1991L0493 — EN — 01.07.1997 — 003.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRETTIVE
of22July1991
laying down the health conditions for the production and the placing on the market of fishery
products
(91/493/EEC)
(OJ L 268, 24.9.1991, p. 15)
Amended by:
Official Journal
No page date
►M1Council Directive 95/71/EC of 22 December 1995 L 332 40 30.12.1995
►M2Council Directive 96/23/EC of 29 April 1996 L 125 10 23.5.1996
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
Corrected by:►
C1Corrigendum, OJ L 284, 12.10.1991, p. 32 (91/493/EEC)
▼B
COUNCILDIRETTIVE
of22July1991
laying down the health conditions for the production and the
placingonthemarketoffisheryproducts
(91/493/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposals from the Commission(1),
Having regard to the opinions of the European Parliament(2),
Having regard to the opinions of the Economic and Social
Committee(3),
Whereas, with a view to achieving the internal market and more espe-
cially to ensuring the smooth operation of the common organization of
the market in fishery products established by Regulation (EEC) No3796/81(
4), as last amended by Regulation (EEC) No 2886/89(5), it is
essential that the marketing of fish and fish products should no longerbe hindered by disparities existing in the Member States in respect of
health requirements; whereas this will enable production and placing
on the market to be better harmonized and bring about competition onequal terms, whilst ensuring quality products for the consumer;
Whereas the European Parliament in its legislative resolution of 17
March 1989(
6) requested the Commission to come forward with
comprehensive proposals on the hygienic production and placing on
the market of fishery products, including solutions for the problem ofnematodes;
Whereas fishery products freshly caught are in principle free of
contamination with micro-organisms; whereas however contamination
and subsequent decomposition may occur when handled and treatedunhygienically;
Whereas therefore the essential requirements should be laid down for
the correct hygienic handling of fresh and processed fishery products
at all stages of production and during storage and transport;
Whereas it is appropriate to apply by analogy certain marketing stan-
dards which are laid down pursuant to Article 2 of Regulation (EEC)No 3796/81, in order to fix the health quality of these products;
Whereas it is the responsibility primarily of the fisheries industry to
ensure that fishery products meet the health requirements laid down inthis Directive;
Whereas the competent authorities of the Member States must, by
carrying out checks and inspections, ensure that producers and manu-facturers comply with the said requirements;
Whereas Community control measures should be introduced to guar-
antee the uniform application in all Member States of the standards
laid down in this Directive;
Whereas, in order to ensure the smooth operation of the internal
market, the measures should apply in an identical manner to tradewithin the Member States and to trade between the Member States;1991L0493 — EN — 01.07.1997 — 003.001 — 2
(1) OJ No C 66, 11. 3. 1988, p. 2; OJ No C 282, 8. 11. 1989, p. 7 and OJ No C
84, 2. 4. 1990, p. 56.
(2) OJ No C 96, 17. 4. 1989, p. 29 and OJ No C 183, 15. 7. 1991.
(3) OJ No C 134, 24. 5. 1988, p. 31 and OJ No C 332, 31. 12. 1990, p. 59.
(4) OJ No L 379, 31. 12. 1981, p. 1.
(5) OJ No L 282, 2. 10. 1989, p. 1.
(6) OJ No C 96, 17. 4. 1989, p. 199.
▼B
Whereas in the context of intra-Community trade, the rules laid down
in Council Directive 89/662/EEC of 11 December 1989 concerningveterinary checks in intra-Community trade with a view to the comple-
tion of the internal market(
1) as amended by Directive 90/675/EEC(2)
apply to fishery products;
Whereas fishery products from third countries intended to be placed on
the market of the Community must not qualify for more favourable
arrangements than those applied in the Community; whereas provisionshould therefore be made for a Community procedure for the inspec-tion in third countries of the conditions of production and placing onthe market in order to permit the application of a common importsystem based on conditions of equivalence;
Whereas the products in question are subject to the rules concerning
checks and to safeguard measures covered by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing
the organization of veterinary checks on products entering the Commu-
nity from third countries;
Whereas, so that account may be taken of particular circumstances,
derogations should be granted to some establishments already operating
before 1 January 1993 so as to allow them to adapt to all the require-
ments laid down in this Directive;
Whereas the Commission should be entrusted with the task of adopting
certain measures for implementing this Directive; whereas, to that end,
procedures should be laid down introducing close and effective coop-
eration between the Commission and the Member States within theStanding Veterinary Committee;
Whereas the essential requirements laid down in this Directive may
need further specification,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
This Directive lays down the health conditions for the production and
the placing on the market of fishery products for human consumption.
Article 2
For the purposes of this Directive, the following definitions shall apply:
1. ‘fishery products ’ means all seawater or freshwater animals or
parts thereof, including their roes, excluding aquatic mammals,frogs and aquatic animals covered by other Community acts;
2. ‘aquaculture products ’ means all fishery products born and raised
in controlled conditions until placed on the market as a foodstuff.However seawater or freshwater fish or crustaceans caught in their
natural environment when juvenile and kept until they reach the
desired commercial size for human consumption are also consid-ered to be aquaculture products. Fish and crustaceans ofcommercial size caught in their natural environment and kept aliveto be sold at a later date are not considered to be aquaculture
products if they are merely kept alive without any attempt being
made to increase their size or weight;
3. ‘chilling’ means the process of cooling fishery products to a
temperature approaching that of melting ice;
4. ‘fresh products ’ means any fishery product whether whole or
prepared, including products packaged under vacuum or in a modi-1991L0493 — EN — 01.07.1997 — 003.001 — 3
(1) OJ No L 395, 30. 12. 1989, p. 13.
(2) OJ No L 373, 31. 12. 1990, p. 1.
▼B
fied atmosphere, which have not undergone any treatment to
ensure preservation other than chilling;
5. ‘prepared products ’ means any fishery product which has under-
gone an operation affecting its anatomical wholeness, such as
gutting, heading, slicing, filleting, chopping, etc.;
6. ‘processed products ’ means any fishery product which has under-
gone a chemical or physical process such as the heating, smoking,salting, dehydration or marinating, etc., of chilled or frozenproducts, whether or not associated with other foodstuffs, or acombination of these various processes;
7. ‘preserve’ means the process whereby products are packaged in
hermetically sealed containers and subjected to heat treatment to
the extent that any micro-organisms that might proliferate are
destroyed or inactivated, irrespective of the temperature at whichthe product is to be stored;
8. ‘frozen products ’ means any fishery product which has undergone
a freezing process to reach a core temperature of − 18 ºC or lowerafter temperature stabilization;
9.‘packaging’ means the procedure of protecting fishery products by
a wrapper, a container or any other suitable device;
10. ‘batch’ means the quantity of fishery products obtained under prac-
tically identical circumstances;
11. ‘consignment ’ means the quantity of fishery products bound for
one or more customers in the country of destination and conveyed
by one means of transport only;
12. ‘means of transport ’ means those parts set aside for goods in auto-
mobile vehicles, rail vehicles and aircraft, the holds of vessels, andcontainers for transport by land, sea or air;
13. ‘competent authority ’ means the central authority of a Member
State competent to carry out veterinary checks or any authority towhich it has delegated that competence;
14. ‘establishment ’ means any premises where fishery products are
prepared, processed, chilled, frozen, packaged or stored. Auction
and wholesale markets in which only display and sale by wholesaletakes place are not deemed to be establishments;
15. ‘placing on the market ’ means the holding or displaying for sale,
offering for sale, selling, delivering or any other form of placingon the market in the Community, excluding retail sales and directtransfers on local markets of small quantities by fishermen to retai-
lers or consumers, which must be subject to the health checks laid
down by national rules for checking the retail trade;
16. ‘importation ’ means the introduction into the territory of the
Community of fishery products from third countries;
17. ‘clean seawater ’ means seawater or briny water which is free from
microbiological contamination, harmful substances and/or toxicmarine plankton in such quantities as may affect the health qualityof fishery products and which is used under the conditions laid
down in this Directive;
18. ‘factory vessel ’ means any vessel on which fishery products
undergo one or more of the following operations followed by
packaging: filleting, slicing, skinning, mincing, freezing or proces-sing.
