Report from the commission

REPORT FROM THE COMMISSION
on Dietary Food Additive Intake in the European Union
TABLE OF CONTENTS
European Parliament and Council Directives 94/35/EC, 94/36/EC and 95/2/EC requireeach Member State to monitor the consumption and usage of food additives. TheCommission is required to submit a report on this monitoring exercise to the EuropeanParliament and Council. Ten Member States and Norway, acting under EU Scientific Co-operation, have beenworking together to develop a tiered approach to evaluate dietary intake of foodadditives. The 'tiers' described are essentially additive intake estimation methods thatprogress in complexity and data requirements, intended to produce gradually a moreaccurate estimate of the additive intake. Where results of the estimates in a tier indicatethat an ADI is unlikely ever to be exceeded, the additives in question are eliminated fromfurther consideration. Resources can then be focused on the remaining additives for amore refined intake estimate. It must be emphasised that these tiers are essentially toolsfor establishing priorities for further monitoring. This report represents a first attempt to obtain an overview of the dietary food additiveintake in the European Union. Even if the results must be regarded as a very preliminaryindication on the dietary intake of food additives, they indicate that the intake of themajority of food additives permitted today in the European Union is below theacceptable daily intake (ADI) set by the Scientific Committee on Food. This report has many limitations. Food consumption data used was insufficient toestimate accurately food additive intake leading to worst case assumptions andconsequent over-estimations of intake. Also several Member States did not use theagreed methodology for estimation of additive intake, leading to lack of comparability ofthe collected data. This highlights the need for Member States to apply the agreed,harmonised methodology to ensure consistency of approach and to allocate adequateresources for all future intake estimations. The current study should then be repeated anda new report should be drawn up within three years from now. The authorisation and use of food additives in the European Union are based on theframework Directive 89/107/EEC1 on food additives. On the basis of the frameworkDirective, three specific directives were adopted by the Council and EuropeanParliament: on sweeteners (Directive 94/35/EC2), colours (Directive 94/36/EC3) and onadditives other than colours and sweeteners (Directive 95/2/EC4). Since the adoption ofthe last directive in 1995, legislation on food additives has been fully harmonised in theEuropean 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 shallestablish a monitoring system for the consumption of food additives. The objective is tomonitor food additive consumption and to ensure that their use does not exceed theacceptable 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. TheSCOOP task was finalised in January 1998.
In August 1999 the Commission sent to the Member States guidelines on how to reporttheir findings to the Commission. Information was received from the following MemberStates: Austria, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands,Spain, Sweden and the United Kingdom. The other Member States had not been able tocarry out the exercise due to lack of resources. From the EFTA countries, Norwaysubmitted information to the Commission.
The report describes the monitoring task, how the results were reported and what kind ofinformation was received. The food consumption data used for the intake calculations aredescribed. Intake results are listed in tables for adults and children separately. The reportalso draws conclusions with regard to future work.
The report represents a first attempt to obtain an overview of the food additive intake inthe European Union. It must be regarded as a very preliminary indication of the dietaryintake of food additives.
The Commission would like to thank Dr Wendy Matthews from the United KingdomFood Standards Agency, Dr Inge Meyland from the Danish Veterinary and FoodAdministration, Dr Pirjo-Liisa Penttilä from the Finnish National Food Administrationand Dr Philippe Verger from the Institut National de la Recherche Agronomique (INRA),for assisting the Commission in drafting this report.
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 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 tofood5, 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 • 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 theUnited Kingdom. In addition, Norway participated in the task. The report was producedin January 19986.
The participants of the SCOOP task reviewed the relevant methods for estimating theintake of food additives and proposed a tiered approach, which could be used by theMember States to meet the monitoring requirements set out in EC directives. Accordingto the report, "monitoring of additive intake should concentrate on discovering whetherthe exposure of consumers to any food additives regularly exceeds the acceptable dailyintake (ADI)". This information can then be used by the Community regulator todetermine 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.
O.J. n° L 052, 04.03.1993, p. 18 The scientific co-operation report on development of methodologies for the monitoring of foodadditive intake across the European Union (SCOOP/INT/REPORT/2) 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 data7and 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 levelsfor the additive (tier 2) and with its actual usage patterns (tier 3).
