1991L0492 — EN — 05.06.2003 — 004.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of15July1991
layingdownthehealthconditionsfortheproductionandtheplacingonthemarketoflivebivalve
molluscs
(91/492/EEC)
(OJ L 268, 24.9.1991, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 97/61/EC of 20 October 1997 L 295 35 29.10.1997
►M2Council Directive 97/79/EC of 18 December 1997 L 24 31 30.1.1998
►M3Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
▼B
COUNCILDIRECTIVE
of15July1991
laying down the health conditions for the production and the
placingonthemarketoflive bivalvemolluscs
(91/492/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 proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas, with a view to achieving the internal market and more espe-
cially to ensure the smooth operation of the common organization ofthe market in fishery products established by Regulation (EEC) No3796/81 (
4) aslas t amended by Regulation (EEC) No 2886/89 (5), it is
essential that the placing on the market of live bivalve molluscs should
no longer be hindered by disparities existing in the Member States inrespect of health requirements; whereas this will enable productionand placing on the market to be better harmonized and bring aboutcompetition on equal termswhile ens uring quality productsfor theconsumer.
WhereasCouncil Directive 79/923/EEC of 30 October 1979 on the
quality required of shellfish waters (
6) lays down that it is necessary to
establish the health requirements to be observed for shellfish products;
Whereas these requirements should be laid down for all stages during
harvesting, handling, storage, transport and distribution of live bivalvemolluscs in order to safeguard the public health of consumers; whereasthese requirements shall apply equally to echinoderms, tunicates andmarine gastropods;
Whereasit isimportant, s hould a health problem occur after the
placing on the market of live bivalve molluscs to be able to traceback the establishment of dispatch and the harvesting area of origin;
whereas it is therefore necessary to introduce a registration and label-
ling system which will enable the route of a batch after harvesting tobe followed;
Whereasit isimportant that the public health s tandardsfor the final
product must be specified; whereas, however, scientific and technolo-
gical knowledge isnot alwaysadvanced enough to lay downdefinitive solutions for certain health problems and whereas it is there-fore necessary, in order to guarantee optimal protection of publichealth, to set up a Community system to ensure rapid adoption andwhere necessary reinforcement of the health standards to safeguard
human health from viruscontamination or other hazards ;
Whereas live bivalve molluscs obtained from harvesting areas which
do not permit direct, safe consumption may be rendered safe bysubmitting them to a purification process or by relaying in clean water
over a relatively long period; whereas it is therefore necessary to define
production areasfrom which mollus cscan bet gathered for directhuman consumption, or from which they have to be purified or relayed;1991L0492 — EN — 05.06.2003 — 004.001 — 2
(1) OJ No C 84, 2. 4. 1990, p. 29.
(2) OJ No C 183, 15. 7. 1991.
(3) OJ No C 332, 31. 12. 1990, p. 1.
(4) OJ No L 379, 31. 12. 1981, p. 1.
(5) OJ No L 282, 2. 10. 1989, p. 1.
(6) OJ No L 281, 10. 11. 1979, p. 47.
▼B
Whereas it is primarily the responsibility of the producers to ensure
that the bivalve molluscs are produced and placed on the market incompliance with the health requirementspres cribed; whereasthe
competent authorities must, by carrying out checks and inspections,
ensure that producers comply with those requirements; whereas thecompetent authorities must in particular submit harvesting areas to aregular control to ensure that molluscs from these harvesting areas donot contain microorganisms and toxic substances in quantities which
are considered to be dangerous to human health;
Whereas control measures organized on a Community level must be
introduced to guarantee the uniform application in all Member Statesof the standards laid down in this Directive;
Whereas the rules, principles and safeguard measures established by
Council Directive 90/675/EEC of 10 December 1990 laying down the
principlesgoverning the organization of veterinary checkson products
entering the Community from third countries(
1), should apply to the
case in question;
Whereasin the context of trade between the Member States , the rules
laid down in Council Directive 89/662/EEC of 11 December 1989concerning veterinary checksin intra-Community trade, with a view
to the completion of the internal market (
2) asamended by Directive
90/675/EEC should also be applied;
Whereaslive bivalve mollus csproduced in a third country and
intended to be placed on the market in the Community must not qualifyfor more favourable conditionsthan thos e applied in the Community;whereas provision must be made for a Community procedure for
checking the conditionsin third countriesof production and of the
placing on the market, in order to allow the Community to apply acommon import system based on conditions of equivalence;
Whereas, so that account may be taken of particular circumstances,
derogations should be granted to certain establishments already oper-
ating before 1 January 1993 so as to allow them to adapt to all the
requirementslaid down in thisDirective;
Whereas, in the case of living animals that are edible whilst they are
alive, a derogation should be made, with regard to the durability date,to the rulesof Council Directive 79/112/EEC of 18 December 1978 onthe approximation of the lawsof the Member Statesrelating to the
labelling, presentation and advertising of foodstuffs for sale (
3) aslas t
amended by Directive 91/72/EEC (4);
Whereas provision should be made for the possibility of adopting tran-
sitional measures in order to cover the absence of certain implementingrules;
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,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
ThisDirective laysdown health conditionsfor the production and
placing on the market of live bivalve molluscs which are intended for1991L0492 — EN — 05.06.2003 — 004.001 — 3
(1) OJ No L 373, 31. 12. 1990, p. 1.
(2) OJ No L 395, 30. 12. 1989, p. 13.
(3) OJ No L 33, 8. 2. 1979, p. 1.
(4) OJ No L 42, 16. 1. 1991, p. 27.
▼B
immediate human consumption or for further processing before
consumption.
With the exception of the provisions on purification, this Directive
applies to echinoderms, tunicates and marine gastropods.