The following are not deemed to be ‘factory vessels’:— fishing vessels in which only shrimps and molluscs are cooked
on board;
— fishing vessels on board which only freezing is carried out.1991L0493 — EN — 01.07.1997 — 003.001 — 4
▼B
Article 3
1. The placing on the market of fishery products caught in their
natural environment shall be subject to the following conditions:
(a) they must have:
(i) been caught and where appropriate handled for bleeding,
heading, gutting and the removal of fins, chilled or frozen, onboard vessels in accordance with hygiene rules to be estab-
lished by the Council acting by a qualified majority on a
proposal from the Commission. The Commission shall submitproposals to that effect before 1 October 1992;
(ii) where appropriate, been handled in factory vessels approved in
accordance with Article 7, and in accordance with the require-ments of Chapter I of the Annex.
The cooking of shrimps and molluscs on board must comply
with the provisions of Chapter III, section I(5) and Chapter
IV, section IV(7), of the Annex. Such vessels shall be specifi-cally registered by the competent authorities;
(b) during and after landing they must have been handled in accor-
dance with Chapter II of the Annex;
(c) they must have been handled and, where appropriate, packaged,
prepared, processed, frozen, defrosted or stored hygienically inestablishments approved in accordance with Article 7, in compli-
ance with the requirements of Chapters III and IV of the Annex.
The competent authority may, notwithstanding Chapter II, section 2
of the Annex, authorize the transfer of fishery products ex quay
into containers for immediate delivery to an approved establish-
ment or registered auction or wholesale market to be checked there;
(d) they must have undergone a health check in accordance with
Chapter V of the Annex;
(e) they must have been appropriately packaged in accordance with
Chapter VI of the Annex;
(f) they must have been given an identification mark in accordance
with Chapter VII of the Annex;
(g) they must have been stored and transported under satisfactory
conditions of hygiene, in accordance with Chapter VIII of the
Annex.
2. Where gutting is possible from a technical and commercial view-
point, it must be carried out as quickly as possible after the productshave been caught or landed.
3. The placing on the market of aquaculture products shall be
subject to the following conditions:
(a) they must have been slaughtered under appropriate conditions of
hygiene. They must not be soiled with earth, slime or faeces. Ifnot processed immediately after having been slaughtered, theymust be kept chilled;
(b) they must, in addition, comply with the requirements laid down
under 1 (c) to (g).
4. (a) The placing on the market of live bivalve molluscs shall be
subject to the requirements laid down in Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for
the production and the placing on the market of live bivalve
molluscs(
1).
(b) When processed, bivalve molluscs must, in addition to the
requirements in point (a), satisfy those of paragraph 1 (c) to (g).1991L0493 — EN — 01.07.1997 — 003.001 — 5
(1) See page 1 of this Official Journal.▼C1
▼B
▼B
Article 4
Fishery products to be placed on the market alive shall at all times be
kept under the most suitable survival conditions.
Article 5
The placing on the market of the following products shall be forbidden:
— poisonous fish of the following families: Tetraodontidae, Molidae,
Diodontidae, Canthigasteridae,
— fishery products containing biotoxins such as ciguatera toxins or
muscle-paralysing toxins.
Detailed requirements concerning the species covered by this Article
and concerning methods of analysis shall be laid down in accordancewith the procedure prescribed in Article 15.
Article 6
1. Member States shall ensure that persons responsible for establish-
ment take all necessary measures, so that, at all stages of the
production of fishery products, the specifications of this Directive are
complied with.
To that end, the said persons responsible must carry out their own
checks based on the following principles;
— identification of critical points in their establishment on the basis of
the manufacturing processes used;
— establishment and implementation of methods for monitoring and
checking such critical points;
— taking samples for analysis in an approved laboratory by the
competent authority for the purpose of checking cleaning and disin-fection methods and for the purpose of checking compliance withthe standards established by this Directive;
— keeping a written record or a record registered in an indelible
fashion of the preceding points with a view to submitting them to
the competent authority. The results of the different checks andtests will in particular be kept for a period of at least two years.
2. If the results of own checks or any information at the disposal of
the persons responsible referred to in paragraph 1 reveal the risk of ahealth risk or suggest one might exist and without prejudice to the
measures laid down in the fourth subparagraph of Article 3 (1) of
Directive 89/662/EEC, the appropriate measures shall be taken, underofficial supervision.
3. Rules for the application of the second subparagraph of paragraph
1 shall be established in accordance with the procedure laid down in
Article 15.
Article 7
1. The competent authorities shall approve establishments once they
have verified that these establishments meet the requirements of thisDirective, with regard to the nature of the activities they carry out.The approval must be renewed if an establishment decides to carryout activities other than those for which it has received approval.
The competent authorities shall take the necessary measures if the
requirements cease to be met. To this end, they shall take particularaccount of the conclusions of any check carried out in accordancewith Article 8.
The competent authority shall register those auction and wholesale
markets which are not subject to approval after verifying that such
installations comply with the provisions of this Directive.
2. However, subject to the express condition that products coming
from factory-vessels and establishments, auction and wholesale marketsmeet the hygiene standards set by this Directive, Member States may,for the requirements relating to equipment and structures laid down in1991L0493 — EN — 01.07.1997 — 003.001 — 6
▼B
Chapters I to IV to the Annex, grant to factory-vessels and establish-
ments, auction and wholesale markets a further period expiring on 31December 1995 ►
A1, except for Finland, where the date to be
adopted shall be 31 December 1997, ◄within which to comply with
the conditions of approval set out in Chapter IX. Such derogations maybe granted only to factory-vessels and establishments, auction andwholesale markets, already operating on 31 December 1991, whichhave, before 1 July 1992, submitted a duly justified application for
derogation to the competent national authority. This application must
be accompanied by a work plan and programme indicating the periodwithin which it would be possible for them to comply with the require-ments in question. Where financial assistance is requested from theCommunity, only requests in respect of projects complying with therequirements of this Directive can be accepted.
3. The competent authorities shall draw up a list of their approved
establishments, each of which shall have an official number.
Each Member State shall notify the Commission of its list of approved
establishments and of any subsequent amendment thereof. TheCommission shall forward this information to the other Member States.
4. The inspection and monitoring of establishments shall be carried
out regularly under the responsibility of the competent authority, whichshall at all times have free access to all parts of establishments, inorder to ensure compliance with the requirements of this Directive.
If such inspections and monitoring reveal that the requirements of this
Directive are not being met, the competent authority shall take appro-priate action.
