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Articles

Estimates of dietary exposure to bisphenol A (BPA) from light metal packaging using food consumption and packaging usage data: a refined deterministic approach and a fully probabilistic (FACET) approach

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Pages 466-489 | Received 02 Apr 2013, Accepted 23 Oct 2013, Published online: 20 Jan 2014

Abstract

The FACET tool is a probabilistic model to estimate exposure to chemicals in foodstuffs, originating from flavours, additives and food contact materials. This paper demonstrates the use of the FACET tool to estimate exposure to BPA (bisphenol A) from light metal packaging. For exposure to migrants from food packaging, FACET uses industry-supplied data on the occurrence of substances in the packaging, their concentrations and construction of the packaging, which were combined with data from a market research organisation and food consumption data supplied by national database managers. To illustrate the principles, UK packaging data were used together with consumption data from the UK National Diet and Nutrition Survey (NDNS) dietary survey for 19–64 year olds for a refined deterministic verification. The UK data were chosen mainly because the consumption surveys are detailed, data for UK packaging at a detailed level were available and, arguably, the UK population is composed of high consumers of packaged foodstuffs. Exposures were run for each food category that could give rise to BPA from light metal packaging. Consumer loyalty to a particular type of packaging, commonly referred to as packaging loyalty, was set. The BPA extraction levels used for the 15 types of coating chemistries that could release BPA were in the range of 0.00005–0.012 mg dm–2. The estimates of exposure to BPA using FACET for the total diet were 0.0098 (mean) and 0.0466 (97.5th percentile) mg/person/day, corresponding to 0.00013 (mean) and 0.00059 (97.5th percentile) mg kg–1 body weight day–1 for consumers of foods packed in light metal packaging. This is well below the current EFSA (and other recognised bodies) TDI of 0.05 mg kg–1 body weight day–1. These probabilistic estimates were compared with estimates using a refined deterministic approach drawing on the same input data. The results from FACET for the mean, 95th and 97.5th percentile exposures to BPA lay between the lowest and the highest estimates from the refined deterministic calculations. Since this should be the case, for a fully probabilistic compared with a deterministic approach, it is concluded that the FACET tool has been verified in this example. A recent EFSA draft opinion on exposure to BPA from different sources showed that canned foods were a major contributor and compared results from various models, including those from FACET. The results from FACET were overall conservative.

Introduction

Bisphenol A (BPA, 2,2-bis(4-hydroxyphenyl)propane) is a chemical used as a starting substance to make resins and plastics (EFSA Citation2013). Residues of BPA may be present in certain epoxy resins used to make protective coatings and linings for food and beverage cans and aluminium foil containers, as well as for the metal lids on glass jars (Oldring Citation1997). BPA is also a starting substance for some polycarbonate plastics used to make food containers such as water bottles, tableware and storage containers (EFSA Citation2013). BPA can migrate in small amounts into food and beverages stored in materials containing the substance (Goodson et al. Citation2002; EFSA Citation2013). Several expert bodies and regulatory authorities have issued risk assessments of consumer exposure to BPA over recent years. EFSA started work in Citation2012 on a new risk assessment of BPA (EFSA Citation2012). It completed a full risk assessment of BPA as recently as 2006 (EFSA Citation2006) and established a TDI of 0.05 mg kg–1 body weight day–1 for the substance, as have other recognised bodies. The TDI is an estimate of the amount of a substance, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable risk. EFSA also evaluated intakes of BPA through food and drink for adults, infants and children (EFSA Citation2006) and found that intakes were all well below the TDI. EFSA has updated its scientific advice on BPA several times since 2006, most recently in 2010 (EFSA Citation2010) when the TDI was reaffirmed. Notwithstanding this, the European Commission and member states decided to prohibit the use of BPA in polycarbonate articles that were considered to be one of the major contributors of exposure, particularly for babies, so the use of BPA to make plastic infant feeding bottles was banned in the European Union from 2011 (EC Citation2011).

The FACET project (Flavours, Additives and Food Contact Materials Exposure Task) was a 4-year project part funded by DG-Research of the European Commission as part of its Framework FP7 Programme. The project’s aim was to develop a probabilistic model to estimate exposure to chemicals in foodstuffs originating from flavours, additives and food contact materials. The FACET tool, described elsewhere (Oldring et al. Citation2013), is a significant advance in assessing exposure to migrants from food packaging.

Polymeric coatings on light metal packaging, used for foods and beverages, are one of the previously identified major sources of exposure to via the diet (EFSA Citation2013). Migration from coatings of canned products and from lids of glass jars and bottles may occur due to the presence of BPA monomer from incompletely polymerised epoxy resin coatings and of BPA present as a residual impurity of the epoxy substance bisphenol A diglycidyl ether (BADGE). EFSA has given an overview of literature data for BPA in foodstuffs (EFSA Citation2013). Oldring et al. (Citation2006) give some references for BADGE and a stochastic model approach in estimating exposure to BADGE from canned foodstuffs.

