PROPOSAL FOR A COUNCIL DECISION AMENDING DECISION 89/657/EEC ESTABLISHING AN ACTION PROGRAMME TO PROMOTE INNOVATION IN THE FIELD OF VOCATIONAL TRAINING RESULTING FROM TECHNOLOGICAL CHANGE IN THE COMMUNITY ( EUROTECNET ) AND DECISION 90/267/EEC ESTABLISHING AN ACTION PROGRAMME FOR THE DEVELOPMENT OF CONTINUING VOCATIONAL TRAINING IN THE EUROPEAN COMMUNITY ( FORCE ) IN ORDER TO ESTABLISH THE ADVISORY COMMITTEE FOR CONTINUING EDUCATION AND TRAINING EMBRACING FORCE AND EUROTECNET
Date: 1990-12-18
Institutions: European Commission
Subjects: EU programme, advisory committee (EU), continuing education, vocational training

COMMISSION  OF  THE  EUROPEAN  COMMUNITIES 

C0MC89) 648 final 

Brussels, 31 January  1990 

Proposal  for a 

COUNCIL  REGULATION  (EEC) 

laying down  the health  conditions  for the production and 

the placing on the market  of  live bivalve molluscs 

(presented  by the  Commission) 

C0M(89)648 final 

- 2 -

EXPLANATORY  MEMORANDUM 

With the adoption of the Single European Act, the Community  has embarked  upon 

a programme  to eliminate  all controls  at frontiers.  The programme  to achieve 

this undertaking  in set out  in the Commissions White  Paper of June  1985, and 

includes the elimination  of barriors  to trade related  to health problems in 

the fisherios sector. 

This proposal  aims  in particular  to lay down the health  conditions  for the 

production  and the placing  on the market  of live bivalve molluscs  (mussels, 

oysters, carpet  shells otc.) which, because of their particular way of 

production  and consumption, need  special  attention. 

It defines therefore the obligations  to be respected  by both professionals  and 

the competent  authorities, and lays down the measures to be taken to ensure 

that the final product  is safe for human consumption.  This  implies a 

surveillance  of the harvesting  areas, the obligation  to submit the molluscs to 

a purification  process, relaying  or processing  in certain circumstances, a 

contrôle of the final product etc. 

Provision  is made for Community  checks  in the Member  States so as to ensure 

the uniform application  of the said requirements.  This must  also allow to 

reinforce the confidence of the Member  States  in each others  inspection 

systems which  is necessary  to ensure  a proper functioning  of an internal 

market without frontiers. 

The proposal covers the placing on the market  in the whole of the Community 

and lays down a procedure to ensure that products originating  from third 

countries  are produced  and placed  on the market under conditions which are 

equivalent  to those applied  in the Community. 

For certain  applicatory decisions to be taken, the Commission  opted  for the 

Regulatory Committee  procedure.  This choice, which  is justified  in this case 

by a desire not to disrupt  the management  process  in the health sector, is 

without prejudice to the Commission's  preference  for the Advisory  Committee 

procedure. 

3 -

PROPOSAL FOR A 

COUNCIL  REGULATION 

laying down the health conditions  for the production 

and the placing on the market of live bivalve molluscs 

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, 

Having  regard to the opinion of the European Parliament, 

Having regard to the opinion of the Economic  and Social Committee, 

Whereas,  in order to ensure the smooth operation  of the Common market and more 

in particular the common  organization  of the market  in products of fisheries, 

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 in respect 

of health requirements; whereas this will enable the production  and the 

placing on the market to be better harmonized  and bring about competition on 

equal terms while assuring  consumers of a quality  product; 

Whereas Council Directive  79/923/EEC of 30 October 1979 on the quality of 

shellfish waters(1) lays down that  it is necessary to establish the health 

requirements  to be observed  for shellfish products; 

Whereas  requirements  should be laid down for all stages during  harvesting, 

handling,  storage, transport  and distribution of live bivalve molluscs in 

order to safeguard  the public health of consumers; whereas these requirements 

shall apply equally to echinoderms and tunicates; 

(1) OJ No L 281, 10.11.1979, p. 47 

- 4 -

Whereas  it is important, would  a health problem occur after the placing  on the 

market of live bivalve molluscs to be able to trace back the establishment of 

dispatch  and the harvesting  area of origin; whereas  it is therefore  necessary 

to introduce  a registration  and labeling  system which will enable to follow 

the flow of a batch  after harvesting; 

Whereas  it is important  that the public health  standards for the final product 

must be specified; whereas, however, scientific  and technological  knowledge is 

not always advanced  enough to lay down definitive  solutions for certain health 

problems  and that  it is therefore necessary,  in order to guarantee  optimal 

protection of public health, to fix a Community  system to ensure rapid 

adoption  and where necessary  improvement  of the health  standards to safeguard 

from virus contamination  or other hazards to human health; 

Whereas  live bivalve molluscs obtained  from harvesting  areas which do not 

permit direct, safe consumption may be rendered  safe by submitting  them to a 

purification  process or by relaying  in clean water over a longer period; 

whereas  it is therefore necessary  to define harvesting  areas from which 

molluscs  can be gathered  for direct human consumption, or from which they have 

to be purified or relayed; 

Whereas  it is the responsibility  of the producers  to ensure that the bivalve 

molluscs  are produced  and placed on the market  in compliance with the health 

requirements  prescribed; whereas  the competent  authorities must by carrying 

out checks and  inspections ensure that producers comply with those health 

requirements; whereas the competent  authorities must  in particular  submit 

harvesting  areas to a regular control to ensure that molluscs from these 

harvesting  areas do not contain microorganisms  and toxic  substances in 

quantities which  are considered to be dangerous to human health; 

Whereas  control measures organised  on a Community  level must be introduced to 

guarantee  the uniform  application  in all Member  States of the standards laid 

down  in this Regulation; 

- 5 

Whereas  in the context  of trade between the Member  States, the rules laid down 

in Council Directive 

, concerning  veterinary  checks in 

intra-Community  trade, with a view to the realisation of the internal market 

(1) should  be applied; 

Whereas  live bivalve molluscs produced  in a third  country and  intended  to be 

placed  on the market  in the Community  must  not qualify  for more  favourable 

conditions  than those applied  in Lhe Community;  whereas  provision munt. bo mado 

for a Community  procedure  for  Inspecting  Lhe conditions  in third  countries of 

the production  and the placing on the market  in order to allow the  Community 

to apply  a common  import  regime based on terms of equivalence; 