Article 2
For the purposes of this Directive, the following definitions shall apply:
1.‘bivalve molluscs’ means filter-feeding lamellibranch molluscs;
2.‘marine biotoxins’ means poisonous substances accumulated by
bivalve molluscs feeding on plankton containing toxin;
3.‘clean sea water’ means sea water or brackish water which is to be
used under the conditions laid down in this Directive and which is
free from microbiological contamination and toxic and objection-
able substances occurring naturally or after discharge in theenvironment such as those listed in the Annex to Directive 79/923/EEC, in such quantities as may adversely affect the healthquality of bivalve molluscs or to impair their taste;
4.‘competent authority’ meansthe central authority of a Member
State competent to carry out veterinary checksor any authority towhich it hasdelegated that competence;
5.‘conditioning’ means the storage of live bivalve molluscs, whose
quality doesnot indicate the need for relaying or treatment in apurification plant, in tanksor any other ins tallation containingclean sea water or in natural sites to remove sand, mud or slime;
6.‘gatherer’ meansany natural or legal pers on who collectslive
bivalve molluscs by any means from a harvesting area for thepurpose of handling and placing on the market;
7.‘production area’ means any sea, estuarine or lagoon area
containing natural deposits of bivalve molluscs or sites used forcultivation of bivalve molluscs from which live bivalve molluscsare taken;
8.‘relaying area’ means any sea, estuarine or lagoon area approved
by the competent authority, with boundariesclearly marked andindicated by buoys, posts or any other fixed means, and usedexclusively for the natural purification of live bivalve molluscs;
9.‘dispatch centre’ means any approved on-shore or off-shore instal-
lation for the reception, conditioning, washing, cleaning, gradingand wrapping of live bivalve molluscs fit for human consumption;
10.‘purification centre’ means an approved establishment with tanks
fed by naturally clean sea water or sea water that has been cleanedby appropriate treatment, in which live bivalve molluscs are placedfor the time necessary to remove microbiological contamination, somaking them fit for human consumption;
11.‘relaying’ meansan operation whereby live bivalve mollus csare
transferred to approved sea or lagoon areas or approved estuarineareas under the supervision of the competent authority for thetime necessary to remove contamination. This does not include
the specific operation of transferring bivalve molluscs to areas
more suitable for further growth or fattening;
12.‘means of transport’ means those parts set aside for goods in auto-
mobile vehicles, rail vehicles and aircraft, the holds of vessels and
containers for transport by land, sea or air;
13.‘wrapping’ meansan operation whereby live bivalve mollus csare
placed in packaging material adequate for the purpose;
14.‘consignment’ meansa quantity of live bivalve mollus cshandled in
a dispatch centre or treated in a purification centre and subse-quently intended for one or more customers;
15.‘batch’ meansa quantity of live bivalve mollus cscollected from a
production area and subsequently intended for delivery to anapproved dispatch centre, purification centre, relaying area orprocessing plant as appropriate;1991L0492 — EN — 05.06.2003 — 004.001 — 4
▼B
16.‘placing on the market’ means the holding or displaying for sale,
offering for sale, selling, delivering or any other form of placingon the market of live bivalve molluscs for human consumption
either raw or for the purpose of processing in the Community,
excluding the direct transfer on the local market in small quantitiesby the coastal fisherman to the retailer or the consumer which mustbe subject to the health checks laid down by national rules forchecking on retail business;
17.‘importation’ meansthe introduction of live bivalve mollus csinto
the territory of the Community from third countries;
18.‘faecal coliform’ meansfacultative, aerobic, gram-negative, non-
sporeforming, cytochrome oxidase negative, rod-shaped bacteriathat are able to ferment lactose with gas production in the presenceof bile salts, or other surface active agents with similar growth-
inhibiting properties, at 44 ºC ± 0,2 ºC within 24 hours at least;
19.‘E. coli’ meansfaecal coliformswhich als o form indole from tryp-
tophan at 44 ºC ± 0,2 ºC within 24 hours.
CHAPTER II
ProvisionsforCommunityproduction
Article 3
1. The placing on the market of live bivalve molluscs for immediate
human consumption shall be subject to the following conditions:
(a) they must originate from production areas which comply with the
requirementslaid down in Chapter I of the Annex; however, inthe case of pectinidae, this provision shall apply only to aquacul-ture productsasdefined in Article 2 (2) of Council Directive 91/493/EEC of 22 July 1991 laying down the health conditionsfor
the production and placing on the market of fishery products (
1);
(b) they must have been harvested and transported from the production
area to a dispatch centre, purification centre, relaying area orprocessing plant under the conditions laid down in Chapter II ofthe Annex;
(c) where provided for in thisDirective, they mus t have been relaid in
suitable areas approved for that purpose and complying with the
conditionslaid down in Chapter III of the Annex;
(d) they must have been handled hygienically, and where appropriate,
they must have been purified in establishments approved for thatpurpose and complying with the requirements of Chapter IV of
the Annex;
(e) they must comply with the criteria set out in Chapter V of the
Annex;
(f) health controlsmus t have been carried out in accordance with
Chapter VI of the Annex;
(g) they must have been appropriately wrapped in accordance with
Chapter VII of the Annex;
(h) they must have been stored and transported under satisfactory
conditionsof hygiene in accordance with ChaptersVIII and IX ofthe Annex;
(i) they must bear a health mark as provided for in Chapter X of the
Annex.
2. Live bivalve molluscs intended for further processing must
comply with the relevant requirements of paragraph 1 and be processedin accordance with the requirementsof Council Directive 91/493/EEC.1991L0492 — EN — 05.06.2003 — 004.001 — 5
(1) See page 15 of thisOfficial Journal.
▼B
Article 4
Member States shall ensure that persons handling live bivalve molluscs
during their production and placing on the market shall adopt allmeasures necessary to comply with the requirements of this Directive.
Persons responsible for dispatch and purification centres shall in parti-
cular ensure that:
— representative numbers of samples for laboratory examination are
regularly taken and analysed in order to establish an historicalrecord on the basis of the areas where batches come from and ofthe health quality of the live bivalve molluscs both before and afterhandling at a dispatch centre or purification centre.
