Commission Regulation (EC) No 1020/2008 of 17 October 2008 amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and Regulation (EC) No 2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products and certain fishery products (Text with EEA relevance)
Date: 2008-10-17
Institutions: European Commission
Subjects: egg, egg product, fishery product, food inspection, food safety, food technology, foodstuff, labelling, milk product

L 277/8

EN

Official Journal of the European Union

18.10.2008

COMMISSION REGULATION (EC) No 1020/2008

of 17 October 2008

amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the
laying down specific hygiene rules for food of animal origin and Regulation (EC) No
Council
2076/2005 as regards identification marking, raw milk and dairy products, eggs and egg products
and certain fishery products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Section VIII of Annex III
853/2004,
on board vessels.

to Regulation (EC) No
in particular for handling fishery products

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 853/2004 of the European
Parliament and the Council of 29 April 2004 laying down
specific hygiene rules for food of animal origin (1), and in
particular Article 9 and Article 10(1) thereof,

Whereas:

(1)

(2)

regarding identification marking laid
The provisions
down in Annex II
to Regulation (EC) No 853/2004
have created confusion in the identification of products
produced within the Community and products produced
outside the Community.
It is therefore appropriate to
clarify those provisions in order to ensure their smooth
implementation. However, in order not to disrupt trade
in the products of animal origin concerned, it should be
provided that products for which an identification mark
has been applied in accordance with Regulation (EC) No
853/2004 before 1 November 2009 may be imported
into the Community until 31 December 2009.

Notwithstanding the general principle laid down in
Article 3(2) of Regulation (EC) No 853/2004 whereby
food business operators are not to use, where hygiene
so requires, any substance other than potable water,
the
provisions allowing the use of clean water
handling of fish are set out in Part A of Annex I and
to Regulation (EC) No
in Chapter VII of Annex II
852/2004 of
the
Council of 29 April 2004 on the hygiene of foodstuffs (2)
and in Part II of Chapter I and Chapters III and IV of

the European Parliament and of

for

(1) OJ L 139, 30.4.2004, p. 55. Corrected version in OJ L 226,

25.6.2004, p. 22.

(2) OJ L 139, 30.4.2004, p. 1. Corrected version in OJ L 226,

25.6.2004, p. 3.

(3)

(4)

(5)

11

(EC) No
of Commission Regulation
Article
2076/2005 of 5 December 2005 laying down transi­
tional arrangements for the implementation of Regu­
lations (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 (3) provides that clean water
may also be used in land-based establishments until
31 December 2009.

It has long been scientifically recognised that the use of
seawater is of technological interest for fishery products
as
their organoleptic
characteristics by eliminating the risk of osmotic shock.

in maintaining intact

it helps

The use of clean seawater for the handling and washing
of fishery products does not represent a risk for public
health as long as control procedures based, in particular,
on the Hazard Analysis and Critical Control Points
in
(HACCP) principles have been developed and put
place by food business operators
it
to ensure that
complies with the definition of clean seawater set out
in Regulation (EC) No 852/2004. It is therefore appro­
priate to delete Article 11 of Regulation (EC) No
2076/2005 and to make the transitional arrangement,
provided for in that Regulation as regards the use of
clean seawater, permanent. Section VIII of Annex III to
Regulation (EC) No 853/2004 should be amended
accordingly.

(6)

Section VIII of Annex III
853/2004 sets out
production and placing on the market of
products intended for human consumption,
fish oil.

to Regulation (EC) No
the requirements governing the
fishery
including

(3) OJ L 338, 22.12.2005, p. 83.

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Official Journal of the European Union

L 277/9

in implementing those
There have been difficulties
specific requirements in some Member States. Problems
have also been encountered as regards fish oil imported
from third countries. Those difficulties mainly relate to
the requirements applying to raw materials in order to
ensure their suitability for the production of fish oil for
to food manufacturing
human consumption and
practices usually in place in the fish oil
industry. It is
therefore appropriate to clarify those provisions in order
implementation. Section VIII of
to harmonise their
Annex III to Regulation (EC) No 853/2004 should be
amended accordingly.

fishery products belonging to that
pretiosus

The opinion of
the European Food Safety Authority
adopted on 30 August 2004 on contaminants in the
food chain related to the toxicity of
fishery products
belonging to the family of Gempylidae has demonstrated
that
in
particular Ruvettus
and Lepidocybium flavo­
brunneum, may have adverse gastrointestinal effects if
not consumed under certain conditions. Chapter V of
Section VIII of Annex III
to Regulation (EC) No
853/2004 lays down specific marketing conditions for
those fishery products.

family,

(12) Article 12 of Regulation (EC) No 2076/2005 provides
for a transitional arrangement aiming at
limiting the
verification of compliance with this criterion to such
circumstances.
therefore appropriate to delete
Article 12 of Regulation (EC) No 2076/2005 and to
make that transitional arrangement permanent. Section
IX of Annex III
to Regulation (EC) No 853/2004
should be amended accordingly.

is

It

(13)

