REPORT FROM THE COMMISSION on Dietary Food Additive Intake in the European Union

Table of Contents

Executive Summary

1 Introduction

2 Background

3 The monitoring task

3.1 Additives excluded from the monitoring task and further examination:

3.2 Additives subject to tier-1 screening

3.3 Additives subject to tier-2 screening

3.4 Additives subject to tier-3 screening

4 The monitoring data

4.1 Instructions for reporting the monitoring data

4.2 The type of monitoring data obtained

4.2.1 Age of data

4.2.2 Representativity

4.2.3 Type of survey

4.2.4 Types of population

4.2.5 Duration of the survey

5 Intake results

5.1 Tier 1

5.2 Tier 2

5.3 Tier 3

6 Discussion

7 Conclusions

Executive Summary

European Parliament and Council Directives 94/35/EC, 94/36/EC and 95/2/EC require each Member State to monitor the consumption and usage of food additives. The Commission is required to submit a report on this monitoring exercise to the European Parliament and Council.

Ten Member States and Norway, acting under EU Scientific Co-operation, have been working together to develop a tiered approach to evaluate dietary intake of food additives. The 'tiers' described are essentially additive intake estimation methods that progress in complexity and data requirements, intended to produce gradually a more accurate estimate of the additive intake. Where results of the estimates in a tier indicate that an ADI is unlikely ever to be exceeded, the additives in question are eliminated from further consideration. Resources can then be focused on the remaining additives for a more refined intake estimate. It must be emphasised that these tiers are essentially tools for establishing priorities for further monitoring.

This report represents a first attempt to obtain an overview of the dietary food additive intake in the European Union. Even if the results must be regarded as a very preliminary indication on the dietary intake of food additives, they indicate that the intake of the majority of food additives permitted today in the European Union is below the acceptable daily intake (ADI) set by the Scientific Committee on Food.

This report has many limitations. Food consumption data used was insufficient to estimate accurately food additive intake leading to worst case assumptions and consequent over-estimations of intake. Also several Member States did not use the agreed methodology for estimation of additive intake, leading to lack of comparability of the collected data. This highlights the need for Member States to apply the agreed, harmonised methodology to ensure consistency of approach and to allocate adequate resources for all future intake estimations. The current study should then be repeated and a new report should be drawn up within three years from now.

Introduction

The authorisation and use of food additives in the European Union are based on the framework Directive 89/107/EEC [1] on food additives. On the basis of the framework Directive, three specific directives were adopted by the Council and European Parliament: on sweeteners (Directive 94/35/EC [2]), colours (Directive 94/36/EC [3]) and on additives other than colours and sweeteners (Directive 95/2/EC [4]). Since the adoption of the last directive in 1995, legislation on food additives has been fully harmonised in the European Union.

[1] O.J. n° L 40, 11.2.1989, p. 27

[2] O.J. n° L 237, 10.09.1994, p.1

[3] O.J. n° L 237, 10.09.1994, p. 13

[4] O.J. n° L 61, 18.03.1995, p. 1

According to European Parliament and Council Directives 94/35/EC (Article 8), 94/36/EC (Article 6) and 95/2/EC (Article 7) on food additives, the Member States shall establish a monitoring system for the consumption of food additives. The objective is to monitor food additive consumption and to ensure that their use does not exceed the acceptable daily intake (ADI) set for additives by the Scientific Committee on Food (SCF).

For this purpose, the Member States discussed, through scientific co-operation (SCOOP), a method to gather data that would be comparable among the Member States. The SCOOP task was finalised in January 1998.

In August 1999 the Commission sent to the Member States guidelines on how to report their findings to the Commission. Information was received from the following Member States: Austria, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Spain, Sweden and the United Kingdom. The other Member States had not been able to carry out the exercise due to lack of resources. From the EFTA countries, Norway submitted information to the Commission.

The report describes the monitoring task, how the results were reported and what kind of information was received. The food consumption data used for the intake calculations are described. Intake results are listed in tables for adults and children separately. The report also draws conclusions with regard to future work.

The report represents a first attempt to obtain an overview of the food additive intake in the European Union. It must be regarded as a very preliminary indication of the dietary intake of food additives.

