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欧盟食品包装印刷油墨指南

EuPIA Guideline on Printing Inks
applied to the non-food contact surface of food packaging materials and articles November 2011
(Replaces the September 2009 version) 1. Introduction
EuPIA member companies have, for many years, followed a policy of Responsible Care / Coatings Care working for Sustainable Development, with a high level of Product Stewardship activity. This is based on a strong commitment to protect consumers’ health, and, through the years, has led to the publication of many recommendations. 1 Having regard to the fact that there is a Framework Regulation applicable to all food packaging, but not yet any specific Community legislation concerning printing inks for food packaging, EuPIA have developed a Guideline for their members, based on current European legislation, which gives detailed recommendations as to how to formulate inks which will comply with this Regulation; this is in line with the EuPIA strategy in the field of packaging inks. It also takes into account the work done in cooperation with the Council of Europe Committee of Experts on Food Contact Materials.
2.
Legislation
Whilst European harmonised legislation does not specifically cover printing inks in their supplied form, there are some legislative instruments which impact on materials and articles intended for direct contact with food, whilst being printed on the non-food-contact side. Regulation (EC) No 1935/2004 requires in Article 3 that materials and articles in contact with food shall be manufactured in accordance with good manufacturing practices, so that under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: - endanger human health; or - bring about an unacceptable change in the composition of the food; or - bring about a deterioration in the organoleptic characteristics thereof. Inks, once printed and dried/cured, on the non-food-contact side of a packaging material in contact with food become a component of this packaging and this packaging has to comply with the requirements of Article 3. EuPIA recommends ensuring traceability during ink manufacturing analogous to the requirements as set out in Article 17: the traceability of printed materials and articles at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility .
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REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, OJEU L338 of 13. 11. 2004
Avenue E. Van Nieuwenhuyse 6 - BE-1160 Brussels Tel: +32 (0)2 676 7480 - Fax: + 32 (0)2 676 7490 - E-mail: eupia@https://www.sodocs.net/doc/4115876732.html, - Internet: https://www.sodocs.net/doc/4115876732.html,/

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
2 Directive 2007/42/EC relating to materials and articles made of regenerated cellulose film states that the printed surface of regenerated cellulose film must not come into contact with food, and therefore is relevant to printing inks for food packaging. The main specific measure pursuant to the Framework Regulation is Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. It lays down an overall migration limit (OML) of 60 mg/kg food or 10 mg/dm2 of surface area. In addition specific migration limits (SML) or maximum contents in the material or article (QM) are set for individual substances. The Regulation contains a positive list (Union list) of substances authorised to be used in the manufacture of plastics. Packaging inks in their supply form are not in the scope of the Regulation, as they may be subject to other EU or national rules. Therefore, inks may be composed of other substances than those authorised at EU level for plastics. However, printed plastic materials and articles are within the scope of the Regulation. If there are ink components which are listed in the Union list, then the relevant restrictions such as specific migration limits (SML) or maximum content (QM) must be met and where there is the presence of dual use additives in the inks the legal provisions must also be followed. Regulation (EC) No 2023/2006, applicable from 1 August 2008, sets out rules on Good Manufacturing Practice for the production of food contact articles. It has an Annex referring to printing inks applied to the non-food-contact surface of food packaging as well as to the storage of printed articles. In summary it can be concluded that the ink manufacturer does not have an independent responsibility for the formulation and application of the inks, but this remains ultimately with the downstream partners. To allow shared and final responsibilities to be met there needs to be cooperation between ink manufacturer and the rest of the supply chain. The cooperation between ink manufacturer and converter is best managed by requirement specifications, e.g. by detailed information about the substrate, type of food packed, printing and converting process parameters, storage and treatment conditions. When provided with this information the ink manufacturer is enabled to formulate inks that comply with the Regulation, if they are correctly used.
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Other legislative references are set out in Appendix 3.
3.
Field of Application
3.1. This Guideline applies to printing inks, coatings and varnishes (hereafter called ‘packaging inks’), applied by an appropriate process to the non food contact surface of any material or article intended to come into contact with foodstuffs. 3.2. Printing inks in direct contact with foodstuffs are excluded from the field of application of the present Guideline.
4.
Definitions
4.1. Packaging inks are preparations (mixtures) manufactured from combinations of colorants (pigments, dyes), binders, solvents, and additives. They are solvent-based, water-borne, oleoresinous or energy-curing (UV or electron beam) systems. They are applied by a printing and/or a coating process, such as flexography, gravure, letterpress, offset, screen, non-impact printing or roller coating. 4.2. Packaging inks layers, in their finished state, are thin dried or cured films of packaging ink on the non-food contact surface of substrates. 4.3. Substrate is any material or article intended to come into contact with food, these include glass, metal, paper, board, plastic, textiles and laminates of these materials.
5.
Requirements
Printed packaging materials and articles intended to come into contact with foodstuffs shall not, in their finished state - under normal and foreseeable conditions of use - transfer their constituents to

