Bruce Zhang 张学华张学华SH SGS HG Lab Food Contact Material Gerneral Introduction食品接触材料介绍食品接触材料介绍2What our products do to our food? 我们的产品对食物有何影响？我们的产品对食物有何影响？FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍Test Method Basis 测试基础测试基础What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？Food Contact Material Gerneral Introduction与食品接触材料介绍与食品接触材料介绍3What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？Food and beverages can be very aggressive products and may interact strongly with materials that they touch.食物和饮料有时候具有很强的食物和饮料有时候具有很强的“进攻性进攻性”，可以与食品接触材料发生强烈的作用。，可以与食品接触材料发生强烈的作用。*4In fact, no food contact material is completely inert and so it is possible for their chemical constituents to migrate into the packaged food. Metals, glass, ceramics, plastics, rubber and paper can all release minute amounts of their chemical constituents when they touch certain types of foods. 实际上，没有材料是完全钝化的，总有可能材料中的物质迁移至食物中。金属、玻璃、陶瓷、塑料、实际上，没有材料是完全钝化的，总有可能材料中的物质迁移至食物中。金属、玻璃、陶瓷、塑料、橡胶、纸张可以释放微量的化学成份进入食物。橡胶、纸张可以释放微量的化学成份进入食物。*1What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？5Ceramic articles may pose a risk to the consumer through heavy metals used in the glazing and colouring. 陶瓷通过其釉彩和着色剂对使用者产生威胁。陶瓷通过其釉彩和着色剂对使用者产生威胁。*What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？6In the 1980s it became evident that rubber teats and soothers may release carcinogenic nitrosamines, which are reaction and degradation products from accelerators and stabilisers used in the rubber. 上世纪上世纪80年代，有证据表明橡胶奶头和安抚奶嘴可以释放致癌的亚硝胺，它是橡胶引发剂和稳定剂年代，有证据表明橡胶奶头和安抚奶嘴可以释放致癌的亚硝胺，它是橡胶引发剂和稳定剂反应和分解的产物。反应和分解的产物。*What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？7Chemical migration is always undesirable and if not controlled it could be hazardous to the health of consumer.人们总不想材料中的化学物质进入食物当中，如果控制不当，将会对人体健康产生影响。人们总不想材料中的化学物质进入食物当中，如果控制不当，将会对人体健康产生影响。*2What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？8It has been estimated that the per-capita use of packaging materials for retail foodstuffs sold in the EU countries is about 1200 cm2 per person per day.据估计，在欧洲每人每天食用的零售食物，与食物接触材料接触的面积大约为据估计，在欧洲每人每天食用的零售食物，与食物接触材料接触的面积大约为1200平方厘平方厘米。米。*What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？9 All parties involved in the production, transport, selling and consumption of foods need to be aware of the potential for chemical migration and ways of minimising it. 所有与食物的生产、运输、销售等相关的企业都需要意识到食品接触材料化学迁移的危害，所有与食物的生产、运输、销售等相关的企业都需要意识到食品接触材料化学迁移的危害，都有义务尽量进少此类迁移。都有义务尽量进少此类迁移。nprimary manufacturers of raw materials, e.g., polymer and paper manufacturersnconverters who turn the raw material into packaging for food usenvendors of the materials, e.g., retailers of articles, supply companiesnusers of the material the food packernfood retailersnenforcement authoritiesnconsumers with respect to the proper use both of pre-packaged foods and of materials and articles used in the home.*What our products do to our food?我们的产品对食物有何影响？我们的产品对食物有何影响？10nLaw Structure 法规构架法规构架uCommunity legislation which is adopted by the EU and national legislation adopted by the Member States, so a Regulation is directly applicable in each Member State.欧洲的颁布的法令法令，将在欧盟成员国中直接执行。uDirectives have to be transposed into national law with transposition times of up to 18 months.欧盟的指令指令，需要在欧盟成员国中转化本国的法律执行，并有最多为18个月的过渡期。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍11uThe Framework Regulation (EC) No 1935/2004 sets out the general principles that apply to materials in contact with food. 欧盟法令(EC) No 1935/2004 是欧盟食品级接触材料所有指令的框架性法令，规定了食品级材料应该遵循的基本原则。uDetails for implementing these general rules taking account of the specific risks of the individual material is given in the specific legislation.本法令的具体实施，要考虑到特定材料的特定风险，这些会在具体的指令中得以体现。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍12This list comprises 17 different materials. Only a few are yet covered by specific Community legislation.本表罗列了17中不同的材料，只有一小部分被欧盟指令明确涵盖。FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍13uCommunity legislation was introduced to harmonise national legislation and to remove barriers to trade. 制定这些指令是为了统一各成员国的立法，消除贸易障碍。制定这些指令是为了统一各成员国的立法，消除贸易障碍。uMember States legislation is based on different principles and this can still be observed in those areas which are not yet covered by Community legislation.个成员国有不同的立法原则，这一点目前仍然能够在欧盟指令没有涵盖的领域可以看到。个成员国有不同的立法原则，这一点目前仍然能够在欧盟指令没有涵盖的领域可以看到。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍14uMost of the 25 Member States do not have specific national rules. 大多数成员国没有自己特有的国家法律。uNewer EU Member States replaced their national legislation with Community legislation before accession to the EU. 欧盟新成员国在进入欧盟前，需要提前修改本国法律，以与欧盟指令一致。uMember States that do not have specific national legislation on food contact materials will sometimes refer to other Member States legislation, such as Dutch warenwet or the German recommendations, when testing for safety compliance. 没有特有食品接触材料安全法律的成员国，通常会借鉴其他国家的食品接触材料安全法律。