Whereas  it is possible  that, due to some particular  situations, some establish 

ments  in function  before 1 January  1992 will not be able to fulfil all the 

rules laid down  in this Regulation; whereas  it is opportune to settle the 

matter of granting  limited  and temporary  derogations  for those  establishments 

in the general framework laid down  in Council Decision  .../.../EEC  [on the 

granting of temporary  limited derogations  from specific Community  health rules 

on the production  and marketing  of products of animal origin] (2); 

Whereas  it is appropriate  to emphasize  that any exceptions  from the health 

rules laid down  in this Regulation  are without  prejudice to the submission of 

all operations of production  and placing on the market of live bivalve 

molluscs  to the general  hoalth rulos laid down by Council  Regulation  (EEC) 

No  .../...  [laying down general health rules applicable to the production and 

placing on the market of products of animal origin and specific health rules 

applicable to certain products of animal origin] (3); 

Whereas  the Commission  should be entrusted with the task of adopting  certain 

measures  for  implementing  this Regulation; whereas to that end, procedures 

should be laid down  introducing  close and effective cooperation between the 

Commission  and the Member  States within  the Standing Veterinary  Committee; 

HAS ADOPTED THIS REGULATION : 

(1) COM(88)383 Final of July 1988 
(2) OJ No L 
(3) OJ No L 

CHAPTER  I : GENERAL  PROVISIONS 

Article 1 

This Regulation  lays down the health conditions  for the production  and the 

placing on the market of live bivalve molluscs which  are destined for 

immediate  human consumption  or for further processing  before  consumption. 

This Regulation  applies mutatis mutandis  also to echinoderms and tunlcates. 

For the purpose of this Regulation, the following  definitions  shall apply : 

. Article 2 

1) Bivalve molluscs  : Lamellibranch molluscs which are filter-feeders and may 

be eaten raw or partially cooked,  and are normally  consumed whole  including 

the viscera or after removal of selected  parts of the viscera. 

2) Marine biotoxins  : poisonous  substances  accumulated  by bivalve molluscs 

feeding on plankton containing  toxin. 

3) Clean seawater  : seawater or estuary water which  is free from 

microbiological  contamination  and toxic and objectionable  substances 

occuring naturally or after discharge  in the environment  such as those 

listed  in the Annex to Directive  79/923/EEC, in such quantities  as may 

adversely  affect the health quality of bivalve molluscs or to impair their 

taste and which  is to be used under the conditions laid down  in this 

Regulation. 

4) Competent  authority  : the department  designated  by the Member  State 

concerned  to monitor the implementation  of this Regulation. 

5) Conditioning  : the temporary wet  storage of live bivalve molluscs, whose 

quality does not  indicate need for relaying or treatment  in a purification 

plant, in tanks or any other  installation containing  clean  seawater or in 

natural sites to remove sand, mud  or slime and to improve product 

palatability. 

6) Gatherer  : any physical or legal person or legal entity who collects live 

bivalve molluscs by any means  from a harvesting  area for the purpose of 

handling  and the placing on the market. 

-  7 -

7)  Harvesting  area  : sea, estuarine  or lagoon  areas with  sites of relaid beds 

or natural deposits of bivalve molluscs, or those sites used for 

cultivation  of bivalve molluscs from which live bivalve molluscs  are taken 

for their placing on the market. 

8)  Establishment  : any on shore or off shore construction or area  in which 

live bivalve molluscs  are handlod  and stored  after harvesting  and before 

placing on the market. 

9)  Purification  : the process of holding contaminated  live bivalve molluscs 

in clean  seawater  for a time sufficient  to permit  removal of 

microbiological  contamination  through normal filter-feeding processes so 

making them suitable for human  consumption. 

10) Expedition  center  : an establishment  for the reception, conditioning, 

washing, cleaning, calibration  and wrapping  of live bivalve molluscs which 

conform to the requirements  of this Regulation. 

11) Purification plant  : an establishment where live bivalve molluscs  ace kept 

for purification under suitable conditions using clean seawater or 

seawater which  is treated  to remove contamination  so causing  the reduction 

of harmful microorganisms  to an acceptable level. 

12) Relaying  : transfer of live bivalve molluscs  to suitable natural  oea or 

estuarine areas under the supervision  of the competent  authority  in order 

for purification  to occur.  It does not  include the specific operation of 

transferring  bivalve molluscs to more  suitable areas for further growth or 

fattening. 

13) Means of transport  : those parts set aside for goods  in automobile 

vehicles, rail vehicles and aircraft, the holds of vessels and containers 

for transport by land, sea or air. 

14) Wrapping  : an operation whereby  live bivalve molluscs  are protected  from 

shock and desiccation by placing  them in packaging material adequate for 

that purpose. 

- 8 -

15) Consignment  : quantity of live bivalve molluscs handled  in an expedition 

center or treated  in a purification  plant and subsequently  bound for one 

or more customers. 

16) Batch  : quantity of live bivalve molluscs collected  from a harvesting  area 

and subsequently destined  for delivery to an approved expedition center, 

purification plant, relaying  area or processing  establishment  as 

appropriate. 

17) Placing on the market  : the holding or displaying  for sale, offering for 

sale, selling, delivering  or any other form of placing on the market of 

live bivalve molluscs for human consumption  either raw or after processing 

in the Community. 

18) Importation  : the introduction of live bivalve molluscs  into the territory 

of the Community  from third countries. 

19) Faecal coliform  : facultative, aerobic, gram-negative, non-sporeforming, 

cytochrome oxidase negative, rod-shaped bacteria that are able to ferment 

lactose with gas production  in the presence of bile salts, or other 

surface active agents with similar growth-inhibiting properties, at 44*C + 

0.2*C within 24h at least. 

20) E. coll  : faecal coliforms which also form indole from tryptophan  at 44*C 

+0.2*C within 24h. 

