2024年5月3日发(作者：家庭用suv前五名)

14.11.2009

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OfficialJournaloftheEuropeanUnionL300/1

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 rules as regards animal by-products and derived products not intended for human

consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO­

PEAN UNION,

(2)

Having regard to the Treaty establishing the European Commu­

nity, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and

Social Committee (

1

),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251

of the Treaty (

2

),

Whereas:

(1)

(3)

Animal by-products arise mainly during the slaughter of

animals for human consumption, during the production of

products of animal origin such as dairy products, and in

the course of the disposal of dead animals and during dis­

ease control measures. Regardless of their source, they

pose a potential risk to public and animal health and the

environment. This risk needs to be adequately controlled,

either by directing such products towards safe means of

disposal or by using them for different purposes, provided

that strict conditions are applied which minimise the health

risks involved.

The disposal of all animal by-products is not a realistic

option, as it would lead to unsustainable costs and risks for

the environment. Conversely, there is a clear interest for all

citizens that, provided the health risks are minimised, a

wide range of animal by-products are safely used for vari­

ous applications in a sustainable manner. A wide range of

animal by-products are indeed commonly used in impor­

tant productive sectors, such as the pharmaceutical, feed

and leather industries.

Animal by-products not intended for human consumption

are a potential source of risks to public and animal health.

Past crises related to outbreaks of foot-and-mouth disease,

the spread of transmissible 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 animal

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, by their impact on the socioeconomic situ­

ation of the farmers and of the industrial sectors concerned

and on consumer confidence in the safety of products of

animal origin. Disease outbreaks could also have negative

consequences for the environment, not only due to the dis­

posal problems posed, but also as regards biodiversity.

(4)

New technologies have widened the possible use of animal

by-products or derived products to a large number of pro­

ductive sectors, in particular for the generation of energy.

However, the use of those new technologies might pose

health risks that must also be minimised.

(5)

Community health rules for collection, transport, handling,

treatment, transformation, processing, storage, placing on

the market, distribution, use or disposal of animal

by-products should be laid down in a coherent and com­

prehensive framework.

(

1

) OJ C 100, 30.4.2009, p. 133.

(

2

) Opinion of the European Parliament of 24 April 2009 (not yet pub­

lished in the Official Journal) and Council Decision of 7 September

2009.

(6)

Those general rules should be proportionate to the risk to

public and animal health which animal by-products pose

when they are dealt with by operators at different stages of

L300/2

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OfficialJournaloftheEuropeanUnion14.11.2009

the chain from collection to their use or disposal. The rules

should also take into account the risks for the environment

posed

work

market,

should

during

include

those operations.

health rules

The Community frame­

animal by-products, where appropriate.

including intra-Community

on

trade

the placing

and import,

on the

of

(7)

In Regulation (EC) No 1774/2002

ment and the Council laid down Community health rules

(

1

), the European Parlia­

concerning

consumption. Based on scientific advice and as an action

animal by-products not intended for human

under

on

aimed at protecting the safety of the food and feed chain,

Food

the

Safety,

Commission

that Regulation

White Paper

introduced

of 12 January

a set of

2000

rules

which

food and feed. Those rules have significantly improved the

is complementary to Community legislation on

level

posed by animal by-products.

of protection in the Community against the risks

(8)

Regulation

tion of animal by-products into three categories according

(EC) No 1774/2002 introduced the classifica­

to the degree of risk involved. It requires operators to keep

animal

each other if they wish to make use of animal by-products

by-products of different categories separate from

which

health,

do

material fit for human consumption. That Regulation also

in

not

particular

pose a

if

significant

such products

risk to

are

public

derived

or animal

from

introduced the principle that high-risk material should not

be fed to farmed animals, and that material derived from

animals

which it is derived. Pursuant to that Regulation, only mate­

is not to be fed to animals of the species from

rial from animals which have undergone veterinary inspec­

tion

rules for processing standards which ensure the reduction

is to enter the feed chain. In addition, it lays down

of risks.

(9)

Under Article 35(2) of Regulation (EC) No 1774/2002, the

Commission is to submit a report to the European Parlia­

ment

Member States to ensure compliance with that Regulation.

and to the Council on the measures taken by the

The report is to be accompanied, if appropriate, by legis­

lative proposals. The report was submitted on 21 October

2005

(EC) No 1774/2002 should be maintained. In addition, it

and emphasised that the principles of Regulation

highlighted

tion were considered necessary, in particular clarifications

the areas where amendments to that Regula­

as

ucts,

regards the applicability of

and the classification of certain material. The findings of a

the relationship with other

the

Community

rules to finished

legislation

prod­

series

States by the Food and Veterinary Office of the Commis­

of fact-finding missions carried out in the Member

sion (FVO) in 2004 and 2005 support those conclusions.

According

regards the traceability of the flow of animal by-products

to the FVO, improvements are necessary as

and

controls.

the effectiveness and harmonisation of official

(

1

) OJ L 273, 10.10.2002, p. 1.

(10)

The Scientific Steering Committee, which was superseded

by

has

the

by-products.

adopted

European

a number

Food Safety

of opinions

Authority

concerning

(EFSA) in

animal

2002,

maintain

Those opinions demonstrate the need to

No

the main principles of Regulation (EC)

derived from animals shown not to be fit for human con­

1774/2002; in particular that animal by-products

sumption as a result of a health inspection should not enter

the feed chain. However, those animal by-products may be

recovered

industrial products under specified health conditions.

and used for the production of technical or

(11)

The

Commission

conclusions

adopted in December 2005, and the subsequent consulta­

report

of the

of

Presidency

21 October

of the

2005

Council

which

on

were

the

tions carried out by the Commission, have highlighted that

the

should

rules laid down in Regulation (EC) No

animal by-products, namely the control of risks to public

be improved. The chief objectives of the

1774/2002

rules on

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 Regulation should permit the achievement

of those objectives.

(12)

The rules on animal by-products laid down in this Regu­

lation should apply to products that may not be used for

human consumption under Community legislation, in par­

ticular where they do not comply with food hygiene legis­

lation or where they may not be placed on the market as

food

ous

since they are unsafe either

by-products

to health or unfit for human

because

consumption

they are

(animal

injuri­

apply to products of animal origin which do comply with

‘by law’). Those rules should, however, also

certain rules regarding their possible 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 (animal by-products ‘by

choice’).

(13)

In addition, in order to prevent risks arising from wild ani­

mals, bodies or parts of bodies of such animals suspected

of

subject

being

inclusion should not imply an obligation to collect and dis­

to

infected

the rules

with

laid

a transmissible

down in this

disease

Regulation.

should

This

be

pose of bodies of wild animals that have died or that are

hunted

are observed, intestines and other body parts of wild game

in their natural habitat. If good hunting practices

may

mitigation

be disposed of safely on site. Such

and

national legislation which regulates the activities of hunt­

are in

of

some

risks

cases

are well-established

based on cultural

in

practices

traditions

Member

for

States

the

or on

ers.

No 853/2004 of the European Parliament and of the Coun­

Community legislation, in particular Regulation (EC)

cil of 29 April 2004 laying down specific hygiene rules for

food of animal origin

meat and animal by-products from wild game. Those rules

(

2

), lays down rules for handling of

(

2

) OJ L 139, 30.4.2004, p. 55.

14.11.2009

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OfficialJournaloftheEuropeanUnionL300/3

also place the responsibility for the prevention of risks on

trained

risks

persons such as hunters. In view of the potential

wild game should only be subject to this Regulation in so

for the food chain, animal by-products from killed

far as food hygiene legislation applies to the placing on the

market of such game and involves operations carried out

by

by-products

game-handling

be covered by this Regulation in order to prevent animal

for the

establishments.

preparation of game

In addition,

trophies

animal

should

health risks arising from such by-products.

(14)

The rules laid down in this Regulation should apply to ani­

mal by-products derived from aquatic animals, other than

material

hygiene legislation. However, risk-proportionate measures

from vessels operating under Community food

should be adopted as regards the handling and disposal of

material

evisceration of fish and which shows signs of disease. Such

which arises on board fishing vessels from the

measures for the implementation of this Regulation should

be adopted on the basis of a risk assessment carried out by

the

able

appropriate scientific institution in view of the avail­

sures

evidence

humans, in particular of certain parasites.

to combat

regarding

the spread

the

of

effectiveness

diseases communicable

of certain mea­

to

(15)

Due to the limited risks arising from materials used as raw

pet

nesses, certain activities related to such raw pet food should

food on farm or supplied to end users by food busi­

not be covered by the rules laid down in this Regulation.

(16)

It is appropriate to clarify in this Regulation which animals

are

derived from such animals are not used in feed for farmed

to be classified as pet animals, so that by-products

animals.

than farming, such as for companionship, should be clas­

In particular, animals kept for purposes other

sified as pet animals.

(17)

For the sake of consistency of Community legislation, cer­

tain definitions set out in Regulation (EC) No 999/2001 of

the

2001

European

eradication

laying

Parliament and of the Council of 22 May

lopathies (

of

down

certain

rules

transmissible

for the prevention,

spongiform

control

encepha­

and

1

Parliament and of the Council of 19 November 2008 on

) and in Directive 2008/98/EC of the European

waste

to

on the approximation of laws, regulations and administra­

Council

(

2

) should be used in this Regulation. The reference

Directive 86/609/EEC of 24 November 1986

tive provisions of the Member States regarding the protec­

tion of animals used for experimental and other scientific

purposes (

3

) should be clarified.

(

1

) OJ L 147, 31.5.2001, p. 1.

(

2

) OJ L 312, 22.11.2008, p. 3.

(

3

) OJ L 358, 18.12.1986, p. 1.

(18)

For the sake of consistency of Community legislation, the

definition of ‘aquatic animal’ as laid down in Council Direc­

tive

requirements

2006/88/EC of 24 October 2006 on animal health

thereof, and on the prevention and control of certain dis­

for aquaculture animals and products

eases in aquatic animals

tion. At the same time, aquatic invertebrates which are not

(

4

) should be used in this Regula­

covered by that definition and which pose no risk of dis­

ease

ments as aquatic animals.

transmission should be subject to the same require­

(19)

Council

landfill of waste

Directive 1999/31/EC of 26 April 1999 on the

of a permit for a landfill. This Regulation should provide

(

5

) specifies the conditions for the issuing

for

which such a permit has been issued.

the disposal of animal by-products on landfills for

(20)

The primary responsibility for carrying out operations in

accordance

tors.

risks to public and animal health requires that a collection

At the

with

same

this

time,

Regulation

the public

should

interest

rest

in

with

preventing

opera­

and disposal system is in place to ensure the safe use or the

safe

used,

disposal of animal by-products which may not be

scope

or

into

of

which

the collection

are not used for economic reasons. The

which accrue in the particular Member State. It should also

account the actual

and

amount

disposal

of animal

system should

by-products

take

reflect, on a precautionary basis, the need for extended dis­

posal capacities in the event of major outbreaks of trans­

missible

existing disposal facility. Member States should be permit­

diseases or of temporary technical failures in an

ted to cooperate with each other and third countries pro­

vided that the objectives of this Regulation are met.

(21)

It

cycle of animal by-products from which the requirements

is important to determine the starting point in the life

of

become

this Regulation

food chain. Special circumstances apply for the handling of

an animal by-product,

should apply.

it should

Once

not

a product

re-enter

has

the

certain raw materials, such as hides, handled in establish­

ments or plants integrated at the same time into the food

chain and the animal by-products chain. In those cases, the

necessary measures should be taken by means of segrega­

tion

can

ments, risk-based conditions should be determined to pre­

arise

to mitigate

from cross-contamination.

potential risks for the

For

food

other

chain

establish­

which

vent cross-contamination, in particular through separation

between the animal by-products chain and the food chain.

(22)

For reasons of legal certainty and proper control of poten­

tial risks, an end point in the manufacturing chain should

be determined for products which no longer have direct

(

4

) OJ L 328, 24.11.2006, p. 14.

(

5

) OJ L 182, 16.7.1999, p. 1.

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OfficialJournaloftheEuropeanUnion14.11.2009

relevance for the safety of the feed chain. For certain prod­

ucts regulated under other Community legislation, such an

end point should be determined at the stage of manufac­

turing. Products which have reached this end point should

be exempt from controls under this Regulation. In particu­

lar, products beyond the end point should be allowed to be

placed on the market without restriction under this Regu­

lation

which have not been approved or registered in accordance

and to be handled and transported by operators

with this Regulation.

(23)

However,

point,

it should be possible to modify such

Regulation (EC) No 1774/2002 exempts certain products,

particularly in the case of newly emerging

an

risks.

end

notably guano, certain hides to which particular forms of

treatment such as tanning have been applied, and certain

game trophies from its requirements. Similar exemptions

should

be adopted under this Regulation for products such as ole­

be provided for in the implementing measures to

ochemical

the production of biodiesel, under appropriate conditions.

products and the end products resulting from

(24)

In order to ensure a high level of protection of public and

animal health, Member States should continue to take the

necessary

by-products from restricted areas or establishments, in par­

measures to prevent the dispatch of animal

ticular

Council

in the event of an outbreak of a

introducing general Community measures for the control

Directive 92/119/EEC of 17 December

disease listed

1992

in

of certain animal diseases and specific measures relating to

swine vesicular disease (

1

).

(25)

Operations

considerable

with

should

degree

animal by-products which give rise to a

which have been approved in advance for such operations

only be carried

of risk

out

to

in

public

establishments

and animal

or

health

plants

by the competent authority. That condition should apply

in

other establishments or plants which handle or store ani­

particular to processing establishments or plants and

mal

the

by-products

by-products

feed chain.

with

the

of more

It should

a direct relevance for the safety of

than one

be

category

permitted

to be

for

handled

animal

contamination is prevented. It should further be permitted

same establishment or plant provided cross-

in

to

disposal

amend

disease, provided it is ensured that the temporary use under

and

those

processing

conditions

rises

if

due

the amount

to a major

of material

outbreak

for

of

such amended conditions does not lead to the propagation

of disease risks.

(26)

However,

establishments

such approvals should not be necessary for

safe materials, such as products processed to such an extent

or plants which process or handle certain

that they no longer pose a risk to public and animal health.

(

1

) OJ L 62, 15.3.1993, p. 69.

Such establishments or plants should be registered so as to

permit official control over the flow of material and ensure

their

apply also to operators who transport animal by-products

traceability. That registration requirement should

or

any

derived

determined.

control

products,

since an

unless

end point

they are

in

no

the

longer

chain

subject

has been

to

(27)

Establishments or plants should be approved following the

submission of information to the competent authority and

following

that the requirements of this Regulation for the infrastruc­

a visit carried out on site which demonstrates

ture and equipment of the establishment or plant will be

met, so that any risks to public and animal health arising

from

should be possible to grant the approvals conditionally in

the process used will be adequately contained. It

order to allow operators to rectify deficiencies before the

establishment or plant obtains full approval.

