NORMPACK GUIDE. A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm.

NORMPACK GUIDE A guideline for evaluation and documentation of Food Contact Materials (FCM) according to the Normpack Norm Kristina Salmén

Foreword The Normpack guide is a support for Normpack members for self-assessment of materials/articles intended to be in contact with food. It helps the user to find legislations, regulations or recommendations applicable for specific materials and it contains instructions to compile necessary and correct documentation to fulfil the Normpack Norm and obtain a Normpack Certificate. The Normpack Norm is based on Swedish, EU and national legislations, regulations and recommendations. The guide also contains overall information about materials and packaging, official organisations involved in food contact materials (FCM) and a list of abbreviations. The guide consists of two parts: The first part consists of chapter 2 and 3. Chapter 2 is a description of the Normpack Norm and what is required to meet its obligations in order to receive a Normpack Certificate. Chapter 3 will help you to navigate on how to compile documentation and show conformity with the applicable rules as a basis to apply for a Normpack Certificate. The second part, chapter 4, contains information about 16 materials. For each material, the guide provides a description about the specific legislation and the supporting documentation needed to obtain a Normpack Certificate. Because of the complexity of this field, fundamental knowledge on food contact materials framework as well as nomenclature and material structure is necessary for the reader. The intention of the first part is to give the reader a general map of how to navigate and to collect the necessary documentation. For details the reader has to consult the applicable legislations, regulations and recommendations to which links are given. Depending on previous knowledge the reader can start on the applicable part in the guide. The guide has been developed within Normpack and is financed by Industry and Trade Group Normpack. I would like to thank Normpack s technical committee for their valuable support, especially Ann Britt Nilseng, BillerudKorsnäs Skog & Industri AB, Therese Parkas and Ingrid Rogne, ICA Sverige AB and Jenny Hörnander, DS Smith Packaging Sweden AB for constructive criticism and relevant remarks. I also would like to thank my co-workers Ann Lorentzon, Kai-Yee Thim, Elisabeth Sjöholm and Kennert Johansson for their constructive comments and remarks as well our discussions. Stockholm, September 2017 2 Kristina Salmén Normpack Guide version 2017 09 page 2 2017 09 30

List of Content Foreword 2 List of Content 3 1 Normpack 5 2 The Normpack Norm 6 2.1 Introduction 6 2.2 The paragraphs in the Normpack Norm 7 2.3 The Normpack Certificate 9 2.3.1 General requirements on documentation for Normpack Certificate 9 2.3.2 The Normpack Certificate form 10 2.3.3 Normpack s demands on Declaration of compliance as supporting documents 12 2.3.4 Overall migration 12 2.3.5 Calculation or testing reports for special substances 13 2.3.6 Testing for non-harmonized FCM 13 2.4 Normpack Certificate Catalogue 14 3 Compilation of documentation 15 3.1 EC Framework Regulation L 1935/2004 15 3.1.1 Purpose and subject 15 3.1.2 Traceability 15 3.1.3 General safety requirements 16 3.1.4 Labelling 17 3.1.5 Declaration of compliance (DoC) 17 3.1.6 Inspections, control measures and sanctions 17 3.2 Good Manufacturing Practice Regulation, GMP, (EC) No 2023/2006 18 3.2.1 Purpose and subject 18 3.2.1 Quality assurance system 18 3.2.2 Documentation 18 3.2.3 Printing inks on the non-food contact side 19 3.3 Steps for compilation of documentation as a basis for application for a Normpack Certificate 20 4 Material specific regulations and demands 22 4.1 Active and intelligent materials and articles 24 4.2 Adhesives 26 4.3 Ceramics 29 4.4 Cork 31 4.5 Rubber 33 4.5.1 Rubber for Teats and soothers 33 4.5.2 Rubber for other products 34 4.6 Glass 36 4.7 Metals and alloys 38 4.8 Paper and board 40 4.9 Plastics 43 4.10 Printing inks 51 4.11 Regenerated cellulose 53 4.12 Silicones 55 4.13 Textiles 57 4.14 Varnishes and coatings 58 3 Normpack Guide version 2017 09 page 3 2017 09 30

4.15 Waxes 60 4.16 Wood 62 Appendix I - Food packaging constructions will be published later Appendix II - Who is working within the area FCM in Europe will be published later Appendix III - Abbreviations and definitions will be published later 4 Normpack Guide version 2017 09 page 4 2017 09 30

