall include 
the use of material: 
(a) from which n o 
unacceptable 
risks 
to public 
and 
animal 
health 
arise;
(b) which 
has been 
collected an d 
transported 
from the poin t 
of 
collection  
to the man ufacturing 
establishment 
or plant 
unde
r 
conditions 
which exclude risk s 
to public 
and 
animal 
health; 
or
(c) which has b een 
imported in to 
the Commun ity 
and 
trans­
ported 
from the poin t 
of first en try 
to the man ufacturing 
establishment 
or plant 
under 
conditions 
which exclude risk s 
to 
public 
and 
animal 
health.
2. For the purpose of safe sourcin g,
 operators shall provide 
documentation
 of the requiremen ts
 of parag raph
 1, includin g,
 
where necessary, 
proof of the safety of b io-security 
measures 
taken 
in 
order to exclude risk s 
arising 
to public 
and 
animal 
health 
from startin g 
material. 
Such documen tation 
shall be 
kept 
available 
to the competen t 
authority 
upon 
request. 
In
 the case referred to in poin t
 (c) of parag raph
 1, the con sign
­
ments 
shall be 
accompan ied 
by 
a health certificate correspon ding 
to 
a model adopted in  
accordance 
with the reg ulatory 
procedure 
referred to in  
Article 52(3). 
Article 38
Safe treatment
Safe treatmen t 
shall include 
application  
of a manufacturing 
pro­
cess to the material used which reduces to an  
acceptable 
level 
risks 
to public 
and 
animal 
health arisin g 
from the material used 
or from other sub stances
 resulting
 from the man ufacturing
 
process.
It
 shall be
 ensured
 that the derived product poses n o
 unaccept
­
able 
risks 
to public 
and 
animal 
health, in 
particular b y 
means 
of 
testing 
of the end 
product.
Article 39
Safe end u ses
Safe 
end 
uses shall in clude 
the use of derived products:
(a) under 
conditions 
which pose n o 
unacceptable 
risks 
to public 
and 
animal 
health; or
(b) which 
may pose a risk  
to public 
and 
animal 
health, for spe­
cific purposes provided that such use is justified b y 
objectives 
set
 out in Commun ity
 legislation,
 in particular for the pro­
tection 
of public 
and 
animal 
health.Article 40
Implementing measu res
Measures 
for the implemen tation 
of this Section  
may be 
laid down  
relating 
to the followin g:
(a) conditions 
for the placin g 
on 
the market 
of imported pet 
food or of pet food produced from imported materials, from 
Category 
1 material referred to in  
Article 8(c);
(b) conditions 
for the safe sourcin g 
and 
movemen t 
of material to 
be 
used under 
conditions 
which exclude risk s 
to public 
and 
animal 
health;
(c) documentation
 as referred to in the first sub paragraph
 of 
Article 37(2);
(d) parameters for the man ufacturing
 process as referred to in 
the first parag raph 
of Article 38, in  
particular as reg ards 
the 
application  
of physical or chemical treatmen ts 
to the mate­
rial used;
(e) testing 
requiremen ts 
applicable 
to the end 
product; an d
(f) conditions 
for the safe use of derived products which pose a 
risk 
to public 
or animal 
health.
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
CHAPTER III
Import, transit and export
Article 41
Import and transit
1. Animal 
by-products 
and 
derived products shall b e 
imported 
into,
 or sent
 in transit
 through,
 the Commun ity
 in accordan ce
 
with: 
(a) the relevan t 
requiremen ts 
of this Reg ulation 
and 
the imple­
menting
 measures thereof for the particular an imal
 
by-product 
or derived product which are at least as strin gent 
as 
those applicab le 
to the production  
and 
marketing 
of such 
animal
 by-products
 or derived products within the 
Community;
(b) conditions 
recognised 
to be 
at least equivalen t 
to the require­
ments
 applicable
 to the production an d
 marketing
 of such 
animal
 by-products
 or derived products un der
 Commun ity
 