— a register is kept for the permanent record of the results of the
variouschecksand kept for pres entation to the competent authority.
Article 5
1. (a) The competent authority shall approve dispatch centres and puri-
fication centres once it is satisfied that they meet therequirementsof thisDirective. The competent authority s halltake the necessary measures if the requirements cease to bemet. In so doing, it shall take account of, in particular, theoutcome of any check carried out in accordance with Article 6
(1).
However, subject to the express condition that live molluscs
coming from such centres meet the hygiene standards set bythisDirective, Member Statesmay, for the requirementsrelatingto equipment and structures laid down in Chapter IV of the
Annex, to be specified before 1 October 1991 in accordance
with the procedure laid down in Article 12, grant to dispatchand purification centres, a further period expiring on 31December 1995 ►
A1, except for Sweden, where the date to
be adopted shall be 31 December 1997, ◄within which to
comply with the conditionsof the approval s et out in the above-
mentioned Chapter. Such derogationsmay be granted only to
establishments, already operating on 31 December 1991, whichhave, before 1 July 1992, submitted a duly substantiated applica-tion for derogation to the competent national authority. Thisapplication must be accompanied by a work plan and
programme indicating the period within which it would be
possible for the establishments to comply with the requirementsin question. Where financial assistance is requested from theCommunity, only requests in respect of projects complyingwith the requirementsof thisDirective can be accepted.
The competent authority shall draw up a list of approved
dispatch centres and purification centres, each of which shall
have an official number.
The list of approved dispatch centres and purification centres,
and any subsequent amendments thereto, must be communicatedby each Member State to the Commission, which shall pass such
information on to the other Member States.
(b) The inspection and monitoring of these centres shall be carried
out regularly under the responsibility of the competent authority,which shall have free access to all parts of the centres, in orderto ensure compliance with the provisions of this Directive.
If such inspections and monitoring reveal that the requirements
of thisDirective are not being met, the competent authority s halltake appropriate action.
2. (a) The competent authority shall establish a list of production and
relaying areas, with an indication of their location and bound-aries, from which live bivalve molluscs may be taken inaccordance with the requirementsof thisDirective and, in parti-cular, with Chapter I of the Annex.1991L0492 — EN — 05.06.2003 — 004.001 — 6
▼B
This list must be communicated to those affected by this Direc-
tive, such as gatherers and operators of purification centres anddispatch centres.
(b) The monitoring of the production and relaying areass hall be
carried out under the responsibility of the competent authority
in accordance with the requirementsof thisDirective.
If such monitoring reveals that the requirements of this Directive
are no longer being met, the competent authority shall close theproduction or relaying area concerned until the situation hasbeen restored to normal.
3. The competent authority may prohibit any production and
harvesting of bivalve molluscs in areas considered unsuitable for these
activities for health reasons.
Article 6
1. Experts from the Commission may, in cooperation with the
competent authorities of the Member States, make on-the-spot checksinsofar as is necessary to ensure the uniform application of this Direc-tive. They may, in particular, check whether centres, production andrelaying areasare in effect complying with the requirementsof thisDirective. A Member State 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 theresults of such checks.
2. The arrangementsfor implementing paragraph 1 s hall be adopted
in accordance with the procedure laid down in Article 12.
3. The Commission, may draw up recommendations containing
guidelineson good manufacturing practicesapplicable at the differentstages of production and placing on the market.
Article 7
1. The ruleslaid down in Directive 89/662/EEC asregardslive
bivalve molluscs, echinoderms, tunicates and marine gastropodsintended for human consumption, shall apply, in particular as regards
the organization of and the action to be taken following the checksto
be carried out by the Member State of destination, and the safeguardmeasures 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 91/492/EEC of 15 July 1991 laying down
the health conditionsfor the production and placing on themarket of live bivalve molluscs, (OJ No L 268, 24. 9. 1991,p. 1.)’;
(b) in Annex B, the following indent shall be deleted:
‘— live bivalve molluscs intended for human consumption’.
CHAPTER III
Importsfromthirdcountries
Article 8
Provisions applied to imports of live bivalve molluscs from third coun-
tries shall be at least equivalent to those governing the production andplacing on the market of Community products.
Article 9
In order to ensure the uniform application of the requirement imposed
in Article 8, the following procedure shall apply:
1. inspections shall be carried out on the spot by experts from the
Commission and the Member States to verify whether the conditions1991L0492 — EN — 05.06.2003 — 004.001 — 7
▼B
of production and placing on the market can be considered as being
equivalent to those applied in the Community.
The expertsfrom the Member Stateswho are to be entrus ted with
these inspections shall be appointed by the Commission, acting on
a proposal from the Member States.
These inspections shall be made on behalf of the Community, which
shall bear the cost of any expenditure in this connection.