(28)

Establishments

been approved in accordance with Community legislation

or plants whose operations have already

on food hygiene should not be required to be approved or

registered under this Regulation, as approvals or registra­

tions

account the objectives of this Regulation. However, estab­

under that Community legislation already take into

lishments

tered

comply with the requirements of this Regulation and sub­

under

or plants

hygiene

which

legislation

have been

should

approved

be obliged

or regis­

to

ject to official controls carried out for the purposes of veri­

fying compliance with the requirements of this Regulation.

(29)

Animal by-products and derived products should be clas­

sified into three categories which reflect the degree of risk

that they pose to public and animal health, on the basis of

risk

products posing a high risk should only be used for pur­

assessments. While animal by-products and derived

poses outside the feed chain, their use posing a lower risk

should be permitted under safe conditions.

(30)

Progress in science and technology may lead to the devel­

opment of processes which eliminate or minimise the risks

to

animal

public and animal health. Amendments to the lists of

possible, in order to take account of such progress. Prior to

by-products set out in this Regulation should be

any such amendments, and in accordance with the general

principles

high level of protection of public and animal health, a risk

of Community legislation aimed at ensuring a

assessment should be carried out by the appropriate scien­

tific

Agency

institution,

ucts,

or the Scientific

such as

Committee

EFSA, the European

for Consumer

Medicines

which risks are to be assessed. However, it should be clear

depending on the type of animal by-products

Prod­

for

that

mixed, the mixture should be handled in accordance with

once animal by-products of different categories are

the standards laid down for the proportion of the mixture

belonging to the highest risk category.

14.11.2009

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OfficialJournaloftheEuropeanUnionL300/5

(31)

Due to the high risk to public health, animal by-products

giving rise to a risk of transmissible spongiform encepha­

lopathy

This restriction should also apply to wild animals through

(TSE) should, in particular, not be used for feed.

which

restriction on the feeding of animal by-products giving rise

a communicable disease may be transmitted. The

to

rules laid down in Regulation (EC) No 999/2001.

a TSE risk should be without prejudice to the feeding

(32)

Animal by-products from animals used for experiments as

defined in Directive 86/609/EEC should also be excluded

from

those

use in feed, due to

allow the use of animal by-products from animals which

animal by-products.

the

However,

potential

Member

risks arising

States

from

may

have been used for experiments to test new feed additives,

in accordance with Regulation (EC) No 1831/2003 of the

European Parliament and of the Council of 22 September

2003 on additives for use in animal nutrition (

1

).

(33)

The

under

use of certain substances and products is unlawful

1990 laying down a Community procedure for the estab­

Council Regulation (EEC) No 2377/90 of 26 June

lishment of maximum residue limits of veterinary medici­

nal products in food stuffs of animal origin

Directive 96/22/EC of 29 April 1996 concerning the pro­

(

2

) and Council

hibition on the use in stockfarming of certain substances

having

nists

29 April 1996 on measures to monitor certain substances

(

).

a hormonal

In addition,

or thyrostatic

Council Directive

action and

96/23/EC

of ß ago­

3

of

and residues thereof in live animals and animal products

lays down further rules on the monitoring of certain sub­

(

4

)

stances

products. Directive 96/23/EC also lays down rules which

and residues thereof in live animals and animal

apply

stances

where the presence of residues

els has been established. In order to ensure the coherence

or contaminants exceeding certain

of authorised

permitted

sub­

lev­

of

which

Community legislation, products

(EEC) No 2377/90 and Directives 96/22/EC and 96/23/EC

substances are detected in breach

of animal

of Regulation

origin in

should be classified as Category 1 or Category 2 material,

as

and feed chain.

appropriate, in view of the risk they pose to the food

(34)

Manure and digestive tract content should not need to be

disposed

diseases

land.

are

of, provided

not transmitted

that proper

during

treatment

their application

ensures that

to

and

not be used in the feed chain. This restriction should also

animals

Animal

killed

by-products

for the

from

eradication

animals

of

that

diseases

die on

should

farm

apply to imported animal by-products which are allowed

into the Community, where they do not comply with

(

1

) OJ L 268, 18.10.2003, p. 29.

(

2

) OJ L 224, 18.8.1990, p. 1.

(

3

) OJ L 125, 23.5.1996, p. 3.

(

4

) OJ L 125, 23.5.1996, p. 10.

Community legislation upon inspection at the Community

border

the

within

applicable

post, and

requirements

to products which

during

do

checks

not comply

carried

with

out

2000/13/EC of the European Parliament and of the Coun­

the Community. Non-compliance with Directive

cil of 20 March 2000 on the approximation of the laws of

the

and advertising of foodstuffs

Member States relating to the labelling, presentation

No 767/2009 of the European Parliament and of the Coun­

(

5

) and with Regulation (EC)

cil of 13 July 2009 on the placing on the market and use

of feed (

6

chain of products presented for border inspection.

) should not result in the exclusion from the feed

(35)

Since

No

the date of entry into force

by-products by default as Category 2 material limits their

1774/2002, the classification

of

of

Regulation

certain animal

(EC)

possible uses severely, while not necessarily being propor­

tionate

by-products should be reclassified as Category 3 material,

to the risks involved. Accordingly those animal

so

any

as to allow their

one of the three categories, the categorisation by default as

other animal by-products

use for certain

which

feeding

are not

purposes.

listed under

For

Category 2 material should be maintained for precaution­

ary reasons, in particular to reinforce the general exclusion

of such material from the feed chain for farmed animals,

other than fur animals.

(36)

Other

the adoption of Regulation (EC) No 178/2002 of the Euro­

legislation which has entered into force following

pean

laying

Parliament and of the Council of 28

food law, establishing the European Food Safety Authority

down the general principles and requirements

January 2002

of

and laying down procedures in matters of food safety (

7

namely Regulation (EC) No 852/2004 of the European Par­

),

liament

hygiene

and of the Council of 29 April 2004 on the

and Regulation (EC) No 183/2005 of the European Parlia­

of foodstuffs (

8

), Regulation (EC) No 853/2004

ment and of the Council of 12 January 2005 laying down

requirements for feed hygiene

(EC) No 1774/2002 is complementary, places the primary

(

9

), and to which Regulation

duty of complying with Community legislation, aimed at

protecting public and animal health, on the food and feed

business operators. In line with that legislation, operators

carrying out activities under this Regulation should also be

primarily

Regulation. That obligation should be further clarified and

responsible for ensuring compliance with this

specified

ensured, such as separate collection and channelling of ani­

as regards the means by which traceability is

mal by-products. Established systems ensuring traceability

for products exclusively circulating at national level by

(

5

) OJ L 109, 6.5.2000, p. 29.

(

6

) OJ L 229, 1.9.2009, p. 1.

(

7

) OJ L 31, 1.2.2002, p. 1.

(

8

) OJ L 139, 30.4.2004, p. 1.

(

9

) OJ L 35, 8.2.2005, p. 1.

L300/6

EN

OfficialJournaloftheEuropeanUnion14.11.2009

other

equivalent

means

promote

mentation which do not involve paper records, as long as

the

information.

should continue to operate, if they provide

use of electronic

Every

and

effort

other

should

means

be made

of docu­

to

they ensure full traceability.

(37)

A system of own checks is necessary to ensure that, within

an establishment or plant, the requirements of this Regu­

lation are fulfilled. During official controls the competent

authorities

own checks. In certain establishments or plants own checks

should take into account the performance of

should be carried out through a system based on the haz­

ard analysis and critical control points (HACCP) principles.

The HACCP principles should be based on the experience

of their implementation under Community legislation on

food

good practice could serve as a useful tool to facilitate the

and feed hygiene. In this respect, national guides to

practical implementation of the HACCP principles, and of

other aspects of this Regulation.

(38)

Animal

public

by-products should only be used if the risks to

their processing and the placing on the market of derived

and animal health are minimised in the course of

products manufactured on the basis of animal by-products.

If

should be disposed of under safe conditions. The options

this option is not available, the animal by-products

available for the use of animal by-products of the different

categories

Community legislation. In general, the options for a higher

should be clarified in coherence with other

risk category should be available for the lower risk catego­

ries as well, unless special considerations apply in view of

the risk attached to certain animal by-products.

(39)

Disposal

should take place in accordance with environmental legis­

of animal by-products and derived products

lation regarding landfilling and waste incineration. In order

to

accordance

ensure consistency,

Parliament and of the Council of 4 December 2000 on the

with Directive

incineration

2000/76/EC

should

of the

take

European

place in

incineration of waste (

1

as a recovery or disposal operation – is subject to similar

). Co-incineration of waste – either

conditions

regarding

regarding approval and operation to

sion limit values, waste water and residue discharge, con­

waste incineration, in particular as to air

those

emis­

trol

Consequently,

and monitoring and measurement requirements.

cessing, of all three categories of materials should be per­

direct co-incineration, without prior pro­

mitted. In addition, specific provisions should be enacted

for

plants.

the approval of low and high-capacity incineration

(40)

The use of animal by-products or derived products as a fuel

in the combustion process should be authorised and

(

1

) OJ L 332, 28.12.2000, p. 91.

should

However,

not

which ensure the protection of public and animal health,

such

be considered

use should

as

take

a waste

place

disposal

under conditions

operation.

as well as the appropriate environmental standards.

(41)

This

down parameters for processing methods regarding time,

Regulation should provide for the possibility to lay

temperature and pressure for animal by-products, in par­

ticular for the methods currently referred to as methods 2

to 7 under Regulation (EC) No 1774/2002.

(42)

Shells

have been removed, should be excluded from the scope of

from shellfish from which the soft tissue or flesh

the

munity regarding the removal of such soft tissue or flesh

Regulation. Due to the various practices in the Com­

from shells, it should be possible to use shells from which

the entire soft tissue or flesh has not been removed, pro­

vided such use does not lead to a risk arising to public and

animal health. National guides to good practice could assist

in the dissemination of knowledge regarding proper con­

ditions under which such use would be possible.

(43)

In view of the limited risk to public or animal health aris­

ing

be

land

able

from

to

such

authorise

products,

the

the

preparation

competent

and

authority

application

should

egory 2 and Category 3 materials, as referred to in Council

of biodynamic preparations, on the basis of Cat­

to

Regulation (EC) No 834/2007 of 28 June 2007 on organic

production and labelling of organic products (

2

).

(44)

Novel technologies which are being developed offer advan­

tageous ways of generating energy on the basis of animal

by-products

products.

or of providing for the safe disposal

nation

by-products on site with established disposal methods, and

of

Safe

methods

disposal

for

may

the

take

safe

place

containment

through

of

a

of

combi­

such

animal

through

eters

a combination of authorised processing

assessed. In order to take account of the related progress in

with new standards which have been favourably

param­

science

authorised as alternative methods for the disposal or use of

and technology, such technologies should be

animal by-products throughout the Community. If a tech­

nological process has been developed by an individual, an

application checked by the competent authority should be

examined by EFSA before such authorisation is granted, in

order

potential of the process is carried out and that the rights of

to ensure that an assessment of the risk reduction

individuals, including the confidentiality of business infor­

mation,

cants a standard format for application should be adopted.

is preserved. In order to provide advice to appli­

Since

should be adopted in accordance with the advisory proce­

that document is intended only to be indicative it

dure in collaboration with EFSA.

(45)

It

the

is

placing

appropriate

on the

to clarify

market

the

of

requirements

animal by-products

applicable

and

to

(

2

) OJ L 189, 20.7.2007, p. 1.

14.11.2009

EN

OfficialJournaloftheEuropeanUnionL300/7

derived

organic

products

protection

fertilisers

material should be used for feeding farmed animals other

of the

and

intended

food

soil

and

improvers,

for feeding purposes and of

feed chain.

so

Only

as to

Category

ensure the

3

than fur animals. Fertilisers produced on the basis of ani­

mal by-products may affect the safety of the feed and food

chain.

and-bone meal derived from Category 2 material or from

Where they have been manufactured from meat-

processed animal protein, a component, such as an inor­

ganic

order to prevent their direct use for feeding purposes. Such

or an indigestible substance, should be added in

mixing should not be required if the composition or pack­

aging

use by the final consumer, prevents the misuse of the prod­

of products, in particular of products destined for

uct

nents,

for feeding purposes. When

and the objective for the use of particular fertilisers should

different circumstances regarding

determining

climate

the

and

compo­

soil

be taken into account.

(46)

Regulation

ment

the

from,

placing

and of

(EC)

on

the

No

the

Council

1523/2007

market

of

and

11 December

of the European Parlia­

the import

2007

to, or

banning

export

containing such fur

the Community

the placing on the market and the import and export of cat

(

) lays down a general prohibition on

of cat and dog fur, and products

1

and

that prohibition should not affect the obligation under this

dog fur and products containing such fur. However,

Regulation to dispose of animal by-products from cats and

dogs, including fur.

(47)

The promotion of science and research, and artistic activi­

ties may require the use of animal by-products or derived

products

the scale of commercial exchanges. In order to facilitate the

of all categories, sometimes in quantities below

import

products, the competent authority should be able to fix the

and use of such animal by-products or derived

conditions

Harmonised conditions should be laid down where action

for such operations on a case-specific basis.

at a Community level is necessary.

(48)

Regulation

sions

(EC) No 1774/2002 contains detailed provi­

Category 2 and Category 3 materials to zoo animals. Simi­

which allow, by way of derogation, the feeding of

lar provisions should be laid down in this Regulation and

the

allowed and complemented by the possibility to lay down

feeding of certain Category 1 material should be

detailed rules to control any possible risks arising to pub­

lic or animal health.

(49)

Regulation

Category 1 material to endangered or protected species of

(EC) No 1774/2002 allows for the feeding of

necrophagous birds and other species living 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 feeding practice should continue to be permitted

(

1

) OJ L 343, 27.12.2007, p. 1.

under this Regulation, in accordance with conditions laid

down to prevent the spread of diseases. At the same time,

health conditions should be laid down in the implement­

ing measures permitting the use of such Category 1 mate­

rial for feeding purposes in extensive grazing systems and

for

wolves.

feeding to other carnivore species, such as bears and

into account the natural consumption patterns of the spe­

It is important that such health conditions take

cies

promotion of biodiversity as referred to in the Communi­

concerned as well as Community objectives for the

cation

‘Halting the loss of biodiversity by 2010 – and beyond’.

from the Commission of 22 May 2006 entitled

(50)

Burial and burning of animal by-products, in particular of

dead animals may be justified in specific situations, in par­

ticular

requiring the emergency disposal of the animals killed as a

in remote areas, or in disease control situations

measure to control an outbreak of a serious transmissible

disease.

under special circumstances, since the available rendering

In particular, disposal on site should be allowed

or incinerator capacity within a region or a Member State

could

disease.

otherwise be a limiting factor in the control of a

(51)

The current derogation concerning burial and burning of

animal

access

by-products should be extended to areas where

health

is

gained

and

not

safety

practically

of the

possible

collection

or presents a risk to the

No

fires and floods in certain Member States has shown that

1774/2002

with the

and with

application

personnel.

natural disasters

of Regulation

Experience

such as forest

(EC)

under

or burning on site can be justified so as to ensure the swift

such exceptional circumstances, disposal by burial

disposal

ease

State

risks.

of

The

animals

overall

and

size

to avoid

of remote

the propagation

areas in a

of dis­

gained

should

No 999/2001 so as to ensure that the general obligation to

with

be

the

limited,

application

on the basis

of

of

Regulation

the experience

Member

(EC)

have

with the rules laid down in this Regulation is fulfilled.

in place a proper disposal system which complies

(52)

Certain establishments or plants which handle only small

quantities of animal by-products which do not pose a risk

to public and animal health should be allowed to dispose

of such by-products by means other than disposal in accor­

dance

However,

with

should be laid down at Community level, so as to ensure

the

this

criteria

Regulation,

for such

under

exceptional

official

circumstances

supervision.

their uniform application, based on the actual situation of

certain

tems in certain Member States.

sectors and the availability of other disposal sys­

(53)

The

authority

possible

should

can

courses

take when

of action

carrying

which

out official

the competent

controls

particular

be specified

regarding

in order

the suspension

to ensure legal

or

certainty,

permanent

in

L300/8

EN

OfficialJournaloftheEuropeanUnion14.11.2009

prohibition of operations or the imposition of conditions

to ensure the proper application of this Regulation. These

official controls should be carried out in the framework of

multi-annual

No 882/2004 of the European Parliament and of the Coun­

control plans under Regulation (EC)

cil

ensure

of 29

law, animal health and animal welfare rules

the

April

verification

2004 on

of compliance

official controls

with feed

performed

(

and food

to

1

).