legislation; 
or
(c) in the case of an imal
 by-products
 and
 derived products 
referred to in  
Articles 33, 35 an d 
36, the requiremen ts 
set out 
in 
those Articles.N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
The measures referred to in poin t (b) of the first sub paragraph,  
designed 
to amend 
non-essential 
elements 
of this Reg ulation 
by 
supplemen ting 
it, shall be 
adopted in  
accordance 
with the reg u­
latory 
procedure with scrutin y 
referred to in  
Article 52(4).
2. By way of derog ation
 from parag raph
 1, the import an d
 
transit 
of: 
(a) specified risk material shall tak e
 place on ly
 in accordan ce
 
with Regulation 
(EC) 
No 999/2001;
(b)
 animal
 by-products
 or derived products mixed or con t
ami­
nated
 with an y
 waste listed as hazardous in Decision 
2000/532/E C
 shall tak e
 place on ly
 subject
 to the require­
ments 
of Regulation 
(EC) 
No 1013/2006;
(c) Category
  1 material, Categ ory
  2 material an d
 products 
derived therefrom which are n ot 
intended 
for the man ufac­
ture 
of derived products referred to in  
Articles 33, 35 an d 
36, 
shall only 
take 
place provided that rules for their import have 
been 
adopted in  
accordance 
with Article 42(2)(a);
(d) animal
 by-products
 and
 derived products destin e
d for the 
purposes referred to in  
Article 17(1) shall take place in  
accor­
dance
 with national
 measures which en sure
 the control
 of 
risks
 to public
 and
 animal
 health, pen ding
 the adoption of 
harmonised 
conditions 
referred to in  
Article 17(2).
3. In 
the case of import an d 
transit 
of Category 
3 material an d 
products 
derived therefrom, the relevan t 
requiremen ts 
as referred 
to in 
point 
(a) of the first sub paragraph 
of paragraph 
1 shall be 
laid 
down. 
Those 
requiremen ts 
may specify that con signments: 
(a)
 must come from a third coun try
 or part of a third coun try
 
listed in 
accordance 
with parag raph 
4;
(b) must 
come from estab lishments 
or plants 
approved or reg ­
istered
 by
 the competen t
 authority of the third coun try
 of 
origin 
and 
listed by 
that authority for that purpose; an d
(c) must 
be 
accompan ied 
at the poin t 
of entry 
into 
the Commu­
nity
 where the veterin ary
 checks
 take
 place by
 documen ta
­
tion such as a commercial documen t
 or a health certificate 
and 
where appropriate b y 
a declaration , 
which correspon ds 
to 
a model laid down  
pursuant 
to point 
(d) of the first sub ­
paragraph 
of Article 42(2).
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Pending 
the adoption  
of the requiremen ts 
referred to in  
points 
(a) 
and 
(c) of the secon d 
subparagraph, 
the Memb er 
States shall 
specify those requiremen ts 
in 
national 
measures.4. Lists of third coun tries or parts of third coun tries from 
which animal 
by-products 
or derived products may b e 
imported 
or transit 
through 
the Commun ity 
shall be 
drawn 
up in 
accor­
dance 
with the reg ulatory 
procedure referred to in  
Article 52(3), 
taking 
into 
account 
in 
particular: 
(a) the legislation 
of the third coun try;
(b) the 
organisation 
of the competen t 
authority an d 
its inspec­
tion 
services in  
the third coun try, 
the powers of those ser­
vices, the supervision to which they are sub ject,
 and
 their 
authority to mon itor
 effectively the application of their 
legislation;
(c) the 
actual health con ditions 
applied to the production ,
 manu­
facture, han dling, 
storage 
and 
dispatch of products of an imal 
origin 
intended 
for the Commun ity;
(d) the 
assurances 
the third coun try 
can 
give 
regarding 
compli­
ance 
with the relevan t 
health con ditions;
(e) experience 
of marketing 
the product from the third coun try 
and 
the results of import check s 
carried out;
(f) the result of an y 
Community 
inspections 
in 
the third coun try;
(g) the 
health status of the livestock , 
other domestic an imals 
and 
wildlife 
in 
the third coun try, 
having 
particular reg ard 
to 
exotic animal 
diseases an d 
any 
aspects of the g eneral 
health 
situation 
in 
the country 
which mig ht 
pose a risk  
to public 
or 
animal 
health in 
the Commun ity;
(h)
 the regularity
 and
 speed with which the third coun try
 sup­
plies information
 about
 the existen ce
 of inf
ectious animal 
diseases in  
its territory, in  
particular the diseases listed in  
the 
Terrestrial An imal
 Health Code an d
 the Aquatic An imal
 
