Commission Regulation (EC) No 123/2005 of 26 January 2005 amending Regulation (EC) No 466/2001 as regards ochratoxin AText with EEA relevance
Date: 2005-01-26
Institutions: European Commission
Subjects: consumer protection, food safety, food standard, foodstuff, public health, toxic substance

28.1.2005

EN

Official Journal of the European Union

L 25/3

COMMISSION REGULATION (EC) No 123/2005

of 26 January 2005

amending Regulation (EC) No 466/2001 as regards ochratoxin A

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 315/93 of 8
February 1993 laying down Community procedures
for
contaminants in food (1), and in particular Article 2(3) thereof,

Whereas:

(1)

(2)

(3)

Commission Regulation (EC) No 466/2001 (2),
sets
maximum levels for certain contaminants in foodstuffs.

review the provisions as

to Regulation (EC) No 466/2001,

the
According
Commission shall
regards
ochratoxin A (OTA) in dried vine fruit and with a view
to including a maximum level for OTA in green and
roasted coffee and coffee products, wine, beer, grape
juice, cocoa and cocoa products and spices taking into
account the investigations undertaken and the prevention
measures applied to reduce the presence of OTA in these
products.

teratogenic,

immunotoxic

are ongoing to elucidate

studies
involved in OTA carcinogenicity.

The Scientific Committee on Food (SCF) concluded in its
opinion on OTA, expressed on 17 September 1998, that
OTA is a mycotoxin which possesses carcinogenic,
nephrotoxic,
and possibly
neurotoxic properties. The Committee mentioned also
the
further
that
mechanisms
is
anticipated that the European research project on the
mechanisms of OTA induced carcinogenicity will be
finished by the end of 2004. Once the comprehensive
research results are available, the European Food Safety
Authority (EFSA) will be requested by the Commission to
update the scientific opinion from SCF in the light of
these new research results.

It

February 1993 on assistance to the Commission and
cooperation by the Member States in the scientific exa-
mination of questions relating to food (3) (SCOOP). The
main contributor to the OTA exposure is cereal and
cereal products. Wine, coffee and beer were identified
as
human OTA
exposure. Dried vine fruit and grape juice contributed
to a significant extent to the OTA-exposure for specific
groups of vulnerable groups of consumers
such as
children.

contributors

significant

the

to

(5)

(6)

(7)

A maximum level
for OTA has been established for
cereal and cereal products and dried vine fruit by Regu-
lation (EC) 466/2001. The level of OTA in beer is
the OTA in beer originates
indirectly controlled as
from the presence of OTA in malt,
for which a
maximum level has been established. The setting of a
maximum level for OTA in beer is therefore not imme-
diately necessary to protect public health, but should be
considered in the frame of the foreseen review.

Given the significant contribution of wine and roasted
coffee together with soluble coffee to the OTA human
exposure and the significant contribution of grape juice
to the OTA exposure of children, it is appropriate to set
already at this stage for these foodstuffs maximum levels
to protect public health by preventing the distribution of
unacceptably highly contaminated foodstuffs.

OTA has also been observed in dried fruit other than
dried vine fruit, cocoa and cocoa products, spices and
liquorice. The appropriateness of setting a maximum
level
including green
coffee, as well a review of the existing maximum levels
will be considered after the availability of
the EFSA
assessment of the research results on OTA toxicology.

for OTA in these foodstuffs,

(8)

Regulation (EC) No 466/2001 should therefore be
amended accordingly.

(4)

An assessment of
the dietary intake of OTA by the
population of the Community has been performed in
the framework of Council Directive 1993/5/EEC of 25

(9)

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ L
284, 31.10.2003, p. 1).

(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation

(EC) 684/2004 (OJ L 106, 15.4.2004, p. 6).

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

opinion

the

the

of

(3) OJ L 52, 4.3.1993, p. 18. Directive as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council.

L 25/4

EN

Official Journal of the European Union

28.1.2005

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 466/2001 is amended as follows:

For this purpose, Member States and interested parties shall
communicate each year to the Commission the results of the
investigations undertaken and the progress with regard to
the application of prevention measures to avoid contami-
nation by OTA. The Commission will make these results
available to the Member States.

1.

in Article 4(2) point (b),
2.2.3, 2.2.4 and 2.2.5’.

‘and 2.2.2’ is replaced by ‘, 2.2.2,

3. Annex I is amended in accordance with the Annex to this

Regulation.

