Control of food safety in aquaculture products

Adapted from a presentation by David Lyons 

BTSF 

Workshop on Hygiene and Control measures for 

Fishery products and LBM 

Control of food safety in aquaculture products 

Amedeo Manfrin 

Chioggia (Venice) – ITALY 

13 September, 2012

BASIC CONCEPTS OF 

AQUACULTURE

Basic concepts of aquaculture 

• Production cycle 

• Production facilities 

• Relevant diseases/pathogens 

• Treatments

Production cycle 

Hatcheries 

Spawning

Production facilities 

• Hatcheries 

• Nurseries 

• Ponds/tanks 

• Cages 

• Biosecurity 

• Water supply 

• Feeding systems

Hatcheries

Hatcheries

Nurseries

Ponds/tanks

Cages

Biosecurity

Water supply

Feeding systems

Relevant diseases/pathogens 

• Compulsory declaration: most viral diseases 

• Public health problems: bacterial diseases 

(antibiotics… and some minor zoonoses) and parasitic 

diseases (anisakis)

Relevant diseases/pathogens

Treatments 

• Antibiotics, disinfectans, antiparasites: 

• Limited available products 

• Variable administration ways: oral, bath, 

injection.. 

• Withdrawal periods: degree-days 

• Alternatives: 

• Vaccines (inactivated) 

• Probiotics

Treatments

FRAMEWORK 

LEGISLATION

Framework Legislation

Relevant EU legislation for aquaculture (1) 

• Regulation (EC) 852/2004 

Hygiene of foodstuff products (Annex I, Primary Production) 


Hygiene of foodstuff of animal origin 


Official controls of products of animal origin to be used for human 

consumption 


On official controls performed to ensure the verification of 

compliance with feed and food law, animal health and animal 

welfare rules



Requirements for feed hygiene 


Additives for use in animal nutrition


• Directive (EC) 2006/88 

Animal health requirements of the aquaculture animals and 

products thereof and on the prevention and control of certain 

diseases of aquatic animals. 


Health rules as regards animal by-products and derived 

products not intended for human consumption. 

• Regulation (EC) 142/2011 implementing Regulation (EC) 1069/2009. 

(Regulation (EC) 1774/2002 is repealed)

AQUACULTURE AND EU 

FOOD SAFETY PACKAGE

Aquaculture and EU food safety package 

• Aquaculture is considered as primary 

production, EU food safety package 

• To respect the primary production hygiene 

provision (SOP, SSOP standards)

Reg 852 / 2004 Art 6 (aquaculture) 

Aquaculture Production Business Operator 

(APBO): 

• approval 

• registration 

• controls 

by Competent Authorities: 

• APBO must provide appropriate documentation 

of the above

Reg 852 / 2004 

Annex I Primary production

Primary production (aquaculture) 

I. Scope 

General hygiene provisions for 

(aquaculture) primary production: 

• Aquaculture production 

• Associated operations as transport, storage, 

handling, packaging of aquaculture products, 

provided that this does not substantially alter 

their nature 

• Including live animals transport from place of 

production to an establishment


II. Hygiene provision (1) 

• Primary production and associated operations protected 

against risk of contamination, far from pollution source 

• Control of hazards in primary production and associated 

operations including: air, soil, water, feed, fertiliser, 

veterinary medical products, plant protection products 

/biocides and waste management … 

• Measures relating to animal health and welfare (also related to 

human health).



“…an APBO must take adequate mesures, as appropriate …” 

(Good practices, GMP, GHP…) 

For activities at aquaculture production site (structure and equipment) 

•Appropriate project, location, (minimizing food safety risk), water quality/quantity 

•Structure: input/output channels network, construction of pond/tank/ raceway/cage, 

fences, waste water treatment system, associated operations (hatchery, feed plant, 

packaging area, cleaning area, transport), appropriate and easy to clean 

•Appropriate storage of feed, veterinary products, cleaning and detergent agents, 

fertiliser, disinfectant, tanks (live fish transport container), container, fuel, lubrificant 

•Aquaculture equipment appropriate and easy to clean: container, tank, feeder, 

oxigenator, selection machine, pump...