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
3 foodstuffs in quantities which could endanger human health, or bring about an unacceptable change in the composition of the foodstuffs, or a deterioration in the organoleptic characteristics thereof, in accordance with Article 3 of Regulation (EC) No 1935/2004. In order to enable the printed packaging in its finished state to achieve the legal requirements the following specifications shall be met. 5.1 Specifications regarding packaging inks 5.1.1 The raw materials shall be selected in accordance with the Appendix 1 “Selection scheme for packaging ink raw materials“. They shall not belong to the following categories (exclusion criteria): (a) classified as “carcinogenic”, “mutagenic” or “toxic for reproduction” categories 1 and 2, according to the provisions of Directive 67/548/EEC on dangerous substances (categories 1A and 1B according to CLP, Regulation (EC) No 1272/2008). Note: Category 3 substances (CLP Category 2) will only be used after a migration study has confirmed that migration levels are either within published SML or TDI values, or are below an intake (threshold of toxicological concern) of 3 0.15 μg/person/day . Category 3 reproductive toxicants (R62, R63; H361f, H361d) without a published limit may be used if the migration levels are confirmed to be not detectable (with a detection limit of 0.01 mg/kg food); (b) classified as toxic and very toxic; (c) colorants based on and compounds of antimony , arsenic, cadmium, chromium (VI), lead, mercury, selenium; (d) all substances identified in the REACH Regulation (EC) No 1907/2006, Title VIII and Annex XVII (restrictions on the manufacturing, placing on the market and use of certain dangerous substances, mixtures and articles) and its amendments, if their use in a packaging ink would lead to an infringement of Article 3 of the Framework Regulation. 5.1.2 The packaging inks shall be formulated and manufactured in accordance with the EuPIA “Good Manufacturing Practices for the Production of Packaging Inks formulated for use on the non-food contact surfaces of food packaging and articles intended to come into contact with food” (“GMP”), available at https://www.sodocs.net/doc/4115876732.html,
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5.2 Specifications regarding the packaging material and article 5.2.1 5.2.2 5.2.3 5.2.4 The packaging inks shall be used and applied in accordance with recognised converters’ good manufacturing practices. The printed or overprint varnished surfaces of food packaging shall not come into direct contact with food. There shall be no visible transfer (i.e. physical) from the printed or varnished nonfood contact surface to the food contact surface. Global and specific migrations from the packaging in its finished state or article shall not exceed the relevant limits.
6.
6.1
Responsibility
The printing ink manufacturers’ responsibility is to supply products that are fit for the intended purpose as defined between members of the packaging chain. They are not liable for any aspects of the production of food packaging once the packaging inks have left the
Raw materials may contain starting substances and/or components which are CMR or T, T+, but at levels which do not affect the classification of the raw material. Any migration of these into foodstuffs must comply with any relevant limit. ILSI, Threshold of Toxicological Concern (TTC), Monograph, 2005, https://www.sodocs.net/doc/4115876732.html,/Europe/Publications 4 With the exception of non-bio-available pigments in which antimony is a constituent of the crystal lattice and of organic derivatives not classified nor labelled as T or T+
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EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
4 manufacturing site. The manufacturer of the packaging and the filler are responsible for the properties of the food packaging and its compliance with legal requirements. 6.2 The packaging ink manufacturers are responsible for the composition of the preparations in accordance with the requirements set out in paragraph 5.1. Moreover, due to the complexity of the process all members of the packaging chain must exchange the relevant information under appropriate confidentiality agreements if necessary - in order to ensure that products can be formulated to be fit for purpose, and thus be compliant with all legal responsibilities including the GMP Regulation 2023/2006. EuPIA members will supply a standard Statement of Composition for the use of these specific packaging inks; for plastic substrate converters this Statement will set out the levels of materials which are specified in the Plastics Regulation (EU) No 10/2011 with a limit value. Additionally it will indicate so-called dual use substances (in accordance with Regulation (EU) No. 10/2011) and ink manufacturers will disclose further potential migrants if necessary. In the absence of current legal requirements for non-plastic substrates EuPIA members will assume further responsibility by supplying a Statement of Composition for all other uses. As outlined above this will likewise set out levels of materials which are specified in the Plastics Regulation, as well as indicating dual use substances and if necessary further potential migrants to be disclosed by ink manufacturers. However, conformance with laid down migration limits must be assessed on the final print and/or package, and is the ultimate responsibility of downstream members of the packaging chain. The provision of a Statement of Composition is critical in this procedure. Moreover information relating to usage and application constraints will be provided in Technical Data Sheets or other recommendation leaflets in order to enable the converters to meet their responsibilities for the printed food packaging.
6.3
It should be noted that the packaging ink manufacturers are not in a position to issue certificates or declarations of compliance which cover all the legal responsibility of the entire packaging chain. To ensure conformity with current legal obligations the packaging ink manufacturer has to safeguard that a) b) packaging inks are formulated in accordance with the Exclusion criteria defined in 5.1.1 the packaging inks are formulated in such a way as to minimise both potential migration through the substrate and set-off from the printed outer side to the food contact surface in the stack or the reel. In regard to this aspect it has to be noted that set-off and migration are also dependent on the processing conditions and barrier properties of the substrate. Appendix 2 describes recommended laboratory practices to assess likely levels of migration. This will allow for an evaluation of the suitability of ink formulations for the intended purposes. This does not replace any of the converters’ legal obligations for compliance of the printed packaging. packaging inks are manufactured in accordance with the EuPIA Good Manufacturing Practices (see 5.1.2).
6.4
c)

