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6.7.2012 Official
Journal
of
the
European
Union L
176/43
COMMISSION REGULATION (EU) No 594/2012
of 5 July 2012
amending Regulation (EC) 1881/2006 as regards the maximum levels of the contaminants
ochratoxin A, non dioxin-like PCBs and melamine in foodstuffs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
species on a consistent basis. It is therefore appropriate
to postpone the application of the lower maximum level
for Capsicum spp.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Wheat
gluten
is
produced
as
a
co-product
of
the
starch
production. Evidence has been provided that the current
maximum level of Ochratoxin A in wheat gluten is no
Having regard to Council Regulation (EEC) No 315/93 of
longer achievable, in particular at the end of the storage
8 February 1993 laying down Community procedures for
season, even with the strict application of good practices
contaminants in food ( 1 ), and in particular Article 2(3) thereof,
as regards storage, possibly due to the changing climate
conditions. It is therefore appropriate to modify the
current maximum level to a level which is achievable
by applying good practices and which still provides a
Whereas:
high level of human health protection.
(1) Commission
Regulation
(EC)
No
1881/2006
( 2 ) sets
(5) The
Scientific
Panel
on
Contaminants
in
the
Food
Chain
maximum levels for certain contaminants in foodstuffs.
of the European Food Safety Authority (EFSA) has, on a
request from the Commission, adopted on 4 April 2006
an updated scientific opinion relating to ochratoxin A in
food ( 5 ), taking into account new scientific information
(2) Commission Regulation (EU) No 1259/2011
( 3 ),
and derived a tolerable weekly intake (TWI) of 120 ng/kg
amending Regulation (EC) No 1881/2006, established
b.w. In accordance with the conclusions of the opinion
new maximum levels for non dioxin-like PCBs applicable
adopted by EFSA, the envisaged changes as regards
as from 1 January 2012. It is appropriate to provide that
Ochratoxin A in this Regulation continue to provide a
those maximum levels are not applicable to foodstuffs
high level of human health protection.
which were lawfully placed on the market before that
date.
(6) The
EFSA
has,
on
a
request
from
the
Commission,
on
18 March 2010, adopted a scientific opinion related to
(3) Commission
Regulation
(EU)
No
105/2010
( 4 ), amending
the melamine in feed and food ( 6 ). Its findings show that
Regulation (EC) No 1881/2006, established a final lower
exposure to melamine can result in the formation of
maximum level for Ochratoxin A in spices, which is
crystals in the urinary tract. Those crystals cause
supposed to be achievable by applying good practices.
proximal tubular damage and have been observed in
To enable the spices producing countries to put
animals and children as a result of incidents involving
prevention measures in place and in order to avoid
adulteration of feed and infant formula with melamine,
disruptions of trade to an unacceptable extent, that Regu
leading to fatalities in some instances. The Codex
lation furthermore provided for a higher maximum level
Alimentarius Commission has established maximum
to be applied for a limited period of time. The Regulation
levels for melamine in feed and food ( 7 ). It is appropriate
furthermore provided that an assessment should be
to include those maximum levels in Regulation (EC) No
performed of the achievability of the lower levels for
1881/2006 to protect public health as those levels are in
ochratoxin A by applying good practices in the
accordance with the conclusions of the EFSA's opinion.
different producing regions in the world. This assessment
had to be done before the lower maximum level of
(
Ochratoxin A would become applicable. Although a