Hansen, S. (1979). Conditions for Use of Food Additives Based on a Budget for an AcceptableDaily 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 ofsome additives, expressed on a bodyweight basis, may be markedly higher than that ofadults. Therefore, in the SCOOP task, it was concluded that adults and children should becovered by a separate assessment.
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
THE MONITORING TASK
The monitoring task was carried out in a stepwise manner. An overview of the methodused is given in Annex I.
Additives excluded from the monitoring task:
Because priorities had to be set, it was decided to exclude from the monitoring exercise aseries 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, thetotal 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 foodcategories.
• 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.
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. Theseadditives 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.
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.
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.
THE MONITORING DATA
Instructions for reporting the monitoring data
A table containing information on additives and the permitted use levels was provided tothe Member States. By adding the information from the national consumption data, thetheoretical intake could be calculated (tier 2). The actual intake could be evaluated (tier3) if both the national consumption data and the additive usage levels were available. Itcould 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 Information submitted from the United Kingdom was for children of age range 1½ - 4½ years oldreferring to bodyweight of 15 kg.
• % 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.
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 additionNorway. Austria, Finland, Germany10, Ireland, Spain and Sweden submitted informationobtained on a basis other than the intake estimation methods defined under the SCOOPtask.
The data were submitted in the form of additive intake tables from the 7 countries in therequested format and 12 reports or notes on national studies.
Intake estimate was reported on average consumption of the population as a whole and insome cases also for high level consumers or special groups of the population.
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: 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 andmeat 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 thefull harmonisation in 1995, the information gathered should have described the situation Information submitted from Spain was for the whole population. The division between adults andchildren was made on the basis of the assumption that children represent a percentage of thewhole population. As data for children did not come from an actual survey, it was consideredappropriate to report only the information for the whole population.
Information for Germany was local data from Bavaria and consisted only of food consumptionfigures. The information on food additive intake was not provided.
after the entry into force of the Community legislation. However, some Member Stateswere collecting data between 1987 and 1999. Because collecting food consumption datais very costly, it was considered useful for the purposes of this report to include any datasubmitted by the Member States, even if it dated from before 1995.
Two surveys were performed locally and are, therefore, not considered to berepresentative of the whole population: In Spain, the intake study of cyclamate inCatalonia, and in Finland, the STRIP (Children's Coronary Heart Disease Risk FactorIntervention) project conducted on children in Turku.
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).
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
Types of population • Individuals for Austria, Italy, Finland, Spain (cyclamate), Denmark (nitrates and nitrites in meat and meat products), Ireland, Italy, The Netherlands, France (11additives - tier 2), Sweden, Norway and the United Kingdom.
• Household for Denmark, France (17 additives - tier 2) and Spain (additives other than 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).
For the purposes of this report, only the data obtained on the basis of the estimationmethods defined under the SCOOP task could be used. Data submitted that wereobtained on a different basis could not be used because of their incomparability.
Nevertheless, it was considered interesting to summarise the information received inAnnex VI.
On the basis of tier 1, it is already possible to exclude a number of food additives fromfurther examination, since the theoretical intake based on conservative assumptions onfood consumption and additive usage did not exceed the ADI. For adults, there were 21additives 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.
The outcome of the tier 2 of this first monitoring of dietary food additive intake in theEuropean Union shows relatively consistent results. Using the mean exposure of thepopulation in six Member States and Norway, it is possible to exclude most additivesfrom the list for tier-3 evaluation since the theoretical intake based on actual foodconsumption data combined with the maximum permitted usage levels for the additivedid not exceed the ADI.
For adults and the whole population, the following food additives and food additivegroups 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 ammoniumphosphatides, E 475 polyglycerol esters, E 476 polyglycerol polyricinoleate, E 479bTOSOM, E 483 stearyl tartrate, E 491/492/495 sorbitan esters, E 535-538ferrocyanides, E 950 acesulfame K, and E 952 cyclamates.
• All the colours For children, the following food additives and food additive groups were excluded fromfurther examination: Additive group = closely related substances that have been allocated a group ADI (e.g. phosphoricacid and phosphates, saccharin and its salts etc.) • 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 479bTOSOM, E 951 aspartame, E 952 cyclamates, E 954 saccharin, E 959 neohesperedineDC 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 thetheoretical intake at tier-2 level approached or exceeded the ADI at least in one MemberState or if there was further information suggesting that some groups of consumers mayhave unusually high intake levels.
