SGS 食品接觸材料介紹

1、Bruce Zhang 張學華張學華SH SGS HG Lab Food Contact Material Food Contact Material Gerneral IntroductionGerneral Introduction食品接觸材料介紹食品接觸材料介紹2What our products do to our food?What our products do to our food? 我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料

2、法規(guī)介紹Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)What affect chemical migration? What affect chemical migration? 什么因素影響測試結(jié)果？什么因素影響測試結(jié)果？Food Contact Material Food Contact Material Gerneral IntroductionGerneral Introduction與食品接觸材料介紹與食品接觸材料介紹3What our products do to our food?What our products do to our

3、food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？Food and beverages can be very aggressive products and may interact strongly with materials that they touch.食物和飲料有時候具有很強的食物和飲料有時候具有很強的“進攻性進攻性”，可以與食品接觸材料發(fā)生強烈的作用。，可以與食品接觸材料發(fā)生強烈的作用。*4In fact, no food contact material is completely inert and so it is possible for their che

4、mical 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. 實際上，沒有材料是完全鈍化的，總有可能材料中的物質(zhì)遷移至食物中。金屬、玻璃、陶瓷、塑料實際上，沒有材料是完全鈍化的，總有可能材料中的物質(zhì)遷移至食物中。金屬、玻璃、陶瓷、塑料、橡膠、紙張

5、可以釋放微量的化學成份進入食物。、橡膠、紙張可以釋放微量的化學成份進入食物。*1What our products do to our food?What our products do to our food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？5Ceramic articles may pose a risk to the consumer through heavy metals used in the glazing and colouring. 陶瓷通過其釉彩和著色劑對使用者產(chǎn)生威脅。陶瓷通過其釉彩和著色劑對使用者產(chǎn)生威脅。*What our products do

6、to our food?What our products do to our food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？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. 上世紀上世紀80年代，有證據(jù)表明橡膠奶頭和安撫奶嘴可以釋放

7、致癌的亞硝胺，它是橡膠引發(fā)劑和穩(wěn)定劑年代，有證據(jù)表明橡膠奶頭和安撫奶嘴可以釋放致癌的亞硝胺，它是橡膠引發(fā)劑和穩(wěn)定劑反應和分解的產(chǎn)物。反應和分解的產(chǎn)物。*What our products do to our food?What our products do to our food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？7Chemical migration is always undesirable and if not controlled it could be hazardous to the health of consumer.人們總不想材料中的化學物質(zhì)進入食物當中，

8、如果控制不當，將會對人體健康產(chǎn)生影響。人們總不想材料中的化學物質(zhì)進入食物當中，如果控制不當，將會對人體健康產(chǎn)生影響。*2What our products do to our food?What our products do to our food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？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 pe

9、r day.據(jù)估計，在歐洲每人每天食用的零售食物，與食物接觸材料接觸的面積大約為據(jù)估計，在歐洲每人每天食用的零售食物，與食物接觸材料接觸的面積大約為1200平方平方厘米。厘米。*What our products do to our food?What our products do to our food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？9 All parties involved in the production, transport, selling and consumption of foods need to be aware of the potential

10、 for chemical migration and ways of minimising it. 所有與食物的生產(chǎn)、運輸、銷售等相關(guān)的企業(yè)都需要意識到食品接觸材料化學遷移的危害所有與食物的生產(chǎn)、運輸、銷售等相關(guān)的企業(yè)都需要意識到食品接觸材料化學遷移的危害，都有義務盡量進少此類遷移。，都有義務盡量進少此類遷移。nprimary manufacturers of raw materials, e.g., polymer and paper manufacturersnconverters who turn the raw material into packaging for food use

11、nvendors 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?W

12、hat our products do to our food?我們的產(chǎn)品對食物有何影響？我們的產(chǎn)品對食物有何影響？10n Law Structure 法規(guī)構(gòu)架法規(guī)構(gòu)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.歐洲的頒布的法令法令，將在歐盟成員國中直接執(zhí)行。uDirectives have to be tran