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
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Appendix 1 Selection scheme for packaging ink raw materials
This appendix gives guidance on the selection process of raw materials used in the manufacture of packaging inks. Considering the fact that packaging inks are not intended to come into contact with food, the selection of raw materials according to this scheme will ensure adequate consumer safety. Definitions “Raw materials” used as components in the manufacture of packaging inks may be substances or preparations, which are defined according to the Directives 67/548/EEC and 1999/45/EC as follows: “Substances” means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity derived from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. “Starting substances” are substances used in the manufacture of raw materials and are, following the chemical reaction, only present in raw materials as traces or impurities. “Preparations” means mixtures or solutions composed of two or more substances. Raw materials Raw materials are selected according to the criteria set in section 5.1.1 of this Guideline and, when possible, from relevant listings such as the Plastics Regulation (EU) No. 10/2011, the Regenerated Cellulose Film Directive 2007/42/EC, or national legislation, including BfR (Bundesinstitut für Risikobewertung – German Federal Institute for Risk Assessment) Recommendations, Council of Europe Resolutions for direct food contact and US FDA regulations. They should comply with relevant restrictions of their use. Raw materials which are authorised food additives may be used. Other raw materials can be used provided that the finished article fulfils Article 3 of the Framework Regulation (EC) No 1935/2004, on the basis of risk assessment described below.
Purity requirements for colorants The term colorants is to be understood to include both pigments and dyestuffs. Whilst pigments are inorganic or organic coloured, white or black materials which are practically insoluble in the medium in which they are incorporated, dyes, unlike pigments, do dissolve during their application and in the process lose their crystalline or particulate structure. All colorants used in the manufacture of packaging inks have to comply with the specifications of the Council of Europe Resolution AP (89) 1 or national recommendations on the use of colorants in plastic materials intended to come into contact with food. However, non soluble barium based pigments can be used provided that the packaging in its finished state meets the specific migration limit (SML) of 1 mg barium/kg food or food simulant.
Evaluation of migration Data on migration should be obtained either by experimental testing in accordance with EU Directives or by other alternative scientific tools such as worst case calculation, migration modelling etc. , done in conjunction with the converter and the filler of the individual printed packaging material and article in its finished state, taking into account normal and foreseeable conditions of use.

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
6 Risk assessment of non-evaluated substances Substance with molecular weight less than 1000 Da should be subjected to appropriate risk assessment taking into account the fact that the same Raw Material may have a different suitability for use depending on many parameters, such as substrate, ink coverage, foodstuff etc in terms of exposure as well as toxicological and structure activity consideration. Appropriate evidence shall be provided by the packaging ink manufacturer in such a way as to allow compliance of the finished package with Article 3 of the Framework Regulation (EC) No 1935/2004, under conditions of correct use. A target migration limit of no concern for non-evaluated substances of 10 ppb is the ultimate objective, to be consistent with other food contact materials. In particular, a substance is acceptable if its specific migration does not exceed: 10 ppb, in case of insufficient toxicological data 5 50 ppb if the substance is demonstrated not to be genotoxic according to EFSA Guidance a value higher than 50 ppb, if supported by favourable toxicological data and/or evaluation done in accordance with EFSA Guidance For packaging scenarios which do not currently achieve this limit, an action plan between the printing ink manufacturer, the converter and other relevant members of the packaging chain should be generated that sets out a programme to ensure compliance within an agreed and manageable timescale. In some instances when determining toxicity risk, the exposure concept may be used as an alternative to fixed migration limits. Exposure can be calculated by the following generally accepted equation: μg/person/day = μg/6dm2 Not all of the data is available yet to estimate exposure to all migrants from inks and non-food contact th coatings, but there is an EU funded 7 Framework research programme called FACET in progress to enable this situation to be addressed. The targeted completion date is 2012.
Continuous Improvement Strategy The printing ink industry has set out a challenging continuous improvement programme that aims to control the presence and the potential level of migration of substances with MW < 1000 Dt present in packaging inks. As part of this programme the European printing ink industry is working to collate toxicological data sets for chemical components used in food packaging, which are susceptible to migration. In order to do this they are working closely with CEFIC/FCA, National and European Regulatory Authorities and the many raw material suppliers to the printing ink industry. Aligned with this initiative a project has been finished, which aimed at collating a European Food Packaging Ink Raw Material Inventory (with inputs from EuPIA member companies), which is included in the Swiss “Bedarfsgegenst?ndeVerordnung”. It is recognised that the printing ink industry uses a wide range of substances in the formulation and manufacture of packaging inks for the many current food packaging structures. The exercise to finalise all the individual action plans (described above) for all substances in all packaging scenarios will take a significant period of time. It has therefore been agreed that substances used in food packaging inks without adequate SML/TDI data shall be subject to the following target migration limit deadlines to be monitored jointly by the converter and by the printing ink manufacturer: up to 50 ppb, completed by December 2010 up to 10 ppb, to be completed by December 2015
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EFSA: European Food Safety Agency

