by Dr Michael E. Knowles

1

EU Legislation on Food Additives

• byDr Michael E. Knowles
• Director Scientific Regulatory Affairs
  Coca-Cola Europe, Eurasia Middle East
• IUFoST Berlin Symposium 25/26 May 2004
• Food Ingredients Product and Perception in a
  New European Environment Challenges of Entering
  the Expanded European Market Place.

2

• What I will try and do in the time allotted to me
  is
• Provide a brief overview of EU food additive and
  related legislation
• Summarize the current Commission Proposal on Food
  Additives
• Describe the approval procedures
• Review recent developments in risk assessment
• Threshold of toxicological concern
• Probabilistic intake assessments
• Public concerns about additive safety
• Actual text of legislation is available on the EU
  website
• http//europa.eu.int/comm/food/food/chemicalsafety
  /additives/index_en.htm

3
Description of Basic Laws
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 Directive, three specific
directives were adopted by the Council and
European 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. After adoption by the EU
community, the directives must be implemented
into national legislation in all EU member
countries. However, the member states have some
degree of flexibility in how the legal text is
formulated, which can differ from the way it is
presented in the directives, provided the legal
content is not changed. Besides, the 15 member
states in the European Union, Iceland and Norway
are also obliged to implement the directives into
their national legislation because of the EEA
agreement.

• O.J. n L40, 11.02.1989, p.27
• O.J. n L237, 10.09.1994, p.1
• O.J. n L237, 10.09.1994, p.13
• O.J. n L61, 18.03.1995, p.1
• European Economic Area agreement between EU
  and EFTA countries (except Switzerland)

4
Framework Directive on Food Additives (89/107/EEC)

• Art 1 - lists categories of food additives and
  defines a food additive as
• any substance not normally consumed as a food in
  itself and not normally used as a characteristic
  ingredient of food whether or not it has
  nutritive value, the intentional addition of
  which to food for a technological purpose in the
  manufacture, processing, preparation, treatment,
  packaging, transport or storage of such food
  results, or may be reasonably expected to result,
  in it or its by-products becoming directly or
  indirectly a component of such foods.
• It also lists substances excluded from its scope,
  such as processing aids.
• Art 2 - labelling by primary function (from
  Annex I) and general criteria in Annex II.
• Art 3 - mandate positive lists of additives and
  foodstuffs to which these
• additives may be added, together with purity
  criteria, methods of analysis and sampling.
• Art 4 - procedure for proctecting public health
  as a result of new knowledge on additives.
• Art 5 - procedure for approvals by individual
  Member States and subsequent EU approvals.

5

• Art 6 - SCF consultation.
• Art 7 - labelling for the trade.
• Art 8 - sale to consumers, labelling and use
  information.
• Art 9 - 14 - procedural requirements.
• Food additives are authorised at EU level for
  all the fifteen Member States, as well as for
  Norway and Iceland.
• The Community legislation on food additives is
  based on the principle that only those additives
  that are explicitly authorised may be used. Most
  food additives may only be used in limited
  quantities in certain foodstuffs. If no
  quantitative limits are foreseen for the use of a
  food additive, it must be used according to good
  manufacturing practice, i.e. Only as much as
  necessary to achieve the desired technological
  effect.
• Food additives may only be authorised if
• - There is a technological need for their use,
• They do not mislead the consumer,
• They present no hazard to the health of the
  consumer.
• Note that the same requirements apply in Codex
  Alimentarius but not in the USA,
• where there is no requirement to demonstrate a
  technological case of need.