Euromonitor International (hereafter referred to as Euromonitor) is a market research company that supplied data on the different types of retail packaging used (Oldring et al. Citation2013). In addition to food and beverage cans (bodies and ends) along with metal lids (closures) used on glass jars and bottles, the assessment of exposure here also covers aerosol cans (as used, for example, for cream and desert toppings) and collapsible metal tubes (as used, for example, for tomato paste, mayonnaise, mustard, some fish products, etc.). These pack types were included for completeness although, as seen below, they make only a minor contribution to exposure because only a limited number of foodstuffs are packaged in them. By far the main exposure for light metal packaging is from cans and lids. It should be noted that in some, but not all, countries there are specific uses for aerosols and tubes reported in the Euromonitor data, e.g. only in Ireland has the use of aerosols for oils and fats (presumably as non-stick on a cooking utensil) been reported. Similarly, for collapsible metal tubes there are specialised uses such as spreadable processed cheese reported for some countries.

This estimation of exposure was conducted using the recently completed FACET exposure tool which is fully probabilistic (Monte Carlo statistical modelling) (Oldring et al. Citation2009; Citation2013; Hearty et al. Citation2011). The food consumption data and the packaging usage data contained within the FACET tool have also been summarised and used here for refined deterministic estimates too. In this way the workings of the FACET tool are described step by step to aid in the understanding of it, and the refined deterministic approach has also been compared with the output of FACET to check if the probabilistic FACET tool is working properly. In this paper the exposure estimate is restricted to food packaged in metal for the UK population of 19–64 year olds. Only results from UK data are presented, and when reference is made to other data, these data are not considered in this paper but are only given for information to show the variability of information within the European market.

Materials and methods

It was necessary to collect different data which were then combined. Food consumption data were combined with data on possible types of packaging and the composition of that packaging. This work only focused on exposure to BPA from canned and jarred foodstuffs, so any food packaged in any other form of packaging than a can, can end, metal closure, metal tube or aerosol was not considered further. The data on concentration of the BPA in the foodstuff were obtained analytically, normally using recognised simulants or solvent extraction. This is expressed as weight per unit area, hence it was necessary to know the surface area to weight ratios of the different sized packaging in order to derive a concentration of BPA in the foodstuff.

For the FACET project, food consumption data were obtained from individual food consumption diaries contained within the national food surveys (Oldring et al. Citation2013). The food consumption data were supplied by the database managers for the countries involved in FACET. For the refined deterministic approach at verifying the FACET results, the UK National Diet and Nutrition Survey (NDNS) survey for 19–64 year olds (Henderson et al. Citation2002) was used as the data were readily available from previous work (Holmes et al. Citation2005; Castle et al. Citation2006; Oldring et al. Citation2006; Northing et al. Citation2009). Data on the type of packaging for different foodstuffs were obtained from Euromonitor data for 2005 as well as information on the surface area to packed food weight of the packaging. Data on packaging materials used for different foodstuffs and whether they could contain BPA were collected by industry. The extraction/migration data were also provided by industry. This section describes how all these data were collected and combined.

The database managers recoded their national surveys into the FACET food-coding system (Hearty et al. Citation2011). These data were then linked to the different types of packaging used for the different food groups consumed. FACET has an agreed list of substance codes, material codes, pack type codes and food codes. The challenge for the packaging industry was to make the link between the food groups (as recorded in the food diaries) to the materials (e.g. glass, metal, plastics, paper, etc.) used to package those foods, and finally to the substances used to make those materials. Once this link is made, it is possible to use migration levels or extraction levels from each material to derive concentrations in the food and thereby estimate exposure at the level of the individual consumer. gives an overview of how the data were linked.

Table 1. Information sources and the linking needed for estimating exposure.

The FACET Industry Group (FIG) supplied information on substances, materials and packaging construction. Market share data for each type of food packaging were obtained for most of the European Union member states from Euromonitor. An accompanying paper (Oldring et al. Citation2013) gives a more detailed description of the FIG and of how data were collected and combined. Whilst the packaging usage factors were from 2005, the food consumption survey for 19–64 year olds was from 2000 (Oldring et al. Citation2013).

Establishing packaging usage factors for each food type

It is necessary to link the food description to its packaging. The national food consumption diaries contained food descriptions and it was necessary to allocate every one of these descriptions to one or more types of food packaging. Information on the types of food packaging was obtained from Euromonitor, but they used their own food item descriptions. Thus, it was necessary to recode all food items into ‘food group codes’ (P.x.y.z). These were split into three tiers, with Tier 1 being common to flavours and additives as well as packaging (Oldring et al. Citation2013) with 18 food groups. Tier 1 is subdivided into 59 food groups (Tier 2), whilst Tier 3 contains 174. Consider as an example vegetables, starchy roots, legumes and seaweeds, which are coded P.04 at Tier 1. Tier 2 has four subcategories, P.04.1 Fresh vegetables, P.04.2 Processed vegetables, P.04.3 Frozen vegetables and P.0.4 Dried vegetables. P.04.2 is further subdivided into P.04.2.1 Preserved vegetables, no sauces; P.04.2.2 Canned/preserved tomatoes; P.04.2.3 Canned beans and pulses; P.04.2.4 Tomato paste/purees; P.04.2.5 Pasta sauces (tomato based); and P.04.2.6 Pickled vegetables.