13、sposed into national law with transposition times of up to 18 months.歐盟的指令指令，需要在歐盟成員國中轉(zhuǎn)化本國的法律執(zhí)行，并有最多為18個月的過渡期。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹11uThe Framework Regulation (EC) No 1935/2004 sets out the general principles that apply to materials in contact

14、with food. 歐盟法令(EC) No 1935/2004 是歐盟食品級接觸材料所有指令的框架性法令，規(guī)定了食品級材料應該遵循的基本原則。uDetails for implementing these general rules taking account of the specific risks of the individual material is given in the specific legislation.本法令的具體實施，要考慮到特定材料的特定風險，這些會在具體的指令中得以體現(xiàn)。*FCM Regulation Introduction FCM Regulation

15、 Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹12This list comprises 17 different materials. Only a few are yet covered by specific Community legislation.本表羅列了17中不同的材料，只有一小部分被歐盟指令明確涵蓋。FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹13uCommunity legislation was introduced to harmonise

16、national legislation and to remove barriers to trade. 制定這些指令是為了統(tǒng)一各成員國的立法，消除貿(mào)易障礙。制定這些指令是為了統(tǒng)一各成員國的立法，消除貿(mào)易障礙。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.個成員國有不同的立法原則，這一點目前仍然能夠在歐盟指令沒有涵蓋的領(lǐng)域可以看

17、到。個成員國有不同的立法原則，這一點目前仍然能夠在歐盟指令沒有涵蓋的領(lǐng)域可以看到。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹14uMost of the 25 Member States do not have specific national rules. 大多數(shù)成員國沒有自己特有的國家法律。uNewer EU Member States replaced their national legislation with Community legislation before a

18、ccession to the EU. 歐盟新成員國在進入歐盟前，需要提前修改本國法律，以與歐盟指令一致。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. 沒有特有食品接觸材料安全

19、法律的成員國，通常會借鑒其他國家的食品接觸材料安全法律。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹15FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹16FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹17FCM Regulation Introduction FCM Regul

20、ation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹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、冰島、列支敦士登作為歐

21、洲經(jīng)濟區(qū)的一部分，也采用歐盟的食品接觸材料安全指令。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹19nMember States Duty 成員國的義務成員國的義務uMember States have the responsibility for enforcing the Community and their own national legislation and must monitor that the requirements of the legislation are

22、 fulfilled by the business operators (general food law). 成員國有責任執(zhí)行歐盟的指令，并監(jiān)控商業(yè)機構(gòu)遵守食品接觸材料安全要求。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹20uMember States have to lay down a catalogue of sanctions and measures including dissuasive penalties for non-conformity with the f

23、ood legislation. 成員國必須制定一系列措施食品接觸材料安全要求得以實施。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, verifi

24、cation, audit, inspection, sampling and analysis. 這些措施包括禁止投放市場，成員國可能監(jiān)控、責令停銷問題產(chǎn)品，召回或者銷毀它們。這些措施還包括監(jiān)督、認可、檢驗、抽樣、測試等。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹21u Furthermore they have the right to detain consignments from third countries. 海關(guān)也可扣押可疑貨物。*FCM Regulation Int

25、roduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹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 Stat

26、es via the electronic Rapid Alert System for feed and food (RASFF). 當一個成員國發(fā)生回收，應通報歐盟的快速警戒系統(tǒng)，本系統(tǒng)會通知其他各歐盟成員國。*FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹23*uThis means they have to make sure that substances they use in the food contact material are authorised (if posit

27、ive 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，商家必須使用許可的材料，并保證材料不得遷移出對人體有害的化學物質(zhì)。 FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹24*uThe consumers

28、 should be informed on: 消費者應被通知到：(i) the suitability of the product for food contact (to this purpose a symbol representing a glass and fork can be used); 本產(chǎn)品適合與食物接觸。(ii) the person responsible for manufacture or placing on the market of the product;商家負責人。(iii) instructions for the safe use of the p

