Commission Regulation (EC) No 2076/2005 of  5 December 2005  laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004   (Text with EEA relevance)
Date: 2005-12-05
Institutions: European Commission
Subjects: agri-foodstuffs, beef, egg, egg product, food inspection, foodstuffs legislation, import (EU), labelling, meat product, pigmeat, poultrymeat, rabbit meat, transitional period (EU)

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COMMISSION REGULATION (EC) No 2076/2005

of 5 December 2005

laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004,
(EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and
amending Regulations (EC) No 853/2004 and (EC) No 854/2004

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 853/2004 of
the
European Parliament and of the Council of 29 April 2004
laying down specific hygiene rules for
food of animal
origin (1), and in particular Article 9 thereof,

Having regard to Regulation (EC) No 854/2004 of
the
European Parliament and of the Council of 29 April 2004
laying down specific rules for the organisation of official
controls on products of animal origin intended for human
consumption (2), and in particular Article 16 thereof,

Having regard to Regulation (EC) No 882/2004 of
the
European Parliament and of the Council of 29 April 2004 on
official controls performed to ensure the verification of
compliance with feed and food law, animal health and animal
welfare rules (3), and in particular Article 63(1) thereof,

Whereas:

(1) The entry into application on 1 January 2006 of
Regulations (EC) No 852/2004 of the European Parlia-
ment and of the Council (4), (EC) No 853/2004, (EC)
No 854/2004 and (EC) No 882/2004 will entail
considerable changes to the rules and procedures to be
followed by food operators and the competent autho-
rities of the Member States. The application of some of
these measures with immediate effect from 1 January
2006 would present practical difficulties in some cases. A
period should therefore be envisaged in order to permit a
smooth transition to the full implementation of the new
rules and procedures.

(2)

It is appropriate that the duration of the transitional
period be fixed taking into account a first review of the
new regulatory framework on hygiene scheduled within
the first four years.

(3)

Provision should therefore be made for a transitional
period during which certain requirements laid down in

(1) OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004,

p. 22.

(2) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226,

25.6.2004, p. 83.

(3) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004,

p. 1

those Regulations can be progressively implemented.
With a view to a harmonised approach, that transitional
period should in principle last four years but could,
where justified, be shorter. Provision should also be made
for the possibility or reviewing any of those arrange-
ments in the light of experience gained.

(4) As a standard transitional arrangement,

should
continue to be possible to place on the market products
produced before the application of the new rules. The
arrangement
the
transitional period, unless the shelf-life of the product
is shorter.

should apply for

the whole of

it

from poultry and lagomorphs

(5) Regulation (EC) No 853/2004 excludes from its scope
the direct supply by the producer of small quantities of
meat
to the final
consumer or to local retail establishment supplying
directly the final consumer as fresh meat. Council
Directive 71/118/EEC of 15 February 1971 (5) on health
problems affecting the production and placing on the
market of fresh poultrymeat and Council Directive 91/
495/EEC of 27 November 1991 (6) concerning public
health and animal health problems affecting the produc-
tion and placing on the market of rabbit meat and
farmed game meat also allowed the Member States to
derogate from the general requirements for such a
purpose without limiting it to fresh meat. That possibility
should be maintained during the transitional period.

(6) The work of approving establishments,

in particular
those that did not have to be approved under the
previously applicable rules but were allowed to market
their production on their national market only, places a
heavy burden on the competent authorities. Provision
should therefore be made for a transitional arrangement
to allow such establishments to continue marketing on
their national markets until they are actually approved.

(7) The transitional arrangement covering the use of
wrapping and packaging materials and marking equip-
ment in point 6 of Section I of Annex II to Regulation

(4) OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004,

p. 3.

(5) OJ L 55, 8.3.1971, p. 23.
(6) OJ L 268, 24.9.1991, p. 41.