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍15FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍16FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍17FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍18uNorway, Iceland and Liechtenstein, as part of the European Economic Area (EEA), also apply the Community legislation while keeping additional national legislation. Switzerland has adopted regulations corresponding to the Community legislation. 挪威、冰岛、列支敦士登作为欧洲经济区的一部分，也采用欧盟的食品接触材料安全指令。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍19nMember States Duty 成员国的义务成员国的义务uMember States have the responsibility for enforcing the Community and their own national legislation and must monitor that the requirements of the legislation are fulfilled by the business operators (general food law). 成员国有责任执行欧盟的指令，并监控商业机构遵守食品接触材料安全要求。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍20uMember States have to lay down a catalogue of sanctions and measures including dissuasive penalties for non-conformity with the food legislation. 成员国必须制定一系列措施食品接触材料安全要求得以实施。uThe measures taken by Member States may include prohibiting placement on the market; they may order and monitor withdrawal of goods from the market, recall and destruction. Official control can cover the following actions: monitoring, surveillance, verification, audit, inspection, sampling and analysis. 这些措施包括禁止投放市场，成员国可能监控、责令停销问题产品，召回或者销毁它们。这些措施还包括监督、认可、检验、抽样、测试等。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍21u Furthermore they have the right to detain consignments from third countries. 海关也可扣押可疑货物。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍22u When Member States take measures that affect other Member States, such as withdrawal from the market when the article originates from, or is distributed to, another Member State, they should inform the Commission and the other Member States via the electronic Rapid Alert System for feed and food (RASFF). 当一个成员国发生回收，应通报欧盟的快速警戒系统，本系统会通知其他各欧盟成员国。*FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍23*uThis means they have to make sure that substances they use in the food contact material are authorised (if positive lists exist) and/or are not transferred into food in concentrations that pose a danger to human health. They have to confirm this in a declaration of compliance. 以上措施表明，商家必须使用许可的材料，并保证材料不得迁移出对人体有害的化学物质。 FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍24*uThe consumers should be informed on: 消费者应被通知到：(i) the suitability of the product for food contact (to this purpose a symbol representing a glass and fork can be used); 本产品适合与食物接触。(ii) the person responsible for manufacture or placing on the market of the product;商家负责人。(iii) instructions for the safe use of the product; 产品安全使用说明。(iv) means of identification of the product for traceability.产品的识别的追溯。FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍25*uDefinitions of traceability追溯的定义。the ability to go back in the history of a food contact material or article, from the retail stage back to the point of its manufacturing, identifying all appropriate information.FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍26*uObviously, traceability can be attained only if the identification elements of each of the above raw materials are properly obtained by the relevant suppliers, but the most difficult part consists of the management of such identification elements in the various steps of storage, transformation and warehousing of finished goods.FCM Regulation Introduction 食品接触材料法规介绍食品接触材料法规介绍27*nWhat is Food Contact Material 什么是食品接触材料？什么是食品接触材料？lmaterials that are already in contact with food such as the packaging of pre-packaged food; lmaterials that are intended to come into contact with food, such as cups, dishes, cutlery, food packaging not yet in use; lmaterials that can reasonably be expected to be brought into contact with food such as table surfaces in food preparation areas or the inner walls and shelves of a refrigerator;land materials that can reasonably be expected to transfer their constituents to food such as a cardboard box around a plastic bag of cereals.Test Method Basis 测试基础测试基础28*u Conventional testing follows the following discrete steps: 食品接触材料测试的几个步骤：食品接触材料测试的几个步骤：1. Gathering information about the composition of the material 收集材料信息2. Select relevant legislation 筛选适合法规3. Check whether composition is in accordance with the legislation 检查成份是否和法规要求4. Performance of the relevant tests 测试 Besides compliance of a products composition with legislation, one needs to demonstrate that the product complies with the limits set for overall migration, specific migration, residual content and requirements.Test Method Basis 测试基础测试基础29*n Plastics food contact materials and articles should comply with Directive 2002/72/EC and its amendments that include: 2002/72/EC的限制要求u an overall migration limit (OML)u specific migration limits (SMLs) on monomersu specific migration limits (SMLs) on additivesu compositional limits (QMs) on some monomers.Test Method Basis 测试基础测试基础30Test Method Basis 测试基础测试基础31Test Method Basis 测试基础测试基础32Test Method Basis 测试基础测试基础33Test Method Basis 测试基础测试基础34Test Method Basis 测试基础测试基础35*n From the available toxicity and migration data, a specific migration limit (SML) is derived and several assumptions are made: 