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
7 There is a continuous use of new and innovative materials in food packaging, including inks. These new materials will need to be assessed for toxicology and migration potential in the same manner as is now to be applied to existing materials.

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
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Selection Scheme for packaging ink raw materials

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
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Appendix 2
TEST METHODS FOR PACKAGING INKS APPLIED TO THE NON-FOOD CONTACT SURFACE OF FOOD PACKAGING MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS
TABLE OF CONTENTS 1 2 3 4 4.1 4.2 4.2.1 4.2.2 4.3 4.3.1 4.3.2 4.3.3 5. Introduction Definition of migration Preparation of samples for indicative migration testing Testing General rules Basic rules for migration testing Plastic materials and articles Paper and board materials and articles Methods of migration testing and analysis Food simulants Migration testing conditions Analytical methods Worst Case Calculation
Annex A Calculation of maximum possible migration; formula and example Annex B Calculation of maximum possible migration: Digital printing applications

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
10 TEST METHODS
1.
Introduction
This Appendix 2 of the EuPIA Guideline gives guidance on the testing methods to be used for the evaluation of the migration of components of packaging inks applied to the non-food contact surface of food packaging materials and articles intended to come into contact with food. It should be read in conjunction with the ‘EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles’. The ink itself shall not be tested as such, since its composition may change during the printing process. In addition, the substrate greatly influences the migration properties of the components of the ink. The specific methods of migration testing and analysis included in this document are described either in EC Directives on materials and articles in contact with foodstuffs or international Standards, with the exception of the preparation of printed samples.
2.
Definition of Migration
From a physics point of view, migration is a partition and diffusion controlled transfer process of small molecules (approx. < 1000 Dalton molecular mass). Transfer of printing ink components from a printed packaging material or article into food or food simulant may occur either directly as migration through the substrate, or via contact to the reverse side in the reel or stack, known as set-off migration, or by gas phase transfer.
3.
Preparation of samples for indicative migration testing
To demonstrate that a packaging ink is likely to meet industry requirements, the ink should be applied to the non food contact side of the relevant substrate in such a way as to reproduce, as far as possible, the printing and drying processes which are used in practice. For the preparation of samples to complete migration testing the relevant substrates as well as further packaging components like adhesives and other packaging layers should be chosen accordingly. The sample for migration testing should reflect the final packaging structure as closely as possible. In the absence of suitable specific results, the packaging ink manufacturer in conjunction with the converter shall evaluate available knowledge in terms of suitability for use in the proposed structure. Size of printed sheets (test pieces) Ink coverage sufficient for migration cell preferable DIN A4 100 % for each colour (e.g. colour/white)
Flexographic ink Ink film weight (dry) The ink film weight must be representative for the printing technology. Values given beside are only indicative. Gravure ink Offset ink Dispersion varnish White basecoat Clear basecoat UV varnish
1-1.5 g/m2 1-2 g/m2 1-2 g/m2 2-3 g/m2 12-16 g/m2 1-2 g/m2 4-7 g/m2
The average ink weight per unit area is required to calculate the maximum possible migration quantity of potential migrants caused by printing ink components.