Section X of Annex III to Regulation (EC) No 853/2004
for eggs and egg
lays down specific hygiene rules
products. Pursuant
that
Section, eggs must be stored and transported at a
preferably constant
temperature that is best suited to
ensure optimal conservation of their hygiene properties.

to point 2 of Chapter I of

temperature

requirements

(14) Article 13(1) of Regulation (EC) No 2076/2005 provides
that Member States which, before 1 January 2006,
applied national
eggs
storage facilities and for vehicles
transporting eggs
between such storage facilities may continue to apply
those requirements until 31 December 2009. Since this
possibility does not
interfere with the food safety
objectives laid down in Regulation (EC) No 853/2004,
it is appropriate to make that transitional arrangement
permanent.

for

(7)

(8)

(9)

risks for

Those conditions apply to fresh, prepared and processed
fishery products derived from those species. However,
similar
the consumer may be encountered
with frozen fishery products derived from the family of
Gempylidae. It is therefore appropriate to require similar
protective and informative conditions for those frozen
fishery products. Section VIII of Annex III to Regulation
(EC) No 853/2004 should be amended accordingly.

(15)

In addition, pursuant to point 1 of Part II of Chapter II of
Section X of Annex III to Regulation (EC) No 853/2004,
cracked eggs may be used for the manufacture of egg
products under certain conditions. Article 13(2) of Regu­
lation (EC) No 2076/2005 provides that food business
operators may, until 31 December 2009, use cracked
eggs for the production of liquid egg in an establishment
approved for
the estab­
lishment of production or
a packing centre has
delivered them directly and they are broken as soon as
possible. Since the use of cracked eggs in the production
of liquid egg does not represent a risk for public health
under such conditions,
it is appropriate to make that
transitional arrangement permanent.

that purpose, provided that

(16) Article 13 of Regulation (EC) No 2076/2005 should
therefore be deleted and Section X of Annex III to Regu­
lation
amended
accordingly.

853/2004

(EC) No

should

be

(17)

Regulations (EC) No 853/2004 and (EC) No 2076/2005
should therefore be amended accordingly.

(10)

Point 1(a) of Part III of Chapter II of Section IX of Annex
III to Regulation (EC) No 853/2004 provides that food
business operators manufacturing dairy products must
raw cows’ milk meets a limit criterion
ensure that
before processing.

(11)

Compliance with that limit is particularly important for
food safety where the milk has to be heat-treated by a
pasteurisation process or a process which is less strict
than pasteurisation, and has not been heat-treated
within a pre-defined time.
In such circumstances, the
application of such heat-treatments does not have a
sufficient bactericidal effect, which may lead to an early
spoilage of the resulting dairy product.

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Official Journal of the European Union

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(18)

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Annex II
accordance with Annex I to this Regulation.

to Regulation (EC) No 853/2004 is amended in

Article 2

Annex III
accordance with Annex II to this Regulation.

to Regulation (EC) No 853/2004 is amended in

Article 3

Article 4

Products of animal origin for which an identification mark has
been applied in accordance with point 8 of Part B of Section I
of Annex II
to Regulation (EC) No 853/2004 before
1 November 2009 may be imported into the Community
until 31 December 2009.

Article 5

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

its publication in the Official

Journal of

In Regulation (EC) No 2076/2005, Articles 11, 12 and 13 are
deleted.

However, point 1(b) of Annex I shall apply from 1 November
2009.

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

Done at Brussels, 17 October 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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Annex II to Regulation (EC) No 853/2004 is amended as follows:

ANNEX I

(1) Section I is amended as follows:

(a) Part A is amended as follows:

(i) Point 1 is replaced by the following:

‘1. The identification mark must be applied before the product leaves the establishment of production.’

(ii) Point 3 is replaced by the following:

‘3. An identification mark is not necessary on packs of eggs when a packing centre code is applied in

accordance with Part A of Annex XIV to Council Regulation (EC) No 1234/2007 (*).
___________
(*) OJ L 299, 16.11.2007, p. 1.’

(b) In Part B, point 8 is replaced by the following:

‘8. When applied in an establishment located within the Community, the mark must be oval

in shape and

include the abbreviation CE, EB, EC, EF, EG, EK, EO, EY, ES, EÜ, EK or WE.

Those abbreviations must not be included in marks applied on products imported into the Community from
establishments located outside the Community.’

(2) Section III is amended as follows:

(a) Point 1 is replaced by the following:

‘1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have
requested, and been provided with, relevant food chain information contained in the records kept at the
holding of provenance in accordance with Regulation (EC) No 852/2004.’

(b) In point 3, the introductory phrase is replaced by the following:

‘3. The relevant food chain information referred to in point 1 is to cover, in particular:’

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Official Journal of the European Union

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Annex III to Regulation (EC) No 853/2004 is amended as follows:

ANNEX II

(1) Section VIII is amended as follows:

(a) The introductory Part is amended as follows:

(i) Point 2 is replaced by the following:

‘2. Chapter III, Parts A, C and D, Chapter IV, Part A and Chapter V apply to retail.’

