Commission Regulation (EC) No 79/2005 of 19 January 2005 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the use of milk, milk-based products and milk-derived products, defined as Category 3 material in that RegulationText with EEA relevance
Date: 2005-01-19
Institutions: European Commission
Subjects: agro-industry, animal nutrition, health legislation, milk, milk by-product, milk product, traceability

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Official Journal of the European Union

20.1.2005

COMMISSION REGULATION (EC) No 79/2005

of 19 January 2005

implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as
regards the use of milk, milk-based products and milk-derived products, defined as Category 3
material in that Regulation

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1774/2002 of
the
European Parliament and of the Council of 3 October 2002
laying down health rules concerning animal by-products not
intended for human consumption (1), and in particular Article
6 (2) (i) thereof,

Whereas:

(1)

(2)

(3)

Regulation (EC) No 1774/2002 lays down the public and
animal health rules for the collection, transport, storage,
handling, processing and use or disposal of animal by-
products
from
presenting a risk to public or animal health.

those products

to prevent

in order

of

for

intended

products

Regulation (EC) No 1774/2002 lays down rules for the
use of certain animal by-products derived from the
production
human
consumption and former foodstuffs of animal origin,
falling within the definition of Category 3 material
in
that Regulation,
and milk-based
including milk
products no longer intended for human consumption.
Regulation (EC) No 1774/2004 also provides for the
possibility to use Category 3 material in other ways, in
accordance with the procedure laid down in that Regu-
lation and after consultation of the appropriate scientific
committee.

the

Scientific

Steering
to opinions of
According
Committee of 1996, 1999 and 2000,
there is no
evidence that milk transmits bovine spongiform encepha-
lopathy (BSE) and any risk from milk is considered to be
negligible. In its state of affairs report of 15 March 2001,
the TSE/BSE ad hoc Group upheld that advice.

(4)

On the basis of
those opinions, milk, milk-based
products and colostrum are derogated from the prohi-
bition on the feeding of animal protein to farmed

fattened or bred for

the
animals, which are kept,
production of food, in accordance with Regulation (EC)
No 999/2001 of the European Parliament and of the
Council of 22 May 2001 laying down rules for the
prevention, control and eradication of certain trans-
missible spongiform encephalophathies (2).

Regulation (EC) No 1774/2002 does not apply to liquid
milk and colostrum disposed of or used on the farm of
origin. That Regulation also permits the application to
land of milk and colostrum as a fertiliser or
soil
improver, if the competent authority does not consider
them to present a risk of spreading any serious trans-
missible disease, given that farmed animals could have
access to such land and therefore could be exposed to
such a risk.

is

Under Regulation (EC) No 1774/2002, Category 3
to be used in accordance with strict
material
conditions and the feeding of such material to farmed
animals is allowed only after processing in an approved
Category 3 processing plant.

in

Animal by-products derived from the production of dairy
products intended for human consumption and former
dairy foodstuffs are generally produced in establishments
approved
accordance with Council Directive
92/46/EEC of 16 June 1992 laying down the health
rules for the production and placing on the market of
raw milk, heat-treated milk and milk-based products (3).
Ready-to-use dairy products are generally wrapped and,
therefore, the possibility for subsequent contamination of
the product is minimal.

The Commission is to seek the advice of the European
Food Safety Authority on the possibility to feed to
farmed animals, and under the required conditions to
minimise risks, ready-to-use milk, milk-based products
and milk-derived products, falling within the definition
of Category 3 material
in Regulation (EC) No
1774/2002, (the products), without further treatment.

(5)

(6)

(7)

(8)

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 668/2004 (OJ L 112, 19.4.2004,
p. 1).

(2) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Regu-

lation (EC) No 1993/2004 (OJ L 344, 20.11.2004, p. 12).

(3) OJ L 268, 14.9.1992, p. 1. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

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(9)

the current
Pending that advice and in the light of
scientific opinions and of the Scientific Committee on
Animal Health and Animal Welfare report on the
strategy for emergency vaccination against
foot-and-
it is appropriate to lay down,
mouth disease of 1999,
on a provisional basis,
the
collection, transportation, processing, and use of these
products.

specific measures

for

(10) Appropriate control systems should be put in place in
the Member States to ensure compliance with this Regu-
lation and to take appropriate actions in case of non-
compliance. Member States should also take into account
their
the best and worst case
scenarios carried out in preparation of their contingency
plans
for epizootic diseases, when deciding on the
number of registered holdings that may be authorised
to use the products concerned.

risk assessment

for

(11)

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

Article 3

Collection, transportation and storage

1.
The products shall be collected, transported and identified
in accordance with the requirements set out in Annex II to
Regulation (EC) No 1774/2002.

However, the first subparagraph shall not apply to operators of
milk-processing establishments approved in accordance with
Article 10 of Directive 92/46/EEC when collecting and
returning to their establishment products which they have
previously delivered to their customers.

2.
The storage of the products shall take place at an appro-
priate temperature to avoid any risk to public or animal health,
either:

(a)

in a dedicated storage plant approved for that purpose in
accordance with Article 11 of Regulation (EC) No
1774/2002; or

HAS ADOPTED THIS REGULATION:

Article 1

(b) in a dedicated, separate storage area in an establishment
approved in accordance with Article 10 of Directive
92/46/EEC.