In order to allocate material codes to the food groups, a spreadsheet was prepared with the food group in the left-hand column. This was done at either FACET Tier 2 or Tier 3. From these data, packaging usage factors were derived. To illustrate how data are used in FACET, the food packaging data from Euromonitor for the UK for 2005 have been linked to FACET food group codes. Euromonitor updates its surveys annually. Although the 2005 data set may seem to be ‘old’ data, none of the food consumption surveys used in FACET was more recent than 2005. The UK 19–64-year-old NDNS survey for food consumption data were from 2000.

gives the individual food groups and the number of packs (millions of units sold per annum) for each type of metal packaging derived from Euromonitor data. Note that for ease of reading the number of beverage or food can ends is not given individually, as it equals the number of cans for that foodstuff group. Also, in as with the others subsequently, some of the figures have been rounded for clarity. The precise (unrounded) numbers have been used in all calculations, however. does not contain 15 food groups at Tier 3, because the relevant data were not available in Euromonitor, because, for example, they were not retail, being vended drinks and takeaway foods. The impact for light metal packaging is negligible. For vended carbonates in beverage cans the packaging is the same as for retail cans. The missing food groups are P.01.1.4, P.04.4.2, P.06.4.2, P.06.5.5, P.07.4.2, P.11.1.2, P.12.2.7, P.14.1.1, P.14.3.4, P.14.3.5, P.18.2.1, P.18.3.3, P.18.4.4, P.18.5.10 and P.18.5.11. For a complete list including a description of these missing food groups, see Oldring et al. (Citation2013).

Table 2. Number of light metal food packaging units sold per annum (2005) in the UK for each packed food type (extracted from Euromonitor data).

More detailed information on metal packaging for foodstuffs is available from Oldring and Nehring (Citation2007). The non-opening end (bottom) of three-piece cans has been considered as part of the body. Information for glass jars/bottles is given because many, but not all, have metal closures (e.g. metal lids for jars). Aluminium ‘roll on’ (the pilfer proof tops on spirit bottles, for example) and ‘crown closures’ (metal bottle tops, normally removed by a bottle opener) are not included in because there is either no (a roll on closure has a plastic wad on top of the coated metal) or only minimal (crowns have a plastic liner on top of the coated metal) contact between the beverage and the metal closure.

Only those food groups for which an epoxy-coated metal would be assumed as packaging and for which no migration could be expected are listed in . Other food groups not carried forward from to are those for which the packaging may be metal, but it will be uncoated metal (hence no BPA) or for which no migration is expected because the foods are dry or because there is, for example, an insert preventing direct contact. These were food groups: P.01.1.7 Powdered milk, P.05.1.1 Sugar confectionery, P.07.3.1 Sweet biscuits, P.07.4.3 Cakes, P.12.1.05 Mustard, P.12.1.13 Gravy granules/sauce powders, P.12.1.14 Bouillon/stock cubes and powders, P.12.4.1 Yeast, P.13.1.1 Infant milk formula, P.13.3.1 Other nutritional foodstuffs, P.14.3.1 Dry coffee, P.14.3.3 Other hot drinks powders, and P.16.1.1 Savoury biscuits and crackers. Also not carried from to is the category of ‘metal other’, which would cover uncoated cans (tins), e.g. for oils and fats or dried herbs, because it is clear from the foodstuffs packaged in them that they are not coated.

Table 3. Food items (millions of units per annum) considered as being packaged in coated metal which could contribute towards exposure to BPA and their market shares.

The metal packaging types considered further are aerosol cans, beverage cans, food cans, metal lids for glass jars/bottles, metal collapsible tubes, and ends for beverage and food cans. From the numbers of packs for each material code (i.e. from the Euromonitor data), the number of metal versus other forms of packaging for those food groups can be derived and these were used as the basis for allocating the market shares (by number of packs) of each metal packaging component per food group. gives the market shares for each of the above metal types. It should be noted that only 42 of the 174 food groups at FACET Tier 3 codes could be packaged in light metal packaging and/or metallic tubes. From the summary of (grand totals) it is clear that less than 10% of foodstuffs are packaged in coated metal from which exposure to BPA could arise, this 9.41% being 12 769 million packs from a total of 135 690 million units of packaged food sold per annum in the UK. As a quick sense-check, the UK population in 2005 was 60.2 million (Office for National Statistics Citation2013) so this gives 6.2 pack units of all types sold per person per day. Of the 42 food groups, eight were solely in food cans, six were in either food cans or jars/bottles (with lids), 16 were solely in jars/bottles (with lids), seven were in beverage cans, one was either in a beverage can or a bottle (with a lid), one was either in an aerosol or a jar (with a lid), one was solely in a tube, one was in either an aerosol, food can or jar (with a lid), and finally one was either in a jar (with a lid) or a tube.