For adults and the whole population, the following food additives and food additivegroups 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 sorbitanmonolaureate and sorbitan monooleate, E 520-523 aluminium sulphates, E 541sodium 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 432-436polysorbates, 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 aluminiumphosphate, 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 tolack of information on the intake of this additive at tier-2 level.
Furthermore, nine additives with numerical ADIs that are permitted for use at quantumsatis were moved directly to tier 3 (see Annex IV) because actual use levels are necessaryfor intake estimations.
Results obtained for the intake of food additives at tier 2 are listed in Annex V for adultsand the whole population (Table 1) and for young children (Table 2). The followinginformation is given in the tables: E-number, the specific name and the ADI of theadditive, the Member State that provided the information, the range of the intake of theadditive expressed as a percentage of the ADI, consequence for tier-estimation.
No Member State submitted complete information on tier 3 results according to themethod agreed.
This report is the first attempt to obtain an overview of the dietary food additive intake inthe European Union. The results reported must be regarded as a very preliminaryindication on the dietary intake of food additives due to the many limitations the currentexercise had.
In its request for information on food additive intake, the objective of the Commissionwas to obtain information from as many Member States as possible. Therefore, apragmatic approach to use information calculated on the food consumption of thepopulation mean was chosen. However, the use of the population mean does not take intoaccount intake by high-level consumers. On the other hand, the estimates reported hereare extremely conservative, since they assume that each additive is used in the widestpossible range of foods at the maximum permitted levels, which in many cases leads toover-estimation of the additive intake. Therefore, more precise studies are needed in thefuture. In several Member States, work is already in progress for gathering information toenable more refined intake estimations to be carried out.
Today, 171 additives and additive groups are permitted for use in the EU. On the basis ofthe 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-2intake estimations, eight additives or additive groups were prioritised for tier-3estimations 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 theADI at least in one Member State or no information was provided on the substance. Itshould be noted that the range of intake of the same additive could vary considerablybetween different countries. In addition, nine additives allocated a numerical ADI, butpermitted for use in certain foods according to quantum satis, were prioritised for tier-3examination.
To carry out the tier-3 estimation for these additives, more detailed information should becollected 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 outwithout delay.
In addition to action being taken on additives prioritised for tier 3, examination shouldalso continue on additives that passed tier 2 and were not prioritised for tier 3. Firstly notall the Member States have studied these additives and, as stated above, the results canvary considerably depending on the country. Secondly, estimation of the intake of theseadditives should be done also on high-level consumers, not only on the population mean.
The Member States should follow up the SCOOP task on methodologies for themonitoring of food additives in order to achieve harmonisation of intake studiesof additives in the European Union. In addition, better food consumption datashould be gathered in order to estimate dietary food additive intake moreaccurately.
The preliminary results with limited data available indicate that for the majorityof 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 additivesthat are permitted at quantum satis (see Annex IV), intake estimations should becarried out using actual food consumption data combined with the actual usagelevels of the additive. The examination should be carried out by all the MemberStates without delay and the results should be reported to the Commission with aview to initiating necessary action, if any.
Intake of additives that did not exceed the ADI in tier 2 should, nevertheless, bere-examined in the light of the more detailed food consumption data (see AnnexV).
Intake studies should be carried out in respect of the additives which, at the timeof this exercise, had only recently been approved.
Co-operation with the food industry should be developed with a view toobtaining better information on food additive usage.
A new report on the overall situation on food additive intake in the EuropeanUnion should be compiled in three years time. It is essential that efforts aremade by all the Member States to participate fully in the next monitoring task ondietary intake of food additives.