Health Code of the World Org anisation 
for Animal 
Health;
(i) the regulations
 on the preven tion
 and
 control
 of infectious
 
animal 
diseases in  
force in 
the third coun try 
and 
their imple­
mentation,
 including
 rules on imports from other third 
countries.
The 
lists of estab lishments 
or plants 
referred to in  
point 
(b) 
of the 
second 
subparagraph 
of paragraph 
3 shall be 
kept 
up to date an d 
communicated
 to the Commission an d
 the Memb er
 States an d
 
made availab le 
to the pub lic.
Article 
42
Implementing measu res
1. Measures 
for the implemen tation 
of Article 41 which may 
exclude an imal 
by-products 
or derived products man ufactured 
in 
certain 
establishments 
or plants 
from import or tran sit 
in 
order to 
protect pub lic 
or animal 
health shall b e 
adopted in  
accordance 
with 
the regulatory 
procedure referred to in  
Article 52(3).N E 8 2 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/29
2. Other measures for the implemen tation of Article 41 shall 
be 
laid down  
relating 
to the followin g: 
(a) conditions 
for the import an d 
transit 
of Category 
1 and 
Cat­
egory 
2 materials an d 
for products derived therefrom;
(b)
 restriction s
 regarding
 public
 or animal
 health applicab le
 to 
imported Categ ory 
3 material or products derived therefrom 
which may b e 
laid down  
by 
reference 
to Commun ity 
lists of 
third coun tries 
or parts of third coun tries 
drawn 
up in 
accor­
dance 
with Article 41(4) or for other pub lic 
or animal 
health 
purposes;
(c) conditions 
for the man ufacture 
of animal 
by-products 
or 
derived products in estab lishments
 or plants
 in third coun­
tries; such con ditions 
may include 
the arrangements 
for con­
trols 
of such estab lishments 
or plants 
by 
the competen t 
authority 
concerned 
and 
may exempt certain  
types of estab ­
lishments 
or plants 
handling 
animal 
by-products 
or derived 
products from approval or reg istration
 as referred to in 
point 
(b) 
of the secon d 
subparagraph 
of Article 41(3); an d
(d)
 models for health certificates, commercial documen t
s and
 
declaration s 
which are to accompan y 
consignments, 
specify­
ing 
the conditions 
under 
which it can  
be 
stated that the an i­
mal
 by-products
 or derived products con cerned
 have been
 
