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3.12.2011 Official
Journal
of
the
European
Union L
320/15
COMMISSION REGULATION (EU) No 1258/2011
of 2 December 2011
amending Regulation (EC) No 1881/2006 as regards maximum levels for nitrates in foodstuffs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
properties that might in some way counteract or provide
a balance to the risks arising from nitrates and the
resulting nitroso-compounds.
Having regard to the Treaty on the Functioning of the European
Union,
(5) On request of the Commission, the Panel on
Having regard to Council Regulation (EEC) No 315/93 of
Contaminants in the Food Chain (the Panel) adopted
8 February 1993 laying down Community procedures for
on 10 April 2008 a Scientific opinion on nitrate in
contaminants in food (
vegetables ( 3 ). The Panel compared the risk and benefits

1 ), and in particular Article 2(3) thereof,
of exposure to nitrate from vegetables. Overall, the
estimated exposures to nitrate from vegetables are
Whereas:
unlikely to result in appreciable health risks, therefore,
the recognised beneficial effects of consumption of
vegetables prevail. The Panel recognised that there are
(1) Commission Regulation (EC) No
1881/2006 of
occasional circumstances (e.g. unfavourable local/home
19 December 2006 setting maximum levels for certain
production conditions) for vegetables which constitute
contaminants in foodstuffs ( 2 ) sets maximum levels for
a large part of the diet, or individuals with a diet high
nitrates in certain leafy vegetables.
in vegetables such as rucola which need to be assessed
on a case-by-case basis.
(2) In
some
cases,
despite
developments
in
good
agricultural
practice, the maximum levels are exceeded and therefore
(6) Following
discussion
on
appropriate
measures
and
a temporary derogation was granted to certain Member
concerns expressed as regards possible risks for infants
States for the placing on the market of certain leafy
and young children following acute dietary intake
vegetables, grown and intended for consumption in
exposure, the Commission asked EFSA for a comple
their territory with nitrate levels higher than the estab
mentary scientific statement on nitrates in vegetables,
lished maximum levels.
whereby the possible risks for infants and young
children related to the presence of nitrates in fresh
(3)
Since the application of the maximum levels of nitrates
vegetables are assessed in more detail, also considering
in lettuce and spinach, many investigations have been
the acute dietary intake, taking into account recent
performed on the factors involved in the presence of
occurrence data on the presence of nitrates in vegetables,
nitrates in lettuce and spinach and on the measures to
more detailed consumption data of vegetables by infants
be taken to reduce the presence of nitrates in lettuce and
and young children and the possibility of the estab
spinach as much as possible. Despite the progress
lishment of slightly higher than the current maximum
achieved in the good agricultural practice to reduce the
levels for nitrates in leafy vegetables. The Panel adopted
presence of nitrates in lettuce and spinach and a strict
on 1 December 2010 a Statement on possible public
application of this good agricultural practice, it is not
health risks for infants and young children from the
possible to achieve in a consistent way nitrate levels in
presence of nitrates in leafy vegetables ( 4 ).
lettuce and fresh spinach below the current maximum
levels in certain regions of the Union. The reason is
that the climate and in particular the light conditions
(7) In
that
statement
the
Panel
concluded
that
exposure
to
are the main determinant factor in the presence of
nitrate at the current or envisaged maximum levels in
nitrates in lettuce and spinach. These climate conditions
spinach cooked from fresh spinach is unlikely to be a
cannot be managed or changed by the producer.
health concern, although a risk for some infants eating
more than one spinach meal per day cannot be excluded.
EFSA noted that it did not take into account possible
(4) To
provide
an
up-to-date
scientific
basis
for
the
longer-
changes of the nitrate content due to processing of the
term strategy for managing the risk arising from nitrates
food commodities, such as washing, peeling and/or
in vegetables, a scientific risk assessment by the European
cooking, as this could not be considered due to lack of
Food Safety Authority (EFSA), taking into account new
information, was needed. Such assessment had to take
( 3 ) Opinion of the Scientific Panel on Contaminants in the Food chain
into account any relevant considerations on risks and
on a request from the European Commission to perform a scientific
benefits, for example, weighing the possible negative
risk assessment on nitrate in vegetables, EFSA Journal (2008), Journal
impact of nitrate versus the possible positive effects of
No 689, p. 1. http://www.efsa.europa.eu/en/scdocs/doc/689.pdf
eating vegetables, such as antioxidant activities or other
( 4 ) EFSA Panel on Contaminants in the Food Chain (CONTAM);
Scientific Opinion on possible health risks for infants and young
children from the presence of nitrates in leafy vegetables. EFSA
( 1 ) OJ L 37, 13.2.1993, p. 1.
Journal 2010; 8(12):1935. doi:10.2903/j.efsa.2010.1935. http://
( 2 ) OJ L 364, 20.12.2006, p. 5.
www.efsa.europa.eu/en/scdocs/doc/1935.pdf

