Good Manufacturing Practice for the Manufacture of Paper - CEPI ...

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Annex 2 – Hazard Inventory and Risk analysis A2.1 Introduction Article 3 (a) of Regulation (EC) No 2023/2006 states: Good manufacturing practice (GMP) means those aspects of quality assurance which ensure that materials and articles are consistently produced and controlled to ensure conformity with the rules applicable to them and with the quality standards appropriate to their intended use by not endangering human health or causing an unacceptable change in the composition of the food or causing a deterioration in the organoleptic characteristics thereof. The adverse elements in packaging which might cause organoleptic changes could be chemical, physical and/or microbiological. To fulfil the regulation it is essential to know how the composition of the paper or board is controlled and how process variables affect that composition. It is also necessary to know about the possibility that contaminants might be introduced, how and where they might occur, what risk they pose and how that risk can be controlled. When implementing GMP, a risk analysis, i.e. a hazard inventory followed by a risk assessment, through the whole process, should be carried out in order to control product safety aspects in paper and board mills. The diagram below (Figure 3) illustrates, in general terms, how severity of risk varies according to production location and product application. Figure 3 -- Severity of Risk Premises Final use - configuration Final use – foodstuff type Increasing Storage areas for raw materials and pulp preparation Indirect food contact Foods likely to be washed or peeled before consumption risk Paper machine and any on-line coating process Dry, non fatty food Areas used for slitting, winding and storing customer reels Direct food contact Fatty and moist food 14
A2.2. General Considerations of the Risk Analysis In a risk analysis, every step of the process, from procurement of raw materials to delivery of products, is categorised for production and contamination hazards which could affect the safety of the end product and thus pose a potential risk. All identified potential hazards must be described and then undergo a risk assessment. This risk assessment is based on the likelihood of the occurrence of the hazard and the effect the hazard might have on consumer health if it occurred. The combination of these two underlined factors gives the risk. It is accepted that the risk posed by contaminants may change over time and this may require rapid response by mills 6 . All defined measures and procedures shall be documented through the management system. The decisions taken in the risk analysis, and the reasons, including when the effect/occurrence is seen as negligible or will be eliminated in a next process step, have to be documented in the hazard inventory overview. The hazard inventory and risk analysis have to be carried out by qualified persons. The validity of the risk analysis shall be reviewed regularly, at least once per year and always when a major process change takes place. Depending upon the result of the review (which should be documented), a repeated risk analysis may be required either in part, in full or it may not be needed at all. 6. Traces of non intentionally added substances (NIASs) will occur in all packaging materials and their complete identification and total elimination is not possible. The mill should select its raw materials to ensure NIASs in its products are present at extremely low levels. In cases where new toxicological evidence is confirmed for NIASs, the mill will take action, if necessary, to rapidly restore its products to compliance. 15
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