collected or man ufactured
 in accordan ce
 with the require­
ments 
of this Reg ulation.
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Article 43
Export
1. The export of an imal 
by-products 
and 
derived products des­
tined 
for incineration 
or landfill 
shall be 
prohibited.
2. The 
export of an imal 
by-products 
and 
derived products to 
third coun tries 
which are n ot 
members 
of the OE CD 
for use in 
a 
biogas 
or compostin g 
plant 
shall be 
prohibited.
3.
 Category
  1 material, Categ ory
  2 material an d
 products 
derived therefrom shall on ly 
be 
exported for purposes other than  
those
 referred to in parag raphs
 1 and
 2 provided that rules for 
their export have b een 
laid down . 
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4). 
4. Article  12 of Reg ulation 
(EC) 
No  178/2002 con cerning 
food 
and 
feed exported from the Commun ity 
shall apply mutatis 
mutandis 
to the export of Categ ory 
3 material or products derived 
therefrom in  
compliance 
with this Reg ulation.5. By way of derog ation from parag raphs  3 and  4, the export 
of: 
(a) specified risk material shall tak e
 place on ly
 in accordance 
with Regulation 
(EC) 
No 999/2001;
(b)
 animal
 by-products
 or derived products mixed or contami­
nated
 with an y
 waste listed as hazardous in Decision 
2000/532/E C
 shall tak e
 place on ly
 subject
 to the require­
ments 
of Regulation 
(EC) 
No 1013/2006.
TITLE III
OFFICIAL 
CONTROLS AND  
FINAL 
PROVISIONS
CHAPTER I
Official controls
Article 44
Procedure 
for approval
1. The competen t
 authority shall approve estab lishments
 or 
plants 
only 
where an 
on 
site visit, prior to start-up of an y 
activity, 
has demon strated
 that they meet the relevant requiremen ts
 laid 
down 
in 
accordance 
with Article 27.
2. The competen t 
authority may g rant 
conditional 
approval if 
it appears, from the on  
site visit, that the estab lishment 
or plant 
meets
 all the in frastructure
 and
 equipmen t
 requiremen ts
 with a 
view to en suring 
the application  
of the operation al 
procedures in  
compliance 
with this Reg ulation. 
It 
shall grant 
full approval on ly 
if
 it appears, from an other
 on site visit carried out within three 
months 
of granting 
conditional 
approval, that the estab lishment 
or 
plant 
meets the other requiremen ts 
referred to in  
paragraph 
1. 
If
 clear prog ress
 has been
 made, but
 the estab lishment
 or plant
 
still does n ot 
meet all of these requiremen ts, 
the competen t 
authority 
may exten d 
conditional 
approval. However, con d
itional 
approval shall n ot 
exceed a total of six mon ths.
3. Operators 
shall ensure 
that an 
establishment 
or plant ceases 
to operate if the competen t 
authority withdraws its approval or 
in 
the case of con ditional 
approval fails to exten d 
it or to grant 
full 
approval.
Article 45
Official controls
1. Without prejudice to Article 5, the competen t
 authority 
shall at reg ular
 intervals
 carry out official con trols
 and
 supervi­
sion 
of the han dling 
of animal 
by-products 
and 
derived products 
falling 
within 
the scope of this Reg ulation.
2.
 Articles 41 an d
 42 of Reg ulation
 (EC
) No 882/2004 shall 
apply mutatis mutan dis
 to official con trols
 carried out to verify 
compliance 
with this Reg ulation.N E 9 0 0 2 . 1 1 . 4 1Official Journ alof the EuropeanUnion 14.11.2009
3. The competen t authority may tak e into account adherence 
to 
guides 
to good 
practice, when  
carrying 
out its official con trols.
4.
 Detailed arran gements
 for implemen ting
 this Article, 
including
 rules con cerning
 the referen ce
 methods for microb io
­
logical 
analyses, 
may be 
laid down . 
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4). 
Article 46
Suspensions, 
withdrawals and prohibitions on operations
1. If
 the official con trols
 and
 supervision carried out b y
 the 
competen t 
authority reveal that on e 
or more of the requiremen ts 
of 
this Regulation 
are not 
met, it shall tak e 
appropriate action . 
The 
competen t 
authority shall in  
particular, as appropriate to the 
nature 
and 
to the gravity 
of the deficien cies 
and 
to the poten tial 
risks 
for public 
and 
animal 
health: 
(a) suspend 
approvals of estab lishments 
or plants 
approved pur­
suant 
to this Reg ulation, 
if:
(i) the conditions 
for approvin g 
or operatin g 
the establish­
ment 
or plant 
are no 
longer 
fulfilled;
(ii) the operator can  
be 
expected to remedy the deficien cies 
within 
a reasonable 
period of time; an d
(iii) the 
potential 
risks 
to public 
and 
animal 
health do n ot 
require 
action 
in 
accordance 
with poin t 
(b);
(b)
 withdraw approvals of estab lishments
 or plants
 approved 
pursuant 
to this Reg ulation, 
if:
(i) the conditions 
for approvin g 
or operatin g 
the establish­
ment 
or plant 
are no 
longer 
fulfilled; an d
(ii) the 
operator can not 
be 
expected to remedy the deficien ­
cies 
within 
a reasonable 
period of time:
—for reason s
 relating
 to the in frastructur
e of the 
establishment 
or plant,
 
