Commission Regulation (EC) No 472/2002 of 12 March 2002 amending Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs (Text with EEA relevance)
Date: 2002-03-12
Institutions: European Commission
Subjects: food contamination, food standard, foodstuff, public health, toxic substance

L 75/18

EN

Official Journal of the European Communities

16.3.2002

COMMISSION REGULATION (EC) No 472/2002

of 12 March 2002

amending Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in
foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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,

After consulting the Scientific Committee for Food (SCF),

Whereas:

(1)

(2)

(3)

(4)

(5)

Regulation (EEC) No 315/93 provides that maximum
levels must be set for contaminants in foodstuffs in
order to protect public health.

Commission Regulation (EC) No 466/2001 (2), as last
amended by Regulation (EC) No 257/2002 (3), sets
maximum levels for certain contaminants in foodstuffs
to apply from 5 April 2002.

Some Member States have adopted, or plan to adopt,
maximum levels for aflatoxins in spices and maximum
levels for ochratoxin A in certain foodstuffs. In view of
the disparities between Member States and the conse-
quent risk of distortion of competition, Community
measures are necessary in order to ensure market unity
while abiding by the principle of proportionality.

in particular aflatoxin B1, are genotoxic
Aflatoxins,
carcinogenic substances. For substances of
this type
there is no threshold below which no harmful effect is
observed and therefore no admissible daily intake can be
set. Current scientific and technical knowledge and
improvements in production and storage techniques do
these moulds and
not prevent
consequently do not enable the presence of the afla-
toxins in spices to be eliminated entirely. Limits should
therefore be set which are as low as reasonably achiev-
able.

the development of

The
results of a coordinated control programme,
performed by the Member States in accordance with
Commission Recommendation 97/77/EC of 8 January
1997 concerning a coordinated programme for the offi-
cial control of foodstuffs for 1997 (4) have become avail-

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 77, 16.3.2001, p. 1.
(3) OJ L 41, 13.2.2002, p. 12.
(4) OJ L 22, 24.1.1997, p. 27.

able since the maximum levels for aflatoxins in other
foodstuffs were established. They show that several
species of spices contain a high level of aflatoxins. It is
therefore appropriate to establish maximum limits for
the species of spices which are used in large quantity
and which have a high incidence of contamination.

The maximum limits should be reviewed and, if neces-
sary, reduced before 31 December 2003 taking into
account possibilities to reduce aflatoxin contamination
in spices by improvements in production, harvesting and
storage methods and the progress of scientific and tech-
nological knowledge.

Ochratoxin A is a mycotoxin produced by several fungi
(Penicillium and Aspergillus species). It occurs naturally in
a variety of plant products, such as cereals, coffee beans,
cocoa beans, and dried fruit, all over the world. It has
been detected in products such as cereal products,
coffee, wine, beer, spices and grape juice but also in
products of animal origin, namely pig kidneys. Investiga-
tions of the frequency and levels of occurrence of ochra-
toxin A in food and human blood samples indicate that
foodstuffs are frequently contaminated.

Ochratoxin A is a mycotoxin with carcinogenic, nephro-
toxic, teratogenic, immunotoxic and possibly neurotoxic
properties.
It has been linked to nephropathy in
humans. Ochratoxin A may have a long half-life in
humans.

The Scientific Committee for Food considered in its
opinion on ochratoxin A of 17 September 1998 that it
would be prudent to reduce exposure to ochratoxin A as
much as possible, ensuring that exposures are towards
the lower end of the range of tolerable daily intakes of
1,2-14 ng/kg bw/day which have been estimated by
other bodies, e.g. below 5 ng/kg bw/day.

(6)

(7)

(8)

(9)

(10) With current scientific and technical knowledge, and
despite improvements in production and storage tech-
niques, it is not possible to prevent the development of
these moulds altogether. Consequently ochratoxin A
cannot be eliminated from food entirely. Limits should
therefore be set which are as low as reasonably achiev-
able.

