No C 84/58 Official Journal of the European Communities 2. 4. 90 
Proposal for a Council Regulation (EEC) laying down the health conditions for the production and the 
placing on the market of fishery products 
COM(89) 645 final 
(Submitted by the Commission on 12 February 1990) 
(90/C 84/05) 
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 especially of the common 
organization of the market in fishery products established by 
Council Regulation (EEC) No 3796/81 (*), as last amended 
by Regulation (EEC) No 1495/89 (2), it is essential that the 
marketing of fish and fish products should not be hindered by 
disparities existing in the Member States in respect of health 
requirements; whereas this will enable marketing to be better 
harmonized and bring about competition on equal terms; 
Whereas the European Parliament in its resolution . . . of 17 
March 1989 (3) requested the Commission to come forward 
with comprehensive proposals on the hygienic production 
and placing on the market of fishery products, including 
solutions for the problem of nematodes; 
Whereas fishery products freshly caught are in principle free 
of contamination with microorganisms, whereas however 
contamination and subsequent decomposition may occur 
when handled and treated improperly; 
Whereas fishery products may pose particular health threats 
such as the presence of nematodes, the presence of naturally 
occuring toxins, or the presence of histamine due to 
decomposition; 
Whereas therefore the essential requirements should be laid 
down for the correct hygienic handling of fresh and processed 
fishery products at all stages of production and during 
storage and transport; 
(') OJ No L 379, 31. 12. 1981, p. 1. 
(2) OJ NoL 148, 1. 6. 1989, p. 1. 
(3) OJ No L 96, 17. 4. 1989, p. 199. Whereas it is appropriate to apply by analogy certain 
marketing standards which are laid down pursuant to 
Article 2 of Regulation (EEC) No 3796/81, in order to fix 
the health quality of these products; 
Whereas it is the responsibility primarily of the fisheries 
industry to ensure that fishery products meet the health 
requirements laid down in this Regulation; 
Whereas the competent authorities of the Member States 
must by carrying out checks and inspections ensure that 
producers and manufacturers comply with the health 
requirements; 
Whereas Community control measures should be introduced 
to guarantee the uniform application in all Member States of 
the standards laid down in this Regulation; 
Whereas, in order to ensure a smooth functioning of the 
internal market, the measures should apply in an identical 
manner to trade within the Member States and to trade 
between the Member States; 
Whereas in the context of intra-Community trade, the rules 
laid down in Council Directive No . . ., concerning 
veterinary controls in intra-Community trade (4), with a 
view to the completion of the internal market should apply to 
fishery products; 
Whereas fishery products from third countries intended to be 
placed on the market of the Community must not qualify for 
more favourable arrangements than those applied in the 
Community; whereas provision should therefore be made for 
a Community procedure for the inspection in third countries 
of the conditions of production and placing on the market in 
order to decide on imports in terms of equivalence; 
Whereas the essential requirements laid down in this 
Regulation may need further specification; whereas this can 
be achieved by the establishment of rules of good 
manufacturing practice in the form of a recommendation; 
Whereas it is possible that, because of particular 
circumstances, some establishments already operating before 
1992 will be unable to comply with all of the measures laid 
down in this Regulation; whereas it is therefore necessary to 
settle the question of granting limited or temporary 
(«) OJ No L . . . 
2. 4. 90 Official Journal of the European Communities No C 84/59 
derogations in the general context of Council Decision 
.../.. ./EEC of ... on the conditions for granting 
temporary, limited derogations from specific Community 
health rules on the production and marketing of products of 
animal origin (J); 
Whereas it is necessary to stress that excluding certain 
activities from the scope of this Regulation or the possible 
grant of derogations from the rules laid down in this 
Regulation is without prejudice to the requirement that all 
production and placing on the market of products of animal 
origin conform to the general health rules laid down by 
Council Regulation (EEC) No .../... of .. . 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 (2); 
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: 
CHAPTER I 
General provisions 
Article 1 
This Regulation lays down the health conditions for the 
production and the placing on the market of fishery products 
for human consumption. 
Article 2 
For the purposes of this Regulation, the following definitions 
shall apply: 
1. 'fishery products': all seawater or freshwater animals or 
parts thereof, including their roes, excluding aquatic 
mammals, frogs and aquatic animals covered by other 
Community acts; 
2 . 'aquaculture products': all fishery products born and 
raised under controlled circumstances until placed on 
the market as a foodstuff, and also fresh or seawater 
fish or crustaceans captured in their natural 
environment when juvenile and kept until they reach 
the desired commercial size for human consumption. 
