Report from the Commission on Dietary Food Additive Intake in the European Union
Date: 2001-10-01
Institutions: European Commission
Subjects: food additive, food inspection, foodstuffs legislation, report

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 01.10.2001
COM(2001) 542 final

REPORT FROM THE COMMISSION

on Dietary Food Additive Intake in the European Union

REPORT FROM THE COMMISSION

on Dietary Food Additive Intake in the European Union

TABLE OF CONTENTS

Executive Summary ...............................................................................................................3

1

2

3

3.1

3.2

3.3

3.4

4

4.1

4.2

Introduction .............................................................................................................. 4

Background .............................................................................................................. 5

The monitoring task.................................................................................................. 7

Additives excluded from the monitoring task and further examination: ..................... 7

Additives subject to tier-1 screening ......................................................................... 7

Additives subject to tier-2 screening ......................................................................... 8

Additives subject to tier-3 screening ......................................................................... 8

The monitoring data.................................................................................................. 8

Instructions for reporting the monitoring data ........................................................... 8

The type of monitoring data obtained........................................................................ 9

4.2.1

Age of data ............................................................................................................... 9

4.2.2

Representativity...................................................................................................... 10

4.2.3

Type of survey........................................................................................................ 10

4.2.4

Types of population ................................................................................................ 10

4.2.5

Duration of the survey ............................................................................................ 10

5

5.1

5.2

5.3

6

7

Intake results .......................................................................................................... 11

Tier 1...................................................................................................................... 11

Tier 2...................................................................................................................... 11

Tier 3...................................................................................................................... 12

Discussion .............................................................................................................. 13

Conclusions ............................................................................................................ 14

2

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.

3

Introduction

The authorisation and use of food additives in the European Union are based on the
framework Directive 89/107/EEC1 on food additives. On the basis of the framework
three specific directives were adopted by the Council and European
Directive,
Parliament: on sweeteners (Directive 94/35/EC2), colours (Directive 94/36/EC3) and on
additives other than colours and sweeteners (Directive 95/2/EC4). Since the adoption of
the last directive in 1995, legislation on food additives has been fully harmonised in the
European Union.

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.

1

2

3

4

O.J. n° L 40, 11.2.1989, p. 27
O.J. n° L 237, 10.09.1994, p.1
O.J. n° L 237, 10.09.1994, p. 13
O.J. n° L 61, 18.03.1995, p. 1

4

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
food5, a task was set up on “Methodologies for monitoring of food additive intakes”
(SCOOP Task 4.2). The objectives of the task were:

• 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 19986.

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.

5

6

O.J. n° L 052, 04.03.1993, p. 18
The scientific co-operation report on development of methodologies for the monitoring of food
additive intake across the European Union (SCOOP/INT/REPORT/2)

5

Box 1:

Scientific Committee on Food (SCF) = A scientific advisory body to the European
Commission on any problem relating to the protection of the health and safety of persons
arising or likely to arise from the consumption of food.

Scientific co-operation (SCOOP) = Assistance to the European Commission and co-
operation by the Member States in the scientific examination of questions relating to
food.

Intake = The amount of food additive ingested in the diet (calculated as food
consumption x food additive concentration).

Acceptable daily intake (ADI) = The amount of a food additive, expressed as mg/kg
body weight, that can be ingested daily over a lifetime without incurring any appreciable
health risk. The ADI is based on an evaluation of available toxicological data and
established by identifying the No-Observed-Adverse-Effect-Level (NOAEL) in the most
sensitive experiment among a battery of studies in test animals performed with the test
compound and extrapolating to man by dividing the NOAEL with a safety factor of
usually 100.

ADI “not specified” = A term used when, on the basis of the available toxicological,
biochemical and clinical data, the total intake of the substance, arising from its natural
occurrence and/or its present use or uses in food at the levels necessary to achieve the
desired technological effect, will not represent a hazard to health. For this reason, the
establishment of a numerical limit for the ADI is not considered necessary for the
substance.

