Development of a new modelling tool (FACET) to assess exposure to chemical migrants from food packaging.

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Food Additives & Contaminants: Part A Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/tfac20

Development of a new modelling tool (FACET) to assess exposure to chemical migrants from food packaging a

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P.K.T. Oldring , C. O’Mahony , J. Dixon , M. Vints , J. Mehegan , C. Dequatre & L. Castle a

Valspar Corporation, Witney OX28 4XR, UK

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Creme Global, The Tower, Trinity Technology and Enterprise Campus, Dublin 2, Ireland

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FIG Consultant, Bristol BS6 6RJ, UK

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Amcor Flexibles Europe & Americas, B-9000 Ghent, Belgium

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School of Public Health, Physiotherapy and Population Science, University College, Dublin, Ireland f

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INEOS Olefins & Polymers Europe, B-1120 Brussels, Belgium

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The Food and Environment Research Agency, York YO41 1LZ, UK Accepted author version posted online: 12 Nov 2013.Published online: 15 Jan 2014.

To cite this article: P.K.T. Oldring, C. O’Mahony, J. Dixon, M. Vints, J. Mehegan, C. Dequatre & L. Castle (2014) Development of a new modelling tool (FACET) to assess exposure to chemical migrants from food packaging, Food Additives & Contaminants: Part A, 31:3, 444-465, DOI: 10.1080/19440049.2013.862348 To link to this article: http://dx.doi.org/10.1080/19440049.2013.862348

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Food Additives & Contaminants: Part A, 2014 Vol. 31, No. 3, 444–465, http://dx.doi.org/10.1080/19440049.2013.862348

Development of a new modelling tool (FACET) to assess exposure to chemical migrants from food packaging P.K.T. Oldringa*, C. O’Mahonyb, J. Dixonc, M. Vintsd, J. Mehegane, C. Dequatref and L. Castleg a

Valspar Corporation, Witney OX28 4XR, UK; bCreme Global, The Tower, Trinity Technology and Enterprise Campus, Dublin 2, Ireland; cFIG Consultant, Bristol BS6 6RJ, UK; dAmcor Flexibles Europe & Americas, B-9000 Ghent, Belgium; eSchool of Public Health, Physiotherapy and Population Science, University College, Dublin, Ireland; fINEOS Olefins & Polymers Europe, B-1120 Brussels, Belgium; gThe Food and Environment Research Agency, York YO41 1LZ, UK

Downloaded by [Selcuk Universitesi] at 11:54 20 January 2015

(Received 12 April 2013; accepted 29 October 2013) The approach used to obtain European Union-wide data on the usage and concentration of substances in different food packaging materials is described. Statistics were collected on pack sizes and market shares for the different materials used to package different food groups. The packaging materials covered were plastics (both flexible and rigid), metal containers, light metal packaging, paper and board, as well as the adhesives and inks used on them. An explanation as to how these data are linked in various ways in the FACET exposure modelling tool is given as well as an overview of the software along with examples of the intermediate tables of data. The example of bisphenol A (BPA), used in resins that may be incorporated into some coatings for canned foodstuffs, is used to illustrate how the data in FACET are combined to produce concentration distributions. Such concentration distributions are then linked probabilistically to the amounts of each food item consumed, as recorded in national food consumption survey diaries, in order to estimate exposure to packaging migrants. Estimates of exposure are at the level of the individual consumer and thus can be expressed for various percentiles of different populations and subpopulations covered by the national dietary surveys. Keywords: FACET; exposure; packaging; chemical migration; probabilistic modelling

Introduction This paper describes the development of the FACET exposure tool to assess chemical migrants from food packaging. The FACET project (Flavours, Additives and Food Contact Materials Exposure Task) was a 4-year project that was part-funded by DG-Research of the European Commission as part of its Framework FP7 Programme. The project ran from September 2008 to August 2012. FACET was coordinated by University College Dublin and it involved 20 research partners from across Europe, coming from academia, industry, research centres, and small to medium-sized enterprises. Hearty et al. (2011) provided an early overview of the project plan, while Oldring et al. (2009) provided an early view of specifically the part of the project plan that dealt with food packaging materials. As the name indicates, the FACET exposure tool provides a single platform with the functionality to estimate consumer exposure to three types of food chemicals, namely: food additives (E-numbers) chemically defined flavouring substances, and substances used to make food contact materials (FCMs). The FACET exposure tool is a computer-based desktop application. It is publicly available and free of charge (Joint Research Centre 2013). The software tool was developed and populated with data gathered throughout the course of *Corresponding author. Email: [email protected] © 2014 Taylor & Francis

the project, with the facility of uploading additional data available to the end-user. This paper describes how the information was gathered for FCMs and how the FACET tool was constructed from its component parts of databases and software. Chemical migration from packaging materials Most of the food sold in the European Union is packaged in order to prevent physical, chemical and microbiological spoilage during transport, distribution, handling and storage. Hundreds of different chemicals are needed to make today’s food packaging made of plastics, paper and board, coated and uncoated metals, etc., along with the inks, adhesives etc. needed to make finished materials and articles. These chemicals are known in the European Union as food contact substances (FCSs) and are used to make FCMs, which are all those materials and articles intended to come into contact with foodstuffs, including packaging materials but also cutlery, dishes, processing machines, containers etc. FACET deals only with exposure to migrants from food packaging materials, since this is by far the most important category of FCMs. When food touches the packaging, a mass transfer process of these chemicals into the food starts which leads to varying concentrations of these chemicals in the packed food. This

Food Additives & Contaminants: Part A process is called chemical migration and the FCSs involved are called “migrants” (Castle 2007). FACET does not have information on substances used to confer active or intelligent functions to food packaging, such as the deliberate release of food additives or flavouring substances, or substances used in time–temperature indicators.


Risk assessment of food contact substances (FCSs) The two general principles on which European legislation of food packaging materials are based are inertness and safety of the material (Schaefer 2010). These are also the guiding principles in most legislation worldwide. With respect to safety, this means simply that materials should not release their constituents in amounts that could endanger human health. Any risk posed by a chemical contaminant in food, irrespective of its source, is a combination of the toxicity of the substance (hazard) and how much of that substance is consumed via the diet (exposure): Risk ¼ function ½hazard exposure In turn, exposure equals the weight of food consumed multiplied by the concentration of the chemical in that food. Thus, to ensure the safety of food packaging, it is necessary to consider the toxicity of any migrating species (hazard evaluation), how much is present in the foodstuffs consumed (occurrence and concentration estimations), and how much of the affected foods are consumed (consumption estimation). Until recently, the main focus in the European Union of risk assessment of packaging was on the hazard assessment of the chemicals used. Exposure assessment leading to a risk assessment and consequent risk management measures (e.g., establishing specific migration limits or compositional limits) was a relatively crude exercise using a basic default scenario for the amount of packaged food consumed each day (Castle 2007). Approaches to assessing exposure to food contact substances (FCSs) An overview of obtaining estimates of exposure to migrants from FCMs is available (Oldring 2007). Pocas et al. (2007) reviewed the literature in 2007 and there is a comprehensive International Life Sciences Institute (ILSI) publication giving both principles and practical guidance for exposure estimates (Brands et al. 2007). In the absence of detailed information, the European Union has used a simple deterministic approach for assessing exposure to migrants from FCMs. This is based on a default scenario that an adult consumes 1 kg of foodstuff each day that is packaged in direct contact with 600 cm2 of material containing the substance of interest and that

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the material releases the substance at the highest concentration observed in worst-case migration tests. For many FCMs this is clearly a conservative model, but for some materials and some consumers, such as infants, it can lead to an underestimate of exposure. This simple model contrasts with the approach taken by the USFDA which uses packaging usage factors and foodtype factors to derive food consumption factors (CFs) to assess exposure. The CF describes the fraction of the daily diet expected to be in contact with specific packaging materials and represents the ratio of the weight of all food contacting a specific packaging material to the weight of all food packaged. To account for the variable nature of food contacting each food contact material, the USFDA has calculated food-type distribution factors (fT) for each packaging material to reflect the fraction of all food types (i.e., aqueous, acidic, alcoholic or fatty) contacting each material. Tables for both factors are supplied by the USFDA (2002). This information is then combined with concentration data (normally from migration studies) to obtain an exposure estimate, assuming a daily consumption of food and drink of 3 kg per person per day. This gives an estimated daily intake (EDI) for a substance per source of packaging. If there is more than one source, then the EDIs are combined to give a cumulative estimated daily intake (CEDI). Further details of the USFDA approach are available at Food and Drug Administration (2002). The USFDA approach of combining statistics on packaging composition and usage with data on food consumption has clear advantages, but adoption of such an approach in Europe has hitherto been hampered by a lack of data. Food consumption diaries have become an established methodology for assessing dietary exposure to chemicals in food in a variety of areas, e.g., pesticides, food additives and environmental contaminants. Whilst food consumption surveys in the European Union member states provide information on the type and quantity of foodstuffs consumed (to enable nutritional data to be extracted), few if any contain information on the packaging of the foodstuff that was consumed. In some cases, such as for Germany, Ireland and the UK, “canned” foodstuffs are identified and treated systematically because the heat treatment that the canned foodstuff undergoes, combined with the long shelf-life that canning affords, may change the nutritional parameters compared with the same foods which are, for example, fresh or frozen. But a systematic collection of information that covers all food packaging materials and substances has been lacking. It is beyond the scope of this paper to review all the efforts conducted in Europe to collect information on packaging usage, but a few key works merit highlighting. The first systematic collection of European data was by the market research organisation Maurice Palmer Associates which was contracted first by the UK