Outline of the tiered approach
All authorized food additives
ADI not specified
Authorized with maximum • Authorized for very
specific uses only
• Recently authorized
Theoritical food consumption x maximum permitted usage of ADI was not exceeded in
ADI was exceeded in
Actual food consumption x maximum permitted usage of ADI was not exceeded in
ADI was exceeded in
Actual food consumption x actual usage of additive ADI was not exceeded in
ADI was exceeded in
Moved to next step in tiered approach No further examination required Tocopherol-rich extract 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
Potassium citrates Polyethyleneglycol 6000 Metatartaric acid Triammonium citrate Chlorophyls and Chlorophyllins Potassium alginate Ammonium alginate Processed eucheuma seeweed Beetroot Red, betanin Calcium carbonates Acacia gum (gum arabic) Iron oxides and hydroxides Biphenyl, diphenyl (ii) Sorbitol syrup Orthophenyl phenol Sodium orthophenyl phenol Hexamethylene tetramine (ii) Konjac glucomannane Dimethyl dicarbonate Polyoxyethylene (40) stearate Potassium acetate Hydroxypropyl cellulose Potassium lactate Hydroxypropyl methyl cellulose Ethyl methyl cellulose Carboxy methyl cellulose Sodium propionate Enzymatically hydrolysed carboxy Calcium propionate Potassium propionate Sodium tetraborate (Borax) Sodium, potassium and calcium salts of fatty acids Magnesium salts of fatty acids Calcium ascorbate Fatty acid esters of ascorbic acid Mono and diglycerides of Disodium guanylate Acetic acid esters of mono Dipotassium guanylate and diglycerides of fatty acids Calcium guanylate Lactic acid esters of mono and diglycerides of fatty acids Disodium inosinate Citric acid esters of mono and Dipotassium inosinate diglycerides of fatty acids Calcium inosinate Tartaric acid esters of mono and diglycerides of fatty acids Mixed acetic and tartaric acid Glycine and its sodium salt esters of mono and diglycerides of fatty acids Beeswax, white and yellow Sodium carbonates Potassium carbonates Ammonium carbonates Magnesium carbonates Microcrystalline wax Hydrochloric acid Montan acid esters Potassium chloride Oxidised polyethylene wax Magnesium chloride Stannous chloride Potassium sulphates Ammonium sulphate Potassium hydroxide Calcium hydroxide Ammonium hydroxide Magnesium hydroxide (i) Maltitol (ii) Maltitol syrup Magnesium silicates Potassium gluconate Monostarch phosphate Calcium gluconate Distarch phosphate Ferrous gluconate Phosphated distarch Acetylated distarch phosphate Monosodium glutamate Acetylated starch Monopotassium glutamate Acetylated distarch adipate Calcium diglutamate Hydroxy propyl starch Monoammonium glutamate Hydroxy propyl distarch Magnesium diglutamate Starch sodium octenylsuccinate Acetylated oxidised starch Glyceryl triacetate (triacetine) 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
Brilliant Blue FCF Potassium sorbate Ethyl p-hydroxybenzoate Sodium ethyl p-hydroxybenzoate Propyl p-hydroxybenzoate Sodium propyl p-hydroxybenzoate Methyl p-hydroxybenzoate Sodium methyl p-hydroxybenzoate Potassium nitrate Sodium phosphates Potassium phosphates Calcium phosphates Magnesium phosphates Calcium disodium ethylene diamine tetra-acetate Propane-1,2-diol esters of fatty acids Sucrose acetate isobutyrate Glycerol esters of wood rosin Dimethyl polysiloxane Saccharin and its sodium, calcium and potassium salts Neohesperidine dihydrochalcone (DC) Table 2: Young children
Ethyl p-hydroxybenzoate Sodium ethyl p-hydroxybenzoate Propyl p-hydroxybenzoate Sodium propyl p-hydroxybenzoate Methyl p-hydroxybenzoate Sodium methyl p-hydroxybenzoate Potassium nitrate Calcium disodium ethylene diamine tetra-acetate Propane-1,2-diol esters of fatty acids Glycerol esters of wood rosin Dimethyl polysiloxane Food additives with numerical ADIs that are permitted for use at quantum satis (moved
to tier 3)
Copper complexes of Chlorophyls and Chlorophyllins Caustic sulphite caramel Sulphite ammonia caramel Ethyl ester of beta-apo-8-carotenoic acid Potassium tartrates Sodium potassium tartrate Mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty esters The Scientific Committee on Food withdrew the ADI for betacarotene (opinion adopted on 7 September2000) and stated that its use is temporarily acceptable as a food colour with currently estimated intake.