Pack sizes and surface area: pack weight ratios

Euromonitor data contain the pack weight for each pack size. The surface area to pack weight ratio is important in deriving concentration levels in foods. A high contact area ratio gives higher concentrations in food. gives the ratio (in cm2 g–1) of the surface area to food weight of the can (food and beverage), can end (food and beverage), metal lid on a glass jar/bottle, metal tube or aerosol for each foodstuff. The data were derived from Euromonitor statistics and reflect the size(s) with the most units sold. When two or more of the most popular sizes were significantly different, the highest surface area to weight ratio was used to be conservative. For example, there are 161 million metal closures (jar and bottle tops) per annum for jars of processed fruit P3.2.3 (jams and preserves) varying in size from 0.11 to 0.18 cm2 g–1 and in number from 3 million to 66 million per size. The surface area to weight ratio for 66 million was 0.157 cm2 g–1 and for 56 million (the next highest number) was 0.142 cm2 g–1. Thus, the ratio used here was 0.157 cm2 g–1, although it is higher than the average of 0.153 cm2 g–1. The areas of the can ends were added to that of their respective bodies to give a total area for that type of can. shows that for cans (bodies plus ends) the ratio is about 1.5–2.0-fold higher than the European Union default ratio of 0.6 cm2 g–1 (Brands et al. Citation2007). Conversely, for lids the ratio is lower than the European Union default, being one-quarter to one-third for jar lids and about one-20th for bottle tops.

Table 4. Surface area to pack weight ratio of metal parts in contact with food (cm2 g–1).

Linking different types of food cans for each food category

It should be borne in mind that different types of coatings, which may or may not be based on BPA-containing materials, can be used for the same type of can or closure. Food cans are the most diverse. Bodies can be manufactured in three different ways: the simple welded cylinder body of a three-piece can, needing two ends, or a drawn and redrawn (DRD) or a drawn and wall-ironed (DWI) body of a two-piece can that needs just one end added. The opening end may be either easy open (ring pull) or classic (can opener needed) (Oldring & Nehring Citation2007). So a classic three-piece food can may have one type of coating for the body, another for the non-opening end and yet another for the easy open end, as well as another coating for the side seam stripe (that covers the weld). Some cans are not fully coated (e.g. for some tomato-based products such as soup and canned beans). Furthermore, different types of can (and coatings) may be used for the same foodstuff. A summary of the splits between the different types of food cans (only) for each food group is given in , along with the split of easy open or classic ends obtained from Euromonitor data. The ratios between classic and easy open ends for food cans will vary country by country, hence the need to use Euromonitor data. Where these data are unavailable the can-makers provided generic European splits as a guideline to fill any data gaps. As a general rule, the light metal packaging industry decided that for a three-piece can the side seam stripe would account for 10% of the area of the body, hence the area of the body is proportionally decreased. It should be noted that not all the food groups in are packaged in food cans or food cans and another form of metal packaging, e.g. P.04.2.6 Pickled vegetables has total sales of 159.4 million packs per annum (), of which 143.8 million are in glass jars and 2.3 million are in food cans (100% three-piece). In the UK, some foodstuffs packaged in light metal packaging are only supplied in jars/bottles with metal closures (e.g. P.12.1.08 Table sauces), whilst others are in beverage cans.

Table 5. Market split of different food can types and food can ends only, along with the area for side seam and three-piece can bodies where a side seam would be used.

Allocating the different coating chemistries

The types of coating chemistries that can be used for light metal packaging are given in . Epoxy resins is a generic term used by the light metal packaging industry and refers to epoxies based on epichlorohydrin and BPA. In some cases epoxy resins were/are used as minor components in the formulation to improve the properties of the cured film, such as sterilisation resistance. It should be noted that closure coatings (P.37.5.2) are in fact a system of an epoxy phenolic basecoat and an organosol topcoat, and the extraction of BPA from the entire (base plus top) coating system has been used.

Table 6. Coating categories used in the FACET project and their extraction values (mg dm–2) for BPA (1 mg dm–2 = 0.01 mg cm–2).

Obtaining representative extraction data for BPA

As part of continual monitoring and in response to brand owner requirements, companies involved have a wealth of in-house data on levels of BPA from different coatings. In most cases, data reported were from extraction into the solvent acetonitrile. These tests were typically performed by total immersion of cut specimens of coated panels in acetonitrile for 24 h at ambient temperature. These extraction conditions are considered to be exhaustive, as demonstrated by using a second and then a third extraction test with fresh solvent which yields little if any additional BPA. For beverage coatings, levels of extraction into relevant food simulants were used. These tests were typically conducted in 10% (v/v) aqueous ethanol solution and/or 3% (w/v) acetic acid solution for 2 h at 100°C. Analysis of the solvent or simulant extracts for BPA was then by HPLC with fluorescence detection in most cases, although some of the providers of data used LC-MS/MS for the analysis. In all cases, the providers of data followed appropriate analytical quality assurance standards.

The results of all these tests for BPA were shared between can-makers and coating suppliers and a range of values were agreed to provide a comprehensive overview of what is considered the worst case. The extraction values for BPA used here are given in . Individual company participation captured extraction data from a minimum of 60% of the total markets for food can and food can end, beverage can and beverage can end, and glass jar and bottle metal closures. In reality the European situation is represented to a higher degree than 60% because a few multinational coating suppliers and can-makers dominate. The same coatings that are supplied by the multinational coating suppliers and used by the multinational can-makers, are also supplied to and used by the smaller can and closure makers. Therefore, the data obtained are considered to represent over 80% of the European Union market. Indeed CEPE, the European trade association for coating suppliers, brings approximately 85% of this industry together in its membership (CEPE Citation2013). There is always an unknown about the coatings (if any) on cans and closures for foods that are imported into the European Union. The major imports are canned fruit, fish and meat (Dionisi & Oldring Citation2002). From the FACET project it was shown that the majority of the imported fruit cans purchased in eight European Union countries were uncoated, including the ends, which is different from the European industry practice of using internally coated ends on plain (uncoated) cans. Coatings on cans, etc. for fish and meat tend to follow (mimic) European Union coatings, particularly as many of the major European Union suppliers have operations in the Far East, South Africa, etc. Therefore, it was concluded that it is not unreasonable to consider the European Union agreed data as being a ‘worst’ case representative for a refined deterministic approach because the coatings of imports are either similar to European Union ones or the cans are not coated, thus the data used here are conservative.

