不同国家和国际组织食品接触材料的风险评估

通过对欧盟、美国、加拿大和我国食品接触材料的基本定义、食品接触材料风险评估需要递交的资料和暴露评估的介绍,了解不同国家或国际组织对食品接触材料的风险评估方法,从而对国际上食品接触材料的风险评估有更清晰的认识。     

我国食品接触材料安全性评估体系构建

食品接触材料中所有可能迁移到食品中的物质均需要评估,包括单体、起始物和添加剂等有意添加物,以及杂质、生产过程中产生的副反应产物和降解物等非有意添加物。食品接触材料的安全性评估主要分为上市前的安全性评估和上市后的监测评估。目前,国际上食品接触材料上市前的安全性评估主要有美国和欧盟两种评估模式,两种方法各有优缺点。我国目前尚未建立食品接触材料上市前安全性评估的基本参数。构建我国食品接触材料安全性评估体系是国家食品安全风险评估专家委员会确定的"十三五"期间的重点工作。本文介绍了我国食品接触材料安全性评估体系的构成、预期目标以及食品接触材料风险评估面临的挑战。     

食品接触材料中寡聚物的风险评估范式研究

研究食品接触材料中包括寡聚物在内的非有意添加物的风险评估，对于保障食品安全具有重要意义。本文通过收集国内外有关寡聚物的文献和风险评估报告，系统分析食品接触材料中寡聚物的来源和风险评估方法，并选择1,2,3,4-四氢萘-2,6-二甲酸二甲酯和Cyclo-di-BADGE等寡聚物为案例，介绍寡聚物的风险评估步骤和方法，从而为我国食品接触材料中寡聚物的风险评估和风险管理提供方法学支持。     

食品接触用聚对苯二甲酸乙二醇酯材料回收再利用风险评估方法学进展

聚对苯二甲酸乙二醇酯(PET)因其优越的性能和安全性而广泛用于饮料包装行业。PET材料的广泛使用产生了大量废弃PET。PET的回收再生不仅可以降低健康风险,还可以减少环境污染、节约资源。再生PET用于食品接触材料需要经过系统的风险评估。美国、欧盟、法国等国家或国际组织已经建立了食品接触用PET材料回收再利用的风险评估体系。本文综述了不同国家或国际组织对食品接触用回收PET材料风险评估的主要方法及其优缺点,从而为我国进行相关工作提供借鉴。     

欧盟塑料食品接触材料新法规浅析

欧盟塑料食品接触材料新法规修改和细化了塑料食品接触材料的安全性要求,进行了更为详细、规范和合理的规定.本文介绍了欧盟塑料食品接触材料新法规的主要内容,及其与原塑料指令之间的变化,旨在全面、深入了解欧盟对塑料食品接触材料的管理模式和走向,分析其中可为我国食品接触材料管理所用的内容,为监管部门以及相关行业、企业提供参考.我国在修订GB 9685-2008、构建食品接触材料标准体系中也可以借鉴法规中的一些管理内容及管理思路.     

欧盟食品和饲料快速通报系统通报我国食品接触材料的安全问题分析

在对欧盟食品和饲料快速通报系统(RASFF)通报分析中发现,食品接触材料的通报日益增多,其已成为食品安全的重要一环。本文通过总结2011~2015年欧盟RASFF通报我国出口食品接触材料的情况,分析其中涉及的风险因素和材料种类等,研究欧盟在食品接触材料方面的关注热点及变化趋势,从而为出口企业提高产品质量和我国行政管理部门制定政策、标准提供参考,以增强我国对欧盟技术贸易壁垒的应对能力,推动和扩大输欧贸易。     

2019年上半年欧盟食品接触材料快速预警系统通报（RASFF）情况

<正>欧盟是我国食品接触材料的主要出口国,近年来,欧盟频频对我国食品接触材料发布召回通报。通过梳理2019年上半年欧盟食品类、饲料类快速预警系统(RASFF)发布的召回通报,针对我国食品接触材料被通报的数量、产品分布、通报原因与国内外标准的差异等进行统计分析,并对出口食品接触材料的召回提出应对的建议和措施。欧盟食品和饲料类快速预警系统(rapid alert system for food and feed,RASFF),是一个连接欧盟各成     

