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"BCOMMISSION REGULATION (EC) No 194/97
of 31 January 1997
setting maximum levels for certain contaminants in foodstuffs
(Text with EEA relevance)
(OJ L 31, 1.2.1997, p. 48)
Amended by:
Official Journal
No page date
"M1 Commission Regulation (EC) No 1525/98 of 16 July 1998 L 201 43 17.7.1998
"M2 Commission Regulation (EC) No 864/1999 of 26 April 1999 L 108 16 27.4.1999
"M3 Commission Regulation (EC) No 1566/1999 of 16 July 1999 L 184 17 17.7.1999
Corrected by:
"C1 Corrigendum, OJ L 138, 29.5.1997, p. 31 (194/97)1997R0194 — EN — 30.06.1999 — 003.001 — 1
COMMISSION REGULATION (EC) No 194/97
of 31 January 1997
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 thereof,
Whereas Regulation (EEC) No 315/93 provides that maximum levels
must be set for certain contaminants in order to protect public health;
whereas these maximum levels must be adopted in the form of a
non-exhaustive Community list which may contain levels for the same
contaminant in different foodstuffs and analytical detection limits;
whereas the sampling and analysis methods to be applied may be
specified;
Whereas it is essential, in order to protect public health, to keep
contaminant levels at contents which are toxicologically acceptable;
whereas contaminants must be eliminated more thoroughly wherever
possible by means of good professional practice;
Whereas vegetables have an essential nutritional function and play an
important role in health protection; whereas the consumption of
vegetables should therefore be encouraged by improving the quality of
the products on offer;
Whereas some Member States have adopted, or are planning to adopt,
maximum levels for nitrates in certain vegetables;
Whereas, in view of the disparities between Member States and the
consequent risk of distortion of competition, Community measures are
necessary in order to ensure market unity while abiding by the principle
of proportionality;
Whereas specific measures designed to provide better control of the
sources of agricultural contamination together with codes of good
practice may help to reduce the contaminant levels of certain vegetables
and in particular the nitrate levels;
Whereas climatic conditions, production methods and eating habits vary
widely in different parts of the Community; whereas different maximum
nitrate levels should therefore be fixed for vegetables depending on the
season; whereas, moreover, Member States should be allowed for a
transitional period to authorize the marketing of lettuces and spinach
grown and intended for consumption in their territory with nitrate levels
higher than those fixed in point 1.1 of Part I of the Annex, provided,
however, that the quantities present remain acceptable from the point of
view of public health;
Whereas lettuce and spinach producers established in the Member States
which have given the abovementioned authorizations should progress-
ively modify their farming methods by applying the good practice
recommended at national level so as to comply at the end of the
transitional period with the maximum levels laid down at Community
level;
Whereas it is desirable to achieve common values as soon as possible;
Whereas a study should be made, based on the available scientific data,
as to whether maximum contaminant levels should be set for baby food
for infants and young children;!B
(1) OJ No L 37, 13. 2. 1993, p. 1.1997R0194 — EN — 30.06.1999 — 003.001 — 2
Whereas the free movement throughout the Community of foodstuffs
with contaminant levels below or equal to those fixed in the Annex
should be guaranteed;
Whereas the Member States must adopt appropriate surveillance
measures regarding the presence of contaminants in foodstuffs;
Whereas any maximum level adopted at Community level will have to be
revised to take account of the advance of scientific and technical
knowledge and improvements in production practice;
Whereas the levels set for lettuce and spinach should be reviewed and, if
necessary, reduced before 1 October 1998; whereas the review will be
based on the results of controls carried out by the Member States;
Whereas the Scientific Committee for Food has been consulted, in
accordance with Article 3 of Regulation (EEC) No 315/93, on the
provisions liable to affect public health;
Whereas the measures provided for in this Regulation are in accordance
with the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS REGULATION:
Article 1
This Regulation sets maximum levels for certain contaminants present in
various foodstuffs.
Article 2
1. (a) The products indicated in the Annex to this Regulation must not,
when placed on the market, contain higher contaminant levels
than those specified therein.
(b) The maximum limits applicable to the products, as laid down in
points I.2.1.1.1 and I.2.1.2.1 of the Annex shall also be
applicable to processed products thereof in so far as no specific
maximum limits are fixed for such processed products.