The Commission would like to thank Dr Wendy Matthews from the United Kingdom Food Standards Agency, Dr Inge Meyland from the Danish Veterinary and Food Administration, Dr Pirjo-Liisa Penttilä from the Finnish National Food Administration and Dr Philippe Verger from the Institut National de la Recherche Agronomique (INRA), for assisting the Commission in drafting this report.

2. Background

In 1996, under Council Directive 93/5/EEC on assistance to the Commission and co-operation by the Member States in the scientific examination of questions relating to food [5], a task was set up on "Methodologies for monitoring of food additive intakes" (SCOOP Task 4.2). The objectives of the task were:

[5] O.J. n° L 052, 04.03.1993, p. 18

* to identify data that can be used to assess likely additive intakes,

* to review methodologies currently used for monitoring additive usage and estimating intakes,

* to consider the need for different approaches to different types of additives,

* to establish systematic procedures for the identification of additives for which potential dietary intake gives most cause for concern

* and to develop a strategy that matches the complexity and cost of intake estimation to the level of concern posed by the potential intake of an additive.

The following Member States participated in the scientific co-operation task: Austria, Denmark, Greece, Finland, France, Ireland, the Netherlands, Spain, Sweden and the United Kingdom. In addition, Norway participated in the task. The report was produced in January 1998 [6].

[6] The scientific co-operation report on development of methodologies for the monitoring of food additive intake across the European Union (SCOOP/INT/REPORT/2)

The participants of the SCOOP task reviewed the relevant methods for estimating the intake of food additives and proposed a tiered approach, which could be used by the Member States to meet the monitoring requirements set out in EC directives. According to the report, "monitoring of additive intake should concentrate on discovering whether the exposure of consumers to any food additives regularly exceeds the acceptable daily intake (ADI)". This information can then be used by the Community regulator to determine what action (if any) is required to ensure that safety advice is being followed.

The definition of a number of key terms used throughout the report is given in box 1.

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In the tiered approach (see box 2), tier 1 is based on theoretical food consumption data [7] and maximum usage levels for additives as permitted by relevant Community legislation. The second and third tiers refer to assessment at the level of individual Member States, combining national data on food consumption with the maximum permitted usage levels for the additive (tier 2) and with its actual usage patterns (tier 3).

[7] Hansen, S. (1979). Conditions for Use of Food Additives Based on a Budget for an Acceptable Daily Intake. Journal of Food Protection 42 5, 429-434.

The SCF has recommended that special attention should be given to intake by children, since there is evidence suggesting that their dietary behaviour means that their intake of some additives, expressed on a bodyweight basis, may be markedly higher than that of adults. Therefore, in the SCOOP task, it was concluded that adults and children should be covered by a separate assessment.

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3. The monitoring task

The monitoring task was carried out in a stepwise manner. An overview of the method used is given in Annex I.

3.1. Additives excluded from the monitoring task:

Because priorities had to be set, it was decided to exclude from the monitoring exercise a series of additives on the basis of the following criteria:

* Additives with an ADI "not specified" allocated by the SCF; since an additive is only allocated an ADI "not specified" when, on the basis of the available scientific data, the total intake of the substance will not represent a hazard to health (see box 1).

* Additives that, based on the safety-in-use evaluation by the SCF, are only authorised in one or few specific food categories since their intake is limited to these food categories.

* New additives that have only been permitted for a short period of time since they were not in full use at the time information was collected.

These additives are listed in Annex II.

3.2. Additives subject to tier-1 screening

In tier 1, all additives with a numerical ADI were examined, with the exception of:

* those falling under 3.1, second and third bullet point and

* those authorised at quantum satis; they could not be examined in tier 1 or 2 since no maximum-permitted-use levels exist and were therefore moved to tier 3. These additives are listed in Annex IV.

The additives of tier 1 were screened using theoretical food consumption data combined with maximum permitted use levels of the additive. Food additives, for which the calculated intake exceeded the ADI, were moved to tier 2.

Up to this stage the exercise was carried out as part of the SCOOP task.

