METALS AND ALLOYS IN CONTACT WITH FOOD. How to establish compliance with European regulations and recommendations

Transcription

1 METALS AND ALLOYS IN CONTACT WITH FOOD How to establish compliance with European regulations and recommendations 6-7 November 2014, LJUBLJANA, Slovenia ************* ABSTRACTS 1

2 SESSION I Council of Europe and its Committee on food contact materials (P-SC-EMB) Ms Susanne Bahrke, EDQM, Council of Europe Council of Europe Resolution CM/Res(2013)9 and its supplementary Technical Guide were released in Harmonised requirements have been set out for the quality of food contact materials made from metals and alloys. This document serves as international reference for manufacturers and authorities and can be transposed into national law. 2

3 Belgian point of view on European harmonisation Dr Fabien Bolle, Vice-Chair of the P-SC-EMB, Scientific Institute of Public Health, Belgium Regulation (EC) No. 1935/2004 covers all materials in contact with foods. However, many materials are not the subject of specific texts in the European Union. Some of these materials are dealt with in Council of Europe (CoE) resolutions and harmonised guidance for non-plastics. There are also more and more national texts following crises concerning nonplastics (inks: Swiss Ordinance; varnish: Belgian Decree, revision in the Netherlands, BfR revision of recommendations ). A lack of harmonisation of regulations on food-contact materials in Europe would be detrimental and could be avoided by the CoE playing a co-ordinating role. The Belgian Scientific Institute of Public Health has established a database derived from CoE lists of substances in food-contact materials. This database provides valuable information on the identity and toxicity of these substances. 3

4 Role of consumer organisations in food safety Ms Marjana Peterman, Slovenian Consumers Association (ZPS) European consumer policy main objectives are: a high common level of consumer protection effective enforcement of consumer protection rules involvement of consumer organisations in EU policies Slovene consumer association ZPS is a non-profit, independent and internationally recognised consumer NGO, established in ZPS is a member of Consumer International- CI, The European Consumers Organization-BEUC, International Consumer Research and Testing-ICRT, The Transatlantic Consumer Dialog-TACD. Our mission is to inform consumers who are aware of their rights and know how to assert them. We are active in creating consumer friendly society. Our main activities are: consumer product testing and research, advice, representation and advocacy, education and empowerment of consumers. Our food experts are active in BEUC, CI, TACD food group, EFSA StaCGER group for example. Who is a consumer? Nobody is just a consumer and consumers are not a separate group of people within society. The overwhelming majority of people are both producers and consumers during their lifetime. At some stages in an individual s life the producer role may be more important. At others after retirement from work, for example the consumer role may be dominant. On this basis, the individual s role as a consumer is distinct from her or his role as a producer. Put into operational terms, this concept might be rephrased as the consumer is an individual who is offered, buys or uses goods and services, whether publicly or privately supplied, for personal or family use. Consumer is at the end of the food chain thus exposed to all the risks of the chain. Consumers are also exposed to a large number of chemicals from products they use every day which aggregate on a daily basis and cumulate throughout the human lifespan. Assessing the risk, account for aggregate and cumulative exposure must be taken into consideration, product, process, and usage consideration of representative group of consumers, especially vulnerable groups of consumers should be limit to exposure and if there is no scientific agreement, then precautionary principle is applied. Migration of chemicals form metals in alloys in contact with food are chemical risks. 4

5 Metals and alloys in food contact applications Ms Viviana Golja, National Institute of Public Health (NIPH), Slovenia Most of the cookware and some tableware, packaging, food processing machinery and kitchen utensils are made of metals and alloys. Metallic food contact materials as well as other food contact materials should be safe and should not release into the foodstuffs constituents that may endanger human health, bring about an unacceptable change in composition of the food or to be cause of deterioration of organoleptic properties of the food. However, inappropriate metallic food contact materials can be sometimes found at the borders of European Union or on the market. In the presentation different metallic food contact materials are showed, legislation and official control are mentioned. Review of the most common issues connected with metallic food contact materials is done and notifications regarding metallic food contact materials on RASFF (Rapid Alert System for Food and Feed) in years 2012, 2013 and 2014 are presented. 5

6 SESSION II Safety evaluation of FCMs by EFSA Prof. Dr Georges Kass, European Food Safety Authority EFSA, Italy The European Food Safety Authority (EFSA) was set up in January 2002, following a series of food crises in the late 1990s, to provide independent scientific advice on risks associated with the food chain. EFSA s work in the area of regulated food ingredients and packaging is carried out by two separate scientific Panels. The Panel on Food Additives and Nutrient Sources Added to Food (ANS) deals with questions of safety in the use of food additives, nutrient sources and other substances deliberately added to food, excluding flavourings and enzymes. The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with questions on the safety of use of materials in contact with food (FCM), enzymes, flavourings and processing aids, and also with questions related to the safety of processes. Framework Regulation (EU) 1935/2004 covers all the materials in contact with food and lays down the workflow for the authorisation of a substance while the Guidelines of the Scientific Committee on Food describes the presentation of an application for safety assessment of a substance to be used in FCM prior to its authorisation. Metals and their salts are subject to requirements, restrictions and specifications when used in FCM as outlined in Commission Regulation (EU) 10/2011. Recent examples of risk assessment by the CEF Panel of metals used in FCM will be presented. In addition, EFSA has been assessing the general risks posed by metals in the food chain. 6