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Ministry of Agriculture Fisheries and Food (MAFF) in 1986 to prepare a database on materials used for food packaging in the UK (Maurice Palmer 1989) and subsequently contracted by DG-SANCO in the European Commission to do the same for several other European Union countries (Maurice Palmer 1993). That work was done mainly by shelf-audits, supplemented by interviews with major packaging suppliers. It covered information on the market shares (millions of units per annum) of the different packaging materials used including any coatings, the types of foods packed, pack sizes including surface area-to-weight ratios, etc. It did not have any information on the chemical composition of the materials. In a survey of packaging usage in the Netherlands, polyolefins (polyethylene at 34% and polypropylene at 27%) were found to account for the majority of the packaging used with polyvinylchloride, polystyrene, polyethylene terephthalate, and paper and board being the next most common forms of packaging for foodstuffs (Bouma et al. 2003). Researchers collected information at the household level in Porto, Portugal, on food packaging usage, relating to the type of package and packaging material with types of food and conditions of use. Data were used to estimate: (1) the CFs that describe the fraction of the daily diet expected to contact specific packaging materials; and (2) the food-type distribution factors that reflect the fraction of all food contacting each material in terms of its classification as aqueous, acidic, alcoholic or fatty (Pocas et al. 2009). In one of the most comprehensive surveys (Duffy, Hearty, Flynn et al. 2006; Duffy, Hearty, Gilsenan et al. 2006; Duffy et al. 2007), the actual items of food packaging were collected from the diets of Irish children aged 5–12 years, thereby becoming the first national food nutritional survey to identify and characterise the packaging of the food consumed. Similarly, the packaging of the foodstuffs consumed by UK children of different ages was collected, measured and identified for material type (Foster et al. 2010). Foster et al.’s approach was then extended to the packaging of foods consumed by students and the elderly (Delve et al. 2010). In these studies, no information on chemical composition was collected. Even knowing that the packaging is derived, e.g., from paper/board or from a particular polymer, may still be inadequate for a more refined exposure assessment. It may be adequate for assessing the exposure to the monomers of the polymer (e.g., polystyrene must be made using styrene monomer), but it does not necessarily help with exposure assessments to other chemicals that may be used in the material – unless the link between substances and materials can be made, i.e., occurrence (probability) and concentrations. FACET is the first pan-European coordinated approach to assessing what substances are in food packaging materials and at what concentrations, as well as what foods are packaged in

those materials and how much of that packaged food is consumed by each individual in 15 dietary intake surveys for eight European Union member states (Finland, France, Hungary, Ireland, Italy, Poland, Portugal and the UK).

Materials and methods General approach taken In order to determine the population distribution of exposure to packaging migrants the FACET tool uses a diary driven approach. For this we require (1) a diary of food consumption events; and (2) the concentration of packaging migrants in foods. The weight of all food items consumed can be obtained from dietary surveys. Much more complicated is deriving the concentration of the FCS in the different food items consumed. Except for a very few targeted substances (e.g., bisphenol A (BPA), phthalates, styrene, epoxidised soybean oil, mineral oils), there is not and there never will be sufficient food analysis data (e.g., from surveys) on all substances in all different food types or food items. Even the probability of the occurrence of the substance in each food item cannot be deduced from the food item description without reference to the packaging used for that food. Therefore, with reference to Figure 1, occurrence and concentration data in foods must be derived either using food simulant data or by migration modelling based on the composition of the packaging materials used. In the FACET tool, the user specifies the migrant and the population of interest. The basic form of the algorithm is as follows: (1) (2) (3) (4)

Choose the migrant of interest. Find all packaging that contains that migrant. Find all foods that are contained in that packaging. Calculate the concentration of migrant in those foods using the migration model. (5) Find all consumption events involving those foods and determine the exposure to the migrant at each eating event. (6) Collate exposures from each consumption event to give distribution of exposure to the migrant in the population. Again with reference to Figure 1, Table 1 describes how the data inputs are used in the algorithm. A mathematical model of the movement of a migrant from packaging materials into food has been developed that provides quantitative estimates of the concentration of migrants in food. The migration model itself is described in other publications on FACET (Seiler et al. Forthcoming 2013), but in order to run the model and determine exposure to migrants at each consumption event, the following need to be known:

Food Additives & Contaminants: Part A

Allocate food category


Database of substances used in packaging materials

Chemical present or not?

START HERE: Food diaries Items eaten

What was the food item packed in? Layer-bylayer description of how the materials are used to make packaging structures

Composition of materials – which of the substances are used and at what concentrations

Figure 1. FACET.

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Concentration of the substance in the food item as consumed

MIGRATION MODELLING

Direct conc. input in some cases, bypassing migration modelling

What are the conditions of use (time, temp etc.) that cause migration

Schematic illustration of how the data for migrants from food contact materials (FCMs) were obtained and used within

Table 1. Data inputs used in the algorithm. Data input Food consumption diary PASTA table

Industry source

Substance concentrations

Description and use in algorithm Deterministic record of food consumption, recoded into the FACET food categories. Food consumption is described at the eating event level, with a number of days of consumption reported per subject Market distribution of pack types at a retail level, recoded into the FACET food categories and including market shares measured by number of packs. Each pack type has a set of components, the weight of food in the pack, the contact ratio for each component and an industry sector responsible for its construction. For a given consumption event, the algorithm randomly assigns a pack type based on its market share Construction and market share of each packaging component in contact with the food, using the FACET food categories and FACET material codes. For each component, the number of layers, the materials used, the arrangement of the layers, the thicknesses of the layers and the time–temperature information for that component are provided. Market shares are described in m2 of packaging and the algorithm randomly assigns a component type based on this market share Description of the concentration of each substance in each material, described using the FACET material codes and statistical distributions. The distributions are constructed using data on the occurrence and tonnage provided by industry. The distributions are either empirical and based on raw data, triangular distributions for minimum– typical–maximum data, or uniform distributions for minimum–maximum ranges. Occurrence is described using a Bernoulli distribution, with a parameter to indicate the percentage of materials containing a substance. For each consumption event, a random sample of concentration is selected for each material and a concentration in food calculated using the migration model

● What packaging foods are packed in (pack types, shapes and sizes)? ● What makes up the pack types that foods are packed in (components, layers, thickness of layers and materials)? ● What are the time–temperature contact conditions between foods and FCMs during filling, storage and use? ● What substances are in the materials that make up the packaging (substance occurrence and concentration)?

● What migration parameters are appropriate for the combination of migrant/material/layer/component/ conditions (migration modelling information)?