(c) For milk products which are dried, processed or composed of
more than one ingredient, the maximum limit applicable shall be
that laid down in point I.2.1.3 of the Annex for milk, taking into
account respectively the concentration caused by the drying
process, by processing or the relative concentrations of the
ingredients in the product, in so far as no specific maximum
limits are fixed for these dried, processed or compound milk
products.
2. Member States may, where justified, authorize for a transitional
period the placing on the market of lettuces and spinach grown and
intended for consumption in their territory with nitrate levels higher than
those set in point 1.1 of Part I of the Annex provided codes of good
practice are applied to achieve gradual progress towards the levels laid
down at Community level.
3. Member States shall inform the other Member States and the
Commission each year of steps taken to implement paragraph 2.
4. With regard to the products mentioned at point I.2.1 of the Annex, it
is prohibited:
— to mix products complying with the maximum limits laid down in
the Annex with products exceeding these maximum limits or to mix
products to be subjected to a sorting technique or physical treatment
with products intended for direct human consumption or as an
ingredient in foodstuffs,
— to use products which do not comply with the maximum limits laid
down in point I.2.1.1.1, I.2.1.2.1 and I.2.1.3 as an ingredient for the
manufacture of other foodstuffs,!B
!M1
!B
!M11997R0194 — EN — 30.06.1999 — 003.001 — 3
— to detoxify products by chemical treatments.
5. Groundnuts, nuts and dried fruit not complying with the maximum
limits laid down in point I.2.1.1.1 of the Annex and cereals not
complying with the maximum limits laid down in point I.2.1.2.1 can be
placed on the market provided that:
(a) these products:
— are not intended for direct human consumption or use as an
ingredient in foodstuffs,
— comply with the maximum limits laid down in point I.2.1.1.2 of
the Annex for groundnuts and point I.2.1.1.3 of the Annex for
nuts and dried fruit, and
— are subjected to a secondary treatment involving sorting or other
physical treatments and that after this treatment the maximum
limits laid down in points I.2.1.1.1 and I.2.1.2.1 of the Annex are
not exceeded, and this treatment does not result in other harmful
residues;
(b) the destination of these products is demonstrated clearly by labelling
comprising the indication ‘product must be subjected to sorting or
other physical treatment to reduce aflatoxin contamination before
human consumption or use as an ingredient in foodstuffs’.
Article 3
Member States shall each year communicate to the Commission by 30
June, the results of their monitoring and report on the measures taken and
the progress made with regard to the application and improvement of
codes of good practices to reduce nitrate levels. This information shall
also contain the data on which their codes of good practice are based.
The Member States, who do not apply Article 2(2) of this Regulation,
shall carry out the monitoring and the application of good practices using
means proportionate to the desired objective, the obtained monitoring
results and, particularly, in the light of the risks and of experience gained.
On the basis of the results of controls carried out by the Member States
to check compliance with the maximum limits laid down in the Annex,
the reports with regard to the application and improvement of codes of
good practice to reduce nitrate levels and the evaluation of the data on
which the Member States have based their good agricultural practices,
the Commission shall proceed each three years and before 31 December
2001 for the first time, to a review of the provisions of this Regulation.
Article 4
The sampling and analysis methods applied shall be those specified in
the Annex hereto.
Article 5
This Regulation shall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
It shall apply from 15 February 1997. Notwithstanding Article 2, the
products referred to in point 1.2 of Part I of the Annex which are already
on the market on the date from which this Regulation applies and which
do not conform to the provisions of this Regulation may continue to be
marketed until stocks are exhausted.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.!M1
!M2
!B1997R0194 — EN — 30.06.1999 — 003.001 — 4
ANNEX
MAXIMUM LEVELS FOR CERTAIN CONTAMINANTS IN FOODSTUFFS
I. Agricultural contaminants
1. Nitrates
1.1. Fresh vegetables
ProductMaximum nitrate levels (1)
(mg NO 3/kg fresh product)Sampling methodRefer-
ence
analysis
method
Spinach (7)
(Spinacia oleracea)Harvested 1 November to 31 March .......... 3 000 (2) Commission Directive
79/700/EEC (3)
Harvested 1 April to 31 October ................ 2 500 (2)
Lettuce (Lactuca
sativa L.)