—for reason s 
relating 
to the person al 
capacity of the 
operator or the staff un der 
his supervision , 
or 
—because 
of serious risk s 
to public 
and 
animal 
health 
requiring 
major adjustmen ts 
to the operation  
of the 
establishment
 or plant
 before
 the operator may 
apply for re-approval;
(c) impose specific con ditions
 on estab lishments
 or plant
s in 
order to rectify existin g 
deficiencies.2. The competen t authority shall, as appropriate to the n ature 
and 
to the gravity 
of the deficien cies 
and 
to the poten tial 
risks 
for 
public
 and
 animal
 health, temporarily or perman ently
 prohibit
 
operators referred to in Articles 23(1) an d
 (3) and
 Article 24(1) 
from carryin g 
out operation s 
under 
this Regulation, 
as appropri­
ate, followin g 
receipt of in formation 
indicating: 
(a) that 
the requiremen ts 
of Commun ity 
legislation 
are not 
met; 
and
(b) potential 
risks 
to public 
or animal 
health arisin g 
from such 
operation s.
Article 
47
Lists
1. Each
 Member
 State shall draw up a list of estab lishments,
 
plants 
and 
operators which have b een 
approved or reg istered 
in 
accordance 
with this Reg ulation 
within 
its territory. 
It 
shall assig n 
an 
official number 
to each approved or reg istered 
establishment,
 plant
 or operator, which iden tifies
 the estab lish
­
ment, 
plant 
or operator with respect to the n ature 
of its activities. 
Member
 States shall in dicate,
 if applicab le,
 an official n umber
 
which has b een 
assigned 
to the estab lishment, 
plant 
or operator 
under 
other Commun ity 
legislation. 
Member 
States shall mak e 
the lists of approved or reg istered 
establishments, 
plants 
and 
operators availab le 
to the Commission  
and 
other Memb er 
States. 
Member 
States shall k eep 
up-to-date the lists of approved or reg ­
istered 
establishments, 
plants 
and 
operators an d 
make 
them avail­
able 
to other Memb er 
States and 
to the pub lic. 
2. Measures 
for the implemen tation 
of this Article may b e 
laid 
down 
in 
accordance 
with the reg ulatory 
procedure referred to in  
Article 
52(3), in 
particular on : 
(a) the 
format for the lists referred to in  
paragraph 
1; and
(b) the 
procedure for mak ing 
the lists referred to in  
paragraph 
1 
available.
Article 
48
Controls for dispatch to other Member States
1. Where an  
operator in tends 
to dispatch Categ ory 
1 material, 
Category
  2 material an d
 meat-and-bone
 meal or an imal
 fat 
derived from Categ ory
 1 and
 Category
 2 materials to an other
 