Aquaculture structure and equipment: 

• Fences 

• Pest traps, pest control plan 

• Waste containers, incinerator 

• Quarantine for ill / introduced animals 

• Place for personnel washing and control



Aquaculture operation management 

SOP: 

• pond preparation 

• feeding protocol 

• veterinary/fertilizer/chemicals treatment 

• toilet/showel/ facilites 

• animals containing system 

• water quality/quantity monitoring (pond, raceways, cage, tank…) 

• health status of animal (in-present-out)• filter 

• fish welfare 

• channel network 

• analysis: water, feed, animal health,… • decantation ponds 

• maintenance building/structures /equipment 

• pest control 

• storage material management 

• Transport 

• others... 

Sanitation SOP: 

• cleaning surfaces 

• surronding 

• personnel hygiene/behavior 

• waste management 

• others…



Aquaculture operation management 

• Traceability of animals and materials 

• Training of personnel


III. Record keeping 

• APBO must provide record on hazards control 

• Records must be written, divided in chapters 

as for the developed SOP, SSOP (II. Hygiene 

provisions) 

• Records must be always available for CA 

inspection

Associated operations (Good Practices) 

• Hatchery (II. Hygiene provisions) 

SOP/SSOP for: surface, tank disinfection, water, personnel 

health, eggs, fingerling … 

• Packaging (II. Hygiene provisions) 

SOP/SSOP for: potable water, ice, fish container management, 

personnel health, surface cleanless, record keeping… 

• Transport (II. Hygiene provisions) 

SOP/SSOP for: personnel health, tank easy to use/clean, surface 

cleanless, record keeping… 

• Primary production of feed 

Ref Art 5.1 Reg 183/2005 Annex 1 (only owner use) 

I. Hygiene provision, SOP, SSOP for: equipment, water, health, 

contaminant/residues, feed, personnel health, record keeping…

FEED

Feed 


Laying down requirements for feed 

hygiene

Management of Feed 

 

 

 

Primary production level 

Good practice, HACCP 

Feeding

Feed business operator responsable for 

feed safety 

Objective “To ensure a high level of consumer 

protection in relation to food and feed safety” 

• Regulation (EC) 183/2005 lays down: 

• Conditions and arrangements for registration, approval and 

control of establishments (CA) 

• General rules on feed hygiene (Good practices and HACCP) 

flexibility 

• Conditions and arrangements ensuring traceability of feed 

along the feed chain

Detail on feed sector 

• Financial Guarantees for FBO (insurance, other) 

• Flexibility for feed manifacturing including associated 

operation at primary production level for his exclusive use* 

• Feeding practices (SOP)

Feed business at level of primary 

production Regulation (EC) 

183/2005, Art 5(1) & Annex I 

• Hygiene provisions (Good practices) 

• Record keeping

Feed business at level of primary 

production 

Regulation (EC) 183/2005, Art 5(1) & Annex I 

‣ Good Practices: facilities and equipment, 

personnel, quality control, storage and 

transport, record keeping, complaints and 

product recall… 

‣ Hazard analysis and critical control points 

(HACCP) system principles

RESIDUES AND 

CONTAMINANTS

What does residue mean? 

Dir. 96/23 

• 'residue' shall mean a residue of “ substances having a 

pharmacological action, their metabolites and other 

substances transmitted to animal products and likely to be 

harmful to human health” 

Residues are substances that can occur in foodstuffs as a side effect of using 

veterinary medicines or phytosanitary products. They are unwanted traces of 

medicines or plant protection products or derivatives thereof which remain in the 

final product. 

• Of veterinay drugs: 

– Antibiotics, antiparasites, sedatives, disinfectant… 

• Of phytosanitary products

Regulation 

315/1993 

What does contaminant mean? 