CHAPTER II  : PROVISIONS FOR COMMUNITY  PRODUCTION 

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 harvesting  areas which comply with the 

requirements  laid down  in Chapter I of the Annex; 

b) they must have been collected  and transported  from the harvesting  area 

to an expedition centre or purification plant under the conditions laid 

down  in Chapter II of the Annex; 

(2) 

9 -

c) where provided  for in this Regulation, they must have been relayed  in 

suitable  sites approved  for that purpose  and complying with the 

conditions  laid down  in Chapter III of the Annex; 

d) they must  havo been handled  hygienically,  and where appropriate, they 

must  have been purified  in establishments  approved  for that purpose and 

complying  with  Lho requirements of Chapter  IV; 

e) they must  comply with  the criteria  set out  in Chapter V of the Annex; 

f) health controls must  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  hygiene 

conditions  in accordance with Chapters VIII and IX of the 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 processed  in conformity with 

the requirements  of Council Regulation  (EEC) No 

laying down the 

health conditions  for the production  and the placing on the market of 

fishery products (1). 

Article 4 

Persons handling  live bivalve molluscs during their production  and placing on 

the market  shall adopt all measures  necessary  to comply with the requirements 

of this Regulation. 

Persons who operate establishments  shall in particular ensure that : 

- adequate numbers  of samples  for laboratory examination  are taken and 

analysed  in order to establish  an historical record of the sanitary quality 

of the live bivalve molluscs  both before and after handling  at an expedition 

center or at a purification  plant; 

-  a register  is kept  for the permanent  record  of the results of the various 

health checks and kept for presentation  to the competent  authority. 

(1) 

10 

Article 5 

1. a) The competent  authorities  shall draw up a list of their approved 

expedition  centers and purification  plants, each of which  shall have an 

official  number. 

The competent  authority  shall approve  such centers or plants only where 

they can be sure that they meet  the requirements of this Regulation. 

Member States shall withdraw approval  if the requirements  cease to be 

met. 

b) The  inspection  and monitoring  of these establishments  shall be carried 

out regularly on the responsibility of the competent  authority, which 

shall at all times have free access to all parts of the establishments, 

in order to ensure compliance with the requirements of this Regulation. 

If such inspections reveal that not all the requirements of this 

Regulation  are being met, the competent  authority  shall take the 

appropriate  action. 

2. a) The competent  authorities  shall establish  a list of harvesting  areas 

with  indication of their location  and bounderies  from which live bivalve 

molluscs may be taken  in conformity with this Regulation, and in 

particular, with Chapter I of the Annex. 

This list must be communicated  to those affected by this Regulation  such 

as harvesters  and operators of purification  plants and expendition 

centers. 

b) The monitoring of the harvesting  areas shall be carried out on the 

responsibility  of the competent  authority  in accordance with the 

requirements of this Regulation. 

If such monitoring  reveals that the requirements  of this Regulation are 

not being met, the competent  authority  shall close the harvesting  area 

concerned until the situation has been  restored. 

3. The competent  authorities  concerned  shall take all measures necessary to 

take account of the results referred  to in Article 6(1). 

- 11 

Article 6 

1. Experts from the Commission may make on-the-spot  checks  in so far as is 

necessary to ensure the uniform application  of this Regulation.  They may 

check whether establishments  and harvesting  sites are in effect  complying 

with tho requirements  of this Regulation.  A Member  State  in whose 

territory  a check  is being carried  out  shall give all necessary  assistance 

to the exports  in carrying  out their duties.  The Commission  shall  inform 

the Mombor States of tho results of such chocks. 

2. The general provisions  for  implomonting  paragraph  1 shall be determined  in 

accordance with the procedure laid down  in Article  16.  If necessary, and 

in accordance with the same procedure, a code shall be established 

containing  the rules to be followed  for the purpose of the checks provided 

for in paragraph 1. 

3. The Commission,  in accordance with the procedure laid down in Article 16, 

may draw up recommendations  containing guidelines on good manufacturing 

practices applicable at the different  stages of production and placing on 

the market. 

Article 7 

The rules laid down  in Diroctive 

, [concerning veterinary  controls 

in intra-Communlty trade, with a view to the realisation of the internal 

market], shall apply, in particular with respect to the organisation  of the 

checks carried out by the Member  State of destination, and the subsequent 

action and the safeguard measures  to be applied. 

However, the definitions  to be applied  are the ones laid down  in this 

Regulation. 

- 12 -

CHAPTER III  : IMPORTS FROM THIRD COUNTRIES 

Article 8 

Provisions  applied to imports of live bivalve molluscs from third  countries 

shall be equivalent  to those governing  the placing on the market of Community 

products. 

Article 9 

In order to ensure the uniform application of the provision  laid down in 

Article 8, the following procedure  shall apply : 

1. Inspections  shall be carried out on the spot by experts of the Commission 

and the Member  States to verify wether the conditions of production and 

placing on the market can be considered  as being equivalent  to those 

applied  in the  Community. 

The experts from the Member  States who are to be entrusted 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 16. 

2. In deciding wether the conditions of production  and placing on the market 

of live bivalve molluscs  in a third country can be deemed equivalent to 

those of the Community,  particular  account shall be taken of : 

a) the legislation of the third  country; 

b) the organisation  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 for monitoring 

the implementation  of their  legislation; 

c) the actual health conditions during the production  and placing on the 

market of live bivalve molluscs and  in particular the surveillance of 

harvesting  areas  in relation to microbiological  and environmental 

contamination, and to the presence of marine biotoxins; 

13 

d) the regularity  and the rapidity of the information by the third country 

on the presence of plankton  containing  toxin  in the harvesting areas; 

e) the assurances  a third country  can give on the compliance  of the 

molluscs with the standards  laid down  in Chapter V of the Annex. 

3. The Commission,  following  the procedure laid down  in Article 14 shall 

decide on : 

a) the third countries  fulfilling  the conditions of equivalence referred to 

in paragraph 2; 

b) for each third country, the conditions for the importation  of live 

bivalve molluscs.  These conditions may  include  in particular : 

i)  the supplying of a health certificate which must  accompany 

consignments when forwarded  to the Community, 

ii)  the definition  of the harvesting  areas from which live bivalve 

molluscs may be collected  and imported, 

iii) the obligation of immedate  information  to the Community  on every 

possible change of the approval of harvesting  areas, 

iv)  possibly the mandatory purification  after arrival at the territory 

of the  Community. 

c) a list of establishments  from which the importation  of live bivalve 

molluscs  is authorized.  For that purpose, one or more lists of such 

establishments  shall be established.  An establishment may not appear on a 

list unless  it is officially  approved  by the competent  authority of the 

third country exporting  to the Community.  Such approval shall be subject 

to observance of the following  requirements : 

compliance with  requirements  equivalent  to those laid down  in this 

Regulation, 

supervision  by an official  inspection  sorvico of tho third  country. 