2.

in Article 5, paragraph 2a is replaced by the following:

Article 2

The Commission shall, based on an up-to-date risk
2a.
assessment on ochratoxin A (OTA) performed by the EFSA
and taking into account the prevention measures applied to
reduce the OTA content, review the provisions under the
heading 2.2 of section 2 of Annex I by 30 June 2006 at
the
the latest. This
maximum level for OTA in dried vine fruit and grape juice
and the consideration of setting a maximum level for OTA
in green coffee, dried fruit other than dried vine fruit, beer,
cocoa and cocoa products,
liqueur wines, meat and meat
products, spices and liquorice.

review will concern in particular

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

It shall apply from 1 April 2005.

This Regulation shall not apply to products which were placed
on the market before 1 April 2005 in conformity with the
provisions
applicable. The burden of proving when the
products were placed on the market shall be borne by the
food business operator.

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

Done at Brussels, 26 January 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Official Journal of the European Union

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In Section 2 Mycotoxins of Annex I, the point 2.2 ochratoxin A is replaced by the following:

ANNEX

Products

Ochratoxin A:
maximum levels
(μg/kg or ppb)

Sampling method

Reference analysis
method

‘2.2.

OCHRATOXIN A

2.2.1.

Cereals (including rice and buckwheat) and derived cereal products

2.2.1.1. Raw cereal grains (including raw rice and buckwheat)

2.2.1.2. All products derived from cereals (including processed cereal products

and cereal grains intended for direct human consumption)

2.2.2. Dried vine fruit (currants, raisins and sultanas)
2.2.3. — Roasted coffee beans and ground roasted coffee with the exception

of soluble coffee

— Soluble coffee (instant coffee)

5,0

3,0

10,0

5,0

10,0

Commission Directive
2002/26/EC (*)

Directive 2002/26/EC

Directive 2002/26/EC

Directive 2002/26/EC

Directive 2002/26/EC

Directive 2002/26/EC

Directive 2002/26/EC

Directive 2002/26/EC

2.2.4. — Wine (red, white and rosé) (**) and other wine and/or grape must

2,0 (****)

Directive 2002/26/EC

Directive 2002/26/EC

based beverages (***)

2.2.5. — Grape juice, grape juice ingredients in other beverages,

including

2,0 (****)

Directive 2002/26/EC

Directive 2002/26/EC

grape nectar and concentrated grape juice as reconstituted (*****)
— Grape must and concentrated grape must as reconstituted, intended

for direct human consumption (*****)

2,0 (****)

Directive 2002/26/EC

Directive 2002/26/EC

2.2.6.

Baby foods and processed cereal-based foods for infants and young
children (******)

0,50

Directive 2002/26/EC

Directive 2002/26/EC

2.2.7. Dietary foods for special medical purposes (*******) intended specifically

0,50

Directive 2002/26/EC

Directive 2002/26/EC

for infants

2.2.8. Green coffee, dried fruit other than dried vine fruit, beer, cocoa and

cocoa products, liqueur wines, meat products, spices and liquorice.

—

(***)

(*)
(**)

(****)
(*****)

OJ L 75, 16.3.2002, p. 38. Directive as last amended by Directive 2004/43/EC (OJ L 113, 20.4.2004, p. 14).
Wines, including sparkling wines but excluding liqueur wines and wines with an alcoholic strength of not less than 15 % vol., as defined in Council Regulation (EC)
No 1493/1999 (OJ L 179, 14.7.1999, p. 1) and fruit wines.
Aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails as defined in Council Regulation (EEC) No 1601/91 (OJ L 149, 14.6.1991,
p. 1). The maximum level for OTA applicable to these beverages is function of the proportion of wine and/or grape must present in the finished product.
Maximum level applies to products produced from the 2005 harvest onwards.
Fruit juices, including fruit juices from concentrates, concentrated fruit juice and fruit nectar as defined in Annex 1 and 2 of Council Directive 2001/112/EC of 20
December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58) and derived from grapes.
(******) Baby foods and processed cereal-based foods for infants and young children as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on
processed cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41,
14.2.2003, p. 33).
The maximum level for baby foods and processed cereal-based foods for infants and young children refer to the dry matter. The dry matter is determined in
accordance with the provisions of Commission Directive 2002/26/EC.

(*******) Dietary foods for special medical purposes as defined in Article 1(2) of Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical

purposes (OJ L 91, 7.4.1999, p. 29).
The maximum level for dietary foods for special medical purposes intended specifically for infants refer
— in the case of milk and milk products, to the products ready for use (marketed as such or reconstituted as instructed by the manufacturer),
— in the case of products other than milk and milk products, to the dry matter. The dry matter is determined in accordance with the provisions of Commission

Directive 2002/26/EC.’