The frequency and the procedure for these inspections shall be
determined in accordance with the procedure laid down in Article
12;
2. in deciding whether the conditionsof production and placing on the
market of live bivalve molluscs in a third country can be deemedequivalent to those of the Community, particular account shall betaken 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 andthe supervision to which they are subject, as well as their facil-
itiesfor monitoring the implementation of their legis lation in
force;
(c) the actual health conditionsduring the production and placing
on the market of live bivalve molluscs and in particular themonitoring of production areasin relation to microbiological
and environmental contamination, and to the presence of marine
biotoxins;
(d) the regularity and the rapidity of the information provided by
the third country on the presence of plankton containing toxinin the production areasand, in particular, of s peciesnot occur-ring in Community waters, and risks that such presence may
signify for the Community;
(e) the assurances which a third country can give on the compliance
with the standards laid down in Chapter V of the Annex;
3. the Commission, following the procedure laid down in Article 12,
shall decide on:
(a) the list of third countries fulfilling the conditions of equivalence
referred to in paragraph 2;
(b) for each third country, the specific conditions for the importa-
tion of live bivalve molluscs. These conditions must include:
(i) the procedure for obtaining a health certificate which must
accompany consignments when forwarded to the Commu-
nity;
(ii) the demarcation of the production areasfrom which live
bivalve molluscs may be harvested and imported;
(iii) the obligation to notify the Community of any possible
change in the approval of production areas;
(iv) any purification after arrival in the territory of the Commu-
nity;
(c) a list of establishments from which the importation of live
bivalve molluscs is authorized. For that purpose, one or morelists of such establishments shall be established. An establish-
ment may not appear on a list unless it is officially approved
by the competent authority of the third country exporting to theCommunity. Such approval shall be subject to observance of thefollowing requirements:
— compliance with requirementsequivalent to thos e laid down
in thisDirective,
— monitoring by an official inspection service of the third
country;
4. the decisions referred to in paragraph 3 may be amended in accor-
dance with the procedure laid down in Article 12.1991L0492 — EN — 05.06.2003 — 004.001 — 8
▼B
These decisions and the amendments thereto shall be published in
theOfficial Journal of the European Communities , L series;
5. pending the decisions referred to in paragraph 3, the conditions
which Member States shall apply to imports of live bivalve molluscs
from third countries shall be at least equivalent to those governing
the production and placing on the market of Community products.
Article 10
The rulesand principleslaid down in Directive 90/675/EEC s hall
apply, with particular reference to the organization of and follow upto the inspections to be carried out by the Member States and the safe-guard measures to be implemented.
CHAPTER IV
Finalprovisions
Article 11
The chaptersof the Annex may be amended by the Council, acting by
a qualified majority on a proposal from the Commission.
The Commission shall, before 1 January 1994, submit to the Council,
after receiving the opinion of the Scientific Veterinary Committee, areport on ChaptersI and V of the Annex, accompanied by any
proposed amendments to those Chapters.
Article 12
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health set up pursuant to Article 58 of
Regulation (EC) No 178/2002 (
1).
2. Where reference ismade to thisArticle, Articles5 and 7 of Deci-
sion 1999/468/EC (2) shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its Rules of Procedure.
Article 13
In order to take into account the possible failure to take a decision on
the detailed rulesfor applying thisDirective by 1 January 1993, neces -sary transitional measures may be adopted in accordance with the
procedure laid down in Article 12 for a period of two years.
Article 14
The Commission shall, after consulting the Member States, submit,
before 1 July 1992, a report to the Council on the minimum require-
ments to be met with regard to structure and equipment by smalldispatch centres or by small establishments ensuring distribution onthe local market and situated in areas subject to particular constraintswith respect to their supply, possibly accompanied by proposals, on
which the Council will take a decision, acting in accordance with the
voting procedure laid down in Article 43 of the Treaty, before 31December 1992.1991L0492 — EN — 05.06.2003 — 004.001 — 9
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.▼M2
▼B
▼M3
▼B
▼B
The provisions of this Directive shall be re-examined before 1 January
1998 by the Council, acting on a Commission proposal, in the light ofthe experience gained.
Article 15
The Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive
before 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 theoccasion of their official publication. The methods of making such areference shall be laid down by the Member States.
Article 16
This Directive is addressed to the Member States.1991L0492 — EN — 05.06.2003 — 004.001 — 10
▼B
ANNEX
CHAPTER I
CONDITIONSFORPRODUCTIONAREAS
1. The location and the boundariesof production areasmus t be fixed by the
competent authority in such a way as to identify the areas from which live
bivalve molluscs:
(a) can be collected for direct human consumption. Live bivalve molluscs
taken from these areas must meet the requirements set out in Chapter V
of thisDirective;
(b) can be collected but only placed on the market for human consumption
after treatment in a purification centre, after relaying. Live bivalve
molluscs from these areas must not exceed the limits of a five-tube,
three-dilution MPN-test of 6 000 faecal coliforms per 100 g of flesh or
4 600E. Coli per 100 g of flesh in 90 % of samples.
After purification or relaying, all the requirementss et out in Chapter V
of thisAnnex mus t be met;
(c) can be collected but placed on the market only after relaying over a long
period (at least two months), whether or not combined with purification,
or after intensive purification for a period to be fixed in accordance with
the procedure provided for in Article 12 of thisDirective, s o asto meet
the requirements under (a). Live bivalve molluscs from these areas must
not exceed the limitsof a five-tube, three-dilution MPN-tes t of 60 000
faecal coliformsper 100 g of fles h.
2. Any change in the demarcation of production areasand the temporary or
definitive closure thereof must be immediately announced by the competent
authority to those affected by this Directive and in particular to producers
and operators of purification and dispatch centres.
CHAPTER II
REQUIREMENTS FOR HARVESTING ANDTRANSPORTATION OF
BATCHESTOADISPATCHORPURIFICATIONCENTRE,RELAYING
AREAORPROCESSINGPLANT
1. Harvesting techniques must not cause excessive damage to the shells or
tissues of live bivalve molluscs.
2. Live bivalve molluscs must be adequately protected from crushing, abrasion
or vibration after harvesting and must not be exposed to extremes of hot or
cold temperature.
3. Techniques for harvesting, transporting, landing and handling live bivalve
molluscs must not result in additional contamination of the product, nor in a
significant reduction in the quality of the product, nor in any changes signif-
icantly affecting their ability to be treated by purification, processing or
relaying.
4. Live bivalve molluscs must not be re-immersed in water which could cause
additional contamination between harvesting and landing.
5. The means of transport used for transporting live bivalve molluscs must be
used under conditions which protect the latter from additional contamination
and crushing of shells. They must permit adequate drainage and cleaning.
In the event of bulk transport over long distances of live bivalve molluscs to
a dispatch centre, purification centre, relaying area or processing plant, the
means of transport must be equipped in such a way as to ensure the best
survival conditions possible, and in particular must comply with the require-
mentslaid down in Chapter IX, Section 2 of thisAnnex.