Maximum usage level = Highest level of a food additive permitted in foodstuff to
achieve an intended technological effect. The levels are set in the specific directives: for
sweeteners in Directive 94/35/EC, for colours in Directive 94/36/EC and for additives
other than colours and sweeteners in Directive 95/2/EC.

Quantum satis = no maximum level is specified for the additive in question. However,
the additive shall be used in accordance with good manufacturing practice, at a level not
higher than necessary to achieve the intended purpose and provided that it does not
mislead the consumer (Article 2(8) of Directive 95/2/EC).

In the tiered approach (see box 2), tier 1 is based on theoretical food consumption data7
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.

6

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.

Box 2:

TIER 1 = theoretical food consumption data combined with the maximum permitted
usage levels for the additive

TIER 2 = actual national food consumption data combined with the maximum
permitted usage levels for the additive

TIER 3 = actual national food consumption data combined with the actual usage
levels of the additive

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.

7

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

theoretical

intake was calculated by combining the mean national

In tier 2 the additives from tier 1 that exceeded the calculated intake were examined.
food
Their
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 years8, referring to a bodyweight of 15 kg

• Adult refers to a bodyweight of 60 kg

Values were requested in:

• mg of additive/day

8

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

8

• % 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, Spain9, the United Kingdom and in addition
Norway. Austria, Finland, Germany10, Ireland, Spain and Sweden submitted information
obtained on a basis other than the intake estimation methods defined under the SCOOP
task.

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.

Box 3:

Mean population intake = total food additive intake divided by the whole population

Mean intake for consumers only = total food additive intake divided by the number of
actual consumers of the additive

High level consumer = a consumer with a high intake of the additive based on the
distribution of individual intake values for actual consumers

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

9

10

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

9

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).

Box 4:

Recall = based on memory of food consumption prior to the interview

Record = food consumption recorded systematically by the consumer over a set period
of time

Food frequency questionnaire (quantitative) = the consumer reports the frequency and
amount of food consumed

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).

10

• 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:

*

Additive group = closely related substances that have been allocated a group ADI (e.g. phosphoric
acid and phosphates, saccharin and its salts etc.)

11

*
• 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.

12

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.

13

7.
▪

▪

▪

▪

▪

▪

▪

CONCLUSIONS

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.

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

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.

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).

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

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

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.

14

Annex I

Outline of the tiered approach

All authorized food additives

Numerical ADI

ADI not specified

Authorized at
quantum satis

Authorized with maximum
permitted level

• Authorized for very
specific uses only
• Recently authorized

ADI was not exceeded in
TIER 1

ADI was not exceeded in
TIER 2

ADI was not exceeded in
TIER 3

TIER 1
Theoritical food consumption x
maximum permitted usage of
additive

ADI was exceeded in
TIER 1

TIER 2
Actual food consumption x
maximum permitted usage of
additive

ADI was exceeded in
TIER 2

TIER 3
Actual food consumption x
actual usage of additive

ADI was exceeded in
TIER 3

Moved to next step in tiered approach

No further examination required

15

Annex II

E No

Name

Tocopherol-rich extract
Alpha-tocopherol
Gamma-tocopherol
Delta-tocopherol
Lecithins
Citric acid
Sodium citrates
Potassium citrates
Calcium citrates
Metatartaric acid
Succinic acid
Triammonium citrate
Alginic acid
Sodium alginate
Potassium alginate
Ammonium alginate
Calcium alginate
Agar
Processed eucheuma seeweed
Locust bean gum
Guar gum
Tragacanth
Acacia gum (gum arabic)
Xanthan gum
Tara gum
Gellan gum
(i) Sorbitol
(ii) Sorbitol syrup
Mannitol
Glycerol
(i) Konjac gum
(ii) Konjac glucomannane
Polyoxyethylene (40) stearate
Pectins
Beta-cyclodextrine
Cellulose
Methyl cellulose
Hydroxypropyl cellulose
Hydroxypropyl methyl cellulose
Ethyl methyl cellulose
Carboxy methyl cellulose
Enzymatically hydrolysed carboxy
methyl cellulose
Crosslinked
methyl cellulose
Sodium, potassium and calcium
salts of fatty acids
Magnesium salts of fatty acids

carboxy

sodium

found acceptable

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

E No

E 100
E 101

E 140
E 150a
E 153
E 160d
E 161b
E 162
E 163
E 170
E 171
E 172
E 173
E 174
E 175
E 230
E 231
E 232
E 235
E 239
E 242
E 260
E 261
E 262
E 263
E 270
E 325
E 326
E 327
E 280
E 281
E 282
E 283
E 284
E 285
E 290
E 296
E 350
E 351
E 352
E 300
E 301
E 302
E 304