The FACET Industry Group (FIG) The challenge for the packaging industry was to link the substances used to materials that were then converted and/ or combined to make food packaging (Figure 1). The FACET Industry Group (FIG) supplied information on

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Table 2. Membership of the FACET Industry Group (FIG). Association of European Producers of Steel for Packaging CEFIC Sector Group covering Food Contact Additives Confederation of European Paper Industries, which also includes CITPA (International Confederation of Paper and Board Converters) CEPE European Council of the Paint, Printing Ink and Artists Colours Industry, which also includes EUPIA (European Printing Ink Association – a sector of CEPE EAA European Aluminium Association EMPAC European Metal Packaging Association EuPC European Plastics Converters Association EWF European Wax Federation FDE FoodDrinkEurope FEICA Association of European adhesives and sealants manufacturers FPE Flexible Packaging Europe PlasticsEurope Association of Plastics Manufacturers in Europe


APEAL CEFIC-FCA CEPI

substances, materials and packaging construction. It covered the following sectors involved in food packaging: plastics; paper and board; light metal packaging; aluminium containers; additives; inks (covering inks, varnishes and coatings used in the printing process); adhesives and waxes. Both the producers of the materials and their converters were represented. In the example of paper and board this was the Confederation of European Paper Industries (CEPI) for the papermakers assisted by the International Confederation of Paper and Board Converters in Europe (CITPA) for the paper converters. The food industry was also included in FIG, represented by FoodDrinkEurope (known as CIAA until 2011). The members of FIG are shown in Table 2. Allocation of food category Since the FACET tool uses a diary-driven approach, starting at the food consumption event box shown in Figure 1, a sequence of steps is necessary to decide if the chemical of interest may be present in that food and at what concentration. The first action was to decide on a food coding system that suited packaging migration. The National Food Survey diaries contained, for each eating event by each consumer, a description and quantity of each foodstuff consumed over the duration of the survey. But each of the national dietary surveys held as databases in the FACET tool were coded using a different coding system unique to that country. So the national food consumption database managers from the eight member states recoded their food consumption data according to a harmonised tiered categorisation system. The following national food consumption databases are included in FACET: ● ● ● ● ●

UK NDNS 1992 1–4. UK NDNS 1997 4–18. UK NDNS 2000 19–64. UK NDNS 1995 Over 65. Finnish FINDIET Survey 2007b.

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Finnish FINDIET Survey 2007c. Finnish FINDIET Survey 2007d. France INCA 2 2005–2007. Hungarian Third Nutrition Survey 2003–2004. Irish National Children’s Food Survey 2003. Irish North/South Ireland Food Consumption Survey 1999. Irish National Teens Food Survey 2005–2006. Italy INRAN SCAI 2005. Polish Household Survey 2000. Portuguese EpiPorto 2003.

These detailed National food consumption statistics, at the level of the individual consumer, are confidential, and although they are contained within the FACET tool and are used by it, the individual statistics cannot be examined or extracted. By developing a harmonised database of food packaging composition data linked to these diaries, the exposure algorithms present a rational methodology for assessing dietary exposure to food packaging migrants based on real market data and conditions. The FACET food packaging codes were at three levels (tiers). Tier 1 has 18 broad food categories. Here the categories were the same for flavours, food additives and packaging, but at Tiers 2 and 3 the coding for the three chemical groups in FACET deviated to suit the special requirements of each. Thus, Tiers 2 and 3 were packaging specific. Tier 2 contains 56 categories and Tier 3 has 172 food categories, i.e., the highest level of detail. Table 3 contains the different food item codes and a brief description of each of the three tiers into which the national database managers recoded. Not all of these 172 categories at Tier 3 were used in practice, but at the outset of the project this was unknown.

Database of food contact substances (FCSs) The starting point for the database of FCSs was the existing publically available inventory lists for each material

04. Vegetables, starchy roots, legumes and seaweeds

03. Fruits, nuts and seeds

02. Fats and oils and fat emulsions

01. Dairy products and analogues

Tier 1

Table 3. FACET three-tier food codes for packaging.

P.04.3. Frozen vegetables P.04.4. Dried vegetables

P.04.2. Processed vegetables

P.03.4. Nut-based spreads P.04.1. Fresh vegetables

P.03.3. Nuts and seeds

P.03.1. Fresh fruit P.03.2. Processed fruit

P.02.2. Liquid oils

P.02.1. Solid fats

P.01.2. Cheese

P.01.1. Milk, cream, dairy drinks and soy equivalents

Tier 2


P.01.1.1. P.01.1.2. P.01.1.3. P.01.1.4. P.01.1.5. P.01.1.6. P.01.1.7. P.01.1.8. P.01.2.1. P.01.2.2. P.02.1.1. P.02.1.2. P.02.1.3. P.02.1.4. P.02.2.1. P.02.2.2. P.03.1.1. P.03.2.1. P.03.2.2. P.03.2.3. P.03.2.4. P.03.2.5. P.03.3.1. P.03.3.2. P.03.3.3. P.03.4.1. P.04.1.1. P.04.1.2. P.04.1.3. P.04.2.1. P.04.2.2. P.04.2.3. P.04.2.4. P.04.2.5. P.04.2.6. P.04.3.1. P.04.4.1. P.04.4.2.

(continued )

Liquid milk Flavoured milk drinks Drinking yoghurt Sour milk drinks Soy beverages Condensed/evaporated milk Powdered milk Cream Processed cheese Unprocessed cheese Butter Cooking margarine Spreadable oils and fats Cooking fats Olive oil Vegetable and seed oil Fresh fruit whole or cut Fruit snacks Fruit, nut, trailmixes Jams and fruit preserves Canned/preserved fruit Frozen fruits or fruit pastes Seeds Dried nuts Nuts Nut-based spreads Fresh vegetables Fresh salads Potatoes Preserved vegetables no sauces Canned/preserved tomatoes Canned beans and pulses Tomato paste/purees Pasta sauces (tomato based) Pickled vegetables Frozen vegetables and potatoes Dried potato powder Other dried vegetables

Tier 3

Food Additives & Contaminants: Part A 449

08. Meat and meat products

07. Bread and bakery wares

06. Cereals and cereal products

05. Chocolate products and confectionery

Tier 1

Table 3. Continued .

Breakfast cereals Cereal bars Flour and starches Rice and other cereal grains

P.08.3. Frozen meat and meat products

P.08.1. Fresh meat P.08.2. Processed meat products

P.07.3. Sweet biscuits P.07.4. Pastries, cakes and other bakery

P.07.1. Dough P.07.2. Bread and bread substitutes

P.06.5. Pasta/noodles

P.06.1. P.06.2. P.06.3. P.06.4.

P.05.3. Chocolate spreads and syrups

P.05.2. Chocolate confectionery

P.05.1. Sugar confectionery

Tier 2


P.05.1.1. P.05.1.2. P.05.2.1. P.05.2.2. P.05.2.3. P.05.2.4. P.05.2.5. P.05.2.6. P.05.3.1. P.05.3.2. P.06.1.1. P.06.2.1. P.06.3.1. P.06.4.1. P.06.4.2. P.06.4.3. P.06.5.1. P.06.5.2. P.06.5.3. P.06.5.4. P.06.5.5. P.07.1.1. P.07.2.1. P.07.2.2. P.07.2.3. P.07.2.4. P.07.3.1. P.07.4.1. P.07.4.2. P.07.4.3. P.07.4.4. P.07.4.5. P.07.4.6. P.08.1.1. P.08.2.1. P.08.2.2. P.08.2.3. P.08.3.1. P.08.3.2.

(continued )

Sugar confectionery Gum Countlines Chocolate tablets Bagged chocolates Boxed chocolates Seasonal chocolate Chocolate with toys Chocolate syrups Chocolate spreads Breakfast cereals Snack bars Flour and starches Dry and ready-to-eat rice Polenta Other cereal grains Dry pasta Fresh pasta Dried noodles Chilled noodles Frozen noodles Dough Bread Chilled bakery products Bread substitutes Frozen bakery products Sweet biscuits Pastries Fruit pies Cakes Pancakes Frozen sweet bakery wares Chilled snacks Fresh meat Processed meat and m-products Coated meat and m-products Preserved meat and m-products Unprocessed. frozen meat and m-products Frozen meat substitutes

Tier 3

450 P.K.T. Oldring et al.

13. Nutritional foodstuffs

12. Salt, spices, herbs, sauces and soups

10. Eggs and egg products 11. Sweeteners and honey

09. Fish and fish products, molluscs, crustaceans and echinoderms

Tier 1


P.13.3. Other nutritional foodstuffs

P.13.2. Other baby food

P.12.4. Yeast P.13.1. Dry baby food

P.12.3. Herbs, spices and salt

P.12.2. Industrial soup

P.12.1. Sauces, dressings and condiments

P.11.2. Honey, syrups etc.