3.3. Additives subject to tier-2 screening

In tier 2 the additives from tier 1 that exceeded the calculated intake were examined. Their theoretical intake was calculated by combining the mean national food consumption data of the whole population with the maximum permitted use levels of the additive. This information was requested for both adults and young children, where available. The basis of the national consumption data was requested. Food additives, for which the calculated intake exceeded the ADI, were moved to tier 3.

3.4. Additives subject to tier-3 screening

At tier 3, two groups of additives were to be examined:

* additives moved to tier 3 from tier 2

* additives with numerical ADIs that are permitted for use at quantum satis

Member States were requested to examine these additives by calculating the actual intake from the national food consumption data combined with actual use levels of the additive.

4. The Monitoring data

4.1. Instructions for reporting the monitoring data

A table containing information on additives and the permitted use levels was provided to the Member States. By adding the information from the national consumption data, the theoretical intake could be calculated (tier 2). The actual intake could be evaluated (tier 3) if both the national consumption data and the additive usage levels were available. It could be calculated by adding the usage level to the table.

For the purpose of the intake report:

* Young children means children under 3 years [8], referring to a bodyweight of 15 kg

[8] Information submitted from the United Kingdom was for children of age range 1½ - 4½ years old referring to bodyweight of 15 kg.

* Adult refers to a bodyweight of 60 kg

Values were requested in:

* mg of additive/day

* % of ADI based on 60 kg bodyweight for an adult or 15 kg for a young child, or on actual bodyweight, which had to be specified.

4.2. The type of monitoring data obtained

The following 6 Member States submitted information to the Commission as requested: Denmark, France, Italy, The Netherlands, Spain [9], the United Kingdom and in addition Norway. Austria, Finland, Germany [10], Ireland, Spain and Sweden submitted information obtained on a basis other than the intake estimation methods defined under the SCOOP task.

[9] Information submitted from Spain was for the whole population. The division between adults and children was made on the basis of the assumption that children represent a percentage of the whole population. As data for children did not come from an actual survey, it was considered appropriate to report only the information for the whole population.

[10] Information for Germany was local data from Bavaria and consisted only of food consumption figures. The information on food additive intake was not provided.

The data were submitted in the form of additive intake tables from the 7 countries in the requested format and 12 reports or notes on national studies.

Intake estimate was reported on average consumption of the population as a whole and in some cases also for high level consumers or special groups of the population.

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The data present the following characteristics:

4.2.1. Age of data

* Collected between 1995 and 1999 for France, Spain (other additives than cyclamate), Austria (adults), Italy, Finland, Sweden, Denmark (nitrates and nitrites in meat and meat products), Ireland (second study) and the Netherlands.

* Collected between 1990 and 1994 for Ireland (first study), Spain (cyclamate), Austria (children over 6 years old, pregnant women, lactating women, elderly, diabetics), Norway and the United Kingdom (children).

* Collected between 1987 and 1989 for Denmark and the United Kingdom (adults).

For the purpose of monitoring the food additive intake in the European Union after the full harmonisation in 1995, the information gathered should have described the situation after the entry into force of the Community legislation. However, some Member States were collecting data between 1987 and 1999. Because collecting food consumption data is very costly, it was considered useful for the purposes of this report to include any data submitted by the Member States, even if it dated from before 1995.

4.2.2. Representativity

Two surveys were performed locally and are, therefore, not considered to be representative of the whole population: In Spain, the intake study of cyclamate in Catalonia, and in Finland, the STRIP (Children's Coronary Heart Disease Risk Factor Intervention) project conducted on children in Turku.

4.2.3. Type of survey

* Recall for Austria (adults), Finland (adults) and Spain (cyclamate).

* Record for Austria (children over 6 years old, pregnant women, lactating women, elderly, diabetics), Denmark, Finland (children), Ireland, Italy, The Netherlands, France, Spain (other additives), and the United Kingdom.

* Food Frequency Questionnaire for Norway and Sweden (diabetics).

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4.2.4. Types of population

* Individuals for Austria, Italy, Finland, Spain (cyclamate), Denmark (nitrates and nitrites in meat and meat products), Ireland, Italy, The Netherlands, France (11 additives - tier 2), Sweden, Norway and the United Kingdom.

* Household for Denmark, France (17 additives - tier 2) and Spain (additives other than cyclamate).