7 An example of risk assessment of metallic food contact material using the Practical Guide on metals and alloys Ms Mateja Bolčič Tavčar, National Institute of Public Health NIPH, Slovenia The Practical Guide on metals and alloys was published in 2013 compared to its precedent, Technical Document Guidelines on metals and alloys used as food contact materials (FCMs), sets Specific Release Limits (SRLs) for the whole mentioned metals in the guidance. The setting of SRLs has been taking into consideration the safety aspects of metals, expected exposures from other sources than FCMs and applying allocation factors. However, because no SRLs of metals are regulated in the EU Regulations, some Competent Authorities require the performance of a risk assessment (RA) for human health for metals, found to release from FCM sampled in the framework of regular national monitoring programme. One way to choose when to perform a RA is to perform it when the release of a metal exceeds its SRL. The example of the leaching nickel (Ni) above the SRL (0.14 mg/ kg food), provisional 0.7 mg/kg food) from a stainless steel baking tray is just one of the ways, an idea, how to perform a consumer refined exposure assessment using consumer food intake data. The declared and presumed use of the FCM has been used to build the exposure scenario. The chronic intake data reported in the EFSA Comprehensive European Food Consumption database were applied and its use was discussed. The predicted exposure for adults and children was compared against 20% of TDI for Ni, which was set taking into account those individuals who are sensitised to Ni. The exposure of adults and children exceeded the reference value and could present a risk to consumers health. The tested sample was not found safe in terms of Article 3 of the Regulation (EC) No 1935/

8 Extent of Metal Release from Food Contact Materials into different Food Simulants and Foodstuffs Dr Frederic Müller, Federal Institute for Risk Assessment, BfR, Germany The use of food contact materials made of metals or alloys is often associated with metal releases into the foodstuffs. Especially the release of metals in high concentrations and the use of toxic alloying components represent an ongoing problem for surveillance authorities which is reflected by the large number of RASFF notices. In 2013 the Council of Europe passed the resolution CM/Res(2013)9 on metals and alloys used in food contact materials and articles. In the technical guide supplementing this resolution specific release limits for 21 metals and methods for release testing are proposed. The technical guide requires analytical methods capable of quantifying concentrations in the range of 20% of these limits. In order to show this capacity, the quantification of the 21 metals in different food simulants and foodstuffs was investigated using an ICP-MS method. 8

9 The practical experience of the aluminium industry Mr Sandro Starita, European Aluminium Association AISBL Aluminium is the third most common element in the earth crust, and in its metallic form it is used in a great variety of applications. In particular, it is since many years used for the safe preservation and storage of foodstuffs, thanks to the material s excellent properties. In addition and to complement the established existing best practices, the Council of Europe introduced in 2013 a Resolution on metals and alloys in contact with food, including recommendations for aluminium used in this context. The presentation from EAA, on behalf of the European aluminium industry, aims at illustrating the experience of the aluminium industry one year after the publication of the Council of Europe s Resolution, indicating the perceived benefits and the suggested areas for further improvement. 9

10 Experience on aluminium release testing into food stuffs and food simulants Mr Antonino Maggio, Istituto Superiore di Sanità, Italy The Italian regulation on Al is today based not on migration testing ( release testing approach ), but on the assessment of alloy composition ( compositional approach ). Thus, the alloy composition is limited to a relatively narrow range of possibilities and to a number of time/temperature contact conditions. Such provision were assessed to be capable to control and limit Al release to foodstuffs to safe levels, mainly becausealloy composition is capable to deeply influence Al release to foodstuffs. In the view to evaluate the enforcment of the CoE Metal Resolution in the Italian legislation, a research project has been granted for the evaluation of both stored and cooked foodstuffs, using Al containers or wrapped in Al films. The results from food testing shall be correlated with results from release tests, to be performed on the same Al alloys exposed to alternative food simulants (e.g., aqueous citric acid). The first part of the program is quite near to be accomplished, while the second is still going on. Practically, the project is expected to provide a clear correlation between the actual results from foodstuffs, Al release to alternative food simulants and Al alloy composition. 10