Name

Polyethyleneglycol 6000
Curcumin
(i) Riboflavin
(ii) Riboflavin-5’phosphate
Chlorophyls and Chlorophyllins
Plain caramel
Vegetable carbon
Lycopene
Lutein
Beetroot Red, betanin
Anthocyanins
Calcium carbonates
Titanium dioxide
Iron oxides and hydroxides
Aluminium
Silver
Gold
Biphenyl, diphenyl
Orthophenyl phenol
Sodium orthophenyl phenol
Natamycin
Hexamethylene tetramine
Dimethyl dicarbonate
Acetic acid
Potassium acetate
Sodium acetates
Calcium acetate
Lactic acid
Sodium lactate
Potassium lactate
Calcium lactate
Propionic acid
Sodium propionate
Calcium propionate
Potassium propionate
Boric acid
Sodium tetraborate (Borax)
Carbon dioxide
Malic acid
Sodium malates
Potassium malate
Calcium malates
Ascorbic acid
Sodium ascorbate
Calcium ascorbate
Fatty acid esters of ascorbic acid

E 306
E 307
E 308
E 309
E 322
E 330
E 331
E 332
E 333
E 353
E 363
E 380
E 400
E 401
E 402
E 403
E 404
E 406
E 407a
E 410
E 412
E 413
E 414
E 415
E 417
E 418
E 420

E 421
E 422
E 425

E 431
E 440
E 459
E 460
E 461
E 463
E 464
E 465
E 466
E 469

E 468

E 470a

E 470b

16

E No
E 471

E 472a

E 472b

E 472c

E 472d

E 472f

E 500
E 501
E 503
E 504
E 507
E 508
E 509
E 511
E 512
E 513
E 514
E 515
E 516
E 517
E 524
E 525
E 526
E 527
E 528
E 529
E 530
E 551
E 552
E 553a
E 553b
E 570
E 574
E 575
E 576
E 577
E 578
E 579
E 585
E 620
E 621
E 622
E 623
E 624
E 625

of

mono

Name
Mono and diglycerides of
fatty acids
Acetic acid esters of mono
and diglycerides of fatty acids
Lactic acid esters of mono and
diglycerides of fatty acids
Citric acid esters of mono and
diglycerides of fatty acids
Tartaric acid esters of mono
and diglycerides of fatty acids
Mixed acetic and tartaric acid
esters
and
diglycerides of fatty acids
Sodium carbonates
Potassium carbonates
Ammonium carbonates
Magnesium carbonates
Hydrochloric acid
Potassium chloride
Calcium chloride
Magnesium chloride
Stannous chloride
Sulphuric acid
Sodium sulphates
Potassium sulphates
Calcium sulphate
Ammonium sulphate
Sodium hydroxide
Potassium hydroxide
Calcium hydroxide
Ammonium hydroxide
Magnesium hydroxide
Calcium oxide
Magnesium oxide
Silicon dioxide
Calcium silicate
Magnesium silicates
Talc
Fatty acids
Gluconic acid
Glucono-delta-lactone
Sodium gluconate
Potassium gluconate
Calcium gluconate
Ferrous gluconate
Ferrous lactate
Glutamic acid
Monosodium glutamate
Monopotassium glutamate
Calcium diglutamate
Monoammonium glutamate
Magnesium diglutamate