1 Normpack Normpack is an independent self-assessment system for producers and users of materials and articles in contact with food. The Normpack trade and industry group was founded 1981 in Stockholm, and currently has nearly 200 members representing every stage of the value chain: materials and packaging manufacturers, the food industry and wholesalers/retailers. The work of the group is based on member companies self-assessments of their materials/articles in contact with food. The system has been created by the industry and it is framed by the Normpack Norm s rules and recommendations selected together with the Swedish National Food Agency, Livsmedelsverket. Materials/articles that are evaluated and meet the requirements of the Normpack Norm receive a Normpack Certificate, confirming to customers and consumers that they are suitable for use with foodstuffs. Normpack Certificates are listed in Normpack Certificate Catalogue. In addition, Normpack also work with: Training, information and advice for member companies Monitoring current and forthcoming legislation and other regulations within the field of Food Contact Material (FCM) Readiness to deal with alerts and topical discussions Knowledge development through self-assessment projects Webb-based tools to help evaluate materials or products Contact information: Normpack c/o RISE Bioeconomy Visiting address: Drottning Kristinas väg 61, Stockholm, Sweden Mail address: Box 5604, SE-114 86 Stockholm, Sweden Ann Lorentzon (Membership and Marketing) E-mail: ann.lorentzon@ri.se Phone: +46 (0)8 676 7067 Kristina Salmén (Normpack Norm, Certification) E-mail: kristina.salmen@ri.se Phone: +46 (0)8 676 7083 Normpack website: www.normpack.se

2 The Normpack Norm 2.1 Introduction The Normpack Norm is also known as the Swedish material norm for materials and articles in contact with foodstuffs. The Normpack Norm is an agreement between Normpack and the Swedish National Food Agency regarding how to work in a reliable way to fulfil the obligations. An overview of Normpack Norm is illustrated in Figure 1. Normpack Certificate is issued for material and products fulfilling the Normpack Norm. Figure 1 Overview of paragraphs in the Normpack Norm. An overview of the legislation, regulations and recommendations covered in the Normpack Norm are listed in Figure 2. The Normpack Norm is updated when legislations, regulations and recommendations is changed. Health and Food Safety (SANTE), DG X, EEC Regulations, Food Contact Materials, EU Livsmedelsverket, National Food Agency, Sweden Bundesinstitut für Risikobewertung, Database BfR Recommendations on Food Contact Materials, Germany STAATSCOURANT Warenwet, Netherlands Food and Drug Administration,Code of Federal Regulations (CFR) Title 21, USA Figure 2 Authorities and their legislations, regulations and recommendations covered in the Normpack Norm Normpack Guide version 2017 09 page 6 2017 09 30

2.2 The paragraphs in the Normpack Norm The present version of the Normpack Norm is the 9 th update 2017: 1. Materials and articles in contact with food shall meet the demands of the Swedish Ordinances SFS 2006:804, SFS 2006:813 the European Regulations (EC)178/2002, (EC) 2232/96, (EC) 2023/2006 and (EC) 1935/2004 the regulation from Swedish National Food Agency on Materials and Articles Intended to come into Contact with Foods (LIVSFS 2011:7), on Nutritional Supplements (LIVSFS 2003:9), on Food Additives (LIVSFS 2004:30) and on Certain Foreign Substances in Food (SLV FS 1993:36) The following harmonised European Directives and Regulations in force, which is specific for materials and products for food contact, are included in the Normpack Norm: 2005/31 (Ceramics), 2007/42 (Cellophane), 282/2008 (Recycled plastic),450/2009 (A&I packaging), L 10 /2011 (Plastic), L 2017/752 (Plastic update), L 1895/2005 (Epoxi), L 1183/2012 and L 93/11 (N-nitrosamine). 2. For materials not covered in detail in Swedish or European harmonised food legislation one of the following regulations shall be invoked: The Dutch Packaging and Food-Utensils Regulation (Warenwet), Netherland Kunststoffe im Lebensmittelverkehr, Empfehlungen des Bundesinstitutes für Risikobewertung (BfR), and Bedarfsgegenständeverordnung published in Bundesgesundheitsblatt, Germany. Code of Federal Regulations, 21, Food and Drugs, 174, 175, 176, 177, 178, 180, 181, 182, 184, 186 and 189 (FDA), USA. 3. To prevent incorrect usage of materials and articles in contact with food, supplier and buyer at all manufacturing and handling levels shall confer about the suitability of the material/article for the intended purpose. Figure 3 Normpack require consultation through the value chain. Normpack Guide version 2017 09 page 7 2017 09 30