- 14 -

4. The Decisions  referred  to in point 3 may be modified  or supplemented  in 

accordance with the procedure laid down  in Article 15. 

These Decisions  and the amendments  thereto  shall be published  in tho 

Official Journal  of the European Communities,  series L. 

Article 10 

Should  an inspection as referred  to in Article 9(1) bring to light  serious 

facts which may render the placing on the market  of live bivalve molluscs 

unsafe  for human consumption,  the Commission  shall immediately  inform the 

Member  States and  forthwith  adopt  a decision  to change the  import  conditions 

or to suspend  the  importation  from a particular establishment, harvesting  area 

or from a part or the whole of the third  country  concerned. 

A final decision  shall be taken  in accordance with the procedure provided for 

in Article 15. 

Article 11 

1. The rules laid down  in Council Regulation  (EEC) No 

, laying down 

the principles  relating  to the organisation  of health controls for products 

arising  from third countries with a view to the completion  of the  internal 

market  (1) will apply. 

2. The  importation  of live bivalve molluscs  shall be prohibited  if the 

conditions  laid down  in this Regulation have not been observed,  and in 

particular when  it is ascertained  that : 

- the consignment  does not comply with the conditions  for importation  laid 

down for the third country  concerned; 

- the consignment  constitutes  a hazard  to human health. 

(1) 

- 15 -

Article 12 

1. If a disease capable of being conveyed  to humans by live bivalve molluscs 

and therefore  liable to be a serious hazard  to public health, breaks out or 

spreads  in a third country or if other considerations  of public health so 

warrant, the Commission  acting  in accordance with the procedure laid down 

in Article 15, or a Member  State may prohibit or subject to specific 

conditions the importation  of those live bivalve molluscs directly or 

indirectly from the whole or part of the territory of the third  country. 

2. Measures taken by the Member  States under paragraph 1 and withdrawal of 

such measures, shall be notified  immediately  to the other Member  States and 

the Commission, together with the reasons therefor. 

3. The Commission  shall as soon as possible appraise the situation and take 

the requisite decisions  in accordance with the procedure laid down in 

Article 15. 

4. The Commission  shall monitor the situation and, in accordance with the 

procedure laid down  in Article 15, shall amend or repeal the decisions 

referred  to in paragraphs 1 and 3, having regard to such situation. 

CHAPTER IV  : FINAL PROVISIONS 

Article 13 

The Annex to this Regulation  shall be amended  in accordance with the procedure 

laid down  in Article  14. 

Article 14 

1. Where the procedure laid down  in this Article  is to be applied, the matter 

shall be referred  forthwith to the Standing Veterinary Committee  set up by 

the Council Decision 68/361/EECU) (hereinafter called "the Committee) 

by its chairman on his initiative or at the request of a Member State. 

(1) 

16 

2. The representative  of the Commission  shall  submit  to the committee  a draft 

of the measures  to be taken.  The committee  shall deliver  its opinion on 

the draft within  a time limit which  the chairman 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 the Treaty  in the case of decisions which 

the Council  is roquired  to adopt  on a proposal  from  tho Commission. Tho 

votes of the represent ativeu of Un» Member  States within  the committ.e shall 

be weighted  in the manner  3ot out  in that Article.  The chairman  shall not 

vote. 

The Commission  shall  adopt  the measure envisaged  if they  are  in accordance 

with the opinion of the Committee. 

If the measures envisaged  are not  in accordance with the opinion of the 

Committee, or if no opinion  is delivered,  the Commission  shall, without 

delay, submit to the Council  a proposal relating  to the measures  to be 

taken.  The Council shall act by a qualified majority. 

If, on the expiry of a period of three months  from the date of referral to 

the Council, the Council has not acted, the proposed measures  shall be 

adopted by the Commission. 

Article 15 

1. Where the procedure  laid down  in this Article  is to be applied, the 

chairman  shall  rc»for tho mattor without, delay  on his own  initiative or at 

the request of a Member  State to the Committee. 

2. The representative  of the Commission  shall submit to the committee  a draft 

of the measures to be taken.  The committee  shall deliver  its opinion on 

the draft within  two days.  The opinion  shall be delivered  by the majority 

laid down  in Article 148(2) of the Treaty  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 the manner  set out  in that Article.  The chairman 

shall not vote. 

The Commission  shall adopt the measures envisaged  if they are in accordance 

with the opinion of the committee. 

13) 

17 

If the measures  envisaged  are not  in accordance with the opinion of the 

committee, or if no opinion  is delivered,  the Commission  shall, without 

delay, submit to the Council a proposal relating to the measures  to be 

taken.  The Council  shall act by a qualified  majority. 

If, on the expiry  of a period  of fifteon working  days from the date of 

referral  to the Council, the Council has not  acted, the proposed measures 

shall be adopted  by the  Commission. 

Article 16 

Where the procedure  laid down  in this Article  is to be applied, the following 

rules  shall apply. 

The representative  of the Commission  shall submit to the Committee  a draft of 

the measures to be taken.  The Committee  shall deliver  its opinion on the 

draft within  a time-limit which the Chairman may lay down according  to the 

urgency of the matter,  if necessary  by taking  a vote. 

The opinion  shall be recorded  in the minutes; in addition, each Member  State 

shall have the right  to ask to have  its position  recorded  in the minutes. 

The Commission  shall  take the utmost  account  of the opinion doiivorod by the 

Committee.  It shall  inform  the Committee  of the mannor  in which  its opinion 

liHti boon  taken  Into account. 

Article _17 

This Regulation  shull enter  into force on  1 January  199T. 

This Regulation  shall be binding  in its entirety  and directly  applicable in 

all Member States. 

Done at Brussels, 

For the Council 

18 

-

A N N EX 

CHAPTER  I 

CONDITIONS FOR HARVESTING  AREAS 

1. The location  and the boundaries  of harvesting  areas must 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 shall meet  the requirements  set out  in Chapter V; 

b) can be collected  but only placed  on the market  after treatment  in a 

purification  system, after relaying or after processing  by a heat 

treatment  sufficient to kill microorganisms  as described  in Chapter III, 

Section III, 4 of the Annex to Regulation  (EEC) No 

concerning 

the health conditions governing  the production  and the placing on the 

market of fishery products.  Live bivalve molluscs  from these areas must 

not exceed  the limits of a 5-tube  3-dilution MPN-test  of 6.000 faecal 

coliforms per 100 g of flesh or 4.600 E. Coli per 100 g of flesh  in 95  % 

of samples.  After purification, relaying  or processing, the 

requirements  set out  in Chapter V  shall be met. 

c) can be collected  but only placed on the market  after relaying over a 

long period or after relaying  combined with purification  to meet the 

requirements under  (a).  Processing  of these molluscs by a heat 

treatment  sufficient  to kill micro organisms  as described in 

Chapter III, Section III, 4 of the Annex to Regulation  (EEC) No 

concerning  the health conditions governing  the production  and the 

placing on the market of fishery products may be carried out  if the 

limits laid down under  (b) are met. 