5. Paragraphs 1, 3 and 4 shall also apply in respect of factory
vessels.
6. Paragraphs 3 and 4 shall also apply to wholesale and auction
markets.
Article 8
1. Experts from the Commission may, in cooperation with the
competent authorities of the Member States, make on-the-spot checks
insofar as this is necessary to ensure the uniform application of thisDirective. They may in particular verify whether establishments are ineffect complying with the requirements of this Directive. A MemberState in whose territory a check is being carried out shall give all
necessary assistance to the experts in carrying out their duties. The
Commission shall inform the Member States of the results of the inves-tigations.
2. The arrangements for implementing paragraph 1 shall be adopted
in accordance with the procedure laid down in Article 15.
Article 9
1. The rules laid down in Directive 89/662/EEC, as regards fishery
products intended for human consumption, shall apply, in particular asregards the organization of and the action to be taken following theinspections to be carried out by the Member States of destination, andthe protective measures to be implemented.
2. Directive 89/662/EEC shall be amended as follows:
(a) in Annex A the following indent shall be added:
‘— Council Directive 91/493/EEC of 22 July 1991 laying down
the health conditions for the production and placing on the
market of fishery products (OJ No L 268, 24. 9. 1991, p. 15);’
(b) In Annex B the following indent shall be deleted:
‘— fishery products intended for human consumption’.1991L0493 — EN — 01.07.1997 — 003.001 — 7
▼B
CHAPTER II
Importsfromthirdcountries
Article 10
Provisions applied to imports of fishery products from third countries
shall be at least equivalent to those governing the production and
placing on the market of Community products.
Fishery products caught in their natural environment by a fishing vessel
flying the flag of a third country must undergo the checks laid down in
Article 18 (3) of Directive 90/675/EEC.
Article 11
1. For each third country or groupof third countries, fishery
products must fulfil the specific import conditions fixed in accordance
with the procedure laid down in Article 15, depending on the healthsituation in the third country concerned.
2. In order to allow the import conditions to be fixed, and in order
to verify the conditions of production, storage and dispatch of fishery
products for consignment to the Community, inspections may becarried out on the spot by experts from the Commission and theMember States.
The experts of the Member States who are to be entrusted with these
inspections shall be appointed by the Commission acting on a proposalfrom the Member States.
These inspections shall be made on behalf of the Community, which
shall bear any expenditure incurred.
The frequency of and procedure for these inspections shall be deter-
mined in accordance with the procedure laid down in Article 15.
3. When fixing the import conditions of fishery products referred to
in paragraph 1, particular account shall be taken of:
(a) the legislation of the third country;
(b) the organization of the competent authority of the third country and
of its inspection services, the powers of such services and the
supervision to which they are subject, as well as their facilities foreffectively verifying the implementation of their legislation inforce;
(c) the actual health conditions during the production, storage and
dispatch of fishery products intended for the Community;
(d) the assurances which a third country can give on the compliance
with the standards laid down in Chapter V of the Annex.
4. The import conditions referred to in paragraph 1 shall include:
(a) the procedure for obtaining a health certificate which must accom-
pany consignments when forwarded to the Community;
(b) the placing of a mark identifying the fishery products, in particular
with the approval number of the establishment of origin, except in
the case of frozen fishery products, landed immediately for canning
and bearing the certificate provided for under (a);
(c) drawing up a list of approved establishments and auction or whole-
sale markets registered and approved by the Commission inaccordance with the procedure laid down in Article 15;
For that purpose, one or more lists of such establishments shall draw
upon the basis of a communication from the comp etent authorities of
the third country to the Commission. An establishment may not appearon a list unless it is officially approved by the competent authority ofthe third country exporting to the Community. Such approval shall besubject to observance of the following requirements:
— compliance with requirements equivalent to those laid down in this
Directive,1991L0493 — EN — 01.07.1997 — 003.001 — 8
▼B
— monitoring by an official inspection service of the third country.
5. The conditions referred to in paragraph 4 (a) and (b) may be
modified in accordance with the procedure laid down in Article 15.
The list referred to in paragraph 4 (c) may be amended by the Commis-
sion, in accordance with the rules established by Commission Decision90/13/EEC(
1).
6. To deal with specific situations and in accordance with the proce-
dure laid down in Article 15, imports may be authorized direct from anestablishment or factory vessel of a third country where the latter is
unable to provide the guarantees laid down in paragraph 3, provided
that the establishment or factory vessel in question has received specialapproval following an inspection carried out in accordance with para-graph (2). The authorization decision shall fix the specific importconditions to be followed for products coming from that establishment
or factory vessel.
7. Pending the fixing of the import conditions referred to in para-
graph 1, the Member States shall ensure that the conditions applied to
imports of fishery products from third countries shall be at leastequivalent to those governing the production and placing on the marketof Community products.
Article 12
1. The rules and principles laid down by Directive 90/675/EEC shall
apply, notably as regards the organization of and follow up to theinspections to be carried out by the Member States.
2. Without prejudice to compliance with the rules and principles
referred to in paragraph 1 of this Article and pending implementationof the decisions provided for in Article 8 (3) and Article 30 of Direc-tive 90/675/EEC, and in Article 11 of this Directive the relevantnational rules for applying Article 8 (1) and (2) of the said Directive
shall continue to apply.
CHAPTER III
Finalprovisions
Article 13
The Annexes shall be amended by the Council, acting by a qualified
majority on a proposal from the Commission.
Article 14
The Commission, after consulting the Member States, shall by 1 July
1992 submit a report to the Council concerning the minimum structural
and equipment requirements to be met by small establishments whichdistribute on the local market and are situated in regions subject toparticular supply constraints, together with any proposals, on whichthe Council, acting under the voting procedure laid down in Article
43 of the Treaty, shall act before 31 December 1992.
Article 15
1. Where the procedure laid down in this Article is to be followed,
the Chairman shall refer the matter to the Standing VeterinaryCommittee set upby Decision 68/361/EEC(
2) hereafter referred to as
the Committee, either on his own initiative or at the request of a
Member State.
2. The representative of the Commission shall submit to the
committee a draft of the measures to be taken. The committee shalldeliver its opinion on the draft within a time limit which the chairman1991L0493 — EN — 01.07.1997 — 003.001 — 9
(1) OJ No L 8, 11. 1. 1990, p. 70.
(2) OJ No L 255, 18. 10. 1968, p. 23.
▼B
may lay down according to the urgency of the matter. The opinion
shall be delivered by the majority laid down in Article 148 (2) of theTreaty in the case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives of
the Member States within the committee shall be weighted in themanner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion
of the committee, or if no opinion is delivered, the Commissionshall, without delay, submit to the Council a proposal relating tothe measures to be taken. The Council shall act by a qualifiedmajority.
If, on the expiry of a period of three months from the date of
referral to the Council, the Council has not acted, the proposedmeasures shall be adopted by the Commission, save where theCouncil has decided against the said measures by a simplemajority.
Article 16
In order to take into account the possible failure to take a decision on
the detailed rules for applying this Directive by 1 January 1993, neces-
sary transitional measures may be adopted in accordance with theprocedure laid down in Article 15 for a period of two years.
Article 17
The provisions of this Directive shall be re-examined before 1 January
1998 by the Council, acting on proposals from the Commission, on thebasis of experience gained.