Fish and crustaceans of commercial size caught in their 
natural surroundings and kept alive to be sold at a later date are not included if they are merely kept alive 
without any attempt being made to increase their size or 
weight; 
3. 'fresh products': fishery products whether whole or 
prepared, including products packaged under vacuum 
or in a controlled atmosphere, which have not been 
submitted to any treatment to ensure preservation other 
than chilling; 
4. 'prepared products': fishery products having undergone 
an operation affecting their physical wholeness such as 
gutting, heading, slicing, filleting, chopping etc.; 
5. 'processed products': fishery products which have been 
submitted to a chemical or physical process such as the 
heating, smoking, salting, dehydration or marinating 
etc. of fresh products, whether or not associated with 
other foodstuffs, or to a combination of these various 
processes; 
6. frozen products': means fishery products which have 
been submitted to a freezing process to reach a core 
temperature of -18 °C or lower; 
7. 'quick-frozen products': fishery products complying 
with the requirements laid down in Council Directive 
89/108/EEC on the approximation of the laws of the 
Member States relating to quick-frozen foodstuffs for 
human consumption (3); 
8. 'packaging': the procedure of protecting fishery 
products by a wrapper, a container or any suitable 
device; 
9. 'consignment': the quantity of fishery products bound 
for one or more customers in the country of 
destination; 
10. '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; 
11. 'batch': a quantity of fishery products obtained under 
the same conditions and during the same working 
period; 
12. 'competent authority': the department designated by 
the Member State concerned to monitor the 
implementation of this Regulation; 
13. 'establishment': the premises authorized for the 
handling and packing of fresh or processed products; 
14. 'placing on the market': the holding or displaying for 
sale, offering for sale, selling, delivering or any other 
form of placing on the market in the Community, 
excluding retail sale; 
0) OJ No L . . . 
(*) OJ No L . . . (3) OJ No L 40, 11. 2. 1989, p. 34. 
No C 84/60 Official Journal of the European Communities 2. 4. 90 
15. 'importation': the introduction into the territory of the 
Community of fishery products from third countries; 
16. 'clean seawater': sea or estuary water which is free from 
the microbiological contamination and objectionable 
substances in such quantities as may adversely affect the 
health quality of fishery products and which is used 
under the conditions laid down in this Regulation. 
CHAPTER II 
Provisions for Community production 
Article 3 
1. The placing on the market of fishery products caught 
wild shall be subject to the following conditions: 
(a) They shall have been caught and handled on board 
vessels in accordance with the conditions laid down 
pursuant to Article 2 of Regulation (EEC) No 
3796/81. 
Factory vessels, preparing and processing or freezing 
fishery products on board, shall comply with 
requirements to be established in accordance with the 
procedure laid down in Article 17; 
(b) During and after landing they shall be handled in 
accordance with the requirements laid down in 
Chapter I of the Annex; 
(c) They shall, where necessary, have been packed, 
prepared, processed, frozen, defrosted or stored 
hygienically in establishments approved in accordance 
with Article 7(1), having regard to the requirements 
laid down in Chapters II and III of the Annex; 
(d) They shall have undergone a health check in accordance 
with the requirements laid down in Chapter IV of the 
Annex; 
(e) They shall have been appropriately packaged in 
accordance with Chapter V of the Annex; 
(f) They shall have been labelled in accordance with 
Chapter VI of the Annex; 
(g) They shall have been stored and transported under 
satisfactory conditions of hygiene, in accordance with 
Chaper VII of the Annex; 
2. The placing on the market of aquaculture products 
shall be subject to the following conditions: 
(a) They shall have been slaughtered under hygienic 
conditions. They shall not be soiled with earth, slime or 
faeces. If not processed immediately after having been 
slaughtered, they shall be kept refrigerated; 3. a) The placing on the market of live bivalve molluscs 
shall be subject to the requirements laid down in 
Council Regulation (EEC) No . . . concerning the 
health conditions governing the production and the 
placing on the market of live bivalve molluscs (*). 
b) When processed, bivalve molluscs must in addition 
satisfy the requirements laid down under 1 (c) 
to (g). 
Article 4 
Fishery products to be placed on the market alive shall at all 
times be kept under the most suitable survival conditions. 
Article S 
The placing on the market of the following products shall be 
forbidden: 
1. Poisonous fish of the following families: Tetra-
odontidae, Molidae, Diodontidae, Canthigasteridae. 
2. Fish containing biotoxines such as ciguatera toxins. 
Detailed provisions concerning the species covered by this 
Article and concerning methods of analysis will be laid down 
in accordance with the procedure prescribed in Article 17. 
