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9.12.2011 Official
Journal
of
the
European
Union L
327/39
REGULATIONS
COMMISSION REGULATION (EU) No 1276/2011
of 8 December 2011
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council
as regards the treatment to kill viable parasites in fishery products for human consumption
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) Though
the
EFSA
Opinion
indicates
that
all
wild
caught
seawater and freshwater fish must be considered at risk
of containing viable parasites of human health hazard if
these products are to be eaten raw or almost raw, in the
Having regard to the Treaty on the Functioning of the European
case that epidemiological data show that the fishing
Union,
grounds do not represent a health hazard with regard
to the presence of parasites, the competent authority
may adopt national measures which authorise an
exemption from the required freezing treatment on
Having regard to Regulation (EC) No 853/2004 of the European
fishery products derived from wild catches. These
Parliament and of the Council of 29 April 2004 laying down
national measures should be notified to the Commission.
specific hygiene rules for food of animal origin ( 1 ), and in
particular Article 10(1) thereof,
(5) The
EFSA
Opinion
concludes
that
where
farmed
Atlantic
salmon is reared in floating cages or onshore tanks, and
Whereas:
fed compound feedstuffs, which are unlikely to contain
live parasites, the risk of infection with larval anisakids is
negligible unless changes in farming practices occur.
Though the Opinion concludes that sufficient monitoring
(1) Regulation
(EC)
No
853/2004
lays
down
specific
rules
data are not available for any other farmed fish EFSA has
on the hygiene of food of animal origin for food
set up criteria for considering when fishery products
business operators. It provides, inter alia, that food
from aquaculture do not present a health hazard with
business operators are to place products of animal
regard to the presence of parasites.
origin on the market in the European Union, only if
they have been prepared and handled exclusively in
establishments that meet the relevant requirements of
Annex III to that Regulation.
(6) Therefore,
if
the
same
rearing
procedures
based
on
these
criteria are followed, farmed fishery products other than
Atlantic salmon may be considered to present a
(2)
Part D of Chapter III of Section VIII of Annex III to
negligible risk for parasites that may be a risk to the
Regulation (EC) No 853/2004 provides that food
health of the consumer. Consequently, such farmed
business operators must ensure that certain fishery
fishery products may also be exempted from the
products, including those to be consumed raw or
freezing requirements while the high level of health
almost raw, undergo a freezing treatment to kill viable
protection is still ensured.
parasites that may represent a risk to the health of the
consumer.
(7)
It is therefore appropriate to amend the requirements set
out in Part D of Chapter III of Section VIII of Annex III
(3) In
April
2010,
the
European
Food
Safety
Authority
to Regulation (EC) No 853/2004 in order to take
adopted a scientific opinion on risk assessment of
account of certain points of the new scientific advice
parasites in fishery products ( 2 ) (the EFSA Opinion).
included in the EFSA Opinion and practical experience
That Opinion includes information regarding the cases
gained.
where fishery products may present a health hazard
with regard to the presence of viable parasites. The
EFSA Opinion also analyses the effects of various
treatments for killing such parasites in fishery products.
(8) The
measures
provided
for
in
this
Regulation
are
in
( 1 ) OJ L 139, 30.4.2004, p. 55.
accordance with the opinion of the Standing
( 2 ) EFSA Journal 2010; 8(4):1543.
Committee on the Food Chain and Animal Health,

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L 327/40
EN
Official Journal of the European Union
9.12.2011
HAS ADOPTED THIS REGULATION:
Article 1
Annex III to Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 December 2011.
For the Commission
The President
José Manuel BARROSO

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EN
9.12.2011 Official
Journal
of
the
European
Union L
327/41
ANNEX
In Annex III, Section VIII, Chapter III to Regulation (EC) No 853/2004, Part D is replaced by the following:
‘D. REQUIREMENTS CONCERNING PARASITES
1. Food business operators placing on the market the following fishery products derived from finfish or
cephalopod molluscs:
(a) fishery products intended to be consumed raw; or
(b) marinated, salted and any other treated fishery products, if the treatment is insufficient to kill the viable
parasite;
must ensure that the raw material or finished product undergo a freezing treatment in order to kill viable
parasites that may be a risk to the health of the consumer.
2. For parasites other than trematodes the freezing treatment must consist of lowering the temperature in all
parts of the product to at least:
(a) – 20 °C for not less than 24 hours; or
(b) – 35 °C for not less than 15 hours.
3. Food business operators need not carry out the freezing treatment set out in point 1 for fishery products:
(a) that have undergone, or are intended to undergo before consumption a heat treatment that kills the viable
parasite. In the case of parasites other than trematodes the product is heated to a core temperature of
60 °C or more for at least one minute;
(b) that have been preserved as frozen fishery products for a sufficiently long period to kill the viable
parasites;
(c) from wild catches, provided that:
(i) there are epidemiological data available indicating that the fishing grounds of origin do not present a
health hazard with regard to the presence of parasites; and
(ii) the competent authority so authorises;
(d) derived from fish farming, cultured from embryos and have been fed exclusively on a diet that cannot
contain viable parasites that present a health hazard, and one of the following requirements is complied
with:
(i) have been exclusively reared in an environment that is free from viable parasites; or
(ii) the food business operator verifies through procedures, approved by the competent authority, that the
fishery products do not represent a health hazard with regard to the presence of viable parasites.
4. (a) When placing on the market, except when supplied to the final consumer, fishery products referred to in
point 1 must be accompanied by a document issued by the food business operator performing the
freezing treatment, stating the type of freezing treatment that the products have undergone.
(b) Before placing on the market fishery products referred to in points 3(c) and (d) which have not undergone
the freezing treatment or which are not intended to undergo before consumption a treatment that kills
viable parasites that present a health hazard, a food business operator must ensure that the fishery
products originate from a fishing ground or fish farming which complies with the specific conditions
referred to in one of those points. This provision may be met by information in the commercial
document or by any other information accompanying the fishery products.’

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