General authorisation by Member States

Member States shall authorise the collection,
transportation,
processing, use and storage of milk, milk-based products and
milk-derived products, falling within the definition of Category
3 material, as referred to in Articles 6(1)(e), 6(1)(f) and 6(1)(g) of
Regulation (EC) No 1774/2002, that have not been processed
in accordance with Chapter V of Annex VII to that Regulation
these activities and products
(the products), provided that
comply with the requirements set out in this Regulation.

Samples of the final products taken during storage or at
3.
the time of withdrawal from storage, shall at least comply with
the microbiological standards set out in Chapter I(D)(10) of
Annex VII to Regulation (EC) No 1774/2002.

Article 2

Authorisation, registration and control measures

Article 4

Use as

feed of processed products
unprocessed products

and whey and

1.
Processed products and whey, as referred to in Annex I,
may be used as feed in accordance with the requirements laid
down in that Annex.

processing

The milk

establishments

1.
in
accordance with Article 10 of Directive 92/46/EEC and the
holdings, which are authorised as provided for in the Annexes
to this Regulation,
shall be registered by the competent
authority for that purpose.

approved

2.
Unprocessed products and other products, as referred to
in Annex II, may be used as feed in accordance with the
requirements laid down in that Annex.

2.
The competent authority shall take the necessary measures
to control compliance by operators of registered establishments
and holdings with the requirements set out in this Regulation.

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Article 5

Suspension of authorisation and registration in case of
non-compliance

Any authorisation and registration issued by the competent
authority in accordance with this Regulation shall be imme-
diately suspended if the requirements of this Regulation are
no longer fulfilled.

Article 6

Review

The Commission shall review the provisions of this Regulation
and adapt them as appropriate in the light of the opinion of the
European Food Safety Authority.

Article 7

Entry into force

The authorisation and registration may be reinstated only after
appropriate corrective measures have been taken as instructed
by the competent authority.

This Regulation shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

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

Done at Brussels, 19 January 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

OTHER USE OF PROCESSED PRODUCTS AND WHEY, AS PROVIDED FOR IN ARTICLE 6 (2)(i) OF
REGULATION (EC) No 1774/2002

A. Products concerned

CHAPTER I

The products, including cleaning water that have been in contact with raw milk and/or milk pasteurised in accordance
with Chapter I(A)(4)(a) of Annex C to Directive 92/46/EEC, subjected to at least one of the following treatments:
(a) ‘ultra high temperature’ (UHT) in accordance with Chapter I(A)(4)(b) of Annex C to Directive 92/46/EEC;

(b) sterilisation whereby either an Fc value equal to or greater than 3 is achieved, or which was carried out in
accordance with Chapter I(A)(4)(c) of Annex C to Directive 92/46/EEC at a temperature of at least 115°C for 20
minutes or equivalent;

(c) pasteurisation in accordance with Chapter I, A, 4(a) or sterilisation, other than that referred to in paragraph (b) of

this Section, in accordance with Chapter I(A)(4)(c) of Annex C to Directive 92/46/EEC, followed by:

(i)

in the case of dried milk or dried milk products, a drying process; or

(ii) in the case of an acidified milk product, a process by which the pH is reduced and kept for at least one hour

at a level below 6.

B. Use

The products, referred to in Section A, may be used as feed material in the Member State concerned, and may be used
in cross-border areas where the Member States concerned have a mutual agreement to that effect. The establishment
concerned must ensure traceability of the products.

A. Products concerned

CHAPTER II

1. the products,

including cleaning water that has been in contact with milk that has only been pasteurised in

accordance with Chapter I(A)(4)(a) of Annex C to Directive 92/46/EEC; and

2. whey produced from non heat-treated milk-based products, which must be collected at least 16 hours after milk
clotting and where the pH must be recorded as < 6,0 before being sent directly to authorised animal holdings.

B. Use

The products and whey, referred to in Section A, may be used as feed material in the Member State concerned subject
to the following conditions:

(a) they are sent from an establishment approved in accordance with Article 10 of Directive 92/46/EEC, which

guarantees the traceability of those products; and

(b) they are sent to a limited number of authorised animal holdings, fixed on the basis of the risk assessment for the
best and worst case scenarios carried out by the Member State concerned in preparation of the contingency plans
for epizootic diseases, in particular foot-and-mouth disease.

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ANNEX II

OTHER USES OF UNPROCESSED PRODUCTS AND OTHER PRODUCTS

A. Products concerned:

Raw products, including cleaning water that has been in contact with raw milk, and other products for which the
treatments referred to in the Chapters I and II of Annex I cannot be ensured.

B. Use

The products referred to in Section A, may be used as feed material in the Member State concerned subject to the
following conditions:

(a)

they are sent from an establishment approved in accordance with Article 10 of Directive 92/46/EEC, which
guarantees the traceability of those products; and

(b) they are sent to a limited number of authorised animal holdings, fixed on the basis of the risk assessment for the
best and worst case scenarios carried out by the Member State concerned in preparation of the contingency plans
for epizootic diseases,
in the
authorised animal holdings can only be moved:

in particular foot-and-mouth disease, and provided that

the animals present

(i) either directly to a slaughterhouse located in the same Member State; or

(ii) to another holding in the same Member State, for which the competent authority guarantees that animals

susceptible to foot-and-mouth disease may leave the holding only:

(a) either in accordance with point (i); or

(b) if the animals have been dispatched to a holding not feeding the products referred to in this Annex, after a

21-day standstill period has elapsed from the introduction of the animals.