• “Contaminants are substances that can unintentionally enter food 

during its production or marketing. These can include environmental 

pollutants, such as dioxins and heavy metals” 

• E.g: mycotoxins, benzopirenes, dioxins, hydrocarbures… 

• 'Contaminant' means any substance not intentionally added to food 

which is present in such food as a result of the production (including 

operations carried out in crop husbandry, animal husbandry and 

veterinary medicine), manufacture, processing, preparation, 

treatment, packing, packaging, transport or handling of such food, or 

as a result of environmental contamination.

Example: cycle of contaminant

Residue analysis importance 

• Sanitary importance 

– Participation of all involved parts of the whole food chain 

• Aquaculture farmers, veterinarians, legislators, 

laboratories, judges, consumers… 

• Comercial importance: residues control affects trade 

products of animal origin. 

– Differences between countries depending on drugs 

viability, analytic methods…

EU legislation 

• Directive 96/23/EC 

On measures to monitor certain substances and residues thereof in live 

animals and animal products 

• Decision 2002/657/EC 

Implementing Council Directive 96/23/EC concerning the performance of 

analytical methods and the interpretation of results 


Laying down a Community procedure for the establishment of maximum 

residue limits of veterinary medicinal products in foodstuffs of animal 

origin, repealing Reg. 2377/1990 and … 

• Regulation 37/2010 

On pharmacologically active substances and their classification 

regarding maximum residue limits in foodstuffs of animal origin

EU legislation 

• Directive 96/23 legal framework control of residues in products of 

animal origin 

• Requires Member States to develope a detection plan of residues 

depending on animal species and risks 

• Sample system depending on: 

Previous results 

Region situation 

Evidence of abuse of substances … 

• Groups to be checked: 

• Veterinary drugs (MLRs, Annex I, Table 1 Reg. 37/2010) 

• Forbidden drugs (Annex I, Table 2 Reg. 37/2010) 

• β-agonists and forbidden drugs (zero tolerance) 

• Enviromental contaminants (dioxins, heavy metals, 

colorants…)

EU legislation: Directive 96/23 

• Group A: Substances having anabolic effect and unauthorised substances 

• Group B: Veterinary drugs and contaminants 

(1)Antibacterial substances, including sulphonomides, quinolones 

(2)Other veterinary drugs 

(a) Anthelmintics 

(b) Anticoccidials, including nitroimidazoles 

(c) Carbamates and pyrethroids 

(d) Sedatives 

(e) Non-steroidal anti-inflammatory drugs (NSAIDs) 

(f) Other pharmacologically active substances 

(3) Other substances and environmental contaminants 

(a) Organochlorine compounds including PCBs 

(b) Organophosphorus compounds 

(d) Chemical elements 

(d) Mycotoxins 

(e) Dyes 

(f) Others

Veterinary drugs residues 

• For the using of a veterinary drug in animals destinated to 

human consumption, its active principle must be in: 

Annex I, Table 1, REGULATION (EC) 37/2010 on 

pharmacologically active substances and their 

classification regarding maximum residue limits in 

foodstuffs of animal origin 

The use of any substances included in Annex I,Table 2, is 

forbidden in EU (chloranphenicol, nitrofuranes and their 

metabollites)

Regulation (EEC) 37/2010 

on pharmacologically active substances and their classification 

regarding maximum residue limits in foodstuffs of animal origin 

• Annex I, Table 1: Allowed substances – with and 

without MRLs 

Antibiotics (streptomycin), antiparasites(albendazol), 

anti-inflammatories (carprofen)… 

• Annex I, Table 2: Prohibited substances 

Aristolochia spp, chloramfenicol, chloroform, 

clorpromazine, colchicine, dapsone, dimetridazole, 

metronidazole, nitrofurazone, ronidazole.

MRL 

• Determination establish residues and contaminats official 

limits that don't mean a risk for human health. Depend on 

substance toxicity. 