E No

Name

Guanylic acid
Disodium guanylate
Dipotassium guanylate
Calcium guanylate
Inosinic acid
Disodium inosinate
Dipotassium inosinate
Calcium inosinate
Calcium 5’-ribonucleotides
Disodium 5’-ribonucleotides
Glycine and its sodium salt
Zinc acetate
Beeswax, white and yellow
Candelilla wax
Carnauba wax
Shellac
Microcrystalline wax
Montan acid esters
Oxidised polyethylene wax
L-Cysteine
Carbamide
Argon
Helium
Nitrogen
Nitrous oxide
Butane
Iso-butane
Propane
Oxygen
Hydrogen
Isomalt
Thaumatine
(i) Maltitol (ii) Maltitol syrup
Lactitol
Xylitol
Invertase
Lysozyme
Polydextrose
Polyvinylpyrrolidone
Polyvinylpolypyrrolidone
Oxidised starch
Monostarch phosphate
Distarch phosphate
Phosphated
phosphate
Acetylated distarch phosphate
Acetylated starch
Acetylated distarch adipate
Hydroxy propyl starch
Hydroxy
phosphate
Starch
succinate
Acetylated oxidised starch
Glyceryl triacetate (triacetine)
Propan-1,2-diol

sodium

propyl

distarch

octenyl

distarch

E 626
E 627
E 628
E 629
E 630
E 631
E 632
E 633
E 634
E 635
E 640
E 650
E 901
E 902
E 903
E 904
E 905
E 912
E 914
E 920
E 927b
E 938
E 939
E 941
E 942
E 943a
E 943b
E 944
E 948
E 949
E 953
E 957
E 965
E 966
E 967
E 1103
E 1105
E 1200
E 1201
E 1202
E 1404
E 1410
E 1412
E 1413

E 1414
E 1420
E 1422
E 1440
E 1442

E 1450

E 1451
E 1518
E 1520

17

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

Annex III

E No

Table 1: Adults

Name

E 102
E 104
E 123
E 129
E 131
E 133
E 154
E 200
E 202
E 203
E 214
E 215
E 216
E 217
E 218
E 219
E 234
E 251
E 252
E 338
E 339
E 340
E 341
E 343
E 450
E 451
E 452
E 385

E 405
E 477
E 444
E 445
E 900
E 951
E 954
E 959
E 999

Tartrazine
Quinoline Yellow
Amaranth
Allura Red AC
Patent Blue V
Brilliant Blue FCF
Brown FK
Sorbic acid
Potassium sorbate
Calcium sorbate
Ethyl p-hydroxybenzoate
Sodium ethyl p-hydroxybenzoate
Propyl p-hydroxybenzoate
Sodium propyl p-hydroxybenzoate
Methyl p-hydroxybenzoate
Sodium methyl p-hydroxybenzoate
Nisin
Sodium nitrate
Potassium nitrate
Phosphoric acid
Sodium phosphates
Potassium phosphates
Calcium phosphates
Magnesium phosphates
Diphosphates
Triphosphates
Polyphosphates
Calcium disodium ethylene diamine
(EDTA)
Propane-1,2-diol alginate
Propane-1,2-diol esters of fatty acids
Sucrose acetate isobutyrate
Glycerol esters of wood rosin
Dimethyl polysiloxane
Aspartame
Saccharin and its sodium, calcium and potassium salts
Neohesperidine dihydrochalcone (DC)
Quillaia extract