中国出台进出口食品包装新规

食品包装安全卫生已受到越来越广泛的重视。2005年1至10月,欧盟向我国通报了54起食品包装及接触材料的安全卫生问题。2005年7月1日,欧委会健康和消费者保护总司司长马德林专门就我国出口欧盟与食品接触材料频繁被检出安全卫生问题致函我国驻欧盟大使,提出如果中方不在7月底前采取有效措施,将对中国的此类产品采取进一步措施。食品包装及接触材料已经成为发达国家设立技术壁垒的新领域。近年来,欧盟、美国、日本等对直接与食品接触的包装及包装材料都制定了详细的法规。如FDA长期以来遵循的美国联邦法规,详细规定了各种与食品直接或间接接触的包装材料及其中所使用的各项物质的要求。欧盟在2004年新拟定的草案“食品接触物质超级指令”则进一步综合了过去所有与食品接触物质相关的旧法规,使其成为欧盟对食品包装材料最主要而且最具影响力的新法规。     

基于RASFF通报分析我国食品接触材料安全

基于2014年欧盟食品和饲料快速预警系统(Rapid Alert System of Food and Feed,RASFF)对我国出口食品接触材料的通报数据,分析了我国食品接触材料存在的主要问题,比较了欧盟食品接触材料监管与我国食品相关产品监管体系差异,并为提高我国食品接触材料的整体安全水平,增强我国贸易市场竞争力提出了具体建议。     

即食食品中单核细胞增生李斯特菌风险管理措施的研究

单核细胞增生李斯特菌是一种重要的食源性致病菌,由于该菌引发的疾病致死率较高,且其暴发常出现于工业加工食品中,从而引起世界范围的广泛关注.FAO/WHO微生物风险评估联合专家委员会(JEMRA)及美国、欧盟、澳大利亚和新西兰等国家分别对即食食品中单核细胞增生李斯特菌进行了风险评估,并根据风险评估采取适当的风险管理措施.本文对国际食品法典委员会及部分国家的风险管理措施进行了横向比较分析,提出进行完整的微生物风险评估是选择适当的微生物风险管理的必要前提,风险管理措施的有效实施需要国家主管机构、企业和消费者三方的共同参与.上述结论可为我国政府部门在现有法规框架内如何控制即食食品中单核细胞增生李斯特菌的风险提供参考.     

Non-targeted multi-component analytical surveillance of plastic food contact materials: Identification of substances not included in EU positive lists and their risk assessment

A procedure used by the Norwegian Food Safety Authority for surveillance of contaminants from plastic food contact materials (polyolefin drinking bottles, water boilers, polyamide cooking utensils and plastic multi-layer materials) is described. It is based on gas chromatographic-mass spectrometric (GC/MS) analysis of food simulants exposed to plastic materials. Most migrants were substances not-intentionally added to the plastic (degradation products, impurities) or originated from non-plastic components, such as printing inks, adhesives, not-listed additives, solvents and coatings. Hence, the majority of the identified migrants were regulated by the general statements in the EU Framework Regulation, which neither specify limits nor requirements regarding risk assessment, rather than by specific migration controls. Risk assessment has been carried out for selected non-authorized substances. The analysis and the management of these substances and materials with respect to safety represents a challenge to the food authorities.     