2. Any change  in the delimitation  of harvesting  areas and the temporary or 

definite closure thereof  shall be  immediately  announced  by the competent 

authorities  to those affected  by this Regulation  and  in particular to 

producers  and operators of purification plants and expedition centers. 

-- 19 

CHAPTER II 

REQUIREMENTS  FOR HARVESTING  AND  TRANSPORTATION 

OF BATCHES TO AN EXPEDITION CENTER OR PURIFICATION  PLANT 

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 excessive  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 of the keeping quality of the product, nor in any 

changes significantly affecting  the ability to be treated by purification 

or processing  or relaying. 

4. Live bivalve molluscs must not be reimmersed  in water which could have 

additional contamination  between  harvesting  and landing onshore. 

5. Means of transport used for transporting  live bivalve molluscs must be used 

under conditions which protect against  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 an expedition center, purification  plant or relaying  site, the means of 

transport must be equiped  in such a way as to ensure the best  survival 

conditions possible, and  in particular must  they comply with the 

requirements  laid down  in Chapter IX, point 2. 

- 20 -

6. A registration  document  for the  identification of batches of live bivalve 

molluscs during  transport  from the harvesting  area to an approved 

expedition  centre, purification  plant, relaying  site or processing plant is 

issued  by the competont  authority upon request of the gatherer.  For each 

batch, the gatherer must  complete  the relevant  sections of the registration 

document  legibly  and  indelibly  and which must  contain  the following 

information : 

- the gatherer's  identity  and signature, 

- the date of harvesting, 

the location of the harvesting  area  in as precise detail as is 

practicable, 

- the shellfish  species and quantity  in as precise detail as is practicable, 

- the approval number  and place of destination  for wrapping, relaying or 

purification  or processing. 

The registration  documents must be permanently  and sequentially  numbered. 

The competent  authority  shall keep a register  indicating the number  of the 

registration documents together with the names of the persons  collecting 

live bivalve molluscs to whom they have been  issued.  The registration 

document  for each batch of live bivalve molluscs must be date-stamped  upon 

delivery of a batch to an expedition center, purification plant relaying 

site or processing  plant and must be kept available by operators of these 

sites or establishments  for at least 60 days. 

However, if the gathering  is carried  out by the same person operating  the 

expedition center, purification  plant, relaying site or processing  plant of 

destination, the registration document may be replaced by a permanent 

derogation granted by the competent  authority. 

7. In case any harvesting  area is closed  temporarily, the competent  authority 

shall refrain  from issuing registration  documents  for that area and 

immediately  suspend  the validity of all registration documents  already 

issued. 

21 -

CHAPTER III 

CONDITIONS FOR RELAYING LIVE BIVALVE MOLLUSCS 

The following  conditions must  be mot : 

1. live bivalve molluscs must  be gathered  and transported  in accordance with 

the requirements  of Chaptor II; 

2. techniques  for handling  live bivalve molluscs destined  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  site for 

an appropriate period which must  exceed the time taken for levels of faecal 

bacteria to become reduced to the levels permitted  in this Regulation, and 

taking  into account  that the standards of Chapter V have to be compted with; 

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  relay site; 

6. sites for relaying  live bivalve molluscs must be approved by the competent 

authority.  The boundaries of the sites must be clearly identified; 

7. sites within  a relaying  area must be woll separated  to prevent mixing of 

batches; 

8. permanent  records of the source of live bivalve molluscs, relaying  period, 

relaying  site and  subsequent  destination  of the batch  after relaying must 

be maintained  by tho operators of relaying  sites for  inspection by the 

competent  authority; 

22 

after harvesting  from the relaying  site, the batches must during  transport 

from the relaying  site to the approved  expedition  center, purification 

plant or processing  plant be accompanied  by the registration  document 

referred  to  in Chaptor  II, point  6, except  in the case where tho samo staff 

is operating  both the relaying  site and the expedition  center, purification 

plant or processing  plant. 

CHAPTER IV 

CONDITIONS FOR THE APPROVAL OF  ESTABLISHMENTS 

I. GENERAL CONDITIONS RELATING TO PREMISES AND EQUIPMENT 

Establishments must be located  in areas which are free from 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. 

Establishments must have at least : 

1. in areas where live bivalve molluscs  are handled  or stored : 

a) buildings or facilities of sound construction  and designed and 

maintained  adequately  for the purpose of preventing  contamination of 

live bivalve molluscs with 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 adequate drainage; 

c) adequate working  spaco  to allow for aatlal'actory performance of all 

operations; 

23 -

d) durable walls which are easy to clean; 

e) adequate natural or artificial  lighting. 

2. Access to an appropriate numbor of changing  rooms, wash basins and 

lavatories; there must  be a sufficient  numbor  of hand wash basins close 

to the lavatories. 

3. Adequate equipment  for washing  tools, containers  and equipment. 

4. Facilities  for the supply and, where appropriate, adequate  storage and 

distribution  of exclusively potable water within the meaning  of Council 

Directive 80/7 78/EEC of 15 July 1980 relating  the quality of water 

intended  for human consumption  (1) or facilities  for the supply of clean 

sea water. 

Facilities  supplying non-potable water may be authorized.  The water 

concerned may not come  into contact with live bivalve molluscs or be 

used for cleaning  or disinfecting  containers, plant or equipment which 

come into contact with the 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 material which 

is easy to wash and clean repeatedly  and resists corrosion. 

(1) OJ No L 229, 30.08.1980, p 11. 

- 24 -

II. GENERAL HYGIENE REQUIREMENTS 

A high degree of cleanliness  and hygiene  shall be required  of staff, 

premises, equipment  and working conditions : 

1. Staff who treat or handle live bivalve molluscs must  in particular wear 

clean working clothes and, where appropriate, clean gloves which are 

suitable for the work in which the person  is engaged. 