tetra-acetate

ADI
7.5 mg/kg
10 mg/kg
0.8 mg/kg
7 mg/kg
15 mg/kg
10 mg/kg
0.15 mg/kg
25 mg/kg

10 mg/kg

0.13 mg/kg
5 mg/kg

70 mg/kg

2.5 mg/kg

25 mg/kg

10 mg/kg
12.5 mg/kg
1.5 mg/kg
40 mg/kg
5 mg/kg
5 mg/kg
5 mg/kg

18

ADI
0.8 mg/kg
0.15 mg/kg
10 mg/kg

0.13 mg/kg
5 mg/kg

tetra-acetate

2.5 mg/kg

25 mg/kg

12.5 mg/kg
1.5 mg/kg

Table 2: Young children

E No

Name

E 123
E 154
E 214
E 215
E 216
E 217
E 218
E 219
E 234
E 251
E 252
E 385

E 405
E 477
E 445
E 900

Amaranth
Brown FK
Ethyl p-hydroxybenzoate
Sodium ethyl p-hydroxybenzoate
Propyl p-hydroxybenzoate
Sodium propyl p-hydroxybenzoate
Methyl p-hydroxybenzoate
Sodium methyl p-hydroxybenzoate
Nisin
Sodium nitrate
Potassium nitrate
Calcium disodium ethylene
(EDTA)
Propane-1,2-diol alginate
Propane-1,2-diol esters of fatty acids
Glycerol esters of wood rosin
Dimethyl polysiloxane

diamine

19

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

Annex IV

E No

E 141
E 150b
E 150d
E 150c
E 160a(ii)
E 160e
E 160f
E 180
E 334
E 335
E 336
E 337
E 354
E 407
E 472e

E 1505

Name
Copper complexes of Chlorophyls and Chlorophyllins
Caustic sulphite caramel
Sulphite ammonia caramel
Ammonia caramel
Beta-carotene
Beta-apo-8-carotenal
Ethyl ester of beta-apo-8-carotenoic acid
Litholrubine BK
Tartaric acid
Sodium tartrates
Potassium tartrates
Sodium potassium tartrate
Calcium tartrate
Carrageenan
Mono- and diacetyltartaric acid esters of mono- and
diglycerides of fatty esters
Triethyl citrate

ADI
15 mg/kg
200 mg/kg

200 mg/kg
5 mg/kg11

1.5 mg/kg
30 mg/kg

75 mg/kg
25 mg/kg

20 mg/kg

11

The Scientific Committee on Food withdrew the ADI for betacarotene (opinion adopted on 7 September
2000) and stated that its use is temporarily acceptable as a food colour with currently estimated intake.

20

Annex V

Results obtained for the intake of food additives at tier 2

Table 1: Adults and the whole population

E No

Name of the additive

ADI

Member States
producing intake
information

Range of
estimated
intake
(% ADI)

Stays at
tier 2 or
moved to
tier 3

acid,

Carminic

E 110

E 120

Sunset Yellow FCF
Orange Yellow 5
Cochineal,
Carmines
Azorubine, Carmoisine
Ponceau 4R, Cochineal Red A
Erythrosine
Red 2G
Indigotine, Indigo carmine
Green S
Brilliant Black BN, Black PN
Brown HT

E 122
E 124
E 127
E 128
E 132
E 142
E 151
E 155
E 160b Annatto, bixin, norbixin
Canthaxanthin
E 161g
Benzoic acid
E 210
Sodium benzoate
E 211
Potassium benzoate
E 212
Calcium benzoate
E 213
E 220
Sulphur dioxide
E 221
Sodium sulphite
E 222
Sodium hydrogen sulphite
E 223
Sodium metabisulphite
E 224
Potassium metabisulphite
E 226
Calcium sulphite
E 227
Calcium hydrogen sulphite
E 228
Potassium hydrogen sulphite
Potassium nitrite
E 249
Sodium nitrite
E 250
Fumaric acid
E 297
E 310
Propyl gallate
E 311
Octyl gallate
E 312
Dodecyl gallate
Erythorbic acid
E 315
Sodium erythorbate
E 316
Butylated hydroxyanisole (BHA)
E 320
Butylated hydroxytoluene (BHT)
E 321
E 355
Adipic acid
E 356
Sodium adipate
E 357
Potassium adipate
Karaya gum
E 416
Ammonium phosphatides
E 442

2.5 mg/kg

DK, ES, IT, UK, NO

2 – 26

Tier 2

5 mg/kg

DK, ES, IT, UK, NO

3 – 22

Tier 2

4 mg/kg
4 mg/kg
0,1 mg/kg
0,1 mg/kg
5 mg/kg
5 mg/kg
5 mg/kg
3 mg/kg
0.065 mg/kg
0.03 mg/kg
5 mg/kg