基于已知的毒性和迁移数据，特殊迁移限值(SML)是通过下列假设制定的：u 1 kg of food eaten every dayu 1 kg of food corresponds to 6 dm2 of packagingu packaging always contains the substanceu migration of the substance at SMLu consumer body weight of 60 kg.Test Method Basis 测试基础测试基础36*nTo avoid possible arguments about what kind of food should be chosen to perform migration testing, EU legislators have agreed on four food simulants, which are able to mimic foods: 为防止关于食物类型的争论，欧盟规定了四种食物模拟液：u Simulant A, water, mimicking aqueous foodstuffsu Simulant B, 3% acetic acid, mimicking acidic foodstuffsu Simulant C, 10% ethanol, mimicking alcoholic foodstuffsu Simulant D, olive oil, or another approved oil, mimicking fatty foodstuffs.Test Method Basis 测试基础测试基础37Test Method Basis 测试基础测试基础38*uDirective 85/572/EEC defines which simulants need to be used to simulate certain foods. In some cases it is not possible to use olive oil as a food simulant because of technical reasons and alternative simulants may be used like isooctane and 95% ethanol. 85/572/EEC指令规定了模拟液。某些情况下，由于技术原因，不能使用橄榄油模拟液，这是可以使用替代液。Test Method Basis 测试基础测试基础39*nThe reason for determining overall migration is that the food contact material may bring about an unacceptable change in the composition of the food (Article 3 of the framework Regulation (EC) 1935/2004). The methods of determining the overall migration into the aqueous simulants (A, B and C) are as follows: 食品接触材料可能给食物的成份带来不可接受的变化，所以要进行全迁移测试，其步骤如下：食品接触材料可能给食物的成份带来不可接受的变化，所以要进行全迁移测试，其步骤如下：uBring the food contact material in contact with the simulant for a selected time and temperature (see section 5.3.1).uSeparate the sample from the simulant and evaporate the simulant.uDetermine the weight of the residue and calculate overall migration. As a consequence volatile chemicals, which migrate, are not included in the overall migration value for the aqueous simulants.Test Method Basis 测试基础测试基础40*uMigration testing has to be performed under worst foreseeable contact time and temperature for the envisaged application. A long-term storage at room temperature is, for example, represented by storage for ten days at 40 C. 测试的条件，通常选择产品使用范围的上限。Test Method Basis 测试基础测试基础41*3nColour release 颜色迁移颜色迁移uWhen food is in contact with food contact material, the colour of the food contact material must remain on the food contact material and may not colour the food. 食品级材料与食物接触时，其颜色不得染污食物。Test Method Basis 测试基础测试基础42*nVolatiles 挥发性挥发性 For silicon materials some volatile components can remain in the silicon material after polymerisation. The method of determination is: 对于硅胶类材料，一些挥发性成份会在硅胶合成后残留在材料中，测定的方法是：u Prepare the silicon material (cut to prescribed sizes).u Remove water from the silicon material using water free calcium chloride.u Determine the weight of the silicon material.u Expose the silicon material for a certain time to a certain temperature.u Determine the weight of the silicon material.u Calculate the weight loss.Test Method Basis 测试基础测试基础43These are exemplified by hard materials such as metals, glass and ceramics.一些“硬质”材料具有此特点，比如金属、玻璃、陶瓷。What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？44These are exemplified by plastic materials such as plastics, rubbers andelastomers.一些合成材料具有此特点，比如塑料、橡胶、弹性体等。一些合成材料具有此特点，比如塑料、橡胶、弹性体等。What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？45Exemplified by paper and board materials with a heterogeneous, open networkof fibres with large air spaces or channels.一些多孔的，具有网络纤维网络结构的材料有此特点，比如纸张。What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？46*nThe mechanistic basis of migration 化学迁移的原理化学迁移的原理uMigration of chemical substances is a diffusion process subject to both kinetic and thermodynamic control and can be described by diffusion mathematics derived from Ficks Law.What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？47*nComposition of the packaging material 食品接触的成份食品接触的成份uThe packaging material is the source of any chemical migration. The extent of any migration depends first on the concentration of the chemical in the packaging.What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？48*nThe nature of the food 所接触食物的特点所接触食物的特点uIf the packaging is not compatible with a given type of food then there can be a strong interaction leading to an accelerated release of chemical substances.Examples are the interaction of fats and oils with certain plastics that leads to swelling of the plastic and leaching of substances from that plastic.uFoods are conventionally classified into five categories: aqueous, acidic, alcoholic, fatty, and dry.What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？49*nThe temperature of contact 接触的温度接触的温度What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？50*nThe duration of contact 接触的时间接触的时间What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？51*What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？nThe duration of contact 接触的时间接触的时间52*nMobility of the chemicals in the packaging 迁移化学物质的移动性迁移化学物质的移动性uThe mobility of a chemical in the packaging material depends on the size and shape of the molecule. 迁移化学物质的移动性取决与其分子的大小和形状。What affect chemical migration? 什么因素影响测试结果？什么因素影响测试结果？