16.3.2002

EN

Official Journal of the European Communities

L 75/19

(11)

The main contributors to the dietary intake of ochra-
toxin A are cereals and cereal products. Prevention is of
major importance to avoid contamination as much as
possible and to protect the consumer. In addition, it is
appropriate to establish maximum limits for cereals and
cereal products at a level reasonably achievable on
condition that preventive actions to avoid contamina-
tion at all stages in the production and commercialisa-
tion chain are applied.

(12) Dried vine fruit (currants, raisins and sultanas) has been
found to be highly contaminated. Dried vine fruit is an
important dietary source of ochratoxin A for people
with high levels of consumption, in particular children.
While it is therefore appropriate to establish for the time
being a limit at a level which is technologically achiev-
able,
it is imperative to further improve practices to
reduce contamination.

(13)

(14)

(15)

The presence of ochratoxin A has also been observed in
coffee, wine, beer, grape juice, cocoa and spices. Investi-
gations and research should be undertaken by Member
States and interested parties (such as professional organ-
isations) to determine the different factors involved in
the formation of ochratoxin A and to determine the
prevention measures to be taken to reduce the presence
of ochratoxin A in these foodstuffs. For these products
every effort should be made with regard to research and
prevention measures to reduce ochratoxin A content as
much as possible pending
establishment of
maximum limits on the basis of the ‘as low as reason-
ably achievable’ (ALARA) principle. If no effort is under-
taken to reduce the ochratoxin A content for certain
products, it will be necessary to establish a maximum
limit for these products in order to protect public health,
without being able to assess the technological feasibility.

the

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

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:

Article 1

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

1. Article 4(2) is amended as follows:

(a) the introductory phrase is replaced by the following:
‘With regard to aflatoxins and ochratoxin A in products
mentioned in points 2.1 and 2.2 of Annex I,
is
prohibited:’;

it

(b) in point (b),

‘and 2.1.3’ is replaced by ‘, 2.1.3, 2.1.4,

2.2.1 and 2.2.2’.

2. In Article 5, the following paragraph 2a is inserted:

‘2a.
The Commission shall review the maximum limits
for aflatoxins laid down in point 2.1.4 of section 2 of
Annex I by 31 December 2003 at the latest and, if appro-
priate, reduce them to take account of the progress of
scientific and technological knowledge.

The Commission shall review the provisions in points 2.2.2
and 2.2.3 of section 2 of Annex I by 31 December 2003 at
the latest as regards the maximum limits for ochratoxin A
in dried vine fruit and with a view to including a maximum
limit for ochratoxin A 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 ochratoxin A in these products.

For this purpose, Member States and interested parties shall
communicate each year to the Commission the results of
investigations undertaken and the progress with regard to
the application of prevention measures to avoid contamina-
tion by ochratoxin A.’

3. Annex I is amended as set out in the Annex to this Regula-

tion.

Article 2

This Regulation shall enter
into force on the 10th day
following its publication in the Official Journal of the European
Communities.

It shall apply from 5 April 2002.

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

Done at Brussels, 12 March 2002.

For the Commission

David BYRNE

Member of the Commission

L 75/20

EN

Official Journal of the European Communities

16.3.2002

In Section 2 (Mycotoxins) of Annex I to Regulation (EC) No 466/2001 the following is added:

ANNEX

Product

‘2.1.4. Following species of spices:

— Capsicum spp.

(dried fruits

thereof,
including chillies,

whole or ground,
chilli powder, cayenne and paprika)

Maximum level
(µg/kg)

B1 + B2 + G1 + G2

M1

Sampling
method

Performance
criteria
for methods
of analysis

10

—

Directive
98/53/EC

Directive
98/53/EC’

B1

5

— Piper

spp.

(fruits

thereof,

including

white and black pepper)

— Myristica fragrans (nutmeg)

— Zingiber officinale (ginger)

— Curcuma longa (turmeric)

‘Product

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. Green and roasted coffee and coffee prod-
ucts, wine, beer, grape juice, cocoa and
cocoa products and spices

(*) OJ L 75, 16.3.2002, p. 44.’

Commission Directive
2002/27/EC (*)

Directive 2002/27/EC

Directive 2002/27/EC

Directive
2002/27/EC

Directive
2002/27/EC

Directive
2002/27/EC

5

3

10

—