Member 
State, it shall in form 
the competen t 
authority of the 
Member 
State of orig in 
and 
the competen t 
authority of the Mem­
ber 
State of destin ation. 
The 
competen t 
authority of the Memb er 
State of destin ation 
shall 
decide upon  
application  
by 
the operator, within  
a specified time 
period: 
(a) to refuse receipt of the con signment;
(b) to 
accept the con signment 
unconditionally; 
orN E 0 3 / 0 0 3 LOfficial Journ alof the EuropeanUnion L 300/31
(c) to make receipt of the con signment subject to the followin g 
conditions:
(i) if 
the derived products have n ot 
undergone 
pressure 
sterilisation , 
it must un dergo 
such treatmen t; 
or
(ii) the animal 
by-products 
or derived products must com­
ply with an y 
conditions 
for the dispatch of the con sign­
ment 
which are justified for the protection  
of public 
and 
animal 
health in 
order to en sure 
that animal 
by-products 
and
 derived products are han dled
 in accordan ce
 with 
this Regulation.
2.
 Formats for application s
 by
 operators referred to in para­
graph 
1 may be 
adopted in  
accordance 
with the reg ulatory 
pro­
cedure referred to in  
Article 52(3).
3. The competen t 
authority of the Memb er 
State of orig in 
shall 
inform 
the competen t 
authority of the Memb er 
State of destin a­
tion, 
by 
means 
of the Traces system in  
accordance 
with Decision  
2004/292/E C, 
of the dispatch of each con signment 
sent 
to the 
Member 
State of destin ation, 
of 
(a) animal
 by-products
 or derived products referred to in 
paragraph 
1;
(b) processed 
animal 
protein 
derived from Categ ory 
3 material.
When 
informed 
of the dispatch, the competen t 
authority of the 
Member 
State of destin ation 
shall inform 
the competen t 
author­
ity of the Memb er 
State of orig in 
of the arrival of each con sign­
ment 
by 
means 
of the Traces system.
4. Category 
1 and 
Category 
2 materials, meat-an d-bone 
meal 
and 
animal 
fat referred to in  
paragraph 
1 shall be 
transported 
directly 
to the estab lishment 
or plant 
of destination, 
which must 
have been 
registered 
or approved in  
accordance 
with Articles 23, 
24 and 
44 or, in 
the case of man ure, 
to the farm of destin ation.
5.
 When animal
 by-products
 or derived products are sent to 
other Memb er 
States via the territory of a third coun try, 
they shall 
be 
sent 
in 
consignments 
which have b een 
sealed in 
the Memb er 
State 
of origin 
and 
shall be 
accompan ied 
by 
a health certificate. 
The sealed con signments 
shall re-en ter 
the Commun ity 
only 
via a 
border 
inspection 
post, in 
accordance 
with Article 6 of Directive 
89/662/EEC. 
6. By 
way of derog ation 
from parag raphs 
1 to  5, an imal 
by-products
 or derived products referred to therein which have 
been 
mixed or con taminated 
with any 
waste listed as hazardous 
in Decision 2000/532/E C
 shall be
 sent
 to other Memb er
 States 
only
 subject
 to the requiremen ts
 of Reg ulation
 (EC)
 
No 1013/2006.
7. Measures for the implemen tation 
of this Article may b e 
adopted 
relating 
to the followin g: 
(a)
 a specified time period for the decision of the competen t
 
authority as referred to in  
paragraph 
1;
(b)
 supplemen tary
 conditions
 for the dispatch of an imal
 
by-products 
or derived products referred to in  
paragraph 
4;(c) models for the health certificates which have to accompan y 
consignments 
sent 
in 
accordance 
with parag raph 
5; and
(d) conditions 
under 
which animal 
by-products 
or derived prod­
ucts intended 
to be 
used for exhib itions, 
artistic activities, for 
diagnostic, 
education al 
or research purposes may b e 
sent 
to 
other Memb er 
States, by 
way of derog atio
n 
from parag raph 
1 
to 5 of this Article.
Those measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
8. Measures for the implemen tation 
of this Article may specify 
the conditions 
subject 
to which, b y 
way of derog ation 
from para­
graphs 
1 to 4, the competen t 
authorities may allow: 
(a) the dispatch of man ure
 transported
 between
 two poin ts
 
located on  
the same farm or b etween 
farms located in  
the 
border 
regions 
of Member 
States sharin g 
a common  
border;
(b)
 the dispatch of other an imal
 by-products
 transported
 
