Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA
Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA
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DOI：
10.2903/j.efsa.2007.587
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发表时间：
2007-12-01
期刊：
影响因子：
3.3
通讯作者：
Vannier, Philippe
中科院分区：
文献类型：
--
作者：
Barlow, Sue;Chesson, Andrew;Vannier, Philippe
在食品和饲料生产中使用了各种各样的微生物物种。有些药物具有长期的明显安全使用历史，而另一些药物则不太为人所知，其使用可能对消费者构成风险。经验表明，需要一种工具，用于在EFSA提到的食品/饲料生产中使用的微生物的风险评估中设定优先级，因此是正式安全评估的主题。为了满足这一需求，提出了一个系统，用于对选定的微生物组进行上市前安全性评估，从而得出“合格的安全性推定（QPS）"。从本质上讲，这意味着可以根据四个支柱（确定身份、知识体系、可能的致病性和最终用途）对一个确定的分类组（例如属或相关物种组）进行安全评估。如果分类组未引起安全性问题，或者如果存在安全性问题，但可以定义和排除（资格），则可以授予分组QPS状态。此后，任何微生物菌株，其身份可以明确确定并分配到QPS组，将不需要进一步的安全性评估，除非满足任何规定的资格。不适合QPS的微生物将继续接受全面的安全评估。EFSA要求其科学委员会考虑是否可以使用该系统来协调EFSA各个科学小组的微生物安全评估方法。如果是这样的话，委员会被要求制定一项战略，以引入基于QPS概念的评估系统。科学委员会审查了可能成为EFSA意见主题的微生物的范围和数量。他们发现，大约有100种微生物已经或预计将提交EFSA进行安全评估;其中大多数是作为食品和饲料添加剂、食品酶和植物保护产品来源的市场授权通知的结果。发现这些种属中的绝大多数属于四大类：i）革兰氏阳性非产孢细菌; ii）芽孢杆菌属; iii）酵母菌和iv）丝状真菌。因此，选择属于这四组的细菌、酵母菌和真菌，对其QPS状态的适用性进行初步评估。科学委员会的结论是，属于四组中前三组的许多鱼种的现有证据的份量足以确保检疫和装运前状态至少提供与逐案安全评估相同程度的可信度。然而，委员会发现，在丝状真菌的情况下，知识体系，特别是与使用历史有关的知识，由于被认为适合QPS状态的微生物数量足够广泛，足以涵盖大多数安全性评估，因此，关于涉及欧洲食品安全局要求的微生物的问题，科学委员会得出结论，为微生物引入QPS系统将达到以下目标：提供一种实用的工具，用于确定优先事项，避免对已知不会引起关注的微生物进行广泛调查。虽然不能从生产菌株的QPS状态推断微生物代谢产物的QPS状态，但委员会认为该系统仍然对评估用于生产此类产品的菌株具有价值。然而，还需要进一步开展工作，将该系统扩大到包括用于生物控制目的的微生物，最后，科学委员会在就检疫和装运前处理作为一种评估工具的价值得出结论时，认识到必须继续规定审查和修改具有检疫和装运前处理地位的生物体清单。他们建议EFSA通过其科学理事会对此承担主要责任，并应至少每年审查现有清单和任何补充清单是否适合QPS状态。必要时可更频繁地进行审查，但应正式要求，即使没有提出任何更改，也应每年发表声明，说明已公布清单的QPS状态得到维持。
A wide variety of microbial species are used in food and feed production. Some have a long history of apparent safe use, while others are less well understood and their use may represent a risk for consumers. Experience has shown that there is a need for a tool for setting priorities within the risk assessment of those microorganisms used in food/feed production referred to EFSA and consequently the subject of a formal assessment of safety. To meet this need a system was proposed for a pre-market safety assessment of selected groups of microorganisms leading to a "Qualified Presumption of Safety (QPS)". In essence this proposed that a safety assessment of a defined taxonomic group (e.g. genus or group of related species) could be made based on four pillars (establishing identity, body of knowledge, possible pathogenicity and end use). If the taxonomic group did not raise safety concerns or, if safety concerns existed, but could be defined and excluded (the qualification) the grouping could be granted QPS status. Thereafter, any strain of microorganism the identity of which could be unambiguously established and assigned to a QPS group would be freed from the need for further safety assessment other than satisfying any qualifications specified. Microorganisms not considered suitable for QPS would remain subject to a full safety assessment.EFSA asked its Scientific Committee to consider whether this system could be used to harmonise approaches to the safety assessment of microorganisms across the various EFSA scientific panels. If so, the Committee was requested to develop a strategy for the introduction of an assessment system based on the QPS concept.The Scientific Committee reviewed the range and numbers of microorganisms likely to be the subject of an EFSA opinion. They found that approximately 100 species of microorganisms have been or are expected to be referred to EFSA for a safety assessment; the majority being the result of notifications for market authorisation as sources of food and feed additives, food enzymes and plant protection products. A large majority of these species were found to fall within four broad groupings: i) Gram-positive non-sporulating bacteria; ii) Bacillus species, iii) yeasts and iv) filamentous fungi. Accordingly, bacteria, yeasts and fungi falling within these four groups were selected for an initial assessment of their suitability for QPS status. The Scientific Committee concluded that the weight of evidence available for many species falling within the first three of the four groups was sufficient to ensure that QPS status provided at least the same degree of confidence as a case-by-case safety assessment. However, the Committee found that, in the case of the filamentous fungi, the body of knowledge, particularly that relating to a history of use, was for a specific purpose and did not allow extrapolation to other uses to be made with confidence and so could not recommend QPS status for such fungi.As the number of organisms considered suitable for QPS status is sufficiently extensive to cover a majority of the safety assessments involving microorganisms required of EFSA, the Scientific Committee concluded that the introduction of a QPS system for microorganisms would meet the objectives of providing a practical tool for setting priorities and avoiding the extensive investigations of organisms known not to cause concern. Although QPS status of metabolic products of microorganisms cannot be inferred from the QPS status of the production strain, the Committee considered that the system still had value for the assessment of strains used in the production of such products. Further work, however, would be required to extend the system to encompass those microorganisms used for biological control purposes.Finally, in reaching its conclusion on the value of QPS as an assessment tool, the Scientific Committee recognised that there would have to be continuing provision for reviewing and modifying the list of organisms given QPS status. They recommended that the EFSA via its Science Directorate should take prime responsibility for this and should review the suitability for QPS status of the existing list and any additions at least annually. Reviews may occur more frequently as necessary but there should be a formal requirement that even when no changes are proposed, a statement should be made annually that QPS status is being maintained for the published list.