4. Control of migration. If there is a migration limit regulating materials/articles, the following alternative methods are suggested to establish whether the material/article meets the demands of the Plastic Regulation (EC) No 10/2011 (with subsequent amendments): a) Measurements using fully validated or recommended methods b) Mathematical calculations by FACET if measurements are missing. Normpack Guide version 2017 09 page 8 2017 09 30

2.3 The Normpack Certificate 2.3.1 General requirements on documentation for Normpack Certificate The Normpack Certificate is issued for materials/articles fulfilling the Normpack Norm. The certificate shows that Normpack has carried out a third-party review of the underlying documentation, and that the evaluation has been completed in accordance with the applicable legislation in the Normpack Norm. The compilation of the documents for the Normpack Certificate shall be performed by whoever applies for the certificate. The company has the responsibility for the information and documentation. The documentation shall demonstrate the construction of the material/article, layer by layer. A Declarations of Compliance (DoC) for each material or a compilation of evaluation (Chapter 3). The documentation shall: state the construction of the material/article with respect to the raw material show results of testing/calculations on migration/extraction of the material or articles as ready for use, which means that the total construction must be evaluated. in general, not older than two years be in line with the Normpack Norm. Figure 4 Overview of the Normpack certification process. The period of validity of the Normpack Certificate is dated on the certificate. The validity is general two years. The Certificate is valid provided: no changes are made in the composition, e.g. replacement of material or material constituent, change of supplier, change of colour or change of the addition of chemicals of the material. no changes are made in the requirements of the current legislation the owner of the certificate is a member of Normpack. All valid certificates are presented in Normpack Certification Catalogue. Normpack Guide version 2017 09 page 9 2017 09 30

2.3.2 The Normpack Certificate form The Normpack Certificate is available on Normpack webb. Information about the certificate is partly applied online on Normpack s members web. The front page of the certificate form is shown in Figure 5 and the back page is shown in Figure 6 with the Normpack Norm and a list of all food categories. Figure 5 First page of the Normpack Certificate form. Normpack Guide version 2017 09 page 10 2017 09 30

Figure 6 Back page of Normpack Certificate with Normpack Norm (specifying version) and list of food categories. Normpack Guide version 2017 09 page 11 2017 09 30

2.3.3 Normpack s demands on Declaration of compliance as supporting documents Declaration of compliance (DoC) for FCM can be issued by a company i.e. each private or public company, related to any part of the manufacture, processing and/or distribution of each materials/articles in concern. This means that for every type of material/article a relevant DoC must be issued. In addition, the finished construction based on these materials/articles has to be evaluated and have its own DoC. The DoC has to be based on one (1) type of legislation or recommendation (harmonized or national) therefore it is not correct to mix different regulations or recommendations on the same FCM construction. The DoC for a composed material (e.g. several layers, glue, etc) harmonised legislation can be applied for e.g. the plastic layer. For individual materials or parts of a construction without harmonised legislation, you have to use one of either BfR, Warenwet or FDA for the whole construction. Fulfilling the American FDA Regulation does not mean that the material/article show compliance with the European demands. The specification on required information needed for the DoC is described in the respective legislation, regulation and recommendation for specific materials. In the absence of EU measures for some food contact materials and articles, Member States may adopt national provisions for declarations of compliance based on BfR, Warenwet or FDA. In general, the declared compliance should be demonstrated by appropriate documentation made available to the authorities on their demand. NOTE: A common misunderstanding is that the Safety Data Sheet (SDS) can be used as a DoC. SDS is issued based on other regulations and is not in line with the FCM-regulations nor part of the Normpack Norm. 2.3.4 Overall migration Overall migration can be regarded as a quality control. Currently there are no valid European CEN standards available for testing overall migration from plastic food contact materials that refer to the Plastic Regulation (EU) No 10/2011. In the framework of the technical guidelines on migration testing for compliance monitoring under Regulation (EU) No 10/2011, a working version of the overall migration test will become available according to JRC. JRC collects information on where it is possible to find the analytical methods for migration testing of substances that are part of Plastic Regulation (EU) No 10/2011. It is done through collection of methods for plastics testing from petitioners via European Food Safety Authority, EFSA. The collection has reached about 320 methods and upon request JRC can make the summary descriptions available for research purposes under the scope of the European Union Reference Laboratory, EURL. Warenwet legislation though requests the overall migration testing for all materials using their own standard. Normpack Guide version 2017 09 page 12 2017 09 30