(54)

In

quantity of material which is introduced for disposal into

order to ensure that Member States may control the

their

the receipt of such material to its territory.

territory, the competent authority should authorise

(55)

Pressure

may

sterilisation

risks.

be imposed so as

and

to

auxiliary

ensure the

transport

control of

conditions

between the competent authorities of Member States con­

In order to ensure traceability and cooperation

possible

trolling

products,

the dispatch of

Decision 2004/292/EC

the Traces system

animal by-products or derived

mation

(

introduced by Commission

2

materials

on

from Category 1 and Category 2 materials, and processed

and

the

meat-and-bone

dispatch

) should be used to provide infor­

of Category

meal or

1

animal

and Category

fat derived

2

animal

materials

protein derived from Category 3 material. For

educational,

typically

should

artistic

sent

or diagnostic

in small quantities

use, special

for

conditions

research,

materials

be

facilitating

within

laid down

the Community.

to facilitate the movement of such

Member

mitted under special circumstances.

States

the control

sharing a

of

common

materials

Bilateral

border

moved

arrangements

should

between

be per­

the

(56)

In order to facilitate the transport of consignments through

third countries neighbouring more than one Member State,

a special regime for the dispatch of consignments from the

territory of one Member State to another through the ter­

ritory of a third country should be introduced in order to

ensure, in particular, that consignments re-entering Com­

munity territory are subject to veterinary checks in accor­

dance with Council Directive 89/662/EEC of 11 December

1989

trade

concerning

market

with

(

a view

veterinary

to the completion

checks in intra-Community

of the internal

3

).

(57)

For the sake of coherence of Community legislation, it is

necessary to clarify the relationship between the rules laid

down in this Regulation and Community legislation on

(

1

) OJ L 165, 30.4.2004, p. 1.

(

2

) OJ L 94, 31.3.2004, p. 63.

(

3

) OJ L 395, 30.12.1989, p. 13.

waste.

the prohibitions on waste exports laid down in Regulation

In particular, consistency should be ensured with

(EC) No 1013/2006 of the European Parliament and of the

Council

order

environment, the export of animal by-products and derived

to

of

prevent

14 June

potentially

2006 on

detrimental

shipments of

effects

waste

for

(

4

).

the

In

products destined for disposal by incineration and by land­

fill should be prohibited. The export of animal by-products

and derived products should also be prevented where the

objective is to use them in a biogas or composting plant to

third countries which are not members of the Organisation

for

order

Economic Cooperation and Development (OECD), in

impacts

to

applying the provisions to derogate from the export ban,

and

prevent

risks to

potentially

public and

adverse

animal

environmental

health. When

the Commission is obliged to fully respect in its decisions

the

movements of hazardous waste and their disposal, as con­

Basel Convention on the control of transboundary

cluded, on behalf of the Community, by Council Decision

93/98/EEC

down in Decision III/1 of the Conference of the Parties, as

(

5

), and the amendment to this Convention laid

approved, on behalf of the Community, by Council Deci­

sion

No 1013/2006.

97/640/EC (

6

), and implemented by Regulation (EC)

(58)

In addition, it should be ensured that animal by-products

mixed or contaminated with hazardous waste, as listed in

Commission

replacing

pursuant to Article 1(a) of Council Directive 75/442/EEC

Decision

Decision

94/3/EC

2000/532/EC

establishing

of

a

3

list

May

of wastes

2000

on

list of hazardous waste pursuant to Article 1(4) of Council

waste and Council Decision 94/904/EC establishing a

Directive

imported, exported or dispatched between Member States

91/689/EEC on hazardous waste (

7

) are only

in

also necessary to lay down rules concerning the dispatch

accordance with Regulation (EC) No 1013/2006. It is

of such material within a Member State.

(59)

The

Member

Commission should be able to carry out controls in

should be carried out in accordance with Regulation (EC)

States. Community controls in third countries

No 882/2004.

(60)

The

into the Community and the transit of such material should

import of animal by-products and derived products

take

strict as those applicable within the Community. Alterna­

place in accordance with rules which are at least as

tively,

derived products in third countries may be recognised to

the rules applicable to animal by-products and

be equivalent to the rules laid down in Community legis­

lation. Due to the potential risk arising from them, a sim­

plified set of import rules should be applicable to products

which are destined for uses outside the feed chain.

(

4

) OJ L 190, 12.7.2006, p. 1.

(

5

) OJ L 39, 16.2.1993, p. 1.

(

6

) OJ L 272, 4.10.1997, p. 45.

(

7

) OJ L 226, 6.9.2000, p. 3.

14.11.2009

EN

OfficialJournaloftheEuropeanUnionL300/9

(61)

Community

products intended for use as cosmetic products, medicinal

legislation on the manufacture of derived

products

framework for the placing on the market of such products:

or medical devices comprises a comprehensive

Council

approximation

Directive 76/768/EEC of 27 July 1976 on the

cosmetic products

of laws of the Member States relating to

pean Parliament and of the Council of 6 November 2001

(

1

), Directive 2001/83/EC of the Euro­

on the Community code relating to medicinal products for

human use (

2

liament

Community

and of

), Directive 2001/82/EC of the European Par­

the Council of 6 November 2001

ucts

the approximation of the laws of the Member States relat­

(

code relating to veterinary medicinal

on

prod­

the

3

), Council Directive 90/385/EEC of 20 June 1990 on

ing

Directive 93/42/EEC of 14 June 1993 concerning medical

to active implantable medical devices (

4

), Council

devices (

5

ment and of the Council of 27 October 1998 on in vitro

) and Directive 98/79/EC of the European Parlia­

diagnostic

However, the specific Directives on cosmetic products and

medical devices (

6

) (the specific Directives).

medical devices do not provide for protection against risks

to

apply to those risks and recourse to safeguard measures in

animal health. In such cases, this Regulation should

accordance with Regulation (EC) No 178/2002 should be

possible.

(62)

Animal by-products or derived products that are supplied

as

derived

material

ments of the specific Directives, in so far as they lay down

products

or ingredients

should also

for

be

the

subject

manufacture

to the

of

require­

such

rules controlling risks to public and animal health. Those

specific Directives already regulate starting material of ani­

mal origin which may be used for the manufacture of the

derived products referred to and impose certain conditions

to ensure the protection of public or animal health. In par­

ticular, Directive 76/768/EEC excludes Category 1 and Cat­

egory 2 materials as part of the composition of a cosmetic

product

facturing practices. Commission Directive 2003/32/EC

and obliges manufacturers to apply good manu­

introduces

(

7

)

devices manufactured utilising tissues of animal origin.

detailed specifications with respect to medical

(63)

However,

down in the specific Directives or where they do not cover

where those conditions have not yet been laid

certain

should apply, and recourse to safeguard measures in accor­

risks to public and animal health, this Regulation

dance

possible.

with Regulation (EC) No 178/2002 should be

(64)

Certain derived products do not enter the feed chain or are

not applied to land which is grazed by farmed animals or

from which herbage for feed is cut. Such derived products

(

1

) OJ L 262, 27.9.1976, p. 169.

(

2

) OJ L 311, 28.11.2001, p. 67.

(

3

) OJ L 311, 28.11.2001, p. 1.

(

4

) OJ L 189, 20.7.1990, p. 17.

(

5

) OJ L 169, 12.7.1993, p. 1.

(

6

) OJ L 331, 7.12.1998, p. 1.

(

7

) OJ L 105, 26.4.2003, p. 18.

include

for

industry,

leather

products

destined

bone

production,

for technical uses, such as treated hides

products

processed

for glue and

wool

processed

for the

material

textile

place such products on the market provided that they are

for petfood. Operators should be permitted to

either derived from raw material requiring no treatment or

the treatment or the end use of the treated material ensures

adequate risk control.

(65)

Certain

Regulation

failures

number of Member States. Accordingly, in addition to the

(EC)

to

No

comply

1774/2002

with

have

the rules

been

laid

revealed

down

in

in

a

strict enforcement of those rules, criminal and other sanc­

tions

rules

against

States

are needed.

operators

Therefore,

which

it

do

is necessary

not comply with those

ments of this Regulation.

lay down rules on penalties applicable

that

to infringe­

Member

(66)

Since the objective of this Regulation, namely to lay down

public and animal health rules for animal by-products and

derived products in order to prevent and minimise risks to

public and animal health arising from those products and,

in

chain,

particular, to protect the safety of the

States and can therefore be better achieved at Community

cannot be sufficiently achieved by

food

the

and

Member

feed

level, the Community may adopt measures, in accordance

with the principle of subsidiarity as set out in Article 5 of

the Treaty. In accordance with the principle of proportion­

ality, as set out in that Article, this Regulation does not go

beyond what is necessary in order to achieve that objective.

(67)

In order to enhance legal certainty and in the light of the

Commission’s

legislation,

general objective to simplify Community

down in this Regulation, taking into account the rules laid

a coherent framework of rules should be laid

down

experience

in Regulation

entry

gained and

(EC)

progress

No 1774/2002,

made

as well as the

No 1774/2002 should therefore be repealed and replaced

into force of that Regulation.

since

Regulation

the date

(EC)

of

by this Regulation.

(68)

The

Regulation should be adopted in accordance with Council

measures necessary for the implementation of this

Decision 1999/468/EC of 28 June 1999 laying down the

procedures for the exercise of implementing powers con­

ferred on the Commission (

8

).

(69)

In order to improve coherence and clarity of Community

legislation,

tions involving

the technical

animal by-products,

rules concerning

which

specific

are currently

opera­

(

8

) OJ L 184, 17.7.1999, p. 23.

L300/10

EN

OfficialJournaloftheEuropeanUnion14.11.2009

laid

No

adopted

1774/2002,

down in

as

the

well

Annexes

as in

to Regulation (EC)

tion (

by the Commission on

implementing

the basis of that

measures

Regula­

1

acts.

socio-professional circles concerned with issues related to

Consultation

), should be laid

and

down

information

in separate

of consumers

implementing

and

this

Commission

Regulation

concerning the creation of an advisory group on the food

Decision

should be

2004/613/EC

carried out in

of

accordance

6 August 2004

with

chain and animal and plant health (

2

).

(70)

In

adopt rules modifying the end point in the manufacturing

particular, the Commission should be empowered to

chain of certain derived products and establishing such an

end point for certain other derived products, rules in regard

to serious transmissible diseases in the presence of which

the

should not be allowed and/or the conditions allowing such

dispatch of animal by-products and derived products

a dispatch, measures changing the categorisation of animal

by-products

restrictions on the use and disposal of animal by-products

and derived products, measures regarding

and

for the application of certain derogations regarding the use,

derived products, measures laying down conditions

collection and disposal of animal by-products and derived

products and measures authorising or rejecting a particu­

lar alternative method for the use and disposal of animal

by-products and derived products.

(71)

In

adopt more specific rules concerning collection and trans­

addition, the Commission should be empowered to

port of animal by-products and derived products, the infra­

structure,

establishments or plants handling animal by-products and

equipment and hygiene requirements for

derived

ments for the handling of animal by-products and derived

products, the conditions and technical require­

products,

purpose of validation of such treatment, conditions for the

including the evidence to be presented for the

placing on the market of animal by-products and derived

products, requirements related to safe sourcing, safe treat­

ment and safe end uses, conditions for the import, transit

and

detailed

export

arrangements

of animal by-products

for implementing

and derived

official

products,

controls

(

1

) Regulation (EC) No 811/2003 on the intra-species recycling ban for

fish,

(OJ L 117, 13.5.2003, p. 14); Decision 2003/322/EC on the feeding

and the burial and burning of certain animal by-products

of

(OJ L 117, 13.5.2003, p. 32); Decision 2003/324/EC on a derogation

certain necrophagous birds with certain Category 1 materials

from

13.5.2003, p. 37); Regulation (EC) No 92/2005 on means of disposal

the intra-species recycling ban for fur animals (OJ L 117,

or uses (OJ L 19, 21.1.2005, p. 27); Regulation (EC) No 181/2006 on

organic

2.2.2006, p. 31); Regulation (EC) No 1192/2006 on lists of approved

fertilisers and soil improvers other than manure (OJ L 29,

plants (OJ L 215, 5.8.2006, p. 10); Regulation (EC) No 2007/2006 on

the

from Category 3 material (OJ L 379, 28.12.2006, p. 98).

importation and transit of certain intermediate products derived

(

2

) OJ L 275, 25.8.2004, p. 17.

including

microbiological analyses as well as conditions for the con­

rules concerning the reference methods for

trol

derived products between Member States. Since those mea­

of the dispatch of certain animal by-products and

sures are of general scope and are designed to amend non-

essential

supplementing

elements of this Regulation, inter alia,

must be adopted in accordance with the regulatory proce­

it with new non-essential elements, they

by

dure with scrutiny provided for in Article 5a of Decision

1999/468/EC.

(72)

On

regulatory procedure with scrutiny should be curtailed for

grounds of efficiency, the normal time-limits for the

the adoption of measures specifying the conditions for the

dispatch

plants or zones. On grounds of urgency, it is necessary to

of animal by-products from restricted holdings,

apply the urgency procedure provided for in Article 5a(6)

of

modifying

Decision

certain products,

the

1999/468/EC

end point in

for

the

the

manufacturing

adoption of measures

chain for

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 prevent

and minimise risks to public and animal health arising from those

products, and in particular to protect the safety of the food and

feed chain.

Article 2

Scope

1. This Regulation shall apply to:

(a) animal by-products and derived products which are excluded

from

and

human consumption under Community legislation;

14.11.2009

EN

OfficialJournaloftheEuropeanUnionL300/11

(b) the

operator,

following

poses other than human consumption:

which

products

shall be

which

irreversible,

pursuant

are

to

destined

a decision

for

by

pur­

an

(i) products

human consumption under Community legislation;

of animal origin which may be destined for

(ii) raw materials for the production of products of animal

origin.