2. It is forbidden for staff to apply types of personal behaviour, such as 

spitting, which could result  in contamination  of live bivalve 

molluscs;  any person  suffering from an illlness which can be 

transmitted  by live bivalve molluscs must be temporarily  prohibited, 

until recovery, from working with or handling 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 production of live bivalve 

molluscs shall 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 

or at such other times as may be appropriate. 

5. Premises, instruments and equipment must not be used for purposes other 

then the production of live bivalve molluscs unless authorization by 

the competent  authority. 

6. Waste products must be stored hygienically  in a separate area and, 

where appropriate, in covered  receptacles  suitable for the purpose 

intended.  Waste material must be removed from the vicinity of the 

establishment  at suitable periods. 

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. 

25 -

III. REQUIREMENTS FOR PURIFICATION PLANTS 

In addition to the requirements under I and II, the following  conditions 

must be met: 

1. The floors and walls of the purification  system and any water storage 

containers must have a smooth, hard and  impermoable surface and be 

easy to clean by scrubbing or use of pressurised water.  The base of 

the purification  system must be sufficiently  sloped and be equipped 

with drains 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  system 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  system must be supplied with sufficient seawater or 

flow of sea water per hour and per tonne of live bivalve molluscs 

treated. 

4. Clean sea water 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; the procedure for 

sanitizing the sea water shall be authorized once its effectiveness 

has been verified by the competent authority; potable water used to 

prepare seawater from its major constituent chemicals shall conform to 

the meaning of Council Directive 80/778/EEC. 

5. Operation of the purification  system must be in accordance with 

instructions  issued by the competent authority to ensure that live 

bivalve molluscs rapidly rosume filter feeding activity, removo sewago 

contamination, do not bocomo rocontaminated and are able to remain 

alive in a suitable condition after purification for wrapping, storage 

and transport before placing on the market. 

- 26 -

6.  The quantity of live bivalve molluscs  shall not exceed  the capacity 

of the purification  system;  the live bivalve molluscs must be 

continuously purified  for a period  sufficient  to allow the 

microbiological  standards laid down  in Chapter V to be met.  This 

period  starts  from the moment  at which the live bivalve molluscs in 

the purification system are adequately  covered  by the water until tho 

moment when water  is drained  away before removal  from the said 

system.  The establishment  operator must  tako account  of the data 

relating  to the raw materials  (the type of bivalve mollusc, its area 

of origin, microbe content, otc.) in case it is necessary  to extend 

the purification period  so as to ensure that the live bivalve 

molluscs meet  the bacteriological requirements  of Chapter V. 

7.  A purification  tank shall not contain more than one batch of molluscs 

during the period of purification. 

8.  Containers used to hold live bivalve molluscs  in purification  system 

must have a mesh-type construction which  allows seawater to flow 

through; the depth of layers of live bivalve molluscs  should not 

impair  the opening of shells during purification; containers of live 

bivalve molluscs  should be placed  at densities recommended  by the 

competent  authorities. 

9.  No crustaceans, fish or other marine  species must be kept  in a 

purification  system  in which live bivalve molluscs  are undergoing 

purification. 

10. After completion  of purification, the shells of live bivalve molluscs 

can be washed  thoroughly by hosing with potable water or clean 

seawater, this may take place in the purification  system if 

necessary, the washing water must not be recirculated. 

11. The purification  plants must have their own laboratory or secure the 

services, or access to data of, a laboratory equipped with the 

necessary  facilities for checking the efficiency of purification by 

use of microbiological  specifications.  Laboratory  facilities must be 

approved  by the competent  authority. 

27 -

12. Purification  plants must regularly keep record of the following data 

- Results of microbiological  tests on purification  system water 

entering  the purification tanks. 

- Results of microbiological  tosts on unpurified  live bivalve 

molluscs. 

- Results of microbiological  tests on purified  live bivalve molluscs. 

- Date and quantity of live bivalve molluscs delivered  to the 

purification  plant  and appropriate  registration document  number. 

- The times of filling  and emptying  of purification  systems 

(purification  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 plants must only accept batches of live molluscs which 

are accompanied  by the registration document referred to in 

Chapter II; 

Purification establishments dispatching batches of live bivalve 

molluscs  to expedition  conters must provide for the registration 

document  referred to in Chapter II, point 6. 

14. Every package containing  purified  live bivalve molluscs must be 

provided with a label certifying  that all molluscs have been purified. 

IV. REQUIREMENTS FOR EXPEDITION CENTERS 

28 

1. In addition to meeting the requirements under I and II, the following 

conditions must be met : 

a) conditioning must not cause any deleterious microbiological 

contamination  of the product; 

b) instructions  for the use of conditioning  facilities  shall be issued 

by the competent  authority and will have special regard to the 

bacteriological  and chemical quality of the seawater used  in the 

facilities; 

c) equipment  and containers  in the conditioning  facilities do not 

constitute a source of contamination; 

d) procedures  for calibration of live shellfish must not result in 

additional contamination of the product or in any changes  affecting 

the ability of the product to be transported  and stored after 

wrapping. 

e) any washing or cleaning of live bivalve molluscs must be carried out 

using pressurised  clean seawater or potable water - cleaning water 

may not be recycled. 

2. Expedition centers must only accept batches of live shellfish which are 

accompanied  by the registration of documents referred to in Chapter II, 

point 6 and coming from an approved harvesting  area, relaying  site or 

purification plant. 

3. The expedition centers must have their own laboratory or secure the 

services of a laboratory equiped with the necessary facilities for 

checking  if the molluscs comply with the microbiological  standards of 

Chapter V.  Laboratory facilities must be approved by the competent 

authority. 

However, this requirements  is invalid  if the expedition centers get 

their molluscs from a purification plant where they have been examined 

after purification. 

29 -

CHAPTER V 

REQUIREMENTS CONCERNING  LIVE BIVALVE MOLLUSCS 

Live bivalve molluscs destined  for  immediate  human consumption  shall comply 

with the following requirements : 

1. The possession of visual characteristics  associated with freshness and 

viability  including  shells free of dirt, an adequate response to 

percussion, and normal amounts of intravalvular  liquid. 

2. They shall contain less than 300 faecal coliforms or less than 230 E. Coli 

per 100 g of mollusc  flesh and  intravalvular  liquid based on a 5-tube, 

3 dilution MPN-test or any other bacteriological procedure  shown to be 

equivalent  in degree of precision. 

