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Official Journal of the European Union
13.11.2012
COMMISSION REGULATION (EU) No 1058/2012
of 12 November 2012
amending Regulation (EC) No 1881/2006 as regards maximum levels for aflatoxins in dried figs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
significant impact on the overall dietary exposure to
aflatoxins. It was demonstrated that by applying good
practices a level of 10 μg/kg aflatoxin total could be
achieved.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Codex
Alimentarius
established
only
a
maximum
level
for aflatoxin total due to the wide variation observed
Having regard to Council Regulation (EEC) No 315/93 of
in the ratio between aflatoxin B1 and aflatoxin total,
8 February 1993 laying down Community procedures for
caused by several factors (crop year, variety, weather).
contaminants in food ( 1 ), and in particular Article 2(3) thereof,
However, given that aflatoxin B1 is the most potent
carcinogen, a separate lower maximum level for
aflatoxin B1 in addition to the level for aflatoxin total
has been established in EU legislation. Aflatoxin total is
Whereas:
the sum of Aflatoxin B1, B2, G1 and G2. It is therefore
appropriate that the maximum level established for
aflatoxin B1 corresponds to the level established for
aflatoxin total. The corresponding aflatoxin B1 level
was determined by making use of the data on occurrence
(1) Commission
Regulation
(EC)
No
1881/2006 of
19 December 2006 setting maximum levels for certain
of aflatoxins in dried figs collected since 2005. From this
contaminants in foodstuffs (
calculation it is evident that the ratio of the content of

2 ) sets maximum levels (MLs)
for aflatoxin B1 and aflatoxin total (aflatoxin B1 + G1 +
aflatoxin B1/aflatoxin total is on average about 0,6 rather
B2 + G2) in a range of foodstuffs.
than the previous assumption that the concentration of

aflatoxin B1 is on average about 50 % of aflatoxin total.
(2) It
is
necessary
to
amend
the
maximum
level
for
aflatoxins in dried figs to take into account developments
(5)
The outcome of the abovementioned JECFA assessment
in Codex Alimentarius, new information on the extent to
on the effect on exposure between different maximum
which the presence of aflatoxins can be prevented by
levels in dried figs was confirmed by an updated
applying good practices and new scientific information
exposure assessment (
on the difference in health risk between different hypo

5 ) performed by the Dietary and
Chemical Monitoring (DCM) Unit in European Food
thetical maximum levels for aflatoxin B1 and aflatoxin
Safety Authority (EFSA) which estimated for different
total in different food commodities.
exposure scenario's the increase of dietary aflatoxin
exposure to be between 0,15 to 0,26
% for a
maximum level of aflatoxin total in dried figs of 10
μg/kg compared to 4 μg/kg. From the previous EFSA
(3) Codex
Alimentarius
established
a
level
of
10
μg/kg
assessments on this issue ( 6 ), it can be concluded that
aflatoxin total in dried figs "ready-to-eat" ( 3 ). The
such an increase would not adversely affect public
maximum level was based on the assessment
health. It is therefore appropriate to replace the
performed by the Joint FAO/WHO Expert Committee
maximum level currently applicable in the Union by
on Food Additives (JECFA) at its sixty-eighth meeting
the Codex maximum level for aflatoxin total in dried
on the impact of exposure and health risk of different
hypothetical maximum levels of aflatoxins for almonds,
( 5 ) European Food Safety Authority; Effect on dietary exposure of an
Brazil nuts, hazelnuts, pistachios and dried figs ( 4 ). The
increase of the levels for aflatoxin total from 4 μg/kg to 10 μg/kg for
Committee concluded as regards dried figs that whatever
dried figs. Supporting Publications 2012:EN-311. [6 pp.]. Available
the hypothetical ML scenario applied there would be no
online: www.efsa.europa.eu/publications
( 6 ) Opinion of the scientific panel on contaminants in the food chain
[CONTAM] related to the potential increase of consumer health risk
( 1 ) OJ L 37, 13.2.1993, p. 1.
by a possible increase of the existing maximum levels for aflatoxins
( 2 ) OJ L 364, 20.12.2006, p. 5.
in almonds, hazelnuts and pistachios and derived products http://
( 3 ) Codex General Standard for Contaminants and toxins in foods
www.efsa.europa.eu/en/efsajournal/doc/446.pdf
(CODEX STAN 193-1995) http://www.codexalimentarius.net/
Effects on public health of an increase of the levels for aflatoxin total
download/standards/17/CXS_193e.pdf
from 4 μg/kg to 10 μg/kg for tree nuts other than almonds,
( 4 ) WHO Food Additive Series: 59. Safety evaluation of certain food
hazelnuts and pistachios - Statement of the Panel on Contaminants
additives and contaminants. http://www.who.int/foodsafety/chem/
in the Food Chain http://www.efsa.europa.eu/en/efsajournal/doc/
jecfa/publications/monographs/en/index.html
1168.pdf

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EN
13.11.2012 Official
Journal
of
the
European
Union L
313/15
figs and the corresponding maximum level for aflatoxin
Committee on the Food Chain and Animal Health and
B1 and to amend Regulation (EC) No 1881/2006 accord
neither the European Parliament nor the Council has
ingly.
opposed them.
(6) As
Codex
Alimentarius
Commission
has
not
established HAS ADOPTED THIS REGULATION:
a maximum level for aflatoxin total in figs other than figs
"ready-to eat" it is appropriate to maintain the existing
Article 1
Union maximum level for aflatoxin total in these figs and
to adapt only the level for aflatoxin B1 for these figs to
The Annex to Regulation (EC) No 1881/2006 is amended in
take into account the more recent data on the ratio of
accordance with the Annex to this Regulation.
the concentration between aflatoxin B1 and aflatoxin
total in dried figs.
Article 2
This Regulation shall enter into force on the twentieth day
(7) The
measures
provided
for
in
this
Regulation
are
in following that of its publication in the Official Journal of the
accordance with the opinion of the Standing
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 November 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX
The Annex to Regulation (EC) No 1881/2006 is amended as follows:
(1) In the Section 2, the entries 2.1.9 and 2.1.10 are replaced by the following entries:
"2.1.9
Dried fruit, other than dried figs, to be subjected to sorting, or other
physical treatment, before human consumption or use as an ingredient in
5,0 10,0
—
foodstuffs
2.1.10
Dried fruit, other than dried figs, and processed products thereof, intended
for direct human consumption or use as an ingredient in foodstuffs
2,0 4,0
—"
(2) In Section 2, the following entry 2.1.18 is added
"2.1.18 Dried
figs
6,0 10,0
—"

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