The Good Practice Guide to Vessel Based Molluscan ... Shellfis… · Web viewThe establishments used for food production must be either registered for primary production and associated

The Development of a Good Practice Guide for Molluscan Shellfish Cultivation and Hand Harvesting Operations

1. Introduction

The development of Good Practice Guidelines (GPGs) to assist the fish industry to achieve optimal operating performance is an ongoing process. Seafish have been instrumental in establishing a programme to produce a series of Good Manufacturing Practice guidelines for the fishing and related industries. The guidelines for the primary production sector form the basis of procedures to be followed under the Responsible Fishing Scheme operated by Seafish through the British Standards Institutes’ publicly available specification.

Seafish GPGs currently cover the following primary production sectors; pelagic fishing, demersal fishing, Nephrops fishing, and the handling and storing of live crustacea. The aim of the GPGs is to help businesses to achieve high operating standards by recognising that their “catch” is a food product, and detailing practices that ensure product safety and quality together with efficient use of the natural resource. The provisions identified within GPGs aim to help fishermen and other primary producers meet their legal obligations with respect to the harvesting, holding and distribution of food products, and ensure overall product safety.

In order to increase the scope of the Seafish Responsible Fishing Scheme, and assist molluscan shellfish businesses, the development of GPGs for molluscan shellfish is required. The wide range of molluscan shellfish prosecuted in the UK and the diverse production techniques indicate the difficulty of establishing a single comprehensive GPG. Molluscan shellfish include bivalves (clams, mussels, oysters etc.) gastropods (whelk, winkle etc.) and cephalopods (squid, cuttlefish etc.). Production techniques range from hand gathering and diving, to offshore dredging activities and for some species cultivation operations predominate. In order to encompass the diverse range of operating conditions embraced by molluscan shellfish producers, two GPGs are required.

This report encompasses the development of a GPG for molluscan shellfish produced through hand harvesting of wild resources and cultivation activities. Consequently the species and activities considered are principally for live bivalve and gastropod molluscs.

The development of a GPG for primary producers (fishermen and businesses from catch to dispatch) operating from fishing vessels and/or associated shore-based facilities, and prosecuting any species of mollusc (bivalve, gastropod, cephalopod) are the subject of a separate report..

2. Purpose and Scope of Good Practice Guides

The primary purpose for the development of GPGs is to help businesses achieve high operating standards and hence ensure their effectiveness within the seafood market. In the context of primary production businesses, this includes the need to meet product quality specifications in addition to ensuring food safety standards are met. Equally operations must be efficient and meet all legal requirements such as staff competency, traceability of outputs, product labelling, and waste disposal procedures etc. In addition consideration must be given as to how and where activities are undertaken in the context of safeguarding natural resources. This is particularly relevant with respect to statutory nature conservation designations and the maintenance of the ecological status of coastal waters. The statutory and non-statutory aspects of good practice must be combined in the operation of each business in order to ensure competitiveness within the market place. In addition the identification of best practice has the potential to be utilised for workplace training purposes and is extremely important in relation to commercial quality assurance schemes. The Seafish Responsible Fishing Scheme is an example of the practical use of GPGs in the context of production assurance, and provides potential benefits for primary producer businesses.

Current EU food hygiene legislation recognises the need for approved guides to good hygiene practice to aid compliance with food law. Regulation 852/2004/EC places the responsibility to identify and control any risks to food safety on the individual businesses. The Regulation encourages the development of GPGs by business sectors and provides for their use in support of the law.

In the context of EU food hygiene legislation it is important for businesses involved in the production of molluscan shellfish products, to recognise their status as a “food business”. The definition is “any business dealing with food” and a “food business operator” is an individual or company responsible for ensuring the requirements of food law are met within the business. In this context fishermen either hand harvesting or operating a fishing vessel together with aquaculture producers are included as “food businesses”.

Equally important is the definition of “primary production” in food law as it relates to the seafood industry. It encompasses any handling of fishery products that does not substantially alter their nature. It applies to all operations on board vessels (excepting factory and freezer vessels), and transport to the first establishment on land. Fishery products remain “primary products” even after slaughter, bleeding, gutting, removing fins, refrigeration, and wrapping. The production, growing and harvesting of live bivalve molluscs and gastropods is also classed as “primary production”, including the transport to a dispatch centre, purification plant or processing establishment.

The one exception to the regulations is the supply of small quantities of primary products by the producer directly to the final consumer. This includes up to 25 tonnes of fishery products or live bivalve/gastropod molluscs per year. However, it is still the

responsibility of the producer to ensure the food is safe and end product standards are met.

The hygiene of foodstuffs regulation (852/2004/EC) does not require HACCP (Hazard Analysis and Critical Control Point) measures to be implemented for primary production activities. However, there is a requirement for national legally recognised Good Manufacturing Practice guidelines to be in place. The regulation encourages the development of national guidelines, their dissemination and use, although uptake by food business operators is voluntary. Specific requirements are identified for the contents of the guidelines in relation to primary production to compensate for businesses not having to apply HACCP measures. The Food Standards Agency in the UK is responsible for reviewing the national guidelines to ensure that they are suitable as guides to compliance for the sectors and foodstuffs covered.

In the context of general industry activities, the development of a GPG for molluscan shellfish hand harvesting and cultivation activities will help businesses comply with food law by establishing a common approach. This will be of particular benefit to the many small and low risk businesses in the seafood industry through hazard identification and control, without the need for HACCP procedures. In addition the broader benefits of establishing good practice for the sectors primary production activities should help businesses to fully exploit commercial development opportunities.

3. Structure of the Good Practice Guide

The following sections of the guide for molluscan shellfish hand harvesting and cultivation activities are structured to encompass best practice for industry operations based on the general characteristics of the sectors. While hand harvesting operations are typically based in the intertidal zone of the foreshore, the GPG also encompasses the potential for hand harvesting from a vessel as may be the case for Scallop diving. Equally cultivation activities typically occur on the intertidal foreshore and sub-tidally from rafts and longlines and may require workboats, potentially both to access sites and serve as transport for harvested products. In this context it is not the method of transport used for the hand harvesting or cultivation of molluscan shellfish that is important, but rather the conditions under which the harvested food products are maintained through each step of the production and distribution chain.

Section 4 outlines the range of statutory measures food businesses are required to adhere to in terms of food safety. In addition requirements for the establishment of shore based facilities including dispatch and purification centres and transport conditions for live molluscs are identified. Key business and mollusc harvesting activities impacted by regulations are detailed, and this includes legislation relating to the environmental impact of production activities.

Section 5 identifies the specific detailed provisions within the legislation that food businesses are required to adhere to, provides a practical interpretation of the meaning for businesses, and describes best practice to ensure food safety, product quality and operational efficiency.

Appendix 1 provides contact details for all government agencies and devolved government bodies responsible for administering and implementing the legislative provisions identified.

Appendix 2 indicates the typical requirements for vessel/establishment and crew hygiene measures aimed at achieving best practice for food safety.

4. Summary of Legislation for Harvesting and Cultivating Molluscan Shellfish

In order to assist food businesses identify the general legal requirements for the production and placing on the market of molluscan shellfish, the individual UK legislative provisions have been identified. The specific details of these measures and implications for food businesses can be found in section 5.

It should be recognised that within the UK, England and the devolved governments (Scotland, Wales, Northern Ireland) are required to implement EU directives and have to interpret and implement EU regulations. In addition national legislation can be created and enforced provided that it meets or exceeds EU minimum requirements. The legislative provisions created by devolved governments in addition to EU or UK measures should be established by contacting the appropriate government departments (see Appendix 1).

It is outwith the scope of this document to cover legislation relating to the licensing of harvesting activities in terms of vessel operation and safety. The requirement for an appropriate fishing vessel or workboat licence is the subject of both national and regional government provisions. Equally access to molluscan stocks through fisheries management provisions is not described. For specific guidance on vessel licensing the respective government departments should be consulted (see Appendix 1). In the context of marine safety the Maritime and Coastguard Agency have responsibility for UK vessels and coastal activities, and the Department of Trade and Industry Health and Safety Directorate for commercial diver based activities. With respect to inshore fisheries management, district Sea Fisheries Committees control coastal waters (0-6NM) in England and Wales. In addition local government throughout the UK and owners of foreshore and seabed rights can place controls on the location of hand harvesting and cultivation activities. Devolved governments in the remainder of the UK control similar fisheries management areas, with DEFRA responsible for overall UK fisheries management legislation and territorial waters (see Appendix 1 for contacts).

4.1 Food Safety and Food Hygiene Legislation

Regulation 178/2002/EC laying down the general principles of food law, establishing the European food safety authority and laying down procedures in matters of food safety.

This is the principle overarching regulation, which contains general definitions applicable to other regulations. This is the main element of food law extending throughout the food chain from primary production to retailing, and encompasses distribution/transport. Fishing and cultivation are determined as primary production. The regulation requires that food should not be unsafe or be misleadingly presented. The responsibility is placed on food business operators to ensure compliance with food law. There is also a requirement that food products should be traceable at all stages of the production and supply chain, with food businesses able to withdraw or recall food that fails to comply.

Important definitions:

“Food” an animal becomes food when it is prepared for placing on the market for human consumption, typically for molluscs at the point of capture or harvesting.

“Primary production” this covers fishing, gathering and cultivation of molluscs and includes transport of products and live animals from the place of production to a dispatch/purification centre, provided this does not substantially alter the products nature.

“Food business operator” is the person or company responsible for ensuring that the requirements of food law are met by the business. Fishermen and cultivation businesses are defined as food businesses. Most food business operators carrying out primary production must comply with the general principles of food law in Regulation 178/2002/EC. Higher risk products such as live molluscs face additional requirements identified within EC/853/2004 (see below).

“Traceability” this is the ability to trace the food, feed, food-producing animal or substance to be included in food back through all stages of production, processing and distribution. Traceability will enable product recall after the product is placed on the market.

Regulation 852/2004/EC on the hygiene of foodstuffs.

The regulation sets out the requirements applicable to any food business for basic hygiene, and includes a specific set of hygiene rules for primary production.

The general provisions identify the principle responsibility for food safety resting with the food business operator, and the necessity to ensure food safety throughout the food chain starting with primary production. The registration of food businesses and the implementation of safety controls based on Hazard and Critical Control Point (HACCP) principles by food business operators is outlined (although strict HACCP measures are not required for primary production).

Small quantities (<25 tonnes) of primary products sold by the producer directly to the final consumer are exempt from the regulation. However, there is still a general requirement that the products are safe and end product standards are met especially for higher risk products such as live molluscs (see 853/2004/EC). The regulation supports the development and use of officially approved guides to good practice especially for primary production. Food businesses must register with the Local Authority before beginning operations.

Regulation 853/2004/EC laying down specific hygiene rules for food of animal origin.

The regulation establishes detailed prescriptive measures for products of animal origin including primary production and specific higher risks such as live molluscs. (This replaces the UK Food Safety (Fishery Products and Live Shellfish) (Hygiene)

Regulations 1998). There is an exemption for food businesses selling direct to the final consumer (retailers) and for fishery products. However, rules do apply for retail sales of live molluscs (and gastropods). Businesses subject to the regulation including live bivalve mollusc purification and dispatch establishments are required to be approved by the Local Authority before trading can begin. The regulation lays down detailed rules for the operation of dispatch and purification centres for live molluscs and for transport between production areas and the first establishment. There is an exemption for the supply of small quantities (<25 tonnes PA) of primary products directly from the producer to the final consumer, or to local retail establishments that directly supply the final consumer. However, it is the responsibility of the food business operator that the food meets end product standards. With respect to live molluscs they must have been harvested from “class A” waters and be suitable for direct human consumption without purification.

Important definition:

“Products of animal origin” in the context of fishery and aquaculture products these include live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption.

Regulation 854/2004/EC laying down specific rules on the organisation of official controls on products of animal origin intended for human consumption.

This regulation deals with enforcement procedures to ensure safe food. Provision is made for official controls and prescribed enforcement procedures to be carried out by competent authorities in respect of Regulation 853/2004/EC.

Regulation 882/2004/EC on official controls to ensure the verification of compliance with feed and food law, animal health and welfare rules.

This regulation deals with enforcement procedures to be carried out by competent authorities in respect to regulations 852/2004/EC and 853/2004/EC.

Regulation 2073/2005/EC on microbiological criteria for foodstuffs.

The regulation sets acceptable microbiological limits for specific foodstuffs. Food safety management plans such as HACCP or Good Manufacturing Practice, are required to meet the set criteria. The criteria have been established to ensure food is safe and to implement official controls. Cooked and live molluscan shellfish have specific microbiological criteria to be achieved.

4.1.1 UK Legislation Supporting European Regulations

The Food Safety Act, 1990 is the vehicle by which Regulation 178/2002/EC is enforced within the UK. In addition exempt products in the context of “small quantities” of live molluscs or fishery products under Regulations 852/2004 EC and 853/2004/EC when placed on the market are subject to The Food Safety Act, 1990 to ensure end product

standards are met. The Food Safety Act 1990 (as amended) prohibits the placing on the market of unsafe food and prohibits food being presented or labelled in such a way as to mislead the consumer.

The Fish Labelling Regulations, 2003 apply to England and the devolved administrations (Scotland, Wales and N. Ireland) and serve to enforce Regulation 2065/2001/EC pertaining to the identification of species, production method and location of production for foodstuffs placed on the market. When molluscan shellfish are the subject of retail sale to the final consumer they must be accompanied by labelling or documentation giving details of their common name, production method (caught at sea or farmed) and the production area.

The General Food Regulations, 2004 serve to enforce Regulation 178/2002/EC and provide the requirement for traceability and recall of unsafe food.

The Food Hygiene (England) Regulations, 2006 (similar in Scotland, Wales, Northern Ireland) provide enabling legislation for EC food hygiene legislation.

4.2 Water Quality and Environmental Legislation

Directive 92/43/EC on the conservation of natural habitats and of wild fauna and flora.

Known as the “Habitats Directive” which together with Directive 79/409/EC on the conservation of wild birds, forms a network of European Marine Sites (EMSs) known as Natura 2000, which aim to protect designated habitats and species. Statutory bodies have the duty to avoid any deterioration of sites in terms of the species or habitats of interest. In UK coastal waters (12NM) the “Habitats Directive” together with other national statutory nature conservation designations are enacted through the “Conservation (Natural Habitats, &c) Regulations, 1994”. In addition Special Areas of Conservation (SAC) throughout territorial waters are enacted through “Offshore Marine Conservation (Natural Habitats, &c) Regulations, 2007”. The “Habitats Directive” requires that for any “plan or project” having a significant effect on an EMS an “Appropriate Assessment” (AA) is required to be undertaken by the competent body authorising the activity. In the context of mollusc harvesting and cultivation the AA would identify activities potentially having a deleterious effect on the site.

Directive 60/2000/EC establishing a framework for Community action in the field of water policy.

Known as the “Water Framework Directive” it seeks to achieve river basin management plans for all fresh and coastal waters. In the context of coastal waters the aim is to achieve “good ecological status” where waters have not been heavily impacted by man, and “pristine condition” in all other areas. In the context of molluscan harvesting and cultivation activities there will be a requirement that the “good ecological status” is not

adversely impacted by operations. In England, Wales and Northern Ireland this designation extends to 1NM in Scotland 3NM.

Directive 88/2006/EC Aquatic Animal Health Directive

This directive seeks to improve the biosecurity of aquaculture operations and replaces the shellfish stock health measures implemented under Directives 91/67/EEC and 95/70/EC. Under the Directive shellfish cultivation businesses will require to be authorised and standardised methods of operating must be implemented. This includes record keeping, biosecurity best practice, reporting of shellfish diseases and disease surveillance. The Fish Health Inspectorate of DEFRA (and equivalents for devolved governments) will be responsible for administering the Directive. The movement of shellfish from a cultivation site must be recorded together with mortality levels and transportation will be the subject of detailed biosecurity measures to reduce the risk of disease spread. Surveillance for the important shellfish diseases will be conducted on a risk basis with the movement of live shellfish for ongrowing attracting increased surveillance in comparison to production for human consumption.