Article 18
The Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directivebefore 1 January 1993. They shall notify the Commission thereof.
When Member States adopt these measures, they shall contain a refer-
ence to this Directive or shall be accompanied by such reference on the
occasion of their official publication. The methods of making such areference shall be laid down by the Member States.
Article 19
This Directive is addressed to the Member States.1991L0493 — EN — 01.07.1997 — 003.001 — 10
▼B
ANNEX
CHAPTER I
CONDITIONSAPPLICABLETOFACTORYVESSELS
I.Conditionsconcerningdesignandequipment
1. The minimum requirements for factory vessels are as follows:
(a) a reception area set aside for taking fishery products on board,
designed and arranged into pounds or pens that are large enough to
allow each successive catch to be separated. The reception area and
its movable parts must be easy to clean. It must be designed in such
a way as to protect the products from the sun or the elements and
from any source of dirt or contamination;
(b) a system for conveying fishery products from the reception area to
the work area that conforms with rules of hygiene;
(c) work areas that are large enough for the preparation and processing of
fishery products in proper conditions of hygiene. They must be
designed and arranged in such a way as to prevent any contamination
of the products;
(d) storage areas for the finished products that are large enough and
designed so that they are easy to clean. If a waste processing unit
operates on board, a separate hold must be designated for the storage
of these by-products;
(e) a place for storing packaging materials that is separate from the
product preparation and processing areas;
(f) special equipment for pumping waste or fishery products that are
unfit for human consumption either directly into the sea or, where
circumstances so require, into a watertight tank reserved for that
purpose. If waste is stored and processed on board with a view to
cleaning, separate areas must be allocated for that purpose;
(g) equipment providing a supply of potable water within the meaning of
Council Directive 80/778/EEC of 15 July 1980 relating to the quality
of water intended for human consumption(1) or pressurized clean
seawater. The seawater intake must be situated in a position where it
is not possible for the water being taken in to be affected by
discharges into the sea of waste water, waste and engine coolant
outlets;
(h) a suitable number of changing rooms, wash basins and toilets, the
latter not opening directly onto areas where fishery products are
prepared, processed or stored. The wash basins must be equipped
with appliances for washing and drying the hands that comply with
hygiene requirements; the wash-basin taps must not be hand-operable.
2. Areas used for the preparation and processing or freezing/quick-freezing
of fishery products must have:
(a) a non-slip floor that is also easy to clean and disinfect and equipped
for easy drainage of water. Structures and fixtures must have limber
holds that are large enough not to be obstructed by fish waste and to
allow water to drain freely;
(b) walls and ceilings that are easy to clean, particularly where there are
pipes, chains or electricity conduits;
(c) the hydraulic circuits must be arranged or protected in such a way as
to ensure that it is not possible for any leakage of oil to contaminate
fishery products;
(d) adequate ventilation and, where necessary, proper vapour extraction;
(e) adequate lighting;
(f) appliances for cleaning and disinfecting tools, equipment and fittings;
(g) appliances for cleaning and disinfecting the hands with taps that are
not hand-operable and with single use towels.
3. Equipment and tools such as cutting benches, containers, conveyors,
gutting or filleting machines, etc., must be resistant to seawater corrosion,
easy to clean and disinfect and well-maintained.1991L0493 — EN — 01.07.1997 — 003.001 — 11
(1) OJ No L 229, 30. 9. 1980, p. 11. Directive last amended by the 1985 Act of Accession
(OJ No L 302, 15. 11. 1985, p. 218).
▼B
4. Factory vessels which freeze fishery products must have:
(a) a refrigeration plant sufficiently powerful to lower the temperature
rapidly so as to achieve a core temperature that complies with the
specifications of this Directive;
(b) refrigeration plants sufficiently powerful to keep fishery products in
the storage holds at a temperature that complies with the specifica-
tions of this Directive. The storage holds must be equipped with a
temperature recording system placed so that it can easily be
consulted.
II.Conditions of hygiene relating to on-board handling and storage of
fisheryproducts
1. A qualified person on board the factory vessel must be responsible for
applying good fishery products manufacturing practices. That person shall
have the authority to ensure that the provisions of this Directive are
applied and shall make available to inspectors the programme for
inspecting and checking critical points as applied on board, a register
containing that person's comments and the temperature recordings that
may be required.
2. The general conditions of hygiene applicable to areas and equipment shall
be those laid down in Chapter III, section II (A), of this Annex.
3. The general conditions of hygiene applicable to staff shall be those laid
down in Chapter III, section II (B), of this Annex.
4. Heading, gutting and filleting must be carried out under the conditions of
hygiene laid down in Chapter IV, section I (2), (3) and (4) of this Annex.
5. On-board processing of fishery products must be carried out under the
conditions of hygiene laid down in Section II, points 2 and 3, Section
IV and Section V of Chapter IV of this Annex.
6. Fishery products must be wrapped and packaged under the conditions of
hygiene laid down in Chapter VI of this Annex.
7. On-board storage of fishery products must be carried out under the condi-
tions of hygiene laid down in Chapter VIII, points 1 and 2, of this Annex.
CHAPTER II
REQUIREMENTSDURINGANDAFTERLANDING
1. Unloading and landing equipment must be constructed of material which is
easy to clean and disinfect and must be kept in a good state of repair and
cleanliness.
2. During unloading and landing, contamination of fishery products must be
avoided. It must in particular be ensured that:
— unloading and landing operations proceed rapidly;
— fishery products are placed without unnecessary delay in a protected
environment at the temperature required on the basis of the nature of the
product and, where necessary, in ice in transport, storage or market facil-
ities, or in an establishment;
— equipment and handling practices that cause unnecessary damage to the
edible parts of the fishery products are not authorized.
3. Parts of auction or wholesale markets where fishery products are displayed
for sale must:
(a) be covered and have walls which are easy to clean;
(b) have waterproof flooring which is easy to wash and disinfect and laid in
such a way as to facilitate the drainage of water and have a hygienic
waste water disposal system;
(c) be equipped with sanitary facilities with an appropriate number of wash
basins and flush lavatories. Wash basins shall be supplied with materials
for cleaning the hands and single use hand towels;
(d) be well lit to facilitate the inspection of fishery products provided for in
Chapter V of this Annex;
(e) when they are used for display or storage of fishery products, not be used
for other purposes; vehicles emitting exhaust fumes which may impair
the quality of the fishery products not be admitted to markets; undesir-
able animals must not be admitted;1991L0493 — EN — 01.07.1997 — 003.001 — 12
▼M1
▼B
▼B
(f) be cleaned regularly and at least after each sale; crates must, after each
sale, be cleaned and rinsed inside and outside with drinking water or
clean seawater; where required, they must be disinfected;
(g) have displayed in a prominent position signs prohibiting smoking, spit-
ting, eating and drinking;
(h) be closeable and be kept closed when the competent authority considers
it necessary;
(i) have facilities to provide adequate water supplies satisfying the condi-
tions laid down in Chapter III, section I, point 7 of this Annex;
(j) have special watertight receptacles made of corrosion-resistant materials
for fishery products which are unfit for human consumption;
(k) insofar as they do not have their own premises on-the-spot or in the
immediate vicinity on the basis of the quantities displayed for sale,
have, for the purposes of the competent authority, an adequately
equipped lockable room and the equipment necessary for carrying out
inspections.