2.3.5 Calculation or testing reports for special substances For assessment of migration of specific substances as a safety control, you could use either tests or calculations. At each stage of manufacturing supporting documentation, substantiating the declaration of compliance, should be kept available for the enforcement authorities. Such demonstration of compliance may be based on relevant calculations or tests of the materials/articles. When the member company asks for a testing report of the materials/articles from a third party, it is important that the testing report contains the trade name of the material/article and that the testing covers the whole construction of the material/article as ready to use. The period of validity for the analysis/reports and calculations are to be judged by the company s own quality assessment system in relation to any updates of EC directives and regulations referred to. This means that if, for example, a limit for a substance has been changed by updates in the Normpack Norm, additional analyses might be required. Analytical reports for plastics, used as supporting documentation of a Normpack Certificate, has to follow the official JRC Technical Guidelines, for clarifying the context of the Plastic Regulation (EU) No 10/2011 (Article 2). The JRC-guideline covers the following topics related to compliance testing of plastic materials and articles: sampling, testing in food, choice of food simulants and test conditions, testing in food simulant, verification testing, screening testing, calculation of migration test results and reporting of test results. Although these technical guidelines are not legally binding, it gives the stateof-the-art of compliance testing in the Plastic Regulation (EU) No 10/2011 and it gives all the elements for the supporting documentation related to the compliance testing of the material or article. Calculations of migrations could be performed using FACET-software. 2.3.6 Testing for non-harmonized FCM EU associations representing the majority of non-harmonized FCMs, have worked together to develop their own recommended guidelines for each FCM sector. These have not been endorsed by the European Commission and are solely the responsibility of respective industrial sector. When testing for non-harmonized FCM for Normpack Certificate, the European Industry Guidelines can be applied, as long they are in line with the Normpack Norm. In addition, JRC has published a guide for non-harmonized FCM in EU: regulatory and market situation Normpack Guide version 2017 09 page 13 2017 09 30

2.4 Normpack Certificate Catalogue Normpack Certificate Catalogue is a tool for the food industry and trade to find suitable materials, articles and packaging. Only certified materials/products are listed in the catalogue, meaning that Normpack has audited that the documentation and the evaluation is done in accordance with applicable law. You can use the catalogue in three different ways: 1. Search by food type Start from the food group and search materials/packaging that are approved for this type of food. Food category can either be specified based on the categorization of food law or categorization of materials in contact with food. 2. Search by packaging Start from different package types and search certified products. 3. Other information Search for information in the catalogue such as certificate number, supplier or trade names. Normpack Guide version 2017 09 page 14 2017 09 30

3 Compilation of documentation As a basis for writing an application for a Normpack Certificate, documentation for the materials/articles needs to be collected in line with applicable legislations, regulations and recommendations. Normpack Certificate is based on self-assessment by the member company. The company also provides the supporting documentation for a Normpack Certificate. The submitted documentation must meet the legislations, regulations and recommendations valid on the date of application. When becoming a Normpack member the company certifies that they have a quality system in operation. Before describing the necessary steps to compilation of the supporting documents we first give an overall description of two general Frameworks which lays the ground for FCM. These legislations are linked to each other and together form the basic regulations that cover all types of the materials and articles in contact with food. The Framework Regulation, L1935/2004 describe the general safety requirements. The GMP Regulation L 2023/2006 Good Manufacturing Practice, describes quality assurance and control in manufacturing, processing and in distribution. 3.1 EC Framework Regulation L 1935/2004 3.1.1 Purpose and subject The rules in the Framework Regulation apply to all materials and articles, including active and intelligent materials, in their finished state that: are intended to be brought into contact with food (e.g. kitchen utensils and tableware), are already in contact with food and are intended for that purpose can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use (e.g. napkins and table mats). The Framework Regulation does not apply to materials and articles supplied as antiques, covering or coating materials (such as materials covering cheese rinds), prepared meat products or fruits which form part of the food and may be consumed together with the food as well as fixed public or private water supply equipment. 3.1.2 Traceability Traceability is an important element of the implementation of current EU Food Contact Material (FCM) rules and, thus, directly impacts both the effective functioning of the internal market and FCM safety. The relevant requirements are laid down in Article 17 of framework Regulation (EC) No 1935/2004. 1. The traceability of FCMs should be ensured at all steps in the supply chain to facilitate control, the recall of defective products, consumer information and the attribution of responsibility. Normpack Guide version 2017 09 page 15 2017 09 30