Article 6 
Persons responsible for the protection and the placing on the 
market of fishery products shall adopt all measures necessary 
to comply with the requirements of this Regulation. They 
shall accordingly institute checks to ensure: 
— the cleanliness of vessels and establishments, 
— the correct handling of products at all stages during 
production, 
— preparation, processing, storage and transport, 
and, where necessary, take samples for laboratory 
analysis. 
Article 7 
1. The competent authorities shall draw up a list of their 
approved establishments, each of which shall have an official 
number. 
The competent authorities shall approve establishments 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) They shall further comply with the requirements laid 
down under 1 (b) to (g). (>) OJ No L . . . 
2. 4. 90 Official Journal of the European Communities No C 84/61 
If a check has been made in accordance with Article 8, the 
competent authorities concerned shall take account of the 
conclusion resulting therefrom. The other Member States 
and the Commission shall be informed in the event of 
approval being withdrawn. 
2. The inspection and monitoring of 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 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. 
3. Paragraphs 1 and 2 shall also apply in respect of 
factory vessels. 
Article 8 
1. Experts from the Commission may make on-the-spot 
checks, in so far as this is necessary to ensure the uniform 
application of this Regulation. They may in particular verify 
whether establishments are in effect complying with the 
requirements of this Regulation. 
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 the results of the investigations. 
2. The general provisions for implementing paragraph 1 
shall be determined in accordance with the procedure laid 
down in Article 19. 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. 
Article 9 
The rules laid down in Directive . . ., (concerning veterinary 
checks in intra-Community trade, with a view to the 
completion of the internal market), shall apply, in particular 
with respect to the organization of the checks carried out by 
the Member State of destination and subsequent action, and 
the safeguard clause shall be applied. 
However, the definitions given in this Regulation shall 
apply. 
CHAPTER HI 
Imports from third countries 
Article 10 
Provisions applied to imports of fishery products from third 
countries shall be equivalent to those governing the placing 
on the market of Community products. Direct landings of fishery products in the territory of the 
Community by third country vessels shall be subject to the 
requirements laid down for landings by Community 
vessels. 
Article 11 
1. The Commission, in accordance with the procedure 
laid down in Article 17, shall for each third country lay down 
the conditions for the importation of fishery products. These 
conditions may include in particular: 
(a) the frequency and the nature of the physical checks to be 
carried out in conformity with Council Regulation 
(EEC) No . . . laying down the principles relating to the 
organization of health controls for products arising 
from third countries with a view to the completion of the 
internal market (J); this frequency shall be fixed in the 
light of the guarantees a third country can offer in 
relation with the checks carried at the place of origin; 
these physical checks must ensure that imported fishery 
products are fit for human consumption, do not 
represent a hazard to human health and comply with the 
requirements of this Regulation, in particular those laid 
down in point IV of Chapter III and point II of 
Chapter IV of the Annex; 
(b) the production of a health certificate which must 
accompany consignments when forwarded to the 
Community; 
(c) the placing of a mark identifying the fishery products, in 
particular with the approval number of the 
establishment of expedition; 
(d) drawing up a list of establishments and factory vessels 
from which the importation of fishery products is 
authorized; 
2. The conditions referred to in paragraph 1 (a), (b) and 
(c) may be amended in accordance with the procedure laid 
down in Article 18. 
The conditions referred to in paragraph 1 (d) may be 
amended by the Commission, which shall inform the 
Member States thereof. 
3. In order to allow decisions on the import conditions to 
be taken, and in order to be informed about the conditions of 
production, storage and expedition of fishery products for 
consignment to the Community, inspections may be carried 
out on the spot by experts from the Commission and the 
Member States. 
The experts of 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 any expenditure incurred. 
(>) OJ No L . . . 
No C 84/62 Official Journal of the European Communities 2. 4. 90 
The frequency and the procedure for these inspections shall 
be determined in accordance with the procedure laid down in 
Article 19. The decisions taken to that effect, and in 
particular those concerning visits to establishments must, for 
each third country, be based on the health situation 
found. 
Article 12 
Should an inspection referred to in Article 11 (3) bring to 
light serious facts which may render the placing on the 
market of fishery products for human consumption unsafe, 
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 or from a part or the whole of the third country 
concerned. 
A decision shall be taken according to the procedure 
provided for in Article 18. 
Article 13 
The importation of fishery products is not allowed 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. 
Article 14 
1. If a disease capable of being conveyed to humans by 
fishery products 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 18 or a Member State, may prohibit or 
subject to specific conditions the importation of those fishery 
products 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 18. 
