L 282/46
EN
Official Journal of the European Union
24.10.2013
COMMISSION REGULATION (EU) No 1019/2013
of 23 October 2013
amending Annex I to Regulation (EC) No 2073/2005 as regards histamine in fishery products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) It
is
appropriate
to
establish
a
separate
food
safety
criterion for fish sauce produced by fermentation of
Having regard to the Treaty on the Functioning of the European
fishery products in order to align the criterion with the
Union,
new Codex Alimentarius standard and the EFSA opinion.
Footnote 2 should also be amended.
Having regard to Regulation (EC) No 852/2004 of the European
Parliament and of the Council of 29 April 2004 on the hygiene
(5) The
normal
sampling
plan
for
histamine
from
fishery
of foodstuffs (
products consists of nine samples which require much

1 ), and in particular Article 4(4) thereof,
sample material. Footnote 18 to food safety criterion
Whereas:
1.26 for fishery products states that single samples may
be taken at retail level. In such cases the whole batch
(1) Commission
Regulation
(EC)
No
2073/2005 of
should not be deemed unsafe based only on the result of
15 November 2005 on microbiological criteria for food
one sample. However, if one of nine samples analysed is
stuffs (
found to be above M the whole batch shall be deemed

2 ) lays down microbiological criteria for certain
micro-organisms and the implementing rules that are
unsafe. This should also be the case when single samples
to be complied with by food business operators when
are found to be above M. Consequently, is is appropriate
implementing the general and specific hygiene measures
to amend footnote 18. Footnote 18 should also be
referred to in Article 4 of Regulation (EC) No 852/2004.
applied to both food safety criteria 1.26 and 1.27.
In particular, it provides for food safety criteria for
(6) Regulation
(EC)
No
2073/2005
should
therefore
be
histamine and sampling plans for fishery products from
amended accordingly.
fish species associated with high amount of histidine.
(7) The
measures
provided
for
in
this
Regulation
are
in
(2) Fish
sauce
produced
by
fermentation
is
a
liquid
fishery
accordance with the opinion of the Standing
product. The Codex Alimentarius Commission ( 3 ) has
Committee on the Food Chain and Animal Health and
fixed new recommended maximum levels of histamine
neither the European Parliament nor the Council have
in such fish sauce which are different from the ones set
opposed them,
out in Annex I to Regulation (EC) No 2073/2005. That
recommendation is in line with the information on
HAS ADOPTED THIS REGULATION:
consumer exposure data presented by the European
Article 1
Food Safety Authority (‘EFSA’) in its Scientific Opinion
on risk based control of biogenic amine formation in
Annex I to Regulation (EC) No 2073/2005 is amended in
fermented foods ( 4 ).
accordance with the Annex to this Regulation.
Article 2
(3) Since
fish
sauce
is
a
liquid
fishery
product
histamine
can
be expected to be evenly distributed. The sampling plan
This Regulation shall enter into force on the twentieth day
can therefore be more simple than for fishery products
following that of its publication in the Official Journal of the
occurring in another form.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 October 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 139, 30.4.2004, p. 1.
( 2 ) OJ L 338, 22.12.2005, p. 1.
( 3 ) Codex Alimentarius Standard for Fish Sauce (CODEX STAN 302 –
2011).
( 4 ) EFSA Journal 2011; 9(10):2393.

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EN
24.10.2013 Official
Journal
of
the
European
Union L
282/47
ANNEX
Chapter 1 of Annex I to Regulation (EC) No 2073/2005 is amended as follows:
(1) row 1.27 is replaced by the following:
‘1.27 Fishery products,
Histamine 9
( 18 )
2 200
mg/kg 400
mg/kg HPLC
( 19 ) Products
except those in food
placed on the
category 1.27a, which
market
have undergone
during their
enzyme maturation
shelf-life’
treatment in brine,
manufactured from
fish species associated
with a high amount of
histidine ( 17 )
(2) the following row 1.27a is inserted:
‘1.27a Fish sauce produced by
Histamine
1 400
mg/kg HPLC
( 19 ) Products
placed
on
the
fermentation of fishery
market during their
products
shelf-life’
(3) footnote 2 is replaced by the following:
‘( 2 ) For points 1.1-1.25, 1.27a and 1.28 m = M.’;
(4) footnote 18 is replaced by the following:
‘( 18 ) Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of
Regulation (EC) No 178/2002, according to which the whole batch should be deemed unsafe, shall not apply,
unless the result is above M.’;
(5) under the heading ‘Interpretation of the test results’ the last paragraph of the text concerning Histamine in fishery
products is replaced by the following:
‘Histamine in fishery products:
Histamine in fishery products from fish species associated with a high amount of histidine except fish sauce produced
by fermentation of fishery products:
— satisfactory, if the following requirements are fulfilled:
1. the mean value observed is ≤ m
2. a maximum of c/n values observed are between m and M
3. no values observed excess the limit of M.
— unsatisfactory, if the mean value observed exceeds m or more than c/n values are between m and M or one or
more of the values observed are > M.
Histamine in fish sauce produced by fermentation of fishery products:
— satisfactory, if the value observed is ≤ the limit,
— unsatisfactory, if the value observed is > the limit.’

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Document Outline

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