• EMA (European Medicines Agency) (formerly EMEA): 

scientific organ which establish veterinay drugs MRL 

http://www.ema.europa.eu/

MRL 

• No MRL for an active substance for every specie: 

Cost/benefit problems. Limit use of drugs 

“Minor spp” (horses, rabbits, bees, fishes…) or rare 

diseases 

“Cascade procedure”

AQUACULTURE VETERINARY DRUGS 

RESIDUES AND CONTAMINANTS

Aquaculture & veterinary drugs 

• Codex Guidelines: 

“ Any veterinay drug for aquaculture must comply with national regulations 

and international guidelines” (in accordance with the International Code 

Recomended of practices of control the Use of Veterinary Drugs CAC/RCP 

38-1993). 

The regulation of the use of these substances must go on in accordance 

with Codex Guidelines for the Establishment of Regulation Programme for 

the Control of veterinary drugs residues on food (CAC/GL 16-1993) 

• Veterinary drugs in aquaculture: 

“whatever active substance applicated or administrated to any animal, in 

particular those destinated to food production like fishes and crustaceans, 

for therapeutic purpose or disease diagnosis”

Good Practices in the use of Veterinay 

Drugs (GPVD) in aquaculture 

• Vigilance in the compliance of withdrawal periods in fish batches 

• Use drugs and medicated feeds under manufacturer instructions 

• National Register on prescribed and dispensed medicines 

• Prescription according national legislation 

• Control of conditions of storage and transport 

• Drugs records 

• If the concentration is higher than the MRL, the harvest should be put off 

• All fishery products that don't comply with national requirements about 

drugs residues should be disposed

Responsible use

Use of drugs in aquaculture 

Example - Regulation (EEC) 37/2010 application 

• Veterinary drugs in salmonids and other fishes: 

Annex I, Table 1, Free use: formaldehyde, hydrogen peroxide, 

chlorure sodium, magnesium sulphate… 

Annex I, Table 1, with MRL: amoxicilin, flumequine, sarafloxacine 

(salmonids), trimetroprim… 

Annex I, Table 2, Prohibited: chloramfenicol, chloroform… 

• Minor spp: cascade procedure 

Give an animal or group of animals an authorized veterinary drug for 

another spp or diferent disease; or human drug, or magistral 

prescription, preparation or oficinal prescription for veterinay use. 

Veterinary will establish a withdrawal period not lower than 500 

degree-day for flesh.

Management of Veterinary Drugs 

and other Chemicals 

Veterinary Drugs, medicated feeds, chemical and 

biological substance are: 

• duly recorded 

• supervised by qualified expert 

• by adequate language, labeled with clear information. 

• adequately stored 

• verified by adequate testing for withdrawal periods and 

residues

Food safety hazards related to 

aquaculture residues 

• Antibiotic residues: 

Used to fight against diseases 

High use before 1990 

Vaccines against principal diseases decrease the use 

Antimicrobial resistances 

“Integrated Agriculture Systems” (pigs+poultry+aquaculture): 

leavings of food can be feed for fishes 

Commission: more antibiotical analysis in aquaculture



• Malachite green : 

Toxic chemical primarily used as a dye 

To treat fungal infections. Great effectivity in fish 

Unathorized as veterinary drug. 

Carcinogenic 

Banned in EU since 2001 

Detection in fish and products malachite and the 

metabollite leucomalachite green 

There is also “crystal violet” in eels 

MRPL = 2 ppb 

Findings in salmon and catfish (bagre) 

Also in fish coming from China



• Environmental contaminants: 

– Heavy metals: 

• E.g. methyl-mercury (not accumulate in fat tissues, 

concentrate along years) 

• Accumulation in food chain 

• Uncontrollable except decreasing atmospheric pollution 

– PCBs and dioxins: persistent organic contaminants 

(industrials) 

• Accumulation in fat 

• Tuna, mackerel, salmon, herring…

RESIDUES MONITORING 

PROGRAMME

Residues Monitoring Programme 

• Establish control measures of substances and 

residues which can be administrated to animals and 

by this way can be detected in whatever phase of 

food chain, in alive animals and their products (CA) 

• Establish business operators responsibility in 

relation to farmer sector.