6. A registration document for the identification of batches of live bivalve
molluscs during transport from the production area to a dispatch centre, puri-
fication centre, relaying area or processing plant must be issued by the
competent authority upon request by the gatherer. For each batch, the gath-
erer must complete legibly and indelibly the relevant sections of the
registration document which must contain the following information:
— the gatherer's identity and address,
— the date of harvesting,
— the location of the production area described in as precise detail as is
practicable or by a code number,
— the health status of the production area as referred to in Chapter I,
— the shellfish species and quantity indicated in as precise detail as is prac-
ticable,1991L0492 — EN — 05.06.2003 — 004.001 — 11
▼M1
▼M1
— the approval number and place of destination for wrapping, relaying,
purification or processing.
The registration document must be dated and signed by the gatherer.The registration documents must be numbered regularly and in sequence. The
competent authority must keep a register indicating numbers of registration
documentstogether with the namesof the pers onscollecting live bivalve
molluscs to whom the documents were issued. The registration document
for each batch of live bivalve molluscs must be date-stamped upon delivery
of a batch to a dispatch centre, purification centre, relaying area or proces-
sing plant and must be kept by operators of such centres, areas or plants for
at least twelve months. In addition, the gatherer is also obliged to keep it for
the same period.
However, if gathering is carried out by the same staff operating the dispatch
centre, purification centre, relaying area or processing plant of destination,
the registration document may be replaced by a permanent transport author-
ization granted by the competent authority. A standard registration document,
containing a reference to the variousrequirementswhich are to be included
in it and which are mentioned in ChaptersII, III and IV of thisAnnex, will
be introduced by the Commission in accordance with the procedure laid
down in Article 12 of the Directive.
7. If a production or relaying area isclos ed temporarily, the competent
authority must refrain from issuing registration documents for that area and
immediately suspend the validity of all registration documents already issued.
CHAPTER III
CONDITIONSFORRELAYINGLIVEBIVALVEMOLLUSCS
The following conditionsmus t be met:1. live bivalve molluscs must be gathered and transported in accordance with
the requirementsof Chapter II of thisAnnex;
2. techniques for handling live bivalve molluscs intended for relaying must
permit the resumption of filter-feeding activity after immersion in natural
waters;
3. live bivalve molluscs must not be relaid at a density which does not permit
purification;
4. live bivalve molluscs must be immersed in seawater at the relaying area for
an appropriate period which must exceed the time taken for levels of faecal
bacteria to become reduced to the levelspermitted by thisDirective taking
account of the fact that the standards of Chapter V of this Annex must be
met;
5. the minimum water temperature for effective relaying must, where necessary,
be determined and announced by the competent authority for each species of
live bivalve mollusc and approved relaying area;
6. areas for relaying live bivalve molluscs must be approved by the competent
authority. The boundaries of the sites must be clearly identified by buoys,
poles or other fixed means; there must be a minimum distance of 300 metres
between relaying areas, and also between relaying areas and production
areas;
7. sites within a relaying area must be well separated to prevent mixing of
batches; the ‘all in, all out’ system must be used, so that a new batch cannot
be brought in before the whole of the previousbatch hasbeen removed;
8. permanent records of the source of live bivalve molluscs, relaying periods,
relaying areas and subsequent destination of the batch after relaying must
be kept by the operatorsof relaying areasfor ins pection by the competent
authority;
9. after harvesting from the relaying area, batches must, during transport from
the relaying area to the approved dispatch centre, purification centre or
processing plant, be accompanied by a registration document, a specimen of
which will be drawn up by the Commission in accordance with the procedure
laid down in Article 12 of the Directive, setting out, in addition to the infor-
mation specified in point 6 of Chapter II of this Annex, inter alia the location
and approval number of the relaying area and the duration of relaying,
together with any other information needed to identify and trace the product.
However, the above shall not be required where the same staff operate both
in the relaying area and in the dispatch centre, purification centre or proces-
sing plant.1991L0492 — EN — 05.06.2003 — 004.001 — 12
▼B
▼M1
▼B
CHAPTER IV
CONDITIONS FOR THE APPROVAL OF DISPATCH OR PURIFICA-
TIONCENTRES
I.Generalconditionsrelatingtopremisesandequipment
Centres must not be located in areas which are close to objectionable
odours, smoke, dust and other contaminants. The location must not be
subject to flooding by ordinary high tides or run-off from surrounding areas.
Centres must have at least:1. on premises where live bivalve molluscs are handled or stored:
(a) buildings or facilities of sound construction, designed and main-
tained adequately for the purpose of preventing contamination of
live bivalve molluscs by any type of waste, dirty water, fumes, dirt
or by the presence of rodents or other animals;
(b) flooring which is easy to keep clean and is laid in such a way as to
facilitate drainage;
(c) adequate working space to allow for satisfactory performance of all
operations;
(d) durable wallswhich are eas y to clean;
(e) adequate natural or artificial lighting;
2. access to an appropriate number of changing rooms, wash basins and
lavatories; there must be a sufficient number of wash basins close to
the lavatories;
3. adequate equipment for washing tools, containers and equipment;
4. facilities for the supply and, where appropriate, storage of exclusively
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 facilities for the supply of clean sea water.
Facilitiess upplying non-potable water may be authorized. The water
concerned may not come into direct contact with live bivalve molluscs
or be used for cleaning or disinfecting containers, plant or equipment
which come into contact with live bivalve molluscs. Pipes and outlets
carrying non-potable water must be clearly distinguished from those
carrying potable water;
5. equipment and instruments or their surfaces which are intended to come
into contact with live bivalve molluscs must be made of corrosion-resis-
tant material which is easy to wash and clean repeatedly.