食品接触材料中非有意添加物及其来源研究进展

食品接触材料（Food Contact Materials, FCMs）在生产、使用和回收过程中都可能引入非有意添加物（Non-Intentionally Added Substances,NIAS）。NIAS的复杂性和未知性给FCMs的安全评估和监管带来严峻的挑战。近些年来,FCMs中NIAS的迁移作为影响食品安全的重要因素而备受关注。本文介绍了FCMs中NIAS的研究流程、分类及主要来源;从目标物及研究目的出发,归纳总结了NIAS的主要分析策略;重点描述了近年来不同类型FCMs中主要NIAS及其来源的研究进展,以期为今后FCMs中NIAS的深入研究提供科学指导。     

塑料食品接触材料中非有意添加物检测方法研究进展

食品接触材料(Food contact materials, FCMs) 与食品安全密切相关。FCMs能有效保护食品,防止其腐败变质,但在生产过程中可能会由于一些原因引发食品安全问题,其中从FCMs中迁移出的非有意添加物(non intentionally added substance,NIAS)成为影响食品安全的重要因素而引起社会各界的广泛关注。由于NIAS非常复杂,且相当数量未知,其检测成为我国乃至全球食品接触材料安全评价的关键点及难点。在这篇综述中,以塑料食品接触材料和NIAS为主,介绍塑料材料中的NIAS来源、种类、国内外相关法律法规、近年来研究现状以及分析方法,最后对NIAS检测以及Orbitrap高分辨质谱检测技术的未来发展方向进行了展望。     

In Vitro Toxicity Testing of Food Contact Materials: State‐of‐the‐Art and Future Challenges

Currently, toxicological testing of food contact materials (FCMs) is focused on single substances and their genotoxicity. However, people are exposed to mixtures of chemicals migrating from food contact articles (FCAs) into food, and toxic effects other than genotoxic damage may also be relevant. Since FCMs can be made of more than 8 thousand substances, assessing them one‐by‐one is very resource‐consuming. Moreover, finished FCAs usually contain non‐intentionally added substances (NIAS). NIAS toxicity can only be tested if a substance's chemical identity is known and if it is available as a pure chemical. Often, this is not the case. Nonetheless, regulations require safety assessments for all substances migrating from FCAs, including NIAS, hence new approaches to meet this legal obligation are needed. Testing the overall migrate or extract from an FCM/FCA is an option. Ideally, such an assessment would be performed by means of in vitro bioassays, as they are rapid and cost‐effective. Here, we review the studies using in vitro bioassays to test toxicity of FCMs/FCAs. Three main categories of in vitro assays that have been applied include assays for cytotoxicity, genotoxicity, and endocrine disruption potential. In addition, we reviewed studies with small multicellular animal‐based bioassays. Our overview shows that in vitro testing of FCMs is in principle feasible. We discuss future research needs and FCM‐specific challenges. Sample preparation procedures need to be optimized and standardized. Further, the array of in vitro tests should be expanded to include those of highest relevance for the most prevalent human diseases of concern.     

我国食品微生物风险评估的进展和挑战

近10余年来,我国依照《食品安全法》开展包括微生物风险评估在内的食品安全风险评估体系建设,微生物风险评估工作体系和技术体系等方面取得明显进展,成为我国开展食源性致病微生物风险评估的重要基础。随着全球后疫情时代食品供应链的变化和新技术的快速发展以及我国食品安全治理现代化需求的增加,构建基于我国膳食消费行为的评估模型、提高风险评估实施能力和质量以及实现现代技术在风险评估中的应用,将成为我国食品微生物风险评估建设的主要挑战和发展方向。     

Food contact substances and chemicals of concern: a comparison of inventories

Food contact materials (FCMs) are intended to be in contact with food during production, handling or storage. They are one possible source of food contamination, because chemicals may migrate from the material into the food. More than 6000 FCM substances appear on regulatory or non-regulatory lists. Some of these substances have been linked to chronic diseases, whilst many others lack (sufficient) toxicological evaluation. The aim of this study was the identification of known FCM substances that are also considered to be chemicals of concern (COCs). The investigation was based on the following three FCM lists: (1) the 2013 Pew Charitable Trusts database of direct and indirect food additives legally used in the United States (or Pew for short), (2) the current European Union-wide positive list for plastic FCMs (or Union for short), and (3) the 2011 non-plastics FCM substances database published by EFSA (or ESCO for short). These three lists of food contact substances (Pew, Union, ESCO lists) were compared with the Substitute It Now! (SIN) list 2.1, which includes chemicals fulfilling the criteria listed in article 57 of Regulation (EC) No. 1907/2006 (REACH), and the TEDX database on endocrine-disrupting chemicals. A total of 175 chemicals used in FCMs were identified as COCs. Fifty-four substances present on the SIN list 2.1 were also found on the Union and/or ESCO lists. Twenty-one of those 54 substances are candidates for Substances of Very High Concern (SVHC), and six of these 21 are listed on Annex XIV and intended for phase-out under REACH. In conclusion, COCs used in FCMs were identified and information about their applications, regulatory status and potential hazards was included.     