The question naturally arises how close is the agreement of these BPA extraction levels () with BPA levels based on analytical measurements in foods surveys? A systematic comparison is difficult because food surveys rarely if ever identify the different coating chemistries used or the ratio of the surface area to packed food weight. The possibility also exists that the food may contain some BPA from sources other than the can coating. Nevertheless, some simple comparisons are informative and reassuring.

The largest body of food survey data for BPA was published by EFSA (Citation2013). Seven out of 17 canned food categories had an average BPA concentration above 30 μg kg–1. These were the EFSA food groups Grain and grain-based products, Legumes, nuts and oilseeds, Meat and meat products, Fish and other seafood, Herbs, spices and condiments, Composite food, and Snacks, desserts, and other foods. Four of the canned food categories had average BPA concentrations between 2.7 and 23.5 μg kg–1 (Vegetables and vegetable products, Fruit and fruit products, Fruit and vegetable juices, and Milk and dairy products), while the remaining six categories had average BPA concentrations below 1.2 μg kg–1.

shows a simplified ratio of surface area to food weight is about 1 g cm–2 (or 100 g dm–2) and so 30 μg kg–1 in food would correspond to a migration of 3 μg dm–2 (or 0.003 mg dm–2). It can be seen in that this value sits squarely inside the minimum–maximum concentration ranges given for coatings used for food cans. By the same simplified approach, the lowest food group concentration reported by EFSA, < 1.2 μg kg–1, would correspond to 0.0001 mg dm–2 and this either sits within the minimum–maximum ranges in or is higher than the minimum value and so the minimum value is conservative. It is concluded that the industry supplied data were ‘worst case’, which is not surprising as the data were based on extracting solvents or food simulants and not actual foodstuffs.

shows an approximate share of the coatings used for different types of beverage and food cans and ends. This share is on a formulation weight (tonnage) basis. Assuming the same application rates giving the same coverage, these shares will approximate to an area-related basis for the share of the coatings market. It should be borne in mind that this is for a pan-European view and reflects the situation for 2005, to which the Euromonitor data also relate. Aerosols for foodstuffs are coated with either organosols (P.37.2.1 or P.37.2.2) or epoxy phenolics (P.37.1.1). Tubes would use an epoxy-based coating (P.37.1.1).

Table 7. Types of coating used for food and beverage cans and their percentage market share (by volume as wet coatings).

Market shares of the different coating chemistries

For each coating category given in , coating companies supplied the amount sold and this was totalled by CEPE to allocate market share data per coating category per company supplying the data. Companies supplied information on the occurrence of BPA (yes/no). Some coatings may or may not contain some substances, e.g. epoxy phenolics (P.37.1.1) always contain epoxies, hence BPA, thus the occurrence is ‘yes’ with a probability of 1. Each can-maker supplied data on the types and relative amounts of each coating used for each of the different types of coated metal packaging as well as their share of the market for each type of metal packaging. This enabled a comprehensive overview of which chemistries were used for the different types of metal packaging and different foodstuffs. Due to anti-cartel rules these data were compiled by a third party for the FACET project and they cannot be viewed in the FACET tool nor be reproduced here. Creme Global (hereafter referred to as Creme), which was the software provider, linked the information supplied by industry into a pack type (PT coding system) (Oldring et al. Citation2013). Those pack types relevant to metal packaging are (PT = pack type; M = main – the major part of the packaging in contact with the foodstuffs; C = closure – seal for main, not always applicable), PT1 – M: Aerosol can, PT3 – M: Aerosol can, C: Plastic other, PT8 – M: Beverage can, PT20 – M: Food can, C: Classic, PT21 – M: Food can, C: Easy open, PT35 – M: Glass bottle, C: Metal twist/lever, PT41 – M: Glass jar, C: Metal twist/lever, and PT48 – M: Metal collapsible tube, C: Plastic screw thread.

Refined deterministic estimate of exposure using this information

In order to evaluate whether the output from FACET for exposure to BPA is soundly based and also as an alternative way to help illustrate how these information sources are combined, a refined deterministic approach was also used here.

Outputs from FACET are required in order to be compared with a refined deterministic approach. This ensured that wherever possible the same input data were used for exposure assessments from both FACET and the refined deterministic approach. The food consumption diaries of the UK NDNS in 2000 adult survey (19–64 year olds) (Henderson et al. Citation2002) were used in FACET to derive the mean, 95th and 97.5th percentile food consumption, for both consumers only (of each food group) and for the total population, for each of the foodstuffs that could be packaged in coated light metal packaging.