Results obtained for the intake of food additives at tier 2
Table 1: Adults and the whole population
Name of the additive
Sunset Yellow FCF DK, ES, IT, UK, NO DK, ES, IT, UK, NO Azorubine, Carmoisine DK, ES, IT, UK, NO Ponceau 4R, Cochineal Red A DK, ES, IT, UK, NO DK, ES, IT, UK, NO Indigotine, Indigo carmine DK, ES, IT, UK. NO DK, ES, IT, UK, NO Brilliant Black BN, Black PN DK, ES, IT, UK, NO DK, ES, IT, UK, NO Annatto, bixin, norbixin ES, FR, IT, UK, NO DK, ES, FR, IT, NL, Potassium benzoate DK, ES, FR, IT, NL, Sodium hydrogen sulphite Sodium metabisulphite Potassium metabisulphite Calcium hydrogen sulphite Potassium hydrogen sulphite Potassium nitrite DK, ES, FR, IT, NL, DK, ES, FR, NL, UK DK, ES, FR, IT, NL, UK Sodium erythorbate Butylated hydroxyanisole (BHA) DK, ES, FR, IT, NL, UK Butylated hydroxytoluene (BHT) DK, ES, FR, IT, NL, UK Potassium adipate DK, ES, IT, NL, UK Ammonium phosphatides DK, ES, FR, IT, NL, UK Conservative intake estimate based on the assumption that the additive is used in the widest possiblerange of foods and at maximum perm itted 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 Name of the additive
Polyoxyethylene sorbitan DK, ES, FR, IT, NL, UK monolaurate (polysorbate 20) Polyoxyethylene sorbitanmonooleate (polysorbate 80) Polyoxyethylene sorbitanmonopalmitate (polysorbate 40) Polyoxyethylene sorbitanmonostearate (polysorbate 60) Polyoxyethylene sorbitan tristearate(polysorbate 65) Polyglycerol esters of fatty acids DK, ES, FR, IT, NL, UK, DK, ES, FR, NL, UK, NO Thermally oxidised soya bean oil DK, ES, FR, IT, NL, UK, DK, ES, FR, IT, NL, UK, Sorbitan monostearate DK, ES, FR, IT, NL, UK, Sorbitan tristearate Sorbitan monopalmitate Sorbitan monolaurate DK, ES, IT, NL, UK, NO Sorbitan monooleate Aluminium sulphate DK, FR, IT, NL, UK, NO Aluminium sodium sulphate Aluminium potassium sulphate Aluminium ammonium sulphate Sodium aluminium phosphate, Sodium aluminium silicate Potassium aluminium silicate Calcium aluminium silicate Aluminium silicate Sodium ferrocyanide Potassium ferrocyanide Calcium ferrocyanide DK, FR, IT, NL, UK, NO Cyclamic acid and its sodium and DK, FR, IT, NL, UK, NO Even if the intake of this additive did not exceed the ADI at tier-2 estimation, it has been prioritised fortier 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.
Table 2: Young children
Name of the additive
Stays at tier 2
or moved to
Sunset Yellow FCF Cochineal, Carminic acid, Carmines Azorubine, Carmoisine Ponceau 4R, Cochineal Red A Indigotine, Indigo carmine Brilliant Blue FCF Brilliant Black BN, Black PN Annatto, bixin, norbixin Potassium sorbate Potassium benzoate Sodium hydrogen sulphite Sodium metabisulphite Potassium metabisulphite Calcium hydrogen sulphite Potassium hydrogen sulphite Potassium nitrite Sodium erythorbate Name of the additive
Stays at tier 2
or moved to tier
Sodium phosphates Potassium phosphates Calcium phosphates Magnesium phosphates Potassium adipate Polyoxyethylene sorbitan monolaurate (polysorbate 20) Polyoxyethylene sorbitanmonooleate (polysorbate 80) Polyoxyethylene sorbitanmonopalmitate (polysorbate 40) Polyoxyethylene sorbitanmonostearate (polysorbate 60) Polyoxyethylene sorbitantristearate (polysorbate 65) Ammonium phosphatides Sucrose acetate isobutyrate Sucrose ester of fatty acids Polyglycerol esters of fatty acids Thermally oxidised soya bean oil Sorbitan monostearate Sorbitan tristearate Sorbitan monopalmitate Sorbitan monolaurate Sorbitan monooleate Name of the additive
Stays at tier 2
or moved to tier
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 Cyclamic acid and its sodium and Saccharin and its sodium, calcium and potassium salts All the Member States did not use the intake estimation methods defined under the SCOOPtask. The reasons for selecting different methods was based on earlier intake work carried outin some Member States. Other information using non-SCOOP intake methodology wasavailable mainly from Austria, Finland, Ireland, Spain and Sweden.