II.Generalhygienerequirements
A high degree of cleanliness and hygiene must be required of staff,
premises, equipment and working conditions:
1. staff who treat or handle live bivalve molluscs must in particular wear
clean working clothesand, where appropriate, gloveswhich are s uitable
for the work in which the person is engaged;
2. staff are obliged to refrain from personal behaviour, such as spitting,
which could result in contamination of live bivalve molluscs; any person
suffering from an illness which can be transmitted by live bivalve
molluscs must be temporarily prohibited, until recovery, from working
with or handling these products;
3. any rodents, insects or other vermin found must be destroyed and further
infestation prevented. Domestic animals must not enter the facilities;
4. premises, equipment and instruments used for handling live bivalve
molluscs must be kept clean and in a good state of repair; equipment
and instruments must be thoroughly cleaned at the end of the day's
work and at such other times as may be appropriate;
5. premises, instruments and equipment must not be used for purposes
other than the handling of live bivalve molluscs without authorization
by the competent authority;
6. waste products must be stored hygienically in a separate area and, where
appropriate, in covered containers suitable for the purpose intended.1991L0492 — EN — 05.06.2003 — 004.001 — 13
(1) OJ No L 229, 30. 8. 1980, p. 11. Directive last amended by the 1985 Act of Accession
(OJ No L 302, 15. 11. 1985, p. 218).
▼B
Waste material must be removed from the vicinity of the establishment
at appropriate intervals;
7. the finished products must be stored under cover and must be kept away
from the areas where animals other than live bivalve molluscs, such as
crustaceans, are handled.
III.Requirementsforpurificationcentres
In addition to the requirementsunder SectionsI and II, the following condi-
tionsmus t be met:
1. the floorsand wallsof the purification tanksand any water s torage
containers must have a smooth, hard and impermeable surface and be
easy to clean by scrubbing or use of pressurized water. The base of
the purification tanks must be sufficiently sloped and be equipped
with drainage sufficient for the volume of work;
2. live bivalve molluscs must be washed free of mud with pressurized
clean sea water or potable water before purification. The initial washing
may also be carried out in the purification tanks before purification
commences, the drainage pipes being kept open during the entire initial
washing and sufficient time being allowed thereafter for the system to
be flushed clean before the purification process begins;
3. the purification tanks must be supplied with a sufficient flow of sea
water per hour and per tonne of live bivalve molluscs treated;
4. clean sea water or sea water cleaned by treatment must be used for
purifying live bivalve molluscs; the distance between the sea water
intake point and the waste water outlets must be sufficient to avoid
contamination; if treatment of the sea water is necessary, the process
shall be authorized once its effectiveness has been verified by the
competent authority; potable water used to prepare sea water from its
major constituent chemicals must comply with the requirements laid
down in Directive 80/778/EEC;
5. operation of the purification system must allow live bivalve molluscs to
rapidly resume filter feeding activity, remove sewage contamination,
not to become recontaminated and be able to remain alive in a suitable
condition after purification for wrapping, storage and transport before
being placed on the market;
6. the quantity of live bivalve molluscs to be purified must not exceed the
capacity of the purification centre; the live bivalve molluscs must be
continuously purified for a period sufficient to allow the microbiolo-
gical standards laid down in Chapter V of this Annex to be met. This
period starts from the moment at which the live bivalve molluscs in the
purification tanksare adequately covered by the water until the moment
when they are removed.
The purification centre must take account of the data relating to the raw
materials(the type of bivalve mollus c, itsarea of origin, microbe
content, etc.) in case it is necessary to extend the purification period
so as to ensure that the live bivalve molluscs meet the bacteriological
requirementsof Chapter V of thisAnnex;
7. should a purification tank contain several batches of molluscs, they
must be of the same species and come from the same production area
or different areas conforming to the same health conditions. The length
of the treatment must be based on the time required by the batch
needing the longest period of purification;
8. containers used to hold live bivalve molluscs in purification systems
must have a construction which allows sea water to flow through; the
depth of layers of live bivalve molluscs should not impede the opening
of shells during purification;
9. no crustaceans, fish or other marine species must be kept in a purifica-
tion tank in which live bivalve molluscs are undergoing purification;
10. after completion of purification, the shells of live bivalve molluscs must
be washed thoroughly by hosing with potable water or clean sea water;
this may take place in the purification tank if necessary; the washing
water must not be recirculated;
11. purification centres must have their own laboratories or secure the
services of a laboratory equipped with the necessary facilities for
checking the efficiency of purification by use of microbiological speci-
fications. Laboratory facilities outside the centres must be recognized
by the competent authority;
12. purification centresmus t regularly keep a record of the following data:
— results of microbiological tests on purification system water
entering the purification tanks;1991L0492 — EN — 05.06.2003 — 004.001 — 14
▼B
— results of microbiological tests on unpurified live bivalve molluscs;
— results of microbiological tests on purified live bivalve molluscs;
— datesand quantitiesof live bivalve mollus csdelivered to the purifi-
cation centre and corresponding registration document numbers;
— the times of filling and emptying of purification systems (purifica-
tion times);
— dispatch details of consignments after purification.
These records must be complete and accurate, legible and recorded in a
permanent ledger book which must be available for inspection by the
competent authority;
13. purification centres must accept only those batches of live molluscs
which are accompanied by the registration document referred to in
Chapter II of thisAnnex;
Purification centres dispatching batches of live bivalve molluscs to
dispatch centres must provide a registration document, a specimen of
which will be drawn up by the Commission in accordance with the
procedure laid down in Article 12 of the Directive, setting out, in addi-
tion to the information specified in point 6 of Chapter II of this Annex,
inter alia the approval number and address of the purification plant and
the duration of purification, the datesof entering and leaving the puri-
fication centre, together with any other information needed to identify
and trace the product;
14. every package containing purified live bivalve molluscs must be
provided with a label certifying that all molluscs have been purified.