(ii) In the first subparagraph of point 3, the following point (c) is added:

‘(c)

In the case of water supply, they supplement the requirements of Annex II, Chapter VII to that Regu­
lation; clean seawater may be used for the handling and washing of fishery products, the production of
ice used to chill fishery products and the rapid cooling of crustaceans and molluscs after their cooking.’

(b) Chapter I Part II is amended as follows:

(i) In point 2, the second sentence is deleted.

(ii) Point 5 is deleted.

(iii) Point 6 is replaced by the following:

‘6. Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon
as possible after capture, and the products must be washed immediately and thoroughly. In that event,
the viscera and parts that may constitute a danger to public health must be removed as soon as possible
and kept apart from products intended for human consumption. Livers and roes intended for human
consumption must be preserved under ice, at a temperature approaching that of melting ice, or be
frozen.’

(c) Chapter III is amended as follows:

(i) In Part A, point 2 is replaced by the following:

‘2. Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a
technical and commercial viewpoint, it must be carried out as quickly as possible after the products have
been caught or landed. The products must be washed thoroughly immediately after these operations.’

(ii) Part E is deleted.

(d) Chapter IV is replaced by the following:

‘CHAPTER IV: REQUIREMENTS FOR CERTAIN PROCESSED FISHERY PRODUCTS

Food business operators must ensure compliance with the following requirements in establishments handling
certain processed fishery products.

A. REQUIREMENTS FOR COOKING OF CRUSTACEANS AND MOLLUSCS

1. Rapid cooling must follow cooking. If no other method of preservation is used, cooling must continue

until a temperature approaching that of melting ice is reached.

2. Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such

operations are done by hand, workers must pay particular attention to washing their hands.

3. After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible

to the temperature set out in Chapter VII.

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B. REQUIREMENTS FOR FISH OIL INTENDED FOR HUMAN CONSUMPTION

1. Raw materials used in the preparation of fish oil for human consumption must:

(a) come from establishments, including vessels, registered or approved pursuant to Regulation (EC) No

852/2004 or in accordance with this Regulation;

(b) derive from fishery products which are fit for human consumption and which comply with the

provisions set out in this Section;

(c) be transported and stored in hygienic conditions;

(d) be chilled as soon as possible and remain at the temperatures set out in Chapter VII.

By way of derogation from point 1(d), the food business operator may refrain from chilling the fishery
for human
products when whole fishery products are used directly in the preparation of
consumption, and the raw material
the
freshness criteria are met and the total volatile basic nitrogen (TVB-N) value of the unprocessed fishery
products do not exceed the limits set out in point 1 of Chapter I of Section II of Annex II to Commission
Regulation (EC) No 2074/2005 (*).

is processed within 36 hours after loading, provided that

fish oil

2. The production process for fish oil must ensure that all raw material intended for the production of crude
fish oil is subject to a treatment including, where relevant, heating, pressing, separation, centrifugation,
processing, refining and purification steps before being placed on the market for the final consumer.

3. Provided that the raw materials and the production process comply with the requirements applying to fish
oil intended for human consumption a food business operator may produce and store both fish oil for
human consumption and fish oil and fish meal not intended for human consumption in the same
establishment.

4. Pending the establishment of specific Community legislation food business operators must ensure

compliance with national rules for fish oil being placed on the market for the final consumer.
___________
(*) OJ L 338, 22.12.2005, p. 27.’

(e) Chapter V is amended as follows:

(i) The following sentence is added to the introductory paragraph:

‘The requirements of Parts B and D shall not apply to whole fishery products that are used directly for the
preparation of fish oil intended for human consumption.’

(ii) In Part E, point 1 is replaced by the following:

‘1. Fishery products derived from poisonous fish of the following families must not be placed on the market:

Tetraodontidae, Molidae, Diodontidae and Canthigasteridae.

Fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae, in particular
Ruvettus pretiosus and Lepidocybium flavobrunneum, may only be placed on the market in wrapped/packaged
form and must be appropriately labelled to provide information to the consumer on preparation/cooking
methods and on the risk related to the presence of substances with adverse gastrointestinal effects.

The scientific name of the fishery products must accompany the common name on the label.’

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(2) In Section IX, Chapter II, Part III, point 1 is replaced by the following:

‘1. Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before

being heat treated and if its period of acceptance specified in the HACCP-based procedures is exceeded:

(a) raw cows’ milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml; and

(b) heat treated cows’ milk used to prepare dairy products has a plate count at 30 °C of less than 100 000

per ml.’

(3) Section X is amended as follows:

(a)

In Chapter I, point 2 is replaced by the following:

‘2. Eggs must be stored and transported until sale to the final consumer at a temperature, preferably constant,
that is best suited to assure optimal conservation of their hygiene properties, unless the competent authority
temperature requirements for egg storage facilities and for vehicles transporting eggs
imposes national
between such storage facilities.’

(b) In Chapter II, Part II, point 1 is replaced by the following:

‘1. The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks.
However, cracked eggs may be used for the manufacture of liquid egg or egg products if the establishment of
production or a packing centre delivers them directly to an establishment approved for the manufacture of
liquid egg or a processing establishment, where they must be broken as soon as possible.’