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
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Storage/conditioning of print samples: In each case 20 or more test pieces are to be wrapped in unlacquered Aluminium foil and loaded with the following pressures which reflect practical conditions of stack or reel. Print sample Reel-fed materials (plastic film) Reel-fed materials (paper) Sheet-fed litho Sheet-fed metal Beverage end aluminium coil Time 10 days 10 days 10 days 10 days 10 days Temperature 25 ° C 25 ° C 25 ° C 25 ° C 25 ° C Pressure 80 kg/cm2 40 kg/cm2 0.02 kg/cm2 0.3 kg/cm2 0.3 kg/ cm2 8000 kPa 4000 kPa 2 k Pa 30 k Pa 30 kPa
4. 4.1
Testing General rules
Since there are no specific standards for packaging inks which deal with the determination of migration of ink components, migration testing, in principle, shall be carried out using the conditions established in Regulation (EU) No 10/2011 relating to plastic materials as well as in European and international standards. However, as a worst case method, a total extraction test using a strong solvent could be carried out; if components are below the relevant limits, further testing is not required. Please note: The total extraction method is unlikely to provide analytical results which are representative of real food packaging storage/use scenarios, or even in line with indicative migration tests – great care and expert advice should be taken in to account when interpreting results.
4.2
Basic rules for migration testing
4.2.1 Plastic materials and articles Regulation (EU) No 10/2011 covers migration testing for plastic materials intended to come into contact with food. Considering the printing ink as part of the plastic material, the migration testing procedures apply to printed plastic materials. . There is a list of suitable food simulants provided in Annex III, and the rules for migration tests such as the conditions of contact times and temperatures are given in Annex V. However, until 31 December 2012, the migration testing conditions described in Directive 82/711/EEC and in Directive 85/572/EEC are still applicable. From 1 January 2013, the food simulants have to be chosen according to Annex III of Regulation (EU) No 10/2011. From 1 January 2013 until 31 December 2015, the migration testing conditions (concerning time and temperature) can be carried out either according to Directive 82/711/EEC or according to Annex V of Regulation (EU) No 10/2011. From 1 January 2016 all migration testing is to be based on the provisions of Regulation (EU) No 10/2011.
The Regulation, Directives and Standards mentioned are ● Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs, and its amendments ● Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, and its amendments.

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
12 ● ● ● Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs, and its amendments. CEN Standard EN 1186 parts 1-15 is a guide for the selection of conditions and test methods for overall migration from plastic materials and articles in contact with foodstuffs. CEN Standard EN 13130 Part 1: Guide to test methods for the specific migration of substances from plastics to foods and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
13 4.2.2 Paper and Board materials and articles Paper and board food contact materials and articles are not yet regulated by a specific EC Directive or Regulation. There is guidance in the Council of Europe Policy Statement concerning paper and board materials and articles intended to come into contact with foodstuffs (Version 2 dated 13.04.2005). It is recommended to apply test methods described in Regulation (EU) No 10/2011 (for transitional provisions see chapter 4.2.1) taking into account the technical nature of paper and board in comparison with plastics. CEN has prepared Standard EN 14338 specific for paper and board. ● EN 14338: Paper and Board intended to come into contact with foodstuffs. Conditions for determination of migration from paper and board using modified polyphenylene oxide (MPPO) as a simulant.
4.3
Methods of migration testing and analysis
The printed or coated samples, prepared in the manner described in paragraph 3 above, are tested in suitable migration cells using appropriate exposure conditions and simulant(s).
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4.3.1 Food simulants
According to Annex III of the Regulation (EU) No 10/2011, the best suited of the following food simulants shall be used for migration testing: Food type Hydrophilic foods Hydrophilic foods with pH below 4.5 Alcoholic foods with up to 20% vol. and foods with relevant amounts of organic ingredients Alcoholic foods with more than 20% vol. and oil in water emulsions Foods with free fats at the surface Dry foods Food simulant Ethanol 10% (v/v) Acetic acid 3% (w/v) Ethanol 20% (v/v) Ethanol 50% (v/v) Vegetable oil Poly(2,6-diphenyl-pphenylene oxide)
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Simulant A Simulant B Simulant C Simulant D1 Simulant D2 Simulant E
4.3.2 Migration testing conditions
Regulation (EU) No 10/2011 defines in Annex V, Compliance Testing, the specific migration conditions to be applied to the food simulants, concerning contact time and temperature. Generally, the testing should apply those test methods that are recognized to reflect the most severe conditions of use. High temperature Temperatures above 100°C shall be used only for foo d simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1, the test may be replaced by a test at 100° (or at reflux temperature) C Until 31 December 2012, the food simulants of Council Directive 85/572/EEC are applicable (see chapter 4.2.1). 7 Until 31 December 2012, the testing conditions as described in Directive 82/711/EEC are applicable (see chapter 4.2.1).
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EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
14 for duration of four times of the expected contact time. The testing should take into account possible degradation products formed at elevated temperatures.
Low temperature / long storage time: Examples for migration testing of frozen foods and/or long storage times: Time 10 days 10 days Temperature 20° C 40° C Conditions covered All storage times for frozen condition s All storage times for refrigerated and frozen conditions 2 hours at 70° C 15 min at 100°C ≤ 6 months at room temperature > 6 months at room temperature
10 days 10 days
50° C 60° C
Overall migration: For analyzing the overall migration, again the worst foreseeable conditions are to be considered for the testing. Food simulants can be replaced, if, based on scientific evidence, the substitute food simulants overestimate the migration compared to the suggested food simulants.
4.3.3 Analytical methods Analytical methods to determine quality and quantity of specific migrants in food simulants are described in the CEN Standards ● EN 13130, Parts 2-28. The Community Reference Laboratory (CRL) for Food Contact Materials provides documents concerning overall migration and specific migration methods on their website http://crl-fcm.jrc.it/
5.
“Worst case” - calculation
Migration testing can be replaced by calculation of the maximum possible migration. A formula and an example are given in Annex A, for digital printing applications see Annex B.
Annex A Calculation of maximum possible migration; formula and example
The “worst case calculation” assumes that migration of the actual substance into the foodstuff represents one hundred percent of the substance present. In addition, the amount of the actual substance in the print, package or article must either be known or determined by exhaustive extraction.