IV.Requirementsfordispatchcentres
1. In addition to the requirementsunder SectionsI and II, the following
conditionsmus t be met:
(a) conditioning must not cause any contamination of the product;
conditioning facilities must be used in accordance with procedures
recognized by the competent authorities, with special regard to the
bacteriological and chemical quality of the sea water used in those
facilities;
(b) equipment and containersin the conditioning facilitiesmus t not
constitute a source of contamination;
(c) procedures for calibration of live bivalve molluscs must not result in
additional contamination of the product or in any changesaffecting
the ability of the product to be transported and stored after wrapping;
(d) any washing or cleaning of live bivalve molluscs must be carried out
using pressurized clean sea water or potable water; cleaning watermay not be recycled.
2. Dispatch centres must accept only those batches of live bivalve molluscs
which are accompanied by the registration document referred to in
Chapter II, section 6 of this Annex and coming from an approved
production area, relaying area or purification centre.
3. Dispatch centres must have their own laboratories or secure the services
of a laboratory equipped with the necessary facilities for checking, inter
alia, whether the molluscs comply with the microbiological standards of
Chapter V of this Annex. Laboratory facilities outside the centres must
be recognized by the competent authority.
However, these requirements do not apply to dispatch centres obtaining
their molluscs exclusively and directly from a purification centre where
they have been examined after purification.
4. Dispatch centres must keep the following at the disposal of the compe-
tent authority:
— the results of microbiological tests on live bivalve molluscs from an
approved production area or relaying area or from a purification
plant,
— the datesand quantitiesof live bivalve mollus csdelivered to the
dispatch centre, together with the corresponding registration docu-
ments,
— dispatch details including the names and addresses of consignees, the
dates and quantities of live bivalve molluscs dispatched, together
with the corresponding entry registration document number(s).1991L0492 — EN — 05.06.2003 — 004.001 — 15
▼M1
▼B
▼M1
▼M1
These data must be classified chronologically and preserved for a period
to be laid down by the competent authority, but not less than twelve
months.
5. Dispatch centres situated aboard vessels shall be subject to the condi-
tionslaid down in point 1 (b), (c) and (d) and in points3 and 4. The
conditions laid down in I and II shall apply mutatis mutandis to such
dispatch centres although special conditions may be laid down in accor-
dance with the procedure laid down in Article 12 of thisDirective.
CHAPTER V
REQUIREMENTSCONCERNINGLIVEBIVALVEMOLLUSCS
Live bivalve molluscs intended for immediate human consumption must comply
with the following requirements:
1. The possession of visual characteristics associated with freshness and viabi-
lity, including shells free of dirt, an adequate response to percussion, and
normal amountsof intravalvular liquid.
2. They must contain less than 300 faecal coliforms or less than 230 E. Coli
per 100 g of mollusc flesh and intravalvular liquid based on a five-tube,
three-dilution MPN-test or any other bacteriological procedure shown to be
of equivalent accuracy.
3. They must not contain salmonella in 25 g of mollusc flesh.4. They must not contain toxic or objectionable compounds occurring naturally
or added to the environment such as those listed in the Annex to Directive
79/923/EEC in such quantities that the calculated dietary intake exceeds the
permissible daily intake (PDI), or that the taste of the molluscs may be
impaired.
In accordance with the procedure laid down in Article 12 of thisDirective,
the Commission shall determine the testing methods for checking the
chemical criteria and the limit valuesapplicable.
5. The upper limitsasregardsthe radionuclide contentsmus t not exceed the
limitsfor foods tuffsaslaid down by the Community.
6. The total Paralytic Shellfish Poison (PSP) content in the edible parts of
molluscs (the whole body or any part edible separately) must not exceed
80 microgrammes per 100 g of mollusc flesh in accordance with the biolo-
gical testing method — in association if necessary with a chemical method
for detection of Saxitoxin — or any other method recognized in accordance
with the procedure laid down in Article 12 of thisDirective.
If the results are challenged, the reference method shall be the biological
method.
7. The customary biological testing methods must not give a positive result to
the presence of Diarrhetic Shellfish Poison (DSP) in the edible parts of
molluscs (the whole body or any part edible separately).
7a. The total Amnesic Shellfish Poison (ASP) content in the edible parts of
mollucs (the entire body or any part edible separately) must not exceed 20
microgramsof domoic acid per gramme us ing the HPLC method.
8. In the absence of routine virus testing procedures and the establishment of
virological standards, health checks must be based on faecal bacteria counts.
Examinationsfor checking compliance with the requirementsof thisChapter
must be carried out in accordance with proven methods which are scientifically
recognized.
For the uniform application of thisDirective s ampling plansaswell asthe
methodsand analytical tolerancesto be applied in order to check compliance
with the requirements of this Chapter must be established in accordance with
the procedure laid down in Article 12 of thisDirective.
The effectiveness of the faecal indicator bacteria and their numerical limits as
well asthe other parameterslaid down in thisChapter mus t be kept under
constant review and, where scientific evidence proves the need to do so, be
revised following the procedure laid down in Article 12 of this Directive.
When there iss cientific evidence indicating the need to introduce other health
checksor to amend the parametersin thisChapter for the purpos e of protecting
public health, such measures must be adopted in accordance with the procedure
laid down in Article 12.1991L0492 — EN — 05.06.2003 — 004.001 — 16
▼B
▼M1
▼B
▼B
CHAPTER VI
PUBLICHEALTHCONTROLANDMONITORINGOFPRODUCTION
A public health control system must be established by the competent authority
in order to verify whether the requirementslaid down in thisDirective are
complied with. This control system must include:
1. periodic monitoring of live bivalve mollusc relaying and production areas in
order to:
(a) avoid any malpractice with regard to the origin and destination of the
live bivalve molluscs;
(b) check the microbiological quality of the live bivalve molluscs in relation
to the production and relaying areas;
(c) check the possible presence of toxin-producing plankton in production
and relaying waters and biotoxins in live bivalve molluscs;
(d) check the possible presence of chemical contaminants, the maximum
authorized level of which will be fixed, in accordance with the procedure
laid down in Article 12 of thisDirective, by 31 December 1992.