2.

by-products:

This Regulation shall not apply to the following animal

(a) entire bodies or parts of wild animals, other than wild game,

which are not suspected of being infected or affected with a

disease

aquatic animals landed for commercial purposes;

communicable to humans or animals, except for

(b) entire bodies or parts of wild game which are not collected

after killing, in accordance with good hunting practice, with­

out prejudice to Regulation (EC) No 853/2004;

(c) animal

meat

No 853/2004;

referred

by-products

to in

from

Article

wild

1(3)(e)

game and

of

from

Regulation

wild game

(EC)

(d) oocytes, embryos and semen destined for breeding purposes;

(e) raw milk, colostrum and products derived therefrom which

are obtained, kept, disposed of or used on the farm of origin;

(f) shells from shellfish with the soft tissue and flesh removed;

(g) catering waste, except if it:

(i) originates

internationally;

from means of transport operating

(ii) is destined for feeding purposes;

(iii) is destined for processing by pressure sterilisation or for

processing by methods referred to in point (b) of the first

subparagraph of Article 15(1) or for transformation into

biogas or for composting;

(h) without prejudice to Community environmental legislation,

material

No

the

852/2004

from

and

vessels

(EC)

complying

No

with Regulations (EC)

sea,

course

fish

except

of

material

their fishing

853/2004, which has arisen in

derived

operations and is disposed of at

communicable to humans;

showing signs of disease,

from

including

on-board

parasites,

evisceration

that are

of

(i) raw pet food originating from retail shops, where the cutting

and storage are performed solely for the purpose of supply­

ing the consumer directly on the spot;

(j) raw pet food derived from animals which are slaughtered on

the farm of origin for private domestic consumption; and

(k) excrement and urine other than manure and non-mineralised

guano.

3.

veterinary legislation having as its objective the control and eradi­

This Regulation shall be without prejudice to Community

cation of animal diseases.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall

apply:

1. ‘animal by-products’ means entire bodies or parts of animals,

products

animals,

including oocytes, embryos and semen;

which

of animal

are

origin

not intended

or other

for

products

human

obtained

consumption,

from

2. ‘derived

more

products’ means products obtained from one or

animal by-products;

treatments, transformations or steps of processing of

3. ‘products of animal origin’ means products of animal origin

as

No 853/2004;

defined in point 8.1 of Annex I to Regulation (EC)

4. ‘carcase’ means carcase as defined in point 1.9 of Annex I to

Regulation (EC) No 853/2004;

5. ‘animal’ means any invertebrate or vertebrate animal;

6. ‘farmed animal’ 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 obtained from animals or

for other farming purposes;

(b) equidae;

7. ‘wild animal’ means any animal not kept by humans;

8. ‘pet animal’ means any animal belonging to species normally

nourished and kept but not consumed, by humans for pur­

poses other than farming;

9. ‘aquatic

Article 3(1)(e) of Directive 2006/88/EC;

animals’ means aquatic animals as defined in

10. ‘competent authority’ means the central authority of a Mem­

ber State competent to ensure compliance with the require­

ments

competence

of this Regulation or any authority

appropriate, the corresponding authority of a third country;

has been delegated; it also includes,

to which

where

that

11. ‘operator’ means the natural or legal persons having an ani­

mal by-product or derived product under their actual control,

including carriers, traders and users;

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12. ‘user’

by-products

means the natural or legal persons using animal

poses, for research or for other specific purposes;

and derived products for special feeding pur­

13. ‘establishment’ or ‘plant’ means any place where any 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 animal by-products or derived products to a

third

against

party

storage with a view to supply to such a third party;

payment

in the

or

Community

free of charge

or any

to

other

such a

form

third

of

party

supply

or

15. ‘transit’ means movement through the Community from the

territory of a third country to the territory of another third

country, other than by sea or by air;

16. ‘export’

country;

means movement from the Community to a third

17. ‘transmissible spongiform encephalopathies (TSEs)’ means all

transmissible

Article 3(1)(a) of Regulation (EC) No 999/2001;

spongiform encephalopathies as defined in

18. ‘specified

defined in Article 3(1)(g) of Regulation (EC) No 999/2001;

risk material’ means specified risk material as

19. ‘pressure

by-products, after reduction in particle size to not more than

sterilisation’ means the processing of animal

50 mm,

least 20 minutes without interruption at an absolute pressure

to a core temperature of more than 133 °C for at

of at least 3 bar;

20. ‘manure’

mals other than farmed fish, with or without litter;

means any excrement and/or urine of farmed ani­

21. ‘authorised

been issued in accordance with Directive 1999/31/EC;

landfill’ means a landfill for which a permit has

22. ‘organic fertiliser’ and ‘soil improver’ means materials of ani­

mal origin used to maintain or improve plant nutrition and

the physical and chemical properties and biological activities

of

manure,

soils, either

compost and digestion residues;

non-mineralised

separately

guano,

or together;

digestive

they

tract

may

content,

include

23. ‘remote area’ means an area where the animal population is

so small, and where disposal establishments or plants are so

far away that the arrangements necessary for the collection

and transport of animal by-products would be unacceptably

onerous compared to local disposal;

24. ‘food’

Article 2 of Regulation (EC) No 178/2002;

or ‘foodstuff’ means food or foodstuff as defined in

25. ‘feed’ or ‘feedingstuff’ means feed or feedingstuff as defined in

Article 3(4) of Regulation (EC) No 178/2002;

26. ‘centrifuge or separator sludge’ means material collected as a

by-product

skimmed milk and cream from raw milk;

after purification of raw milk and separation of

27. ‘waste’

Directive 2008/98/EC.

means waste as defined in point 1 of Article 3 of

Section 2

Obligations

Article 4

Starting point in the manufacturing chain and obligations

1.

derived products falling within the scope of this Regulation, they

As soon as operators generate animal by-products or

shall identify them and ensure that they are dealt with in accor­

dance with this Regulation (starting point).

2.

handling, treatment, transformation, processing, storage, placing

Operators shall ensure at all stages of collection, transport,

on

nesses

the market, distribution, use and

products satisfy the requirements of this Regulation which are rel­

under their control that animal

disposal

by-products

within

and

the

derived

busi­

evant to their activities.

3.

requirements

Member States shall monitor and verify that

the

of this Regulation are fulfilled by operators

the relevant

along

referred to in paragraph 2. For that purpose, they shall maintain a

entire chain of animal by-products and derived products as

system of official controls in accordance with relevant Commu­

nity legislation.

4.

place on their territory ensuring that animal by-products are:

Member States shall ensure that an adequate system is in

(a) collected,

and

identified and transported without undue delay;

(b) treated,

Regulation.

used or disposed of in accordance with this

5.

graph

Member

countries.

4 in cooperation

States may

with

fulfil

other

their

Member

obligations

States

under

or

para­

third

Article 5

End point in the manufacturing chain

1.

reached the stage of manufacturing regulated by the Community

Derived products referred to in Article 33 which have

legislation referred to in that Article shall be regarded as having

reached the end point in the manufacturing chain, beyond which

they are no longer subject to the requirements of this Regulation.

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Those derived products may subsequently be placed on the mar­

ket without restrictions under this Regulation and shall no longer

be subject to official controls in accordance with this Regulation.

The end point in the manufacturing chain may be modified:

(a) for products referred to in Article 33(a) to (d), in case of risks

to animal health;

(b) for products referred to in Article 33(e) and (f), in case of risks

to public or animal health.

Those measures, designed to amend non-essential elements of this

Regulation,

procedure with scrutiny referred to in Article 52(6).

shall be adopted in accordance with the regulatory

2.

no longer pose any significant risk to public or animal health, an

For derived products referred to in Articles 35 and 36 which

end point in the manufacturing chain may be determined, beyond

which

Regulation.

they are no longer subject to the requirements of this

Those derived products may subsequently be placed on the mar­

ket without restrictions under this Regulation and shall no longer

be subject to official controls in accordance with this Regulation.

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be adopted

Article 52(5).

the regulatory procedure with scrutiny referred

in accordance

to in

3.

and 54 of Regulation (EC) No 178/2002 concerning emergency

In the event of risks to public or animal health, Articles 53

measures

referred to in Articles 33 and 36 of this Regulation.

shall apply mutatis mutandis to the derived products

Section 3

Animal health restrictions

Article 6

General animal health restrictions

1.

species

Animal by-products and derived products from susceptible

plants or zones which are subject to restrictions:

shall not be dispatched from holdings, establishments,

(a) pursuant to Community veterinary legislation; or

(b) due to the presence of a serious transmissible disease:

(i) listed in Annex I to Directive 92/119/EEC; or

(ii) laid down in accordance with the second subparagraph.

The measures referred to in point (b)(ii) of the first subparagraph,

designed to amend non-essential elements of this Regulation by

supplementing it, shall be adopted in accordance with the regu­

latory procedure with scrutiny referred to in Article 52(4).

2.

derived products are dispatched under conditions designed to pre­

Paragraph 1 shall not apply where animal by-products and

vent the spread of diseases transmissible to humans or animals.

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(5).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Section 4

Categorisation

Article 7

Categorisation of animal by-products and derived products

1.

egories which reflect the level of risk to public and animal health

Animal by-products shall be categorised into specific cat­

arising

lists laid down in Articles 8, 9 and 10.

from those animal by-products, in accordance with the

2.

cific category of animal by-products from which they have been

Derived products shall be subject to the rules for the spe­

derived, unless otherwise specified in this Regulation, or provided

for in measures for the implementation of this Regulation which

may specify the conditions under which derived products are not

subject to those rules adopted by the Commission.

3.

account scientific progress as regards the assessment of the level

Articles 8, 9 and 10 may be amended in order to take into

of risk, provided such progress can be identified on the basis of a

risk

tion. However, no animal by-products listed in those Articles may

assessment carried out by the appropriate scientific institu­

be

additions may be made.

removed from those lists, only changes of categorisation or

4.

amend

The measures referred to in paragraphs 2 and 3, designed to

supplementing it, shall be adopted in accordance with the regu­

non-essential elements of this Regulation, inter alia, by

latory procedure with scrutiny referred to in Article 52(4).

Article 8

Category 1 material

Category

by-products:

1 material shall comprise the following animal

(a) entire bodies and all body parts, including hides and skins, of

the following animals:

(i) animals

dance

suspected of being infected by a TSE in accor­

the presence of a TSE has been officially confirmed;

with Regulation (EC) No 999/2001 or in which

(ii) animals

measures;

killed in the context of TSE eradication

(iii) animals other than farmed and wild animals, including

in particular pet animals, zoo animals and circus animals;

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(iv) animals used for experiments as defined by Article 2(d)

of

Article 3(2) of Regulation (EC) No 1831/2003;

Directive 86/609/EEC without prejudice to

(v) wild animals, when suspected of being infected with dis­

eases communicable to humans or animals;

(b) the following material:

(i) specified risk material;

(ii) entire bodies or parts of dead animals containing speci­

fied risk material at the time of disposal;

(c) animal

submitted to illegal treatment as defined in Article 1(2)(d) of

by-products derived from animals which have been

Directive 96/22/EC or Article 2(b) of Directive 96/23/EC;

(d) animal by-products containing residues of other substances

and

Annex

environmental

permitted

I to

contaminants listed in Group B(3) of

the absence thereof, by national legislation;

level

Directive

laid down

96/23/EC,

by Community

if such residues

legislation

exceed

or,

the

in

(e) animal by-products collected during the treatment of waste

water required by implementing rules adopted under point (c)

of the first paragraph of Article 27:

(i) from

material; or

establishments or plants processing Category 1

(ii) from other establishments or plants where specified risk

material is being removed;

(f) catering

internationally;

waste from means of transport operating

(g) mixtures of Category 1 material with either Category 2 mate­

rial or Category 3 material or both.

Article 9

Category 2 material

Category

by-products:

2 material shall comprise the following animal

(a) manure, non-mineralised guano and digestive tract content;

(b) animal by-products collected during the treatment of waste

water required by implementing rules adopted under point (c)

of the first paragraph of Article 27:

(i) from

material; or

establishments or plants processing Category 2

(ii) from

Article 8(e);

slaughterhouses other than those covered by

(c) animal

stances

by-products

referred to in Article 15(3) of Directive 96/23/EC;

or contaminants

containing

exceeding

residues

the permitted

of authorised

levels

sub­

as

(d) products of animal origin which have been declared unfit for

human consumption due to the presence of foreign bodies in

those products;

(e) products

that are:

of animal origin, other than Category 1 material,

(i) imported or introduced from a third country and fail to

comply with Community veterinary legislation for their

import

where

or introduction into the Community

introduction

Community

return to the third country; or

subject

legislation

to specific

allows

restrictions

their import

except

or their

or

(ii) dispatched to another Member State and fail to comply

with requirements laid down or authorised by Commu­

nity legislation except where they are returned with the

authorisation

ber State of origin;

of the competent authority of the Mem­

(f) animals and parts of animals, other than those referred to in

Article 8 or Article 10,

(i) that

human

died other than by being slaughtered or

ease control purposes;

consumption, including animals killed

killed

for dis­

for

(ii) foetuses;

(iii) oocytes, embryos and semen which are not destined for

breeding purposes; and

(iv) dead-in-shell poultry;

(g) mixtures of Category 2 material with Category 3 material;

(h) animal

egory 3 material.

by-products other than Category 1 material or Cat­

Article 10

Category 3 material

Category

by-products:

3 material shall comprise the following animal

(a) carcases

game, bodies or parts of animals killed, and which are fit for

and parts of animals slaughtered or, in the case of

human

lation,

consumption in accordance with Community

commercial reasons;

but are not intended for human consumption

legis­

for

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(b) carcases and the following parts originating either from ani­

mals that have been slaughtered in a slaughterhouse and were

considered fit for slaughter for human consumption follow­

ing an ante-mortem inspection or bodies and the following

parts of animals from game killed for human consumption

in accordance with Community legislation:

(i) carcases

rejected as unfit for human consumption in accordance

or bodies and parts of animals which are

with

any

Community

animals;

signs of disease

legislation,

communicable

but which

to

did

humans

not show

or

(ii) heads of poultry;

(iii) hides

thereof, horns and feet, including the phalanges and the

and skins, including trimmings and splitting

carpus

bones, of:

and metacarpus bones, tarsus and metatarsus

—animals,

ing, and

other than ruminants requiring TSE test­

—ruminants

result in accordance with Article 6(1) of Regulation

which have been tested with a negative

(EC) No 999/2001;

(iv) pig bristles;

(v) feathers;

(c) animal

tered on the farm as referred to in Article 1(3)(d) of Regula­

by-products from poultry and lagomorphs slaugh­

tion

disease communicable to humans or animals;

(EC) No 853/2004, which did not show any signs of

(d) blood

communicable

of animals which

obtained from the following animals that have been slaugh­

through

did

blood

not show

to humans

any signs

or

of

animals

disease

tered in a slaughterhouse after having been considered fit for

slaughter for human consumption following an ante-mortem

inspection in accordance with Community legislation:

(i) animals other than ruminants requiring TSE testing; and

(ii) ruminants which have been tested with a negative result

in

No 999/2001;

accordance with Article 6(1) of Regulation (EC)

(e) animal by-products arising from the production of products

intended

bones, greaves and centrifuge or separator sludge from milk

for human consumption, including degreased

processing;

(f) products of animal origin, or foodstuffs containing products

of

consumption for commercial reasons or due to problems of

animal origin, which are no longer intended for human

manufacturing

which no risk to public or animal health arise;

or packaging defects or other defects from

(g) petfood

containing

and feedingstuffs of animal origin, or feedingstuffs

are no longer intended for feeding for commercial reasons or

animal by-products or derived products, which

due

other defects from which no risk to public or animal health

to problems of manufacturing or packaging defects or

arises;

(h) blood,

raw milk originating from live animals that did not show any

placenta, wool, feathers, hair, horns, hoof cuts and

signs

humans or animals;

of disease communicable through that product to

(i) aquatic animals, and parts of such animals, except sea mam­

mals, which did not show any signs of disease communicable

to humans or animals;

(j) animal

establishments or plants manufacturing products for human

by-products from aquatic animals originating from

consumption;

(k) the

not

following

material to humans or animals:

show any

material

signs of

originating

disease communicable

from animals

through

which

that

did

(i) shells from shellfish with soft tissue or flesh;

(ii) the following originating from terrestrial animals:

—hatchery by-products,

—eggs,

—egg by-products, including egg shells,

(iii) day-old chicks killed for commercial reasons;

(l) aquatic and terrestrial invertebrates other than species patho­

genic to humans or animals;

(m) animals and parts thereof of the zoological orders of Roden­

tia and Lagomorpha, except Category 1 material as referred

to in Article 8(a)(iii), (iv) and (v) and Category 2 material as

referred to in Article 9(a) to (g);

(n) hides and skins, hooves, feathers, wool, horns, hair and fur

originating from dead animals that did not show any signs of

disease

animals,

communicable

Article;

other than those

through

referred

that

to

product

in point

to humans

(b) of this

or

(o) adipose tissue from animals which did not show any signs of

disease

animals,

communicable through that material to humans

which were considered fit for slaughter for human consump­

which were slaughtered in a slaughterhouse and

or

tion

with Community legislation;

following an ante-mortem inspection in accordance

(p) catering waste other than as referred to in Article 8(f).

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CHAPTER II

Disposal and use of animal by-products and derived products

Section 1

Restrictions on use

Article 11

Restrictions on use

1.

ucts shall be prohibited:

The following uses of animal by-products and derived prod­

(a) the feeding of terrestrial animals of a given species other than

fur animals with processed animal protein derived from the

bodies or parts of bodies of animals of the same species;

(b) the

catering

feeding of farmed animals other than fur animals with

catering waste;

waste or feed material containing or derived from

(c) the feeding of farmed animals with herbage, either directly by

grazing or by feeding with cut herbage, from land to which

organic fertilisers or soil improvers, other than manure, have

been

the expiry of a waiting period which ensures adequate con­

applied unless the cutting or grazing takes place after

trol

days; and

of risks to public and animal health and is at least 21

(d) the

derived from the bodies or parts of bodies of farmed fish of

feeding of farmed fish with processed animal protein

the same species.

2. Measures relating to the following may be laid down:

(a) the checks and controls to be carried out to ensure the appli­

cation of the prohibitions referred to in paragraph 1, includ­

ing

presence

detection

thresholds

of materials

methods and tests to be used to verify the

proteins referred to in points (a) and (d) of paragraph 1 which

for insignificant

originating

amounts

from

of

certain

processed

species

animal

and

are

contamination;

caused by adventitious and technically unavoidable

(b) the conditions for the feeding of fur animals with processed

animal protein derived from bodies or parts of bodies of ani­

mals of the same species; and

(c) the conditions for the feeding of farmed animals with herb­

age from land to which organic fertilisers or soil improvers

have

ing period as referred to in paragraph 1(c).

been applied, in particular a modification of the wait­

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Section 2

Disposal and use

Article 12

Disposal and use of Category 1 material

Category 1 material shall be:

(a) disposed of as waste by incineration:

(i) directly without prior processing; or

(ii) following

competent authority so requires, and permanent mark­

processing, by pressure sterilisation if the

ing of the resulting material;

(b) recovered or disposed of by co-incineration, if the Category 1

material is waste:

(i) directly without prior processing; or

(ii) following

competent authority so requires, and permanent mark­

processing, by pressure sterilisation if the

ing of the resulting material;

(c) in the case of Category 1 material other than material referred

to in Article 8(a)(i) and (ii), disposed of by processing by pres­

sure sterilisation, permanent marking of the resulting mate­

rial and burial in an authorised landfill;

(d) in the case of Category 1 material referred to in Article 8(f),

disposed of by burial in an authorised landfill;

(e) used as a fuel for combustion with or without prior process­

ing; or

(f) used for the manufacture of derived products referred to in

Articles

dance with those Articles.

33, 34 and 36 and placed on the market in accor­

Article 13

Disposal and use of Category 2 material

Category 2 material shall be:

(a) disposed of as waste by incineration:

(i) directly without prior processing; or

(ii) following

competent authority so requires, and permanent mark­

processing, by pressure sterilisation if the

ing of the resulting material;

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(b) recovered or disposed of by co-incineration, if the Category 2

material is waste:

(i) directly without prior processing; or

(ii) following

competent authority so requires, and permanent mark­

processing, by pressure sterilisation if the

ing of the resulting material;

(c) disposed of in an authorised landfill, following processing by

pressure

ing material;

sterilisation and permanent marking of the result­

(d) used

improvers

for the

Article

to be

manufacturing

placed on

of organic fertilisers or soil

when

32 following processing

the market

by

in accordance with

material;

applicable, and permanent marking

pressure

of the

sterilisation,

resulting

(e) composted or transformed into biogas:

(i) following

manent marking of the resulting material; or

processing by pressure sterilisation and per­

(ii) in

milk,

the case of manure, digestive tract and its

products which the competent authority does not con­

milk-based products, colostrum, eggs and

content,

egg

sider to present a risk for the spread of any serious trans­

missible disease, following or without prior processing;

(f) applied

digestive

to land without processing, in the case

milk, milk-based products and colostrum which the compe­

tract content separated from the digestive

of manure,

tract,

tent

spread of any serious transmissible disease;

authority does not consider to present a risk for the

(g) in

ensiled, composted or transformed into biogas;

the case of material originating from aquatic animals,

(h) used as a fuel for combustion with or without prior process­

ing; or

(i) used for the manufacture of derived products referred to in

Articles

dance with those Articles.

33, 34 and 36 and placed on the market in accor­

Article 14

Disposal and use of Category 3 material

Category 3 material shall be:

(a) disposed of as waste by incineration, with or without prior

processing;

(b) recovered or disposed of by co-incineration, with or without

prior processing, if the Category 3 material is waste;

(c) disposed of in an authorised landfill, following processing;

(d) processed,

has

except in the case of Category 3 material which

present

changed

through that product, and used:

an unacceptable

through decomposition

risk to public

or

or

spoilage

animal

so

health,

as to

(i) for the manufacturing of feed for farmed animals other

than

dance

fur

referred to in Article 10(n), (o) and (p);

with

animals,

Article

to

31,

be placed

except

on

in

the

the

market

case of

in

material

accor­

(ii) for

placed on the market in accordance with Article 36;

the manufacturing of feed for fur animals, to be

(iii) for the manufacturing of pet food, to be placed on the

market in accordance with Article 35; or

(iv) for

improvers,

the manufacturing of organic

with Article 32;

to be placed on the market

fertilisers

in accordance

or soil

(e) used for the production of raw petfood, to be placed on the

market in accordance with Article 35;

(f) composted or transformed into biogas;

(g) in

ensiled, composted or transformed into biogas;

the case of material originating from aquatic animals,

(h) in the case of shells from shellfish, other than those referred

to

determined by the competent authority which prevent risks

in Article 2(2)(f), and egg shells, used under conditions

arising to public and animal health;

(i) used

processing;

as a fuel for combustion with or without prior

(j) used for the manufacture of derived products referred to in

Articles

dance with those Articles;

33, 34 and 36 and placed on the market in accor­

(k) in the case of catering waste referred to in Article 10(p) pro­

cessed

referred

by pressure

Article 15(1) or composted or transformed into biogas; or

to in point

sterilisation

(b) of the

or by

first

processing

subparagraph

methods

of

(l) applied to land without processing, in the case of raw milk,

colostrum and products derived therefrom, which the com­

petent

disease communicable through those products to humans or

authority does not consider to present a risk of any

animals.

Article 15

Implementing measures

1.

down relating to the following:

Measures for the implementation of this Section may be laid

(a) special conditions for the on-board handling and the disposal

of material derived from on-board evisceration of fish show­

ing

cable to humans;

signs of disease, including parasites, that are communi­

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(b) processing methods for animal by-products other than pres­

sure sterilisation, in particular as regards the parameters to be

applied for those processing methods, in particular the time,

temperature, pressure and size of particles;

(c) parameters

including catering waste, into biogas or compost;

for the transformation of animal by-products,

(d) conditions for the incineration and co-incineration of animal

by-products and derived products;

(e) conditions

derived products;

for the combustion of animal by-products and

(f) conditions

by-products referred to in Article 10(c);

for the generation and handling of animal

(g) ensilage of material originating from aquatic animals;

(h) permanent marking of animal by-products;

(i) the application to land of certain animal by-products, organic

fertilisers and soil improvers;

(j) the use of certain animal by-products for feeding to farmed

animals; and

(k) the level of risk to public or animal health with respect to cer­

tain material which is considered as unacceptable as referred

to in Article 14(d).

Those measures designed to amend non-essential elements of this

Regulation, by supplementing it, shall be adopted in accordance

with

Article 52(4).

the regulatory procedure with scrutiny referred to in

2. Pending the adoption of rules referred to:

(a) in

graph 1, Member States may adopt or maintain national rules

points (c), (f) and (g) of the first subparagraph of para­

for:

(i) the

referred to in Article 10(c);

generation and handling of animal by-products

(ii) the transformation of animal by-products referred to in

Article 10(p); and

(iii) for

animals;

the ensilage of material originating from aquatic

(b) in point (a) of the first subparagraph of paragraph 1, animal

by-products

without prejudice to Community environmental legislation.

referred to therein may be disposed of at sea,

Section 3

Derogations

Article 16

Derogations

By

by-products may be:

way of derogation from Articles 12, 13 and 14, animal

(a) in the case of animal by-products referred to in point (a) of

the first subparagraph of Article 15(1), handled and disposed

of in accordance with special conditions laid down pursuant

to that point;

(b) used for research and other specific purposes in accordance

with Article 17;

(c) in

used

the case of animal by-products referred to in Article 18,

Article;

for special feeding purposes in accordance with that

(d) in

disposed of in accordance with that Article;

the case of animal by-products referred to in Article 19,

(e) disposed of or used in accordance with alternative methods

which

based on parameters which may include pressure sterilisation

have been authorised in accordance with Article 20,

or other requirements of this Regulation or the implement­

ing measures thereof;

(f) in

authorised

the case

ration and application to land of bio-dynamic preparations as

by

of

the

Category

competent

2 and

authority,

Category

used

3 materials

for the prepa­

and if

referred

No 834/2007;

to in Article 12(1)(c) of Regulation (EC)

(g) in the case of Category 3 material and, if authorised by the

competent authority, used for feeding to pet animals;

(h) in

material, which arise in the course of surgical intervention on

the case of animal by-products, except for Category 1

live animals or during birth of animals on farm and, if autho­

rised by the competent authority, disposed of on that farm.

Article 17

Research and other specific purposes

1.

Articles 12, 13 and 14, authorise the use of animal by-products

The competent authority may, by way of derogation from

and

diagnostic,

derived products for exhibitions, artistic activities,

which ensure the control of risks to public and animal health.

educational or research purposes under conditions

and for

Such conditions shall include:

(a) the

by-products or derived products for other purposes; and

prohibition of any subsequent use of the animal

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(b) the obligation to dispose of the animal by-products or derived

products safely, or to re-dispatch them to their place of ori­

gin, if appropriate.

2.

the adoption of measures for the whole territory of the Commu­

In the case of risks to public and animal health which require

nity,

ised conditions for the import and use of the animal by-products

in particular in the case of newly emerging risks, harmon­

and derived products referred to in paragraph 1 may be laid down.

Such

packaging, identification, transport and disposal.

conditions may include requirements regarding storage,

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Article 18

Special feeding purposes

1.

Articles 13 and 14, authorise, under conditions which ensure the

The competent authority may, by way of derogation from

control of risks to public and animal health, the collection and use

of

which were not killed or did not die as a result of the presence or

Category 2 material, provided that it comes from animals

suspected presence of a disease communicable to humans or ani­

mals, and of Category 3 material for feeding to:

(a) zoo animals;

(b) circus animals;

(c) reptiles and birds of prey other than zoo or circus animals;

(d) fur animals;

(e) wild animals;

(f) dogs from recognised kennels or packs of hounds;

(g) dogs and cats in shelters;

(h) maggots and worms for fishing bait.

2.

tion from Article 12, and in accordance with the conditions laid

The competent authority may authorise, by way of deroga­

down pursuant to paragraph 3 of this Article:

(a) the

Article 8(b)(ii) and of material derived from zoo animals for

feeding of the Category 1 material referred to in

feeding to zoo animals; and

(b) the

Article

feeding of the

necrophagous birds and other species living in their natural

8(b)(ii) to endangered

Category 1

or

material

protected

referred

species

to in

of

habitat, for the promotion of biodiversity.

3.

down relating to the following:

Measures for the implementation of this Article may be laid

(a) conditions under which the collection and use as referred to

in paragraph 1 may be authorised with respect to the move­

ment,

egory 3 material for feeding, including in the case of newly

storage and use of Category 2 material and of Cat­

emerging risks; and

(b) conditions under which, in certain cases by way of deroga­

tion from the obligation laid down in Article 21(1), the feed­

ing

this Article may be authorised, including:

of Category 1 material as referred to in paragraph 2 of

(i) the

birds

endangered or

which such material may be fed;

and other species

protected

in certain

species

Member

of necrophagous

States to

(ii) measures to prevent risks to public and animal health.

Those measures, designed to amend non-essential elements of this

Regulation

with

by

Article 52(4).

the regulatory

supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Article 19

Collection, transport and disposal

1.