P.10.1. Eggs P.11.1. Sugar

P.09.3. Frozen fish and seafood

P.09.1. Fresh fish and seafood P.09.2. Processed fish and seafood

Tier 2


(continued )

P.09.1.1. Chilled fish/seafood P.09.2.1. Chilled processed fish P.09.2.2. Chilled coated fish P.09.2.3. Chilled smoked fish P.09.2.4. Preserved fish/seafood no sauce P.09.2.5. Pickled fish and seafood P.09.3.1. Unprocessed. frozen fish or seafood P.09.3.2. Frozen coated fish/seafood P.10.1.1. Eggs P.11.1.1. Sugar P.11.1.2. Artificial sweeteners P.11.2.1. Honey P.11.2.2. Ice cream toppings and desserts etc. P.12.1.01. Mayonnaise P.12.1.02. Vinaigrettes P.12.1.03. Salad dressings P.12.1.04. Ketchup P.12.1.05. Mustard P.12.1.06. Vinegar P.12.1.07. Soy-based sauces P.12.1.08. Table sauces P.12.1.09. Pasta sauces P.12.1.10. Wet sauces P.12.1.11. Dips P.12.1.12. Liquid stocks and fonds P.12.1.13. Gravy granules/sauce powders P.12.1.14. Bouillon/stock cubes and powders P.12.1.15. Other sauces, dressings etc. P.12.2.1. Frozen soup P.12.2.2. Fresh soup P.12.2.3. UHT soup P.12.2.4. Canned/preserved soup P.12.2.5. Dehydrated soup P.12.2.6. Instant soup P.12.2.7. Hot vended soup P.12.3.1. Herbs and spices P.12.3.2. Salt P.12.4.1. Yeast P.13.1.1. Infant milk formula P.13.1.2. Dried baby food P.13.2.1. Prepared baby food P.13.2.2. Other baby food P.13.3.1. Other nutritional foodstuffs

Tier 3

Food Additives & Contaminants: Part A 451

16. Ready-to-eat savouries

17. Desserts (except bakery and fruit desserts)

P.15.2. Wine P.15.3. Spirits P.16.1. Savoury biscuits and pretzels

P.17.3. Dry dessert mixes

P.17.2. Ice creams etc.

P.17.1. Yoghurt and desserts

P.16.2. Crisps and snacks

P.15.1. Beers, ciders, lagers and flavoured alcoholic beverages

P.14.3. Hot non-alcoholic beverages

P.14.2. Cold non-alcoholic beverages

P.14.1. Water

Tier 2

15. Alcoholic beverages

14. Non-alcoholic beverages (except dairy beverages)

Tier 1



P.14.1.1. P.14.1.2. P.14.2.1. P.14.2.2. P.14.2.3. P.14.2.4. P.14.2.5. P.14.2.6. P.14.2.7. P.14.3.1. P.14.3.2. P.14.3.3. P.14.3.4. P.14.3.5. P.15.1.1. P.15.1.2. P.15.1.3. P.15.2.1. P.15.3.1. P.16.1.1. P.16.1.2. P.16.2.1. P.16.2.2. P.16.2.3. P.16.2.4. P.17.1.1. P.17.1.2. P.17.1.3. P.17.2.1. P.17.2.2. P.17.2.3. P.17.3.1.

(continued )

Tap water Packaged water Carbonates Juices Functional drinks Liquid concentrates Powder concentrates (cold) Ready-to-drink pre-packed coffee Ready-to-drink pre-packed tea Dry coffee Dry tea Other hot drinks powders Flavoured powder milk drinks Hot vended beverages Beer Cider Flavoured alcoholic beverages Wine Spirits Savoury biscuits and crackers Pretzels Popcorn Chips/crisps Extruded snacks Tortilla/corn chips Spoonable yoghurt Chilled and shelf stable desserts Fromage frais and quark Impulse ice cream Take home ice cream Frozen yoghurt Dessert mixes

Tier 3

452 P.K.T. Oldring et al.

P.18.5. Ready meals

P.18.4. Pasta, noodle and rice dishes

P.18.1.1. Dressed salads P.18.2.1. Sandwiches P.18.3.1. Frozen pizza P.18.3.2. Chilled pizza P.18.3.3. Hot pizza P.18.4.1. Instant noodles P.18.4.2. Canned/preserved pasta P.18.4.3. Dried ready meals P.18.4.4. Hot pasta, noodle and rice dishes P.18.5.01. Frozen ready meals P.18.5.02. Frozen proc. red meat and poultry P.18.5.03. Frozen processed fish/seafood P.18.5.04. Other processed frozen food P.18.5.05. Dinner mixes P.18.5.06. Canned/preserved ready meals P.18.5.07. Preserved fish/seafood plus sauce P.18.5.08. Chilled ready meals P.18.5.09. Chilled lunch kit P.18.5.10. Meat pies and quiches P.18.5.11. Hot meals 18. Composite foods

Tier 1


P.18.1. Dressed salads P.18.2. Sandwiches P.18.3. Pizza

Tier 2


Tier 3


453

sector group, such as the EuPIA list for ink substances, Technical Document #1 of CoE Resolution AP 2005/1 for substances used in coatings, Regulation (EU) No. 10/2011 for plastics, BfR Recommendation 36 for paper/board, etc. (EFSA 2012). In total, after removing duplicates and synonyms etc., 6475 substances are listed in the substance database in FACET. The majority are unique (discrete) substances, but a significant number are defined or non-defined mixtures or even generic descriptions into which others could be fitted. Not all of these substances are actually used as some of the inventory lists are historical and industry is reluctant to remove substances from lists drawn up by authorities or recognised bodies. The company Decernis (http://www.decernis.com), which has global regulatory databases, checked the industry lists and removed duplicate entries. The database is also linked, by reference, to the DG-SANCO database covering European Union-regulated FCSs (DG-SANCO 2013). The database contains synonyms, CAS number, molecular formulae and other features to aid searching. Most importantly, the physicochemical parameters of the substances are provided since they are required for migration modelling. A total of 3167 of the listed substances have log Po/w (log of the octanol–water partition coefficient, a measure of lipophilicity) and a molecular weight entered. A reason for the incomplete list of parameters for migration modelling is that in many cases the substance descriptions are too imprecise (see above). In the operation of the model, if a substance is selected that does not have any preloaded parameters for migration modelling, then the user is informed and has the opportunity to enter their own parameters. These modelling parameters are not required when concentration data in foods are entered directly, as the migration modelling is then bypassed. Chemical composition of packaging materials It was necessary to agree a material coding system so that the FCSs could be allocated to the materials in which they occur, either as additives or as residues of reactive starting substances. The FIG agreed on material codes (207 in total) that best described the packaging market and for which they could obtain data from their membership on composition and concentrations. These codes with their packaging industry inputs would then be the basis for linking with other data. These material codes are given in Table 4. It should be noted that ink material codes (code #21) were more than 200 in total and lacquer/over-varnish codes (code #27) were 19 in total. For brevity, not all have been included in Table 4. Those codes reflect not only the printing process used (e.g., flexo or gravure) and the chemistry of the inks (e.g., nitrocellulose (NC) based or polyvinylbutyrate (PVB) based), but also the substrate that


454


Table 4. Material codes used in FACET.


Material codes used in FACET


01. Not known 02. Metal 02.1. Aluminium 02.1.1. Alloy series 1XXX 02.1.2. Alloy series 3XXX 02.1.3. Alloy series 4XXX 02.1.4. Alloy series 5XXX 02.1.5. Alloy series 6XXX 02.1.6. Alloy series 8XXX 02.2. Steel 02.3. Tin 03. Paper/board 03.1. Case materials 03.1.1. Kraftliner 03.1.1.1. Unbleached Kraftliner 03.1.1.2. White top plus other Kraftliner 03.1.2. Recycled liners 03.1.2.1. Testliner 03.1.2.2. Other recycled liners 03.1.3. Flutings 03.1.3.1. Semi-chemical fluting 03.1.3.2. Recycled fluting (Wellenstoff) 03.2. Carton board 03.2.1. Solid bleached board (SBB or SBS or GZ) 03.2.2. Solid unbleached board (SUB or SUS) 03.2.3. Folding box board (FBB or GC2) 03.2.4. White lined chipboard (WLC or GD2/3) 03.3. Wrapping paper 03.3.1. Sack Kraft 03.3.1.1. Unbleached sack Kraft 03.3.1.2. Bleached plus other sack Kraft 03.3.2. Wrapping Kraft 03.3.2.1. Unbleached wrapping Kraft 03.3.2.2. Bleached plus other wrapping Kraft 03.3.3. Other wrapping paper and packaging 03.3.3.1. Glazed transparent/translucent papers 03.3.3.2. Glassine papers 03.3.3.3. Vegetable parchment 03.3.3.4. Recycled paper bags (imitation Kraft) 03.3.3.5. Other 03.4. Other paper and board for packaging 03.4.1. Moulded egg boxes 03.4.2. Coreboard for tubes 03.4.3. Other 03.5. Special paper and board (non-packaging) 03.5.1. Filter paper 03.5.2. Baking paper 03.5.3. Long fibre paper 03.5.4. Other special paper and board 04. RCF 05. Other non-plastic 05.1. Glass 05.2. Other non-plastic 06. PE 06.1. HDPE ± MB additives 06.1.1. HDPE without MB additives 06.1.2. HDPE with MB additives 06.2. LDPE ± MB additives 06.2.1. LDPE without MB additives 06.2.2. LDPE with MB additives