Residues Monitoring Programme EU 

• Directive 96/23 establishes measures to 

monitor certain substances and residues 

thereof in live animals and animal products 

• A central organization must: 

• Design national plan 

• Coordinate central and regional activities 

• Recover necessary data 

• Send plans y results to EC

Residues Monitoring Programme 

Directive 96/23/EC 

• Residues of unauthorised or banned substances e.g. 

hormones, steroids … Directive 96/22/EC 

• Residues of permitted veterinary drugs in excess of 

the maximum permitted limits (MRL) e.g. antibiotics, 

anticoccidiostats … Regulation 37/2010/EC 

• Environmental contaminants e.g. heavy metals, 

dioxins, etc. Regulation 1881/2006/EC 

Pesticides Regulation 396/2005/EC

EU FINDINGS 2007- 

2010

Principal findings EU 2010 

• Similar number and distribution of NC than previous years 

• Slight decrease of NC for steroids, resorcylic acid lactones, 

anticoccidials, organochlorine compounds and mycotoxins 

• Increment of NC for chemical elements (mainly heavy metals) 

• Green malachite problem continues, its prevalence 

continues decreasing slowly. In many cases the research 

has not identified illegal use and its presence can only be 

understood by the long persistence of green leuco malachite 

in water and ground (depending on the concentrations and 

later researches)

Aquaculture Results 2008 

2010 2009 2008 2007 

UE production 

(tons) 

622 032 627 109 644 875 602 555 

Samples directed 8 668 8 606 8 751 9 257 

NC directed 41 61 75 69 

Samples 

suspected 

171 335 235 344 

NC suspected 26 57 116 122

Non-compliant Aquaculture 

Results 

2010 2009 2008 2007 

A3. Steroids - 2 9 2 

A6. Prohibited 

substances 

1 

AMOZ 

- 1 

Chloranfenicol 

3 

Chloranfenicol 

B1. Antibacterials 1 9 8 10 

B2a. Antihelmintics - 3 2 - 

B3a. Dioxins 2 3 4 4 

B3c. Heavy metals - 4 10 3 

B3e. Malaquite 

green 

37 / 26 40 / 57 41 / 112 47 / 117

2010

2010

Laboratory network in the EU 

Anabolics 

Sedatives 

Beta-agonists 

NSAIDs 

Coccidiostats 

Antibiotics 

Malachite green 

Heavy metals

HEALTH STATUS

Health National Competent Authority tasks 

Directive 2006 / 88 

• Authorisation Art.4 granted by CA to Aquaculture 

Production Business Operator based on: traceability, GHP, 

definition of epidiemological unit, surveillance scheme, 

contingency plan. 

• CA cover the following: APBO art 10, FBO art 4, 

Ornamental APBO art 21 , transport art 8, wild population 

Art 15-36-4 , game fish lake art 15. 

• Regular CA official controls health inspection: 

Clinical diagnosis 

Samples 

Register health status 

Releasing certificate

Aquaculture Production Business Operators tasks 

Directive 2006 / 88, Art 8, 9 &10 

APBO tasks: 

• Traceability: mortality, animal 

movements, transport water exchange. 

• Good Hygiene Practices 

• Risk based health surveillance scheme

Stamping out of infected farm, 

disinfection for trucks

Official control and animal health surveillance 

Directive 2006 / 88, Art 7 &10 CA 

• Animal health surveillance scheme (CA) 

based on: risk analysis, register at national level, 

control programme and vaccination, introduction 

from EU producers 

• Third countries same system than EU with audit 

by EU for local CA (Art 58) 

• Animal health certification: placing on the 

market, processing, partial processing, restoking, 

parents, gametes, quarantine, …

Health status of aquaculture zones or compartments 

Directive 2006 / 88, Annex III Part A 

Health 

category 

Health status 

Intro 

from 

Dispatch 

to 

I Disease free (Art 49, 50) I I – V 

II 

Surveillance programme (Art 

44) 1 

I 

III + V 

III 

Undetermined: ”Not known to 

be infected but not subject to 

eradication programme for 

achieving disease free status 

I-II-III 

III + V 

IV 

Eradication programme (Art 

44) 2 

V Infected (Art 39) I - V V 

I 

V

Keeping Records 

 