Articles 12, 13, 14 and 21, authorise the disposal:

The competent authority may, by way of derogation from

(a) by burial of dead pet animals and equidae;

(b) by burning or burial on site or by other means under official

supervision which prevent the transmission of risks to pub­

lic

Article 8(a)(v) and (b)(ii), Category 2 and Category 3 materi­

and animal health of Category 1 material referred to in

als in remote areas;

(c) by burning or burial on site or by other means under official

supervision which prevent the transmission of risks to pub­

lic

Article 8(b)(ii), Category 2 and Category 3 materials in areas

and animal health of Category 1 material referred to in

where access is practically impossible or where access would

only be possible under circumstances, related to geographi­

cal

would pose a risk to the health and safety of the personnel

or climatic reasons or due to a natural disaster, which

carrying out the collection or where access would necessitate

the use of disproportionate means of collection;

(d) by means other than burning or burial on site, under official

supervision, in the case of Category 2 and Category 3 mate­

rials

when

which do not pose a risk to public and animal health,

volume per week, this volume being determined in relation

the amounts of materials do not exceed a particular

to the nature of the activities carried out and the species of

origin of the animal by-products concerned;

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(e) by burning or burial on site, under conditions which prevent

the transmission of risks to public and animal health, of ani­

mal by-products other than Category 1 material referred to

in

disease,

Article

cessing or disposal of the animal by-products would increase

if

8(a)(i)

transport

in the

to

event

the nearest

of an

plant

outbreak

approved

of a notifiable

for pro­

the

widespread

danger of

that the disposal capacities of such plants were exceeded; and

outbreak

propagation

of an

of

epizootic

health risks

disease,

or,

would

in case

mean

of a

(f) by burning or burial on site, under conditions which prevent

the transmission of risks to public and animal health, of bees

and apiculture by-products.

2.

areas referred to in paragraph 1(b) shall not exceed a maximum

The animal population of a particular species in the remote

percentage of the animal population of this species in the Mem­

ber State concerned.

3.

information on:

Member States shall make available to the Commission

(a) the areas that they categorise as remote areas for the purpose

of applying paragraph 1(b) and the reasons for that categori­

sation,

such categorisation; and

and updated information concerning any change to

(b) the

points (c) and (d) of paragraph 1 with respect to Category 1

use they make of the authorisations provided for in

and Category 2 materials.

4.

down relating to the following:

Measures for the implementation of this Article shall be laid

(a) conditions aimed at ensuring control of risks to public and

animal health in the event of burning and burial on site;

(b) the

referred to in paragraph 2;

maximum percentage of the animal population as

(c) the volume of animal by-products, in relation to the nature

of activities and the species of origin, as referred to in para­

graph 1(d); and

(d) the list of diseases referred to in paragraph 1(e).

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be adopted

Article 52(4).

the regulatory procedure with scrutiny referred

in accordance

to in

Section 4

Alternative methods

Article 20

Authorisation of alternative methods

1.

use or disposal of animal by-products or derived products may be

The procedure for authorisation of an alternative method of

initiated either by the Commission or, following an application,

by

sent several interested parties.

a Member State or by an interested party, which may repre­

2.

petent authority of the Member State where they intend to use the

Interested parties shall send their applications to the com­

alternative method.

The

months following receipt of a complete application, whether the

competent authority shall evaluate, within a period of two

application

referred to in paragraph 10.

complies with the standard format for applications

3.

tions of the Member States and interested parties, together with a

The competent authority shall communicate the applica­

report

(EFSA) and inform the Commission thereof.

on its evaluation to the European Food Safety Authority

4.

sation, it shall send a report on its evaluation to EFSA.

When the Commission initiates the procedure for authori­

5.

complete application, whether the method submitted ensures that

EFSA shall assess, within six months following receipt of a

risks to public or animal health are:

(a) controlled

before

implementing measures thereof; or

disposal

in a manner

in accordance

which

with

prevents

this

their

Regulation

proliferation

or the

(b) reduced to a degree which is at least equivalent, for the rel­

evant

methods laid down pursuant to point (b) of the first subpara­

category of animal by-products, to the processing

graph of Article 15(1).

EFSA shall issue an opinion on the application submitted.

6.

mation

In duly justified cases where EFSA requests additional infor­

graph 5 may be extended.

from applicants, the period provided for in para­

After

decide

consulting

vided

on a period

the

within

Commission

which

or the applicant, EFSA shall

appropriate of the additional period needed.

to it and inform the Commission

that information

and the

shall

applicant

be pro­

as

7.

their own initiative, they shall send it directly to EFSA.

Where applicants wish to submit additional information on

In that case the period provided for in paragraph 5 shall not be

extended by an additional period.

8.

applicant

EFSA shall forward its opinion to the Commission, the

concerned.

and the competent authority of the Member State

9.

EFSA and taking account of that opinion, the Commission shall

Within three months following receipt of the opinion of

inform the applicant of the proposed measure to be adopted in

accordance with paragraph 11.

10.

ods shall be adopted in accordance with the advisory procedure

A standard format for applications for alternative meth­

referred to in Article 52(2).

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11.

shall be adopted:

Following receipt of the opinion of EFSA, the following

(a) either a measure authorising an alternative method of use or

disposal of animal by-products or derived products; or

(b) a measure rejecting the authorisation of such an alternative

method.

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall

Article 52(4).

the regulatory procedure with

be

scrutiny

adopted

referred

in accordance

to in

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.

by-products without undue delay under conditions which prevent

Operators shall collect, identify and transport animal

risks arising to public and animal health.

2.

products

Operators shall ensure that animal by-products and derived

document or, when required by this Regulation or by a measure

are accompanied during transport by a commercial

adopted in accordance with paragraph 6, by a health certificate.

By way of derogation from the first subparagraph, the competent

authority

points located on the same farm or between farms and users of

may authorise the transport of manure between two

manure

document or health certificate.

within the same Member State without a commercial

3.

ing animal by-products or derived products during transport shall

Commercial documents and health certificates accompany­

at least include information on the origin, the destination and the

quantity

by-products

of such products,

marking is required by this Regulation.

or derived products

and

and

a description

their marking,

of the

when

animal

such

However,

ported

for animal by-products and derived products

authority of the Member State concerned may authorise transmis­

within the territory of a Member State, the competent

trans­

sion

way of an alternative system.

of the information referred to in the first subparagraph by

4.

catering waste, in accordance with national measures foreseen in

Operators shall collect, transport and dispose of Category 3

Article 13 of Directive 2008/98/EC.

5.

latory procedure referred to in Article 52(3):

The following shall be adopted in accordance with the regu­

(a) models

accompany animal by-products during transport; and

for commercial documents which are required to

(b) models

the

for health

derived products during transport.

way they must

certificates

accompany

and the

animal

conditions

by-products

governing

and

6.

down relating to the following:

Measures for the implementation of this Article may be laid

(a) cases where a health certificate is required, having regard to

the level of risk to public and animal health arising from cer­

tain derived products;

(b) cases

graph of paragraph 2 and having regard to the low level of

where, by way of derogation from the first subpara­

risk to public and animal health arising from certain animal

by-products or derived products, transport of derived prod­

ucts

referred to in that paragraph;

may take place without the documents or certificates

(c) requirements

for

for the identification, including labelling,

by-products during transport; and

the separation of different categories of animal

and

(d) conditions to prevent risks to public and animal health aris­

ing

by-products,

during the collection and transport of animal

those products with respect to containers, vehicles and pack­

including conditions for the safe transport of

aging material.

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Article 22

Traceability

1.

by-products or derived products shall keep a record of consign­

Operators consigning, transporting or receiving animal

ments and related commercial documents or health certificates.

However, the first subparagraph shall not apply when an autho­

risation

without

to

granted

commercial

transport

documents

animal by-products

or

or derived products

Article

in accordance with the

health

second

certificates has been

adopted under Article 21(6)(b).

21(2) or in accordance with implementing

subparagraph

measures

of

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2.

systems and procedures to identify:

The operators referred to in paragraph 1 shall have in place

(a) the

derived products have been supplied; and

other operators to which their animal by-products or

(b) the operators from whom they have been supplied.

This

authorities on request.

information shall be made available to the competent

3.

adopted in accordance with the regulatory procedure referred to

Measures for the implementation of this Article may be

in Article 52(3), in particular on:

(a) the

authorities;

information to be made available to the competent

(b) the

kept.

period of time during which this information must be

Section 2

Registration and approval

Article 23

Registration of operators, establishments or plants

1. With a view to registration, operators shall:

(a) before

authority of any establishments or plants under their control

commencing operations, notify the competent

which

handling, processing, storage, placing on the market, distri­

are active at any stage of the generation, transport,

bution,

products;

use or disposal of animal by-products and derived

(b) provide the competent authority with information on:

(i) the category of animal by-products or derived products

under their control;

(ii) the

by-products or derived products as starting material.

nature of the operations performed using animal

2.

date information on any establishments or plants under their con­

Operators shall provide the competent authority with up-to-

trol

significant change in activities such as any closure of an existing

as referred to in point (a) of paragraph 1, including any

establishment or plant.

3.

graph 1 may be adopted in accordance with the regulatory pro­

Detailed rules regarding registration as referred to in para­

cedure referred to in Article 52(3).

4.

with

respect

a

By

view

way

to

of

registration

derogation from paragraph 1, no notification

have

to which establishments

shall

generating

be required

animal

for activities

by-products

with

Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004;

already been approved or registered in accordance with

and for activities with respect to which establishments or plants

have already been approved in accordance with Article 24 of this

Regulation.

The

generation of animal by-products on site only, which are carried

same derogation shall apply for the activities involving the

out on farms or other premises where animals are kept, bred or

taken care of.

Article 24

Approval of establishments or plants

1.

their

Operators shall ensure that establishments or plants under

such

lowing activities:

establishments

control are approved

or plants

by

carry

the competent

out one or

authority,

more of the

where

fol­

(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 by alternative methods autho­

rised in accordance with Article 20;

(b) disposal, as waste, by incineration of animal by-products and

derived products, excluding establishments or plants which

have

2000/76/EC;

a permit to operate in accordance with Directive

(c) disposal or recovery of animal by-products and derived prod­

ucts,

lishments

if they are waste, by

accordance with Directive 2000/76/EC;

or plants which

co-incineration,

have a permit

excluding

to operate

estab­

in

(d) use

combustion;

of animal by-products and derived products as fuel for

(e) manufacturing of pet food;

(f) manufacturing of organic fertilisers and 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 operations such as sorting, cutting, chilling, freezing, salt­

ing, removal of hides and skins or of specified risk material;

(i) storage of animal by-products;

(j) storage of derived products intended to be:

(i) disposed of by landfill or incineration or intended to be

recovered or disposed of by co-incineration;

(ii) used as fuel for combustion;

(iii) used

approved

as feed,

(EC) No 183/2005;

or registered

excluding

in accordance

establishments

with Regulation

or plants

(iv) used as organic fertilisers and soil improvers, excluding

storage at a place of direct application.

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2.

establishment

The approval referred to in paragraph 1 shall specify if the

by-products and/or derived products of:

or plant is approved for operations with animal

(a) a particular category referred to in Articles 8, 9 or 10; or

(b) more

indicating if such operations are carried out:

than one category referred to in Articles 8, 9 or 10,

(i) permanently under conditions of strict separation which

prevent any risk to public and animal health; or

(ii) temporarily under conditions which prevent contamina­

tion, in response to a shortage of capacity for such prod­

ucts arising due to:

—a widespread outbreak of an epizootic disease, or

—other extraordinary and unforeseen circumstances.

Article 25

General hygiene requirements

1.

their

Operators shall ensure that establishments or plants under

Article 24(1)(a) and (h):

control carrying out the activities referred to in

(a) are

and disinfection and where appropriate the construction of

constructed in a way permitting their effective cleaning

floors facilitates the draining of liquids;

(b) have access to adequate facilities for personal hygiene such as

lavatories, changing rooms and washbasins for staff;

(c) have appropriate arrangements for protection against pests,

such as insects, rodents and birds;

(d) keep

ensure that measuring equipment is calibrated regularly; and

installations and equipment in good condition and

(e) have appropriate arrangements for the cleaning and the dis­

infection of containers and vehicles in place to avoid risks of

contamination.

2.

to in paragraph 1 shall wear suitable, clean and, where necessary,

Any person working in the establishment or plant referred

protective clothing.

Where appropriate in a particular establishment or plant:

(a) persons

clean

working in the unclean sector

shoes or without having disinfected them;

sector without first changing their

shall

work

not

clothes

enter

and

the

(b) equipment

unclean

and machinery shall not be moved from the

disinfected; and

to the clean sector without first being cleaned and

(c) the operator shall establish a procedure relating to the move­

ments of persons in order to monitor their movements and

describe the correct use of footbaths and wheel baths.

3.

referred to in Article 24(1)(a):

In establishments or plants carrying out the activities

(a) animal

avoid risks of contamination;

by-products shall be handled in such a way as to

(b) animal

After

stored in such a way as to avoid risks of contamination;

processing,

by-products

derived

shall be

products

processed

shall

as soon

be handled

as possible.

and

(c) where appropriate, during any processing applied to animal

by-products

by-product and derived products shall be treated to a given

and derived products every part of the animal

temperature

re-contamination shall be prevented;

for a given period of time and risks of

(d) the operators shall check regularly the applicable parameters,

particularly

where appropriate by automatic devices;

temperature, pressure, time, size of particles,

(e) cleaning procedures shall be established and documented for

all parts of the establishments or plants.

Article 26

Handling of animal by-products within food businesses

1.

in establishments or plants approved or registered in accordance

The treatment, processing or storage of animal by-products

with Article 4 of Regulation (EC) No 853/2004 or in accordance

with

out

Article 6 of Regulation (EC) No 852/2004 shall

appropriate in a dedicated part of the establishment or plant.

under conditions which prevent cross-contamination

be carried

and if

2.

not intended for human consumption may be stored, treated or

Raw materials for the production of gelatine and collagen

processed in the establishments specifically authorised in accor­

dance with Regulation (EC) No 853/2004, Annex III, Section XIV,

Chapter I, point 5, and Section XV, Chapter I, point 5, provided

the

such raw materials from the raw materials for the production of

transmission of disease risk is prevented by segregation of

products of animal origin.

3.

specific

Paragraphs 1 and 2 shall apply without prejudice to more

legislation.

requirements laid down in Community veterinary

Article 27

Implementing measures

Measures for the implementation of this Section and Section 1 of

this Chapter shall be laid down relating to the following:

(a) infrastructure and equipment requirements applicable within

establishments or plants;

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OfficialJournaloftheEuropeanUnion14.11.2009

(b) hygiene

animal

sures modifying hygiene requirements for establishments or

by-products

requirements

and

applicable

derived

to

products,

all types

including

of handling

mea­

of

plants referred to in Article 25(1);

(c) conditions and technical requirements for the handling, treat­

ment,

by-products

transformation, processing

ment of waste water;

or derived products and

and

conditions

storage of

for

animal

treat­

(d) evidence to be presented by the operator for the purpose of

validation of the treatment, transformation and processing of

animal

prevent public and animal health risks;

by-products or derived products, on their ability to

(e) conditions for the handling of animal by-products or derived

products of more than one category referred to in Articles 8,

9 or 10 in the same establishment or plant:

(i) where such operations are carried out separately;

(ii) where

certain circumstances;

such operations are carried out temporarily in

(f) conditions for the prevention of cross-contamination when

animal by-products are stored, treated or processed in a dedi­

cated

Article 26;

part of an establishment or plant referred to in

(g) standard transformation parameters for biogas and compost­

ing plants;

(h) requirements

co-incineration in plants of high and low capacity as referred

applicable to the incineration or

to in Article 24(1)(b) and (c); and

(i) requirements

by-products

applicable to the

Article 24(1)(d).

and derived products

combustion

as referred

of animal

to in

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it shall

with

be

scrutiny

adopted

referred

in accordance

to in

Section 3

Own ch

c

e

r

c

i

k

ti

s

ca

a

l

nd

co

h

n

a

t

z

r

a

o

r

l

d

p

a

o

n

in

al

t

y

s

sis and

Article 28

Own checks

Operators shall put in place, implement and maintain own checks

in their establishments or plants in order to monitor compliance

with this Regulation. They shall ensure that no animal by-products

or derived products suspected or discovered not to comply with

this Regulation leave the establishment or plant, unless destined

for disposal.