06.3. VLLD or LLD ± MB additives 06.3.1. VLLD or LLD without MB additives 06.3.2. VLLD or LLD with MB additives 06.4. Unspecified PE ± MB additives 06.4.1. Unspecified PE without MB additives 06.4.2. Unspecified PE with MB additives 07. EVOH 08. Ionomer 09. OPP unspecified 09.1. OPP voided 09.2. OPP not voided 10. Other PP 11. Polyamide 11.1. OPA 11.2. PA (cast) 12. PC 13. oPET 13.1. Plain oPET 13.2. Other/unknown oPET 14. Other PET 14.1. APET 14.2. CPET 14.3. PETG 15. PS 15.1. Non-expanded PS 15.2. EPS 16. PVC 16.1. Plasticised PVC 16.2. Non-plasticised PVC 17. PVdC (film/resins) 18. PLA and other biopolymer based 19. Other plastic 19.1. Extrusion tie layers 19.2. Other plastics, not tie layers 19.2.1. PBT 19.2.2. PEN 19.2.3. Melamine 19.2.4. SBS 19.2.5. Silicones 19.2.6. PMMA 19.2.7. SAN 19.2.8. ABS 20. Masterbatches and additives added by converters 20.1. Colorant 20.1.1. Organic 20.1.1.1. Organic pigments 20.1.1.2. Organic dyes 20.1.2. Inorganic 20.1.2.1. White 20.1.2.2. Black 20.1.2.3. Others 20.2. Antioxidant 20.2.1. Phenolic 20.2.2. Phosphate based 20.3. Anti UV 20.4. Slipping agent 20.5. Antifog 20.6. Antistatic 20.6.1. GMS/GML/GMO 20.6.2. Ethoxylated amines

(continued )

(continued )


Food Additives & Contaminants: Part A Table 4. Continued .




20.6.3. Other 20.7. Antiblock 20.8. Plasticiser 20.8.1. Adipates 20.8.2. Citrates 20.8.3. Phosphates 20.8.4. ESBO 20.8.5. Others 20. 9. Fillers 20.10. Other 21. Printing ink 21.1. Solvent-based ink 21.1.1. Flexo ink 21.1.1.1. NC-based flexo 21.1.1.2. PVB-based flexo 21.1.1.3. Two-component flexo 21.1.1.4. Other flexo 21.1.2. Gravure ink 21.1.2.1. NC-based gravure 21.1.2.2. PVB-based gravure 21.1.2.3. PVC-based gravure 21.1.2.4. Two-component gravure 21.1.2.5. Other gravure 21.2. Water-based ink 21.2.1. Water-based flexo 21.2.2. Water-based gravure 21.3. Energy curable ink 21.3.1. UV ink 21.4. Direct food contact ink 21.5. Oleo-resinous (litho/offset) 21.6. Ink-jet 21.7. Other ink 22. Release coating 22.1. NC- plus PA-based release 22.2. Other release coating 23. Coldseal coating 23.1. Natural latex-based Coldseal 23.2. Synthetic latex-based Coldseal 24. Wax/hotmelt coating 25. Heat sealable coating 25.1. PVdC-based HSC 25.2. PVC-based HSC 25.3. Epoxy-based HSC 25.4. Polyester-based HSC 25.5. PET-melamine-based HSC 25.6. Styrene copolymer-based HSC 25.7. Acrylic-based HSC 25.8. Acid/ester copolymer-based HSC 26. Primer 26.1. Ink primer 26.2.1. Other primer, solvent based 26.2.2. Other primer, water based 27.1. Non-curing lacquer 27.1.1. Solvent-based lacquer 27.1.2. Water-based lacquer 27.2. Chemically curing lacquer 27.3. Heat-set lacquer 27.4. UV-cured lacquer 27.5. EB-cured lacquer 28. Barrier coating (organic)

28.1. PVOH based 28.2. PVdC based 28.3. EVOH based 28.4. Other barrier coating 29. Other organic coating 29.1. Foil lubricants 29.2. Antifog coating 29.3. Acrylic-based water resistant 30. Colorants and additives for coatings 31. Unspecified organic coating 32. Inorganic coating 33. Metallisation 33.1. Metallisation on PET 33.2. Metallisation on OPP 33.3. Metallisation on OPA 33.4. Metallisation on PVC 33.5. Metallisation on Paper 33.6. Metallisation on PE or PP 34. Adhesive 34.1. Reactive adhesive 34.1.1. Epoxy/amine adhesive 34.1.2. Polyurethane adhesive 34.1.2.1. Aromatic PU adhesive 34.1.2.2. Aliphatic PU adhesive 34.1.3. Acrylic adhesive 34.1.4. Other reactive adhesive 34.2. Natural polymer-based adhesive 34.2.1. Vegetable adhesive 34.2.2. Protein adhesive 34.2.3. Other natural polymer-based adhesive 34.3.1. Vinyl acetate polymers (PVAc) 34.3.2. Acrylics and acrylic copolymers 34.3.3. Styrene-butadiene rubber (SBR) 34.3.4. Other synthetic rubber latices 34.3.5. Natural rubber latex 34.3.6. Polyvinyl alcohol 34.3.7. Other water borne adhesives 34.4. UV-cured adhesive 34.5. HotMelt adhesive 34.5.1. Polyolefin (PE, PP, APP) 34.5.2. Ethylene vinyl acetate (EVA) 34.5.3. Polyamide (PA) 34.5.4. Polyester, saturated (SP) 34.5.5. Styrene block copolymers 34.5.6. Acrylic and acrylic copolymers 34.5.7. Other hotmelt adhesive 35. Wax 36. All other adhesives 37. Can coatings 37.1. Epoxy 37.1.1. Phenolic 37.1.2. Anhydride 37.1.3. Amino 37.1.3.1. Amino bev 37.1.3.2. Amino food 37.1.4. Acrylate 37.1.4.1. Acrylate bev 37.1.4.2. Acrylate food 37.1.5. Other 37.2. PVC (continued )

(continued )

455

456




Material codes used in FACET 37.2.1. Epoxy containing 37.2.2. Other 37.3. Polyester 37.3.1. Phenolic 37.3.2. Amino 37.3.3. Polyurethane 37.3.4. Other 37.4. Acrylic 37.5. Other 37.5.1. Polymer coated 38. Can sealants 38.1. Rubber based 38.2. Latex based 38.3. Other 39. Metal closure compounds 39.1. PVC plastisol 39.2. Polyolefin 40. Closure wads 40.1. Polyester 40.2. Other

was intended to be printed and if the ink was intended either as an intermediate layer between two other layers, as an external layer, or below a varnish. These permutations were included since the exact application could influence the substances used and their concentrations in the ink formulation. In practice, not all of this coding detail was used. In some cases, such as the manufacturers of plastics, the monomers and additives in the plastic were known to that sector group. In other cases, such as converters, the sector group had hardly any information at all the substances involved. Companies supplying formulations of two or more substances to converters generally had an intermediate level of knowledge on the detailed composition of their products. This problem was resolved in various ways. Some associations (e.g., EuPIA for inks, FEICA for adhesives and CEPE for coatings) compiled anonymous and confidential lists of raw materials that they used in their formulations and the associations representing the suppliers (e.g., Cefic-FCA for additives) compiled lists of all substances which could be present in that sector’s raw materials. When known to the material supplier, the occurrence (yes/no) and concentration data for each substance were reported to Creme Global (hereafter called Creme) using confidential processes as well as the market shares that each company had for a material or substance. In instances where migration modelling was not used, such as can coatings, a range for the extraction levels of the substance into solvents or food simulants (units of mg dm–2) was reported. A worked example is given in Oldring et al. (2013) for BPA.

