2002R0472 — EN — 26.03.2002 — 000.001 — 1
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►B COMMISSIONREGULATION(EC)No472/2002
of12March2002
amendingRegulation(EC)No466/2001settingmaximumlevelsforcertaincontaminantsinfood-
stuffs
(TextwithEEArelevance)
(OJ L 75, 16.3.2002, p. 18)
Corrected by:
►C1Corrigendum, OJ L 80, 23.3.2002, p. 42 (472/2002)
▼B
COMMISSIONREGULATION(EC)No472/2002
of12March2002
amendingRegulation(EC)No466/2001settingmaximumlevelsfor
certain contaminantsinfoodstuffs
(TextwithEEArelevance)
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)Regulation (EEC) No 315/93 provides that maximum levels
must be set for contaminants in foodstuffs in order to protect
public health.
(2)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.
(3)Some Member States have adopted, or plan to adopt, maximumlevels for aflatoxins in spices and maximum levels for ochra-
toxin A in certain foodstuffs. In view of the disparities between
Member States and the consequent risk of distortion of competi-tion, Community measures are necessary in order to ensuremarket unity while abiding by the principle of proportionality.
(4)Aflatoxins, in particular aflatoxin B1, are genotoxic carcinogenicsubstances. For substances of this type there is no thresholdbelow which no harmful effect is observed and therefore noadmissible daily intake can be set. Current scientific and tech-nical knowledge and improvements in production and storage
techniques do not prevent the development of these moulds and
consequently do not enable the presence of the aflatoxins inspices to be eliminated entirely. Limits should therefore be setwhich are as low as reasonably achievable.
(5)The results of a coordinated control programme, performed bythe Member States in accordance with Commission Recommen-dation 97/77/EC of 8 January 1997 concerning a coordinatedprogramme for the official control of foodstuffs for 1997(
4)
have become available 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 thereforeappropriate to establishmaximum limits for th e species of spiceswhich are used in large quantity and which have a high inci-dence of contamination.
(6)The maximum limits should be reviewed and, if necessary,reduced before 31 December 2003 taking into account possibili-ties to reduce aflatoxin contamination in spices by improvementsin production, harvesting and storage methods and the progress
of scientific and technological knowledge.
(7)Ochratoxin A is a mycotoxin produced by several fungi ( Penicil-
liumandAspergillus species). It occurs naturally in a variety of
plant products, suchas cereals, coffee beans, cocoa beans, and
dried fruit, all over the world. It has been detected in products
suchas cereal products, coffee, wine, beer, spices and grapejuice but also in products of animal origin, namely pig kidneys.2002R0472 — EN — 26.03.2002 — 000.001 — 2
(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.
▼B
Investigations of the frequency and levels of occurrence of
ochratoxin A in food and human blood samples indicate thatfoodstuffs are frequently contaminated.
(8)Ochratoxin A is a mycotoxin with carcinogenic, nephrotoxic,teratogenic, immunotoxic and possibly neurotoxic properties. Ithas been linked to nephropathy in humans. Ochratoxin A mayhave a long half-life in humans.
(9)The Scientific Committee for Food considered in its opinion onochratoxin A of 17 September 1998 that it would be prudent toreduce exposure to ochratoxin A as much as possible, ensuringthat exposures are towards the lower end of the range of toler-able daily intakes of 1,2-14 ng/kg bw/day which have beenestimated by other bodies, e.g. below 5 ng/kg bw/day.
(10)Withcurrent scientific and tech nical knowledge, and despiteimprovements in production and storage techniques, it is notpossible to prevent the development of these moulds altogether.Consequently ochratoxin A cannot be eliminated from foodentirely. Limits should therefore be set which are as low as
reasonably achievable.
(11)The main contributors to the dietary intake of ochratoxin A are
cereals and cereal products. Prevention is of major importance toavoid contamination as muchas possible and to protect th econsumer. In addition, it is appropriate to establishmaximum
limits for cereals and cereal products at a level reasonably
achievable on condition that preventive actions to avoid contam-ination at all stages in the production and commercialisationchain 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 consump-tion, in particular children. While it is therefore appropriate toestablish for the time being a limit at a level which is technolo-gically achievable, it is imperative to further improve practices
to reduce contamination.
(13)The presence of ochratoxin A has also been observed in coffee,
wine, beer, grape juice, cocoa and spices. Investigations andresearchsh ould be undertaken by Member States and interestedparties (suchas professional organisations) to determine th e
different factors involved in the formation of ochratoxin A and
to determine the prevention measures to be taken to reduce thepresence of ochratoxin A in these foodstuffs. For these productsevery effort should be made with regard to research and preven-tion measures to reduce ochratoxin A content as much aspossible pending the establishment of maximum limits on the
basis of the ‘as low as reasonably achievable’ (ALARA) prin-
ciple. If no effort is undertaken to reduce the ochratoxin Acontent for certain products, it will be necessary to establishamaximum limit for these products in order to protect publichealth, without being able to assess the technological feasibility.
(14)Regulation (EC) No 466/2001 should therefore be amendedaccordingly.
(15)The measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee on the Food Chainand Animal Health,2002R0472 — EN — 26.03.2002 — 000.001 — 3
▼B
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 inpoints 2.1 and 2.2 of Annex I, it is prohibited:’;
(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 afla-
toxins laid down in point 2.1.4 of section 2 of Annex I by 31
December 2003 at the latest and, if appropriate, reduce them totake account of the progress of scientific and technological knowl-edge.
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 asregards the maximum limits for ochratoxin A in dried vine fruit andwitha view to including a maximum limit for och ratoxin A in greenand roasted coffee and coffee products, wine, beer, grape juice,cocoa and cocoa products and spices taking into account the inves-
tigations 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 commu-
nicate each year to the Commission the results of investigations
undertaken and the progress with regard to the application of
prevention measures to avoid contamination by ochratoxin A.’
3. Annex I is amended as set out in the Annex to this Regulation.
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.2002R0472 — EN — 26.03.2002 — 000.001 — 4
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ANNEX
In Section 2 (Mycotoxins) of Annex I to Regulation (EC) No 466/2001 the following is added:
ProductMaximum level
(µg/kg) Sampling
methodPerformance
criteria for
methods of
analysis B1B1+B2+G1+G2M1
‘2.1.4. Following species of
spices:
—Capsicum spp. (dried
fruits thereof, whole
or ground, including
chillies, chilli
powder, cayenne and
paprika)
—Piperspp. (fruits
thereof, including
white and black
pepper)
—Myristica fragrans
(nutmeg)
—Zingiber officinale
(ginger)
—Curcuma longa
(turmeric)5 10 — Directive
98/53/ECDirective
98/53/EC’
‘ProductMaximum
levels
(µg/kg or ppb)Sampling methodReference 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)5 Commission
►C1Directive 2002/
26/EC◄(*)►C1Directive
2002/26/EC ◄
2.2.1.2. All products derived from
cereals (including processed cereal
products and cereal grains intended
for direct human consumption)3 ►C1Directive 2002/
26/EC◄►C1Directive
2002/26/EC ◄
2.2.2. Dried vine fruit (currants,
raisins and sultanas)10 ►C1Directive 2002/
26/EC◄►C1Directive
2002/26/EC ◄
2.2.3. Green and roasted coffee and
coffee products, wine, beer, grape
juice, cocoa and cocoa products and
spices—
►C1(*) OJ L 75, 16.3.2002, p. 38. ◄’2002R0472 — EN — 26.03.2002 — 000.001 — 5