4. The Commission shall monitor the situation and, in 
accordance with the procedure laid down in Article 18, shall 
amend or revoke the decisions referred to in paragraphs 1 
and 3, having regard to such situation. CHAPTER IV 
Final provisions 
Article 15 
The Annex to this Regulation shall be amended in 
accordance with the procedure laid down in Article 17, in 
particular with a view to adapting; to take account of 
scientific and technological progress. 
Article 16 
The Commission, in accordance with the procedure laid 
down in Article 19 may draw up recommendations 
containing guidelines on good manufacturing practice at the 
different stages of production and placing on the market. 
Article 1 7 
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 /EEC (a) (hereinafter called 'the Committee') by its 
Chairman on his initiative or at the request of a Member 
State. 
2. The representative of the Commission shall submit to 
the Committee a draft of the measure to be taken. The 
Committee shall deliver its opinion on the draft within a time 
limit to be determined by the Chairman in relation to the 
urgency of the matter to be considered. 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. 
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, within three months from the date on which the proposal 
was put to it, the Council has not acted, the proposed 
measures shall be adopted by the Commission. 
Article 18 
1. Where the procedure laid down in this Article is to be 
applied, the Chairman shall refer the matter without delay on 
(') OJNoL . . . 
2. 4. 90 Official Journal of the European Communities No C 84/63 
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. 
If the measures 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. Article 19 
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 delivered by the Committee. It shall inform the 
Committee of the manner in which its opinion has been taken 
into account. 
Article 20 
This Regulation shall enter into force on 1 January 1993. 
If, on expiry of a period of fifteen working days from the date 
of referral to the Council, the Council has not acted, the 
proposed measures shall be adopted by the Commission. This Regulation shall be binding in its entirety and directly 
applicable in all the Member States. 
ANNEX 
CHAPTER I 
REQUIREMENTS DURING AND AFTER LANDING 
1. Unloading and landing equipment must be constructed of material which is easy to clean and disinfect and 
must be kept in a good state of repair. 
2. During unloading and landing, contamination of fishery products must be avoided. It must in particular be 
ensured that: 
— unloading and landing operations proceed rapidly, 
— fishery products are placed without unnecessary delay in the protected environment of transport, storage 
or market facilities, or in an establishment, 
— equipment and practices that cause unnecessary damage to the edible parts of the fishery products are not 
used. 
3. Markets where fishery products are displayed for sale or stored must: 
(a) have walls which are easy to clean; 
(b) have waterproof flooring which is easy to wash and disinfect and laid in such a way as to facilitate the 
drainage of the water; 
(c) be equipped with sanitary facilities with an appropriate number of wash basins and flush lavoratories. 
Wash basins shall be supplied with materials for cleaning the hands and disposable hand towels; 
No C 84/64 Official Journal of the European Communities 2. 4. 90 
(d) be well lit to facilitate the inspection of fishery products; 
(e) when they are used for display or storage of fishery products, not be used for other purposes; vehicles 
emitting exhaust fumes which may impair the quality of the fishery products may not be admitted to 
markets; undesirable animals must not be admitted; 
(f) be cleaned regularly and at least after each sale; crates must, after each sale, be cleaned and rinsed inside 
and outside with drinking water or clean seawater; where required, they must be disinfected; 
(g) have displayed in a prominent position signs prohibiting smoking and spitting. 
4. After landing or, where appropriate, after first sale, fishery products must be transported without delay, under 
appropriate conditions, to their place of destination. 
CHAPTER II 
GENERAL CONDITIONS FOR ESTABLISHMENTS ON SHORE 
I. General conditions relating to premises and equipment 
Establishments shall afford at least the following facilities: 
1. Working areas of adequate size for work to be carried out under hygienic conditions. Their design and 
layout shall be such as to preclude contamination of the product. 
2. In areas where products are handled, prepared and processed: 
(a) waterproof flooring which is easy to clean and disinfect and laid down in such a way as to facilitate 
the drainage of the water or provided with equipment to remove water; 
(b) walls which are easy to clean, durable and impermeable; 
(c) ceilings or roof linings which are easy to clean; 
(d) doors in durable materials; 
(e) adequate ventilation and, where necessary, good steam and water-vapour extraction facilities; 
(f) adequate natural or artificial lighting; 
(g) an adequate number of facilities for cleaning and disinfecting hands; taps must not be hand operated; 
these facilities must be provided with hand towels which can be used once only; 
(h) facilities for cleaning plant, equipment and utensils. 
3. In cold rooms where fishery products are stored: 
— the provisions set out under point 2 (a), (b), (c) and (d), 
— where necessary, a sufficiently powerful refrigeration plant to keep products at temperatures 
prescribed in this Regulation. 