Combining food packaging materials with substances used Industry (FIG) purchased food packaging data for 21 European countries (namely Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Turkey and the UK for pre-packaged food and the same countries except Slovakia for packaging used for fresh foods) for 2005 from Euromonitor International (hereafter Euromonitor). The Euromonitor data are proprietary and although they are contained within the FACET tool and are used by it, the raw Euromonitor data cannot be examined or extracted. Although 2005 may seem to be “old” data, none of the food consumption surveys used in FACET is more recent. Indeed, many are significantly before 2005. FACET has a user group and one of its main tasks will be the continuing refresh of the exposure tool by including new food consumption surveys as they become available. These Euromonitor data on packaging usage were used exclusively. Although some national food consumptions surveys do collect information on pack types (as discussed above), this information is very patchy, being only limited (e.g., just metal cans) for some countries and completely lacking for most countries. It is necessary to know which FCMs contain the substance of interest and what foodstuffs could be packaged in that FCM. In addition, it is necessary to know the concentration of the FCSs in either the material to enable migration modelling or the foodstuff or food simulant for direct input. The FIG obtained data that were never previously available throughout the supply chain. Due to anticartel and proprietary information, these data are not available to anyone other than Creme (the software supplier for the FACET project). These data were then encrypted for use in the FACET Tool. Linking food codes with packaging codes The Euromonitor data include food item, size of pack, pack type, type of closure and number of packs of each size. This enables market shares by number of packs to be derived. For complex packs (e.g., a bag of biscuits inside a folding carton), “primary” and “secondary” descriptions enabled the identification of those components actually in direct contact with the food. Surface area-to-weight ratios (cm2 g–1) were calculated from the pack sizes and shapes. It was necessary to agree on some packaging definitions that could be used to link Euromonitor statistics with the data obtained by industry. In FACET, packaging is decomposed in a very specific way. The following terms are very important and have specific meanings in the FACET tool: ● Pack type: This is a basic description used by Euromonitor of what a food is packaged in.


Food Additives & Contaminants: Part A Examples are plastic bottle, aluminium tray/foil, canned/tinned, and paper/board rigid box. ● Pack components: These are used in the FACET project to describe the pack types in more detail. There are four possible categories of components: ● Mainpack: This part provides the majority of the contact with the food. ● Closure, e.g., a cap, lid or sealed membrane. The opening ends of food cans are counted within this category. ● Outer pack, e.g. a carton that holds an open tray, or a flexible overwrap of an unlidded tray. This may have some potential contact with the food. ● Insert: This is a sheet that can either act as a base for the pack (e.g., the base board found in many smoked salmon pouches), the drip pad (sometimes used under meat and fish products) or can act as interleaving between layers of the food (e.g., sheets of film separating slices of cheese or cured meats, glassine sheets in a box of chocolates). There may be multiple inserts per pack. Table 5 shows the possible individual component types within each category ● Component type: Each pack component is of a given type, e.g. a Mainpack may have the component type plastic bottle and a closure may have the

457

component type plastic screw thread, which would then be: M: Plastic bottle; C: Plastic screw thread. ● Component structures: Each component type can be of more than one possible construction. An example is a 500 ml bottle with many different lid types – it is one pack type, with two pack components, with the lid component having several possible component structures. The distribution of these component structures for a given component comes from data collected by the relevant packaging industry sector. ● Materials: Each component structure can be in turn made of a layer or layers of materials. All materials in FACET are predefined and have a specific material code, acting as a unique identifier for each material. The number, order and thickness of each layer are crucial in defining each component structure. ● Migrants: Finally, each material can contain a number of potential migrants. Migrant (or FCSs) occurrence and concentration data were collected by each packaging industry sector. Each sector represented in the FIG “sense checked” the Euromonitor data to ensure that the data collection method and definitions etc. were correctly interpreted and that the conclusions drawn were reliable. In some cases two associations were involved. These data were then used further as this section explains.

Table 5. Packaging material components. Mains Aerosol can Aluminium container/tray Beverage can Blister/strip Brick shaped beverage carton Carton/case Flexible wrapper/bag/pouch Food can Gable top beverage carton Glass bottle Glass jar Metal collapsible tube Metal other Other beverage carton Other packaging Other rigid plastic Paper/board based tub or tube Paper-based tray Plastic bottle Plastic collapsible tube Plastic jar Plastic tray/pot/tub/cup Outer packs Carton/case Flexible wrapper/bag/pouch Metal other Other rigid plastic

Closures Aluminium roll on Blisterfoil Classic Cork Crimped aluminium Crown closure Easy open Glass Metal twist/lever Other closure Overcap Plastic other Plastic screw thread Plastic snap on lidding Pourer/spout Sealed lidding/membrane Unknown cap Beverage ends Unknown closure

Inserts Drip pad Other sheet Total inserts

The PASTA table One of the most important data sets in the FACET project is the Pack Size Type and Association (or PASTA) table. This connects a food type to its packaging components and is based on the commercial market research performed by Euromonitor. The PASTA table provides the following information: ● Market share distribution of pack types for a given food. ● Amount of food contained in that pack. ● Pack components for those pack types (i.e., main, closure, outer and insert). ● Contact ratio for each of those components. ● Industry association responsible for the construction of those particular components. An outline of the structure of the PASTA table can be seen in Figure 2 (note that the figures are fictitious and the actual table provides far more detail than this). The last piece of information provided by the table (the industry source) is crucially important. For a given food in a given pack type, the information provided by the appropriate industry sector for the structure of that particular component is used for the next link in the chain.

458


Figure 2.


The PASTA table.

Component structure tables Component structure tables provided by each industry sector give the following information: ● FACET Food Code for packaging. ● Component type (e.g., sealed lidding, flexible bag etc.). ● A description of the layers of the component structure, providing: ● FACET material code. ● Thickness of each layer. ● Conditions of use, i.e. time and temperature information for that component. ● Volume (i.e., distribution) for each food/structure combination. Note that the FACET Food Code is still required at this stage. This connection to food is crucially important and

cannot be ignored. For example, a particular closure construction for a container may be used across many different foods, but for each of the foods and each pack structure the market share may be different – we cannot simply have a single market share across all foods for that closure construction. From a data-gathering point of view, this link in the chain is the greatest possible source of data gaps. Different industry sectors may be responsible for the collection of component structure information for the same component, requiring a “breakdown-by-sector” factor to account for this. The FACET tool has an extensive treatment of uncertainties and these are declared as part of the output of exposure estimates. Figure 3 shows how the link is made from the PASTA table to the appropriate component structure table, using a simplified Flexible Plastics Europe (FPE) table as an example.

FPE Food Tier

Figure 3.

Linking the PASTA table to a component structure table.

Component

Structure Freq.

P.08.1.1 Sealed Lidding Fresh Meat

PET/ PE

P.08.1.1 Flexible Fresh Meat

oPA/ PE

Food Additives & Contaminants: Part A Food


Figure 4.

P.16.2.2

Component Type Flexible

Layer 1

Layer 2

2 µm Ink

30 µm OPP

P.08.1.1

Sealed Lidding

12 µm OPET

P.08.1.1

Flexible

15 µm OPA

3 µm Adhesive 4.5 µm Adhesive

Table 6. Pack types used in FACET.

PT1 PT2 PT3 PT4 PT5 PT6 PT7 PT8 PT9 PT10 PT11 PT12 PT13 PT14 PT15 PT16 PT17 PT18 PT19 PT20 PT21 PT22 PT23 PT24 PT25 PT26 PT27 PT28 PT29

50 µm LDPE 70 µm PP

Regime 1 23 °C for 13 weeks 5 °C for 6 days 5 °C for 1 month

Regime 2

23 °C for 8 hours 100 °C for 30 mins

Layer information from FPE (Flexible Plastics Europe) for the component type for particular foods.

In slightly more detail, a component structure table looks like Figure 4, again taking fictitious FPE data as an example and only a two- or three-layer structure. It should be borne in mind that some structures can have seven or more layers. The time–temperature regimes are standardised to cover typical use conditions, since the actual and exact time and temperature conditions are not, of course, known for each and every food pack. Creme linked the information supplied by industry into a pack type (PT coding system), which is shown in Table 6 for all the combinations, but it should be noted

Pack code

Layer 3

459

Pack type description used in FACET M: Aerosol can M: Aerosol can, C: Overcap M: Aerosol can, C: Plastic other M: Aluminium container/tray M: Aluminium container/tray, O: Carton/case M: Aluminium container/tray, C: Other closure M: Aluminium container/tray, C: Sealed lidding/ membrane M: Beverage can M: Beverage can, C: Aluminium roll on M: Beverage can, C: Crown closure M: Beverage can, C: Overcap M: Beverage can, C: Sealed lidding/membrane M: Blister/strip, C: Blisterfoil M: Brick shaped beverage carton M: Brick shaped beverage carton, C: Pourer/spout M: Carton/case M: Flexible wrapper/bag/pouch M: Flexible wrapper/bag/pouch, C: Plastic screw thread M: Food can M: Food can, C: Classic M: Food can, C: Easy open M: Food can, C: Metal twist/lever M: Food can, C: Other closure M: Food can, C: Overcap M: Food can, C: Plastic other M: Food can, C: Plastic screw thread M: Food can, C: Plastic snap on lidding M: Food can, C: Sealed lidding/membrane M: Gable top beverage carton (continued )

