HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 91/12
EN
Official Journal of the European Union
3.4.2013
RECOMMENDATIONS
COMMISSION RECOMMENDATION
of 27 March 2013
on the presence of T-2 and HT-2 toxin in cereals and cereal products
(Text with EEA relevance)
(2013/165/EU)
THE EUROPEAN COMMISSION,
sensitive animal species. Due to the limited data and the
severe adverse health effects at low dose levels, no
NOAEL or LOAEL could be established. Therefore this
Recommendation is not of application for feed for cats,
Having regard to the Treaty on the Functioning of the European
for which stricter measures will be established.
Union, and in particular Article 292 thereof,
(5) The
CONTAM
Panel
further
concluded
that
the
carry-
Whereas:
over of T-2 and HT-2 toxins from feed to food
products of animal origin is limited and hence
contributes only to a negligible extent to human
exposure.
(1) T-2
toxin
and
HT-2
toxin
are
mycotoxins
produced
by
various Fusarium species. T-2 toxin is rapidly metabolised
to a large number of products, HT-2 toxin being a major
metabolite.
(6) Taking
into
account
the
conclusions
of
the
scientific
opinion, together with the large year to year variation
in occurrence of T-2 and HT-2 toxin, it is appropriate to
collect more data on T-2 and HT-2 in cereals and cereal
(2) The
Scientific
Panel
on
Contaminants
in
the
Food
Chain
products and more information on the effects of food
(CONTAM panel) of the European Food Safety Authority
processing (i.e. cooking) and agronomic factors on the
(EFSA) adopted an opinion on a request from the
presence of T-2 and HT-2 toxin. Furthermore, it is
Commission related on the risks for animal and public
necessary to obtain more information on the different
health related to the presence of T-2 and HT-2 toxin in
factors which lead to relative high levels of T-2 and
food and feed (
HT-2 toxin in cereals and cereal products in order to

1 ).
be able to identify the measures to be taken to avoid
or to reduce the presence of T-2 and HT-2 toxin in
cereals and cereal products. Investigations have to be
(3) The
CONTAM
Panel
established
a
group
tolerable
daily
undertaken in order to collect information on the
intake (TDI) of 100 ng/kg b.w. for the sum of T-2 and
factors resulting in relative high levels of T-2 and HT-2
HT-2 toxins. Estimates of chronic human dietary
toxin in cereals and cereal products and on the effects of
exposure to the sum of T-2 and HT-2 toxins based on
feed and food processing. Based on the available data, T-
the available occurrence data are below the TDI for
2 and HT-2 do not occur or only in very low levels in
populations of all age groups, and thus not an
rice and rice products and therefore it is appropriate to
immediate health concern.
exclude these products from the scope of this Recom
mendation.
(4)
As regards the animal health risk, the CONTAM Panel
concluded that for ruminants, rabbits and fish, the
(7)
The results of monitoring of cereals and cereal products
current estimated exposure to T-2 and HT-2 toxin is
will be used to assess changes and trends in human and
considered unlikely to be a health concern. For pigs,
animal exposure to T-2 and HT-2 toxin. It is therefore
poultry, horses and dogs, the estimates of exposure to
appropriate to use methods of analysis with a sufficient
T-2 and HT-2 toxin indicate that the risk of adverse
sensitivity.
health effects is low. Cats are amongst the most
( 1 ) EFSA Panel on Contaminants in the Food Chain (CONTAM);
(8) To
provide
orientation
in
which
cases
it
would
be
appro
Scientific Opinion on risks for animal and public health related to
priate to perform such investigations, it is appropriate to
the presence of T-2 and HT-2 toxin in food and feed. EFSA Journal
2011; 9(12):2481. [187 pp.] doi:10.2903/j.efsa.2011.2481.
provide indicative values above which such investigations
Available online: www.efsa.europa.eu/efsajournal
would be appropriate. To determine these indicative