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(EC) No 853/2004 needs to be reviewed in order to
tighten up the previous rules on the use of marking
equipment while giving due
consideration to the
expectations of food business operators concerning the
regarding the use of marking material
tolerance
the new
purchased prior to the implementation of
framework. The relevant provisions of that Regulation
should therefore be deleted and a new arrangement
adopted under this Regulation. Given the risk of abuse of
such a transitional arrangement, its duration should be
limited and care taken to ensure that old marking
equipment not complying with the new rules
is
withdrawn as soon as possible and not later than the
end of the transitional period. Annex II to Regulation
(EC) No 853/2004 and Annex I to Regulation (EC)
No 854/2004 should be amended accordingly.

(8) The health import requirements for food of animal origin
will not be completely harmonised for certain types of
products and the import conditions applicable to such
products during the transitional period should be made
clear.

(9) The provision of

food chain information is a new
requirement on food business operators. A transitional
period should be introduced for the full implementation
of food chain information requirements. In particular, a
smooth flow of
information from the farm to the
slaughterhouse should be facilitated by a transitional
arrangement relaxing the requirement
to supply the
information 24 hours in advance of the animals' arrival
at the slaughterhouse.

(10) Section III of Annex III to Regulation (EC) No 853/2004
requires the official veterinarian or approved veterinarian
to sign the certificate accompanying the farmed non
domestic ungulates from the farm to the slaughterhouse.
the
Directive 91/495/EEC requires the signature of
veterinary service. That provision should be maintained
during the transitional period.

(11) The certificate required by Regulation (EC) No 854/2004
in Chapter X Part B of Annex I is more detailed than the
certificate previously prescribed. The model certificate set
out in Annex III to Directive 91/495/EEC should be
accepted during the transitional period.

for minced meat

(12) Section V of Annex III to Regulation (EC) No 853/2004
requires the raw material
to meet
certain criteria and lays down labelling requirements.
regarding in
Composition criteria of minced meat
particular the content of fat and the connective tissue:
meat protein ratio should be assessed. Pending the
outcome of this assessment, it is appropriate to maintain
current criteria established by Council Directive 94/65/
EC of 14 December 1994 (1) laying down the require-
ments for the production and placing on the market of
minced meat and meat preparations.

(13) Notwithstanding the general principle laid down in
Article 3(2) of Regulation (EC) No 853/2004 whereby

(1) OJ L 368, 31.12.1994, p. 10.

food business operators are not to use, where hygiene so
than potable water,
requires, any substance other
provisions allowing the use of clean water for
the
handling of fish are set out in Chapter VII of Annex II to
Regulation (EC) No 852/2004 and Part II of Chapter I
and Chapters III and IV of Section VIII of Annex III to
Regulation (EC) No 853/2004, in particular for handling
fish on board vessels. Since the use of clean water does
not represent a risk for public health as long as it meets
the definition laid down in Regulation (EC) No 852/
2004, and with a view to allowing land-based establish-
ments handling fishery products to adapt progressively,
the scope of the relevant provisions in Regulation (EC)
No 853/2004 should be extended to such establishments
during the transitional period.

that

(14) Part III(1)(a) of Chapter II of Section IX of Annex III to
food
Regulation (EC) No 853/2004 provides
business operators manufacturing dairy products must
ensure that raw cows' milk meets a limit criterion before
processing. Compliance with that limit is particularly
important for food safety where the milk has to be heat-
treated and has not been processed within a pre-defined
time. By way of a transitional measure, verification of
compliance with this criterion immediately before
processing should be limited to such circumstances.

(15) Section X of Annex III to Regulation (EC) No 853/2004
lays down specific hygiene rules for eggs and egg
products. According to Chapter I(2), eggs should be
stored and transported at a constant temperature that is
best suited to ensuring optimal conservation of their
hygiene properties. As before 1 January 2006 Member
States were authorised to apply controlled temperature
standards within their territory to egg storage facilities
and to transport from one facility to another, it should be
made clear that those standards may continue to apply
on a transitional basis if still authorised by the competent
authority. This will give operators time to adapt their
activities and procedures to new temperature standards
that may be required by the competent authority.

(16) Under Part II(1) of Chapter II of Section X of Annex III to
Regulation (EC) No 853/2004, cracked eggs may be used
the manufacture of egg products under certain
for
conditions. As a transitional arrangement, provision
should be made to extend this possibility to other
establishments producing liquid egg, where they comply
with the same conditions.