4. After landing or, where appropriate, after first sale, fishery products must be
transported without delay, under the conditions laid down in Chapter VIII, of
this Annex, to their place of destination.
5. However, if the conditions laid down in point 4 are not fulfilled, the markets
in which fishery products may be stored before being displayed for sale or
after being sold and pending transport to their place of destination must
have sufficiently large cold rooms which satisfy the conditions laid down in
Chapter III, section I, point 3 of this Annex. In such cases, fishery products
must be stored at a temperature approaching that of melting ice.
6. The general conditions of hygiene laid down in Chapter III, section II —
with the exception of point B 1(a) — of this Annex shall apply mutatis
mutandis to the markets in which fishery products are displayed for sale or
stored.
7. The wholesale markets in which fishery products are displayed for sale or
stored shall be subject to the same conditions as those laid down in points 3
and 5 of this Chapter and to those set out in points 4, 10 and 11 of Chapter
III, section I of this Annex.
The general conditions of hygiene laid down in Chapter III, section II of this
Annex shall apply mutatis mutandis to wholesale markets.
CHAPTER III
GENERALCONDITIONSFORESTABLISHMENTSONLAND
I.General conditionsrelatingtopremisesandequipment
Establishment shall afford at least the following facilities:
1. working areas of sufficient size for work to be carried out under
adequate hygienic conditions. Their design and layout shall be such as
to preclude contamination of the product and keep quite separate the
clean and contaminated parts of the building;
2. in areas where products are handled, prepared and processed:
(a) waterproof flooring which is easy to clean and disinfect and laid
down in such a way as to facilitate the drainage of the water or
provided with equipment to remove water;
(b) walls which have smooth surfaces and are easy to dean, durable and
impermeable;
(c) ceilings or roof linings which are easy to clean;
(d) doors in durable materials which are easy to clean;
(e) adequate ventilation and, where necessary, good steam and water-
vapour extraction facilities;
(f) adequate natural or artificial lighting;
(g) an adequate number of facilities for cleaning and disinfecting hands.
In work rooms and lavatories taps must not be hand-operable. These
facilities must be provided with single use hand towels;
(h) facilities for cleaning plant, equipment and utensils;
3. in cold rooms where fishery products are stored:
— the provisions set out under point 2 (a), (b), (c), (d) and (f);
— where necessary, a sufficiently powerful refrigeration plant to keep
products at temperatures prescribed in this Directive;1991L0493 — EN — 01.07.1997 — 003.001 — 13
▼B
4. appropriate facilities for protection against pests such as insects, rodents,
birds, etc.;
5. instruments and working equipment such as cutting tables, containers,
conveyor belts and knives made of corrosion-resistant materials, easy to
dean and disinfect;
6. special watertight, corrosion-resistant containers for fishery products not
intended for human consumption and premises for the storage of such
containers if they are not emptied at least at the end of each working
day;
7. facilities to provide adequate supplies of drinking water within the
meaning of Directive 80/778/EEC, or alternatively of clean seawater or
seawater treated by an appropriate system, under pressure and in suffi-
cient quantity. However, by way of exception, a supply of non-drinking
water is permissible for the production of steam, fire-fighting and the
cooling of refrigeration equipment, provided that the pipes installed for
the purpose preclude the use of such water for other purposes and
present no risk of contamination of the products. Non-drinking-water
pipes must be clearly distinguished from those used for drinking water
or dean seawater;
8. hygienic waste water disposal system;9. an adequate number of changing-rooms with smooth, water-proof, wash-
able walls and floors, wash basins and flush lavatories. The latter may
not open directly onto the work rooms. The wash basins must have
materials for cleaning the hands and disposable towels; the wash basin
taps must not be hand-operable;
10. if the volume of products treated requires regular or permanent presence
an adequately equipped lockable room for the exclusive use of the
inspection service;
11. adequate facilities for cleaning and disinfecting means of transport.
However, such facilities are not compulsory if there is a requirement
for the means of transport to be cleaned and disinfected at facilities offi-
cially authorized by the competent authority;
12. establishments keeping live animals such as crustaceans and fish must
have appropriate fittings ensuring the best survival conditions provided
with water of a quality such that no harmful organisms or substances
are transferred to the animals.
II.General conditionsofhygiene
A.General conditions of hygiene applicable to premises and equipment
1. Floors, walls and partitions, ceilings or roof linings, equipment and
instruments used for working on fishery products must be kept in a
satisfactory state of cleanliness and repair, so that they do not consti-
tute a source of contamination for the products.
2. Rodents, insects and any other vermin must be systematically extermi-
nated in the premises or on the equipment; rodenticides, insecticides,
disinfectants and any other potentially toxic substances must be stored
in premises or cupboards which can be locked; their use must not
present any risk of contamination of the products.
3. Working areas, instruments and working equipment must be used only
for work on fishery products. However, following authorization by the
competent authority they may be used at the same time or other times
for work on other foodstuffs.
4. Drinking water, within the meaning of Directive 80/778/EEC, or clean
seawater must be used for all purposes. However, by way of an excep-
tion, non-drinking waster may be used for steam production, fire-
fighting and the cooling of refrigeration equipment, provided that the
pipes installed for the purpose preclude the use of such water for other
purposes and present no risk of contamination of the products.
5. Detergents, disinfectants and similar substances must be approved by
the competent authority and used in such a way that they do not have
adverse effects on the machinery, equipment and products.
B.General conditions of hygiene applicable to staff
1. The highest possible standard of cleanliness is required of staff. More
specifically:
(a) staff must wear suitable clean working clothes and headgear
which completely encloses the hair. This applies particularly to
persons handling exposed fishery products;1991L0493 — EN — 01.07.1997 — 003.001 — 14
▼B
(b) staff assigned to the handling and preparation of fishery products
must be required to wash their hand at least each time work is
resumed; wounds to the hands must be covered by a waterproof
dressing;
(c) smoking, spitting, eating and drinking in work and storage
premises of fishery products must be prohibited.
2. The employer shall take all the requisite measures to prevent persons
liable to contaminate fishery products from working on and handling
them, until there is evidence that such persons can do so without risk.
When recruited, any person working on and handling fishery products
shall be required to prove, by a medical certificate, that there is no
impediment to such employment. The medical supervision of such a
person shall be governed by the national legislation in force in the
Member State concerned or in the case of third countries by specific
guarantees to be fixed under the procedure set out in Article 15.
CHAPTER IV
SPECIAL CONDITIONS FOR HANDLING FISHERY PRODUCTS ON
SHORE
I.Conditionsforfreshproducts
1. Where chilled, unpackaged products are not dispatched, prepared or
processed immediately after reaching the establishment, they must be
stored or displayed under ice in the establishment's cold room. Re-icing
must be carried out as often as is necessary; the ice used, with or without
salt, must be made from drinking water or clean seawater and be stored
under hygienic conditions in receptacles provided for the purpose; such
receptacles must be kept clean and in a good state of repair. Prepacked
fresh products must be chilled with ice or mechanical refrigeration plant
creating similar temperature conditions.
2. If they are not carried out on board, operations such as heading and
gutting must be carried out hygienically. The products must be washed
thoroughly with drinking water or clean seawater immediately after
such operations.
3. Operations such as filleting and slicing must be carried out in such a
way as to avoid the contamination or spoilage of fillets and slices, and
in a place other than that used for heading and gutting operations.