6
Description of Additive Functions Acids
Substances which increase the acidity of a
foodstuff and/or impart a sour taste to
it. Anti-caking agents Substances which reduce
the tendency of individual particles of a
foodstuff to adhere to one another. Anti-foaming
agents Substances which prevent or reduce
foaming. Antioxidants Substances which prolong
the shelf-life of foodstuffs by protecting the
against deterioration caused by oxidation, such
as fat rancidity and colour changes. Bulking
agents Substances which contribute to the volume
of a foodstuff without contributing significantly
to its available energy value. Carriers
(including carrier solvents) Substances used to
dissolve, dilute, disperse or otherwise
physically modify a food additive without
altering its technological function (and without
exerting any technological effect themselves) in
order to facilitate its handling, application, or
use. Colours Substances which add or restore
colour in a food, and include natural
constituents of foodstuffs and natural sources
which are normally not consumed as foodstuffs as
such and not normally used as characteristic
ingredients of food. Preparations obtained from
foodstuffs and other natural source materials
obtained by physical and/or chemical extraction
resulting in a selective extraction of the
pigments relative to the nutritive or aromatic
constituents, are colours.
7
Description of Additive Functions
(contd) Emulsifiers Substances which make it
possible to form or maintain a homogeneous
mixture of two or more immiscible phases, such as
oil and water, in a foodstuff. Emulsifying salts
Substances which convert proteins contained in
cheese into a dispersed form and thereby bring
about a homogeneous distribution of fat and other
components. Firming agents Substances which make
or keep tissues of fruits or vegetables firm or
crisp, or intact with gelling agents to produce
or strengthen a gel. Flavour enhancers
Substances which enhance the existing taste
and/or odour of a foodstuff. Flour treatment
agents Substances other than emulsifiers which
are added to flour or dough to improve its baking
quality. Foaming agents Substances which make it
possible to form a homogeneous dispersion of a
gaseous phase in a liquid or solid
foodstuff. Gelling agents Substances which give
a foodstuff texture through formation of a
gel. Glazing agents (including lubricants)
Substances which, when applied to the external
surface of a foodstuff, impart a shiny appearance
or provide a protective coating. Humectants
Substances which prevent foodstuffs from drying
out, by counteracting the effect of an atmosphere
having a low degree of hymidity, or promote the
dissolution of a powder in an aqueous medium.
8
Description of Additive Functions
(contd) Modified starches Substances obtained
by one or more chemical treatments of edible
starches, which may have undergone a physical or
enzymatic treatment, and may be acid or alkali
thinned or bleached. Packaging gases Gases other
than air, introduced into a container before,
during, and after the placing of a foodstuff in
that container. Preservatives Substances which
prolong the shelf-life of foodstuffs by
protecting them against deterioration caused by
micro-organisms. Propellants Gases other than
air, which expel a foodstuff from a
container. Raising agents Substances or
combinations of substances which liberate gas and
thereby increase the volume of a dough or a
batter. Sequestrants Substances which form
chemical complexes with metal ions. Stabilizers
Substances which make it possible to maintain the
physicochemical state of a foodstuff.
Stabilizers include substances which enable the
maintenance of a homogeneous dispersion of two or
more immiscible substances in a foodstuff, and
include also substances which stabilize, retain,
or intensify and existing colour of a
foodstuff. Sweeteners Substances which impart a
sweet taste to foodstuffs. Thickeners Substances
which increase the viscosity of a foodstuff.
9

• Other definitions
• Processing aids Any substance which is not
  consumed as a food ingredient by itself, but
  which is intentionally used in the processing of
  raw materials, foods, or their ingredients, to
  fulfil a certain technological purpose during
  treatment or procesiing and which may result in
  the unintentional but technically unavoidable
  presence of residues of the substance or its
  derivatives, provided that these residues do not
  present any health hazard and do not have any
  technological effect on the finished product.
• With no added sugar Without any added mono-or
  disaccharides or any other foodstuff used for its
  sweetening properties.
• Energy-reduced With an energy value reduced by
  at least 30 compared with the original foodstuff
  or a similar product.
• Maximum usable doses (in the Directive on
  Sweeteners) refer to ready-to-eat foodstuffs
  prepared according to the instructions for use.
• Maximum levels (in the Directive on Colours)
• Relate to ready-to-eat foodstuffs prepared
  according to the instructions for use,
• Refer to the quantities of active colouring
  principle contained in the colouring preparation.
• Maximum levels (in the Miscellaneous
  Directive) refer to foodstuffs as marketed,
  unless otherwise stated.

10

• Other definitions (contd)
• Quantum satis (q.s.) No maximum level is
  specified. However, food additives shall be used
  in accordance with good manufacturing practice,
  at a level not higher than is necessary to
  achieve the intended purpose and provided that
  they do not mislead the consumer.
• Unprocessed foodstuffs Foodstuffs which have not
  undergone any treatment resulting in a
  substantial change in the original state of the
  foodstuffs however, the foodstuffs may have
  been, for example, divided, parted, severed,
  boned, minced, pared, peeled, ground, cut,
  cleaned, trimmed, deep-frozen or frozen, chilled,
  milled or husked, packed or unpacked.
• Carry-over (in the Directive on Colours) The
  presence of a colour in a foodstuff is
  permissible
• In a compound foodstuff other than one mentioned
  in Annex II in the Directive, to the extent that
  the colour is permitted in one of the ingredients
  of the compound foodstuff, or
• If the foodstuff is destined to be used solely
  in the preparation of a compound foodstuff and to
  such an extent that the compound foodstuff
  conforms to the provisions of the directive.
• Carry-over (in the Miscellaneous Directive)
  The presence of a food additive in a foodstuff is
  permissible
• In a compound foodstuff other than one mentioned
  in Art. 2 (3), to the extent that the food
  additive is permitted in one of the ingredients
  of the compound foodstuff, or
• If the foodstuff is destined to be used solely
  in the preparation of a compound foodstuff and to
  an extent such that the compound foodstuff
  conforms to the provisions of the directive.
• The above does not apply to infant formulae,
  follow-on forumulae, and weaning foods, except
  where specially provided for.