(17) Regulation (EC) No 854/2004 requires the slaughter-
house staff authorised by the competent authority to
carry out tasks of official auxiliaries to be trained and
qualified in the same way as the official auxiliaries.
During the transitional period, it is appropriate to allow
the competent authority time for planning and organis-
ing additional training and qualification of slaughter-
house staff assisting with official controls, and to limit

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consequently the requirement to ensuring that slaughter-
house staff
is trained for the specific tasks they are
allowed to carry out.

provided that they bear, as appropriate, the marks provided for
in the Acts listed in Article 2 of Directive 2004/41/EC of the
European Parliament and of the Council (2).

(18) Article 12 of Regulation (EC) No 882/2004 requires
laboratories carrying out analysis of samples taken
during official controls to be accredited. Laboratories,
which were not required under previous Community
legislation to be accredited, might require some addi-
tional time to obtain full accreditation, since accredita-
tion is an intricate and laborious process.
is
appropriate to give to such laboratories additional time
to enable them to arrange for accreditation.

It

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

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISION

Article 1

Transitional period

Products referred to in paragraph 1, for which the food
2.
business operator has defined a shelf-life longer than the
transitional period, may remain on the market until the end of
their shelf-life.

Article 3

Direct supply of small quantities of meat from poultry
and lagomorphs

By way of derogation from Article 1(3)(d) and without
prejudice to Article 1(4) of Regulation (EC) No 853/2004, the
provisions laid down in that Regulation shall not apply to the
direct supply, by the producer, of small quantities of meat
from poultry and lagomorphs slaughtered on the farm to the
to local retail establishments directly
final consumer or
supplying such meat to the final consumer.

Article 4

Placing of food of animal origin on the national market
pending the approval of establishments

For the purposes of this Regulation, a transitional period of
four years ending on 31 December 2009 (hereinafter referred
to as the transitional period) is established.

The transitional arrangements provided for in this Regulation
shall apply for the transitional period, except where otherwise
provided for in Articles 5 and 8.

By way of derogation from Article 4(1) of Regulation (EC)
No 853/2004, food business operators who before 1 January
2006 were allowed to place food of animal origin on their
national market may continue to place such products on this
market under a national mark that cannot be confused with
the marks provided for in Article 5(1) of Regulation (EC)
No 853/2004 until such time as the competent authority, in
accordance with Article 4(2) of Regulation (EC) No 853/2004,
has approved the establishments handling such products.

CHAPTER II

TRANSITIONAL ARRANGEMENTS FOR THE
IMPLEMENTATION OF REGULATION (EC) No 853/2004

Food of animal origin bearing such national marks may be
marketed only in the national territory of the Member State
where they are produced.

Article 2

Article 5

Stocks of food of animal origin

Wrapping, packaging and labelling materials bearing pre-
printed health or identification marks

1. Without prejudice to relevant Community legislation, and
in particular Directive 2000/13/EC of the European Parlia-
ment and of the Council (1) on the approximation of the laws
of the Member States relating to the labelling, presentation
and advertising of foodstuffs, stocks of food of animal origin
produced before 1 January 2006 may be placed on the market

Food business operators may continue until 31 December
2007 to use stocks of wrapping, packaging and labelling
materials bearing pre-printed health or identification marks
purchased by them before 1 January 2006.

(1) OJ L 109, 6.5.2000, p. 29.

p. 12.

(2) OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004,

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Article 6

Marking equipment

Food business operators and competent authorities may
continue to use marking equipment with which they are
equipped on 31 December 2005 until its replacement or until
the end of the transitional period at the latest, provided that
the approval number of the establishment concerned remains
unchanged.

When that equipment is replaced, the competent authority
shall ensure that it is withdrawn so that it cannot be used any
more.

Article 7

Health import conditions

1. Article 6(1) of Regulation (EC) No 853/2004 shall not
apply to imports of food of animal origin for which no
harmonised health import conditions have been established,
including lists of third countries and parts of third countries
and of establishments from which imports are permitted.

Pending future harmonisation of Community legislation
concerning imports of such products, such imports shall
comply with the health import conditions of the Member
State concerned.