For the purposes of points (c) and (d), sampling plans must be estab-
lished by the competent authorities for checking such possible presence
at regular intervals or on a case-by-case basis in the event of irregular
periodsof harves ting.
2. Sampling plansasprovided for in point 1, mus t in particular take account of:
(a) likely variationsin faecal contamination at each production and relaying
area;
(b) possible variations in production at relaying areas in the presence of
plankton containing marine biotoxins. The sampling must be carried out
asfollows :
(i) monitoring: periodic sampling organized to detect changes in the
composition of the plankton containing toxins and the geographical
distribution thereof. Information leading to a suspicion of accumula-
tion of toxins in mollusc flesh must be followed by intensive
sampling;
(ii) intensive sampling:
— monitoring plankton in the growing and fishing waters by
increasing the number of sampling points and the number of
samples, and
— toxicity tests using the molluscs from the affected area which are
most susceptible to contamination.
Placing on the market of molluscs from that area may not be re-
authorized until new sampling has provided satisfactory toxicity
test results;
(c) possible contamination of the molluscs in the production and relaying
area;
If the result of a sampling plan shows that placing on the market of live
bivalve molluscs may constitute a hazard to human health, the competent
authority must close the production area, as regards molluscs concerned, until
the situation has been restored.
3. Laboratory tests in order to check compliance with the requirements for the
end product as laid down in Chapter V of this Annex. A control system must
be established to verify that the level of marine biotoxins does not exceed
safety limits.
4. An inspection of establishments at regular intervals. These inspections must
include in particular checks:
(a) to verify whether the approval conditionsare s till being complied with;
(b) on the cleanliness of the premises, facilities, equipment and on staff
hygiene;
(c) to verify whether the live bivalve molluscs are handled and treated
correctly;
(d) on the correct application and functioning of purification or conditioning
systems;
(e) on the ledger booksreferred to in Chapter IV s ection III, 12 of this
Annex,
(f) on the correct use of health marks.
These checks may include the taking of samples for laboratory tests; the
results of these tests are notified to the persons responsible for the establish-
ments.1991L0492 — EN — 05.06.2003 — 004.001 — 17
▼B
5. Checks on the storage and transport conditions for consignments of live
bivalve molluscs.
CHAPTER VII
WRAPPING
1. Live bivalve molluscs must be wrapped under satisfactory conditions of
hygiene.
The wrapping material or container must:— not impair the organoleptic characteristics of the live bivalve molluscs,
— not be capable of transmitting substances harmful to human health to the
live bivalve molluscs,
— be strong enough to give adequate protection to the live bivalve molluscs.
2. Oysters must be wrapped with the concave shell downwards.3. All wrappings of live bivalve molluscs must be sealed and remain sealed
from the dispatch centre until delivery to the consumer or retailer.
CHAPTER VIII
PRESERVATIONANDSTORAGE
1. In any storing rooms, live bivalve molluscs must be kept at a temperature
which doesnot advers ely affect their quality and viability; the wrapping
must not come into contact with the floor of the store room, but must be
placed on a clean, raised surface.
2. Reimmersion in or spraying with water of live bivalve molluscs must not
take place after they have been wrapped and have left the dispatch centre
except in the case of retail sale at the dispatch centre.
CHAPTER IX
TRANSPORTFROM THEDISPATCHCENTRE
1. Consignments of live bivalve molluscs intended for human consumption
must be transported wrapped as sealed parcels from the dispatch centre until
offered for sale to the consumer or retailer.
2. The means of transport used for consignments of live bivalve molluscs must
have the following characteristics:
(a) their interior wallsand any other partswhich might come into contact
with the live bivalve molluscs must be made of corrosion-resistant mate-
rials; the walls must be smooth and easy to clean;
(b) they must be suitably equipped to provide efficient protection of the live
bivalve molluscs against extremes of hot and cold, contamination with
dirt or dust, and damage to the shells from vibration and abrasion;
(c) the live bivalve molluscs must not be transported with other products
which might contaminate them.
3. Live bivalve molluscs must be transported and distributed using closed vehi-
clesor containerswhich maintain the product at a temperature which does
not adversely affect their quality and viability.
The parcels containing live bivalve molluscs must not be transported in direct
contact with the floor of the vehicle or container but must be supported on
raised surfaces or by some other means which prevents contact.
Where ice is used in transporting consignments of live bivalve molluscs, it
must have been made from potable water or clean sea water.
CHAPTER X
MARKINGOFCONSIGNMENTS
1. All parcels in a consignment of live bivalve molluscs must be provided with
a health mark so that the original dispatch centre may be identified at all
times during transport and distribution until retail sale. Without prejudice to
Directive 79/112/EEC, the mark must contain the following information:
— the country of dispatch,
— the species of bivalve mollusc (common name and scientific name),
— the identification of the dispatch centre by the approval number issued by
the competent authority,
— the date of wrapping, comprising at least the day and the month.
By way of derogation from Directive 79/112/EEC the date of durability may
be replaced by the entry ‘these animals must be alive when sold’.1991L0492 — EN — 05.06.2003 — 004.001 — 18
▼B
2. The health mark may be printed on the wrapping material or be put on a
separate label which is then affixed to the wrapping material or put inside
the wrapping. It may also be of a twist-tie or staple design; self-adhesive
health marks must not be used, unless they are not detachable. All types of
health mark must be for single use only and may not be transferred.
3. The health mark must be durable and waterproof, and the information
presented must be legible, indelible and in easily decipherable characters.
4. The health mark attached to consignments of live bivalve molluscs which are
not wrapped in individual consumer-size parcels must be kept for at least 60
days by the retailer after splitting up the contents of the consignment.1991L0492 — EN — 05.06.2003 — 004.001 — 19