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
15 The maximum possible migration M is calculated by the formula: M = W x C x S / (Q x 10)
M: W: C: S: maximum concentration [mg/kg] of the substance in the foodstuff. ink weight [g/m2] on the surface of the printed package or article. concentration as a percentage of the substance in the dried ink. actual area of package or article [dm2] being in contact with 1 kg foodstuff by default for all packaging for infants and young children and for all packaging sizes between 500 millilitres and 10 liters (Exceptions: According to Regulation (EU) No 10/2011, for packaging sizes below 500 millilitres or above 10 litres, for sheets and films that are not yet in contact with food and for articles for which the surface:volume ratio is impracticable to estimate, the value of migration shall be expressed in mg/kg 2 applying a surface to volume ratio of 6 dm per kg of food). Q: quantity of food simulant [kg]. Example: 2 The ink weight on a paper box is 1 g/m . The concentration of the actual substance in the print is 0.5 %. 2 The area of the paper box in contact with food is 6 dm . M = 1 x 0.5 x 6 / 1 x 10 = 0.3 mg/kg Consequently, the maximum possible migration, M is 0.3 mg/kg foodstuff
Annex B Calculation of maximum possible migration: Digital printing applications For Digital printing applications, it is often inappropriate to assume the printed article is fully printed with a given coat weight. Instead, the worst case migration calculation is based on the actual mass of ink deposited and the concentration of the potential migrant in the ink as well as the mass of the food product being printed. The mass of ink deposited is based on the number of drops deposited in the printed code and the mass of each drop, both of which are known for a given printing device. I = 4/3 πr .n.1
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M= I.[pm]/mass of foodstuff in Kg Where: I is the mass of ink deposited in mg M is the maximum migration possible from the ink in mg/Kg r is the droplet radius in m pm is the potential migrant concentration in the ink n is the number of drops pinted For a continuous inkjet printer a table may be prepared as below which allows the customer to work out the mass of code they are depositing. A table of maximum migration based on the concentration of the potential migrant, assuming a food product mass of 10 or 100g can also be supplied to help them with their risk assessment Nozzle size 100 drop code (μg) 400 drop code (μg) 1000 drop code (μg) 75μ (micron) nozzle 177 707 1767 60μ (micron) 90 362 905 40μ (micron) 27 107 268

EuPIA Guideline on Printing Inks applied to the non-food contact surface of food packaging materials and articles – November 2011
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Appendix 3 Legislation References
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (Framework Regulation)
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Plastics Implementation Measure – PIM)
Further information on food contact material, including legislation, is available on the following website of the European Commission: http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_en.htm

塑料食品包装材料和印刷油墨的安全性分析

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食品包装学试题及答案 HEN system office room 【HEN16H-HENS2AHENS8Q8-HENH1688】

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食品质量与安全专业人才培养方案一、专业名称、代码专业名称：食品质量与安全专业代码：082702 二、培养目标本专业培养德、智、体、美、劳全面发展，具有化学、生物学、食品质量与安全等方面的基本理论、基本知识和基本技能，富有强烈的社会责任感和创新精神，且能在食品生产、流通、消费等相关领域从事食品检验、品质控制、质量管理、科学研究等方面适应新世纪食品工业和社会发展所需要的能力强、素质高的复合应用型人才。三、基本规格本专业学生主要学习食品质量与安全方面的基本理论和基本知识，通过学习掌握食品质量与安全的基本知识和基本技能，受到科学思维和科学实验训练，具有较好的科学素养及在食品加工过程、食品流通及消费领域从事分析检测、安全评价、品质监控、技术管理、企业管理及科学研究等方面的基本能力。毕业生应具备以下知识、能力与素质： 1.热爱祖国，拥护中国共产党的领导，遵纪守法，诚实守信。 2.掌握数学、物理学、化学等方面的基本理论和基本知识。 3.了解食品质量与安全的理论前沿、国内外食品质量及安全领域的发展动态。 4.掌握生物化学、食品微生物学、食品工程原理、仪器分析、食品工艺学、食品添加剂、食品营养与卫生、食品分析、食品安全与质量控制等食品质量与安全专业所需的基本理论、基本知识和基本技能。 5.熟悉食品法规与标准，掌握现代食品加工和食品检测的技术与方法；具备在食品企业、市场和质检机构从事分析检验、品质监控和质量评价等方面的知识与能力；具有在食品监控、卫生监督及食品国际贸易机构从事食品检验的基本能力。 6.熟练应用计算机辅助科研，较好地运用一门外语进行交流与写作。 7.掌握文献资料查阅的基本方法及基本技能，具备一定的自主学习和实际工作能力。具有创造性的设计实验，归纳、整理、分析实验结果，撰写研究论文，参与学术交流及研究能力。