4.2.5. Duration of the survey

* One-day survey in Austria, Finland (adults) and Spain.

* Two-day survey in the Netherlands.

* 4-day survey in Finland (children) and the United Kingdom (children).

* 7-day survey in Austria, Denmark (nitrates and nitrites in meat and meat products), Italy, France (11 additives - tier 2), Spain and the United Kingdom (adults).

* One month collection of typical consumption in Denmark

* One-year record in France (17 additives - tier 2).

5. Intake results

For the purposes of this report, only the data obtained on the basis of the estimation methods defined under the SCOOP task could be used. Data submitted that were obtained on a different basis could not be used because of their incomparability. Nevertheless, it was considered interesting to summarise the information received in Annex VI.

5.1. Tier 1

On the basis of tier 1, it is already possible to exclude a number of food additives from further examination, since the theoretical intake based on conservative assumptions on food consumption and additive usage did not exceed the ADI. For adults, there were 21 additives or additive groups* that were excluded from further examination. For children, 9 additives or additive groups were excluded. These additives are listed in Annex III.

5.2. Tier 2

The outcome of the tier 2 of this first monitoring of dietary food additive intake in the European Union shows relatively consistent results. Using the mean exposure of the population in six Member States and Norway, it is possible to exclude most additives from the list for tier-3 evaluation since the theoretical intake based on actual food consumption data combined with the maximum permitted usage levels for the additive did not exceed the ADI.

For adults and the whole population, the following food additives and food additive groups were excluded from further examination:

* E 210-213 benzoates, E 297 fumaric acid, E 310-312 gallates, E 315-316 erythorbates, E 320 BHA, E 321 BHT, E 355- 357 adipates, E 416 karaya gum, E 442 ammonium phosphatides, E 475 polyglycerol esters, E 476 polyglycerol polyricinoleate, E 479b TOSOM, E 483 stearyl tartrate, E 491/492/495 sorbitan esters, E 535-538 ferrocyanides, E 950 acesulfame K, and E 952 cyclamates.

* All the colours

For children, the following food additives and food additive groups were excluded from further examination:

* E 200-203 sorbates, E 297 fumaric acid, E 310-312 gallates, E 315-316 erythorbates, E 320 BHA, E 355- 357 adipates, E 416 karaya gum, E 442 ammonium phosphatides, E 444 sucrose acetate isobutyrate, E 476 polyglycerol polyricinoleate, E 479b TOSOM, E 951 aspartame, E 952 cyclamates, E 954 saccharin, E 959 neohesperedine DC and E 999 quillaia extract.

* All the colours (except E 160b annatto).

Additives were moved to tier 3 for further detailed intake estimation on the basis that the theoretical intake at tier-2 level approached or exceeded the ADI at least in one Member State or if there was further information suggesting that some groups of consumers may have unusually high intake levels.

For adults and the whole population, the following food additives and food additive groups were moved to tier 3:

* E 220-228 sulphites, E 249-250 nitrites, E 432-436 polysorbates, E 473-474 sucrose esters and sucroglycerides, E 481-482 stearoyl-2-lactylates, E 493-494 sorbitan monolaureate and sorbitan monooleate, E 520-523 aluminium sulphates, E 541 sodium aluminium phosphate and E 554-556/559 aluminium silicates.

For children, the following food additives and food additive groups were moved to tier 3:

* E 160b annatto, E 220-228 sulphites, E 210-213 benzoates, E 249-250 nitrites, E 321 BHT, E 338-341/343/450-452 phosphoric acid and phosphates, E 432-436 polysorbates, E 473-474 sucrose esters and sucroglycerides, E 475 polyglycerol esters, E 481-482 stearoyl-2-lactylates, E 483 stearyl tartrate, E 491-495 sorbitan esters, 535-538 ferrocyanides, E 520-523 aluminium sulphates, E 541 sodium aluminium phosphate, E 554-556/559 aluminium silicates and E 950 acesulfame-K.

In addition, E 558 bentonite (both for adults and children) was moved to tier 3 due to lack of information on the intake of this additive at tier-2 level.

Furthermore, nine additives with numerical ADIs that are permitted for use at quantum satis were moved directly to tier 3 (see Annex IV) because actual use levels are necessary for intake estimations.