---

EN
3.4.2013 Official
Journal
of
the
European
Union L
91/13
values the occurrence data available in the EFSA database
5 μg/kg for T-2 and HT-2 toxin individually, except for
have been used. To perform the investigations traceability
unprocessed cereals for which the LOQ should
is of major importance.
preferably not be higher than 10 μg/kg for T-2 and
HT-2 toxin individually. In the case of the use of an
analytical screening technique, the limit of detection
should preferably not be higher than 25 μg/kg for the
(9) In
2015
an
assessment
of
the
gathered
information
sum of T-2 and HT-2 toxin.
in the frame of this Recommendation should be under
taken. The monitoring data obtained as a result of this
Recommendation will also enable a better understanding
of the year–to-year variance and the presence of T-2 and
HT-2 toxin in the wide range of cereal products the
The sampling procedure applied by the food business
factors resulting in higher levels and the measures
operator might deviate from the provisions of Regu
which could be taken to prevent the presence or
lation (EC) No 401/2006 but should be representative
mitigate the presence of T-2 and HT-2 toxins,
for the lot sampled.
including through agronomic factors and through
processing,
(4) The sampling and analysis for cereals and cereal products
intended for feed and compound feed should be performed
HAS ADOPTED THIS RECOMMENDATION:
in accordance with the provisions provided for in
Commission Regulation (EC) No 152/2009 of 27 January
2009 laying down the methods of sampling and analysis
(1) Member States should, with the active involvement of feed
for the official control of feed ( 2 ). The Limit of Quantifi
and food business operators, perform monitoring for the
cation (LOQ) should preferably not be higher than
presence of T-2 and HT-2 toxin in cereals and cereal
10 μg/kg for T-2 and HT-2 toxin individually. In the case
products. For the purpose of this Recommendation rice is
of the use of an analytical screening technique, the limit of
not included in cereals and rice products are not included in
detection should preferably not be higher than 25 μg/kg for
cereal products.
the sum of T-2 and HT-2 toxin.
(2) Member States should encourage that samples are simulta
The sampling procedure applied by the feed business
neously analysed for the presence of T-2 and HT-2 and
operator might deviate from the provisions of Regulation
other Fusarium-toxins such as deoxynivalenol, zearalenone
(EC) No 152/2009 but should be representative for the lot
and fumonisin B1 + B2 to allow the extent of co-occurrence
sampled.
to be assessed.
In case the used method of analysis enables it, it would be
(5) Member States, with the active involvement of the feed and
appropriate to analyse also the masked mycotoxins in
food business operators, should perform investigations to
particular the mono- and di-glycosylated conjugates of
identify the factors resulting in these levels above the
T-2 and HT-2 toxin.
indicative level and determine the measures to be taken to
avoid or reduce such presence in future. These investi
gations should certainly be performed in case of repetitive
findings within a certain period of time of levels above the
(3) The sampling and analysis for cereals and cereal products
indicative levels of T-2 and HT-2 toxin in cereals and cereal
intended for human consumption should be performed in
products mentioned in Annex to this Recommendation. The
accordance with the provisions provided for in Commission
sampling and analysis with the objective to obtain more
Regulation (EC) No 401/2006 of 23 February 2006 laying
information on the different factors, including agronomic
down the methods of sampling and analysis for the official
factors, which lead to relative high levels of T-2 and HT-2
control of the levels of mycotoxins in foodstuffs ( 1 ) in
toxin in cereals and cereal products, should be targeted on
particular:
cereals and cereal products from primary processing.
— Annex I Part B for the sampling of cereals and cereal
products,
(6) Member States, with the active involvement of the feed and
food business operators, should perform investigations on
the effects of feed and food processing on the presence of
T-2 and HT-2 toxin. These investigations should certainly be
— Annex II, point 4.3.1(g) Performance criteria for the
performed in case of repetitive findings within a certain
analysis of T-2 and HT-2 toxin. The Limit of Quantifi
period of time of levels above the indicative level of T-2
cation (LOQ) should preferably not be higher than
and HT-2 toxin in cereal products.
( 1 ) OJ L 70, 9.3.2006, p. 12.
( 2 ) OJ L 54, 26.2.2009, p. 1.

---

L 91/14
EN
Official Journal of the European Union
3.4.2013
(7) Member States should ensure that the analytical results are provided on a regular basis to EFSA for
compilation into a single database and that the outcome of the investigations is provided to the
European Commission every year, the first time by December 2013. A guidance note will be elaborated
to ensure uniform application of this Recommendation and to ensure comparable reporting of results of
investigations.
Done at Brussels, 27 March 2013.
For the Commission
Tonio BORG
Member of the Commission

---

EN
3.4.2013 Official
Journal
of
the
European
Union L
91/15
ANNEX
Indicative levels for cereals and cereals products (*) (**)
Indicative levels for the sum of T-2 and HT-2
(μg/kg) from which onwards/above which
investigations should be performed, certainly
in case of repetitive findings (*)
1. Unprocessed
cereals (***)
1.1. barley (including malting barley) and maize 200
1.2. oats (with husk) 1
000
1.3. wheat, rye and other cereals 100
2. Cereal
grains
for
direct
human
consumption (****)
2.1. oats
200
2.2. maize
100
2.3. other cereals 50
3. Cereal
products
for
human
consumption
3.1. oat bran and flaked oats 200
3.2. cereal bran except oat bran, oat milling products other than oat
100
bran and flaked oats, and maize milling products
3.3. other cereal milling products 50
3.4. breakfast cereals including formed cereal flakes 75
3.5. bread (including small bakery wares), pastries, biscuits, cereal snacks,
25
pasta
3.6. cereal-based foods for infants and young children 15
4. Cereal
products
for
feed
and
compound
feed (*****)
4.1. oat milling products (husks) 2
000
4.2. other cereal products 500
4.3. compound feed, with the exception of feed for cats 250
(*) The levels referred to in this Annex are indicative levels above which, certainly in the case of repetitive findings, investigations
should be performed on the factors leading to the presence of T-2 and HT-2 toxin or on the effects of feed and food processing.
The indicative levels are based on the occurrence data available in the EFSA database as presented in the EFSA opinion. The
indicative levels are not feed and food safety levels.
(**) For the purpose of this Recommendation rice is not included in cereals and rice products are not included in cereal products.
(***) Unprocessed cereals are cereals which have not undergone any physical or thermal treatment other than drying, cleaning and
sorting.
(****) Cereal grains for direct human consumption are cereal grains which have undergone drying, cleaning, de-husking and sorting
processes and on which no further cleaning and sorting processes will be performed before their further processing in the food
chain.
(*****) The indicative levels for cereals and cereal products intended for feed and compound feed are relative to a feed with a moisture
content of 12 %.

---

Document Outline

• �

---