11 One Year after CoE resolution: Metals and Alloys used in food contact. Experience by EU industry and remaining challenges Dr Gernot Strehl, Zwilling J.A. Henckels AG Germany, member of the Federation of European Cutlery and Cookware Industries, FEC Members of the FEC contributed in developing the new CoE / EDQM testing guide for metals and alloys since 2011, as their industry is involved with the food contact testing of articles like knives, cutlery, silver flatware and hollowware, cookware made of stainless steel, cast iron or aluminium. Temperature measurements during cooling down after hot filling of coffee and tea pots or spoons in soup plates have been carried out as well as migration tests on divers kinds of products. Testing conditions for kitchen knives and flatware with 2 h / 70 C as well as for silver items for cold use with 24 h / 40 C overestimate the migration under real use conditions. It is therefore proposed to test knives and flatware with 30 min / 70 C and the latter with 2 h / RT. Products made of cast iron or carbon steel have been found to exceed the approved SRLlevel when tested in citric acid. They can be used with non-acidic food, because tests in artificial tap water have been passed. These products need an appropriate labeling. The implementation of the testing guide showed that there are interlaboratory challenges if it comes to temperature measurement, evaporation of water or time between multiple migrations. As in the past the European manufacturers under the roof of the FEC are willing to contribute to solutions to these challenges with additional test programs. 11

12 SESSION III Innovative approach to product testing Dr Fabien Bolle, Vice-Chair of the P-SC-EMB, Scientific Institute of Public Health, Belgium The Resolution on metals and alloys had to be innovative in the field of the regulation of food-contact materials. This is because metals and alloys have properties that differ from those of materials such as plastics and also because some concepts applied in the current legislation needed to be revised or improved. For example, when calculating the release limits for metals and alloys, other sources of the chemical elements concerned also have to be taken into account. Specific Migration Limit: The term has been replaced by the term Specific Release Limit. Release from metals and alloys is governed by electrochemical laws that have nothing to do with the migration of plastics. New, more realistic, simulants are described. A double limit for articles used repeatedly is intended to avoid the risk of acute poisoning. 12

13 Envelope volume, a new concept Dr Ingo Ebner, Federal Institute for Risk Assessment, BfR, Germany For calculating the migration test results for articles that cannot be filled, regulation (EU) No 10/2011 foresees the measurement of surface coming into contact with food. The value of migration shall be expressed in mg/kg applying a surface to volume ratio of 6 dm 2 per kg of food. As the measurement of the surface area might be complex and error-prone the Council of Europe in the resolution CM/Res(2013)9 on metals and alloys introduced a different approach. It is based on the determination of the rectangular box enwrapping the food contact part of an article. The envelope volume is calculated from the dimensions of that box on a 5cm-scale. In 2013 the European Reference Laboratory for Food Contact Materials organised an interlaboratory comparison on the surface area of kitchen utensils including the determination of the envelop volume. The results regarding the envelope volume method are discussed here. To overcome the strong deviation shown in that exercise, proposals for improvements are given. 13

14 Interlaboratory comparisons of the European Union Reference Laboratory on protocols for surface area measurements and their impact on migration measurements for kitchen articles. Anja Mieth, E. Hoekstra and C. Simoneau European Commission, Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), Chemical Assessment and Testing Unit, Via Fermi 2749, Ispra, Italy In 2013, the European Union Reference Laboratory for Food Contact Materials (hosted by the European Commission s Joint Research Centre) organised interlaboratory comparisons (ILCs) that focused on the determination of the food contact surface area of different kitchen utensils. Its general aim was to assess the capability of National Reference Laboratories (NRLs) and official control laboratories to measure the food contact surface area of kitchen utensils and to compare the most common approaches for the determination of the surface area in terms of reproducibility and trueness. Four protocol were selected based on the usage and feedback received from questionnaires to official controls laboratories. The results from laser scanning were adopted as true values. An additional voluntary exercise aimed at the determination of the envelope volume of five samples on a 2-cm-scale and a 5-cm-scale (EDQM "Metals and Alloys used in food contact materials and articles", 1 st edition, 2013). For the determination of the surface area, the trueness and precision of the methods depended on the sample shape. "Calculation" generated accurate results for all sample types. "Drawing the shape" was most convenient and provided accurate results for flat samples of negligible thickness. For round-shaped samples, "wrapping in aluminium foil" was most convenient but the surface area was overestimated due to the formation of crinkles in the foil. "Wrapping in paper" generated accurate results for flat samples and simple geometric shapes. For roundshaped samples, the surface area was overestimated as well. With respect to the final migration result, the obtained reproducibility standard deviations for all four protocols to determine the surface area were acceptable with respect to their impact on the migration measurement itself. The determination of the envelope volume was of interest in concept to test in these exercises because it required only the determination of H f and the measurement of the depth and width of the sample. Critical steps were the definition of H n (i.e. the functional part of the sample with necessary food contact), H handle (especially when can a handle be regarded as "clearly separated"?) and the measurement of the sample width for compressible items (e.g. kitchen tongs). 14

