Interpretation Guideline to Control Points Compliance Criteria

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1 Section:Introduction Page: 1 of 9 EUREPGAP Interpretation Guideline to Control Points Compliance Criteria Integrated Aquaculture Assurance Version 1.1-May06 Excerpt Valid and Compulsory from: 10 May 2006

2 Section:CP & CC Page: 2 of 9 Nº CONTROL POINT COMPLIANCE CRITERIA LEVEL 1 Base Module for Aquaculture 1.5. Management of Production sites, Land, Buildings and Facilities T2 This section is intended to ensure that the land, aquaculture sites, buildings and other facilities, which constitute the fabric of the farm, are properly managed to ensure the safe production of food Site Management When a new or restarted aquaculture farm site is to be used, is a human health, food safety, or animal health and welfare assessment undertaken, taking into account the prior use of the land or site and all potential environmental impacts? A Risk Assessment on human health, food safety, or animal health and welfare must be carried out when new aquaculture enterprises are to be introduced near to existing fish farms. This Risk Assessment must be available on the farm. No N/A Site Entry Are prohibited unauthorised signs displayed Visual assessment of the site clearly at the facility? Are covered sanitised footbaths provided at pedestrian entrances to all facilities and Visual assessment of the site preferably on each block of cages and/or each boat? Are hand wash and hand disinfection points installed and utilised on entry into areas Hand wash and hand disinfection points are installed and utilised. where food safety or fish health may be at Visual assessment of the site. risk? E.g. At hatcheries and harvesting stations Pest Control Does the farm minimise the risk of pest infestation in buildings, fish holding areas and other facilities to eradicate infestation? Documented pest control plan and associated management controls, Is the location of all pest control measures must be assessed. No N/A identified on a plan/diagram of the site and include other operators within the same biological area? Is pest control contract with a specialist company (or the procedures must be included in the Veterinary Health Plan)? In Contracts must be assessed. certain remote locations, does the farmer perform this function in-house? 1.6. Fish Welfare, Management and Husbandry Identification and Traceability of Stock In the initial phase of application of this Standard, have all fish spent their last six Movement traceability records must be assessed to prove that all fish months of their life on EUREPGAP have lived on EUREPGAP approved farms for the last six months approved farm(s) where the fish lives that before slaughter. No N/A long?

3 Section:CP & CC Page: 3 of 9 Nº CONTROL POINT COMPLIANCE CRITERIA LEVEL Fish Health & Welfare On aquaculture farms, are all staff aware of the contingency procedures relevant to their enterprise in the event of emergencies, which pose a threat to food safety or animal health and welfare? Do these contingency procedures cover the event of failure of an adequate supply of feed and oxygen? Written contingency procedures. Staff to demonstrate awareness at interview on how to act where food safety is threatened and animals are guaranteed food and water within 24 hours of an emergency. No N/A Are withdrawal periods for veterinary medicine known and strictly adhered to? Does any fish holding area that can be exposed to the same water as a fish holding area subject to withdrawal period is subject to the same withdrawal period? Is there a Site must must be assessed. Staff must be able to demonstrate written confirmation of the nature and date awareness at interview for recent treatments in medicine administration of treatment and the date that the records and view stock for identification. No N/A withdrawal period will be completed and does this accompany any fish subsequently sold to another farm before the withdrawal period has expired? Do any such fish are clearly and readily identified as having been treated? Is each hatchery or gro-on farm equipped with suitable facilities to isolate or remove Site must must be assessed. No N/A sick or injured batches of fish? Does each site have an active water quality monitoring programme linked to those Records for each site must must be assessed. No N/A parameters considered critical in the Risk Assessment (see point )? Medicines Is there a current list kept for all medicines Records must be assessed to prove that medicines in store/use are on used? Are medicines banned in the the records of current use and are not banned in the EU. No N/A European Union NOT used? Are residue test results traceable to the Written procedures for residue testing and monitoring plan after specific batch of fish unless covered by treatments on fish stocks, or evidence of test results for residues from point ? the competent authority must be assessed. No N/A Aquaculture Feed Where purchased feed is supplied by a company it must be licensed Are purchased feed and industry byproducts manufactured by, and obtained with the relevant competent authority and must demonstrate that it complies with the requirements for quality assurance set by from, a source approved by EUREPGAP? EUREPGAP. Licence and details must be assessed. No N/A Are protein and fat elements NOT obtained from the same fish species? Feed records must be assessed and they must demonstrate source from different species. No N/A

4 Section:CP & CC Page: 4 of 9 Nº CONTROL POINT COMPLIANCE CRITERIA LEVEL Feed Records Do Feed Producers (selling to a EUREPGAP Fish farm) obtain from their Labels / invoices / statements specifying constituents must be supplier a declaration of constituents for assessed for five years each compound diet and supplement fed to No N/A their stock and records of them are kept for five years? Do Feed Producers (selling to a EUREPGAP Fish farm) have a list of all Detailed records must be assessed for all additives utilised in feed. No antibiotics, colourants, antioxidants, N/A immune stimulants, probiotics and other additives utilised in feed? Are labels of the feeding stuffs kept by the farmer as evidence of feed origin and ingredient composition? 1.7 Machinery and Equipment Feedstuffs labels must be kept for each batch (for a minimum of 2 years or long enough to cover full life cycle of a fish or crop), must be assessed detailing the contents of the feed. No N/A, unless no feedstuff supplied. Are vehicles and boats used for transporting fish or aquaculture feed, whether owned by Record of Inspection of each lorry/boat and records of any corrective the Producer or contractors, inspected for actions must be available as evidence for the existence of an cleanliness prior to loading and any inspection system. No N/A necessary corrective action taken? 1.9 Fresh Water Water Usage and Disposal Is water quality monitored on intake and/or outlet of each tank, for oxygen and The records of inspecting of oxygen, temperature and ph (ph and temperature? Are ph and carbon dioxide oxygen at inlet and outlet) is sufficient, for all sites must be assessed. parameters checked as required on groups Where water is recycled, nitrate and ammonia records must be of tanks? Where water is recycled, are assessed. nitrate and ammonia levels checked? Sampling and Testing Techniques All fish must be sampled and tested to monitor food safety, quality and legality for the species produced on the farm Is the sampling programme based on likely contaminants, residues and substances for The sampling procedures and plan for all tests on raw materials and the type of aquaculture practiced and has fish must be assessed. No N/A analysis of these risks been incorporated into the HACCP system? For all tests, are duplicate samples taken and held for independent analysis by the Inspect records of samples taken with batches and sample numbers supplier, using identification numbers and etc. No N/A security seals to eliminate mixing of samples? Is testing carried out at a recognised laboratory with valid International The results of all samples taken must be assessed. Proof of Accreditation (ISO17025) of Measurement accredited status of subcontracted laboratory. and Sampling, using applicable methods to ensure LOQ lower than MRL?

5 Section:CP & CC Page: 5 of 9 Nº CONTROL POINT COMPLIANCE CRITERIA LEVEL 2 Salmonids Species Module 2.1 Freshwater (Applicable to Fresh Water farms only) Water Temperature Is water temperature surrounding the eggs kept below 8 degrees for salmon and 10 degrees for trout until hatching? In the first feeding period the temperature can be raised up to 12 degrees for salmon and 15 degrees for trout. The water temperature records must be available for inspection. Staff must be able to demonstrate awareness at interview. 2.4 Husbandry on the Farm (Sea Water) Smolt Source Are smolts sourced from a EurepGAP The records of the smolts must be available for inspection. Staff must certified hatchery source, and certified be able to demonstrate awareness at interview according to official legislative requirements? Are smolts vaccinated according to minimum legal requirements as specified by local government veterinary authorities? Smolts, which have been purchased from outside companies, are these grown in conditions which comply with EUREPGAP IAA requirements (certified supplier)? The vaccination records must be available for inspection. Staff must be able to demonstrate awareness at interview. Proof of certified status of supplier.

6 Section:Interpretation Guide Page: 6 of 9 Nº INTERPRETATION GUIDELINE LEVEL 1 Base Module for Aquaculture 1.5. Management of Production sites, Land, Buildings and Facilities T2 This section is intended to ensure that the land, aquaculture sites, buildings and other facilities, which constitute the fabric of the farm, are properly managed to ensure the safe production of food Site Management Following should be followed under this title: "All Farm and farm facilities shall be maintained in good repair and be dedicated and suitable for the regarding fish (life stage) species. The farm and farm facilities shall be maintained in good order and regularly tended. Water supplies and feeding equipment are functional, well maintained and dedicated to the fish species life stock. Text in compliance criteria: "near to existing farms" to be taken out. Control Point should read: "When a new or restarted aquaculture farm site is to be used, is a human health, food safety, AND animal health and welfare assessment undertaken, taking into account the prior use of the land or site and all potential environmental impacts? " / Compliance criteria should read: "A Risk Assessment on human health, food safety, AND animal health and welfare must be carried out when new aquaculture enterprises are to be introduced. This Risk Assessment must be available on the farm. No N/A" Start of production after fallowing period is not considered as restart, only when a site is new or taken in use after a longer period than normal fallowing period. The time perspective to consider a farm site as "restarted" should follow legislation requirements if shorter that normal fallowing periods practiced by the farmer Site Entry The boundaries of the farm should be clearly indicated. Measures shall be in place to maintain farm security and ensure that only authorised staff have access to the farm and farm facilities. Compliance Criteria should read: "Visual assessment of the site to verify that Prohibited and "Unauthorized signs are in place." Target of requirement is that there must be in place a suitable method to guarantee no contamination (e.g. change boots at entrance). Control point should read: "Are covered sanitised footbaths, or other suitable method to guarantee no contamination, provided at pedestrian entrances to all facilities and preferably on each block of cages and/or each boat?" Compliance criteria remains as it is This control point is "No N/A", text under compliance criteria should read: "Hand wash and hand disinfection points are installed and utilised. Visual assessment of the site. No N/A" Pest Control Second sentence in Control Point should read: "Is the location of all pest control measures identified on a plan/diagram of the site and include other operations within the same biological area? " Control Point refers that this also applies for remote locations. In certain remote areas the farmer must have in-house appropriately trained personnel for this function. 1.6 Fish Welfare, Management and Husbandry Identification and Traceability of Stock Text "EUREPGAP approved" should be replaced by "registered". All fish should spent their last six months of their life on the farm intending to be EUREPGAP certified before the registration date of farm done in the EUREPGAP system Fish Health & Welfare Target of requirement is that there must be in place a contingency written procedure in case of system failure (e.g. due to mechanical problems, failure of energy supply, etc). Failures in the operating system can affect animal health and welfare in aquaculture farms. Control point should read: "On aquaculture farms, are all staff aware of the contingency procedures relevant to their enterprise in the event of emergencies?" Compliance criteria should read: "Written contingency procedures. Staff to demonstrate awareness at interview on how to act when system fails (e.g. mechanical problems, failure of energy supply, etc.). No N/A" Not only for the direct treated aquaculture livestock is a withdrawal periods adhered but also for livestock which has been in contact with the same medicated feed or water. Control Point should read: "Is each hatchery or grown-on farm equipped with suitable facilities to isolate or remove sick or injured batches of fish?" Control Point should read: "Does each site have an active water quality monitoring programme taken into account the fish health and welfare?"

7 Section:Interpretation Guide Page: 7 of 9 Nº INTERPRETATION GUIDELINE LEVEL Medicines Text in control point should be added: "...in the EU and countries intended to be exported ". Control Point should read: "Is there a current list kept for all medicines used? Are medicines banned in the European Union and countries intended to be exported NOT used? Same applies for compliance criteria Control Point should read: "Are residue test results traceable to the specific batch of fish unless covered by point ?" Aquaculture Feed Compound Feed Manufacturers (CFM) approved by EUREPGAP are placed on the approved list on the website after completing an acceptable self-assessment and registration process. The CFM must be certified against the EUREPGAP CFM Standard (when certification ready) OR against a standard that has been successfully benchmarked against the EUREPGAP CFM Standard, before the end of 2007 or within 12 months of registration, whichever is the later. Protein and fat elements in feed should not be obtained from the same fish species. This applies as well for all species considered in the same module, e.g. no salmon-derived protein and fat can be included in feed given to trout Local/national legislation should be followed. Compliance criteria should read: "Feed records must be assessed and they must demonstrate source from different species. Unless proven that legislation (in the EU and countries of destination) allows this practice, No N/A." Feed Records Feed used on farms have to be obtained from a EurepGAP approved source, the EUREPGAP COMPOUND FEED MANUFACTURER REFERENCE MODULE (CFM) is available for download from our EurepGAP website (see under documents checklists for IFA and IAA). The way in which the process for demonstrating compliance is twofold (choice depends on whether the feed mill is already working with a scheme or not), as described in the introduction of the CFM CPCC document. Detailed records must be assessed for: Additives used in normal feed (such as vitamins, minerals and pigments); - Additives used in special feeds (immune stimulants, probiotics, antibiotics, etc.) For compliance of this control point, invoice number must be registered in the production data base and this number to be traced back to the feed batch information kept by the feed supplier when feed bag labels not kept after feed consumption. 1.7 Machinery and Equipment For compliance of this control point, inspection of logbooks, conductance of ad hoc controls of cleanliness or compliance of a valid certificate of a EUREPGAP recognised Transport Standard can be shown as evidence. 1.9 Fresh Water Water Usage and Disposal Control point should read: "Is water quality monitored on intake and/or outlet of each tank? When water is recycled, are nitrogen levels also recorded?" / Compliance criteria should read: "The records of water monitoring must be available. When water is recycled, nitrogen levels to be included in this records (internal control to keep safe levels of nitrogen for animal welfare and environmental protection)." 1.11 Sampling and Testing Techniques All fish must be sampled and tested to monitor food safety and legality for the species produced on the farm. List of substances to be analyzed based on local/national legislation, requirements given by purchaser and results on the Risk Assessment. Risk assessment should focus on contaminants and food safety issues. This is a tool for the farmer to demonstrate Good Aquaculture Practices are well implemented and producing a safe and legal fish, including feed. Compliance criteria should read: "The sampling procedures and plan for all tests on feed, raw materials and fish must be assessed. No N/A. Control Point remains as it is. In this Control Point, the supplier refers to the farmer. Text "by the supplier" to be taken out to avoid confusion. Control point should read: "For all tests, are duplicate samples taken and held for independent analysis, using identification numbers and security seals to eliminate mixing of samples?" Compliance criteria should include the sampling of feed. Text in compliance criteria should read: "Inspect records of samples taken with batches and sample numbers. Samples taken must include feed used in farm. No N/A".

8 Section:Interpretation Guide Page: 8 of 9 Nº INTERPRETATION GUIDELINE LEVEL For clarification purposes, requirement modified based on EurepGAP Fruit and Vegetables standard. Control point should read: "Is the laboratory used for residue testing accredited by a competent national authority to ISO or equivalent standard? " / Compliance criteria should read: "There is clear documented evidence either on the letter headings or copies of accreditations etc. that the laboratories used for chemicals residue analysis have been accredited to the applicable scope by a competent national authority to ISO or an equivalent standard (in which case evidence of participation in proficiency tests is available). " 2 Salmonids Species Module 2.1 Freshwater (Applicable to Fresh Water farms only) Water Temperature Temperatures given as references. When these temperatures are not achieved, the possibility to have as a Non-Applicable Control Point is given and justification based on acceptable criteria and evidence (animal, welfare, food safety, environment or worker safety) must be provided by the Fish Farmer. First feeding period refers to first feeding period up to the average size of 1g. The first feeding temperature can be 10 C or higher depending on the space the hatchery will have later in the growing cycle. This applies to farms buying ova for fish production. For farms starting from smolts, inspections in the egg supplier instalations must be made. Compliance criteria should read: "The water temperature (sorrounding the eggs) records must be available for inspection. Staff must be able to demonstrate awareness at interview." Husbandry on the Farm (Sea Water) Smolt Source Smolt suppliers must be EUREPGAP Certified. For initial compliance purposes, it is required that Smolt Suppliers to EUREPGAP Fish Farms must be registered on the EUREPGAP System (as EUREPGAP Fish Farms) at the time of the Fish Farmer s first EUREPGAP Audit, and must demonstrate Certified Status to EUREPGAP on Self Assessment and full compliance at subsequent annual audits. After this first year, any additional Smolt Suppliers that start supplying the alredy Certified EUREPGAP Fish Farmer, have to have been registered on the EUREPGAP System from the moment Smolts are purchased, and must demonstrate EUREPGAP Certified Status at the first External Audit after they started supplying. This also applies for Ova Suppliers when ova is purchased by the EUREPGAP Fish Farm as basis for own Smolt Production.

9 Section:Document History Page: 9 of 9 1. Document History Guideline Replaces Version Replaced doc. obsolete Comes into force Description of Addition/ Modification IAA 1.0 CP Excerpt Dec 2005 IAA 1.1 CP Excerpt May 06 IAA 1.1 CP Excerpt May 06 IAA 1.0 CP Excerpt Dec 2005 IAA 1.0 CP Excerpt Dec 2005_update 28July06 22 December 2005 Clarification and Interpretation Guide for control points: / / / / / / / / / / / / / / / / / / and Clarification and Interpretation Guide for control points: / / / / / / / / Section 1.11 ( ) / Title corrected following CPCC "Pest Control" / Compliance criteria: also applies EU and Countries intended to be used.