Article 29

Hazard analysis and critical control points

1.

put in place, implement and maintain a permanent written pro­

Operators carrying out one of the following activities shall

cedure

control points (HACCP) principles for the:

or procedures based on the hazard analysis and critical

(a) processing of animal by-products;

(b) transformation

compost;

of animal by-products into biogas and

(c) handling

by-products or derived products in the same establishment or

and storage of more than one category of animal

plant;

(d) manufacturing of pet food.

2. Operators as specified in paragraph 1 shall in particular:

(a) identify

reduced to acceptable levels;

any hazards that must be prevented, eliminated or

(b) identify the critical control points at the step or steps at which

control is essential to prevent or eliminate a hazard or reduce

it to acceptable levels;

(c) establish critical limits at critical control points which sepa­

rate

elimination or reduction of identified hazards;

acceptability from unacceptability, for the prevention,

(d) establish and implement effective monitoring procedures at

critical control points;

(e) establish corrective action when monitoring indicates that a

critical control point is not under control;

(f) establish procedures to verify that the measures outlined in

points (a) to (e) are complete and working effectively. Verifi­

cation procedures shall be carried out regularly;

(g) establish

nature and size of the businesses to demonstrate the effective

documents and records commensurate with the

application of the measures set out in points (a) to (f).

3.

any

operators

stage

When any modification is made to a product, process or

changes.

shall

of production,

review their

processing,

procedures

storage

and make

or

the

distribution,

necessary

4.

may

Measures to facilitate the implementation of this Article

referred to in Article 52(3).

be adopted in accordance with the regulatory procedure

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Article 30

National guides to good practice

1.

development, dissemination and voluntary use of national guides

Where necessary, competent authorities shall encourage the

to good practice in particular for the application of HACCP prin­

ciples as referred to in Article 29. Operators may use such guides

on a voluntary basis.

2.

ensure that:

The competent authority shall assess national guides to

(a) they

tives of parties whose interests may be substantially affected,

have been developed in consultation with representa­

and have been disseminated by sectors of operators; and

(b) their

refer.

contents are practicable for the sectors to which they

CHAPTER II

Placing on the market

Section 1

A

f

n

o

i

r

m

f

a

e

l

ed

b

i

y

n

-

g

pr

t

o

o

du

f

f

u

a

c

r

r

t

m

s

a

e

a

n

d

nd

im

a

a

n

derived products

l

i

s

mals excluding

Article 31

Placing on the market

1.

ing to farmed animals, excluding fur animals, may only be placed

Animal by-products and derived products destined for feed­

on the market provided:

(a) they are or they are derived from Category 3 material other

than material referred to in Article 10(n), (o) and (p);

(b) they have been collected or processed, as applicable, in accor­

dance with the conditions for pressure sterilisation or other

conditions

health

Article 15 and any measures which have been laid down in

in accordance

to prevent

with

risks

measures

arising to

adopted

public

pursuant

and animal

to

accordance with paragraph 2 of this Article; and

(c) they

plants,

come

product concerned.

as applicable

from approved

for the

or

animal

registered

by-product

establishments

or derived

or

2.

down relating to the public and animal health conditions for the

Measures for the implementation of this Article may be laid

collection,

derived products referred to in paragraph 1.

processing and treatment of animal by-products and

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall

Article 52(4).

the regulatory procedure with

be

scrutiny

adopted

referred

in accordance

to in

Section 2

Organic fertilisers and soil improvers

Article 32

Placing on the market and use

1.

market and used provided:

Organic fertilisers and soil improvers may be placed on the

(a) they are derived from Category 2 or Category 3 material;

(b) they have been produced in accordance with the conditions

for pressure sterilisation or with other conditions to prevent

risks arising to public and animal health, in accordance with

the requirements laid down pursuant to Article 15 and any

measures

paragraph 3 of this Article;

which have been laid down in accordance with

(c) they

plants, as applicable; and

come from approved or registered establishments or

(d) in the case of meat-and-bone meal derived from Category 2

material and processed animal proteins intended to be used

as or in organic fertilisers and soil improvers, they have been

mixed

the mixture for feeding purposes and marked when required

with a component to exclude the subsequent use of

by measures adopted under paragraph 3.

In addition, digestion residues from transformation into biogas or

compost may be placed on the market and used as organic ferti­

lisers or soil improvers.

Member

additional conditions for or restricting the use of organic fertilis­

States may adopt or maintain national rules imposing

ers

grounds of the protection of public and animal health.

and soil improvers, provided that such rules are justified on

2.

ing shall not be required for materials whose use for feeding pur­

By way of derogation from point (d) of paragraph 1, mix­

poses is excluded due to their composition or packaging.

3.

down relating to the following:

Measures for the implementation of this Article may be laid

(a) public and animal health conditions for the production and

use of organic fertilisers and soil improvers;

(b) components or substances for the marking of organic fertil­

isers or soil improvers;

(c) components

improvers;

to be mixed with organic fertilisers or soil

(d) supplementary

for

conditions, such as the methods to be used

when preparing the mixture, in order to exclude the use of

marking and the minimum proportions to be observed

such fertilisers or soil improvers for feeding purposes; and

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(e) cases where the composition or packaging allows the mate­

rials to be exempted from the mixing requirement.

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be adopted in

Article 52(4).

the regulatory procedure with scrutiny referred

accordance

to in

Section 3

Deriv

o

e

t

d

he

p

r

ro

C

d

o

u

m

ct

m

s

u

r

n

e

i

g

ty

ula

le

te

g

d

isl

b

a

y

tio

c

n

ertain

Article 33

Placing on the market

Operators

products:

may place on the market the following derived

(a) cosmetic

76/768/EEC;

products as defined in Article 1(1) of Directive

(b) active

Article 1(2)(c) of Directive 90/385/EEC;

implantable medical devices as defined in

(c) medical

93/42/EEC;

devices as defined in Article 1(2)(a) of Directive

(d) in

Article 1(2)(b) of Directive 98/79/EC;

vitro diagnostic medical devices as defined in

(e) veterinary

Directive 2001/82/EC;

medicinal products as defined in Article 1(2) of

(f) medicinal

2001/83/EC.

products as defined in Article 1(2) of Directive

Article 34

Manufacture

1.

by-products and derived products destined for establishments or

The import, collection and movement of animal

plants for the manufacture of the derived products referred to in

Article 33 and the manufacture of those derived products shall be

carried out in accordance with the Community legislation referred

to in that Article.

Unused material from such establishments or plants shall be dis­

posed of in accordance with that legislation.

2.

legislation

However, this Regulation shall apply where the Community

tions

referred to in Article 33 does not provide

accordance with the objectives of this Regulation.

controlling potential risks to public and animal

for

health

condi­

in

Section 4

Other derived products

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 Category 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

referred

imported

down

to in Article

materials,

8(c),

from

subject

Category

to conditions

1 material

Article 40; or

pursuant to point (a) of the first paragraph

laid

of

(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 treatment in accordance with Article 38, where safe

sourcing in accordance with Article 37 does not ensure suf­

ficient control.

Article 36

Placing on the market of other derived products

Operators may place on the market derived products, other than

the products referred to in Articles 31, 32, 33 and 35, provided:

(a) those products are:

(i) not intended for use for the feeding to farmed animals

or for application to land from which such animals are

to be fed; or

(ii) intended for feeding 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 treatment in accordance with Article 38, where safe

sourcing does not ensure sufficient control; or

(iii) verifying

uses in accordance with Article 39 where safe treatment

that the products are only used for safe end

does not ensure sufficient control.

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Article 37

Safe sourcing

1. Safe sourcing shall include the use of material:

(a) from

health arise;

which no unacceptable risks to public and animal

(b) which has been collected and transported from the point of

collection to the manufacturing establishment or plant under

conditions which exclude risks to public and animal health;

or

(c) which

ported

has

establishment or plant under conditions which exclude risks

from

been

the

imported

point of first

into

entry

the Community

to the manufacturing

and trans­

to public and animal health.

2.

documentation

For the purpose

where

of the

of

requirements

safe sourcing,

of

operators shall provide

taken in order to exclude risks arising to public and animal health

necessary, proof of the safety of

paragraph

bio-security

1, including,

measures

from starting material.

Such

authority upon request.

documentation shall be kept available to the competent

In

ments shall be accompanied by a health certificate corresponding

the case referred to in point (c) of paragraph 1, the consign­

to a model adopted in accordance with the regulatory procedure

referred to in Article 52(3).

Article 38

Safe treatment

Safe treatment shall include application of a manufacturing pro­

cess

risks to public and animal health arising from the material used

to the material used which reduces to an acceptable level

or

process.

from other substances resulting from the manufacturing

It

able risks to public and animal health, in particular by means of

shall be ensured that the derived product poses no unaccept­

testing of the end product.

Article 39

Safe end uses

Safe end uses shall include the use of derived products:

(a) under conditions which pose no 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 by objectives

set

tection of public and animal health.

out in Community legislation, in particular for the pro­

Article 40

Implementing measures

Measures for the implementation of this Section may be laid down

relating to the following:

(a) conditions

food or of pet food produced from imported materials, from

for the placing on the market of imported pet

Category 1 material referred to in Article 8(c);

(b) conditions for the safe sourcing and movement of material to

be used under conditions which exclude risks to public and

animal health;

(c) documentation

Article 37(2);

as referred to in the first subparagraph of

(d) parameters

the first paragraph of Article 38, in particular as regards the

for the manufacturing process as referred to in

application of physical or chemical treatments to the mate­

rial used;

(e) testing requirements applicable to the end product; and

(f) conditions for the safe use of derived products which pose a

risk to public or animal health.

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

CHAPTER III

Import, transit and export

Article 41

Import and transit

1.

into,

with:

or

Animal by-products and derived products shall be imported

sent in transit through, the Community in accordance

(a) the relevant requirements of this Regulation and the imple­

menting

by-product or derived product which are at least as stringent

measures thereof for the particular animal

as those applicable to the production and marketing of such

animal

Community;

by-products or derived products within the

(b) conditions recognised to be at least equivalent to the require­

ments

animal

applicable

legislation; or

by-products

to

or

the

derived

production

products

and marketing

under Community

of such

(c) in

referred to in Articles 33, 35 and 36, the requirements set out

the case of animal by-products and derived products

in those Articles.

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The

designed to amend non-essential elements of this Regulation by

measures referred to in point (b) of the first subparagraph,

supplementing it, shall be adopted in accordance with the regu­

latory procedure with scrutiny referred to in Article 52(4).

2.

transit of:

By way of derogation from paragraph 1, the import and

(a) specified

with Regulation (EC) No 999/2001;

risk material shall take place only in accordance

(b) animal

nated

2000/532/EC

with

by-products

any

or derived products mixed or contami­

ments of Regulation (EC) No 1013/2006;

shall

waste

take

listed

place only

as hazardous

subject to

in

the

Decision

require­

(c) Category

derived therefrom which are not intended for the manufac­

1 material, Category 2 material and products

ture of derived products referred to in Articles 33, 35 and 36,

shall only take place provided that rules for their import have

been adopted in accordance with Article 42(2)(a);

(d) animal

purposes referred to in Article 17(1) shall take place in accor­

by-products and derived products destined for the

dance

risks

with national measures which ensure the control of

harmonised conditions referred to in Article 17(2).

to public and animal health, pending the adoption of

3.

products derived therefrom, the relevant requirements as referred

In the case of import and transit of Category 3 material and

to in point (a) of the first subparagraph of paragraph 1 shall be

laid down.

Those requirements may specify that consignments:

(a) must

listed in accordance with paragraph 4;

come from a third country or part of a third country

(b) must come from establishments or plants approved or reg­

istered

origin and listed by that authority for that purpose; and

by the competent authority of the third country of

(c) must be accompanied at the point of entry into the Commu­

nity

tion

where the veterinary

and where appropriate by a declaration, which corresponds

such as a commercial

checks

document

take

or

place

a health

by documenta­

certificate

to a model laid down pursuant to point (d) of the first sub­

paragraph of Article 42(2).

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be

Article 52(4).

the regulatory procedure with scrutiny

adopted

referred

in accordance

to in

Pending the adoption of the requirements referred to in points (a)

and

specify those requirements in national measures.

(c) of the second subparagraph, the Member States shall

4.

which animal by-products or derived products may be imported

Lists of third countries or parts of third countries from

or

dance with the regulatory procedure referred to in Article 52(3),

transit through the Community shall be drawn up in accor­

taking into account in particular:

(a) the legislation of the third country;

(b) the organisation of the competent authority and its inspec­

tion

vices,

services in the third country, the powers of those ser­

authority

the supervision to which they are subject, and their

legislation;

to monitor effectively the application of their

(c) the actual health conditions applied to the production, manu­

facture, handling, storage and dispatch of products of animal

origin intended for the Community;

(d) the assurances the third country can give regarding compli­

ance with the relevant health conditions;

(e) experience of marketing the product from the third country

and the results of import checks carried out;

(f) the result of any Community inspections in the third country;

(g) the health status of the livestock, other domestic animals and

wildlife

exotic animal diseases and any aspects of the general health

in the third country, having particular regard to

situation in the country which might pose a risk to public or

animal health in the Community;

(h) the

plies

regularity

diseases in its territory, in particular the diseases listed in the

information

and

about

speed with

the existence

which the

of

third

infectious

country

animal

sup­

Terrestrial

Health Code of the World Organisation for Animal Health;

Animal Health Code and the Aquatic Animal

(i) the

animal diseases in force in the third country and their imple­

regulations on the prevention and control of infectious

mentation,

countries.

including rules on imports from other third

The lists of establishments or plants referred to in point (b) of the

second subparagraph of paragraph 3 shall be kept up to date and

communicated

made available to the public.

to the Commission and the Member States and

Article 42

Implementing measures

1.

exclude animal by-products or derived products manufactured in

Measures for the implementation of Article 41 which may

certain establishments or plants from import or transit in order to

protect

with the regulatory procedure referred to in Article 52(3).

public or animal health shall be adopted in accordance

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2.

be laid down relating to the following:

Other measures for the implementation of Article 41 shall

(a) conditions for the import and transit of Category 1 and Cat­

egory 2 materials and for products derived therefrom;

(b) restrictions

imported Category 3 material or products derived therefrom

regarding public or animal health applicable to

which may be laid down by reference to Community lists of

third countries or parts of third countries drawn up in accor­

dance with Article 41(4) or for other public or animal health

purposes;

(c) conditions

derived

tries; such conditions may include the arrangements for con­

products

for the

in

manufacture

establishments

of

or

animal

plants

by-products

in third coun­

or

trols

authority concerned and may exempt certain types of estab­

of such establishments or plants by the competent

lishments or plants handling animal by-products or derived

products

point (b) of the second subparagraph of Article 41(3); and

from approval or registration as referred to in

(d) models

declarations which are to accompany consignments, specify­

for health certificates, commercial documents and

ing the conditions under which it can be stated that the ani­

mal

collected

by-products

ments of this Regulation.

or manufactured

or derived

in

products

accordance

concerned

with the

have

require­

been

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Article 43

Export

1.

tined for incineration or landfill shall be prohibited.