Results obtained for the intake of food additives at tier 2 are listed in Annex V for adults and the whole population (Table 1) and for young children (Table 2). The following information is given in the tables: E-number, the specific name and the ADI of the additive, the Member State that provided the information, the range of the intake of the additive expressed as a percentage of the ADI, consequence for tier-estimation.

5.3. Tier 3

No Member State submitted complete information on tier 3 results according to the method agreed.

Discussion

This report is the first attempt to obtain an overview of the dietary food additive intake in the European Union. The results reported must be regarded as a very preliminary indication on the dietary intake of food additives due to the many limitations the current exercise had.

In its request for information on food additive intake, the objective of the Commission was to obtain information from as many Member States as possible. Therefore, a pragmatic approach to use information calculated on the food consumption of the population mean was chosen. However, the use of the population mean does not take into account intake by high-level consumers. On the other hand, the estimates reported here are extremely conservative, since they assume that each additive is used in the widest possible range of foods at the maximum permitted levels, which in many cases leads to over-estimation of the additive intake. Therefore, more precise studies are needed in the future. In several Member States, work is already in progress for gathering information to enable more refined intake estimations to be carried out.

Today, 171 additives and additive groups are permitted for use in the EU. On the basis of the limited data available, it can be concluded that for the majority of these additives, intake is below the ADI set by the Scientific Committee on Food. As a result of tier-2 intake estimations, eight additives or additive groups were prioritised for tier-3 estimations for adults and seventeen additives or additive groups were prioritised for tier-3 estimations for children. The tier-2 values for these additives theoretically exceeded the ADI at least in one Member State or no information was provided on the substance. It should be noted that the range of intake of the same additive could vary considerably between different countries. In addition, nine additives allocated a numerical ADI, but permitted for use in certain foods according to quantum satis, were prioritised for tier-3 examination.

To carry out the tier-3 estimation for these additives, more detailed information should be collected on the real use of additives and on the real food consumption (actual intake, special groups of consumers, high-level consumers). This work should be carried out without delay.

In addition to action being taken on additives prioritised for tier 3, examination should also continue on additives that passed tier 2 and were not prioritised for tier 3. Firstly not all the Member States have studied these additives and, as stated above, the results can vary considerably depending on the country. Secondly, estimation of the intake of these additives should be done also on high-level consumers, not only on the population mean.

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7. Conclusions

ú The Member States should follow up the SCOOP task on methodologies for the monitoring of food additives in order to achieve harmonisation of intake studies of additives in the European Union. In addition, better food consumption data should be gathered in order to estimate dietary food additive intake more accurately.

ú The preliminary results with limited data available indicate that for the majority of food additives the dietary intake is below the acceptable daily intake.

ú For the additives that were moved to tier 3 (see Annex V) and certain additives that are permitted at quantum satis (see Annex IV), intake estimations should be carried out using actual food consumption data combined with the actual usage levels of the additive. The examination should be carried out by all the Member States without delay and the results should be reported to the Commission with a view to initiating necessary action, if any.

ú Intake of additives that did not exceed the ADI in tier 2 should, nevertheless, be re-examined in the light of the more detailed food consumption data (see Annex V).

ú Intake studies should be carried out in respect of the additives which, at the time of this exercise, had only recently been approved.

ú Co-operation with the food industry should be developed with a view to obtaining better information on food additive usage.

ú A new report on the overall situation on food additive intake in the European Union should be compiled in three years time. It is essential that efforts are made by all the Member States to participate fully in the next monitoring task on dietary intake of food additives.

Annex I

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Outline of the tiered approach

Annex II

List of food additives with ADI "not specified", found acceptable for specified use as recommended by the SCF or new additives. These additives were excluded from the examination

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Annex III

Food additives for which the calculated intake in tier 1 did not exceed the ADI. These additives need no further examination at this stage

Table 1: Adults

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Table 2: Young children

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Annex IV

Food additives with numerical ADIs that are permitted for use at quantum satis (moved to tier 3)

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Annex V

Results obtained for the intake of food additives at tier 2

Table 1: Adults and the whole population

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Table 2: Young children

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Annex VI

Other information

All the Member States did not use the intake estimation methods defined under the SCOOP task. The reasons for selecting different methods was based on earlier intake work carried out in some Member States. Other information using non-SCOOP intake methodology was available mainly from Austria, Finland, Ireland, Spain and Sweden.