►M1Fillets and slices must not remain on work tables any longer
than is necessary for their preparation and must be protected from
contamination by appropriate packaging. ◄Fillets and slices to be sold
fresh must be chilled as quickly as possible after preparation.
4. Guts and parts that may constitute a danger to public health must be
separated from and removed from the vicinity of products intended for
human consumption.
5. Containers used for the dispatch or storage of fresh fishery products must
be designed in such a way as to ensure both their protection from
contamination and their preservation under sufficiently hygienic condi-
tions and, more particularly, they must provide adequate drainage of
melt water.
6. Unless special facilities are provided for the continuous disposal of
waste, the latter must be placed in leakproof, covered containers which
are easy to clean and disinfect. Waste must not be allowed to accumulate
in working areas. It must be removed either continuously or as soon as
the containers are full and at least at the end of each working day in the
containers or to the premises referred to in Chapter III, section I, para-
graph 6 of this Annex. The containers, receptacles and/or premises set
aside for waste must always be thoroughly cleaned and, if appropriate,
disinfected after use. Waste stored there must not constitute a source of
contamination for the establishment or of pollution of its surroundings.
II.Conditionsforfrozenproducts
1. Plants must have:
(a) freezing equipment sufficiently powerful to achieve a rapid reduction
in the temperature so that the temperatures laid down to in this
Directive can be obtained in the product;
(b) freezing equipment sufficiently powerful to keep products in storage
rooms at a temperature not exceeding those laid down in this Direc-
tive, whatever the ambient temperature may be.1991L0493 — EN — 01.07.1997 — 003.001 — 15
▼B
However, for technical reasons related to the method of freezing and to
the handling of such products, for whole fish frozen in brine and
intended for canning, higher temperatures than those laid down in this
Directive are acceptable although they may not exceed − 9 ºC.
2. Fresh products to be frozen or quick-frozen must comply with the
requirements of section I of this Chapter.
3. Storage rooms must have a temperature recording device in a place
where it can easily be read. The temperature sensor of the recorder
must be located in the area furthest away from the cold source, i.e.
where the temperature in the storage room is the highest.
Temperature charts must be available for inspection by the supervisory
authorities at least during the period in which the products are stored.
III.Conditionsforthawingproducts
Establishments that carry out thawing operations must comply with the
following requirements:
1. fishery products must be thawed under hygienic conditions; their
contamination must be avoided and there must be adequate drainage for
any melt water produced.
During thawing, the temperature of the products must not increase exces-
sively;
2. after thawing, fishery products must be handled in accordance with the
requirements of this Directive. When they are prepared or processed,
these operations must be carried out without delay. If they are put
directly onto the market, particulars as to the thawed state of the fish
must be clearly marked on the packaging in accordance with Article 5
(3) of Council Directive 79/112/EEC of 18 December 1978 on the
approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs(1).
IV.Conditionsforprocessedproducts
1.►M1Fresh, frozen and thawed products used for processing must
comply with the requirements set out in I, II or III of this Chapter. ◄
2. Where the processing treatment is carried out to inhibit the development
of pathogenic micro-organisms, or if it is a significant factor in the
preservation of the product, the treatment must be scientifically recog-
nized by the law in force, or in the case of a treatment of products
referred to in Chapter I Section 1 (b) and (c) of Directive 91/492/EEC
which have not been relayed or purified, such treatment must be
approved, in accordance with the procedure laid down in Article 15 of
this Directive, within four months of receipt of a request from a Member
State.
The person responsible for an establishment must keep a register of the
processing carried out. Depending on the type of process employed,
heating time and temperature, salt content, pH, water content, etc., must
be monitored and controlled. Records must be kept at least for the
expected storage life of the products and be available to the competent
authority.
3. For products which are preserved for a limited period by a treatment
such as salting, smoking, drying or marinading, the appropriate condi-
tions for storage must be clearly marked on the packaging, in
accordance with Directive 79/112/EEC.
In addition, the following conditions shall be complied with.
4.Canning
In the case of fishery products which have been subjected to sterilization
in hermetically sealed containers:
(a) the water used for the preparation of cans must be drinking water;
(b) the process used for the heat treatment must be appropriate, having
regard to such major criteria as the heating time, temperature, filling,
size of containers, etc., a record of which must be kept; the heat
treatment must be capable of destroying or inactivating pathogenic
organisms and the spores of pathogenic micro-organisms. The
heating equipment must be fitted with devices for verifying whether
the containers have in fact undergone appropriate heat treatment.1991L0493 — EN — 01.07.1997 — 003.001 — 16
(1) OJ No L 33, 8. 2. 1979, p. 1. Directive last amended by Directive 91/72/EEC (OJ No L
42, 16. 1. 1991, p. 22).
▼B
Drinking water must be used to cool containers after heat treatment,
without prejudice to the presence of any chemical additives used in
accordance with good technological practice to prevent corrosion of
the equipment and containers;
(c) further checks must be carried out at random by the manufacturer to
ensure that the processed products have undergone appropriate heat
treatment,viz.:
— incubation tests: incubation must be carried out at 37 ºC for
seven days or at 35 ºC for ten days, or at any other equivalent
combination;
— microbiological examination of contents and containers in the
establishment's laboratory or in another approved laboratory;
►M1(d) samples must be taken of production each day at predeter-
mined intervals to ensure the efficacy of sealing or of any other
method of hermetic closure. ◄For that purpose, appropriate equip-
ment must be available for the examination of cross-sections of the
can-seams;
(e) checks are carried out in order to ensure that containers are not
damaged;
(f) all containers which have undergone heat treatment under practically
identical conditions must be given a batch identification mark, in
accordance with Council Directive 89/396/EEC of 14 June 1989 on
indications or marks identifying the lot to which a foodstuff
belongs(1).
5.Smoking
Smoking must be carried out in separate premises or a special place
equipped, if necessary, with a ventilation system to prevent the smoke
and heat from the combustion from affecting other premises or places
where fishery products are prepared, processed or stored.
(a) Materials used to produce smoke for the smoking of fish must be
stored away from the place of smoking and must be used in such a
way that they do not contaminate the products.
(b) Materials used to produce smoke by burning wood that has been
painted, varnished, glued or has undergone any chemical preserva-
tion treatment must be prohibited.
(c) After smoking, products must be cooled rapidly to the temperature
required for their preservation before being packaged.
6.Salting
(a) Salting operations must take place in different premises and suffi-
ciently removed from the premises where the other operations are
carried out.
(b) Salt used in the treatment of fishery products must be clean and
stored in such a way as to preclude contamination. It must not be
re-used.
(c) Any container used for salting or brining must be constructed in
such a way as to preclude contamination during the salting or
brining process.
(d) Containers or areas used for salting or brining must be cleaned
before use.
7.Cooked crustacean and molluscan shellfish products
Crustaceans and molluscan shellfish must be cooked as follows:
(a) any cooking must be followed by rapid cooling. Water used for this
purpose must be drinking water or dean seawater. If no other method
of preservation is used, cooling must continue until the temperature
approaching that of melting ice is reached;
(b) shelling or shucking must be carried out under hygienic conditions
avoiding the contamination of the product. Where such operations
are done by hand, workers must pay particular attention to the
washing of their hands and all working surfaces must be cleaned
thoroughly. If machines are used, they must be cleaned at frequent
intervals and disinfected after each working day.