4. Appropriate facilities for protection against pests such as insects, rodents, etc. 
5. Instruments and working equipment such as cutting tables, containers, conveyor belts and knives made of 
corrosion-resistant materials, easy to clean and disinfect. 
6. Special watertight, corrosion-resistant containers for fishery products not intended for human 
consumption, or premises for such products, if the quantities thereof so require. 
7. Facilities to provide adequate supplies of drinking water within the meaning of Directive 80/778/EEC 
relating to the quality of water intended for human consumption (1), or alternatively of clean seawater or 
seawater treated by an appropriate system, under pressure and in sufficient quantity. However, by way of 
exception, a supply of non-drinking water is permissible for the production of steam, fire-fighting and the 
cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of 
such water for other purposes and present no risk of contamination of the products. Non-drinking water 
pipes must be clearly distinguished from those used for drinking water or clean seawater. 
8. A hygienic waste water disposal system. 
(') OJ No L 229, 30. 8. 1980, p. 11. 
Official Journal of the European Communities No C 84/65 
9. An adequate number of changing-rooms with smooth, water-proof, washable walls and floors, wash 
basins and flush lavatories. The latter may not open directly onto the work rooms. The wash basins must 
have materials for cleaning the hands and towels which can be used once only; the wash basin taps must 
not be hand-operable. 
10. Adequate facilities for cleaning and disinfecting means of transport. However, such facilities are not 
compulsory if there is a requirement for the means of transport to be cleaned and disinfected at officially 
authorized facilities. 
11. Establishments keeping live animals such as lobsters or eels must have appropriate fittings ensuring the 
best survival conditions provided with water of a quality such that no harmful organisms or substances 
are transferred to the animals. 
II. General hygiene conditions 
A. General conditions of hygiene applicable to premises and equipment 
1. Floors, walls and partitions, ceilings or roof linings, equipment and instruments used for working on fishery 
products must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source 
of contamination for the products. 
2. Rodents, insects and any other vermin must be systematically exterminated; rodenticides, insecticides, 
disinfectants and any other potentially toxic substances must be stored in premises or cupboards which can 
be locked. Their use must not present any risk of contamination of the products. 
3. Working areas, instruments and working equipment must be used only for work on fishery products. 
However, following authorization by the competent authority they may be used at any time for work on 
other foodstuffs. 
4. Drinking water or clean seawater must be used for all purposes; however, by way of an exception, 
non-drinking water may be used for steam production, fire-fighting and the cooling of refrigeration 
equipment, provided that the pipes installed for the purpose preclude the use of such water for other 
purposes and present no risk of contamination of the products. 
5. Detergents, disinfectants and similar substances must be used in such a way that they do not have adverse 
effects on the machinery, equipment and products. 
B. General conditions of hygiene applicable to staff 
1. The highest possible standard of cleanliness is required of the staff. More specifically: 
(a) staff must wear suitable clean working clothes and headgear. This applies particularly to persons 
handling exposed fishery products; 
(b) staff assigned to the handling and preparation of the fishery products must be required to wash their 
hands at least each time work is resumed; 
(c) smoking, spitting, eating and drinking in work and storage premises must be prohibited. 
2. The employer shall take all the requisite measures to prevent persons liable to contaminate fishery products 
from working on and handling them, until there is evidence that such persons can do so without risk. 
CHAPTER HI 
SPECIAL CONDITIONS FOR HANDLING FISHERY PRODUCTS ON SHORE 
I. Conditions for fresh products 
1. Where fresh products are not dispatched, prepared or processed within a reasonable time after landing, 
they must be stored under ice in the establishment's cold room. Re-icing must be carried out as often as is 
necessary; ice used for re-icing must be made from drinking water or clean seawater and be stored under 
hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in a 
good state of repair. Prepacked fresh products must be chilled with ice or mechanical refrigeration plant 
creating similar temperature conditions. 
2. Heading and gutting operations must be carried out hygienically; the products must be washed thoroughly 
with drinking water or clean seawater immediately after such operations; 
No C 84/66 Official Journal of the European Communities 2. 4. 90 
3. Operations such as filleting and slicing must be carried out in such a way as to avoid the contamination or 
spoilage of fillets and slices, especially during heading and gutting operations. Fillets^and slices to be sold 
fresh must be chilled as quickly as possible after preparation; 
4. Containers used for the dispatch or storage of fresh fishery products must be designed in such a way as to 
ensure both their protection from contamination and their preservation under sufficiently hygienic 
conditions and, more particularly, they must provide adequate drainage of melt water. 