3. Absence of salmonella  in 25 g mollusc flesh. 

4. Live bivalve molluscs  are not contaminated with 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 acceptable daily  intake  (ADD, or 

that the taste of the molluscs  is  impaired. 

5. The upper limits as regards the radionuclide contents shall not exceed the 

limits for foodstuffs  as laid down by the  Community. 

6. The total Paralytic  Shellfish Poison  (PSP) content  shall not exceed 

80 micrograms per 100 g of mollusc  flesh. 

7. The Diarrhetic Shellfish Poison  (DSP) content of the flesh shall not exceed 

levels which may be considered  dangerous to human health. 

8. In the absence of routine virus testing procedures and establishment of 

virological  standards sanitary evaluation must use counts of faecal 

bacteria. 

- 30 -

Examinations  for checking  the compliance with  the requirements of this Chapter 

must be carried out  in accordance with proven methods which are scientifically 

recognised. 

Where necessary  for the uniform  application of this Regulation, sampling  plans 

as well as the methods  and  analytical tolerances to be applied  in order to 

check compliance with the requirements  of this Chapter shall be established  in 

accordance with the procedure  laid down  in Article 14. 

The effectiveness  of the faecal indicator bacteria and their numerical limits 

as well as the other parameters  laid down  in this Chapter  shall constantly be 

kept under review and, where scientific  evidence proves the need to do so, be 

revised  following  the procedure laid down  in Article 15. 

When there is scientific evidence  indicating the need to introduce other 

parameters to safeguard public health such as the possible contamination with 

Neurotoxin-Shelfish Poisson  (NSP), this shall be done applying the same 

procedure. 

CHAPTER VI 

PUBLIC HEALTH CONTROL AND SUPERVISION  OF PRODUCTION 

A public health control system shall be established  by the competent 

authorities  in order to verify whether the requirements  laid down  in this 

Regulation are complied with.  This control system shall include : 

1. Periodic  supervision of live bivalve mollusc relaying  and harvesting  areas 

in order : 

a) to avoid any abuse of the origin and destination of the live bivalve 

molluscs; 

b) to check the microbiological quality of the live bivalve molluscs in 

relation to the area of harvesting  as laid down  in Chapter I; 

c) to check the possible presence of toxin-producing  plankton. 

31 -

For that purpose, sampling  plans shall be established  by the competent 

authorities  for checking  at regular  intervals or on a case-by-case basis in 

the situation of irregular periods of harvesting. 

Sampling  plans must  in particular  take account of : 

a) likely variations  in faecal contamination  at each harvesting area; 

b) possible variations of the presence of plankton containing marine 

biotoxins; the sampling must be designed  as follows : 

(i)  surveillance  : periodic  sampling  organised  to detect changes in 

the composition  of the plankton containing toxins and the 

geographical distribution  thereof.  Information  leading to a 

suspicion of accumulation of toxins  in muscle flesh must be 

followed by 

(ii)  intensive sampling : 

- control of the plankton  in the growing  and fishing waters by 

increasing  the number of sampling  points and the number of 

samples and 

- toxicity tests on molluscs from the affected zone and most 

susceptible to the contamination. 

This  intensive sampling  plan must be continued until the results 

of toxicity tests permit  again the placing on the market of the 

molluscs; 

c) possible contamination  of the molluscs  in the harvesting  area. 

If the result of a sampling  plan shows that the placing on the market of 

live bivalve molluscs may constitute a hazard to human health, the 

competent  authority shall close the harvesting  area untill the situation 

has been restored. 

2. Laboratory tests in order to check the respect of the requirements  for the 

end product as laid down  in Chapter V of this Annex. 

There shall in particular be established  a control system to verify that 

the level of marine biotoxins do not exceed the safe levels required by 

this Regulation. 

- 32 

3. An inspection  at regular  intervals of establishments.  These  inspections 

shall include  in particular  checks : 

a) to verify whether  the approval conditions  are still being  complied with; 

b) on the cleanliness of the premises, facilities, equipment  and of 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) of the record books referred  to in Chapter IV under III, 12; 

f) the correct use of health marks. 

These checks may  include the taking of samples for laboratory tests; the 

results of these tests shall be notified  to the persons responsible for the 

establishments. 

4. Checks on the storage and transport conditions of the consignments of live 

bivalve molluscs. 

CHAPTER VII 

WRAPPING 

1. Live bivalve molluscs  shall be wrapped under  satisfactory  hygiene 

conditions. 

The wrapping material or container must : 

- not  impair the organoleptic  characteristics  of the live bivalve molluscs; 

- must not be capable of transmitting  substances which are harmful to human 

health to the live bivalve molluscs; 

- be strong enough to give adequate protection to the live bivalve molluscs. 

33 

2. Oysters must  be wrapped with the concave  shell downwards. 

3. All wrappings of live bivalve molluscs must be sealed and remain  sealed 

from tho expedition  centre until delivery to the consumer or retailer. 

CHAPTKR VIII 

PRESERVATION  AND STORAGE 

1. In any storing rooms, live bivalve molluscs must be kept at a temperature 

which does not adversely  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  of live bivalve molluscs  in seawater must not take place after 

being wrapped  and having  left the expedition  center except  in the case of 

retail sale at the expedition centre. 

CHAPTER IX 

TRANSPORT  FROM THE EXPEDITION CENTER 

1. Consignments  of live bivalve molluscs destined  for human consumption must 

be transported wrapped  as a sealed parcel from the expedition  center up to 

the time of being offered  for immediate  sale to the consumer or retailer. 

2. The means of transport used  for consignments of live bivalve molluscs must 

have the following  characteristics : 

34 

a) their  interior walls  and any other parts which might come  into contact 

with the live bivalve molluscs must be made of  corrosion-resistant 

materials; the walls must  be smooth and easy to clean; 

b) they must  bo sultubly equipped  to provide efficient  protection  of tho 

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. Consignments of live bivalve molluscs must be transported  and distributed 

using closed vehicles or containers which maintain the product  at a 

temperature which does not adversely  affect their quality and viability. 

The parcels containing  live 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 

MARKING OF  CONSIGNMENTS 

1. All parcels in a consignment  of live bivalve molluscs must be provided with 

a health mark so enabling  at all times during transport  and distribution 

until retail, the identification of their original expedition center. 