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L 320/16
EN
Official Journal of the European Union
3.12.2011
representative data. The non-consideration of the quanti
Committee on the Food Chain and Animal Health and
tative impact of food processing on nitrate levels may
neither the European Parliament nor the Council have
consequently lead to an overestimation of the exposure.
opposed them,
It was furthermore concluded that levels of nitrate in
lettuce are not a health concern for children. Enforcing
the current maximum levels for nitrate in lettuce and
HAS ADOPTED THIS REGULATION:
spinach, or envisaged maximum levels at 500 mg/kg
higher than the current maximum levels, would have a
minor impact.
Article 1
Regulation (EC) No 1881/2006 is amended as follows:
(8) In
order
to
provide
legal
security
for
the
producer
in
all
regions of the European Union which applies strictly the
good agricultural practices to reduce the presence of
(1) in Article 7, paragraphs 1, 2 and 3 are deleted;
nitrates in spinach and lettuce as much as possible, it
is therefore appropriate to slightly increase the
maximum level for nitrates in fresh spinach and lettuce
(2) in Article 9, paragraph 1 is replaced by the following:
without endangering public health.
‘1. Member States shall monitor nitrate levels in
(9) Given
the
sometimes
very
high
levels
of
nitrates
found
in
vegetables which may contain significant levels, in particular
rucola, it is appropriate to set a maximum level for
green leaf vegetables, and communicate the result to EFSA
rucola. The maximum level for rucola should be
on a regular basis.’;
reviewed in 2 years in view of a reduction of the levels
after having identified the factors involved in the
presence of nitrate in rucola and the full implementation
(3) in the Annex, Section 1: Nitrate is replaced by the Section
of good agricultural practice in rucola to minimise the
in the Annex to this Regulation.
nitrate content.
Article 2
(10) Given
that
EFSA
has
been
mandated
by
the
Commission
to compile all occurrence data on contaminants,
This Regulation shall enter into force on the 20th day following
including nitrates, in food into one database, it is appro
its publication in the Official Journal of the European Union.
priate to communicate the results directly to EFSA.
It shall apply from the date of its entry into force. However, the
(11) The
measures
provided
for
in
this
Regulation
are
in
maximum levels for rucola provided for in point 1.5 of the
accordance with the opinion of the Standing
Annex shall apply from 1 April 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 December 2011.
For the Commission
The President
José Manuel BARROSO

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EN
3.12.2011 Official
Journal
of
the
European
Union L
320/17
ANNEX
‘Section 1: Nitrate
Foodstuffs ( 1 ) Maximum
levels
(mg
NO 3 /kg)
1.1 Fresh
spinach
(Spinacia oleracea) ( 2 ) 3
500
1.2 Preserved,
deep-frozen
or
frozen
spinach 2
000
1.3 Fresh
Lettuce
(Lactuca sativa L.) (protected Harvested 1 October to 31 March:
and open-grown lettuce) excluding lettuce lettuce grown under cover 5
000
listed in point 1.4
lettuce grown in the open air 4
000
Harvested 1 April to 30 September:
lettuce grown under cover 4
000
lettuce grown in the open air 3
000
1.4 “Iceberg”
type
lettuce Lettuce
grown
under
cover 2
500
Lettuce grown in the open air 2
000
1.5 Rucola
(Eruca sativa, Diplotaxis sp., Brassica Harvested 1 October to 31 March: 7
000
tenuifolia, Sisymbrium tenuifolium)
Harvested 1 April to 30 September: 6
000
1.6 Processed
cereal-based
foods
and
baby
foods
200’
for infants and young children ( 3 ) ( 4 )

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