These countries have based their intake estimations on earlier selective studies, information from the food industry, marketing surveys or product databases. Quite often stepwise or hierarchical approaches have been used; moving from conservative, less refined to more refined exposure estimates.

Food additive occurrence data have been studied using preliminary surveys based on national food ingredient databases in Austria and Ireland. In Finland, similar data were collected using a market survey, based on labelling information. Information on the use of food additives was also provided from laboratories, the food industry or marketing associations. Only when additives were found in specific food categories, was that food category considered in the intake estimation or samples taken to the laboratory for analysis. Quite often these preliminary studies revealed that food additives were not widely used in the products even if they were permitted by legislation (Finland, Ireland).

Austria

Austria submitted a report on a detailed study based on the tiered approach described in the SCOOP report. However, as this study was not reported in accordance with the guidelines sent out by the Commission, it was not possible to include the results in chapter 5 of this report. The reported tier-2 calculation showed that, on the basis of intakes by high-level consumers, the ADI was likely to be exceeded for 15 additives or groups of additives. A tier-3 calculation has been carried out for several additives. Intake calculated for both 'whole population' and for 'consumers only' are reported. While intake by high-level consumers exceeding the ADI was only reported for a few additives based on 'whole population' estimates, intake by high-level consumers exceeding the ADI was reported for several additives based on 'consumers only' estimates.

Finland

Intake estimations (from 1999) submitted by Finland were done at tier-3 level and were targeted especially at children from 1-6 years. Estimations for children's intake were based on individual food consumption and analysed food additive levels in products consumed in Finland. The only food additives for which the ADI was exceeded were nitrites and benzoates.

For adults (consumers only, see box 3) nitrite intake was 93 % of the ADI; for children from 1-6 years (consumers only) 67% of ADI when the actual weight of each child was used. For high level consumers (95th percentile) the intake of children was 121-189 % of the ADI.

The average intake of benzoic acid for adults was 8.6 % of the ADI and with consumers only 113 % of the ADI. Average intake of children was 40 % of the ADI and with high-level consumers (95th percentile) 101-160 % of the ADI.

Ireland

The food additives in the Irish food supply were monitored using the Irish National Food Ingredient Database (INFID). This exercise showed the trend of individual additives' usage between two sampling periods 1995/97 and 1998/99. It also indicated which additives were most widely used in the foods chosen for the study. A number of additives were found not to be present in the foods included in the database.

Following the SCOOP tier-1 exercise, a variety of approaches such as portion size back calculations, food-intake data and nutrient-intake back calculations were used as a second stage screen. This identified 20 additives for further consideration.

Spain

Spain submitted information on cyclamate intake related to a published study conducted in 1992 in a region of Spain (Catalonia). For the cyclamate level in foodstuffs, the study was based on information from industry.

This study can be considered as a "tier 3" survey despite the fact that it is not designed to be representative of the whole population of Spain. The information provides clear indications of the major contribution made by soft drinks to cyclamate exposure and confirms that, even if it was unlikely to have caused any safety concerns at the time of the study, the margin of safety between the exposure and the ADI is small for high consumers of cyclamates.

Sweden

Information submitted by Sweden consists of a report of the Swedish Food Administration on intake of aspartame, acesulfame-K, saccharin and cyclamate among diabetics. This study was conducted in January 1999 on 1120 Swedish diabetic adults (16-90 years) and children (0-15 years).

Concerning sweetened foods, the maximum amount allowed was assumed to have been added. An estimated worst case calculation was performed assuming that all the foods consumed were sweetened by the same sweetener.

This study provides different scenarios for exposure assessment of diabetics, including children, who are a particularly exposed population for artificial sweeteners. The calculations are based on the measurement of intake of sweetened foods and on several assumptions concerning the type and the concentration of the substances in the food commodities. It shows that the intake of aspartame, acesulfame-K, saccharin and cyclamate, can be close to or exceed their respective ADI for the population of diabetics if they consume only one type of sweetener.