After shelling or shucking, cooked products must immediately be
frozen or kept chilled at a temperature which will preclude the
growth of pathogens, and be stored in appropriate premises;1991L0493 — EN — 01.07.1997 — 003.001 — 17
(1) OJ No L 186, 30. 6. 1989, p. 21.
▼B
(c) every manufacturer must carry out micro-;biological checks on his
production at regular intervals, complying with the standards to be
fixed in accordance with Chapter V, Section 4 of this Annex.
8.Mechanically recovered fish flesh
The mechanical recovery of fish flesh must be carried out under the
following conditions:
(a) mechanical recovery of gutted fish must take place without undue
delay after filleting, using raw materials free of guts. Where whole
fish are used, they must be gutted and washed beforehand;
(b) the machinery must be cleaned at frequent intervals and at least
every two hours;
(c) after recovery, mechanically recovered flesh must be frozen as
quickly as possible or incorporated in a product intended for freezing
or stabilizing treatment.
V.Conditionsconcerningparasites
1. During production and before they are released for human consumption,
fish and fish products must be subject to a visual inspection for the
purpose of detecting and removing any parasites that are visible.
Fish or parts of fish which are obviously infested with parasites, and
which are removed, must not be placed on the market for human
consumption.
The detailed rules for this inspection shall be adopted in accordance with
the procedure laid down in Article 15 of this Directive, on a proposal
from the Commission to be submitted before 1 October 1992.
2. The fish and fish products referred to in point 3 which are to be
consumed as they are must, in addition, be subjected to freezing at a
temperature of not more than − 20 ºC in all parts of the product for not
less than 24 hours. Products subjected to this freezing process must be
either raw or finished.
3. Fish and products subject to the conditions in point 2:
(a) fish to be consumed raw or almost raw, e.g. raw herring ‘maatje’;
(b) the following species, if they are to undergo a cold smoking process
at which the internal temperature of the fish is less than 60 ºC:
— herring,
— mackerel,
— sprat,
— (wild) Atlantic and Pacific salmon;
(c) marinated and/or salted herring where this process is insufficient to
►M1kill◄the larvae of nematodes.
This list may be amended, in the light of scientific data, in accordance
with the procedure laid down in Article 15 of this Directive. In accor-
dance with the same procedure, criteria will be laid down which must
enable the processes which are deemed sufficient or insufficient to
destroy nematodes to be defined.
4. Manufacturers must ensure that fish and fish products listed in point 3 or
the raw materials for use in their manufacture are subjected to the treat-
ment described in point 2, prior to their release for consumption.
5. The fishery products listed in point 3 must, when they are placed on the
market, be accompanied by a document from the manufacturer stating
the type of process they have undergone.
CHAPTER V
HEALTH CONTROL AND MONITORING OF PRODUCTION CONDI-
TIONS
I.General monitoring
Arrangements for checking and monitoring must be made by the competent
authorities in order to establish whether the requirements laid down in this
Directive are complied with.
Such arrangements will include, in particular:1. a check on the fishing vessels, on the understanding that such a check
may be carried out during the stay in port;
2. a check on the conditions of landing and first sale;1991L0493 — EN — 01.07.1997 — 003.001 — 18
▼B
3. an inspection at regular intervals of establishments to check, in particular:
(a) whether the conditions for approval are still fulfilled;
(b) whether the fishery products are handled correctly;
(c) the cleanliness of the premises, facilities and instruments and staff
hygiene;
(d) whether identification marks are put on correctly;
4. an inspection of the wholesale and auction markets;
5. a check on storage and transport conditions.
II.Specialchecks
1.Organoleptic checks
Without prejudice to the derogations provided for by Council Regulation
(EEC) No 103/76 of 19 January 1976 laying down common marketing
standards for certain fresh or chilled fish(1), each batch of fishery
products must be submitted for inspection by the competent authority at
the time of landing or before first sale to check whether they are fit for
human consumption. This inspection comprises an organoleptic check
carried out by sampling.
Fishery products complying, as far as the freshness criteria are concerned,
with the common marketing standards already laid down pursuant to
Article 2 of Regulation (EEC) No 3796/81 are considered to fulfil the
organoleptic requirements necessary for compliance with the provisions
of this Directive.
The Commission may, where necessary, in accordance with the procedure
referred to in Article 15 of this Directive, lay down specific organoleptic
requirements for fishery products not harmonized under Regulation (EEC)
No 3796/81.
The organoleptic examination must be repeated after the first sale of
fishery products, if it is found that the requirements of this Directive
have not been complied with or when considered necessary. After the first
sale, fishery products must at least comply with the minimum freshness
requirements of the aforementioned Regulation.
If the organoleptic examination reveals that the fishery products are not
fit for human consumption, measures must be taken to withdraw them
from the market and denature in such a way that they cannot be re-used
for human consumption.
If the organoleptic examination reveals any doubt as to the freshness of
the fishery products, use may be made of chemical checks or microbiolo-
gical analyses.
2.Parasite checks
Before they are released for human consumption, fish and fish products
must be subject to a visual inspection, by way of sample, for the purpose
of detecting any parasites that are visible.
Fish or parts of fish which are obviously infested with parasites, and
which are removed, must not be placed on the market for human
consumption.
The detailed rules for this inspection shall be established in accordance
with the procedure laid down in Article 15.
3.Chemicals checks
A. Samples must be taken and subjected to laboratory analysis for the
control of the following parameters:
(a) TVB-N (Total Volatile Basic Nitrogen) and TMA-N (Trimethyla-
mine-Nitrogen)
The levels of these parameters must be specified for each category
of species in accordance with the procedure laid down in Article
15 of this Directive.
(b) Histamine
Nine samples must be taken from each batch. These must fulfil
the following requirements:
— the mean value must not exceed 100 ppm;1991L0493 — EN — 01.07.1997 — 003.001 — 19
(1) OJ No L 20, 28. 1. 1976, p. 29. Regulation last amended by Regulation (EEC) No 33/
89 (OJ No L 5, 7. 1. 1989, p. 18).
▼B
— two samples may have a value of more than 100 ppm but less
than 200 ppm;
— no sample may have a value exceeding 200 ppm.
►M1These limits apply only to fish species of the following
families: scombridae, clupeidae, engraulidae and
coryphaenidae .◄However, fish belonging to these families
which have undergone enzyme ripening treatment in brine may
have higher histamine levels but not more than twice the above
values. Examinations must be carried out in accordance with reli-
able, scientifically recognized methods, such as high-performance
liquid chromatography (HPLC).
B. Contaminants present in the aquatic environment
Without prejudice to the Community rules concerning water protec-
tion and management, and in particular those concerning pollution of
the aquatic environment, fishery products must not contain in their
edible parts contaminants present in the aquatic environment such as
heavy metals and organochlorinated substances at such a level that the
calculated dietary intake exceeds the acceptable daily or weekly
intake for humans.
C. In accordance with the procedure laid down in Article 15 of this
Directive, the following shall be decided on by not later than 31
December 1992:
(a) the methods of analysis to be used to check the chemical para-
meters, as well as the sampling plans;
(b) the acceptable levels for the chemical parameters.
4.Microbiological analyses
In accordance with the procedure laid down in Article 15 of this Direc-
tive, microbiological criteria, including sampling plans and methods of
analysis, may be laid down when there is a need to protect public health.