4.2.1 UK Legislation Impacting Molluscan Shellfish Producers

The Water Industry Act, 1991 seeks to regulate the release of trade effluent from shore based holding or processing facilities. In the context of the public drainage system all waste liquids (including “clean” seawater) from shore-based premises are considered as “trade effluent” and require a consent to discharge licence.

The Groundwater Regulations, 1998 seek to regulate the release of trade effluent (see above) to natural surface waters and ground waters and require a consent to discharge licence.

The Welfare of Animals Transport Order, 1997 (SI 1480, 1997). Within the general provisions it is stated that no person shall transport an animal in any way, which causes or is likely to cause injury or unnecessary suffering. Any person carrying cold-blooded animals shall do so in accordance with Schedule 6, which states that, “cold-blooded animals shall be transported under such conditions (in particular with regard to space, ventilation, temperature and security), and with such a supply of oxygen and liquid as are appropriate for the species concerned” In terms of transport by air freight the Order requires that conditions meet the standards established by the International Air Transport Association (IATA).

5. Legislation and Good Practice for Mollusc Harvesting and Production

The information in this section aims to identify good practice for food business operators’ hand harvesting and cultivating molluscan shellfish, in the context of statutory measures relating to harvesting activities.

Information presented indicates the legal responsibilities of those in business undertaking hand gathering or cultivation harvesting activities and who in the context of the food hygiene legislation, are considered to be food business operators, undertaking primary production of food. Guidance is provided on suitable facilities and hygiene practices for hand harvesting operations of wild molluscan shellfish, and the harvesting and placing on the market of cultivated shellfish, including the requirement for premises and facilities suitable for operations onshore. The working practices associated with food business operations include those at sea and onshore and cover the transportation and dispatch of live molluscs and distribution of fresh molluscan products. In addition legislation relating to the potential impact of fishing and cultivation activities with respect to nature conservation obligations, the maintenance of the water environment, and biosecurity for cultivation businesses, is detailed and best practice measures identified to fulfil statutory obligations.

It should be noted that the information on statutory obligations is not intended to be a definitive interpretation of the law in the UK. This can only be provided by seeking the opinion of the courts. It is the ultimate responsibility of individual businesses to ensure that they comply with current legislation pertaining to their specific operations, and areas of geographic activity.

The information has been laid out in a three-column format;

The left hand column identifies the current legislation governing an identified activity or facility. Sub headings and associated legislative text describe required actions for compliance.

The middle column provides a practical interpretation of the legal statement. This outlines the production activities encompassed and actions necessary for businesses to undertake in order to comply with the law.

The right hand column provides an assessment of good practice for commercial operations, which meet or exceed the minimum requirements of the legislation.

The commercial activity to which legislation and good practice relate has been subdivided to allow focused access to the information. The key categories identified are;

Operations at sea (including harvesting activities on the foreshore) Operations onshore (post harvest treatment and distribution requirements)

Where appropriate these categories make reference to the requirements for live molluscs as distinct from molluscan fresh, prepared or processed fishery products.

The definition of molluscan shellfish products in the context of legislative provisions in comparison to common names and scientific descriptions can lead to confusion. This is particularly relevant where products may be offered for sale in a live, fresh, prepared or processed state. It should be appreciated that with respect to the law and food safety provisions there are only two definitions for molluscan shellfish products. These are “live bivalve molluscs” which covers all bivalve molluscs, and in the main includes gastropods, tunicates and echinoderms, and “fishery products” which encompasses all molluscan shellfish. In order to provide clarification of the legal definition in relation to the condition of some typical molluscan shellfish when placed on the market reference should be made to the table below.

Table – Molluscan Shellfish Products and Legal Definitions

Common Name Scientific Description

Legal DefinitionLive Fresh or Processed

Oyster Bivalve mollusc Live Bivalve Mollusc Fishery ProductMussel Bivalve mollusc Live Bivalve Mollusc Fishery ProductScallop Bivalve mollusc Live Bivalve Mollusc Fishery ProductClam etc. Bivalve mollusc Live Bivalve Mollusc Fishery ProductWinkle Gastropod mollusc Live Bivalve Mollusc Fishery ProductAbalone Gastropod mollusc Live Bivalve Mollusc Fishery Product

5.1 Hand Harvesting and Cultivation Operations at Sea

Food business operators undertaking harvesting and handling operations of wild or cultivated molluscan shellfish must ensure they comply with the relevant legislation. In the context of food safety requirements, operations include the movement of harvested food products to the first establishment onshore, and/or the potential use of a vessel or offshore facility as a dispatch/processing centre. Detailed application of the legislation as applied to live bivalve and gastropod molluscs (such as mussel and whelk) as opposed to shellfish prepared or processed before placing on the market is identified where appropriate.

5.1.1 Hand Harvesting and Cultivation Operations at Sea (Food Safety Requirements)

Legal Requirement Interpretation Recommended “Best Practice”Regulation 178/2002/EC laying down the general principles of food law etc. enforced through;UK Food Safety Act, 1990 (as amended)UK General Food Regulations, 2004

Regulation 178/2002/EC replaces the food safety requirements found in the UK Food Safety Act, 1990. It identifies a food business operator as a person or company responsible for ensuring the requirements of food law are met by the business.Fishermen who harvest molluscs and those undertaking shellfish cultivation activities are considered to be food business operators. The regulation applies to all those who handle food products including those on board vessels.

Food business operators harvesting molluscan shellfish must comply with the Articles identified within the Regulation as detailed below.

5.1.1 Hand Harvesting and Cultivation Operations at Sea (Food Safety) (Cont.)

Legal RequirementRegulation 178/2002/EC

Interpretation Recommended “Best Practice”

Article 14. Food Safety Requirements

Article 14.1 Food shall not be placed on the market if it is unsafe.

Article 14.2 Food shall be deemed to be unsafe if it is considered to be:

(a) injurious to health;(b) unfit for human consumption.

Article 14.3 In determining whether any food is unsafe, regard shall be had:

(a) to the normal condition of use of the food by the consumer and at each stage of production, processing and distribution;

(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

Molluscan shellfish at the point of harvesting are considered to become a food product either if alive or in a fresh form.

Molluscan shellfish harvested for food must not be contaminated with substances harmful to human health.

When considering health risks posed by molluscan shellfish allowances can be made for intended processing that would remove the risk

Molluscan shellfish would not be considered to be unsafe if the consumer is provided with sufficient information on how to make it safe. Information about risks of which the consumer should already be aware does not have to be included.

Food business operators are required to be competent in, and to train and supervise employees to recognise and comply with, basic food hygiene standards. It is the employees’ responsibility to adhere to instructions in order to minimise any personal liability from their actions.

Only harvest molluscs from uncontaminated areas (either natural or man made contaminants). Do not allow the catch to be contaminated or spoil at the point of harvest or during transportation.

Food business operators must keep informed about food safety risks associated with the food products they are handling. Where processing is intended, food business operators must be aware of food safety risks not removed by the identified processing.

Food business operators must become familiar with available information concerning food safety risks associated with live and/or fresh molluscan shellfish. Reference should be made to Seafish guidance www.seafish.org On Land > legislation > guidance > Hygiene

http://www.seafish.org/




Article 14.4 In determining whether any food is injurious to health, regard shall be had:

(a) not only to the probable immediate and/or short-term and/or long-term effects of the food on the health of the person consuming it, but also to subsequent generations;

(b) to the probable cumulative toxic effects.

Molluscan shellfish intended for human consumption may be considered unsafe if they contain contaminants that may be immediately harmful, or if consumed over a long period of time, or have short-term and/or long-term effects.

Food business operators must be familiar with information regarding molluscan shellfish contaminants making them harmful if consumed. Correct handling, storage and distribution practices must be implemented to prevent spoilage. Food business operators must keep informed of health warnings relating to harvesting restrictions for molluscan shellfish.

Article 18. Traceability

The traceability of food shall be established at all stages of production.

The ability for dangerous or contaminated foods to be recalled from the food chain must be established. This requires food businesses to keep records showing who and what food products were supplied to them, and to whom they supply food products. The records must be kept available for inspection by relevant authorities if required.

Food business operators must keep comprehensive records which detail when and to whom they supply molluscan shellfish. Specific requirements must be met for the documentation relating to the supply of live animals. Reference should be made to Seafish guidance www.seafish.org On Land > legislation > guidance > Labelling and Traceability

Article 19. Responsibilities for Food: Food Business Operators

If a food business operator considers or has reason to believe that a food is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food and inform the competent authorities there-of.

Food businesses must immediately recall and/or withdraw food from the market if it does not comply with food safety requirements. Relevant authorities must be immediately informed.

Food business operators must ensure consignments of harvested shellfish meet all food safety requirements. If a food safety problem occurs the records kept must allow the products to be immediately identified and recalled. The relevant food authority must be immediately informed.



Legal Requirement Interpretation Recommended “Best Practice”Regulation 852/2004/EC on the hygiene of foodstuffs, (as amended) enforced through;UK Food Hygiene Regulations, 2006

This Regulation lays down the basic rules for the hygiene of foodstuffs. It applies to food businesses throughout the food chain and includes food handling at sea and onshore.

Molluscan shellfish food business operators must be informed of and comply with this Regulation.

Chapter I General ProvisionsArticle 1. Scope

Article 1.1 This Regulation lays down general rules for food businesses on the hygiene of foodstuffs, taking particular account of the following principles:

(a) primary responsibility for food safety rests with the food business operator;(b) it is necessary to ensure food safety throughout the food chain, starting with primary production;(e) guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of HACCP principles;

Article 1.2 This Regulation shall not apply to:(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

The Regulation applies to all food business operators including those undertaking hand harvesting or cultivation of molluscan shellfish, with the individual food business operator directly responsible for the production of safe food. The regulation applies throughout the food chain to all food handlers including transportation and wholesale distribution. The implementation of guides to good practice are designed to support compliance with food hygiene rules based on HACCP (Hazard and Critical Control Point) principles.

The Regulation does not apply to food business operators supplying small quantities of less than 25 tonnes of molluscan shellfish directly to the final consumer. Equally sales to local businesses that supply the final consumer such as fishmongers or restaurants are also exempt. However, food safety end product standards must be met.

Food business operators that harvest and handle molluscan shellfish must comply with the relevant articles of the Regulation as detailed below. Reference should be made to Seafish guidance on the application of HACCP principles for the seafood industry. www.seafish.org On Land > legislation > guidance >Guide to Recent Developments in European Food Law for the Seafood Industry.

While food business operators are exempt from the Regulation if they supply less than 25 tonnes PA of molluscan shellfish to the final consumer, it is the operator’s responsibility to ensure the food is safe and end product standards are met. The UK Food Safety Act, 1990 still applies, and in the case of live shellfish from classified waters, they must come from designated “class A” waters.





Chapter II Food Business Operators’ ObligationsArticle 3. General obligation

Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

The person or company responsible for the operations associated with the harvesting and handling of molluscan shellfish must ensure that all relevant articles of the Regulation are adhered to. This includes the food business owner, operator or employees if they take decisions regarding the operation of the food business.

The food business owner, operator or employees making decisions relating to the safety of molluscan shellfish food products, must be aware of food safety issues especially those associated with live bivalve molluscs. Those responsible for decisions must ensure all aspects of the relevant Good Practice Guidelines are followed.

Article 4. General and specific hygiene requirements.

Article 4.1 Food business operators carrying out primary production and those associated operations listed in Annex 1, shall comply with the general hygiene provisions laid down in part A of Annex I and any specific requirements provided for in Regulation (EC) 853/2004.

Primary production includes fishing and cultivation, and associated operations involve transport, storage and handling at the place of production. Transport of live animals is included, together with delivery of “not substantially altered” primary products from the place of production to an establishment.

Food business operators harvesting and handling molluscan shellfish must comply with the general food safety provisions in Annex 1 Part A of this Regulation (see below). In addition specific food safety provisions contained within Regulation (EC) 853/2004 relating to products of animal origin must also be adhered to.

Article 4.2 Food business operators carrying out any stage of production, processing and distribution of food after those stages to which 4.1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) 853/2004.

Where food business operations exceed those of primary production (such as the operation of a vessel based dispatch centre or processing facility) additional requirements for production, processing and distribution must be met.

Food business operators undertaking activities in addition to primary production identified in Annex I, Part A: 1, principally production, processing and distribution of food, must adhere to the relevant requirements of Annex II of this Regulation and Regulation (EC) 853/2004.

Article 4.3 Food business operators shall as appropriate, adopt the following specific hygiene measures:(a) compliance with microbiological criteria for foodstuffs;

The food business operator responsible for the primary production of molluscan shellfish must ensure the microbiological food safety criteria are met for the specific food products produced. Regulation EC/2073/2005 identifies the microbiological criteria for all relevant molluscan shellfish species.

Food business operators harvesting and handling molluscan shellfish must ensure that food products comply with the microbiological criteria laid down in Regulation EC/2073/2005. Specifically these relate to Salmonella and E.coli in live bivalve molluscs and gastropods, and Salmonella in cooked molluscs.




Article 5. Hazard Analysis and Critical Control Points.

Article 5.1 Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.Article 5.3 Paragraph 5.1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex 1.

Food business operators undertaking primary production should seek to ensure food safety procedures employed are based on Hazard and Critical Control Point (HACCP) principles. However, there is no statutory requirement for full HACCP procedures to be introduced for primary production.

Food business operators must ensure that they implement the recommendations detailed in the Good Practice Guide for hand harvesting and cultivation of molluscan shellfish.Reference should be made to Seafish guidance on the application of HACCP principles for the seafood industry. www.seafish.org On Land > legislation > guidance >Guide to Recent Developments in European Food Law for the Seafood Industry.

Article 6. Official Controls, Registration and Approval.

Article 6.1 Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.

Food business operators must comply with any reasonable requests from their local food authority, made under EC or national legislative provisions.

Food business operators must ensure that they comply with and respond to all reasonable requests from their local food authority i.e. Environmental Health Officer or Port Health Authority.

Article 6.2 In particular, every food business operator shall notify the appropriate competent authority, in the manner the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.

Food business operators must notify their local food authority of their existence within 28 days of commencing production. The authority will require details of the business including the processes undertaken and number of establishments (any unit of a food business) utilised. Registration is to allow local authorities to maintain a register of businesses and establishments in order to plan their inspection duties effectively. Registration cannot be refused or revoked on the basis of one hygiene inspection.

Food business operators undertaking primary production must contact their local food authority (local authority environmental health department or port health authority) at the earliest opportunity and within 28 days of commencing production to ensure the food business is registered.





Article 6.2 Cont. Food business operators shall also ensure that the competent authority always has up-to-date information on the establishments, including by notifying any significant change in activities and any closure of an existing establishment.

Food business operators must notify within 28 days, their local food authority under which they are registered, of any material changes to their business. Such changes would include change of ownership, processes or closure of establishments.

Food business operators must ensure they contact their local food authority at the earliest opportunity and within 28 days, to inform them of any material changes to their business operations.

Article 6.3 However, food business operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required:

(a) under the national law of the Member State in which the establishment is located.

(b) Under Regulation (EC) 853/2004

Approval must be sought by some businesses before they can legally trade. The local food authority can refuse or revoke an approval if the food safety standards are not sufficient. Businesses subject solely to this regulation do not have to gain approval. However, those subject to (EC) 853/2004 need to be approved before trading.

Food business operators undertaking solely primary production and associated operations including transportation must be registered. Those food business operations involving dispatch, purification or processing activities must seek approval from their local food authority before commencing trading.

Article 7. Development, Dissemination and Use of Guides.

Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP principles in accordance with Article 8.The dissemination and use of both national and Community guides shall be encouraged. Nevertheless, food business operators may use these guides on a voluntary basis.

The production of good practice guides for food business operators based on HACCP food safety principles, should be supported by government. The use of such guides by food business operators should be encouraged but uptake is voluntary.

Food business operators should ensure that primary production operations meet or exceed the requirements identified in the Good Practice Guide for Molluscan Shellfish Cultivation and Hand Harvesting Operations.

Article 8. National Guides.Article 8.1 When national guides to good practice are developed, they shall be developed and disseminated by food business sectors:(c) when they concern primary production and those associated operations listed in Annex 1, having regard to the recommendations set out in Part B of Annex 1.

The development of good practice guides by the food business sector concerning primary production are required to encompass the recommendations detailed in Part B of Annex 1 of this Regulation.

Vessel operators harvesting and handling molluscan shellfish must comply with the general food safety provisions in Annex 1 Part B of this Regulation and described below.




Annex 1 Primary ProductionPart A: General Hygiene Provisions for Primary Production and Associated Operations

I. Scope1. This annex applies to primary production and the following associated operations:

(a) the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;

(b) the transport of live animals, where this is necessary to achieve the objectives of this Regulation; and

(c) in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment.

Food business operators harvesting primary products must comply with the requirements of Annex 1. In the context of molluscan shellfish this includes live bivalve and gastropod molluscs hand harvested from wild stocks or cultivated. The provisions of the Regulation cover the transport, storage and handling of primary products, including the transport of live animals, from the place of production (the point at which they were harvested) to an establishment. “Establishment” means any unit of a food business.

Food business operators must ensure that primary production and associated operations undertaken with any molluscan shellfish species, comply with the food hygiene provisions identified in Section II of this Regulation detailed below.

II. Hygiene Provisions.2. As far as possible, food business operators are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo.

Food business operators must protect molluscan shellfish from the point of harvesting, from any source of contamination (physical, chemical, biological, radiological). Processes that the molluscs will undergo and which are designed to remove contamination can be taken into account when deciding if the molluscs are contaminated.

Food business operators must ensure that molluscan shellfish are harvested from waters that are free from contaminants. Within coastal waters bivalve molluscs must only be harvested from areas designated by the competent authority. In all other areas harvesting of molluscan shellfish (principally scallops) must avoid physical, chemical, biological and radiological sources of contamination.




II. Hygiene Provisions Cont.2. Cont.

Harvested molluscs must be handled and stored to protect against contamination. The animals must be held and transported under hygienic conditions and covered to ensure they avoid contamination from seabirds, pests, foreign materials, and contaminating liquids.

3. Notwithstanding the general duty laid down in paragraph 2, food business operators are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including:(a) measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides, and the storage, handling and disposal of waste.

Food business operators must comply with all legislation to control food safety hazards relating to the primary production process. Procedures must be followed to identify potential hazards and control measures implemented. Waste materials associated with the primary production process must be handled, stored and disposed of without presenting a contamination risk to the food products.

Food business operators harvesting and handling molluscan shellfish must ensure that food products are only exposed to “clean seawater” (that does not contain substances capable of directly or indirectly affecting the health quality of the food). Any sediment on the external surfaces of the animals should be removed with clean seawater prior to storage. Natural waste from the primary production process must be separated from the food products to avoid cross contamination.

4. Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are to take adequate measures, as appropriate:(a) to keep any facilities used in connection with primary production and associated operations, including facilities used to store and handle feed, clean and where necessary after cleaning, to disinfect them in an appropriate manner;

Food business operators must ensure that all aspects of the facilities used in the production of primary products are maintained in a clean condition and where appropriate subject to disinfection.

Food business operators must ensure that facilities used for the harvesting and handling of molluscan shellfish are maintained in a clean condition to ensure food hygiene standards are met. Where necessary food-safe chemicals should be used as directed to ensure adequate disinfection.Procedures to ensure hygienic conditions are maintained within facilities are outlined in Appendix 2 of this GPG.




II. Hygiene Provisions Cont.4. Cont.

(b) to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels;

(c) as far as possible to ensure the cleanliness of animals going to slaughter and, where necessary, production animals;(d) to use potable water, or clean water,

whenever necessary to prevent contamination;

(e) to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

(f) as far as possible to prevent animals and pests from causing contamination;

(g) to store and handle waste and hazardous substances so as to prevent contamination;

Food business operators must ensure that all facilities and equipment that food products could come into contact with, are maintained in a clean condition and where appropriate disinfected.

Food business operators must ensure animals presented as food products are presented in a clean condition.Food business operators must ensure that water coming into contact with primary products is clean.Clean means clean seawater or freshwater.Food business operators must ensure staff health is not a risk to the food safety of products and that staff are adequately trained to identify health risks.

Food business operators must ensure facilities for primary production are maintained free from pests, and animals excluded from production or storage areas.Food business operators must ensure that hazardous substances are appropriately stored to prevent contamination of primary products. In addition waste stored within the production facility must be isolated from food products.

Food business operators must ensure that facilities and equipment used for the harvesting and handling of molluscan shellfish are maintained in a clean condition to ensure food hygiene standards are met. Where necessary food-safe chemicals should be used as directed to ensure adequate disinfection.Both personnel and facility hygiene provisions must be enforced (see Appendix 2 of this GPG).Food business operators must ensure the external surfaces of molluscan shellfish are washed down using clean seawater to remove any sediment.Food business operators must ensure that only clean seawater comes into contact with live molluscan shellfish (see Regulation (EC)853/2004)Food business operators must ensure that adequate training is conducted to safeguard food products from health risks associated with staff hygiene and health. Personnel hygiene rules must be enforced (see Appendix 2 of this GPG).Food business operators must ensure rules are in place to maintain pest free production facilities. Domestic animals must be prevented from entering the production or storage areas for food products.Food business operators must ensure hazardous substances (cleaning chemicals, fuel, oil, bait etc) are stored securely away from food production areas. Waste materials generated from the production facility must be stored securely for appropriate disposal onshore.




II. Hygiene Provisions Cont.6. Food business operators are to take appropriate remedial action when informed of problems identified during official controls.

Food business operators must ensure remedial action is undertaken at the earliest opportunity in response to official control notifications.

III. Record Keeping.7. Food business operators are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. Food business operators are to make relevant information contained in these records available to the competent authority and receiving food business operators on request.

Food business operators must ensure comprehensive records of measures implemented to control food hygiene hazards are maintained and updated frequently. Details of appropriate record keeping procedures are contained in Seafish guidance. www.seafish.org On Land > legislation > guidance >Guide to Recent Developments in European Food Law for the Seafood Industry.

8. Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep records on:

(h) the results of any analysis carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health; and

(i) any relevant reports on checks carried out on animals or products of animal origin.

Food business operators must maintain records of checks undertaken on primary products and in particular those with importance for human health i.e. contaminants (biotoxins, micro-organisms, heavy metals, hydrocarbons etc)





Part B: Recommendations for Guides to Good Hygiene Practice.

1. National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations.2. Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and associated operations and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:

(a) the control of contamination such as mycotoxins, heavy metals and radioactive material;

(b) the use of water, organic waste and fertilisers;

(f) the proper disposal of dead animals, waste and litter;(h) procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;

The contents of good practice guides should include appropriate information on food safety and hygiene based on hazards for primary production and associated operations, and further production, processing and distribution of food products. The hazards and control measures identified should be based on both national and Community requirements for food safety.

Food business operators must ensure that they implement all appropriate measures within the relevant sections of this Good Practice Guide. The objective being to identify and manage or remove food safety hazards related to molluscan shellfish primary production and associated operations, and those associated with further production, processing and distribution of molluscan food products.




Part B: Cont.2. Cont.

(i) measures relating to the cleanliness of slaughter and production animals;

(j) measures relating to record keeping.

Annex II General Hygiene Requirements for all Food Business Operators (Except When Annex I Applies)

Annex II relates to the general hygiene requirements for all food business operators. This excludes those already covered in Annex 1 for primary production and associated activities (harvesting, transport, storage and handling at the place of production (i.e. on board vessels or at the point of harvest), transport of live molluscs, and transport of primary products from the place of production to an establishment).

In the current context of hand harvesting and cultivation activities this Annex covers the ability for a vessel (or other appropriate offshore facility) to be used as a dispatch centre or for heat treatment processing. Dispatch could be undertaken for live bivalve molluscs harvested from class “A” waters or those harvested from classified relaying areas. The processing by heat treatment of bivalve molluscs harvested from classified waters of class “C” or above, and gastropod molluscs harvested from areas classified for production could also be undertaken at a suitably equipped facility.

Food business operators must identify and address food hygiene hazards associated with dispatch and primary processing facilities located at sea. The relevant requirements are identified in the following Chapters of Annex II.

Food business operators undertaking such activities are required to be inspected and approved by the local food authority before commencing operations. In order to fully comply with the Annex II requirements the advice of the local food authority should be sought.




Annex II Cont.Chapter I General Requirements for Food Premises.

1. Food premises are to be kept clean and maintained in good repair and condition.

2. The layout, design, construction, siting and size of food premises are to:

(a) permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and provide adequate working space to allow for the hygienic performance of all operations;

(b) be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces;

(c) permit good food hygiene practices, including protection against contamination and, in particular, pest control; and

The dedicated area onboard the vessel or offshore structure where operations associated with primary processing or dispatch are undertaken must be appropriately constructed and maintained. The food premises facilities must meet the range of requirements identified in points 2-10 dependent on the dispatch or primary processing operations for which it has been approved by the local food authority.

The food business operator must implement the advice of the local food authority to ensure the on board food premises meet, and are maintained to fulfil, the requirements for dispatch or primary processing operations for which they are approved.




2. Cont.(d) where necessary, provide suitable temperature-controlled handling and storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored and, where necessary, recorded.3. An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories are not to open directly into rooms in which food is handled.4. An adequate number of washbasins is to be available, suitably located and designed for cleaning hands. Washbasins for cleaning hands are to be provided with hot and cold running water, materials for cleaning hands and for hygienic drying. Where necessary, the facilities for washing food are to be separate from the hand-washing facility.5. There is to be suitable and sufficient means of natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area is to be avoided. Ventilation systems are to be so constructed as to enable filters and other parts requiring cleaning or replacement to be readily accessible.6. Sanitary conveniences are to have adequate natural or mechanical ventilation.




Chapter I Cont.7. Food premises are to have adequate natural and/or artificial lighting.8. Drainage facilities are to be adequate for the purpose intended. They are to be designed and constructed to avoid the risk of contamination. Where drainage channels are fully or partially open, they are to be so designed as to ensure that waste does not flow from a contaminated area towards or into a clean area, in particular an area where foods likely to present a high risk to the final consumer are handled.9. Where necessary, adequate changing facilities for personnel are to be provided. 10. Cleaning agents and disinfectants are not to be stored in areas where food is handled.Chapter IV Transport

1. Conveyances and/or containers used for transporting foodstuffs are to be kept clean and maintained in good repair and condition to protect foodstuffs from contamination and are, where necessary, to be designed and constructed to permit adequate cleaning and/or disinfection.

The transport of food products from vessel based (or offshore) dispatch and or primary processing food premises must be undertaken to ensure no subsequent contamination occurs. The transportation of primary production from harvesting operations, and any other products, must be separated from food premises production through good hygiene practices outlined in points 1-7.

The food business operator must ensure that the transport conditions for food products from food premises meet the requirements of the local food authority.The food business operator should establish a cleaning and disinfection schedule for all areas, vehicles and containers used for the transport of food premises products. All such maintenance activity should be the subject of scheduled monitoring/recording.

2. Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where this may result in contamination.




Chapter IV Cont.3. When conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting different foodstuffs at the same time, there is, where necessary, to be effective separation of products.5. Where conveyances and/or containers have been used for transporting anything other than foodstuffs or for transporting different foodstuffs, there is to be effective cleaning between loads to avoid the risk of contamination.6. Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimise the risk of contamination.7. Where necessary, conveyances and/or containers used for transporting foodstuffs are to be capable of maintaining foodstuffs at appropriate temperatures and allow those temperatures to be monitored. Chapter V Equipment Requirements

1. All articles, fittings and equipment with which food comes into contact are to:

(a) be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination;(b) be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination.

The materials and equipment used within food premises must be of a standard, designed, and maintained to allow cleaning and disinfection in order to prevent contamination of the food products. Hygiene measures to achieve this are outlined in points 1-3.

The food business operator must ensure that the facilities and equipment within the on board food premises meet the requirements of the local food authority.The food business operator should establish a cleaning, and where appropriate disinfection, schedule for all food premises areas, equipment and facilities. All maintenance, cleaning and disinfection activity should be monitored and recorded.




Chapter V Cont.(c) with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be disinfected; and(d) be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area.

2. Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this Regulation’s objectives.3. Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in accordance with good practice.Chapter VI Food Waste

1. Food waste, non-edible by-products and other refuse are to be removed from the rooms where food is present as quickly as possible, so as to avoid any accumulation.

Solid waste generated from processes undertaken within on-board food premises, are to be contained and removed from the premises to prevent contamination of the food products. On-board storage and disposal of waste must meet the hygiene measures outlined in points 1-4.

The food business operator must ensure that the waste facilities provided for the on board food premises meet the requirements of the local food authority.The food business operator should establish an emptying, cleaning and disinfection schedule for all waste containers and areas. All maintenance, cleaning and disinfection activity should be logged.Reference should be made to Seafish guidance on the handling of seafood waste. www.seafish.org > On Land > legislation > guidance > waste > Legislative Requirements for the Disposal of Seafood Waste.

2. Food waste, non-edible by-products and other refuse are to be deposited in closable containers, unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers are to be of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect.





Chapter VI Cont.3. Adequate provision is to be made for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores are to be designed and managed in such a way as to enable them to be kept clean and, where necessary, free of animals and pests.4. All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community legislation applicable to that effect, and is not to constitute a direct or indirect source of contamination.

The disposal of food waste from food premises must be undertaken in an environmentally responsible manner and in line with Community legislation.

The food business operator must ensure waste from food premises is categorised and disposed of appropriately in line with all appropriate local, national, and Community legislation.

Chapter VII Water Supply

1. (a) There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated;(b) Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs, echinoderms, tunicates and marine gastropods; clean water may also be used for external washing. When clean water is used, adequate facilities and procedures are to be available for its supply to ensure that such use is not a source of contamination for the foodstuff.

Water used within the on-board food premises and coming into contact with food products must be clean. Clean seawater may be used for external washing of molluscan shellfish. However, live bivalve molluscs must only be re-immersed in clean seawater subject to Regulation (EC) 853/2004. The supply of water within food premises is to meet the hygiene provisions outlined in points 1-6.“clean seawater” means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food; “potable water” means water intended for human consumption meeting minimum Community requirements (Directive 98/83/EC).

The food business operator must ensure that the water supply facilities provided for any on board food premises meet the requirements of the local food authority. The food business operator must also ensure that clean seawater is only taken on board from areas free from all possible contaminants. There must be no potential for contamination of the water supply through the operations of the dispatch or processing facilities.

2. Where non-potable water is used, for example for fire control, steam production, refrigeration and other similar purposes, it is to circulate in a secondary duly identified system. Non-potable water is not to connect with, or allow reflux into, potable water.




Chapter VII Cont.3. Recycled water used in processing or as an ingredient is not to present a risk of contamination. It is to be of the same standard as potable water, unless the competent authority is satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form.4. Ice which comes into contact with food or which may contaminate food is to be made from potable water or, when used to chill whole fishery products, clean water. It is to be made, handled and stored under conditions that protect it from contamination.5. Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely to contaminate the food.6. Where heat treatment is applied to foodstuffs in hermetically sealed containers it is to be ensured that water used to cool the containers after heat treatment is not a source of contamination for the foodstuff.Chapter VIII Personal Hygiene

1. Every person working in a food handling area is to maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing.

The maintenance of personal hygiene standards within food premises is of paramount importance to prevent contamination of food products. Specific measures to be taken are identified in points 1-2.