The meaning of consumers only is that in any dietary survey (which is normally of a rather short duration) there will be people surveyed who do not consume particular foods during the time of that survey, even though over a longer time period they might. By way of a simple example, during a 5-day survey it may be that only 10% of participants report eating fish. So if the simple per capita fish consumption (i.e. for the whole population) derived from that survey was, say, 10 g day–1, then by simple arithmetic the average consumption for consumers only must be 100 g/person/day. This is not to say that only 10% of the population ever eat fish. It relates only to the duration of the survey. This is a known weakness in dietary surveys because, clearly, if the survey period is extended then simply by chance more of the participants will consume a higher number of the different food types and the difference between the total population estimate and that for consumers only will narrow or even disappear.

Consumers only are a subset of the total population and the number will vary considerably depending on the popularity of the foodstuff. These are shown as g/person/day in per food group at Tier 3 and these are only for those 42 food groups that could be packaged in coated metal and are listed in . For certain food groups in the total population the 95th percentile is zero whilst the mean is non-zero. This is not an error. It is because fewer than 95% of the population consume that food group. If, for example, only 2% are consumers of that food group (during the period of the survey) then there are by definition no consumers below the 97.5th percentile. But as some food has been consumed (in this example by just 2% of the people surveyed) there will be a non-zero mean.

Table 8. Mean, 95th and 97.5th percentile consumptions (g/person/day) for consumers only and the total population for food categories packaged in light metal packaging.

The number of consumers only is given in , whereas the total population in the survey was 1631. In some instances, although packaging has been recorded for a particular food group, no consumption of that food appears in the food consumption diaries. This occurred for five food groups, namely: P.09.2.5 Pickled fish and seafood, P.12.1.12 Liquid stocks and fonds, P.13.2.1 Prepared baby food, P.14.2.3 Functional drinks, and P.14.2.6 Ready-to-drink pre-packed coffee. As this assessment was for 19–64 year olds, it was not surprising that prepared baby food was not consumed by them. In contrast, for P.13.2.2 Other baby foods, which includes any other products marketed for babies such as baby rusks, teething biscuits, baby fruit juices, etc., consumption is reported by four consumers only with a mean of 24.3 g. For the total population (n = 1631) the mean is 0.1 g day–1 (i.e. 4 × 24.3/1631), but clearly there is no 95th or 97.5th percentile consumption figure. A similar situation exists for P.04.2.4 Tomato paste/purees with only 11 reported consumers. As a summary 10 food groups had fewer than 50 consumers and nine food groups had between 50 and 100 reported consumers of a total of 1631 participants in the survey.

As an aside, and to show that the tool was working correctly, the consumption of prepared baby food in the 1–4 year olds was from 48 to 145 g/person/day depending on age. The most likely explanation for the lack of consumption events being recorded for the four other food groups is the limitations of dietary surveys. As far as National dietary surveys go, the UK NDNS surveys are considered to be good since they survey approximately 2000 individuals over 4–7 days. Many other national surveys have fewer participants and/or fewer days. Notwithstanding the above average quality of the UK surveys, the fact that no eating occasions for four food groups were recorded indicates the limitations of surveys in general. Depending on the importance of the food group, consumption figures at high percentiles can be very unreliable since the survey has limited statistical power with few or even no consumers out at the high percentiles.

For the UK 19–64 year olds, the FACET tool was run for all food groups, at Tier 3, recorded as being in light metal packaging (and metallic tubes). Packaging (or consumer) loyalty was set (Oldring et al. Citation2013). In brief this means that, not withstanding market share, if the probabilistic model ‘decides’ on the first eating occasion that the food item (or group) is packaged in metal (e.g. a canned beer rather than a bottled beer) then all subsequent consumptions of that food item (group) by that individual would be taken to be canned too. The FACET reports used for this exercise did not show the 95th percentile, hence these data along with amount of food consumed at the various percentiles were extracted independently from the output data from FACET. The exposures to BPA (mg/person/day) for each food group (packaged in metal) at the mean, 95th and 97.5th percentiles were obtained for both total population and consumers only and these are given in , except for those where no food consumption was recorded. For each food group, the exposure for each packaging type (as a PT code) is given. In , if a foodstuff could be packaged in more than one type of packaging (e.g. P.12.1.10 Wet sauces; food can or jar with metal lid) and each had a substantial market share, then the exposures from all types of metal packaging for that food group were added (note that rounding errors may give a slightly different total), because the packaging of the food consumed is unknown and a consumer may or may not differentiate between them. If for a food group no exposure was recorded for more than one packaging type, then the PT codes have been combined for convenience.

Table 9. BPA exposure estimates (mg/person/day) from FACET for all foodstuffs packaged in metal.

It should be noted that the FACET reports contain exposures to foodstuffs at Tier 1. For lower tier exposure estimates, calculations can be run in FACET at Tier 3 by the user. The advantage of using Tier 3 (the highest level of refinement with the most detailed food description) is that it can be more food group and more packaging specific, unlike Tier 1 which covers a much wider range of packaging types at a higher (coarser) level of food classification. Thus, exposure to foodstuffs only reported at the first tier will not necessarily match those values in the tables here. In the case of P.13.3.1 Other nutritional foodstuffs, whilst reportedly being packaged in beverage cans there is no link to them being consumed in beverage cans in this survey. In reality this has negligible effect on any exposure assessment because of the low consumption.