5 ) EFSA Panel on Contaminants in the Food Chain (CONTAM);
Scientific Opinion on Ochratoxin A in Food EFSA Journal 2006;
significant improvement in the application of good
365:1-56. Available online: http://www.efsa.europa.eu/en/efsajournal/
practices in the different producing regions in the
doc/365.pdf
world has been noticed, the projected lower maximum
( 6 ) EFSA Panel on Contaminants in the Food Chain (CONTAM) and
level for Ochratoxin A is not yet achieavable in Capsicum
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and
Processing Aids (CEF); Scientific Opinion on Melamine in Food and
Feed. EFSA Journal 2010; 8(4):1573. [145 pp.]. doi:10.2903/
( 1 ) OJ L 37, 13.2.1993, p. 1.
j.efsa.2010.1573. Available online: www.efsa.europa.eu
( 2 ) OJ L 364, 20.12.2006, p. 5.
( 7 ) Report on the Thirty-Third Session of the Joint FAO/WHO Food
( 3 ) OJ L 320, 3.12.2011, p. 18.
Standards Programme, Codex Alimentarius Commission, Geneva,
( 4 ) OJ L 35, 6.2.2010, p. 7.
Switzerland, 5-9 July 2010 (ALINORM 10/33/REP).

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L 176/44
EN
Official Journal of the European Union
6.7.2012
(7) Therefore,
Regulation
(EC)
No
1881/2006
should
be
(b) the following points (e) and (f) are added:
amended accordingly.
"(e) 01 January 2012 as regards the maximum levels for
(8) The
measures
provided
for
in
this
Regulation
are
in
non dioxin-like PCBs laid down in section 5 of the
accordance with the opinion of the Standing
Annex;
Committee on the Food Chain and Animal Health and
neither the European Parliament nor the Council have
opposed them,
(f) 01 January 2015 as regards the maximum level for
Ochratoxin A in Capsicum spp. laid down in point
HAS ADOPTED THIS REGULATION:
2.2.11. of the Annex."
Article 1
(2) The Annex is amended in accordance with the Annex to
this Regulation.
Amending provisions
Regulation (EC) No 1881/2006 is amended as follows:
Article 2
(1) In Article 11, the first paragraph is amended as follows:
Entry into force
This Regulation shall enter into force on the twentieth day
(a) the introductory sentence is replaced by the following:
following that of its publication in the Official Journal of the
European Union.
"This Regulation shall not apply to products that were
placed on the market before the dates referred to in
It shall apply from the date of entry into force with the
points (a) to (f) in conformity with the provisions
exception of the provisions laid down in point 2.2.11 of the
applicable at the respective date:"
Annex which shall apply from 1 July 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 July 2012.
For the Commission
The President
José Manuel BARROSO

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EN
6.7.2012 Official
Journal
of
the
European
Union L
176/45
ANNEX
The Annex to Regulation (EC) No 1881/2006 is amended as follows:
(1) Section 2.2 Ochratoxin A is amended as follows:
(a) Point 2.2.2 is replaced by the following:
"2.2.2. All
products
derived
from
unprocessed
cereals,
including
3,0"
processed cereal products and cereals intended for direct
human consumption with the exception of foodstuffs listed in
2.2.9, 2.2.10 and 2.2.13
(b) Point 2.2.11 is replaced by the following:
"2.2.11. Spices,
including
dried
spices
Piper spp (fruits thereof, including white and black pepper)
15 μg/kg
Myristica fragrans (nutmeg)
Zingiber officinale (ginger)
Curcuma longa (turmeric)
Capsicum spp. (dried fruits thereof, whole or ground, including
30 μg/kg until 31.12.2014
chillies, chilli powder, cayenne and paprika)
15 μg/kg as from 1.1.2015
Mixtures of spices containing one of the abovementioned spices 15
μg/kg"
(c) The following point 2.2.13 is inserted after point 2.2.12:
"2.2.13. Wheat gluten not sold directly to the consumer 8,0"
(2) The following section 7: Melamine and its structural analogues is added:
"Section 7: Melamine and its structural analogues
Foodstuffs
Maximum levels
(mg/kg)
7.1. Melamine
7.1.1.
Food with the exception of infant formulae and follow-on
2,5
formulae (*)
7.1.2. Powdered
infant
formulae
and
follow-on
formulae
1
(*) The maximum level does not apply to food for which it can be proven that the level of melamine higher than 2,5 mg/kg is the
consequence of authorized use of cyromazine as insecticide. The melamine level shall not exceed the level of cyromazine."

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