29、roduct; 產(chǎn)品安全使用說明。(iv) means of identification of the product for traceability.產(chǎn)品的識別的追溯。FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹25*u Definitions of traceability追溯的定義。the ability to go back in the history of a food contact material or article, from the retail stage

30、back to the point of its manufacturing, identifying all appropriate information.FCM Regulation Introduction FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹26*uObviously, traceability can be attained only if the identification elements of each of the above raw materials are properly obtained by the

31、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 FCM Regulation Introduction 食品接觸材料法規(guī)介紹食品接觸材料法規(guī)介紹27*nWhat is Food Contact Material 什

32、么是食品接觸材料？什么是食品接觸材料？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 con

33、tact 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 Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)2

34、8*u Conventional testing follows the following discrete steps: 食品接觸材料測試的幾個步驟：食品接觸材料測試的幾個步驟：1. Gathering information about the composition of the material 收集材料信息2. Select relevant legislation 篩選適合法規(guī)3. Check whether composition is in accordance with the legislation 檢查成份是否和法規(guī)要求4. Performance of the rel

35、evant tests 測試 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 Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)29*n Plastics food contact mat

36、erials 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 T

37、est Method Basis 測試基礎(chǔ)測試基礎(chǔ)30Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)31Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)32Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)33Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)34Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)35*n From the available toxicity and migratio

38、n data, a specific migration limit (SML) is derived and several assumptions are made: 基于已知的毒性和遷移數(shù)據(jù)，特殊遷移限值(SML)是通過下列假設制定的：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

39、 60 kg.Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)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: 為防止關(guān)于食物類型的爭論，歐盟規(guī)定了四種食物模擬液：u Simulant A, water, mimicking aqueous

40、 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 Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)37Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)38*uDire

41、ctive 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指令規(guī)定了模擬液。某些情況下，由于技術(shù)原因，不能使用橄欖油模擬液，這是可以使

42、用替代液。Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)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 mig

43、ration into the aqueous simulants (A, B and C) are as follows: 食品接觸材料可能給食物的成份帶來不可接受的變化，所以要進行全遷移測試，其步驟如下：食品接觸材料可能給食物的成份帶來不可接受的變化，所以要進行全遷移測試，其步驟如下：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 simulan

44、t 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 Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)40*uMigration testing has to be

45、 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. 測試的條件，通常選擇產(chǎn)品使用范圍的上限。Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)41*3nColour release 顏色遷移顏色遷移uWhen food

46、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. 食品級材料與食物接觸時，其顏色不得染污食物。Test Method Basis Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)42*nVolatiles 揮發(fā)性揮發(fā)性 For silicon materials some volatile components can remain in

47、the silicon material after polymerisation. The method of determination is: 對于硅膠類材料，一些揮發(fā)性成份會在硅膠合成后殘留在材料中，測定的方法是：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 t

48、he 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 Test Method Basis 測試基礎(chǔ)測試基礎(chǔ)43These are exemplified by hard materials such as metals, glass and ceramics.一些“硬質(zhì)”材料具有此特點，比如金屬、玻璃、陶瓷。What affect che

49、mical migration? What affect chemical migration? 什么因素影響測試結(jié)果？什么因素影響測試結(jié)果？44These are exemplified by plastic materials such as plastics, rubbers andelastomers.一些合成材料具有此特點，比如塑料、橡膠、彈性體等。一些合成材料具有此特點，比如塑料、橡膠、彈性體等。What affect chemical migration? What affect chemical migration? 什么因素影響測試結(jié)果？什么因素影響測試結(jié)果？45Exempl

50、ified by paper and board materials with a heterogeneous, open networkof fibres with large air spaces or channels.一些多孔的，具有網(wǎng)絡纖維網(wǎng)絡結(jié)構(gòu)的材料有此特點，比如紙張。What affect chemical migration? What affect chemical migration? 什么因素影響測試結(jié)果？什么因素影響測試結(jié)果？46*nThe mechanistic basis of migration 化學遷移的原理化學遷移的原理uMigration of chemical substances is a diffusion process subject to both kinetic and