Refined deterministic approach

A refined deterministic exposure assessment was only made for food groups that were more than 50% packaged in metal. These 20 food groups are listed in and , where those food groups that have greater than 50% packaged in metal are shown along with pack types, percentage (by number) market share, area to weight (cm2 g–1) ratio, and the minimum and maximum levels of extractable BPA for the coatings assigned to that metal packaging. Although P.14.2.1 Carbonates are significant contributors to exposure to BPA (), less than 50% are packaged in metal, thus it is questionable to use this foodstuff category for comparison of a refined deterministic estimate of exposure for carbonates to that from FACET, because of the relatively low market share compared with some of the other foodstuffs used in this verification exercise. For a ‘pure exposure assessment’ then this contribution would be considered, but this exercise is, in significant part, a verification of the FACET probabilistic tool.

These data are used in the refined deterministic approach, along with the food consumption statistics for the total population () and consumers only (). For food groups packaged in food cans it is necessary to consider the contribution from cans with classic and easy open ends, because the amount of food consumed is the important parameter. Therefore, the exposures to BPA per food group packaged in a food can with either classic or easy open end are totalled per food group. In essence and for simplicity only three coating types were assigned, namely: epoxy phenolics (P.37.1.1) for food cans and ends, epoxy acrylate beverage (P.37.1.4.1) for beverage cans, and closure coatings (P.37.5.2) for metal lids. This is a conservative assumption. The consumption of foodstuffs in aerosols or tubes was considered insufficient to be used for this verification exercise (see for further details of coating chemistries). For convenience and to be conservative, it was assumed that both easy open and classic ends for food cans as well as side seam stripes were coated with the same epoxy phenolic coating as the can body. For food group P.12.1.10 Wet sauces the market shares, surface areas to weight and different levels of extractable BPA were used for food cans and closures (PT21/PT41). An average of the surface areas and market shares cannot be used because the amount of extractable BPA is different for the different coatings. The mean, 95th and 97.5th percentiles for PT21 were added to the mean, 95th and 97.5th percentiles, respectively, for PT41 to give an overall summary, although this simple summation of values is not rigorous from a statistical viewpoint.

Table 10. Refined deterministic assessment of exposure for the total population to BPA from light metal packaging for those metal packs with significant market shares.

Results and discussion

Estimate of consumer exposure to BPA using the FACET tool

In the exposures for the total population only have been derived using the amount of food consumed per statistic (mean, 95th and 97.5th percentiles) and the minimum and maximum extractible levels of BPA. This gives a range for each consumption statistic. It would be anticipated that any (probabilistic) FACET exposure assessment for the same food group and same statistic would lie somewhere within this (refined deterministic) range. For food group P.12.1.10 Wet sauces the minimum and maximum exposures from being packaged in food cans or jars with metal closures is given and then the third row gives the exposure assuming consumption (pro rata) from the ratio of cans and jars. Similarly the same has been done for consumers only and these results are shown in . It should be noted that it is statistically incorrect to sum the mean, 95th or 97.5th percentiles over a range of foods as it leads to an unrealistic aggregation of exposure.

Table 11. Refined deterministic assessment of exposure to BPA (consumers only) from light metal packaging for those metal packs with significant market shares.

and show comparisons between exposures from the FACET output for the UK 19–64 year olds per food group at Tier 3, for which there is a relatively high proportion of foodstuffs packaged in cans or jars/bottles with metal closures, and the minimum and maximum exposures obtained deterministically using the minimum and maximum levels for BPA. The values from FACET lie within the range of the refined deterministic ones. Due to the fact that not every food group has 100% market share in metal and that various coatings (including non-BPA based) could be used, the values from FACET are not exactly midway because the FACET exposure model uses market share of different coatings and occurrence probability of BPA in those coatings, whereas the refined-deterministic approach assumes the food groups are all packed in light metal packaging, with epoxy-based coatings. The refined deterministic approach only used three basic types of coating and used food cans: beverage cans, large closures for metal jars and small closures for bottles. Indeed, the agreement is considered good and sufficient to verify the FACET model when concentration data are used as inputs in this example.

In FACET there is the capability to obtain in the report as defaults the overall mean, 90th and 97.5th percentile exposures to a substance from selected packaging for each survey, in addition to each selected food group. This has now been modified to the 95th rather than the 97.5th percentile. To obtain other percentiles it is necessary to preselect them before undertaking an exposure assessment. Exposures were run with packaging (consumer) loyalty (rather than brand loyalty) and the values obtained are given in . Note that the total exposure values in do not simply equal the sum of all the individual food groups listed in (total population) and (consumers only). This is because for the arithmetic sum of the mean is 0.0081 mg/person/day whereas in the corresponding value is 0.0097 mg/person/day. The small difference is because only those food groups with more than 50% market share in light metal packaging are listed in , whereas in it is the sum of all food groups. In contrast there is no summation in because it is inappropriate to sum exposure values from two or more different food groups for consumers only, because the consumers are different. For example, consumers only of beer (n = 713; ) are not the same individuals as consumers only of cider (n = 84; ).

Table 12. Comparison of refined deterministic estimate (RD) of exposure to BPA with FACET output (mg/person/day) for UK NDNS 19–64 year olds, 2000 survey, for total population (not all canned/jarred foodstuffs are included).