11
Directive on Sweeteners (94/35/EC), as Amended by
Directives 96/83/EC and 2003/115/EC

• Art 1 - specific Directive under the Framework
  Directive, 89/107/EEC.
• - defines with no added sugar and energy
  reduced.
• - exclusion for foods with sweetening
  properties.
• Art 2 - specific uses as detailed in the Annex.
• Art 5 - specific warning labelling requirements
  for polyols and aspartame.
• Art 7 - Standing Committee for Foodstuffs
  procedures.

12
Directive on Colours for use in Foodstuffs
(94/36/EC)

• Art 1 - a specific Directive under the
  Framework Directive, 89/107/EEC.
• - definition of colour and exclusion criteria
  for certain coloured foodstuffs.
• Art 2 - describes the specific authorizations in
  the Annexes.
• explains quantum satis (see earlier
  definitions) as applied to colours.
• lists which colours may be sold directly to
  consumers and definition of unprocessed.
• Art 3 - presence of colours in compound
  foodstuffs.
• Art 5 - Standing Committee for Foodstuffs
  procedures.

13
Directive of Food Additives other than Colours
and Sweeteners (95/2/EC) Miscellaneous
Additives Directive. Amended by 96/85/EC,
98/72/EC, 2001/5/EC.

• Art 1 - specific Directive under the Framework
  Directive, 89/107/EEC.
• - defines the additive functions (see earlier
  definitions)
• - explains flour treatment agents.
• Art 2 - explains the Annexes in relation to the
  specific uses of additives.
• gives exclusions for foodstuffs from addition of
  additives.
• Art 5 - q.s. reference
• Art 6 - Standing Committee for Foodstuffs
  procedure.

14
Directives on Purity Criteria for the Additives

• They are adopted by the Directives
• Commission Directive 95/31/EC laying down
  specific criteria of purity concerning sweeteners
  for use in foodstuffs
• Commission Directive 95/45/EC laying down
  specific purity criteria concerning colours for
  use in foodstuffs
• Commission Directive 96/77/EC laying down
  specific purity criteria on food additives other
  than colours and sweeteners

15

• The following amendments have also been adopted
• Commission Directive 98/66/EC amending Directive
  95/31/EC laying down specific criteria of purity
  concerning sweeteners for use in foodstuffs
• Commission Directive 98/86/EC amending Directive
  96/77/EC laying down specific purity criteria on
  food additives other than colours and sweeteners
• Commission Directive 1999/75/EC amending
  Directive 95/45/EC laying down specific purity
  criteria concerning colours for use in foodstuffs
• Commission Directive 2000/63/EC amending
  Directive 96/77/EC laying down specific purity
  criteria on food additives other than colours and
  sweeteners
• Commission Directive 2001/30/EC amending
  Directive 96/77/EC laying down specific purity
  criteria on food additives other than colours and
  sweeteners
• Commission Directive 2001/50/EC amending
  Directive 95/45/EC laying down specific purity
  criteria concerning colours for use in foodstuffs
• Corrigendum to Commission Directive 2001/50/EC
  amending Directive 95/45/EC laying down specific
  purity criteria concerning colours for use in
  foodstuffs
• Commission Directive 2001/52/EC amending amending
  Directive 95/31/EC laying down specific criteria
  of purity concerning sweeteners for use in
  foodstuffs

16
Related EU Legislation

• General Food Law Regulation (178/2002)
  definition of food includes additives (Art 2)
  risk analysis (Art 6), safety (Art 14),
  traceability (Art 18)
• Labelling (2000/13/EC) ingredients definition
  and listing (Art 6)
• Genetically Modified Food and Feed (1829/2003)
  definitions includes additives (Art 2)
• Traceability and Labelling of Genetically
  Modified Organisms ... (1830/2003) definitions
  of food and ingredient (Art 3), traceability
  requirements throughout food chain (Art 5).