5. Unless special facilities are provided for the continuous disposal of waste, the latter must be placed in 
leakproof, covered containers, which are easy to clean and disinfect. Waste must not be allowed to 
accumulate in working areas. These must be removed at least at the end of each working day to a premises 
or an area designated for the purpose. Containers must always be thoroughly cleaned and disinfected after 
use. 
II. Conditions for frozen and quick frozen products 
1. Plants must have: 
(a) freezing equipment sufficiently powerful to achieve a rapid reduction in the temperature so as to allow 
that the temperatures referred to in this Regulation are obtained in the products; 
(b) freezing equipment sufficiently powerful to keep products in storage rooms at a temperature not 
exceeding those laid down in this Regulation, whatever the ambient temperature may be. 
However, for tunny fish frozen in brine and intended for canning, higher temperatures than the ones laid 
down in this Regulation are acceptable for technical reasons related to the method of freezing and to the 
handling oi such products. 
2. Fresh products to be frozen or quick-frozen must comply with the requirements of section I of this 
Chapter. 
3. Storage rooms must have a temperature recording device in a place where it can easily be read. The 
temperature sensor of the recorder must be located in the area furthest away from the cold source, i.e. 
where the temperature in the storage room is the highest. 
Temperature charts must be available for inspection by the supervisory authorities at least during the 
period for which the products are stored. 
4. Fishery products must be thawed under hygienic conditions: their contamination must be avoided and 
there must be adequate drainage for any drip produced. 
During thawing, the temperature of the products must not increase excessively. 
After thawing, fishery products must be handled in accordance with the requirement of this Regulation. 
When they are prepared or processed, these must be carried out without delay. 
III. Conditions for processed products 
1. Fresh or frozen products used for processing must comply with the requirements of sections I or II of this 
Chapter. 
2. Where the processing treatment is carried out for the destruction of pathogenic microorganisms, or if it is a 
significant factor in the preservation of the product, the treatment process must be monitored and 
controlled and be subject to approval by the competent authority. In particular heating time and 
temperature, salt content, pH, water content, etc. must be monitored and controlled. Records must be 
kept at least for the expected storage life of the products and be available to the competent 
authority. 
3. For products which are preserved for a limited period by a treatment such as salting, smoking, drying or 
marinading, the appropriate conditions for storage must be clearly marked on the packaging, in 
conformity with Council Directive 79/112/EEC on the approximation of the laws of the Member States 
relating to the labelling, presentation and advertising of foodstuffs, as last amended by Directive 
89/395/EEC(1)-
In addition, the following conditions must be complied with: 
(') OJ No L 180, 30. 6. 1989, p. 17. 
^ ^0 C^t^c^]o^rnaio^rri^^^ror^c^nCornrnnn^n^ ^oC^B^ 
^t C^m^ 
In the case of fishery products which have been subjected to stabilizing heat treatment in hermetically 
sealed containers 
m^ the process used for the heat treatment must be appropriate, having regard to such ma^or criteria as 
the heating time,temperature,filling,size of contamersetc,arecordofwhichmust be kept,the heat 
treatment must be capable of destroying all pathogenic and spoilage organisms and the spores of 
pathogenicmicroorgamsms Theheatmg equipment must be fitted with devicesfor monitoring 
whether the containers have in fact undergone appropriate heat treatment, 
^b^ further checks must be carnedout at random by the manufacturer to ensure that the processed 
products have undergone appropriate heat treatment viz 
— incubation tests for that purpose, establishmentsmusthave facilities fortheincubationof 
samples of canned fishery products atrB^e for seven days or at e^^^e for ten days^ 
— microbiological examination of contents and containers in the estabhshment^slaboratory or in 
anotherapprovedlaboratorv, 
^0 samples must be taken of production each day at predetermined intervals, to ensure the efficacy of 
sealing, for that purpose, appropriate equipment must be available for the examination of 
crosssectionsofthecanseams, 
^ checks are carried out in order to ensure that containers are not damaged, 
^ all containers which have undergone heat treatment in a single batch must be given a batch 
identification mark 
m^ sawdust used in the smoking of fish must be stored away from the area used for smoking andmust be 
used in suchaway so as to preclude contamination of the products 
d^ The use of sawdust made from wood treated with preservatives is prohibited 
^ ^fter smoking, products must be cooled rapidly prior to packaging 
m^ ^alt used in the treatment of fishery products must be cleaned and stored in suchaway as to preclude 