 

 

 

 

 

 

 

Pond management 

Notification and minimum measures for control of diseases 

Slaughter and processing 

Type, origin and use of feed and feed ingredients 

Veterinary drugs or other treatments administered 

Eggs, fry and fingerling traceability 

Buyers of final products 

… any activities connected with health status

ANIMAL BY-PRODUCTS NOT 

INTENDED FOR HUMAN 

CONSUMPTION

Animal by-products (ABP) not intended for 

human consumption 


Health rules as regards animal by-products 

and derived products not intended for human 

consumption. 


Implementing Regulation (EC) 1069/2009

Aim 

• ABPs can spread animal diseases or chemical 

contaminants, and can be dangerous to animal 

and human health if not properly disposed of. 

• EU rules regulate their movement, processing and 

disposal. 

• ABPs are categorised according to their risk using 

the basic principles in Regulation EC 1069/2009

Basic principles 

• ABP not intended for human consumption 

don’t come back to the food chain (directly 

or indirectly) 

• Recycling intraespecie is forbidden. Animals 

can’t be feeded on protein of their own 

specie 

• Management, use, elimination without 

spread harmful agents for public health, 

animal health and environment

Measures to apply 

Depend on ABPs category is necessary to handling: 

• Production 

• Collection 

• Transport 

• Storage 

• Use 

• Disposal 

EU national authorities make official controls on 

ABP imports from non-EU countries.

What is new 

• Clear requirements based on ABPs' technical standards 

• Enforcement measures for new risk-proportionate approach 

• End point in manufacturing chain for processed and 

packaged pet food, biodiesel, tanned hides and skins and 

other products 

• Better traceability from food production; 

• Risk-proportionate solutions for transport, processing, use 

and imports

Regulation objective: 

Preserve… 

• Public Health 

• Animal Health 

• Environment

To achieve: 

• Correct treatment of Animal by-products 

not intended for human consumption 

• Suitable handling of processing 

products. 

• Identification, registration, approval and 

control of agents. 

• Traceability: documentation, recording, 

labelling.

Classification 

Bases for 

classification 

Examples 

Possible uses 

BSE risk 

CATEGORY 1 

Unknown hazards or 

related to illegal 

substances or 

environmental 

pollutants. 

Material Specified of Risk 

in ruminants 

Specific treatment and 

controlled destruction 

CATEGORY 2 

Other hazards related to 

animal diseases or 

residues of veterinary 

medicinal products 

Dead animals in farms 


controlled destruction 

or possible uses (e.g. 

manure, production of 

bio-gas, ...). 

CATEGORY 3 

Healthy animals with 

ante and post-mortem 

inspection 

Procesing plants vessels 

products suitable for 

human consumption, but 

they aren’t destined to 

such purpose for different 

reasons 


possible uses (e.g. animal 

feed for pets, leather 

tanning, ...).

Dangers derived from their use 

• Biologicals: pathogens 

(zoonoses, BSE…) 

For Public Health 

For Animal Health 

For Enviroment 

• Residues of drugs 

(resistances, 

intolerances, allergies) 

• Contaminants (dioxins) 

• Water contamination 

(high content of organic 

matter) 

• …

Dangers derived from their 

elimination 

For Public Health 

For Animal Health 

For Enviroment 

• Incineration, pollution, 

greenhouse effect 

• Dumps: water 

contamination, high 

oxygen biological 

demand 

• …

Objectives 

‣ Food Safety: 

Coherence with the White Book of Food Safety and BSE legislation. 

Traceability. 

“Mad cows, nevermore” 

‣ Animal Health: 

Threat of highly contagious and exotic/emergent diseases 

“Prevent, better than treat” 

‣ Environment: 

Connect with residues legislation, principle of respectfully to the 

environment 

“Who contaminates, pays”

THANK YOU for YOUR ATTENTION 

manfrin@izsvenezie.it

Control of food safety in aquaculture products

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