Without prejudice to Council Directive  79/112/EEC on the approximation of 

laws of the Member  States relating  to the labelling, presentation and 

advertising  of foodstuffs 
advertising  of foodstuffs 

as last amended  by Directive 89/395/EEC (2), 
as last amended  by D 

the mark must contain the following  information : 

(1) OJ No L  33, 08.02.19/9, p.  1 
(2) OJ No L 186, 30.06.1989, p. 17 

35 

- the country of dispatch, 

species of bivalve mollusc  (common  name and  scientific  name) 

- the identification of the expedition  center by the approval  number 

granted  by the competent  authority, 

- the date of wrapping. 

2. The health mark may be printed  on the wrapping material or be put on a 

separate tag which  is then fixed on the wrapping material or put  inside the 

wrapping.  They may also be of a twist-tie or staple design;  self-adhesive 

health marks must not be used.  All types of health marks must be designed 

for single use and be not transferable. 

3. The health mark must be durable and waterproof  and the  information 

presented  as legible, indelible and  in easily decipherable characters. 

4. The health mark attached  to consignments of live bivalve molluscs which are 

not wrapped  as consumer  size parcels must be kept for at least 60 days by 

the retailer  after splitting up the content of the consignment. 

-  36  -

F I N A N C I AL 

S T A T E M E NT 

c o n c e r n i ng 

: 

Draft proposal for a Council Regulation  concerning  the health conditions  governing 
the production  and the placing on the market  of live bivalve molluscs 

1. BUDGET HEADING: 

III B 

Item: 
382  (1) 

Title: 
Inspection  in Agriculture 

2. LEGAL BASIS: Article 43 of the Treaty 

3. CLASSIFICATION : Non-compulsory expenditure 

4. PURPOSE/DESCRIPTION  OF THE MEASURE: 

Verification of the application of the Regulation  (Art. 6 and 9) 

T!  METHOD OF CALCULATION: 

5.1.Form of expenditure: Mission  expenses 

5.2.Community contribution: 100 % 
5.3.Calculation: 

300 mission days per year at ECU 170 per day  (currant  cost of  inspection) 
ECU 51.000 per year 

T.  FINANCIAL  IMPLICATION AS REGARDS OPERATING  APPROPRIATIONS 

6.1.Schedule of appropriations  (m ECU): 

Year 
1991 
1992 
1993 
1994 
1995 
following years 

Total 

0,051 
0,051 
0,051 

0.153 

6.2.Financing during current year: NIL 

7. OBSERVATIONS: 

(1) When the preliminary draft budget  is prepared, an examination will be made to 

see where this category of expenditure  is to be charged  in the budget. 

This proposal also calls for 3 additional A7/6 posts. 
Staff requirements  set out above must  be met by redeployment within the  Commission 
or by the budget procedure for the year  concerned. 

- 37 -

STATEMENT OF  IMPACT ON BUSINESS 

NAME OF THE PROPOSAL 

Draft  proposal  for  a  Council  Regulation  on  the  health  conditions 
affecting  the production  and  the placing on  the market  of  live bivalve 
moi(uses. 

OBJECTIVES 

The  proposal  outlines  the  health  requirements  to  be  respected  by 
Industry  and  commerce,  as well  as  by  the  competent  authorities  during 
production,  handling,  storage  and  distribution  of  live  bivalve 
mo I I uses. 

These  requirements  replace  the  different  health  conditions  at  present 
applied  by  the  Member  States  and  will  help  to  bring  about  a  single 
market. 

IMPACT ON BUSINESS 

The  national  rules  of  the  Member  States  as  regards  health  problems 
related  to  live bivalve molluscs are not  always on  an  equivalent  level 
or are conceived  in a different  manner. 

Live bivalve mol lues are extremely  sensitive as far as health  risks are 
concerned.  The  creation  of  a  single  market  where  bivalve  molluscs  are 
allowed  to be moved  freely  requires  a  harmonisation  of  the  conditions 
for production  and marketing, based on a high  level of  protection. 

This  will  Inevitably  require  for  a  certain  number  of  mainly  small 
enterprises an effort  in order  to adapt  to the proposed  rules as far as 
upgrading  of  premises  and  control  procedures  are  concerned.  It  Is also 
likely  that,  In  order  to  meet  the  proposed  standards,  a  number  of 
establishments which are situated  In zones where  the quality of coastal 
waters  is  not  satisfactory  will  need  to  provide  for  purification 
equipment. 

In order  to allow  smooth  adaptation  to the proposed  rules  and  in order 
to  limit  possible  influence  on  business,  transitional  periods  are 
proposed  for certain  requirements. 

-  38 -

Member  States  will  also  be  allowed,  under  the  conditions  set  out  In 
laying  down  the  conditions  for  granting 
Council  Decision 

derogations  to  the  Community  health  requirements  for  the  production  and 

the  placing  on  the  market  of  products  of  animal  o r i g i n ^ ),  to  submit 

to  the  Commission  requests  for  dorogatlons  to  the  proposed  rules  If 

those  are  well  grounded  and  documented. 

It  must  be  further  emphasized  that  the  Community  Is prepared  to  assist 
the  Member  States  in  achieving  higher  health  standards.  For  that 
purpose,  the  Commission  has  submitted  to  the  Council  a  proposal  for  a 
Regulation  on  the  Improvement  of  the  conditions  under  which  fishery 
products  and  aquaculture  products  are  processed  and  marketed  [COM  (89) 
187  final]  <2>. 

It must  also  be  carried  In mind  that  Member  States  are  already  bound  to 
respect  certain  standards  for  the  shellfish  waters  by  virtue  of 
Directive  79/923/EEC  on  the  quality  required  of  shellfish  w a t e r s ^3). 
The  respect  of  these  standards  will  to  a  large  extend  help  to  achieve 
the  product  standards  as envisaged  In  the  present  proposal. 

Furthermore,  free  trade  will  be  ensured  once  consignments  comply  with 
the  proposed  standards:  this  will  be  without  doubt  to  the  benefit  of 
enterprIses. 

<1>  O.J.  n° 
(2) O.J.  n° C  143 of  09.06.89, p.  6 
<3>  O.J.  n°  L  281  of  10.11.79,  p.  47 

ISSN 0254-1475 

COM(89) 648 final 

DOCUMENTS 

EN 

03  04  05 

Catalogue number : CB-CO-90-057-EN-C 

ISBN 92-77-57297-3 

Office  for Official  Publications of the European Communities 

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