2. By way of derogation from Article 6(4) of Regulation (EC)
No 853/2004,
importing food
food business operators
containing both products of plant origin and processed
products of animal origin shall be exempt from the obligation
provided for in that Article.

Pending the development of a risk-based approach for the
implementation of harmonised health import conditions and
checks of such food products, imports shall comply with the
harmonised Community rules in force before 1 January 2006
where applicable, and with the national rules implemented by
the Member States before that date in other cases.

Article 8

Food chain information

1. By way of derogation from the requirements laid down in
Section III of Annex II to Regulation (EC) No 853/2004, the
Member States shall progressively implement these require-
ments in various sectors in addition to the poultry sector
where they shall apply immediately, so that the porcine sector
in that Member State is covered by the implementation of
food chain information requirements by the end of the second
year of transition, and the equine and veal calf sectors by the
end of the third year.

Member States applying that transitional arrangement shall
report to the Commission on its implementation at the end of
each year.

2. By way of derogation from the requirements laid down in
point 2 of Section III of Annex II to Regulation (EC) No 853/
2004 concerning the provision of food chain information to
slaughterhouse operators no less than 24 hours in advance,
the competent authority may permit such information to be
sent to the slaughterhouse operator with animals of all species
to which it relates and in all circumstances where this does not
jeopardise the objectives of Regulation (EC) No 853/2004.

However, any item of food chain information, knowledge of
which may result in serious disruption of the slaughterhouse
activity, shall be made available to the slaughterhouse operator
in good time before the animals arrive at the slaughterhouse.

Article 9

Meat of farmed non-domestic ungulates

By way of derogation from the requirements laid down in
point (3)(j) of Section III of Annex III to Regulation (EC)
No 853/2004, the certificate referred to in Article 16, attesting
to a favourable result of the ante-mortem inspection, is issued
and signed by the veterinary service.

Article 10

Composition criteria and labelling requirements for
minced meat

1. By way of derogation from the requirements laid down in
Chapter II(1) of Section V of Annex III of Regulation (EC)
No 853/2004, the food business operator must check the raw
materials entering the establishment to ensure compliance
with the name of the product in the table below in respect of
the final product.

Table: Composition criteria checked on the basis of a daily average

Fat content

≤ 7 %

≤ 20 %

Connective
tissue: meat
protein ratio

≤ 12

≤ 15

— lean minced meat

— minced pure beef

— minced meat containing

pigmeat

≤ 30 %

≤ 18

— minced meat of other spe-

cies

≤ 25 %

≤ 15

2. By way of derogation from the requirements laid down in
Chapter IV of Section V of Annex III of Regulation (EC)
No 853/2004, the labelling must also display the following
words:

— ‘percentage of fat under…’,

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— ‘connective tissue: meat protein ratio under…’.

CHAPTER III

3. The Member States may allow the placing on their
national market of minced meat which does not comply with
these criteria under a national mark that cannot be confused
with the marks provided for in Article 5(1) of Regulation (EC)
No 853/2004.

Article 11

Use of clean water

1. By way of derogation from Article 3(2) of Regulation (EC)
No 853/2004 and Chapter
III(A)(1) of Section VIII of
Annex III to that Regulation, ice used to chill fresh fishery
products may be made from clean water in establishments on
land.

2. By way of derogation from Article 3(2) of Regulation (EC)
No 853/2004 and Chapter III(A)(2) and (3) of Section VIII of
Annex III to that Regulation,
food business operators in
establishments,
including vessels, handling fishery products
may use clean water.

3. By way of derogation from Article 3(2) of Regulation (EC)
No 853/2004 and Chapter IV(1) of Section VIII of Annex III
to that Regulation, food business operators in establishments
on land may use clean water for cooling after cooking
crustaceans and molluscs.

Article 12

Raw milk and dairy products

in
By way of derogation from the requirement set out
Chapter II(III)(1)(a) of Section IX of Annex III to Regulation
(EC) No 853/2004, the maximum plate count for raw cows'
milk shall apply only where such milk is to be heat-treated and
has not been so treated within the period of acceptance
specified in the HACCP-based procedures put in place by food
business operators.