The food business operator must ensure that only adequately trained staff have access to the food premises. Rules must be in place for appropriate work-wear and operating procedures including reporting of health issues. (see Appendix 2 of this GPG)




Chapter VIII Cont.2. No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator.Chapter IX Provisions Applicable to Foodstuffs

1. A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic micro-organisms or toxic, decomposed or foreign substances to such an extent that, even after the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the final product would be unfit for human consumption.

The dispatch of live bivalve molluscs from an on-board food premises would not require the input of additional food ingredients. Equally the heat treatment of bivalve and gastropod molluscs is unlikely to require additional raw food materials or ingredients (except possibly salt) to create food products. The receipt of any fresh molluscs (i.e. Queen Scallops) for heat treatment would require that the hygiene conditions identified as appropriate in points 1-8 are adhered to.

The food business operator must ensure that any fresh molluscan shellfish products handled within the on-board food premises, are only accepted on the basis that the final product leaving the premises would be rendered fit for human consumption. The advice of the local food authority must be sought to ensure food premises and procedures meet all the requirements for the foodstuffs intended to be prepared.

2. Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination.




Chapter IX Cont.3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state.4. Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent domestic animals from having access to places where food is prepared, handled or stored (or, where the competent authority so permits in special cases, to prevent such access resulting in contamination).5. Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient refrigerated storage.




Chapter IX Cont.6. Where foodstuffs are to be held or served at chilled temperatures they are to be cooled as quickly as possible following the heat processing stage, or final preparation stage if no heat process is applied, to a temperature which does not result in a risk to health.7. The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic micro-organisms or the formation of toxins in the food. During thawing, foods are to be subjected to temperatures that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of growth of pathogenic micro-organisms or the formation of toxins.8. Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and secure containers.




Chapter X Provisions Applicable to the Wrapping and Packaging of Foodstuffs

1. Materials used for wrapping and packaging are not to be a source of contamination. The definition of wrapping means the placing of a

foodstuff in a wrapper or container in direct contact with the foodstuff concerned; and packaging means the placing of one or more wrapped foodstuffs in a container.

In the context of live bivalve molluscs these must be wrapped and packaged according to Regulation (EC) 853/2004.

The wrapping and packaging of all food products from food premises must meet the hygiene requirements identified in points 1-4.

The food business operator must ensure wrapping and packaging of food products meets the criteria laid down and is not in itself a source of contamination.

2. Wrapping materials are to be stored in such a manner that they are not exposed to a risk of contamination.3. Wrapping and packaging operations are to be carried out so as to avoid contamination of the products. Where appropriate and in particular in the case of cans and glass jars, the integrity of the container’s construction and its cleanliness is to be assured.4. Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary, to disinfect.Chapter XI Heat Treatment

The following requirements apply only to food placed on the market in hermetically sealed containers:1. any heat treatment process used to process an unprocessed product or to process further a processed product is:(a) to raise every part of the product treated to a given temperature for a given period of time; and

The placing on the market of live bivalve molluscs from class B and class C production areas, which have not been subjected to purification or relaying, can only be through processing using heat treatment to eliminate pathogenic micro-organisms. The specific requirements for this are contained in Regulation (EC) 853/2004. Primary processing using heat treatment in an on-board food premises must meet the general hygiene measures identified in points 1-3.

The food business operator must ensure that procedures are in place to monitor and record the heat treatment process for batches of food products. The advice of the local food authority should be sought to ensure adequate procedures are in place to monitor and record any heat treatment process.




Chapter XI Cont.(b) to prevent the product from becoming contaminated during the process;2. to ensure that the process employed achieves the desired objectives, food business operators are to check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices;3. the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high temperature or sterilisation).Chapter XII Training

Food business operators are to ensure:

1. that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity;

The operation of a vessel based approved food premises for the dispatch or primary processing of molluscan shellfish requires that the principles of HACCP are applied in support of general food hygiene measures. There is a requirement for food handlers to be appropriately trained in food safety matters as identified in points 1-3

The food business operator must seek the advice of the local food authority with respect to the appropriate level of training required for each aspect of the food production process. Training should be proportional to the tasks undertaken by individual members of staff in a food production business.Guidance on the appropriate levels of training required for seafood business operators should be obtained from Seafish. www.seafish.org > On Land > training > Hygiene and HACCP Training.

2. that those responsible for the development and maintenance of the procedure referred to in Article 5 (1) of this Regulation or for the operation of relevant guides have received adequate training in the application of the HACCP principles; and3. compliance with any requirements of national law concerning training programmes for persons working in certain food sectors.



Legal Requirement Interpretation Recommended “Best Practice”Regulation 853/2004/EC laying down specific hygiene rules for food of animal origin, enforced through;UK Food Hygiene Regulations, 2006

This Regulation lays down specific rules for the hygiene of foodstuffs derived from animal origins. It applies to food businesses throughout the food chain and includes detailed provisions for live molluscan shellfish.

Food business operators must ensure the appropriate provisions within the Regulation are implemented and adhered to.

Chapter I General ProvisionsArticle 1 Scope

1. This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation EC 852/2004. They shall apply to unprocessed and processed products of animal origin.

Food business operators whether undertaking primary production or food premises operations including dispatch, or purification of live bivalve molluscs, must in addition to Regulation (EC) 852/2004 implement the appropriate provisions of this Regulation.

Food business operators that harvest, handle, purify, transport, dispatch or process molluscan shellfish must comply with the relevant articles of the Regulation as detailed below

3. This Regulation shall not apply in relation to:

(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

The Regulation does not apply to operators supplying small quantities of less than 25 tonnes of molluscan shellfish directly to the final consumer. Equally sales to local businesses that supply the final consumer such as fishmongers or restaurants are also exempt. However, food safety end product standards must be met.

While food business operators are exempt from the Regulation if they supply less than 25 tonnes PA of molluscan shellfish to the final consumer, it is the operator’s responsibility to ensure the food is safe and end product standards are met. In the case of the supply of live shellfish from classified waters, they must come from designated “class A” waters.

4. Member States shall establish, according to national law, rules governing the activities and persons referred to in paragraph 3 (c). Such national rules shall ensure the achievement of the objectives of this Regulation.

The UK Food Safety Act, 1990 applies to the placing on the market of food products which must be fit for human consumption.

Food business operators supplying less than 25 tonnes PA of molluscan shellfish to the final consumer must meet all the provisions of The UK Food Safety Act, 1990, with regard to food safety end product standards.

6. This Regulation shall apply without prejudice to:(c) requirements concerning the identification of animals and the traceability of products of animal origin.

Article 18 of Regulation (EC) 178/2002 makes provision for the traceability of foodstuffs placed on the market for human consumption.

Food business operators must ensure that all molluscan shellfish products placed on the market are able to be identified and traced throughout the food chain, with appropriate records maintained to facilitate the process.




Chapter II Food Business Operators Obligations

Article 3 General Obligations

2. Food business operators shall not use any substance other than potable water – or, when Regulation (EC) 852/2004 or this Regulation permits its use, clean water – to remove surface contamination from products of animal origin, unless use of the substance has been approved in accordance with the procedure referred to in Article 12(2).

The definition; of “clean water” means clean seawater and freshwater of a similar quality; of “clean seawater” means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food.

Food business operators must implement the provisions of this Chapter.

Only clean water should be used for the removal of sediment or debris from the surface of harvested molluscan shellfish. Live molluscan shellfish must only be hosed down with clean seawater and not exposed to or immersed in seawater of a lower quality (classification) than that from which they were harvested.

Article 4 Registration and Approval of Establishments

1. Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments:

(a) that meet the relevant requirements of Regulation (EC) 852/2004, those of Annexes II and III of this Regulation and other requirements of food law; and

(b) that the competent authority has registered or, where required in accordance with 4.2, approved.

The definition of an “establishment” means any unit of a food business. All molluscan shellfish intended for human consumption must meet the general requirements of Regulation (EC) 852/2004; and the specific requirements of this Regulation (EC/853/2004) relating to products of animal origin and the detailed provisions associated with live molluscan shellfish.Establishments must be registered with the local food authority or, approved where required before placing foodstuffs on the market.

Food business operators placing molluscan shellfish foodstuffs on the market must meet the relevant provisions of Regulation (EC) 852/2004 identified above, and the specific provisions of this Regulation (EC/853/2004) as identified below. The establishments used for food production must be either registered for primary production and associated activities, or approved, for dispatch, purification or processing operations, by the local food authority.




Article 4 Cont.2. Without prejudice to Article 6(3) of Regulation (EC) 852/2004, establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article, with the exception of establishments carrying out only:

(a) primary production;(b) transport operations;(c) the storage of products not requiring

temperature-controlled storage conditions;

Food business operators harvesting and handling molluscan shellfish must be registered with the local food authority if they undertake operations identified in points (a-c).

An “establishment” means any unit of a food business.

Establishments operating as a dispatch centre for live bivalve molluscs must be approved together with those undertaking primary processing such as heat treatment. The definition of “dispatch centre” means any on-shore or offshore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

Food business operators must register with the local food authority any establishment where molluscan shellfish are harvested and handled, or which is used to transport the animals (vessel, offshore facility or vehicle etc).

Where a vessel or offshore facility based dispatch or processing operation is established the vessel operator must gain approval for it from the local food authority prior to operations being undertaken.

The advice of the local food authority must be sought regarding the requirement for registration or approval of establishments used by hand harvesting fishermen or cultivation operators.

3. An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with Regulation (EC) 854/2004:

(a) granted the establishment approval to operate following an on-site visit; or

(b) provided the establishment with conditional approval.

Food business operators must gain approval or conditional approval for an establishment used for the dispatch or processing of live bivalve molluscs prior to commencing operations.

Food business operators undertaking the dispatch or processing of live bivalve molluscs and gastropods must ensure that approval or conditional approval of the establishment is provided by the local food authority before commencing operations.




Article 5 Health and Identification Marking

1. Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4 (2) unless it has either:(a) a health mark applied in accordance with Regulation (EC) 854/2004; or(b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation.

Food business operators must apply an identification mark to any product produced in an approved establishment prior to placing it on the market.

Food business operators undertaking dispatch or processing of live bivalve molluscs and gastropods must ensure that an identification mark is applied to the product in accordance with Annex II, Section I as detailed below.

2. Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with this Regulation in establishments meeting the requirements of Article 4.

Food business operators must only apply an identification mark to products that have been produced in an approved establishment.

Food business operators may only apply an identification mark to live or processed bivalve molluscs and gastropods if they are from an approved establishment.

Annex II Requirements Concerning Several Products of Animal OriginSection 1: Identification Marking

When required in accordance with Article 5 or 6, and subject to the provisions of Annex II, food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions.

Food business operators must ensure that live or processed bivalve molluscs and gastropods from an approved establishment carry an identification mark complying with the requirements of this section.

Food business operators must ensure that live bivalve molluscs and gastropods from an approved dispatch or processing facility have an appropriate identification mark attached as required by this section.




Annex II Section 1 Cont.A. Application of the Identification Mark

1. The identification mark must be applied before the product leaves the establishment.2. However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is further processed in another establishment, in which case the new mark must indicate the approval number of the establishment where these operations take place.4. Food business operators must, in accordance with Article 18 of Regulation (EC) 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin.

The identification mark must be applied to the live bivalve molluscs and gastropods before they leave the dispatch or processing facility. Records must be kept of the food business operators to which the products are delivered. In the case of wrapped and/or packaged products being received from an approved establishment and unwrapped or further processed, a new mark must be attached indicating the approval number of the establishment where the most recent operation has taken place.

Food business operators must ensure that all live bivalve molluscs and gastropods leaving an approved establishment have an identification mark attached.

B. Form of the Identification Mark

5. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities.

The identification mark must be clearly displayed and robust.

Food business operators must ensure the identification mark is fit for purpose, clearly displayed, securely attached to the packaging and robust.

6. The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard.In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK.

The relevant ISO standard code for the United Kingdom is UK

Food business operators with approved establishments in the United Kingdom must include the country name or code within the identification mark.




Annex II Section 1 B Cont.7. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food.8. When applied in an establishment located within the community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK, EY.

Food business operators must include the local food authority approval number of the establishment within the identification mark. The mark must be oval in character and include the abbreviation EC for approvals in the European Community.

Food business operators with approved establishments must ensure the identification mark contains the local food authority approval number and abbreviation EC within an oval border.

C. Method of Marking

9. The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material.

The method of marking must be robust and easily identifiable ensuring that each consignment retains the identification mark during transport and distribution operations.

Annex III Specific Requirements

Section VII: Live Bivalve Molluscs

1. This section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods.

Section VII applies to live bivalve molluscs and with the exception of purification operations to gastropod molluscs (i.e. Whelk and Winkle)

Food business operators placing bivalve and gastropod molluscs on to the market through approved dispatch or processing facilities must ensure the appropriate requirements of Chapters I-IX are met. (For purification centres see onshore)

2. Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) 854/2004. Chapter IX applies to pectinidae harvested outside those areas.

Bivalve and gastropod molluscs harvested from classified waters must meet the requirements of Chapters I-VIII, except in the case of pectinidae (i.e. King scallop, Pecten maximus) from other areas where Chapter IX applies.

Food business operators must ensure that bivalve molluscs are harvested only from classified waters except in the case of pectinidae where additional harvesting areas are acceptable, subject to specific conditions identified in Chapter IX.

5.1.1 Hand Harvesting and Cultivation Operations at Sea (Food Safety) (Cont.)Legal Requirement

Regulation 853/2004/ECInterpretation Recommended “Best Practice”

Section VII Cont.3. Chapters V, VI, VIII and IX, and point 3 of Chapter VII, apply to retail.

Food business operators should be aware of the retailers’ duties and requirements relating to the distribution and final sale of live bivalve molluscs.

4. The requirements of this section supplement those laid down in Regulation (EC) 852/2004:

(a) In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation.

(b) In the case of other operations, they supplement the requirements of Annex II to that Regulation.

Food business operators who are undertaking primary production must ensure that the handling and distribution of live bivalve molluscs prior to dispatch or purification activities meet these Regulations in addition to Annex I of (EC) 852/2004. In the context of the dispatch or primary processing of bivalve and gastropod molluscs these Regulations supplement the requirements of Annex II of (EC) 852/2004.

Food business operators must ensure that where operations take place before live bivalve molluscs arrive at a dispatch or purification centre these Regulations as identified below supplement those of Annex I of Regulation (EC) 852/2004. In the context of dispatch or primary processing operations these Regulations as identified below, supplement the requirements of Annex II of Regulation (EC) 852/2004.

Chapter I: General Requirements for the Placing on the Market of Live Bivalve Molluscs1. Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an identification mark must be applied in accordance with Chapter VII.

The term “dispatch centre” means any on-shore or offshore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

Food business operators must ensure that live bivalve molluscs are only placed on the market via a dispatch centre where an appropriate identification mark must be applied.

2. Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in points 3 to 7 have been complied with.

Food business operators maintaining dispatch facilities must only accept live bivalve molluscs if documentary requirements set out in points 3-6 below have been met, and subject to point 7.

Food business operators maintaining dispatch, processing or purification facilities must ensure that batches of live bivalve molluscs meet the documentary requirements identified in points 3-7.

3. Whenever a food business operator moves a batch of live bivalve molluscs between establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, a registration document must accompany the batch.

Food business operators are responsible for compiling a registration document for each batch of live bivalve molluscs and gastropods immediately at harvest and prior to their arrival at an approved facility.

Food business operators must ensure that each batch of live bivalve molluscs harvested is the subject of a registration document containing the details identified in point 4 below.




Chapter I Cont.4. The registration document must be in at least one official language of the Member State in which the receiving establishment is located and contain at least the information specified below.(a) In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:

(i) the gatherer’s identity and address;(ii) the date of harvesting;(iii) the location of the production area described in as precise detail as is practicable or by a code number;(iv) the health status of the production area;(v) the shellfish species and quantity; and(vi) the destination of the batch.

(b) In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:

(i) the location of the relaying area; and(ii) the duration of relaying.

The term “production area” means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.

The term “relaying area” means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs.

Food business operators must ensure that all detailed requirements for information identified on a registration document is compiled immediately following harvesting.

5. Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the registration document so they are easy to read and cannot be altered. Food business operators receiving batches must date stamp the document on receipt of the batch or record the date of receipt in another manner.

Food business operators must ensure that the registration document for harvested live bivalve molluscs is completed clearly and with indelible markings. Food business operators receiving batches of live bivalve molluscs for dispatch must ensure the date of delivery to the dispatch facility is recorded, subject to point 7 below.




Chapter I Cont.6. Food business operators must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify).

Food business operators must ensure accurate records of registration documents issued and received are maintained including the filing of copies for a minimum of twelve months.

7. However, if:(a) the staff gathering live bivalve molluscs

also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs; and

(b) a single competent authority supervises all the establishments concerned,

registration documents are not necessary if that competent authority so permits.

Food business operators must seek the advice of their local food authority to ensure compliance with the requirement for registration documents, especially where harvested live molluscs are supplied to facilities maintained by the food business operator.

Chapter II Hygiene Requirements for the Production and Harvesting of Live Bivalve Molluscs

A. Requirements for Production Areas1. Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that the competent authority has classified – where appropriate, in cooperation with food businesses operators – as being of class A, B, or C in accordance with Regulation (EC) 854/2004.

The term “gatherer” means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market. The harvesting of pectinidae from unclassified areas is subject to the special provisions of Chapter IX.

Food business operators must ensure that live bivalve molluscs are only harvested from production areas classified as being of class A, B, or C. In the case of pectinidae harvested from unclassified areas provisions under Chapter IX must be applied.




Chapter II A. Cont.2. Food business operators may place live bivalve molluscs collected from class A production areas on the market for direct human consumption only if they meet the requirements of Chapter V.

Food business operators with dispatch facilities may place live bivalve molluscs from class A production areas directly on the market provided they meet the Chapter V requirements.

Food business operators with dispatch facilities may place live bivalve molluscs from class A production areas directly on the market provided they meet the Chapter V requirements as below.

3. Food business operators may place live bivalve molluscs collected from class B production areas on the market for human consumption only after treatment in a purification centre or after relaying.

Food business operators must ensure live bivalve molluscs from class B production areas are treated in a purification centre or relayed prior to a dispatch facility placing them on the market, and subject to point 5 below.

4. Food business operators may place live bivalve molluscs collected from class C production areas on the market for human consumption only after relaying over a long period in accordance with part C of this Chapter.

Food business operators must ensure live bivalve molluscs from class C production areas are relayed over a long period in accordance with part C of this Chapter, prior to a dispatch facility placing them on the market, and subject to point 5 below.

5. After purification or relaying, live bivalve molluscs from class B or C production areas must meet all of the requirements of Chapter V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic micro-organisms (where appropriate after removal of sand, mud, or slime in the same or another establishment). The permitted treatment methods are:(a) sterilisation in hermetically sealed containers; and

Food business operators may take live bivalve molluscs from class B or C production areas and subject them to a prescribed treatment aimed at eliminating pathogenic micro-organisms. The treatments include sterilisation in hermetically sealed containers, and various forms of heat treatment as described in 5(b).

Where live bivalve molluscs from class B and C production areas are not subjected to a purification process, food business operators with approved processing facilities must ensure that prescribed heat treatment is undertaken in compliance with local food authority guidance, prior to placing on the market.




Chapter II A. Cont.(b) heat treatments involving;

(i) immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90C and maintenance of this minimum temperature for not less than 90 seconds.(ii) cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160C and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core temperature of –20C; and(iii) steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used. Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat.




Chapter II A. Cont6. Food business operators must not produce live bivalve molluscs in, or harvest them from, areas that the competent authority has not classified, or which are unsuitable for health reasons. Food business operators must take account of any relevant information concerning areas’ suitability for production and harvesting, including information obtained from own checks and the competent authority. They must use this information, particularly information on environmental and weather conditions, to determine the appropriate treatment to apply to harvested batches.

Food business operators must not harvest live bivalve molluscs from areas not classified by the local food authority, with the exception of provisions for pectinidae identified in Chapter IX. The decision to harvest from classified production areas must take into account specific environmental factors pertaining from time to time especially where these may influence the food safety status of the molluscs. Where harvesting may be considered to be unsuitable for health reasons additional monitoring may be required or harvested stock subjected to appropriate treatment.

Food business operators must ensure environmental conditions with potential to impact the food safety status of bivalve molluscs, are taken into account when harvesting from classified waters. Where concerns exist additional monitoring should be undertaken and harvested stock subjected to appropriate treatment to maintain the food safety status.

B. Requirements for Harvesting and Handling Following Harvesting

Food business operators harvesting live bivalve molluscs, or handling them immediately after harvesting, must ensure compliance with the following requirements.

Food business operators harvesting and handling live bivalve molluscs must ensure the requirements of Part B identified below are adhered to.

1. Harvesting techniques and further handling must not cause additional contamination or excessive damage to the shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment by purification, processing or relaying. Food business operators must in particular:

Food business operators must ensure that the process of harvesting and subsequent handling of live bivalve molluscs does not contaminate them or reduce their ability to adequately maintain life functions. Specific conditions are identified in points (a-d) below.




Part B. 1. Cont.(a) adequately protect live bivalve molluscs

from crushing, abrasion or vibration;(b) not expose live bivalve molluscs to

extreme temperatures;(c) not re-immerse live bivalve molluscs in

water that could cause additional contamination; and

(d) if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of class A.

The term “conditioning” means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging.

Food business operators must ensure storage containers for harvested molluscs are not over filled and are located to prevent crushing, abrasion and vibration. Storage on deck should ensure the molluscs are covered to prevent desiccation, and heating by direct sunlight. Food business operators must ensure that live bivalve molluscs are not re-immersed in water of a lower classification status than that which they were harvested from, or that may present additional risks for contamination.

2. Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and provide efficient protection against contamination.

Food business operators must ensure the transport facilities for harvested live bivalve molluscs, both at sea and on land, provide suitable conditions to maintain the life functions and prevent contamination.

C. Requirements for Relaying Live Bivalve Molluscs

Food business operators relaying live bivalve molluscs must ensure compliance with the following requirements.1. Food business operators may use only those areas that the competent authority has approved for relaying live bivalve molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a minimum distance between relaying areas, and also between relaying areas and the production areas, so as to minimise any risk of the spread of contamination.

Food business operators seeking to relay live bivalve molluscs must ensure the relaying area is approved by the local food authority and is adequately delineated. All operations between harvesting and relaying must take account of the requirement for the molluscs to subsequently undergo natural purification, and therefore to be maintained in optimum physical condition. The requirement to prevent cross contamination between relaying areas and between production and relaying areas must be addressed through minimum separation distances agreed with the local food authority.




Part C. Cont.2. Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:

(a) use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter feeding activity after immersion in natural waters;

(b) not relay live bivalve molluscs at a density that prevents purification;

(c) immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature, which period must be at least two months’ duration unless the competent authority agrees to a shorter period on the basis of the food business operator’s risk analysis; and

(d) ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the “all in, all out” system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed.

Food business operators in seeking to establish and maintain relaying facilities must ensure the points detailed in point 2 are enforced.

3. Food business operators managing relaying areas must keep permanent records of the source of live bivalve molluscs, relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by the competent authority.

Food business operators maintaining relaying areas must ensure that adequate records are kept to identify the history of batches of live bivalve molluscs and the relaying conditions as noted in point 3. Records must be permanent and available for inspection by the local food authority.




Chapter IV: Hygiene Requirements for Purification and Dispatch Centres

B. Requirements for Dispatch CentresFood business operators operating dispatch centres must ensure compliance with the following requirements.


Food business operators maintaining on-board dispatch facilities for live bivalve molluscs must comply with the requirements identified in points 1-4.

1. Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not cause contamination of the product or affect the viability of the molluscs.

Food business operators must ensure all handling operations are conducted under conditions suitable to maintain the viability of the live bivalve molluscs.

2. Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water.

The term “clean water” means clean seawater and fresh water of a similar quality.

Food business operators must ensure that clean seawater is used and that live bivalve molluscs are not allowed to be immersed in contaminated water.

3. Live bivalve molluscs must come from:(a) a class A production area;(b) a relaying area(c) a purification centre; or(d) another dispatch centre.

Food business operators must ensure on-board dispatch facilities only handle live bivalve molluscs from class A production areas or relaying areas, as required by point 4 below.

4. The requirements laid down in points 1 and 2 also apply to dispatch centres situated on board vessels. Molluscs handled in such centres must come from a class A production area or a relaying area.

Food business operators must ensure on-board dispatch facilities only handle live bivalve molluscs from class A production areas or relaying areas.




Chapter V: Health Standards for Live Bivalve Molluscs

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) 852/2004, food business operators must ensure that live bivalve molluscs placed on the market for human consumption meet the standards laid down in this Chapter.

Food business operators must ensure that the microbiological criteria for live bivalve molluscs identified in Regulation (EC) 852/2004 is met together with the standards laid down in this chapter before products are placed on the market for human consumption.

1. They must have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion and normal amounts of intravalvular liquid.

Food business operators must ensure that the handling and cleaning of live bivalve molluscs maintains their viability and products are not delayed in distribution prior to being placed on the market.

2. They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits:

(a) for paralytic shellfish poisoning (PSP), 800 micrograms per kilogram;

(b) for amnesic shellfish poisoning (ASP), 20 milligrams of domoic acid per kilogram;

(c) for okadaic acid, dinophysistoxins and pectenotoxins together, 160 micrograms of okadaic acid equivalents per kilogram;

(d) for yessotoxins, 1 milligram of yessotoxin equivalent per kilogram; and

(e) for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram.

The term “ marine biotoxin” means poisonous substances accumulated by bivalve molluscs, in particular as a result of feeding on plankton containing toxins.

The Food business operator must ensure that adequate monitoring and testing of batches of live bivalve molluscs is undertaken prior to dispatch. The local food authority will undertake monitoring for public health purposes and may close classified harvesting areas. Food business operators must ensure that guidance from the local food authority is accessed and implemented. It is the ultimate responsibility of the food business operator to ensure that live bivalve molluscs placed on the market are not contaminated with marine biotoxins.




Chapter VI: Wrapping and Packaging of Live Bivalve Molluscs

1. Oysters must be wrapped or packaged with the concave shell downwards.2. Individual consumer-size packages of live bivalve molluscs must be closed and remain closed after leaving the dispatch centre and until presented for sale to the final consumer.

The term “ wrapping” means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned; and “packaging” means the placing of one or more wrapped foodstuffs in a second container.

The food business operator must ensure that live bivalve molluscs are placed in wrapping suitable to maintain their viability and prevent contamination from external sources

Chapter VII: Identification Marking and Labelling

1. The label, including the identification mark, must be waterproof.2. In addition to the general requirements for identification marks contained in Annex II, Section I, the following information must be presented on the label:

(a) the species of bivalve mollusc (common name and scientific name); and

(b) the date of packaging, comprising at least the day and the month. By way of derogation from Directive (EC) 13/2000, the date of minimum durability may be replaced by the entry “these animals must be alive when sold”.

3. The retailer must keep the label attached to the packaging of live bivalve molluscs that are not in individual consumer size packages for at least 60 days after splitting up the contents.

Food business operators should use the following names when labelling live bivalve molluscs;Common Name Latin NameMussel Mytilus spp.Cockle Cerastoderma spp.Pacific Oyster Crassostrea gigasFlat Oyster Ostrea edulisKing Scallop Pecten maximusQueen Scallop Aequipecten opercularisRazor Clam Solen spp Ensis spp.Surf Clam Spisula spp.Carpet Shell Tapes spp.Whelk Buccinum undatumPeriwinkle Littorina littoreaOther species can be found in the Seafish guidance document.

The food business operator must ensure that all the required information is included in an appropriate format of label with each batch of live bivalve molluscs placed on the market. The requirements identified in points 1-3 must be followed, and the words “these animals must be alive when sold” should be clearly visible on the label.

Seafish guidance on the requirements for fish labelling should be consulted. www.seafish.org > On Land > legislation > labelling > Seafood Labelling Guidance – Overview; and > Brief Guide.





Chapter VIII: Other Requirements

1. Food business operators storing and transporting live bivalve molluscs must ensure that they are kept at a temperature that does not adversely affect food safety or viability.

The food business operator must ensure that during the distribution of live bivalve molluscs the temperature maintained does not affect the viability of the animals. Live bivalve molluscs must not be placed directly in contact with melting ice, or be immersed in the melt water.

2. Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged for retail sale and left the dispatch centre.

The food business operator must ensure that live bivalve molluscs are not immersed in, or sprayed with water once packaged and dispatched.

Chapter IX: Specific Requirements for Pectinidae Harvested Outside Classified Production Areas

Food business operators harvesting pectinidae outside classified production areas or handling such pectinidae must comply with the following requirements.

Food business operators harvesting and handling King and Queen Scallop from outside of classified production areas must adhere to the conditions in this Chapter.

Food business operators harvesting and handling King and Queen scallops from areas not classified for shellfish production must adhere to the requirements of points 1-4.

1. Pectinidae may not be placed on the market unless they are harvested and handled in accordance with Chapter II, Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks.

Food business operators must ensure that scallops are not subjected to production conditions which would result in contamination or lower viability. Biotoxin monitoring should be undertaken routinely to avoid food safety risks.

Food business operators must seek the advice of the local food authority with regard to appropriate levels of biotoxin monitoring and testing before placing products on the market. All steps must be taken to maintain the viability and prevent contamination of harvested scallops.

2. In addition, where data from official monitoring programmes enable the competent authority to classify fishing grounds – where appropriate, in cooperation with food business operators – the provisions of Chapter II, Part A, apply by analogy to pectinidae.

Food business operators harvesting King and Queen scallops from areas classified for shellfish production must adhere to the requirements identified for live bivalve molluscs harvested from class A, B or C areas accordingly.

Food business operators harvesting and handling scallops from classified waters must ensure that they are treated in accordance with identified measures for live bivalve molluscs harvested from class A, B, or C waters as appropriate.




Chapter IX. Cont.3. Pectinidae may not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment. When they handle pectinidae, food business operators operating such establishments must inform the competent authority and, as regards dispatch centres, comply with the relevant requirements of Chapters III and IV.

Food business operators must only place King and Queen scallops on the market through a registered fish auction, a dispatch centre or a processing establishment.

Food business operators maintaining on-board dispatch or primary processing facilities must inform the local food authority if they handle King or Queen scallops before placing them on the market.

4. Food business operators handling pectinidae must comply:

(a) with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area where the pectinidae were harvested; or

(b) as regards packaged pectinidae, and wrapped pectinidae if the wrapping provides protection equivalent to that of packaging, with the requirements of Chapter VII concerning identification marking and labelling.

Food business operators must ensure an appropriate registration document accompanies any batch of King and Queen scallops, with the location of harvesting clearly described. In the case where scallops have been appropriately wrapped and/or packed in a dispatch centre an appropriate label complete with the identification mark for the establishment must be attached.

Food business operators harvesting and handling King and Queen scallops must ensure a registration document clearly indicating the area where they were harvested, accompanies each batch prior to arrival at an auction market, or final dispatch or processing establishment.

Food business operators maintaining on-board dispatch or processing facilities must ensure all products are placed on the market clearly labelled and containing the identification mark of the approved dispatch or processing establishment.

Section VIII: Fishery Products1. This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when placed on the market live. With the exception of Chapters I and II, it applies to such animals when not placed on the market live, in which case they must have been obtained in accordance with Section VII.

Food business operators placing bivalve molluscs and gastropods on the market in a fresh or prepared state must ensure they have been harvested and handled in an appropriate manner.

Food business operators harvesting and handling molluscan shellfish to be placed on the market in a fresh or prepared state (not live), and/or maintaining on-board preparation and storage facilities for such products, must ensure the requirements of Section VIII are fulfilled.




Section VIII: Fishery Products Cont.2. Chapter III, Parts A, C and D, Chapter IV and Chapter V apply to retail.

Food business operators must be aware of the requirements associated with retail sales.

3. The requirements of this Section supplement those laid down in Regulation (EC) 852/2004:

(a) In the case of establishments, including vessels, engaged in primary production and associated operations they supplement the requirements of Annex I to that Regulation.

Food business operators involved in primary production, in this context cultivation, fishing and associated activities, must implement the requirements of Annex I of Regulation (EC) 852/2004 supplemented by provisions within this Regulation.

Food business operators must ensure the relevant provisions of Regulation (EC) 852/2004 are implemented together with the requirements as appropriate of this Section, where molluscan shellfish fishery products are placed on the market.

4. In relation to fishery products:(a) primary production covers the farming,

fishing and collection of live fishery products with a view to their being placed on the market; and

(b) associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter, bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:

2. the transport of fishery products the nature of which has not been substantially altered, including live fishery products, from the place of production to the first establishment or destination.

Food business operators undertaking primary production and associated operations, cultivation, and the transportation of fishery products to the first establishment or destination, must meet the requirements of this Regulation. The term “ fresh fishery products” means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling.The term “prepared fishery products” means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping.

Food business operators undertaking primary production and transportation of fishery products to be placed on the market in a fresh or prepared state must ensure the provisions of this Regulation are implemented.




Chapter I: Requirements for Vessels

Food business operators must ensure that:

1. vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, comply with the structural and equipment requirements laid down in Part I; and2. operations carried out on board vessels take place in accordance with the rules laid down in Part II.

Food business operators harvesting and handling molluscan shellfish fishery products must ensure vessels and operations undertaken comply with the requirements of Part I and II of this Chapter.

Food business operators must ensure that vessels used to harvest and/or handle and/or prepare fishery products comply with the structural and equipment requirements identified in Part I of this Chapter. Operations carried out on board the vessel must take place in accordance with the rules laid down in Part II of this Chapter.

Part I. Structural and Equipment RequirementsA. Requirements for all vessels

1. Vessels must be designed and constructed so as not to cause contamination of the products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances.

Food business operators must seek and implement the advice of the local food authority to ensure the design and construction of the vessel and the equipment used for molluscan fishery products meets all the requirements identified in points 1-4 below.Seafish guidance should be referred to for fishing vessel hygiene compliance. www.seafish.org > On Land > legislation > guidance > Fishing Vessel Hygiene Checklist.

2. Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is smooth and easy to clean. Surface coatings must be durable and non-toxic.3. Equipment and materials used for working on fishery products must be made of corrosion-resistant material that is easy to clean and disinfect.4. When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids contamination of the water supply.





Part II Hygiene Requirements

1. When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water.

Food business operators must ensure that areas and containers used for the storage of fishery products are maintained in accordance with points 1-5 identified below.

2. As soon as possible after they are taken on board, fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either potable water or, where appropriate, clean water.


3. Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided that the flesh of the products suffers no damage.4. Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when chilling is not possible, fishery products must be landed as soon as possible.

In the current context of bivalve and gastropod molluscs being treated as fishery products they would not be placed on the market live but as fresh or prepared products.

5. Ice used to chill fishery products must be made from potable water or clean water.




Chapter II: Requirements During and After Landing

1. Food business operators responsible for the unloading and landing of fishery products must:

(a) ensure the unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness; and

(b) avoid contamination of fishery products during unloading and landing, in particular by:

(i) carrying out unloading and landing operations rapidly;

(ii) placing fishery products without delay in a protected environment at the temperature specified in Chapter VII; and(iii) not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.

Food business operators must ensure that the unloading and landing of fresh fishery products does not represent an additional source of contamination or spoilage of the products. Attention must be paid to the requirements of points 1 and 3 below.

3. When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

In the current context of bivalve and gastropod molluscs as fishery products they would not be placed on the market live, but as fresh, prepared or processed products.




Chapter III: Requirements for Establishments, Including Vessels, Handling Fishery Products

Food business operators must ensure compliance with the following requirements, where relevant, in establishments handling fishery products.

Food business operators handling molluscan fresh fishery products must ensure the appropriate requirements of Chapter III are complied with.

A. Requirements for Fresh Fishery Products

1. Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after reaching an establishment on land, they must be stored under ice in appropriate facilities. Re-icing must be carried out as often as necessary. Packaged fresh fishery products must be chilled to a temperature approaching that of melting ice.

The term “establishment” means any unit of a food business.

Food business operators must ensure that where unpackaged fresh molluscan fishery products are landed prior to being distributed, dispatched, prepared or processed the chill chain must be maintained.

2. Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly with potable water or, on board vessels, clean water immediately after these operations.

Food business operators must ensure that any necessary preparation of fresh molluscan fishery products such as washing or evisceration must be undertaken as soon as possible after capture, either on-board or when landed.

4. Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water does not remain in contact with the products.

Food business operators must ensure that the containers used to store or dispatch fresh molluscan fishery products chilled with ice, allow the melt water to drain away from the food products.




Chapter III A Cont.

5. Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, and be transported from aquaculture establishments, until they arrive at the first establishment on land carrying out any activity other than transport or sorting.

Food business operators must ensure that where fresh molluscan fishery products are transported or stored in chilled water facilities, the water must be “clean” and the temperature maintained at that of melting ice. Conditions within the tanks should ensure an even temperature is maintained.

Chapter IV: Requirements for Processed Fishery Products

Food business operators cooking crustaceans and molluscs must ensure compliance with the following requirements.

1. Rapid cooling must follow cooking. Water used for this purpose must be potable water or, on board vessels, clean water. If no other method of preservation is used, cooling must continue until a temperature approaching that of melting ice is reached.

Food business operators cooking molluscan shellfish fishery products must ensure the requirements of Section VII are met for the sourcing of bivalve and gastropod molluscs. Cooking of bivalve molluscs from “class A” waters should be undertaken in an approved facility, while those from other areas must meet the additional requirements of Chapter II A point 5.

Food business operators cooking fresh molluscan fishery products on-board must ensure facilities are approved by the local food authority. Bivalve molluscs and gastropods harvested from “class A” production areas may be cooked and rapidly chilled to the temperature of melting ice. Bivalve molluscs from other areas must be subject to the specific requirements of Chapter II A point 5.

2. Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands.

Food business operators must ensure that hygienic conditions are maintained in order to avoid contamination of the food product. The advice of the local food authority should be sought to ensure appropriate compliance with this Regulation.




Chapter IV Cont.3. After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the temperature laid down in Chapter VII.

The appropriate temperature laid down in Chapter VII is that of melting ice.

The vessel operator should seek the advice of the local food authority to ensure appropriate conditions for the storage of specific cooked molluscan fishery products are maintained.

Chapter V: Health Standards for Fishery Products

In addition to ensuring compliance with the microbiological criteria adopted in accordance with Regulation (EC) 852/2004, food business operators must ensure, depending on the nature of the product or the species, that fishery products placed on the market for human consumption meet the standards laid down in this Chapter.

Food business operators producing fishery products and specifically cooked products, must ensure microbiological criteria relevant for molluscan shellfish are met, and particularly the absence of Listera and Salmonella. In addition general provisions are identified below.

Food business operators placing fishery products on the market in either a fresh or processed state must comply with Regulation (EC) 852/2004 and the requirements of this Chapter as identified below.

A. Organoleptic Properties of Fishery ProductsFood business operators must carry out an organoleptic examination of fishery products. In particular, this examination must ensure that fishery products comply with any freshness criteria.

Food business operators must undertake an organoleptic assessment of each batch of fishery products prior to placing on the market and maintain records of the examinations undertaken

C. Total Volatile NitrogenUnprocessed fishery products must not be placed on the market if chemical tests reveal that the limits with regard to TVB-N or TMA-N have been exceeded.

Where chemical tests are undertaken to support organoleptic assessments, food business operators must ensure unprocessed fishery products are not placed on the market where Total Volatile Nitrogen limits are shown to be exceeded.




Chapter V Cont.

E. Toxins Harmful to Human Health2. Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII and comply with the standards laid down in Chapter V, point 2, of that section.

Food business operators must ensure that bivalve and gastropod molluscs meet the criteria laid down for live bivalve molluscs in Section VII and specifically comply with the standards for marine biotoxins identified in Chapter V, point 2.

Chapter VI: Wrapping and Packaging of Fishery Products1. Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt-water does not remain in contact with the products.

Food business operators must ensure that fresh molluscan fishery products when chilled with ice are wrapped or packaged in water resistant materials that allow drainage of all melt-water.

3. When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:

(a) is not a source of contamination;(b) is stored in such a manner that it is not

exposed to risk of contamination;(c) intended for re-use is easy to clean and,

where necessary, to disinfect.

Food business operators must ensure the wrapping of molluscan shellfish fishery products does not present an additional risk of contamination, either through the process or wrapping material. Where the wrapping material can be reused it must be easy to clean and disinfect.




Chapter VII: Storage of Fishery Products

Food business operators storing fishery products must ensure compliance with the following requirements.1. Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.

Food business operators must ensure that the storage conditions for all forms of molluscan shellfish fishery products, maintain the cold chain at a temperature approaching that of melting ice.

3. Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability.

In the current context of hand harvested and cultivated molluscan shellfish they would not be placed on the market as live fishery products.

Chapter VIII: Transport of Fishery Products

Food business operators transporting fishery products must ensure compliance with the following requirements.

Food business operators transporting any form of fishery product must meet the appropriate requirements of this Chapter as identified below.

1. During transport, fishery products must be maintained at the required temperature. In particular:

(a) fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.

3. If fishery products are kept under ice, melt water must not remain in contact with the products.

Food business operators must ensure that the method of transport for all forms of molluscan shellfish fishery products, maintains the cold chain at a temperature approaching that of melting ice. The containers used for the storage and transport must allow melt-water to completely drain from the vicinity of the fishery products.




Chapter VIII Cont.4. Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability.

In the current context of hand harvested and cultivated bivalve and gastropod molluscs as fishery products they would not be placed on the market live.


Legal Requirement Interpretation Recommended “Best Practice”Regulation 854/2004/EC laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

Food business operators must be aware of the requirements of the local food authority in determining appropriate measures for the implementation of Regulation (EC) 853/2004 and associated provisions.

Annex II Live Bivalve MolluscsChapter I: Scope

This Chapter applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.Chapter II: Official Controls Concerning Live Bivalve Molluscs from Classified Production Areas

A. Classification of Production and Relaying Areas1. The competent authority must fix the location and boundaries of production and relaying areas that it classifies. It may, where appropriate, do so in cooperation with the food business operator.

Food business operators must ensure they are aware of the exact location of the boundaries of classified shellfish production and relaying areas. These should be recorded for reference along with the classification category.

2. The competent authority must classify production areas from which it authorises the harvesting of live bivalve molluscs as being of one of three categories according to the level of faecal contamination. It may, where appropriate, do so in cooperation with the food business operator.

The Food business operator must ensure that regular contact is maintained with the local food authority and provision for rapid communication is made to allow changes to classifications or closures to be notified.




Chapter II A Cont.3. The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs taken from these areas must meet the health standards for live bivalve molluscs laid down in Annex III, Section VII, of Regulation (EC) 853/2004.

Food business operators must ensure primary production from classified areas described under points 3-5, meets the health standards for live bivalve molluscs described in Annex III, Section VII of Regulation (EC) 853/2004 before being placed on the market. Food business operators must conduct appropriate testing to ensure primary production from classified waters meet these standards.

4. The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected and only placed on the market for human consumption after treatment in a purification centre or after relaying so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed in 90% of the samples, 4 600 E.coli per 100g of flesh and intravalvular liquid. In the remaining 10% of samples, live bivalve molluscs must not exceed 46 000 E. coli per 100g flesh and intravalvular liquid. The reference method for this analysis is the five tube, three dilutions Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.




5. The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected but placed on the market only after relaying over a long period so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution MPN test of 46 000 E.coli per 100g of flesh and intravalvular liquid.




Chapter II Cont.B. Monitoring of Classified Relaying and Production Areas

1. Classified relaying and production areas must be periodically monitored to check:

(a) that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

(b) the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;

(c) for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs; and

(d) for the presence of chemical contaminants in live bivalve molluscs.

Food business operators should be aware of the requirement for the local food authority to request appropriate records to be inspected, and documentation to be matched to primary production activities. Food business operators should be prepared to fulfil all reasonable requests from the local food authority with respect to the supply of samples of molluscan shellfish in order for contamination testing to be undertaken.Contaminants in molluscan shellfish can be varied based on natural back ground levels and man made pollution. Seafish has produced guidance on potential contaminants within seafood. www.seafish.org > On Land > legislation > guidance > Contaminants

C. Decisions After Monitoring

1. Where the results of sampling show that the health standards for molluscs are exceeded, or that there may be otherwise a risk to human health, the competent authority must close the production area concerned, preventing the harvesting of live bivalve molluscs. However, the competent authority may reclassify a production area as being of Class B or C if it meets the relevant criteria set out in Part A and presents no other risk to human health.

Food business operators must make provisions to ensure notifications by the local food authority of closure, or changes to the health status of classified waters, are quickly received and acted upon.





Chapter II Cont.D. Additional Monitoring Requirements

2. In addition to the monitoring of relaying and production zones referred to in paragraph 1 of Part B, a control system must be set up comprising laboratory tests to verify food business operators compliance with the requirements for the end product at all stages of production, processing and distribution. This control system is, in particular, to verify that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health.

Food business operators should be aware of the local food authorities responsibility to conduct tests and verify compliance of food business operations with end product standards, at all stages of production. Food business operators must be prepared to provide appropriate samples to permit the local food authority to undertake such tests

F. Food Business Operators’ Own Checks

To decide on the classification, opening or closure of production areas, the competent authority may take into account the results of controls that food business operators or organisations representing food business operators have carried out. In that event, the competent authority must have designated the laboratory carrying out the analysis and, if necessary, sampling and analysis must have taken place in accordance with a protocol that the competent authority and the food business operators or organisations concerned have agreed.

Food business operators either alone or in conjunction with a representative trade body may undertake sampling and testing of molluscan shellfish in support of the opening or closure of classified production areas. The sampling and analysis protocol undertaken must be agreed in advance by the local food authority, with the laboratory undertaking testing being accredited by the food authority.




Chapter III: Official Controls Concerning Pectinidae Harvested Outside Classified Production Areas

Official controls on pectinidae harvested outside classified production areas are to be carried out in fish auctions, dispatch centres and processing establishments. Such official controls are to verify compliance with the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, to Regulation (EC) 853/2004 as well as compliance with other requirements of Annex III, Section VII, Chapter IX to that Regulation.

Food business operators should be aware that pectinidae (scallops) harvested from outside of classified bivalve mollusc production areas, will be subject to controls when placed on the market. These will be undertaken at fish auctions, dispatch centres and processing establishments where samples will be taken to determine compliance with the health standards for live bivalve molluscs, and other requirements of Annex III, Section VII, Chapter IX of Regulation (EC) 853/2004.

Annex III Fishery Products

Chapter 1: Official Controls of Production and Placing on the Market

1. Official controls on the production and placing on the market of fishery products are to include, in particular:(a) a regular check on the hygiene conditions of landing and first sale;

Food business operators placing molluscan fishery products either fresh, prepared or processed on to the market should be aware of the compliance checks to be undertaken by the local food authority as identified in point 1.




Annex III Chapter I Cont.(b) inspections at regular intervals of vessels

and establishments on land, including fish auctions and wholesale markets, to check, in particular:

(i) where appropriate, whether the conditions for approval are still fulfilled,

(ii) whether the fishery products are handled correctly,(iii) for compliance with hygiene and temperature requirements, and(iv) the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene; and(c) checks on storage and transport conditions.

Chapter II: Official Controls of Fishery Products

Official controls of fishery products are to include at least the following elements.A. Organoleptic ExaminationsRandom organoleptic checks must be carried out at all stages of production, processing and distribution. One aim of these checks is to verify compliance with the freshness criteria established in accordance with Community legislation. In particular, this includes verifying, at all stages of production, processing and distribution, that fishery products at least exceed the baselines of freshness criteria established in accordance with Community legislation.

Food business operators must be aware that the local food authority has the responsibility to undertake random organoleptic checks at any stage in the process of placing fishery products either fresh, prepared or processed, on the market.




Chapter II Cont.B. Freshness IndicatorsWhen the organoleptic examination reveals any doubt as to the freshness of the fishery products, samples may be taken and subjected to laboratory tests to determine the levels of total volatile basic nitrogen (TVB-N) and trimethylamine nitrogen (TMA-N)

When the organoleptic examination gives cause to suspect the presence of other conditions which may affect human health, appropriate samples are to be taken for verification purposes.

Food business operators should be aware that when organoleptic checks as identified in point 1 give cause for concern as to the freshness of the fishery products, samples are required to be taken for laboratory analysis. The analysis of total volatile nitrogen is used to assess freshness.

Where organoleptic checks reveal tainting other than that associated with freshness, additional samples may be required to determine the source of the contamination

Chapter III: Decisions After Controls

Fishery products are to be declared unfit for human consumption if:1. Organoleptic, chemical, physical, or microbiological checks or checks for parasites have shown that they are not in compliance with the relevant Community legislation;4. the competent authority considers that they may constitute a risk to public or animal health or are for any other reason not suitable for human consumption.

Food business operators should be aware that if the local food authority declares the fishery products to be unfit for human consumption, and may constitute a risk to public or animal health, they must be immediately withdrawn from the market.

5.1.1 Hand Harvesting and Cultivation Operations at Sea (General Requirements)

Legal Requirement Interpretation Recommended “Best Practice”Directive 92/43/EC on the Conservation of Natural Habitats and of Wild Fauna and Flora, enforced in the UK through;

The Conservation (Natural Habitats & c) Regulations, 1994; Offshore Marine Conservation (Natural Habitats, &c) Regulations, 2007

Known as the “Habitats Directive” and in conjunction with the “Birds Directive” (79/409/EC) a network of European Marine Sites has been established for nature conservation purposes. Fishing or cultivation operations within such sites, and additional areas identified through The Conservation (Natural Habitats & c) Regulations, 1994; and Offshore Marine Conservation (Natural Habitats, &c) Regulations, 2007, must seek to maintain the conservation objectives for the habitats and/or species for which the sites are designated. It is the responsibility of business operators to be aware of such nature conservation designations and ensure operations do not impact on the nature conservation objectives.

Hand gathering and cultivation operations must ensure compliance with the statutory obligations placed on them relating to nature conservation objectives, when operating within a European Marine Site (EMS).

The protocol for identifying fishing and cultivation activities compliant with EMS designations, and procedures to be undertaken before commencing operations, have been outlined in a guidance document published by Seafish. Industry operators must be aware of the scope and contents of the Seafish guidance. www.seafish.co.uk > On Land > search our publications > guidelines > Guidance Note – Protected Wildlife Sites 2008.

Directive 60/2000/EC Establishing a Framework for Community Action in the Field of Water Policy, enforced through;

The Water Environment (Water Framework Directive) (England & Wales) Regulations 2003.

Known as the “Water Framework Directive” this seeks to achieve “good ecological status” or waters of “pristine condition” where impacted by man, through river basin management plans. These will extend through out inland waters and out to 1NM offshore in England, Wales and Northern Ireland and 3NM in Scotland. Fishing or cultivation operations adversely impacting the maintenance of “good ecological status” will be the subject of appropriate control measures implemented through the competent authority. Industry operators must ensure that their activities do not compromise the maintenance of “good ecological status” within coastal waters.

Hand gathering and cultivation businesses should be aware of the requirements of the Water Framework Directive and any local river basin management plan affecting shellfish production activities within a location.

The scope and potential implications of the Water Framework Directive for industry operators, has been outlined in a Seafish report. www.seafish.co.uk > On Land > search our publications > technical report > Water Framework Directive – Technical Briefing 2007.

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5.1.1 Hand Harvesting and Cultivation Operations at Sea (General Requirements) (Cont.)

Legal Requirement Interpretation Recommended “Best Practice”The Welfare of Animals Transport Order, 1997 (SI 1480, 1997).

Schedule 4.1. No person shall transport any animal in a way which causes or is likely to cause injury or unnecessary suffering to that animal.Schedule 6. Article 4.7. Other vertebrate animals and cold-blooded animals shall be transported in such receptacles or means of transport, under such conditions (in particular with regard to space, ventilation, temperature and security) and with such supply of liquid and oxygen as are appropriate for the species concerned.

Hand gathering and cultivation operators must be aware of the requirements to protect all animals from injury or unnecessary suffering during transportation. The requirement to provide adequate space, liquid and oxygen to achieve this objective complements that for the primary production and transport of live molluscs (Regulation (EC) 853/2004). Industry operators in seeking to achieve the requirements of Regulation (EC) 853/2004 must also ensure the welfare of the animals transported.

Directive 88/2006/EC On Animal Health Requirements for Aquaculture Animals and Products Thereof, and on the Prevention and Control of Certain Diseases in Aquatic Animals.

Known as “The Aquatic Animal Health Directive” this seeks to improve the biosecurity of cultivation operations through control measures relating to the monitoring of stock movements, and targeted surveillance and assessment of the disease status of animals. Shellfish cultivation businesses will be required to be authorised with obligations for standardised record keeping, biosecurity best practice and notification of suspicion of important shellfish diseases. The transport of shellfish is also covered and operators may need to be registered.

Shellfish cultivation businesses must ensure that operations are authorised by the Fish Health Inspectorate of DEFRA or relevant devolved government department. Where shellfish are transported by a third party the cultivation business must ensure where required that they are registered to undertake such activities and that biosecurity measures are in place. The FHI must be informed immediately of the suspicion of one of the important shellfish diseases (Marteilia refringens, Bonamia ostreae, B. exitiosa, Microcytos mackini, Perkinsus marinus).

5.2 Production Operations Onshore

The basic food safety requirements for primary production either of wild stock or cultivated molluscs, are implemented at the point shellfish are harvested and become a food product. The transfer of food products to the first establishment onshore is encompassed within the legislation covering activities at sea (5.1.1), as is the potential to establish a dispatch and/or processing centre on board a vessel or offshore facility. In the context of placing live bivalve molluscs on the market a potential additional activity that requires dedicated shore-based facilities is the operation of a purification centre.

The basic food hygiene legislation applying to molluscs for hand harvesting and cultivation operations identified in section 5.1.1 also applies (where appropriate but excluding primary production) to onshore food business operations. In order to avoid duplication section 5.1.1 is not repeated here (except sections of Regulation 853/2004/EC to aid clarity) but all measures should be considered to apply except where noted. The food safety requirements for fresh, prepared or processed molluscan fishery products identified in section 5.1.1 apply equally to shore based activities.

5.2.1 Production Operations Onshore (Food Safety Requirements)

Legal Requirement Interpretation Recommended “Best Practice”Regulation 178/2002/EC laying down the general principles of food law etc.

All requirements identified in 5.1.1 Food business operators must ensure all relevant aspects of the Regulation are implemented.

Regulation 852/2004/EC on the hygiene of foodstuffs

All requirements identified in 5.1.1 Food business operators must ensure all relevant aspects of the Regulation are implemented.

Regulation 853/2004/EC laying down specific hygiene rules for food of animal origin, enforced through;UK Food Hygiene Regulations, 2006

Requirements identified in 5.1.1, plus additional requirements noted below in italics (set within original Regulations’ text as presented in 5.1.1 to aid the perspective)

Food business operators must ensure all relevant aspects of the Regulation are implemented including the specific requirements for live bivalve molluscs and the operation of a purification establishment.

Regulation 854/2004/EC laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

All requirements identified in 5.1.1 Food business operators must be aware of the requirements for official controls for the placing on the market of products of animal origin.

5.2.1 Production Operations Onshore (Food Safety Requirements) (Cont.)



Annex III Specific Requirements

Section VII: Live Bivalve Molluscs

1. This section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods.

Section VII applies to live bivalve molluscs and with the exception of purification operations, to gastropod molluscs (i.e. Abalone and Winkle)

Food business operators placing bivalve and gastropod molluscs on to the market through approved dispatch centres or processing establishments must ensure the appropriate requirements of Chapters I-IX are met.

2. Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) 854/2004. Chapter IX applies to pectinidae harvested outside those areas.

Bivalve and gastropod molluscs harvested from classified waters must meet the requirements of Chapters I-VIII, except in the case of pectinidae (i.e. King scallop, Pecten maximus) from other areas where Chapter IX applies.

Food business operators must only accept bivalve molluscs harvested from classified waters except in the case of pectinidae where additional harvesting areas are acceptable, subject to specific conditions identified in Chapter IX.

3. Chapters V, VI, VIII and IX, and point 3 of Chapter VII, apply to retail.

Food business operators should be aware of the retailers’ duties and requirements relating to the distribution and final sale of live bivalve molluscs.

4. The requirements of this section supplement those laid down in Regulation (EC) 852/2004:(c) In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation.(d) In the case of other operations, they supplement the requirements of Annex II to that Regulation.

Food business operators who are undertaking dispatch, purification, or primary processing of bivalve and gastropod molluscs as appropriate, must implement these Regulations which supplement the requirements of Annex II of (EC) 852/2004.

Food business operators undertaking dispatch, purification, or primary processing operations with live bivalve molluscs must implement these Regulations as identified below, which supplement the requirements of Annex II of Regulation (EC) 852/2004.




Chapter I: General Requirements for the Placing on the Market of Live Bivalve Molluscs

1. Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an identification mark must be applied in accordance with Chapter VII.


Food business operators must ensure that live bivalve molluscs are only placed on the market via a dispatch centre where an appropriate identification mark must be applied.

2. Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in points 3 to 7 have been complied with.

Food business operators maintaining dispatch, purification, or processing facilities must only accept live bivalve molluscs if documentary requirements set out in points 3-6 below have been met, and subject to point 7.

Food business operators maintaining dispatch, purification or processing facilities must ensure that batches of live bivalve molluscs received from primary producers, meet the documentary requirements identified in points 3-7.

3. Whenever a food business operator moves a batch of live bivalve molluscs between establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, a registration document must accompany the batch.

Primary producers are responsible for compiling a registration document for each batch of live bivalve molluscs and gastropods immediately at harvest and prior to their arrival at an approved facility.

Food business operators must ensure that each batch of live bivalve molluscs received at a dispatch, purification or processing establishment is the subject of a registration document containing the details identified in point 4 below.




Chapter I Cont.4. The registration document must be in at least one official language of the Member State in which the receiving establishment is located and contain at least the information specified below.(a) In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:

(i) the gatherer’s identity and address;(ii) the date of harvesting;(iii) the location of the production area described in as precise detail as is practicable or by a code number;(iv) the health status of the production area;(v) the shellfish species and quantity; and(vi) the destination of the batch.

Food business operators must ensure that all detailed requirements for information identified on a registration document have been completed before accepting any batch of live bivalve molluscs for dispatch, purification or processing.

(b) In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:

(i) the location of the relaying area; and(ii) the duration of relaying.

(c) In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in (a) and the following information;

Food business operators undertaking purification of live bivalve molluscs must provide additional information for inclusion on the registration document.

Food business operators sending batches of live bivalve molluscs from purification centres to dispatch centres must ensure an appropriate registration document is attached.




Chapter I; 4 (c) Cont.(i) the address of the purification centre;(ii) the duration of purification; and(iii) the dates on which the batch entered

and left the purification centre.

Food business operators undertaking purification of batches of live bivalve molluscs must ensure additional information is contained on the accompanying registration document as detailed in point 4 (c).

5. Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the registration document so they are easy to read and cannot be altered. Food business operators receiving batches must date stamp the document on receipt of the batch or record the date of receipt in another manner.

Food business operators must ensure that the registration document for purified live molluscs is completed clearly and with indelible markings.Food business operators receiving batches of live bivalve molluscs for dispatch or processing must ensure the date of delivery to the establishment is recorded, subject to point 7 below.

6. Food business operators must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify).

Food business operators must ensure accurate records of registration documents issued and received are maintained including the filing of copies for a minimum of twelve months.

7. However, if:(a) the staff gathering live bivalve molluscs

also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs; and

(b) a single competent authority supervises all the establishments concerned, registration documents are not necessary if that competent authority so permits.

Food business operators must seek the advice of their local food authority to ensure compliance with the requirement for registration documents, especially where the harvesting of live bivalve molluscs and maintenance of dispatch, purification, or processing facilities are all undertaken by the same food business operator.




Chapter III: Structural Requirements for Dispatch and Purification Centres

1. The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding areas.

Food business operators must ensure establishments for dispatch and purification are not subject to routine tidal or surface water flooding.

2. Tanks and water storage containers must meet the following requirements:

a. Internal surfaces must be smooth, durable, impermeable and easy to clean.

b. They must be constructed so as to allow complete draining of water.

c. Any water intake must be situated in a position that avoids contamination of the water supply.

3. In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be purified.

Food business operators should seek the advice of the local food authority with respect to the design, construction and scale of facilities needed to accommodate intended throughputs. All facilities must be approved prior to commencing operations.

Seafish has produced a good manufacturing practice guideline for live bivalve molluscs, that should be adhered to by food business operators maintaining dispatch and purification facilities. www.seafish.org > On Land > search our publications > guidelines > Good Manufacturing Practice Guidelines - Live Bivalves Workbook, 2007.

Chapter IV: Hygiene Requirements for Purification and Dispatch Centres

A. Requirement for Purification CentresFood business operators purifying live bivalve molluscs must ensure compliance with the following requirements.

Food business operators maintaining purification facilities for live bivalve molluscs must meet the requirements identified in points 1-7 below. Reference should be made to the Seafish Live Bivalves Workbook for safe operating practices.

1. Before purification commences, live bivalve molluscs must be washed free of mud and accumulated debris using clean water.


Food business operators must use clean seawater to remove external debris from live bivalve molluscs and ensure they are not immersed in wastewater.





Chapter IV: A Cont.2. Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter feeding activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market.

Food business operators maintaining purification facilities must ensure operating practices conform to the Seafish Good Practice Guidelines detailed in the Live Bivalves Workbook.

3. The quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre. The live bivalve molluscs must be continuously purified for a period sufficient to achieve compliance with and allow the health standards of Chapter V and microbiological criteria adopted in accordance with Regulation (EC) 852/2004.

Food business operators must ensure that the local food authority approves the purification facilities and operating practices, based on the species and maximum quantities of bivalve molluscs to be purified.

4. Should a purification tank contain several batches of live bivalve molluscs, they must be of the same species and the length of the treatment must be based on the time required by the batch needing the longest period of purification.

Food business operators must ensure that only one species of bivalve mollusc is placed in a purification tank at any one time. Where multiple batches of the same species are purified treatment must be based on those needing the longest time.

5. Containers used to hold live bivalve molluscs in purification systems must have a construction that allows clean seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during purification.

Food business operators must ensure that bivalve molluscs are placed in containers allowing adequate opening of shells during purification.

6. No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are undergoing purification.

Food business operators must ensure that no other marine species are placed in the purification system while bivalve molluscs are undergoing treatment.




Chapter IV: A Cont.7. Every package containing purified live bivalve molluscs sent to a dispatch centre must be provided with a label certifying that all molluscs have been purified.

Food business operators moving a batch of purified live bivalve molluscs to a dispatch centre must ensure a clear and indelible label is attached stating the approval number of the purification centre, the date, and a statement certifying the molluscs have been purified.

Section VIII: Fishery ProductsChapter II: Requirements During and After Landing1. Food business operators responsible for the unloading and landing of fishery products must:

(a) ensure the unloading and landing equipment that comes into contact with fishery products is constructed of material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness; and

(b) avoid contamination of fishery products during unloading and landing, in particular by:

(j) carrying out unloading and landing operations rapidly;

(ii) placing fishery products without delay in a protected environment at the temperature specified in Chapter VII; and

(iii) not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.

Food business operators must ensure that the unloading and landing of molluscan fishery products does not represent an additional source of contamination or spoilage of the products. Attention must be paid to the requirements of points 1-3 below.




Section VIII: Chapter II Cont.2. Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.

(a) (i) There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable facilities for the storage of fishery products declared unfit for human consumption.

(b) At the time of display or storage of fishery products:

(i) the premises must not be used for other purposes;

(ii) vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;

(iii) persons having access to the premises must not introduce other animals; and

(iv) the premises must be well lit to facilitate official controls.

Food business operators must be aware of the conditions under which molluscan fishery products must be displayed for sale in auction or wholesale markets, and identified in point 2.

3. When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

In the current context of hand harvested and cultivated molluscan shellfish they would not be placed on the market as live fishery products but potentially as fresh, prepared or processed.

Food business operators must ensure that fresh fishery products are chilled to a temperature approaching that of melting ice as soon as possible after landing.




Section VII: Cont.Chapter III: Requirements for Establishments, Including Vessels, Handling Fishery Products

D. Requirements Concerning Parasites

The term “establishment” means any unit of a food business.

1. The following fishery products must be frozen at a temperature of not more than –20C in all parts of the product for not less than 24 hours; this treatment must be applied to the raw product or the finished product:(a) fishery products to be consumed raw or almost raw;

Where fishery products are to be consumed raw or almost raw as may be the case for Abalone, the risk of parasites presenting a health risk can be overcome by killing them through appropriate freezing temperatures and times.

Food business operators must seek the advice of the local food authority when placing raw products on the market in order to ensure adequate treatment of the products is undertaken to counter any risk from parasite infection. Appropriate documentation must accompany the products as required in point 3 below.

2. Food business operators need not carry out the treatment required under point 1 if:(b) the competent authority so authorises.3. A document from the manufacturer, stating the type of process they have undergone, must accompany fishery products referred to in point 1 when placed on the market, except when supplied to the final consumer.

5.2.2 Production Operations Onshore (General Requirements)

Legal Requirement Interpretation Recommended “Best Practice”Directive 60/2000/EC Establishing a Framework for Community Action in the Field of Water Policy, enforced through;

The Water Environment (Water Framework Directive) (England & Wales) Regulations 2003.

Known as the “Water Framework Directive” this seeks to achieve “good ecological status” or waters of “pristine condition” where impacted by man, through river basin management plans. These would extend through out inland waters within the UK and into the coastal environment. Operators of onshore establishments including dispatch and purification centres, should ensure that any discharge of trade effluents (including “clean” seawater) does not compromise the good ecological status of the receiving water body. In this respect there is a requirement to comply with the river basin management plan in force within the area.

Food business operators must ensure that waste material generated from the operation of dispatch and purification facilities is handled in compliance with local waste regulations. In the context of liquid waste the discharge of clean seawater into surface water drains or watercourses especially freshwater systems may be a source of pollution.

The scope and potential implications of the Water Framework Directive for food business operators, has been outlined in a Seafish report. www.seafish.org > On Land > search our publications > technical report > Water Framework Directive – Technical Briefing 2007.

Directive 88/2006/EC On Animal Health Requirements for Aquaculture Animals and Products Thereof, and on the Prevention and Control of Certain Diseases in Aquatic Animals.

Known as “The Aquatic Animal Health Directive” this seeks to improve the biosecurity of cultivation operations through control measures relating to the monitoring of stock movements, and targeted surveillance and assessment of the disease status of animals. Shellfish cultivation businesses will be required to be authorised with obligations for standardised record keeping, biosecurity best practice and notification of suspicion of important shellfish diseases. The transport of shellfish is also covered and operators may need to be registered.

Shellfish cultivation businesses must ensure that operations are authorised by the Fish Health Inspectorate (FHI) of DEFRA or relevant devolved government department. Where shellfish are transported by a third party the cultivation business must ensure where required that they are registered to undertake such activities and that biosecurity measures are in place. The FHI must be informed immediately of the suspicion of one of the important shellfish diseases (Marteilia refringens, Bonamia ostreae, B. exitiosa, Microcytos mackini, Perkinsus marinus).


Appendix 1 Contact Details for Government Departments and Agencies

The following list of contacts covers both UK government and devolved government responsibilities in the context of vessel licensing, safety, and food safety of fishery products etc.

Shellfish Hygiene Issues

Food Standards AgencyAviation House, 125 Kingsway, London, WC2B 6NH (Tel. 0207 276 8000)( www.food.gov.uk )

Food Standards Agency (Wales)Southgate House, Wood Street, Cardiff CF10 1EW (Tel. 0292 678 918)

Food Standards Agency (Scotland)St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ (Tel. 0122 428 5100)

Food Standards Agency (N. Ireland)10C Clarendon Road, Belfast BT1 3 BG (Tel. 0289 041 7711)

Vessel Licensing and Fisheries Management

Department for the Environment, Food and Rural Affairs (UK)Nobel House, 17 Smith Square, London SW1P 3JR (Tel. 0207 238 3000)( www.defra.gov.uk )

Welsh Assembly Government, Agriculture and Rural Affairs DepartmentNew Crown Buildings, Cathays Park, Cardiff CF1 3NQ (Tel. 0292 082 3567)( www.wales.gov.uk )

Scottish Government, Environment and Rural Affairs DepartmentPentland House, 47 Robbs Loan, Edinburgh EHG14 1TW (Tel. 0131 244 6224)( www.scotland.gov.uk )

Department of Agriculture and Rural Development for Northern IrelandFisheries Division, 4th Floor, Dundonald House, Upper Newtownards Road,Belfast BT4 3SB (Tel. 0289 052 4366)( www.dardni.gov.uk )

Marine and Fisheries Agency (UK)Area 6D, 3-8 Whitehall Place, London SW1A 2HH (Tel. 0207 270 8778)( www.mfa.gov.uk )

http://www.mfa.gov.uk/

http://www.dardni.gov.uk/

http://www.scotland.gov.uk/

http://www.wales.gov.uk/

http://www.defra.gov.uk/

http://www.food.gov.uk/

Vessel Licensing and Fisheries Management cont.

The Association of Sea Fisheries Committees of England and Wales6 Ashmeadow Road, Arnside, Carnforth,Lancashire LA5 0AE (Tel. 0152 476 1616)( email: [email protected] )

Vessel Safety and Working Practices

Maritime and Coastguard AgencySpring Place, 105 Commercial Road, SouthamptonSO15 1EG (Tel. 0238 032 9102)( www.mcga.gov.uk )

Department of Trade and IndustryHealth and Safety Directorate1 Victoria Street, London SW1H 0ET (Tel. 0207 215 5000)( email: [email protected] )

Shellfish Health and Hygiene Controls

Department for the Environment and Rural AffairsCentre for Environment, Fisheries and Aquaculture ScienceWeymouth Laboratory, Barrack Road, The Nothe,Weymouth, Dorset DT4 8UB (Tel. 0130 520 6600)( www.cefas.co.uk )

Scottish GovernmentFisheries Research ServicesMarine Laboratory, PO Box 101, Victoria Road,Aberdeen AB11 9DB (Tel. 0122 487 6544)( www.marlab.ac.uk )

Statutory Nature Conservation Bodies

Joint Nature Conservation Committee (UK)Monkstone House, City Road, Peterborough PE1 1JY (Tel. 0173 356 2626)( www.jncc.gov.uk )Natural England, Natural England, 1 East Parade,Sheffield, S1 2ET (Tel. 0114 241 8920)( www.naturalengland.org.uk )

Countryside Council for WalesFfordd Penrhos, Bangor, LL57 2LQ (Tel. 0124 838 5500)( www.ccw.gov.uk )

http://www.ccw.gov.uk/

http://www.naturalengland.org.uk/

http://www.jncc.gov.uk/

http://www.marlab.ac.uk/

http://www.cefas.co.uk/

mailto:[email protected]

http://www.mcga.gov.uk/


Scottish Natural Heritage12 Hope Terrace, Edinburgh EH9 2AS (Tel. 0131 447 4784)( www.snh.org.uk )

Industry Support

The Shellfish Association of Great BritainFishmongers’ Hall, London Bridge, London EC4R 9EL (Tel. 0207 283 8305)( www.shellfish.org.uk )

Sea Fish Industry Authority18 Logie Mill, Logie Green Road, Edinburgh EH7 4HS (Tel. 0131 558 3331)(Seafish Legislation Team, ( Tel. 0131 524 8677, email: [email protected] )( www.seafish.org )



http://www.shellfish.org.uk/

http://www.snh.org.uk/

Appendix 2 Vessel (Establishment) and Staff Hygiene Measures

This appendix indicates the best practice procedures necessary to achieve vessel/food business establishment, the production facilities and crew, hygiene provisions associated with the harvesting, handling and placing on the market of molluscan shellfish. Specific guidance on appropriate hygiene and cleaning measures recommended for the seafood industry can be obtained from Seafish ( www.seafish.org > On Land > legislation > guidance > Hygiene; On Land > legislation > guidance > Fishing Vessel Hygiene Checklist; On Land > search our publications > training materials > Hygiene and Cleaning in the Seafood Industry 2007 ).

Food business operators both those responsible for primary production and associated activities (vessel operators) and those undertaking dispatch, purification or processing operations, are required to meet strict hygiene standards at all stages of production. In the context of molluscan shellfish the various production stages and final product type placed on the market means that food safety risks vary. The regulations identified in this good practice guide clearly recognise the relative levels of risk associated with molluscan shellfish products and their treatment prior to being placed on the market. Consequently it is extremely important that good hygiene practices are followed throughout the production process.

In the context of the range of types of molluscan shellfish products which are placed on the market, and for which relevant sections of the regulations exist, the following list indicates the potential complexity of ensuring appropriate food safety provisions are applied.

Live bivalve molluscs (Oyster, Mussel, Scallop etc.)Live gastropod molluscs (Abalone)Live cephalopod molluscs (Octopus)Heat-treated bivalve molluscs (Cockle, Mussel, Clam etc)Heat-treated gastropod molluscs (Whelk, Winkle)Fresh fishery products (Cephalopods, Abalone)Prepared fishery products (Cephalopods, Scallops)Processed fishery products (Any molluscan shellfish)

While the range and the relative food safety risks of molluscan shellfish products is extensive, with consumption of live bivalve molluscs associated with the highest potential risk, the requirement for appropriate production hygiene measures applies to all products and production stages.

The requirement to address food safety risks is identified throughout the regulations with reference made to the application of Hazard and Critical Control Point (HACCP) principles. With respect to primary production and associated activities there is no requirement to implement full HACCP procedures but rather to assess potential hazards to food safety based on the general principles of HACCP. In this respect the local food authority will take account of the nature and size of the food business when assessing the


food safety risks of placing products on the market. In many instances involving primary production good hygiene practices implemented by vessel operators will suffice.

In order to ensure compliance with all food safety provisions it is important to contact the local food authority at the earliest opportunity. Depending on the level of food safety risk involved in the production process the local food authority will require the establishment (including vessels) to be either registered or approved. Detailed provisions for the potential hazards identified in the production process will be determined in line with the requirements of the regulations in this good practice guide.

Examples of such hazards emanating from the vessel/buildings, equipment, procedures or personnel include:

Physical hazards such as dangerous or unwanted foreign bodies in the foodstuff (wood or metal objects, marine detritus, pieces of plastic or glass, flakes of paint etc.)

Biological hazards such as other animals or pests and their faecal contamination also microbiological contamination from dirty fish rooms, storage facilities, equipment and poor hygiene standards of the food business personnel.

Chemical hazards such as the inappropriate storage and handling of substances including fuel, oil, greases, detergents, and cleaning agents.

The identification of such hazards and the implementation of practices to control them is the major principle behind the application of HACCP measures. The local food authority will require appropriate measures to be in place for all such hazards and be satisfied that the measures are utilised and maintained. While good working practices should suffice for many activities there will be a requirement to document others and record compliance on a regular basis. An example of the type of operating procedure which may be implemented by food business operators to ensure compliance, in this example the correct use of potentially hazardous chemicals, is outlined below.

Rules for the Use of Cleaning Chemicals All cleaning materials are to be stored in a lockable cupboard away from food

production. All containers of cleaning solutions are to be clearly marked to ensure they cannot

be inadvertently used for anything other than for which they were intended. Cleaning solutions are to be made up in accordance with the manufacturer’s

instructions. Cleaning solutions are to be made up as required and any made up solution left at

the end of the cleaning should be disposed of in line with the manufacturer’s instructions.

Protective clothing is to be worn as directed by the manufacturers of the products. Only chlorine based disinfectants or sanitisers must be used on any surfaces that

food comes into contact with. Phenol based disinfectants must only be used in toilet and drain areas etc. All cleaning equipment is to be maintained in a clean and serviceable condition

and reserved for specific cleaning functions.

A “clean as you go policy” must be maintained in all working areas to ensure that there is no build up of waste and waste material in any of the working areas.

Staff involved in the cleaning regime must be adequately trained in the use of the chemicals and equipment.

The implementation of systems to ensure food hygiene measures are adhered to include the adequate training of staff by food business operators. In the context of primary production and associated activities it is extremely important that crew aboard fishing vessels appreciate their responsibilities with respect to food safety. Equally staff operating dispatch, processing or purification systems must be adequately trained and the food business operator must ensure that all staff are qualified to undertake their jobs with respect to the specific food safety implications. The local food authority will advise on suitable training for food business operators and employees.

In order to fulfil the vessel operators responsibility for food hygiene during primary production it is important that all crewmembers are aware of their own responsibilities. In line with HACCP principles there is a need to ensure that all crew adhere to set rules, an example is given below of conditions relating to personal hygiene.

Personal Hygiene for Crew The crew harvesting, handling, grading, washing, preparing, storing, transporting

and landing molluscan shellfish must ensure the food products are not contaminated during operations.

Crewmembers must ensure personal hygiene standards do not lead to the contamination of the food products.

Crewmembers must wear protective clothing when undertaking any food handling operations and ensure it is kept clean.

Crew members must only eat, drink or smoke in designated areas separate from those for food product operations.

Crewmembers must not cough, sneeze or spit over molluscs when handling them. Crewmembers must ensure that gloves worn for handling food products are

reserved for the purpose and frequently cleaned. Crew members must wash and dry their hands before handling food products and

particularly after visits to the toilet and nose blowing etc. Crewmembers must cover open skin wounds such as cuts and grazes with

waterproof plasters. Crewmembers must inform the vessel skipper if they are carrying any health

condition transmissible through food products, or suffering from vomiting, diarrhoea or other stomach upset.

In all cases it is the responsibility of the food business and/or vessel operator to ensure food hygiene conditions are maintained according to HACCP principles. The local food authority should be contacted to ensure all appropriate provisions are in place.

Documents

The Good Practice Guide to Vessel Based Molluscan ... Shellfis… · Web viewThe establishments used for food production must be either registered for primary production and associated