between
 establishments
 or plants
 located in the b order
 
regions 
of Member 
States sharin g 
a common  
border; 
and
(c)
 the transport
 of a dead pet an imal
 for incineration
 to an 
establishment 
or plant 
located in 
the border 
region 
of another 
Member 
State sharin g 
a common  
border.
Those 
measures, desig ned 
to amend 
non-essential 
elements 
of this 
Regulation
 by
 supplemen ting
 it, shall b e
 adopted in accordan ce
 
with the reg ulatory
 procedure with scrutin y
 referred to in 
Article 52(4).
Article 49
Community 
controls in Member States
1. Experts
 from the Commission may mak e
 on-the-spot
 
checks,
 in cooperation with the competen t
 authorities of Mem­
ber 
States, in 
so far as is n ecessary 
for the un iform 
application  
of 
this Regulation. 
The 
Member 
State on 
whose territory the check s 
are made shall 
provide the experts with all the assistan ce 
necessary 
for carryin g 
out 
their duties. 
The Commission shall in form
 the competent authority of the 
results of the check s 
made. 
2. Measures for the implemen tation 
of this Article may b e 
adopted 
in 
accordance 
with the reg ulatory 
procedure referred to 
in 
Article 52(3), in  
particular on  
the procedure for the coopera­
tion 
with national 
authorities.N E 9 0 0 2 . 1 1 . 4 1L 300/32 EN Official Journ alof the EuropeanUnion 14.11.2009
Article 50
Application of Regu lation 
(EC) No 882/2004 for the 
purposes 
of certain controls
1. Article  46 of Reg ulation 
(EC) 
No  882/2004 shall apply 
mutatis mutan dis 
to Commun ity 
controls 
in 
third coun tries 
car­
ried out to verify complian ce 
with this Reg ulation.
2. Article 
50(1)(a) of Reg ulation 
(EC) 
No 882/2004 shall apply 
mutatis mutan dis 
to the phased in troduction 
of the requiremen ts 
of 
Article 41(3) of this Reg ulation.
3. Article 
52 of Reg ulation 
(EC) 
No  882/2004 shall apply 
mutatis mutan dis 
to third-coun try 
controls 
in 
Member 
States 
related to operation s 
under 
this Regulation.
CHAPTER II
Final provisions
Article 51
National provisions
Member 
States shall commun icate 
to the Commission  
the text of 
the provision s 
of national 
law they adopt in  
areas under 
their 
competen ce 
which directly con cern 
the proper implemen tation 
of 
this Regulation.
Article 
52
Committee procedu re
1. The 
Commission  
shall be 
assisted by 
the Standing 
Commit­
tee on the Food Chain an d
 Animal
 Health estab lished
 by
 
Article 58(1) of Reg ulation 
(EC) 
No 178/2002.
2. Where referen ce 
is made to this parag raph, 
Articles 3 an d 
7 
of Decision  
1999/468/E C 
shall apply, havin g 
regard 
to the pro­
visions 
of Article 8 thereof.
3. Where referen ce 
is made to this parag raph, 
Articles 5 an d 
7 
of Decision  
1999/468/E C 
shall apply, havin g 
regard 
to the pro­
visions 
of Article 8 thereof. 
The period laid down  
in 
Article 5(6) of Decision  
1999/468/E C 
shall 
be 
set at three mon ths. 
4. Where 
reference 
is made to this parag raph, 
Article 5a(1) 
to (4) and 
Article 7 of Decision  
1999/468/E C 
shall apply, havin g 
regard 
to the provision s 
of Article 8 thereof.5. Where referen ce 
is made to this parag raph, 
Article 5a(1) 
to (4) and 
(5)(b) 
and 
Article 7 of Decision  
1999/468/E C 
shall 
apply, havin g 
regard 
to the provision s 
of Article 8 thereof. 
The time limits laid down  
in 
Article 5a(3)(c), (4)(b ) 
and 
(4)(e) of 
Decision 
1999/468/E C 
shall be 
two months, 
one 
month 
and 
two 
months 
respectively. 
6. Where referen ce 
is made to this parag raph
, Article 5a(1), (2), 
(4) and
 (6) and
 Article 7 of Decision 1999/468/E C
 shall apply, 
having 
regard 
to the provision s 
of Article 8 thereof.
Article 53
Penalties
The Memb er
 States shall lay down the rules on pen alties
 appli­
cable 
to infringements 
of this Reg ulation 
and 
shall take 
all mea­
sures necessary 
to ensure 
that they are implemen ted. 
The penalties 
provided for must b e effective, proportion ate and dissuasive. The 
Member
 States shall n otify
 those provision s
 to the Commission 
by 4 
June 
2011 and 
shall notify 
it without delay of an y 
subse­
quent 
amendment 
affecting 
them.
Article 54
Repeal
Regulation 
(EC) 
No 1774/2002 shall b e 
repealed with effect from
4 March 2011.
References 
to Regulation 
(EC) 
No 1774/2002 shall b e 
construed 
as
 references
 to this Reg ulation
 and
 shall be
 read in accordan ce
 