Table 13. Comparison of refined deterministic estimate (RD) of exposure to BPA with FACET output (mg/person/day) for UK NDNS 19–64 year olds, 2000 survey, for consumers only (not all canned/jarred foodstuffs are included).

Table 14. Estimates of exposure from FACET for BPA emanating from canned foodstuffs for different percentiles for UK 19–64 year olds.

The levels of exposure to BPA emanating from light metal packaging using conservative assumptions are well below the TDI of 0.05 mg kg–1 body weight day–1 (EFSA Citation2006) even for the highest percentile consumers () taking into account the assumption that the European Union consumer average body weight is 60 kg.

The ‘drivers’ of exposure to BPA from light metal packaging can be derived from for UK 19–64 year olds, only. Considering consumers only and the 97.5th percentile consumer, the main ‘drivers’ of exposure are (mg/person/day): P.15.1.1 Beer (0.049), P.12.2.4 Soup and P.15.1.2 Cider (both 0.023), P.14.2.1 Carbonates (0.02), P.18.4.2 Preserved pasta and P.18.5.6 Preserved ready meals (both 0.018), P.03.2.4 Canned fruit (0.012), P.04.2.1 Canned vegetables (0.011) and P.04.2.4 Canned tomatoes (0.010). All others are below 0.010 with many < 0.0001. Other percentiles or total population can be treated in a similar manner to determine the relevant ‘drivers’ of exposure. It should be noted that in the more recent software release of FACET the drivers of exposure are automatically generated in the report at food group Tier 1.

A comparison of the FACET estimate for BPA with a recent estimate performed by EFSA

During the journal’s reviewing stage of this paper, EFSA published a new estimate of exposure to BPA (EFSA Citation2013). EFSA used a deterministic not a probabilistic approach. For food, the average exposure was assessed based on combining average concentrations in different groups of foods and beverages, with average consumption data for those food and beverage groups. Estimates of high exposure were based on average concentration and high consumption. The aim was to estimate the mean and the highest 95th percentile among all European Union countries, meaning that estimates were made for each country separately and the highest results (the ‘highest country’) were taken forward.

EFSA used two different scenarios to allow for the fact that few of the national dietary surveys in the EFSA Comprehensive Database have information on what the food was packaged in. In Scenario 1, only foodstuffs, specifically codified as canned in the dietary survey, were assigned the corresponding occurrence level for BPA. In Scenario 2, any foodstuff, at FoodEx level 4, which has been codified as canned in at least one national survey, was always considered to be consumed as canned in all dietary surveys considered in the EFSA Comprehensive Database. Scenario 2 was chosen for the total exposure estimation, although it was recognised that this might overestimate the dietary exposure.

For a comparison with this work, where UK adults aged 19–64 years are considered, the three relevant age groups considered by EFSA are: men aged 18–45 years; women aged 18–45 years; and other adults aged 45–65 years.

Using Scenario 2, average dietary exposure from food and beverages for these three groups was estimated by EFSA to be in the range 126–132 ng kg–1 bw day–1. Similarly, high (95th percentile) dietary exposure from food and beverages for the same three groups of adults was in the range 335–388 ng kg–1 bw day–1. Under Scenario 2, EFSA found that canned products dominated in all surveys, with the percentage contribution to BPA from canned foods mainly ranging between 75% and 90%.

From this work () the estimates for the population mean, the 90th and 97.5th percentiles are 130, 290 and 590 ng kg–1 bw day–1 dietary exposure to BPA from light metal packaging, respectively. These figures from the FACET tool are very similar to the EFSA estimates for exposure from canned food and beverages. Scenario 2 used by EFSA is conservative in that any food canned in at least one national survey is always considered to be consumed as canned in all dietary surveys. In contrast, the FACET tool used actual market share data for the proportion of foods packed in light metal packaging and the different coating chemistries used, some releasing BPA and some not, and assumed packaging loyalty. On the other hand, the FACET tool made conservative assumptions about release concentrations of BPA from coatings and on surface area to weight ratios whereas the EFSA calculations drew upon a large database on BPA concentrations measured in food and beverages. Also, the FACET results presented here are for the UK only. The close agreement between the (conservative) estimate from FACET and the (conservative) estimates by EFSA, at the mean and also at high percentiles, is satisfactory.

Conclusions

This paper is a demonstration that the results from the FACET tool for a particular migrant (BPA) for a specific population (UK 19–64 year olds) are reliable, lying as they do between minimum and maximum values obtained using a refined deterministic approach. The recent EFSA draft opinion (EFSA Citation2013) on exposure to BPA from different sources showed that canned foodstuffs were a major contributor and compared results from various models, including those from FACET. The results from FACET were overall conservative.

This demonstration could aid the acceptance of FACET as a reliable tool for estimating dietary exposure by industry, regulators and risk assessors across Europe. A summary of how FACET is foreseen to progress has been given (Oldring et al. Citation2013). Both the packaging usage and food consumption data are dated with packaging usage coming from 2005 and food consumption from 2000. Assessing trends over time, as both diet and packaging usage changes, could be the subject of a further research project using the FACET tool.

Funding

Development of the FACET exposure tool was co-funded by the European Union under Grant Agreement 211686 (Project FACET – Flavours, Additives and Food Contact Material Exposure Task), by a consortium of 12 packaging trade associations, 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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