contamination 
^ ^ny contamerusedforsaltingmustbeconstructedin suchaway as to precludecontammation during 
the salting process 
^ eontamersorareas used for salting must be cleaned betore use 
shellfish and molluscs must be cooked as follows 
ea^ any cookmgmust be followed by rapid cooling, waterusedforthispurposemustbedrmkingwater or 
clean seawater, 
^b^ shelling or shuckingmustbecarned out underhygienicconditionsavoidmgthe contamination of the 
product ^here such operations are done by hand,workers must pay particular attentionto the 
washing of their hands and all working surfaces must be cleaned thoroughly tfmachmes are used, 
they must be cleaned at frequent intervals 
^fter shelling or shucking,precooked shellfish must immediately be frozenorkept chilled ata 
temperature which will preclude the growth of pathogens, and be stored in appropriate 
premises 
^ ^vf^^^^^yr^o^r^^^^^ 
The mechanical recovery of fish flesh must be carried out under the following conditions 
m^ Mechanical recovery of gutted fish must take place immediately after filleting ^here whole fish are 
used, they must be gutted and washed beforehand 
^ The machinery must be cleaned at frequent intervals and at least every two hours 
^ Mechanically recovered flesh must be frozen immediately after recovery or incorporated in suitably 
stabilized or frozen products 
No C 84/68 Official Journal of the European Communities 2. 4. 90 
IV. Conditions concerning nematodes 
1. Before distribution, the fish and fishery products listed under 2 and to be consumed as such, must be 
subject to: 
(a) a visual inspection carried out during their processing in accordance with a sampling scheme to be 
established in accordance with the procedure laid down in Article 17, for the purpose of detecting 
nematodes and removing any that are visible; 
(b) freezing of either the finished or raw product at a temperature of not more than -20 °C in all parts of 
the product for not less than 24 hours. 
2. List of fish and fishery products covered by paragraph 1. 
(a) fish to be consumed raw or almost raw e.g. raw herring; 
(b) the following products if they are to be subjected to a cold smoking process at which the internal 
temperature of the fish is less than 60 °C: 
— herring, 
— mackerel, 
— sprat, 
— Atlantic and Pacific (wild) salmon. 
(c) Marinated or salted herring where this process is insufficient to destroy the larvae of nematodes. 
This list may be amended in accordance with the procedure laid down in Article 17. In accordance with the 
same procedure, criteria will be laid down which must ensure adequate definition of the processes which 
are insufficient to destroy nematodes. 
3. Manufacturers must ensure that fish and fishery products listed under 2 or the raw materials for use in their 
manufacture are subjected to the treatment described in 1 (b) prior to their release for consumption. 
4. The fishery products listed under 2 must, when they are placed on the market, be accompanied by a 
document certifying that they have been properly treated. 
CHAPTER IV 
HEALTH CONTROL AND SUPERVISION OF PRODUCTION 
I. General supervision 
Arrangements for supervision must be made by the competent authorities, in order to establish whether the 
requirements laid down in this Regulation are complied with. Such arrangements will include: 
1. a check on the vessels; 
2. a check on the conditions of landing and first sale; 
3. an inspection at regular intervals of establishments to check: 
(a) whether the conditions for approval are still fulfilled; 
(b) whether the fishery products are handled correctly; 
(c) the cleanliness of the premises, facilities and instruments and staff hygiene; 
(d) whether labels are put on correctly. 
4. checks on storage and transport conditions. 
II. Special checks 
1. Sensory checks 
Fishery products must be subjected to an inspection by the competent authority at the time of landing or 
before first sale to check whether they are fit for human consumption. This inspection comprises a sensory 
check. 
2. 4. 90 Official Journal of the European Communities No C 84/69 
Fishery products complying as far as the freshness criteria are concerned with the common marketing 
standards already laid down in accordance with Article 2 of Council Regulation (EEC) No 3796/81 are 
considered to fulfil the sensory requirements necessary for the respect of this Regulation. 
The Commission may, by the procedure referred to in Article 19, in cases where it is necessary, lay down 
specific sensory requirements for fishery products not harmonized under Council Regulation (EEC) No 
3796/81. 
The sensory check is repeated after first sale of fishery products, if it is found that the requirements of this 
Regulation have not been complied with or when considered necessary. After first sale, fishery products 
must at least comply with the minimum freshness requirements of forementioned Regulation. If the sensory 
examination reveals that the fishery products are not fit for human consumption, they must be withdrawn 
from the market and denaturated in such a way that they cannot be used for human consumption. 