The export of animal by-products and derived products des­

2.

third countries which are not members of the OECD for use in a

The export of animal by-products and derived products to

biogas or composting plant shall be prohibited.

3.

derived therefrom shall only be exported for purposes other than

Category 1 material, Category 2 material and products

those

their export have been laid down.

referred to in paragraphs 1 and 2 provided that rules for

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be adopted in accordance

Article 52(4).

the regulatory procedure with scrutiny referred to in

4.

food and feed exported from the Community shall apply mutatis

Article 12 of Regulation (EC) No 178/2002 concerning

mutandis to the export of Category 3 material or products derived

therefrom in compliance with this Regulation.

5.

of:

By way of derogation from paragraphs 3 and 4, the export

(a) specified

with Regulation (EC) No 999/2001;

risk material shall take place only in accordance

(b) animal

nated

by-products or derived products mixed

2000/532/EC

with any waste listed as hazardous in

or contami­

ments of Regulation (EC) No 1013/2006.

shall take place only subject to the

Decision

require­

TITLE III

OFFICIAL CONTROLS AND FINAL PROVISIONS

CHAPTER I

Official controls

Article 44

Procedure for approval

1.

plants only where an on site visit, prior to start-up of any activity,

The competent authority shall approve establishments or

has

down in accordance with Article 27.

demonstrated that they meet the relevant requirements laid

2.

it appears, from the on site visit, that the establishment or plant

The competent authority may grant conditional approval if

meets

view to ensuring the application of the operational procedures in

all the infrastructure and equipment requirements with a

compliance with this Regulation. It shall grant full approval only

if

months of granting conditional approval, that the establishment

it appears, from another on site visit carried out within three

or plant meets the other requirements referred to in paragraph 1.

If

still

clear progress has been made, but the establishment or

authority may extend conditional approval. However, conditional

does not meet all of these requirements, the competent

plant

approval shall not exceed a total of six months.

3.

to operate if the competent authority withdraws its approval or

Operators shall ensure that an establishment or plant ceases

in the case of conditional approval fails to extend it or to grant full

approval.

Article 45

Official controls

1.

shall

sion of the handling of animal by-products and derived products

at

Without

regular

prejudice

intervals carry

to Article

out official

5, the

controls

competent

and

authority

supervi­

falling within the scope of this Regulation.

2.

apply

Articles 41 and 42 of Regulation (EC) No 882/2004 shall

compliance with this Regulation.

mutatis mutandis to official controls carried out to verify

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3.

to guides to good practice, when carrying out its official controls.

The competent authority may take into account adherence

4.

including

Detailed

logical analyses, may be laid down.

rules

arrangements

concerning the

for

reference

implementing

methods for

this

microbio­

Article,

Those measures, designed to amend non-essential elements of this

Regulation

with

Article 52(4).

the regulatory

by supplementing

procedure

it, shall

with

be

scrutiny

adopted

referred

in accordance

to in

Article 46

Suspensions, withdrawals and prohibitions on operations

1.

competent authority reveal that one or more of the requirements

If the official controls and supervision carried out by the

of this Regulation are not met, it shall take appropriate action.

The competent authority shall in particular, as appropriate to the

nature and to the gravity of the deficiencies and to the potential

risks for public and animal health:

(a) suspend approvals of establishments or plants approved pur­

suant to this Regulation, if:

(i) the conditions for approving or operating the establish­

ment or plant are no longer fulfilled;

(ii) the operator can be expected to remedy the deficiencies

within a reasonable period of time; and

(iii) the

require action in accordance with point (b);

potential risks to public and animal health do not

(b) withdraw

pursuant to this Regulation, if:

approvals of establishments or plants approved

(i) the conditions for approving or operating the establish­

ment or plant are no longer fulfilled; and

(ii) the operator cannot be expected to remedy the deficien­

cies within a reasonable period of time:

—for

establishment or plant,

reasons relating to the infrastructure of the

—for reasons relating to the personal capacity of the

operator or the staff under his supervision, or

—because of serious risks to public and animal health

requiring major adjustments to the operation of the

establishment

apply for re-approval;

or plant before the operator may

(c) impose

order to rectify existing deficiencies.

specific conditions on establishments or plants in

2.

and to the gravity of the deficiencies and to the potential risks for

The competent authority shall, as appropriate to the nature

public

operators

and

from carrying out operations under this Regulation, as appropri­

referred

animal

to

health,

in Articles

temporarily

23(1) and

or permanently

(3) and Article

prohibit

24(1)

ate, following receipt of information indicating:

(a) that the requirements of Community legislation are not met;

and

(b) potential risks to public or animal health arising from such

operations.

Article 47

Lists

1.

plants and operators which have been approved or registered in

Each Member State shall draw up a list of establishments,

accordance with this Regulation within its territory.

It shall assign an official number to each approved or registered

establishment,

ment, plant or operator with respect to the nature of its activities.

plant or operator, which identifies the establish­

Member

which has been assigned to the establishment, plant or operator

States shall indicate, if applicable, an official number

under other Community legislation.

Member

establishments, plants and operators available to the Commission

States shall make the lists of approved or registered

and other Member States.

Member States shall keep up-to-date the lists of approved or reg­

istered establishments, plants and operators and make them avail­

able to other Member States and to the public.

2.

down in accordance with the regulatory procedure referred to in

Measures for the implementation of this Article may be laid

Article 52(3), in particular on:

(a) the format for the lists referred to in paragraph 1; and

(b) the procedure for making the lists referred to in paragraph 1

available.

Article 48

Controls for dispatch to other Member States

1.

Category

Where an operator intends to dispatch Category 1 material,

derived

2 material and meat-and-bone

Member

from

Member State of origin and the competent authority of the Mem­

State,

Category

it shall inform

1 and Category

the competent

2 materials

meal or animal

authority

to another

fat

of the

ber State of destination.

The competent authority of the Member State of destination shall

decide upon application by the operator, within a specified time

period:

(a) to refuse receipt of the consignment;

(b) to accept the consignment unconditionally; or

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(c) to make receipt of the consignment subject to the following

conditions:

(i) if

sterilisation, it must undergo such treatment; or

the derived products have not undergone pressure

(ii) the animal by-products or derived products must com­

ply with any conditions for the dispatch of the consign­

ment which are justified for the protection of public and

animal health in order to ensure that animal by-products

and

this Regulation.

derived products are handled in accordance with

2.

graph 1 may be adopted in accordance with the regulatory pro­

Formats for applications by operators referred to in para­

cedure referred to in Article 52(3).

3.

inform the competent authority of the Member State of destina­

The competent authority of the Member State of origin shall

tion, by means of the Traces system in accordance with Decision

2004/292/EC,

Member State of destination, of

of the dispatch of each consignment sent to the

(a) animal

paragraph 1;

by-products or derived products referred to in

(b) processed animal protein derived from Category 3 material.

When informed of the dispatch, the competent authority of the

Member State of destination shall inform the competent author­

ity of the Member State of origin of the arrival of each consign­

ment by means of the Traces system.

4.

and

directly to the establishment or plant of destination, which must

animal

Category 1 and Category 2 materials, meat-and-bone meal

fat referred to in paragraph 1 shall be transported

have been registered or approved in accordance with Articles 23,

24 and 44 or, in the case of manure, to the farm of destination.

5.

other Member States via the territory of a third country, they shall

When animal by-products or derived products are sent to

be sent in consignments which have been sealed in the Member

State of origin and shall be accompanied by a health certificate.

The sealed consignments shall re-enter the Community only via a

border inspection post, in accordance with Article 6 of Directive

89/662/EEC.

6.

by-products

By way of derogation from

been mixed or contaminated with any waste listed as hazardous

or derived products referred

paragraphs

to therein

1 to

which

5, animal

have

in

only

Decision 2000/532/EC shall be sent to

No 1013/2006.

subject to the requirements of

other

Regulation

Member States

(EC)

7.

adopted relating to the following:

Measures for the implementation of this Article may be

(a) a

authority as referred to in paragraph 1;

specified time period for the decision of the competent

(b) supplementary

by-products or derived products referred to in paragraph 4;

conditions for the dispatch of animal

(c) models for the health certificates which have to accompany

consignments sent in accordance with paragraph 5; and

(d) conditions under which animal by-products or derived prod­

ucts intended to be used for exhibitions, artistic activities, for

diagnostic, educational or research purposes may be sent to

other Member States, by way of derogation from paragraph 1

to 5 of this Article.

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be adopted in accordance

Article 52(4).

the regulatory procedure with scrutiny referred to in

8.

the conditions subject to which, by way of derogation from para­

Measures for the implementation of this Article may specify

graphs 1 to 4, the competent authorities may allow:

(a) the

located

dispatch of manure

border regions of Member States sharing a common border;

on the same farm

transported

or between

between

farms located

two points

in the

(b) the

between

dispatch

regions of Member States sharing a common border; and

establishments

of other animal

or plants

by-products

located in

transported

the border

(c) the

establishment or plant located in the border region of another

transport of a dead pet animal for incineration to an

Member State sharing a common border.

Those measures, designed to amend non-essential elements of this

Regulation

with

by supplementing it, shall be adopted in accordance

Article 52(4).

the regulatory procedure with scrutiny referred to in

Article 49

Community controls in Member States

1.

checks,

Experts from the Commission may make

ber States, in so far as is necessary for the uniform application of

in cooperation with the competent authorities

on-the-spot

of Mem­

this Regulation.

The Member State on whose territory the checks are made shall

provide the experts with all the assistance necessary for carrying

out their duties.

The

results of the checks made.

Commission shall inform the competent authority of the

2.

adopted in accordance with the regulatory procedure referred to

Measures for the implementation of this Article may be

in Article 52(3), in particular on the procedure for the coopera­

tion with national authorities.

L300/32

EN

OfficialJournaloftheEuropeanUnion14.11.2009

Article 50

Application of Regulation (EC) No 882/2004 for the

purposes of certain controls

1. Article 46 of Regulation (EC) No 882/2004 shall apply

mutatis mutandis to Community controls in third countries car­

ried out to verify compliance with this Regulation.

2. Article 50(1)(a) of Regulation (EC) No 882/2004 shall apply

mutatis mutandis to the phased introduction of the requirements

of Article 41(3) of this Regulation.

3. Article 52 of Regulation (EC) No 882/2004 shall apply

mutatis mutandis to third-country controls in Member States

related to operations under this Regulation.

CHAPTER II

5. Where reference is made to this paragraph, Article 5a(1)

to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall

apply, having regard to the provisions of Article 8 thereof.

The time limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of

Decision 1999/468/EC shall be two months, one month and two

months respectively.

6. Where reference is made to this paragraph, Article 5a(1), (2),

(4) and (6) and Article 7 of Decision 1999/468/EC shall apply,

having regard to the provisions of Article 8 thereof.

Article 53

Penalties

The Member States shall lay down the rules on penalties appli­

cable to infringements of this Regulation and shall take all mea­

sures necessary to ensure that they are implemented. The penalties

provided for must be effective, proportionate and dissuasive. The

Member States shall notify those provisions to the Commission

by 4 June 2011 and shall notify it without delay of any subse­

quent amendment affecting them.

Article 54

Repeal

Regulation (EC) No 1774/2002 shall be repealed with effect from

4 March 2011.

References to Regulation (EC) No 1774/2002 shall be construed

as references to this Regulation and shall be read in accordance

with the correlation table laid down in the Annex.

Article 55

Transitional measure

Establishments, plants and users approved or registered in accor­

dance with Regulation (EC) No 1774/2002 before 4 March 2011

shall be deemed to be approved or registered, as required, in

accordance with this Regulation.

Article 56

Entry into force

This Regulation shall enter into force on the 20th day following

its publication in the Official Journal of the European Union.

It shall apply from 4 March 2011.

Final provisions

Article 51

National provisions

Member States shall communicate to the Commission the text of

the provisions of national law they adopt in areas under their

competence which directly concern the proper implementation of

this Regulation.

Article 52

Committee procedure

1. The Commission shall be assisted by the Standing Commit­

tee on the Food Chain and Animal Health established by

Article 58(1) of Regulation (EC) No 178/2002.

2. Where reference is made to this paragraph, Articles 3 and 7

of Decision 1999/468/EC shall apply, having regard to the pro­

visions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and 7

of Decision 1999/468/EC shall apply, having regard to the pro­

visions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC

shall be set at three months.

4. Where reference is made to this paragraph, Article 5a(1)

to (4) and Article 7 of Decision 1999/468/EC shall apply, having

regard to the provisions of Article 8 thereof.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 21 October 2009.

For the European Parliament

The President

J. BUZEK

For the Council

The President

C. MALMSTRÖM

14.11.2009

EN

OfficialJournaloftheEuropeanUnionL300/33

ANNEX

CORRELATION TABLE

Regulation (EC) No 1774/2002This Regulation

Article 1

Article 2

Article 3(1)

Article 3(2)

Article 3(3)

Article 4(1)

Article 4(2)

Article 4(3)

Article 4(4)

Article 5(1)

Article 5(2)

Article 5(3)

Article 5(4)

Article 6(1)

Article 6(2)

Article 6(3)

Article 7

Article 8

Article 9

Articles 10 to 15, 17 and 18

Article 16

Article 19

Article 20(1)

Article 20(2)

Article 20(3)

Article 21

Article 22

Article 23

Article 24

Article 25

Article 26

Article 27

Article 28

Article 29

Article 30

Article 31

Article 32

Article 33

Article 34

Article 35

Article 36

Article 37

Article 38

Articles 1 and 2

Article 3

Article 4(1) and(2)

Article 41(3), fourth subparagraph

Article 4(3), (4) and (5)

Article 8

Articles 12, 15 and 16

Article 24(h), (i) and (j)

Article 41(2)(c), Article 43(3) and (5)(a)

Article 9

Articles 13, 15 and 16

Article 24(h), (i) and (j)

Article 41(2)(c) and Article 43(3)

Article 10

Articles 14, 15 and 16

Article 24(h), (i) and (j)

Article 21

Article 48

Article 22

Articles 23, 24, 27 and 44

Article 6

Article 31

Articles 35 and 36

Article 32

Article 36

—

Article 11

Articles 17 and 18

Article 19

Articles 28 and 29

Articles 45, 46 and 47

Article 49

Article 35(a)(ii) and Article 41(1)

Articles 41 and 42

Article 41(1)(b)

Article 50(1)

—

Article 52

—

Article 15(2) and Article 51

—

Article 54

Article 56