Table 6. Continued . Pack code PT30 PT31 PT32 PT33 PT34 PT35 PT36 PT37 PT38 PT39 PT40 PT41 PT42 PT43 PT44 PT45 PT46 PT47 PT48 PT49 PT50 PT51 PT52 PT53 PT54 PT55 PT56 PT57 PT58 PT59 PT60 PT61 PT62 PT63 PT64 PT65 PT66 PT67 PT68 PT69 PT70 PT71 PT72 PT73 PT74

Pack type description used in FACET M: Gable top beverage carton, C: Pourer/spout M: Glass bottle, C: Aluminium roll on M: Glass bottle, C: Cork M: Glass bottle, C: Crimped aluminium M: Glass bottle, C: Crown closure M: Glass bottle, C: Metal twist/lever M: Glass bottle, C: Other closure M: Glass bottle, C: Plastic other M: Glass bottle, C: Plastic screw thread M: Glass bottle, C: Unknown cap M: Glass jar, C: Glass M: Glass jar, C: Metal twist/lever M: Glass jar, C: Other closure M: Glass jar, C: Plastic other M: Glass jar, C: Plastic screw thread M: Glass jar, C: Plastic snap on lidding M: Glass jar, C: Sealed lidding/membrane M: Glass jar, C: Unknown cap M: Metal collapsible tube, C: Plastic screw thread M: Metal other, C: Aluminium roll on M: Metal other, C: Easy open M: Metal other, C: Other closure M: Metal other, C: Overcap M: Metal other, C: Plastic screw thread M: Metal other, C: Sealed lidding/membrane M: Other beverage carton M: Other beverage carton, C: Pourer/spout M: Other packaging M: Other packaging, C: Other closure M: Other packaging, C: Sealed lidding/membrane M: Other rigid plastic M: Other rigid plastic, C: Other closure M: Other rigid plastic, C: Overcap M: Other rigid plastic, C: Plastic other M: Other rigid plastic, C: Plastic screw thread M: Other rigid plastic, C: Plastic snap on lidding M: Other rigid plastic, C: Sealed lidding/membrane M: Paper-based tray M: Paper-based tray, O: Carton/case M: Paper-based tray, O: Flexible wrapper/bag/pouch M: Paper-based tray, C: Sealed lidding/membrane M: Paper/board-based tub or tube, C: Other closure M: Paper/board-based tub or tube, C: Overcap M: Paper/board-based tub or tube, C: Plastic snap on lidding M: Paper/board-based tub or tube, C: Sealed lidding/ membrane (continued )

460


Table 6. Continued . Pack code PT75


PT76 PT77 PT78 PT79 PT80 PT81 PT82 PT83 PT84 PT85 PT86 PT87 PT88 PT89 PT90 PT91 PT92 PT93 PT94 PT95 PT96 PT97 PT98 PT99 PT100 PT101 PT102

Pack type description used in FACET M: Paper/board-based tub or tube, C: Unknown closure M: Plastic bottle, C: Aluminium roll on M: Plastic bottle, C: Crown closure M: Plastic bottle, C: Plastic other M: Plastic bottle, C: Plastic screw thread M: Plastic bottle, C: Plastic snap on lidding M: Plastic bottle, C: Sealed lidding/membrane M: Plastic bottle, C: Unknown closure M: Plastic collapsible tube, C: Sealed lidding/ membrane M: Plastic jar, C: Plastic other M: Plastic jar, C: Plastic screw thread M: Plastic jar, C: Plastic snap on lidding M: Plastic jar, C: Sealed lidding/membrane M: Plastic jar, C: Unknown closure M: Plastic tray/pot/tub/cup M: Plastic tray/pot/tub/cup, O: Carton/case M: Plastic tray/pot/tub/cup, O: Flexible wrapper/bag/ pouch M: Plastic tray/pot/tub/cup, O: Flexible wrapper/bag/ pouch, I: Drip pad M: Plastic tray/pot/tub/cup, O: Flexible wrapper/bag/ pouch, I: Other sheet M: Plastic tray/pot/tub/cup, O: Metal other M: Plastic tray/pot/tub/cup, O: Other rigid plastic M: Plastic tray/pot/tub/cup, C: Easy open M: Plastic tray/pot/tub/cup, C: Overcap M: Plastic tray/pot/tub/cup, C: Plastic snap on lidding M: Plastic tray/pot/tub/cup, C: Sealed lidding/ membrane M: Plastic tray/pot/tub/cup, C: Sealed lidding/ membrane, I: Drip pad M: Plastic tray/pot/tub/cup, C: Sealed lidding/ membrane, I: Other sheet M: Plastic tray/pot/tub/cup, C: Sealed lidding/ membrane, O: Carton/case

Note: M, Main; C, Closure; I, Insert; O, Outer Pack.

that in practice not all combinations of main pack and closure would exist (e.g., beverage can with roll on closure (ROPP) – PT9). These have not been removed in case packaging innovation produces “new” types of pack combinations. Indeed, since 2005 easy-peel ends for food cans (PT28) have started to make inroads into the traditional types of food can packaging.

Establishing packaging usage factors for each food type The PASTA table (derived from Euromonitor data) is pivotal in allocating packaging usage factors. For each food category (at Tier 3) the number of packs of each size and pack type are given for both the main and the closure, which allows packaging usage factors for both pack type and pack size within a given pack type to be

derived. Although FIG developed the PASTA tables, they were based on Euromonitor data, which are proprietary. A worked example for exposure to BPA from coatings on light metal packaging in Oldring et al. (2013) demonstrates how the linkages are made. Using the PASTA table, a spreadsheet was specially constructed for the UK to show the number and type of packs per food category (Tier 3). The PASTA tables enable a decision to be made as to whether or not the substance of interest is present. If the latter, then there is no further processing of the data. If the substance could have been in the material, then it is necessary to use either migration modelling or the concentration data that have been entered directly. Conditions of use that influence migration In addition to log Po/w and the molecular weight of the substance, a number of other inputs are required to enable migration to be modelled. Most of these are the materialand food-specific parameters that help model the kinetic and thermodynamic aspects of migration (i.e., diffusion coefficients and partition coefficients); they are described in Seiler et al. (Forthcoming 2013). Other inputs needed are the time(s), temperature(s), surface area-to-food weight ratio for the contact of the food with its packaging, and thickness and density of each of the layers. The FIG agreed a standard set of storage conditions of time and temperature distributions for the different foodstuffs, e.g., frozen, refrigerated and ambient storage of foods up to the end of their shelf-life. In the case that the food could be processed in the pack (by the food producer/packer) and/or cooked in the pack by the consumer prior to consumption, it was decided to use the guidelines on processing conditions published by TNO (DG SANCO 2003), which were checked for their correctness and current relevance by FoodDrinkEurope. The Euromonitor data contained pack sizes that were converted, using formulae for each pack shape, into surface area-to-weight ratios for the packaging components of every food item in the Euromonitor database. These were used after some adjustments, such as, for example, to recalculate surface area-to-weight ratios from multipacks to single packed items (e.g., bouillon cubes). The area in contact with the foodstuffs per component was placed in the PASTA table. Direct input in some cases, e.g., survey or simulant data In addition to migration modelling, concentration data can be used in FACET. For some sectors, such as light metal packaging, concentration data were preloaded. These data were obtained in either food simulants or extraction solvents, such as acetonitrile, and were reported as mg dm–2. An example of this is given in Oldring et al. (2013).



FACET also has a facility that allows concentration data in food to be input directly. This would be the case, for example, with data obtained from surveillance studies. In this case, the data would be entered in tabular form in units of mg kg–1 in the foodstuff.

Results and discussion As described at the outset, to determine the population distribution of exposure to packaging migrants the FACET tool uses a diary driven approach that requires information on food consumption (from the diaries of food consumption events) combined with the concentration of packaging migrants in foods. The procedures described above in the “Materials and Methods” section were necessary to derive distributions of concentration values in the food items eaten. This is now described using a simple example not requiring mathematical migration modelling.