DK, ES, IT, UK, NO
DK, ES, IT, UK, NO
DK, ES, IT, UK
DK, ES, IT, UK, NO
DK, ES, IT, UK. NO
DK, ES, IT, UK, NO
DK, ES, IT, UK, NO
DK, ES, IT, UK, NO
ES, FR, IT, UK, NO
ES, FR, IT, UK
DK, ES, FR,
UK, NO

IT, NL,

3 – 16
3 –16
0
2 – 20
2 – 13
3 – 20
3 – 20
3 – 22
0 - 62
0
6 - 84

Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2

0.7 mg/kg

DK, ES, FR,
UK, NO

IT, NL,

20 - 26612

Tier 3

0.1 mg/kg

6 mg/kg
0.5 mg/kg

IT, NL,

DK, ES, FR,
UK, NO
DK, ES, FR, NL, UK
DK, ES, NL, UK

1- 17
12 - 34

40 - 23012

Tier 3

6 mg/kg

DK, ES, FR, IT, NL, UK 1- 24

0.5 mg/kg
0.05 mg/kg
5 mg/kg

DK, ES, FR, IT, NL, UK 12 - 37
DK, ES, FR, IT, NL, UK 23 - 80
2 – 20
DK, FR, UK

12.5 mg/kg
30 mg/kg

DK, ES, IT, NL, UK
0 – 65
DK, ES, FR, IT, NL, UK 1 – 11

Tier 2
Tier 2

Tier 2

Tier 2
Tier 2
Tier 2

Tier 2
Tier 2

12

Conservative intake estimate based on the assumption that the additive is used in the widest possible
range of foods and at maximum permitted levels. Work is in progress to refine intake estimates using
actual usage data, which will considerably reduce the degree of overestimation in the current figure

21

E No

Name of the additive

ADI

Member States
producing intake
information

10 mg/kg

DK, ES, FR, IT, NL, UK

Range of
estimated
intake
(% ADI)

2 – 78
(QS uses)

Stays at
tier 2 or
moved to
tier 3
Tier 313

E 432

E 433

E 434

E 435

E 436

E 475

E 476
E 479b

E 481
E 482
E 483

E 491
E 492
E 495
E 493
E 494
E 520
E 521
E 522
E 523
E 541
.
E 554
E 555
E 556
E 559
E 535
E 536
E 538
E 558
E 950
E 952

E 1505

Polyoxyethylene sorbitan
monolaurate (polysorbate 20)
Polyoxyethylene sorbitan
monooleate (polysorbate 80)
Polyoxyethylene sorbitan
monopalmitate (polysorbate 40)
Polyoxyethylene sorbitan
monostearate (polysorbate 60)
Polyoxyethylene sorbitan tristearate
(polysorbate 65)
Polyglycerol esters of fatty acids

Polyglycerol polyricinoleate
Thermally oxidised soya bean oil
(TOSOM)
Sodium stearoyl-2-lactylate
Calcium stearoyl-2-lactylate
Stearyl tartrate

Sorbitan monostearate
Sorbitan tristearate
Sorbitan monopalmitate
Sorbitan monolaurate
Sorbitan monooleate
Aluminium sulphate
Aluminium sodium sulphate
Aluminium potassium sulphate
Aluminium ammonium sulphate
Sodium aluminium phosphate,
acidic
Sodium aluminium silicate
Potassium aluminium silicate
Calcium aluminium silicate
Aluminium silicate
Sodium ferrocyanide
Potassium ferrocyanide
Calcium ferrocyanide
Bentonite
Acesulfame-K
Cyclamic acid and its sodium and
calcium salts
Triethyl citrate