食品包装学实验指导

食品包装学实验指导实验一常见食品包装材料及其制品的认识一、实验目的： 1、了解常见食品包装材料的种类及其特性； 2、了解并掌握食品包装的用途及方法； 3、了解常用的食品包装基本技术方法。二、实验原理食品是一种品质最易受环境因素影响而腐败变质的商品。包装作为食品的保护手段，必须保证食品作为商品在其流通贮运过程中的品质质量和卫生安全；包装作为商品的组成部分，在现代商品市场营销策略中，对提高商品的附加值和竞争力起着越来越显著的作用。几乎所有的的加工食品都需经过包装才能成为商品进行销售，每一种包装食品在其保质期内都应有相应的质量和卫生标准，因此，了解五种常用的包装材料的包装特性、食品包装的用途及方法、食品基本包装方法及环境因素对食品品质的影响规律，是食品包装设计的重要依据。三、实验方式食品科学10-1，2两个班计61人，分为四个小组，分别去阿拉市的四大超市进行参观、通过认真的观察，并经小组集体讨论、分析、汇总，得出实验结果。四、实验内容：各种食品包装塑料材料的感性认识；纸及纸板的质量指标；包装纸盒与纸箱；金属罐；铝箔及软包装；其他金属包装容器；玻璃瓶罐的制造与质量检测；陶瓷容器的主要原料及常见陶瓷容器。五、实验结果与分析实验二食品包装技术认识与分析一、实验目的： 1、了解食品包装的基本原理与基本方法； 2、利用包装材料、技术与方法等知识，对食品的包装进行分析；二、实验原理食品是一种品质最易受环境因素影响而腐败变质的商品。包装作为食品的保护手段，必须保证食品作为商品在其流通贮运过程中的品质质量和卫生安全；包装作为商品的组成部分，在现代商品市场营销策略中，对提高商品的附加值和竞争力起着越来越显著的作用。几乎所有的的加工食品都需经过包装才能成为商品进行销售，每一种包装食品在其保质期内都应有相应的质量和卫生标准。本实验通过对市场上的食品包装从材料选择、材料的特性、包装的原理与技术方法及优缺点等进行分析，以期对食品包装的材料、包装容器、包装原理和方法等有更好的掌握。三、实验方式每名同学选择某一种包装，对之进行分析，得出实验结果。四、实验内容：选择某一食品包装从材料选择、材料的特性、包装的原理与技术方法及优缺点等进行分析。五、结果与分析实验三自行设计美观的食品包装