2. Business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials and articles (including substances) are supplied. This information should be made available to the competent authorities on demand. 3. The materials and articles which are placed on the market in the European Community should be identifiable by an appropriate system which allows their traceability by means of labelling or relevant documentation or information. Considering what is technically possible, the company shall apply systems and procedures that make it possible to identify the delivering/receiving party of the materials and articles and, where necessary, substances or products covered by this regulation. Such information shall be made available for concerned authorities upon request. Traceability and compliance documentation are key prerequisites for effective enforcement of the EU FCM rules. Materials and articles marketed within the EU shall be identifiable through a system that makes it possible to trace them by means of marking or relevant documentation or information. NOTE: In the Normpack Certificate form the company must answer the question whether they have a traceability system for materials and articles intended for food contact. 3.1.3 General safety requirements The general requirements that constitute the legal basis for enforcement by the national competent authorities and apply to all possible Food Contact Materials (FCM) point out two general areas. First, all food contact materials and articles should be manufactured in compliance with good manufacturing practice, so that, under normal and foreseeable conditions of use, they do not transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or a deterioration of its organoleptic characteristics. Article 4 of the regulation foresees special requirements about active and intelligent articles and materials. Second, the labelling, advertising and presentation of a food contact material or article should not mislead the consumers. The Framework Regulation 1935/2004 provides in Annex I a list of groups of materials and articles which may be covered by specific measures (chapter 4). Normpack Guide version 2017 09 page 16 2017 09 30

3.1.4 Labelling The Article 15 Framework Regulation states the rules regarding the labelling of food contact materials and articles intended to come in contact with food when placed on the market. The food contact materials in question are to be accompanied by the following words for food contact, an indication as to their use (e.g. as coffee machine, wine bottle, soup spoon) or the symbol in Figure 7. Figure 7 The symbol of for food contact in accordance to Annex II in Framework Regulation (EC) No 1935/2004 The required information should be conspicuous, clearly legible and indelible. Within its own territory, the Member State in which the material or article is marketed may stipulate that those labelling should be given in one or more languages. L 1935/2004 lays down requirements for displaying the necessary information in each marketing stage, including the retail stage. 3.1.5 Declaration of compliance (DoC) Article 16 Framework Regulation 1935/2004 stipulates that the specific measures referred to in Article 5 require that materials and articles covered by those measures are accompanied by a written declaration stating that they comply with the rules applicable to them. Appropriate documentation shall be available to demonstrate such compliance. That documentation shall be available to the competent authorities on demand. For some food contact materials/articles, Member States may adopt national provisions for declarations of compliance in the absence of EU measures. 3.1.6 Inspections, control measures and sanctions Article 24 Framework Regulation 1935/2004 contains provisions on official controls that Member States should carry out to enforce compliance. Enforcement activities should be performed in accordance with relevant provisions of EU law relating to official food and feed controls, such as Regulation (EC) No 882/2004 on food and feed controls. Joint Research Centre (JRC) - The EU Reference Laboratory on Food Contact Materials (EU- RL FCM) and the National Reference Laboratories (NRL) should assist Member States in their control activities by contributing to a high quality and uniformity of analytical results. The NRLs are officially nominated by the Member States. NRL for food in Sweden is Livsmedelsverket. Member States are also obliged to lay down rules on sanctions (Article 25) applicable to infringements of the provisions of the framework regulation and shall take all measures necessary to ensure that they are implemented. The regulations says that sanctions must be effective, proportionate and dissuasive. Normpack Guide version 2017 09 page 17 2017 09 30