25 mg/kg

7.5 mg/kg
25 mg/kg

20 mg/kg

20 mg/kg

25 mg/kg

DK, ES, FR, IT, NL, UK,
NO
DK, ES, FR, NL, UK, NO 4 – 33
1 – 10
DK, NL, UK, NO

3 – 53

Tier 2

Tier 2
Tier 2

DK, ES, FR, IT, NL, UK,
NO
DK, ES, FR, IT, NL, UK,
NO
DK, ES, FR, IT, NL, UK,
NO

2 – 11412

Tier 3

1 – 98

Tier 2

3 – 75

Tier 2

5 mg/kg

DK, ES, IT, NL, UK, NO

16 – 35412

Tier 3

7 mg/kg14

DK, FR, IT, NL, UK, NO

6 – 62412

Tier 3

0.03 mg/kg

DK, IT, NL, NO

0

Tier 2

7 mg/kg14
9 mg/kg
11 mg/kg15

DK, FR, IT, NL, UK, NO
DK, FR, IT, NL, UK, NO

20 mg/kg

DK

No info
2 –37
0 – 10

0
(QS uses)

Tier 3
Tier 2
Tier 2

Tier 313

13

14

15

Even if the intake of this additive did not exceed the ADI at tier-2 estimation, it has been prioritised for
tier 3 as it has some uses that are permitted at quantum satis.
Provisional tolerable weekly intake (PTWI)
The SCF allocated a new ADI for cyclamic acid (7 mg/kg) on 13 March 2000.

22

Table 2: Young children

E No

Name of the additive

ADI

Member States
producing intake
information

Range of
estimated
intake
(% ADI)

Stays at tier 2
or moved to
tier 3

E 102
E 104
E 110

E 120
E 122
E 124
E 127
E 128
E 129
E 131
E 132
E 133
E 142
E 151
E 155
E 160b
E 161g
E 200
E 202
E 203
E 210
E 211
E 212
E 213
E 220
E 221
E 222
E 223
E 224
E 226
E 227
E 228
E 249
E 250
E 297
E 310
E 311
E 312
E 315
E 316

Tartrazine
Quinoline yellow
Sunset Yellow FCF
Orange Yellow 5
Cochineal, Carminic acid, Carmines
Azorubine, Carmoisine
Ponceau 4R, Cochineal Red A
Erythrosine
Red 2G
Allura Red AC
Patent Blue V
Indigotine, Indigo carmine
Brilliant Blue FCF
Green S
Brilliant Black BN, Black PN
Brown HT
Annatto, bixin, norbixin
Canthaxanthin
Sorbic acid
Potassium sorbate
Calcium sorbate
Benzoic acid
Sodium benzoate
Potassium benzoate
Calcium benzoate
Sulphur dioxide
Sodium sulphite
Sodium hydrogen sulphite
Sodium metabisulphite
Potassium metabisulphite
Calcium sulphite
Calcium hydrogen sulphite
Potassium hydrogen sulphite
Potassium nitrite
Sodium nitrite
Fumaric acid
Propyl gallate
Octyl gallate
Dodecyl gallate
Erythorbic acid
Sodium erythorbate

7.5 mg/kg
10 mg/kg
2.5 mg/kg

UK
UK
UK

5 mg/kg
4 mg/kg
4 mg/kg
0.1 mg/kg
0.1 mg/kg
7 mg/kg
15 mg/kg
5 mg/kg
10 mg/kg
5 mg/kg
5 mg/kg
3 mg/kg
0.065 mg/kg
0.03 mg/kg
25 mg/kg

UK
UK
UK
UK
UK
UK
UK
UK
UK
UK
UK
UK
FR, UK
UK
UK

52
20
80

80
50
50
0
40
55
13
40
38
76
76
67
108 - 17012
0
76

Tier 2
Tier 2
Tier 2

Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 2
Tier 3
Tier 2
Tier 2

5 mg/kg

FR, UK

17 – 96

Tier 3

0.7 mg/kg

FR, UK

83 - 122712

Tier 3

0.1 mg/kg

FR, UK

6 mg/kg
0.5 mg/kg

FR, NL, UK
NL, UK

50 – 36012

6 – 66
17 – 70

Tier 3

Tier 2
Tier 2

6 mg/kg

NL, UK

1 – 80

Tier 2

23

E No

Name of the additive

ADI

Member States
producing intake
information

Range of
estimated
intake
(% ADI)