The Commission will to this end submit appropriate proposals for
measures by 1 October 1992.
CHAPTER VI
PACKAGING
1. Packaging must be carried out under satisfactory conditions of hygiene, to
preclude contamination of the fishery products.
2. Packaging materials and products liable to enter into contact with fishery
products must comply with all the rules of hygiene, and in particular:
— they must not be such as to impair the organoleptic characteristics of the
fishery products;
— they must not be capable of transmitting to the fishery products
substances harmful to human health;
— they must be strong enough to protect the fishery products adequately.
3. With the exception of certain containers made of impervious, smooth and
corrosion-resistant material which are easy to clean and disinfect, which
may be re-used after cleaning and disinfecting, packaging materials may not
be re-used. Packaging materials used for fresh products held under ice must
provide adequate drainage for melt water.
4. Unused packaging materials must be stored in premises away from the
production area and be protected from dust and contamination.
CHAPTER VII
IDENTIFICATION
Without prejudice to the provisions of Directive 79/112/EEC, it must be
possible to trace for inspection purposes the establishment of dispatch of
consignments of fishery products, by means either of labelling or of the accom-
panying documents.
For that purpose, the following information must appear on the packaging or, in
the case of a non-packaged product, in the accompanying documents:1991L0493 — EN — 01.07.1997 — 003.001 — 20
▼M2
▼B
▼M1
▼M1
— the country of dispatch, which may be written out in full or shown as an
abbreviation, using capital letters, i. e. for the Member States of the Commu-
nity, one of the following:
B—D K—D—E L—E—F—I R L—I—L—NL—P—U K—
AT — FI — SE,
— identification of the establishment or factory vessel by its official approval
number or, in the case of marketing from a freezer vessel covered by point
7 of Annex II to Directive 92/48/EEC, the identification number of the
vessel, or, in the case of separate registering of auction or wholesale markets
as laid down in the third subparagraph of Article 7 (1) of this Directive, the
registration number of the auction or wholesale market,
— one of the following abbreviations: CE — EC — EG — EK — EF — EY.
All the letters and figures must be fully legible and grouped together on the
packaging in a place where they are visible from the outside without any need
to open the said packaging.
CHAPTER VIII
STORAGEANDTRANSPORT
1. Fishery products must, during storage and transport, be kept at the tempera-
tures laid down in this Directive and in particular:
— fresh or thawed fishery products and cooked and chilled crustacean and
molluscan shellfish products must be kept at the temperature of melting
ice;
— frozen fishery products, with the exception of frozen fish in brine
intended for the manufacture of canned foods, must be kept at an even
temperature of − 18 ºC or less in all parts of the product, allowing for
the possibility of brief upward fluctuations of not more than 3 ºC, during
transport;
— processed products must be kept at the temperatures specified by the
manufacturer, when the circumstances so require, prescribed in accor-
dance with the procedure laid down in Article 15 of this Directive.
2. Where frozen fishery products are transported from a cold-storage plant to an
approved establishment to be thawed on arrival for the purposes of prepara-
tion and/or processing and where the distance to be covered is short, not
exceeding 50 km or one hour's journey, the competent authority may grant
a derogation from the conditions laid down in point 1, second indent.
3. Products may not be stored or transported with other products which may
contaminate them or affect their hygiene, unless they are packaged in such
a way as to provide satisfactory protection.
4. Vehicles used for the transport of fishery products must be constructed and
equipped in such a way that the temperatures laid down in this Directive
can be maintained throughout the period of transport. If ice is used to chill
the products, adequate drainage must be provided in order to ensure that
water from melted ice does not stay in contact with the products. The inside
surfaces of the means of transport must be finished in such a way that they
do not adversely affect the fishery products. They must be smooth and easy
to clean and disinfect.
5. Means of transport used for fishery products may not be used for transporting
other products likely to impair or contaminate fishery products, except where
the fishery products can be guaranteed uncontaminated as a result of such
transport being thoroughly cleaned and disinfected.
6. Fishery products may not be transported in a vehicle or container which is
not dean or which should have been disinfected.
7. The transport conditions of fishery products to be placed on the market alive
must not adversely affect the products.
CHAPTER IX
POINTSOFANNEXIWHICHMAYBESUBJECTTODEROGATIONS
ANDPOSSIBLECONDITIONSAPPLICABLEINTHECASEOFDERO-
GATIONS
ReChapterIPartIoftheAnnex
1.Point 1 (a)
provided products are sheltered from the sun and the elements and from any
source of dirt or contamination.
2.Point 1 (c)1991L0493 — EN — 01.07.1997 — 003.001 — 21
▼B
▼B
provided any contamination of the products is prevented.
3.Point 1 (d), first sentence
provided the finished products are stored on board at the required tempera-
ture.
4.Point 1 (g), last sentence
provided products cannot be contaminated by waste water, waste or engine
coolant.
5.Point 1 (h)
provided staff handling fishery products can wash their hands after using the
toilet.
6.Point 2 (a)
provided floors are properly cleaned and disinfected.
7.Point 2 (b), (c) and (d)
8.Point 2 (g) on taps and towels
9.Point 3
provided equipment and tools are well maintained.
ReChapterIIoftheAnnex
10.Point 3 (a)
provided the walls are kept clean.
11.Point 3 (b)
provided the flooring is kept clean after every sale.
12.Point 3 (c), first sentence
13.Point 3 (e): vehicles emitting exhaust fumes
provided products contaminated by exhaust fumes are withdrawn from the
market.
14.Point 3 (j)
provided that products which are not fit for human consumption cannot
contaminate or be mixed with fishery products.
15.Point 3 (k)
16.Point 7
insofar as it refers to point 3 of the same Chapter and point 10 of Chapter
III, section I.
ReChapterIIIPartIoftheAnnex
17.Point 1
provided finished products cannot be contaminated by raw materials or
waste.
18.Point 2 (a)
provided the flooring is cleaned and disinfected accordingly.
19.Point 2 (b)
provided the walls are kept clean.
20.Point 2 (c)
provided the ceiling is not a source of contamination.
21.Point 2 (d)
22.Point 2 (e)
provided products cannot be spoilt or contaminated by the steam.
23.Point 2 (g)
provided there are facilities available for staff to wash their hands.
24.Point 3
25.Point 5
insofar as it relates to corrosion-resistant materials provided instruments and
working equipment are kept clean.
26.Point 6
provided products cannot be contaminated by waste or leakage therefrom.
27.Point 101991L0493 — EN — 01.07.1997 — 003.001 — 22
▼B
ReChapterIVoftheAnnex
28.Part I, point 1
in respect of the requirement for products being held over to be put in the
establishment's cold room provided the products are re-iced as often as
necessary during a period not in excess of 12 hours or that a nearby cold
room not belonging to the establishment can be used.
29.Part I, point 6
in respect of the requirement for waste to be put in leakproof covered
containers provided products cannot be contaminated by waste or leakage
therefrom.
30.Part IV, point 5, first paragraph
provided that every precaution is taken to prevent fishery products that are
being prepared or stored from being affected by the smoke.
31.Part IV, point 6 (a)
provided fishery products that are being prepared or stored are not affected
by salting operations.1991L0493 — EN — 01.07.1997 — 003.001 — 23