Article 13

Eggs and egg products

1. Member States which, before 1 January 2006, applied
national temperature requirements for egg storage facilities
and for vehicles transporting eggs between such storage
facilities may continue to apply those requirements.

2.
Food business operators may use cracked eggs for the
production of liquid egg in an establishment approved for that
purpose, provided that the establishment of production or a
packing centre has delivered them directly and they are broken
as soon as possible.

TRANSITIONAL ARRANGEMENTS FOR THE
IMPLEMENTATION OF REGULATION (EC) No 854/2004

Article 14

Training of slaughterhouse staff assisting with official
controls

By way of derogation from Article 5(6)(a)(i) to Regulation (EC)
No 854/2004 and Chapter III(A)(a) of Section III of Annex I to
slaughterhouse staff authorised by the
that Regulation,
competent authority to carry out specific tasks of official
auxiliaries shall be trained in the same way as official
auxiliaries only with regard to the specific tasks they are
authorised to perform and shall not be required to have passed
the same examination as official auxiliaries.

The competent authority shall ensure that such training is
satisfactory before authorising slaughterhouse staff to take
over tasks of official auxiliaries.

It shall check that the additional training and organisation
necessary for slaughterhouse staff
to qualify through the
examination procedure that apply to official auxiliaries are in
place as soon as possible and at the latest by the end of the
transitional period.

Article 15

Certification of establishments using staff assisting with
official controls in slaughterhouses

By way of derogation from the second subparagraph of
Chapter III(A)(a) of Section III of Annex I to Regulation (EC)
No 854/2004, establishments wishing to use their staff
assisting with official controls shall, during the transitional
period, be exempted from the requirement to possess an
internationally recognised certification, provided that
the
establishment demonstrates
initiated and is
pursuing certification in accordance with international
standards, such as relevant EN ISO standards on quality
management or food safety.

it has

that

Article 16

Model certificate for meat from farmed non domestic
ungulates

By way of derogation from Chapter VII (A)(4) of Section IV of
the model
to Regulation (EC) No 854/2004,
Annex I
certificate set out in Annex III to Directive 91/495/EEC may
be used for
the transportation from the farm to the
slaughterhouse of farmed non domestic ungulates.

Article 17

Health import conditions

Chapter III of Regulation (EC) No 854/2004 shall not apply to

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imports of food of animal origin for which no harmonised
health import conditions have been established, including lists
of
third countries and of
establishments from which imports are permitted.

third countries and parts of

Pending future harmonisation of Community legislation
concerning imports of such products, such imports shall
comply with the health import conditions of the Member
State concerned.

CHAPTER IV

TRANSITIONAL ARRANGEMENTS FOR THE
IMPLEMENTATION OF REGULATION (EC) No 882/2004

Article 18

Accreditation of laboratories

CHAPTER V

FINAL PROVISIONS

Article 19

Review

including the conditions
The transitional arrangements,
thereof,
laid down in this Regulation may be reviewed at
any time in the light of experience gained in the implementa-
tion of those arrangements and of Regulations (EC) No 853/
2004, (EC) No 854/2004 and (EC) No 882/2004.

Article 20

Amendment to Regulation (EC) No 853/2004

In Section I(B)(6) of Annex II to Regulation (EC) No 853/
2004, the third subparagraph is deleted.

Article 21

By way of derogation from Article 12(2) of Regulation (EC)
No 882/2004,
the competent authority may designate a
laboratory not accredited, provided that the laboratory:

Amendment to Regulation (EC) No 854/2004

In point (6) in Section I, Chapter III of Annex I to Regulation
(EC) No 854/2004, the second sentence is deleted.

(a)

demonstrates that it has initiated and is pursuing the
necessary accreditation procedures in accordance with
Regulation (EC) No 882/2004;

Article 22

Entry into force

(b) provides

the competent authority with satisfactory
guarantees that quality control schemes for the analyses
it conducts for the purpose of official controls are in
place by 1 January 2006.

This Regulation shall enter into force on the 20th day
following that of its publication in the Official Journal of the
European Union.

It shall apply from 1 January 2006.

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

Done at Brussels, 5 December 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission