Information sheet 64. Food safety guarantees in the food chain regarding the hazards of raw materials
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1 Update :17 Information sheet 64 Food safety guarantees in the food chain regarding the hazards of raw materials Contact Introduction Under EU Regulation (EC) 852/2004 primary responsibility for food safety rests with food business operators. They must put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. They must be able to identify any hazards that must be prevented, eliminated or reduced to acceptable levels. On the basis of a hazard analysis they must establish control measures, limits at the critical control points (CCPs) and implement effective monitoring procedures. DG Sanco s guidance document says to Article 5 of this regulation (Sanco/1955/2005/Rev. 3) that all potential biological, chemical or physical hazards that might be reasonably expected to occur at each process step must be identified, including those of raw materials and ingredients. This information sheet drawn up by the Food and Consumer Product Safety Authority of the Netherlands (VWA) sets out the guidelines for food business operators on how to manage the hazards related to the use of raw materials. Food business operators may deviate from the guidelines if they can substantiate their arguments and demonstrate that the alternative method they propose guarantees at least the equivalent level of food safety. Implementation Food business operators must include raw materials in their hazard analysis. They must determine the potential hazards that must be prevented, eliminated or reduced to acceptable levels and draw up adequate hazard management measures. Legal food safety standards can apply to products, whether they are raw materials or end products. When there is specific legal standard there may be other substantiated threshold levels. A company may produce a semi-finished product that serves as a raw material for the next upstream company. Products may go through various links in the chain before reaching their finished state. Suppliers of raw material or semi-finished products must comply with the safety Page 1 of 5
2 standards that apply to the raw material or semi-finished product they deliver, regardless of what the end product will be. Suppliers do t always kw what their product will end up like. And of course delution of unsafe raw materials it is t allowed. Control measures to prevent, eliminate or reduce a particular hazard may be taken by s of a raw material or semi-finished product or by the processors of that product. In such cases mutual arrangements must be clear, on condition that it is possible to take effective measures in the next link of the food chain. Only the food producer for end products may take into account the quantity of raw material, and with that the possible remaining hazards in the end product. Suppliers of a raw material or semi-finished product may submit a specification or declaration of the product as part of an arrangement but such documents alone are t sufficient guarantee of the product s safety and control measures that have been taken. The food business operator will have to check whether the product is in compliance with the mutual arrangements. Obviously, long term s can build up a relation of trust with their clients which allows for less intensive verification procedures. Verification methods accepted by the Food and Consumer Product Safety Authority of the Netherlands (VWA). 1. Suppliers of a raw material or semi-finished product shall submit a food safety certificate at every batch drawn up by an independent auditor. The raw material or semi-finished product must never exceed legal standards or other substantiated threshold levels. A batch is an identifiable and specified quantity of goods. A batch may be larger than a consignment or a delivery. Some products, parameters, reference or analysis methods and/or certificates may be subject to legal requirements that must be met. An analysis is related to a single batch and must be carried out at an ISO/IEC accredited laboratory. The laboratory must report the analysis results in accordance with the ISO/IEC criteria. See attachment I for more information on the analysis certificate or test report. 2. In the absence of a food safety certificate from the of a raw material or semi-finished product the buyer carries out an analysis itself, in which case the same or equivalent criteria as those referred to under point 1 apply. Regular s of a raw material or semi-finished product with invariably good test results may after five deliveries be marked kwn and have their sampling frequencies reduced to n (See diagram under regular ). Page 2 of 5
3 Sampling frequency is stepped up again when samples do t pass muster until ather five samples in a row get good results. Every must be screened in this way. Where a regular s deliveries contain several types of products a part of the delivery ( n) is sampled in turns. If deliveries from this regular go to different locations the sum of the samples carried out may count as ( n). 3. Companies have their s audited at least once a year to find out whether they are able to manage the hazard related to the raw materials or semi-finished products they buy from them. The audit report shall at least describe: The hazard related to the product concerned The method used for preventing, eliminating or reducing the hazard to acceptable levels. The corrective measures used The final assessment and the agreements made. This audit must take place before the s first delivery and must be carried out by an independent body by order of the buyer. 4. Companies work under a VWA approved food safety quality assurance programme which is specially designed for the management of hazards in raw materials. More information on the VWA website The mentioned verification methods are summarised in attachment 2. Page 3 of 5
4 Attachment I: the analysis certificate or test report The analysis certificate or test report must comply with the ISO/IEC standard. The results of all the laboratory analyses or tests must be reported accurately, clearly, unambiguously and objectively. All information needed for the interpretation of the results must be included in the certificate or the report. The analysis certificate or test report must contain the following information: Name and address of the laboratory or the location if the analyses/tests are carried out elsewhere; Clear description of the method of analysis applied and mention of the laboratory s ISO/IEC accreditation plus date of issue and issuing body; A unique identification of the analysis certificate or test report; Name and address of client; Name, function and signature (or equivalent form of identification) of the person issuing the analysis certificate or test report; Description and identification of the analysed/tested product; the product was received and date of analysis/test; Results of the analysis or test plus measurement units or measurement uncertainties. Further information on sampling where relevant for the interpretation of the results. Page 4 of 5
5 Attachment II: verification New Regular Different or or Analysis of first 5 deliveries Audit Participation quality assurance system analysis n deliveries, n products Annual audit Participation quality assurance system Analysis every batch In compliance? In compliance? yes yes As regular As new As regular As new Page 5 of 5
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