with the correlation  
table 
laid down  
in 
the Annex.
Article 
55
Transitional measu re
Establishments, 
plants 
and 
users approved or reg istered 
in 
accor­
dance 
with Regulation 
(EC) 
No 1774/2002 b efore 4 
March 2011 
shall be 
deemed to b e 
approved or reg istered, 
as required, in  
accordance 
with this Reg ulation.
Article 
56
Entry into force
This Regulation 
shall enter 
into 
force on 
the 20th day followin g 
its 
publication 
in 
the Official Journal of the European Union.
It 
shall apply from 4 March 2011.
This Regulation 
shall be 
binding 
in 
its entirety 
and 
directly applicab le 
in 
all Member 
States.
Done 
at Strasbourg, 21 
October 
2009.
For the European Parliament
The President
J. BUZEKFor the Council
The President
C. MALMSTRÖMOfficial Journ alof the EuropeanUnion L 300/33
ANNEX
CORRELATION TABLE
Regulation (EC) No 1774/2002 This  Regulation
Article 1 Articles 1 an d 2
Article 2 Article 3
Article 3(1) Article 4(1) an d(2)
Article 
3(2) Article 41(3), fourth sub paragraph
Article 
3(3) Article 4(3), (4) an d 
(5)
Article 4(1) Article 8
Article 4(2) Articles 12, 15 an d 
16
Article 4(3) Article 24(h), (i) an d 
(j)
Article 4(4) Article 41(2)(c), Article 43(3) an d 
(5)(a)
Article 5(1) Article 9
Article 5(2) Articles 13, 15 an d 
16
Article 5(3) Article 24(h), (i) an d 
(j)
Article 5(4) Article 41(2)(c) an d 
Article 43(3)
Article 6(1) Article 10
Article 6(2) Articles 14, 15 an d 
16
Article 6(3) Article 24(h), (i) an d 
(j)
Article 7 Article 21
Article 8 Article 48
Article 9 Article 22
Articles 10 to 15, 17 an d 
18 Articles 23, 24, 27 an d 
44
Article 16 Article 6
Article 19 Article 31
Article 20(1) Articles 35 an d 
36
Article 20(2) Article 32
Article 20(3) Article 36
Article 21 —
Article 22 Article 11
Article 23 Articles 17 an d 
18
Article 24 Article 19
Article 25 Articles 28 an d 
29
Article 26 Articles 45, 46 an d 
47
Article 27 Article 49
Article 28 Article 35(a)(ii) an d 
Article 41(1)
Article 29 Articles 41 an d 
42
Article 30 Article 41(1)(b )
Article 
31 Article 50(1)
Article 32 —
Article 33 Article 52
Article 34 —
Article 35 Article 15(2) an d 
Article 51
Article 36 —
Article 37 Article 54
Article 38 Article 56N E 9 0 0 2 . 1 1 . 4 1