2. Chemical checks 
A. If the sensory examination reveals any doubt as to the freshness of the fishery products, samples shall be 
taken and subjected to laboratory analysis for the control of the following parameters: 
(a) TVB-N (total volatile basic nitrogen) and TMA-N (trimethylamine-nitrogen) 
Controls for the determination of the levels of these parameters are carried out in order to obtain 
guidance: increased levels must not automatically induce withdrawal of the fishery products, but 
must lead to an enquiry in order to detect the reason for the increased values. 
b) Histamine 
Nine samples shall be taken from each batch. These must fulfil the following requirements: 
— the mean value must not exceed 100 ppm, 
— two samples may have a value of more than 100 ppm but less than 200 ppm, 
— no sample may have a value exceeding 200 ppm. 
These limits may only apply to fish species of the following families: 
Scombridae and Clupeidae. Examinations must be carried out in accordance with proven 
scientifically recognized methods, such as high performance liquid chromatography (HPLC). 
B. Contaminants from the aquatic environment 
Without prejudice to the Community rules concerning water protection and management, and in 
particular those concerning pollution of the aquatic environment, fishery products must not contain in 
their edible parts contaminants from the aquatic environment such as heavy metals and 
organochlorinated substances at such a level that the calculated dietary intake exceeds the acceptable 
daily intake (ADI). 
A monitoring system must be established by the Member States for checking the level of contamination 
of fishery products with contaminants. 
The Commission, following the procedure laid down in Article 17, 
(a) shall modify or complete the requirements laid down for the chemical analysis with a view to adapt 
them to technological and scientific progress; 
(b) shall lay down the methods of analysis to be used for checking the chemical parameters, as well as 
the sampling plans; 
(c) shall lay down the acceptable levels for the chemical parameters. 
3. Microbiological analyses 
In accordance with the procedure laid down in Article 17, microbiological criteria, including sampling 
plans and methods of analysis, can be laid down when there is a need to protect public health. 
CHAPTER V 
WRAPPING AND PACKAGING 
1. Packaging must be carried out under satisfactory conditions of hygiene, to preclude contamination of the 
fishery products. 
2. Packaging materials must comply with all the rules of hygiene, and in particular: 
— they must not be such as to impair the organoleptic characteristics of the fishery products, 
No C 84/70 Official Journal of the European Communities 2. 4. 90 
— they must not be capable of transmitting to the fishery products substances harmful to human health, 
— they must be strong enough to protect the fishery products adequately. 
3. With the exception of certain special containers made of impervious, smooth and corrosion resistant material 
easy to clean and disinfect, which may be re-used after cleaning and disinfecting, packaging materials may not 
be re-used. Packaging used for fresh fishery products held under ice must provide adequate drainage for melt 
water. 
4. Unused packaging materials must be stored in an area away from the production area and be protected from 
dust and contamination. 
CHAPTER VI 
LABELLING 
Without prejudice to the requirements laid down in Council Directive 79/112/EEC (!), on the approximation of 
the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs as last amended 
by Directive 89/395/EEC (2), it must be possible to trace back for inspection purposes the establishment of 
dispatch of consignments of fishery products, by means of either labelling or the accompanying documents. For 
that purpose, the following information must appear on the packaging or in the accompanying documents: 
— the country of dispatch, 
— particulars of the establishment of dispatch, including its official approval number. 
CHAPTER VII 
STORAGE AND TRANSPORT 
1. Fishery products must at all times during storage and transport be kept at the temperatures laid down in this 
Regulation and in particular: 
— fresh fishery products must be kept at the temperature of melting ice, 
— frozen fishery products must be kept at a temperature below -18 °C, 
— processed products must be kept at the temperatures specified by the manufacturer. 
2. No other products which may contaminate or affect the hygiene of fishery products may be stored with them, 
unless the fishery products are packaged. 
3. Vehicules used for the transport of fishery products must be constructed and equipped in such a way that the 
temperatures laid down in this Regulation can be maintained throughout the period of transport. If ice is used 
to chill the products, adequate drainage must be provided in order to ensure that water from melted ice does 
not stay in contact with the products. The inside surfaces of the means of transport must be finished in such a 
way that they do not adversely affect the fishery products. They must be smooth and easy to clean and 
disinfect. 
4. Means of transport used for fishery products may not be used for transporting other products likely to impair 
or contaminate fishery products, either simultaneously or at different times. 
5. Fishery products may not be transported in a vehicle or container which is not clean and where necessary, has 
not been disinfected. 
6. The transport conditions of fishery products to be placed on the market alive must not adversely affect the 
products. 
(') OJ No L33, 8. 2. 1979, p. 1. 
(2) OJ No L 186, 30. 6. 1989, p. 17.