3.2 Good Manufacturing Practice Regulation, GMP, (EC) No 2023/2006 3.2.1 Purpose and subject Good manufacturing practice (GMP) is defined in Regulation (EC) No 2023/2006 and applies to all food contact materials and all stages of manufacturing, processing and distribution of materials and articles. The production of starting substances in not included. Under the GMP regulation, business operators are obliged to establish, implement and apply quality assurance and quality control systems. Detailed rules about processes involving the application of printing inks to the non-food contact side of a material or article are also laid down in this Regulation. There are several industries, manufacturing, processing or distributing FCM, which have developed guidelines on good manufacturing practice. These guidelines aim at helping companies to ensure compliance with GMP requirements. 3.2.2 Quality assurance system Article 5 in the GMP-regulation sets demands on quality assurance system. The system is the total sum of the organized and documented arrangements made with the purpose of ensuring that materials and articles are of the quality required to ensure conformity with the rules applicable to them, and the quality standards necessary for their intended use. The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system. That system shall: take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them, be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business. 3.2.3 Documentation The business operator shall establish and maintain appropriate documentation in paper or electronic format with respect to: specifications, manufacturing formulae and processing which are relevant to compliance and safety of the finished material or article. records covering the various manufacturing operations performed which are relevant to compliance and safety of the quality control system. Normpack Guide version 2017 09 page 18 2017 09 30

3.2.4 Printing inks on the non-food contact side Framework Regulation 1935/2004 and GMP regulation 2023/2006 are linked to each other. Processes involving the application of printing inks to the non-food contact side of a material or article has certain rules: 1. Printing inks applied to the non-food-contact side of materials and articles shall be formulated and/or applied in such a manner that substances from the printed surface are not transferred to the food-contact side: through the substrate or by set-off in the stack or the reel in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004. 2. Printed materials and articles shall be handled and stored in their finished and semifinished states in such a manner that substances from the printed surface are not transferred to the food- contact side: through the substrate or by set-off in the stack or the reel in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004. 3. The printed surfaces shall not come into direct contact with food. Normpack Guide version 2017 09 page 19 2017 09 30

3.3 Steps for compilation of documentation as a basis for application for a Normpack Certificate Depending on the construction of the material/article, documentation is collected using the basic outline in Figure 8. The Normpack Certificate is based on evaluation of the FCM inline with either EEC harmonized regulation or national non-harmonized legislation/recommendations as well as the Normpack Norm. Material specific requirements are described in chapter 4. Figure 8 Basic Normpack rules applied for FCM Below are five steps you can follow in order to collect the necessary documentation to apply for a Normpack Certificate. Step 1 - Identification of the materials in each layer i.e. mixture of chemicals or raw materials The documentation shall demonstrate a description of the construction of the material/article layer by layer, starting with the food contact layer. An example of the documentation of a multi-material of one polymer type is illustrated in Table 1. FILM DOC TRADE NAME PRODUCER Food contact SIDE LDPE 1 A A1 Intermediate layer LDPE + LLDPE 1+2 A+B A1+B2 Intermediate layer LDPE 1 A A1 Non-food contact side Solvent based ink 3 C Table 1: Example of requested documentation based on the description of the construction of a multi-layered plastic film. For each layer supporting documents describing content and substances with special restrictions, should be compiled. There is no general description of the FCM construction since there are numerous of variations, e.g. an article could contain both a bottle and screw cup. Normpack Guide version 2017 09 page 20 2017 09 30

Step 2 - Intended use of the FCM (food type, time/temperature conditions) The food types are stated in the Normpack Norm divided in main food groups following a classification in the Plastic Regulation (EC) No 10/2011. It is important to know what kind of food the material is intended for. The speed of migration is higher with a higher temperature and is also time dependant. You should therefore map the filling and storing temperature as well as the contact time (e.g. from filled packaging until time of use), stating how long time the food will be in contact with the material during its life time. Step 3 - Calculation or testing of migration from the FCM-material/article as-readyfor-use The producer should evaluate the need of testing based on the background information that is collected. The evaluation of the collected documentation has to be performed (step 1) before the testing profile can be stated. The testing should be in line with the corresponding regulation, legislation or recommendation. E.g. in an evaluation you cannot use DoC based on BfR and testing described by Warenwet, as these two systems are not harmonized with each other. Calculations could be applied for specific migrations. The relation of food packaging area (S) to food volume (V), influence the migration. Step 4 - Declaration of compliance for the finished FCM as-ready-for-use The Declaration of compliance is built on the analysis of the collected documentation and executed test (if required) of the final construction as-ready-for-use. Step 5 Complete and submit the Normpack Certificate Download the Normpack Certificate form from Normpack member s website. Fill in the form with the information collected and submit the completed form together with required supported documentation. Normpack Guide version 2017 09 page 21 2017 09 30