我国食品安全风险评估与风险监测现状研究

食品安全问题作为人类生存的基本问题,关系到国家生存和发展,国家对食品安全风险评估与风险监测一向非常重视。近年来,为了及时发现食品安全隐患、判断食品安全总体状况、确定食品安全监管重点领域和品种以及为风险管理提供政策建议,我国的食品安全监管理念也从事后查处向事前预防转变。本文从覆盖面、资源共享程度、资源投入和体系方面浅析了我国食品安全风险评估与风险监测现状,并在提高风险监测与评估的科技水平、提升数据收集能力和共享程度、完善我国食品安全风险监测与评估运行机制、健全我国食品安全风险监测与评估法律体系方面为我国的食品安全风险监测的实施措施提出建议,旨在提升我国食品安全与社会稳定,维护广大人民群众的切身利益。     

日本及欧美食品安全风险交流机制及其启示

建设风险交流制度是在国际食品安全领域中被公认的预防管理食品问题的重要手段之一,将其运用到食品安全管理中已成为各国的共识。文章系统阐述了日本、欧盟、美国食品安全风险交流机制,分析了其建立的框架、职能,深入探究域外食品安全风险交流机制,对中国食品安全风险交流机制的建立及实施提供启示。     

Mutagenicity assessment of food contact material migrates with the Ames MPF assay

ABSTRACT

A major challenge in the safety assessment of food contact materials (FCM) is the evaluation of unknown non-intentionally added substances (NIAS). Even though consumer exposure levels may be quantitatively low, these substances are considered to be of high toxicological concern if they act as DNA reactive mutagens. From a safety assessment perspective, it is therefore important to detect their presence in FCM migrates. The present study applied the Ames MPF assay to assess the mutagenicity of migrates obtained from 30 food contact material samples out of 3 categories: plastics, composite materials and coatings. As a food simulant, 95% ethanol (EtOH) had a superior performance to less volatile simulants when evaluating recovery rates of representative model substances in different volatility categories. To monitor possible interference of the FCM matrix with Ames MPF results, migrates were spiked with reference substances and recovery rates were established. Out of 30 samples tested, two caused significant inhibition of revertant formation in the presence of the spiking control. Overall detection limits of the applied test method were estimated by determination of the lowest effective concentrations (LEC) for 10 Ames-positive substances. Even though the current limits of detection are not sufficient to entirely fulfil regulatory and safety requirements, three out of 30 FCMs showed evidence of dose-dependent effects in the Ames MPF assay. Overall, the data obtained supported the relevance of testing FCM migrates for DNA reactive contaminants and showed the value of the Ames MPF assay for the safety assessment of FCMs.     

食品中的化学性风险及预防措施

食品的化学性污染分为内源性和外源性。初级农产品中可能含有某些对人体不利的成分;农作物在生长过程中也有可能受到外来化学物质的污染,包括环境中的污染物、生长过程中使用的农药和肥料等;食物在从农场到餐桌的过程中经过加工也可能会发生一系列衍生性反应,产生新的有害物质;另外,不法商贩的非法添加和成品的包装污染也会给食品带来化学性风险。本文分析和总结了我国食品化学性风险现状,并提出了预防食品化学性污染的措施。建议有关部门制订完善的法律法规,形成多部门统一联动的监管队伍,增加风险监测频次和扩大覆盖范围,并及时公布检测结果,必要时可以根据风险评估对食品企业提出预警。同时应加强宣传,普及科学知识,让全民参与到维护食品安全中来,实施食品安全战略,全面提升食品质量安全。