These countries have based their intake estimations on earlier selective studies, informationfrom the food industry, marketing surveys or product databases. Quite often stepwise orhierarchical approaches have been used; moving from conservative, less refined to morerefined exposure estimates.
Food additive occurrence data have been studied using preliminary surveys based on nationalfood ingredient databases in Austria and Ireland. In Finland, similar data were collected usinga market survey, based on labelling information. Information on the use of food additives wasalso provided from laboratories, the food industry or marketing associations. Only whenadditives were found in specific food categories, was that food category considered in theintake estimation or samples taken to the laboratory for analysis. Quite often thesepreliminary studies revealed that food additives were not widely used in the products even ifthey were permitted by legislation (Finland, Ireland).
Austria submitted a report on a detailed study based on the tiered approach described in theSCOOP report. However, as this study was not reported in accordance with the guidelinessent out by the Commission, it was not possible to include the results in chapter 5 of thisreport. The reported tier-2 calculation showed that, on the basis of intakes by high-levelconsumers, the ADI was likely to be exceeded for 15 additives or groups of additives. A tier-3calculation has been carried out for several additives. Intake calculated for both ‘wholepopulation' and for ‘consumers only' are reported. While intake by high-level consumersexceeding 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 severaladditives based on ‘consumers only' estimates.
Intake estimations (from 1999) submitted by Finland were done at tier-3 level and weretargeted especially at children from 1-6 years. Estimations for children's intake were based onindividual food consumption and analysed food additive levels in products consumed inFinland. The only food additives for which the ADI was exceeded were nitrites andbenzoates.
For adults (consumers only, see box 3) nitrite intake was 93 % of the ADI; for children from1-6 years (consumers only) 67% of ADI when the actual weight of each child was used. Forhigh 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 only113 % of the ADI. Average intake of children was 40 % of the ADI and with high-levelconsumers (95th percentile) 101-160 % of the ADI.
The food additives in the Irish food supply were monitored using the Irish National FoodIngredient Database (INFID). This exercise showed the trend of individual additives' usagebetween two sampling periods 1995/97 and 1998/99. It also indicated which additives weremost widely used in the foods chosen for the study. A number of additives were found not tobe present in the foods included in the database.
Following the SCOOP tier-1 exercise, a variety of approaches such as portion size backcalculations, food-intake data and nutrient-intake back calculations were used as a secondstage screen. This identified 20 additives for further consideration.
Spain submitted information on cyclamate intake related to a published study conducted in1992 in a region of Spain (Catalonia). For the cyclamate level in foodstuffs, the study wasbased on information from industry.
This study can be considered as a "tier 3" survey despite the fact that it is not designed to berepresentative of the whole population of Spain. The information provides clear indications ofthe major contribution made by soft drinks to cyclamate exposure and confirms that, even if itwas unlikely to have caused any safety concerns at the time of the study, the margin of safetybetween the exposure and the ADI is small for high consumers of cyclamates.
Information submitted by Sweden consists of a report of the Swedish Food Administration onintake of aspartame, acesulfame-K, saccharin and cyclamate among diabetics. This study wasconducted in January 1999 on 1120 Swedish diabetic adults (16-90 years) and children (0-15years).
Concerning sweetened foods, the maximum amount allowed was assumed to have beenadded. An estimated worst case calculation was performed assuming that all the foodsconsumed were sweetened by the same sweetener.
This study provides different scenarios for exposure assessment of diabetics, includingchildren, who are a particularly exposed population for artificial sweeteners. The calculationsare based on the measurement of intake of sweetened foods and on several assumptionsconcerning the type and the concentration of the substances in the food commodities. It showsthat the intake of aspartame, acesulfame-K, saccharin and cyclamate, can be close to orexceed their respective ADI for the population of diabetics if they consume only one type ofsweetener.

Source: https://agri.najah.edu/sites/default/files/Acceptable%20Daily%20Intake%20ADI.pdf