Stays at tier 2
or moved to tier
3

E 338
E 339
E 340
E 341
E 343
E 450
E 451
E 452
E 355
E 356
E 357
E 416
E 432

E 433

E 434

E 435

E 436

E 442
E 444
E 473
E 474
E 475
E 476
E 479b

E 481
E 482
E 483
E 491
E 492
E 495
E 493
E 494

Phosphoric acid
Sodium phosphates
Potassium phosphates
Calcium phosphates
Magnesium phosphates
Diphosphates
Triphosphates
Polyphosphates
Adipic acid
Sodium adipate
Potassium adipate
Karaya gum
Polyoxyethylene sorbitan
monolaurate (polysorbate 20)
Polyoxyethylene sorbitan
monooleate (polysorbate 80)
Polyoxyethylene sorbitan
monopalmitate (polysorbate 40)
Polyoxyethylene sorbitan
monostearate (polysorbate 60)
Polyoxyethylene sorbitan
tristearate (polysorbate 65)
Ammonium phosphatides
Sucrose acetate isobutyrate
Sucrose ester of fatty acids
Sucroglycerides
Polyglycerol esters of fatty acids
Polyglycerol polyricinoleate
Thermally oxidised soya bean oil
(TOSOM)
Sodium stearoyl-2-lactylate
Calcium stearoyl-2-lactylate
Stearyl tartrate
Sorbitan monostearate
Sorbitan tristearate
Sorbitan monopalmitate
Sorbitan monolaurate
Sorbitan monooleate

70 mg/kg

NL, UK

53 - 17212

Tier 3

5 mg/kg

NL, UK

3 – 7

Tier 2

12.5 mg/kg NL, UK
NL, UK
10 mg/kg

17 – 48
47 – 10712
(QS uses)

Tier 2
Tier 3

30 mg/kg
10 mg/kg
20 mg/kg

25 mg/kg
7.5 mg/kg
25 mg/kg

NL, UK
UK
FR, NL, UK

FR, NL, UK
FR, NL, UK
NL, UK

20 mg/kg

FR, NL, UK

20 mg/kg
25 mg/kg

FR, NL, UK
FR, NL, UK

8 – 33
13
226 – 37512

114 – 16012
49 – 53
5

136 – 26812

49 – 11212
150 – 19012

Tier 2
Tier 2
Tier 3

Tier 3
Tier 2
Tier 2

Tier 3

Tier 3
Tier 3

5 mg/kg

NL, UK

657 – 80212

Tier 3

24

E No

Name of the additive

ADI

Member States
producing intake
information

Range of
estimated
intake
(% ADI)

Stays at tier 2
or moved to tier
3

E 520
E 521
E 522
E 523
E 541

E 554
E 555
E 556
E 559
E 535
E 536
E 538
E 558
E 950
E 951
E 952

E 954

E 959

E 999

Aluminium sulphate
Aluminium sodium sulphate
Aluminium potassium sulphate
Aluminium ammonium sulphate
Sodium aluminium phosphate,
acidic
Sodium aluminium silicate
Potassium aluminium silicate
Calcium aluminium silicate
Aluminium silicate
Sodium ferrocyanide
Potassium ferrocyanide
Calcium ferrocyanide
Bentonite
Acesulfame-K
Aspartame
Cyclamic acid and its sodium and
calcium salts
Saccharin and its sodium, calcium
and potassium salts
Neohesperidine
(DC)
Quillaia extract

dihydrochalcone

7 mg/kg14

FR, NL, UK

40 – 75012

Tier 3

0.03 mg/kg

No info

Tier 3

7 mg/kg14
9 mg/kg
40 mg/kg
11 mg/kg

FR, NL, UK
NL, UK
FR, NL, UK

5 mg/kg

FR, NL, UK

5 mg/kg

NL, UK

5 mg/kg

FR, NL, UK

No info
3 – 10712
1 – 40
1 – 74

2 – 51

1 – 18

1 – 71

Tier 3
Tier 3
Tier 2
Tier 2

Tier 2

Tier 2

Tier 2

25

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.

26

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.

including
This study provides different scenarios for exposure assessment of diabetics,
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.

27