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As an example of distributions of concentrations, the concentrations of BPA in different canned foodstuffs illustrate the principles. These actual distributions were used in an exposure assessment for BPA emanating from light metal packaging (Oldring et al. 2013), using extraction data ranging from 0.00005 to 0.012 mg dm–2. Figures 5–8 show the distribution of concentration of BPA in mg kg–1 (parts per million) in some selected food categories consumed in the UK and packaged in light metal packaging. The distribution is obtained by considering the variation in the packaging types in which that the food or beverages are contained. The packaging that contains certain food or beverage types will have different contact surface areas, quantities of

Concentration distributions of migrant in foodstuff Both the migration model and extraction or simulant data have units of migration level by area (mg dm–2). These are then used to obtain a distribution of the concentration of the migrant in the foodstuff. These distributions are obtained by combining the migration/extraction (mg dm–2) with the surface areas in contact with the foodstuffs, using the sizes and market share data from Euromonitor. Note that for data from surveillance studies, the concentration in foodstuffs is obtained directly, and if more than one pack of the same foodstuff was sampled, a distribution is obtained. The migrant concentration C is calculated by the following equation:

Figure 5. Probability distribution for concentration (ppm or mg kg–1) of bisphenol A (BPA) in FACET Food Code P.14.2.1. Carbonates for pack type beverage can in the UK.

mg 2 Extraction dm 2 Contact Area ðdm Þ mg kg1 C¼ Mass of Food ðkg Þ where all the parameters have their own variability, which is the root cause of distributions being obtained rather than point values. These distributions may be different country by country, even for the same packaging materials, because different pack sizes and different market shares per pack size may exist in different countries. When analysing the amount of a chemical that the population could be exposed to, a combination of food consumption diaries and the concentration distributions must be used. Unfortunately, food consumption diaries do not discriminate between pack sizes, but rather only the amount of food consumed is recorded. Consequently, a combination of food diaries and concentration distributions is used to determine a distribution of exposure for a specific demographic.

Figure 6. Probability distribution for concentration (ppm or mg kg–1) of BPA in FACET Food Code P.15.1.1. Beer for pack type beverage can in the UK.


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Figure 7. Probability distribution for concentration (ppm or mg kg–1) of BPA in FACET Food Code P.4.2.2. Canned/preserved tomatoes for pack type food can in the UK.

Figure 8. Probability distribution for concentration (ppm or mg kg–1) of BPA in FACET Food Code P.4.2.3. Canned beans and pulses for pack type food can in the UK.

food/beverage and ranges of extraction values for coatings that contain BPA. Based on the market share of each packaging type, a probability is calculated to indicate the likelihood that the food came in one packaging over another. For a given consumption event and food category in the food consumption diary, the model selects a packaging type for that food with a probability given by the market share. Take, for example, a non-alcoholic carbonated beverage (Figure 5). A carbonated beverage may be contained within a 330 ml can or a 150 ml can. So it has to be assumed that a consumer could potentially have drank from either can size. However, since we know that 330 ml cans have a much greater market share than 150 ml cans, those market

shares can be used to give a greater weighting to the likelihood of an individual drinking from the 330 ml can over the 150 ml can. The market shares for beverage cans versus other forms of beverage packaging are first allocated followed by the market shares for different sizes of that type of packaging. As these are probability functions, they total 1. Furthermore, the cans could be made from aluminium or steel, which have their own market shares, which adds further variability to the concentration of BPA in our beverages. BPA may be used as a monomer in resins that are incorporated into some coatings (e.g., epoxy, PVC etc.) for the inside of food and beverage cans and metal closures. Again, these polymer coatings will have their own market shares for beverage cans, so it might be more likely that some cans will have a higher concentration of BPA than other cans. The market shares of different packaging types at a retail level are specific to each country, and applied on a per-country basis. The databases on packaging composition are however at a pan-European level. Distributions of chemical concentrations of packaging migrants are calculated probabilistically and linked to the consumption diaries per survey, and exposure is calculated using random sampling from these distributions. Once a distribution of exposure is calculated for a population, this distribution is described using statistics, and the variability in the Monte Carlo sampling described using confidence intervals and standard errors. All of this variability produces the graphs shown in Figures 5–8 for different foods and packaging types. As can be seen, there are different distributions even for pack types that are similar. For example, beer (P15.1.1) and carbonates (P14.1.1) are both packaged in beverage cans (PT8), with similar BPA extraction levels, but the beer cans tend to be larger (beer 44 or 50 cl and carbonates 33 cl), hence the surface area-to-food weight ratio (cm2 g–1) is lower and the concentration in the beer is lower. Since the consumer is unlikely to display such random choices, selecting from the whole marketplace (in the short-term at least), then consumer loyalty can be set off or on by the user when running the FACET tool. The effect that this has is described below. Software options FACET is driven by a choice of menus, from which the user chooses options. A user can input their own migration data or use preloaded compositional information to calculate migration levels for the existing materials and structures and time–temperature conditions etc., that are contained in the databases. The output from the migration model module is not visible to the user. The migration model is proprietary and it cannot be used to get migration results directly. A user can enter a new or an existing substance and link it with new or existing packaging applications



(materials, structures, foods). There is a standard output report. In addition, the user can tailor the output, but this entails copying output data etc. to separate documents. It is possible to determine “drivers” of exposure, but these are reported at the packaging type, rather than the layer(s) or material(s) containing the substance, as requested by industry to reduce the possibilities of “back engineering” to replicate competitive products. An example of drivers of exposure is given for BPA in Oldring et al. (2013). Output can be viewed by food category or pack type. For

Figure 9.

Figure 10.

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a given food category the exposure can be broken down by contributing types or, conversely, for a given pack type the exposure can be viewed broken down by different food categories. For a global estimate of aggregate exposure, the exposure can be viewed for all foods and all pack types (Figures 9 and 10). The histogram in Figure 9 shows the exposure by food group at Tier 1. It illustrates, for example, the highest contribution comes from food group P15, Alcoholic beverages. The pie chart in Figure 10 shows the distribution of exposure, now organised by

Exposure (mg kg–1 bodyweight) by food group.

(colour online) Exposure by pack type, where M is the main component and C is closure.


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pack type. This shows, for example, the highest contribution comes from PT8, Beverage can. It is possible to run exposure assessments at any tier, or combination of tiers, of food categories, as well as for selected foodstuffs only or for only preselected pack types. The percentiles of interest can be selected, although some default ones are used (e.g., mean, 97.5th). Exposure for “consumers only” or “the total population” can be assessed. Exposure can be expressed as mg per bw, using the body weights (bw) of the actual consumers, or mg per person per day. When considering exposure, packaging loyalty has to be taken into account. Unlike brand loyalty, where a consumer may always drink, for example, one brand of cola irrespective of its packaging, a packaging loyal consumer will always drink a can or bottle of cola irrespective of its brand. The user has the option to run with and without loyalty. This will give a range of exposures. Loyalty can be selected for any food item at any food tier. As a generalisation, running an exposure assessment with loyalty should stretch out the exposure distributions and give the highest exposure and so can be considered to be conservative. It should be borne in mind that for some foodstuffs that have a high market share in a particular type of package, there may be only small differences in setting the loyalty flag off or on. In a separate paper (Oldring et al. 2013) the case of BPA migration from coatings on light metal packaging was used in a verification exercise to compare the exposure estimates obtained using the FACET tool with estimates from a refined deterministic approach and also the very recent estimate for BPA made by EFSA (2013). There was satisfactory agreement between the different approaches used and the results from FACET were overall conservative. Conclusions The development of the FACET exposure tool is described. It makes estimating the exposure of European consumers to packaging substances both easier and more accurate. Using actual food consumption data, packaging usage information and the substances used to make these packaging materials etc., the FACET tool enables a more realistic assessment of consumer exposure than the European Union conventional approach of everyone consuming every day 1 kg of foodstuff that is in contact with 6 dm2 of the same FCM containing the same substance at the maximum use level. By necessity (to preserve confidentiality) the raw data on food consumption by individuals along with detailed information on packaging composition and packaging usage cannot be viewed or extracted by the user. A FACET user group has been established under the auspices of the European Union Reference Laboratory for Food Contact Materials of the

Joint Research Centre (JRC) at Ispra (Italy). One aim will be to explore to what extent the contents of the databases can be shared in confidence with stakeholders and especially EFSA and the European Commission. Furthermore, introductory sessions for stakeholders including industry, EFSA and European Commission staff have been organised by the JRC to promote the use of this tool. Funding Development of the FACET exposure tool was co-funded by the European Union [Grant Agreement 211686] (Project FACET – Flavours, Additives and Food Contact Material Exposure Task), by a consortium of 12 packaging trade associations (named in the text) and with top-up funds (to Fera) from the UK Food Standards Agency. The findings and the conclusions in this paper are the responsibility of the authors alone and they should not be taken to represent the opinion of the funding bodies.

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