包装设计

食品包巧装克学力课内程外设包计装设计指导教师：黄亮设计人员：杨振邦古蔷薇崔涛江琪设计时间：2004年10月23日

前言一、纸质包装的发展现状以纸包装代替塑料包装、布袋包装已成为包装市场的新时尚。业内人士指出，在现代包装四大材料--纸、塑料、玻璃和金属中，由于纸和塑料价格便宜，便于加工，且原料来源广泛，不像玻璃那样易碎，不像金属那样重，因此，纸和塑料包装在日常生活中能应用广泛。然而，由于塑料包装材料不易自行降解，会造成环境污染等问题，经国际权威专家量化评估确定，纸才是比较具有发展前景的绿色包装材料。另一方面，人类对环保的重视，也使纸包装成为包装市场的主导产品，大有逐步替代塑料包装制品之势。纸包装食品的突出优点是无毒、无味、无污染，符合国家食品卫生标准。目前，在国外食品包装一般都采用纸盒、纸袋、纸筒、纸罐等各类纸质容器。特别是上世纪八九十年代，在食品行业中，纸质容器包装已大量替代了马口铁罐和铝罐等。现在国际上纸质品的发展方向是产品具有多功能性，如具有防潮、保鲜、保温、杀菌、防腐等各种功能，以更好地保护和保存食品。在我国"十五"包装工业规划中提到：到2005年，我国包装工业总产值将达到3000亿元，平均每年以8％的速度递增，其中，纸包装制品将达到2000万吨，平均每年以9％的速度递增。尽管纸包装制品增长为最快，但在品种及质量上仍不能满足出白和高档商品的需要，因此约有1/4的缺口还需要依赖进口解决。国外对食品纸质包装质量之高，设计之精美、功能之多样是值得我国包装业好好学习和借鉴的。在经济全球化的进程日益加快的形势下，我国虽已在不少方面推广应用了纸质包装，但还需加快对纸容器的开发研究步伐，这不仅是行业生存发展的需要，亦是环境保护的必然趋势。二、包装的目的食品包装从始至今，历来都是包装的主体。食物易腐败变质而丧失其营养价值，食品必须适当包装才能贮存和成为商品流通，随着科学技术水平和人们消费水平的日益提高，对食品包装的要求也越来越高。食品包装的迅猛发展和千姿百态，既丰富了人们的生活，也逐渐改变着人们的生活方式。现代商品社会中，包装对商品流通起着极其重要的作用，包装的科学合理性会影响到商品的质量可靠性，及能否以完美的状态传达到消费者手中，包装的设计和装潢水平直接影响到商品本身的市场竞争力乃至品牌、企业形象。现代包装有以下四方面功能：保护商品、方便贮运、促进销售、提高商品价值。实现这些功能需要有合理的包装结构。包装最主要的作用就是保护商品。商品在贮运、销售、消费等流通过程中常会受到各种不利条件及环境因素的破坏和影响，采用科学合理的包装可使商品免受或减少这些破坏和影响，以期达到保护商品的目的。同时包装也是提高商品竞争能力、促进销售的重要手段。精美的包装在心理上征服购买者，增加其购买欲望；在超级市场中，包装更是充当着无声推销员的角色。随着市场竞争由商品内在质量、价格、成本竞争转向更高层次的品牌形象竞争，包装形象将直接反映一个品牌和一个企业的形象。

食品包装用油墨的安全隐患及防控措施

食品包装用油墨的安全隐患及防控措施摘要印刷油墨是食品包装的重要组成部分，承担着美化商品、促进销售等责任，但油墨是由颜料、连接料和助剂等组成的，不可避免的含有苯类、醇类、酯类、重金属、多环芳烃和增塑剂等有害物质，这些物质有可能会迁移至食品上，严重影响消费者的身体健康，因此必须要加强食品包装印刷油墨中有害物质的控制。本文主要就食品包装印刷油墨存在的安全隐患及控制方法进行初步的探讨分析，仅为相关行业的有关工作提供简单的参考。关键词食品包装；印刷油墨；安全隐患；控制方法食品是人类赖以生存的基础，食品包装直接接触食品，是食品商品的组成部分。食品包装有两个基本作用，一是保护食品完好，使食品方便储存，安全的到达消费者手里；二是保证食品质量，使食品不会受到外界环境污染的影响，食品包装在与食物直接接触的过程中，其中的成分会发生转移，尤其是有害成分会迁移至食物中去，不仅影响食物的味道，更重要的是会对食品的安全和人体的健康造成危害。目前最为常用的基础食品包装材料有纸、塑料、玻璃和金属，而其中用量最大的是塑料（包括复合材料）和纸，占食品包装份额的70%以上。食品包装企业需要在包装上印制商标、文字以及装饰性图形，使产品更具说明性和吸引性。食品用纸包装和塑料包装均需使用油墨进行印刷，所以油墨是食品包装必不可少的元素之一，占总成分的10%～20%。虽然食品包装材料表面的印刷油墨并没有与食品直接接触，但是油墨中的有害物质会随着环境和时间的变化迁移至食品中，会对食品造成污染。 1 食品包装用印刷油墨中的安全隐患目前市场上用于食品包装印刷的油墨主要是树脂油墨和溶剂型油墨，溶剂型油墨又包括苯、醇和水溶性油墨。油墨的三大重要组成部分是颜料、连接料和助剂[1]。从油墨的构成分析，油墨对食品包装的安全隐患有以下几方面： 1.1 有机溶剂油墨中所含有机溶剂是溶剂残留的主要来源。有机溶剂占油墨组成的30%～50%或更多，这些有机溶剂有苯系物（甲苯、二甲苯、氯代苯等），醇类（乙醇、丁醇、丙醇和异丙醇等），酯类（醋酸乙酯、醋酸丁酯等），酮类和醚类等。这些物质虽然在印刷干燥过程中会被去除一部分，但不可避免地会有残留。在某些条件下会迁移至食品中。已有研究表明，这些有机溶剂能引起机体免疫水平失调，影响中枢神经系统功能，还可能影响消化系统，严重时可损伤肝脏和造血系统。 1.2 颜料

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食品质量与安全专业人才培养方案

食品包装学实验指导

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