15 Release testing according to the Practical Guide, Council of Europe 2013 Mr Markus Jahns, TUEV Sued Product Service GmbH, Germany The presentation shows the experience gained within the implementation of the Practical Guide, Council of Europe A short comparison between the old and the new migration solution is shown and an overview about test results for a wide range of household appliances in contact with food. The challenges and questions coming up with the Practical Guide will also be shown: Different materials with different legal requirements combined in one product, Certification of products, different implementation of the guideline in one European Market. 15

16 Test conditions for hermetically sealed containers and pack tests Dr. Ulrich Nehring, INSTITUT NEHRING GmbH, Braunschweig, Germany It is the scope of edqm/coe Practical Guide Metals and alloys used in food contact materials and articles to give guidance on the application of Council of Europe Resolution CM/Res (2013)9. The practical guide contains several exemptions and remarks regarding the testing of release of metals from metal packaging and cans in particular. The presentation describes the specific properties of metal packaging and the relevant differences to other metallic materials and articles intended to come into contact with food. The hermetical seaming of cans, the absence of oxygen, thermal processing conditions and the complex chemical properties of foodstuffs are important factors for the stability of canned food and allow shelf lives up to 5 years without significant release of metals from the packaging material into food. The release of metals from metal packaging cannot be tested with food simulants and usually requires long term storage of seamed cans filled with real food. In order to control the release of toxic metals and other impurities from metal packaging according to GMP Guidelines the canmakers industry selects metallic substrates which do not exceed the acceptable level of impurities and meet international standards. During the development and qualification process of metal packaging and canned food industry carries out a cascade of so called pack tests. An increasing number of cans are filled under industrial conditions with a representative real food product. The cans are stored under controlled conditions until the end of the intended shelf life. During storage samples are regularly drawn for performance assessments. This includes tests for release of metals in case of suspect samples. According to the long lasting experience the storage time cannot be shortened by forced conditions, e.g. elevated storage temperatures or shaking, because such measures lead to results which significantly differ from reality. The results therefore must not be used to judge about safety and durability of the canned food or about compliance of the applied packaging material. Whenever test conditions differ from real industrial process conditions the procedure needs full specific validation. 16

17 Metals and Alloys Nordic Guidance for industry and trade Mr Grimur Olafsson, Norwegian Food Safety Authority The Nordic countries have a long tradition for co-operation in the field of food and nutrition and now also on food contact materials (FCM). Former projects include guidelines for trade, industry and the food control on: paper and board, in-house documentation (DoC and SD) and printing inks. Some of these publications have been based on Council of Europe declarations. Currently there are two projects ongoing: 1) Nordic checklist for food contact materials, an update of the publication on in-house documentation and 2) Metals and alloys - Nordic guidance for industry and trade. The participants in the projects are Denmark, Finland, the Faroe Islands, Iceland, Norway and Sweden. Metals and alloys as FCM are not specifically regulated in the EU. The general requirements in EU regulation 1935/2004 and 2023/2006 apply. However some metals are regulated as contaminants in food in EU regulation 1881/2006 (lead, cadmium, mercury and inorganic tin). This project is meant to result in a guidance document to support compliance work in trade and industry and as a tool for the official food inspection with regards to FCM composed of metals and alloys. However, it is underlined that in the official control, the limits should be used as guidance only, and specific FCM exceeding one of the limits should be evaluated on a case-by-case basis. The report collates, evaluates and recommends risk based guidance limits for migration from metals and alloys used as food contact material. It is based on the work done by the Council of Europe, risk assessments from the European Food Safety Authority and by the WHO/FAO Joint Expert Committee on Food Additives The main part of the report are tables with guidance limits containing information on 23 metals, 15 are metals used as FCM by themselves or as alloys and 8 are contaminants. The tables summarize information on the main source and the level of dietary intake, toxicological effects, risk assessment, Co E limits and limits set by other bodies, Nordic comments additional comments on toxicology and analytical feasibility, analysis, food source and special recommendations. In annexes to the document are links to risk assessment for the individual elements, links to legislation and guidance (EU and Nordic webpages), information on declaration of compliance, process equipment, analytical testing and alloys including a section on stainless steel. 17

18 Testing of metallic food contact materials in an NRL Ms Andreja Zorič, National Laboratory of Health, Environment and Food, Slovenia National Laboratory of Health, Environment and Food carries out the tasks of Slovenian national reference laboratory for food contact materials. In the presentation an overview of Slovenian legislation on metallic food contact materials and metals release testing procedures used is given. In addition, test results for chromium and nickel release from stainless steel articles in the period on Slovenian market are presented. The test results show that the percentage of uncompliant samples is not decreasing. In the absence of european legislation Technical guide on metals and alloys used in food contact materials and articles with harmonised testing procedures is essential guidance document for NRL. 18