(protected and
open-grown lettuce)Harvested 1 October to 31 March .............. 4 500 (2) Directive 79/700/EEC
However, the mini-
mum number of unitsper laboratory sampleis 10
Harvested 1 April to 30 September............ 3 500 (
2)(8)
with the exception of open grown lettuce
harvested from 1 May to 31 August2 500 (2)(8)
1.2. Other processed vegetables for consumption
ProductMaximum nitrate levels (1)
(mg NO 3/kg processed product)Sampling methodRefer-
ence
analysis
method
Preserved, deep-
frozen or frozen
spinach2 000 Directive 79/700/EEC
(1)The maximum levels do not apply to food particularly prepared for babies and young children.
(2)Subject to review before 31 December 2001 pursuant to the provisions of Article 3.
(3)OJ L 207, 15.8.1979, p. 26.
(7) The maximum limits for fresh spinach do not apply for fresh spinach to be subjected to processing and which is directly
transported in bulk from field to processing plant.
(8) In the absence of appropriate labelling, indicating the production method, the limit established for the open-grown lettuce
applies.!B
!M21997R0194 — EN — 30.06.1999 — 003.001 — 5
!M1
2. Mycotoxins
2.1. Aflatoxins
ProductsAflatoxins: maximum admissible levels (1)
(µg/kg)
Sampling methodReference
analysis method
B1 B1+B 2+G 1+G 2 M1
2.1.1. Grou ndnuts, nuts and
dried fruit
2.1.1.1. Grou ndnuts, nuts and
dried fruit and processed
products thereof, in-tended for direct humanconsumption or as an
ingredient in foodstuffs2(
1)4 (1) — Directive
98/53/EC (*)Directive
98/53/EC
2.1.1.2. Groundnuts to be sub-
jected to sorting, or
other physical treatment,
before human consump-tion or use as an in-gredient in foodstuffs.8(
1)1 5 (1) — Directive
98/53/ECDirective
98/53/EC
2.1.1.3. Nuts and dried fruit to
be subjected to sorting,or other physical treat-
ment, before human
consumption or use asan ingredient in food-stuffs5(
1)(2)1 0 (1)(2) — Directive
98/53/ECDirective
98/53/EC
2.1.2. Cereals (including buck-
wheat, Fagopyrum sp.)
2.1.2.1. Cereals (including buck-
wheat, Fagopyrum sp.)and processed productsthereof intended for di-
rect human consumption
or as an ingredient infoodstuffs2 4 — Directive
98/53/ECDirective
98/53/EC
2.1.2.2. Cereals (including buck-
wheat, Fagopyrum sp.)to be subjected to sort-ing, or other physical
treatment, before human
consumption or use asan ingredient in food-stuffs—(
3)— (3) — Directive
98/53/ECDirective
98/53/EC1997R0194 — EN — 30.06.1999 — 003.001 — 6
ProductsAflatoxins: maximum admissible levels (1)
(µg/kg)
Sampling methodReference
analysis method
B1 B1+B 2+G 1+G 2 M1
2.1.3. Milk (raw milk, milk for
the manufacture of
milk-based products
and heat-treated milk asdefined by Council Di-rective 92/46/EEC of 16
June 1992 laying down
the health rules for theproduction and placingon the market of raw
milk, heat-treated milk
and milk-based prod-ucts)— — 0,05 Directive
98/53/ECDirective
98/53/EC
(*) See page 93 of this Official Journal.
(1)The maximum limits apply to the edible part of groundnuts, nuts and dried fruits. If nuts ‘in shell’ are analysed, it is assumed
when calculating the aflatoxin content, all the contamination is on the edible part.
(2)The maximum limits shall be reconsidered before 1 "M3 July 2001 3 according to the progress of scientific and
technological knowledge.
(3)In as far as no specific limit will be fixed before 1 "M3July 2001 3, the limits laid down in point 2.1.2.1 of the table will
apply thereafter to the cereals referred to in this point.
II. Other contaminants!M1
!B1997R0194 — EN — 30.06.1999 — 003.001 — 7