17
Current Commission Proposal on Food Additives
(WGA/OO4/03 rev 6)

• Consolidates existing food additive legislation
• Confers implementing power on the Commission to
  update list of additives
• Consultation of EFSA for safety evaluation
• Sets up re-evaluation programme for existing
  authorisations of food additives within 10 year
  (EFSA)
• Requires authorizations of GMO-derived
  additives
• Chapter I - General Provisions (scope,
  definitions, functional claims, risk
  assessment, purity criteria)
• Chapter II - Placing on the Market of a food
  additive (authorisations -10 years
  conditions, application EFSA via MS,
  renewal)
• Chapter III - Labelling (to manufacturers,
  consumers)
• Chapter IV - Placing on the market (conditions of
  use) (principle for use, compliance, intake,
  traditional foods)
• Chapter V - Other Provisions (public access,
  confidentiality, data protection

18
Current Commission Proposal on Food Additives
(WGA/OO4/03 rev 6) - contd

• Re-evaluations by EFSA start in 2005 with
• Colours
• Miscellaneous
• Sweeteners
• Screening stage - original SCF Opinion
• - comments of Nordic Report (2000), JECFA
• - consider new data since 2000
• b) EFSA decides on full or partial re-evaluation
  on grounds of
• critical data gaps
• uncertainties in existing data
• new evidence of potentially harmful effects

19
Application for Authorisation of an Additive
In 1980 the Scientific Committee for Food (SCF)
issued its first guidelines for the safety
assessment of food additives (Tenth Report
Series, 1980). When the work on the present
report started, these guidelines were still the
official guidelines for the toxicological
assessment of food additives, but simultaneaously
with the work on the present report the SCF
started the updating of its 1980 report. In 2001
the SCF adopted its new guidelines Guidance on
Submissions for Food Additive Evaluations by the
Scientific Committee on Food (Opinion expressed
on 11 July 2001). This opinion explains in detail
the important elements of a dossier
Administrative data, Technical data,
Toxicological data, and References and reports.
In an annex the SCF describes in detail, which
studies it considers to be the core toxicological
studies for the establishment of the Acceptable
Daily Intake (ADI) and which studies are
supportive for reaching the most correct ADI seen
from a human health point of view. The section
on toxicological data in the Guidance document
describes very well, how SCF performs the safety
evaluation of the individual food additives and
thus how the SCF might handle the type of
information delivered by the monographs in this
report.
20
General Criteria for the Use of Food Additives

• There can be demonstrated reasonable
  technological need (i.e. demonstrate benefit to
  the consumer) and the purpose cannot be achieved
  by other means which are economically and
  technologically practicable
• They present no hazard to health of the consumer
  at the level of use proposed, so far as can be
  judged on the scientific evidence available,
• They do not mislead the consumer.

21

• TECHNICAL DATA
• Identity of substance
• Microbiological characteristics
• Proposed chemical and microbiological
  specifications
• Manufacturing process
• Methods of analysis in food
• Reaction and fate in food
• Case of need and proposed uses
• Exposure
• Additives produced by microbiological processes
• Additives produced from genetically modified
  organisms
• Information on national authorisations

22

• TOXICOLOGICAL DATA
• General framework for the toxicological
  evaluation of food additives
• Study protocols
• Toxicological section of the dossier
• 3.1 Core studies
• a) Metabolism / Toxicokinetics
• b) Subchronic toxicity
• c) Genetic toxicity
• d) Chronic toxicity and carcinogenicity
• e) Reproduction and developmental toxicity
• 3.2 Other studies
• a) Immunotoxicity
• b) Allergenicity
• c) Food intolerance
• d) Neurotoxicity
• e) Human volunteer studies
• f) In vitro studies as alternatives to in vivo
  studies
• g) Special studies
• h) Acute toxicity

23
(No Transcript)
24
(No Transcript)
25
Intake of Food Additives Report from the
Commission (COM(2001) 542 final

• BACKGROUND
• In 1996, under Council Directive 93/5/EEC on
  assistance to the Commission and cooperation 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.

5 O.J. n L 052, 04.03.1993, p. 18 6 The
scientific co-operation report on development of
methodologies for the monitoring of food additive
intake across the European Union
(SCOOP/INT/REPORT/2)
26
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 (see next
slide)
27
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 cooperation 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). Accep
table 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.
28
Box 1 (contd) 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).
29
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). 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
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.
30

• 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.

31
Because the current procedures for estimating
intake of additives (and other chemicals in food)
results in worst-case point estimates rather than
distributions of intakes, an EU-funded project,
the Monte-Carlo Project, coordinated by Prof.
Gibney, Trinity College, Dublin, was funded
This project will validate the use of
probabilistic modelling to permit distributions
of intakes, variabilities and uncertainties to be
made. Such distributions represent a more
realistic picture of the intake of food
additives. This methodology will be combined
with the work of the International Life Science
Institute (ILSI) on risk assessment. Links
http//www.tchpc.tcd.ie/projects/montecarlo/ http
//www.ilsi.org/misc/fosie/index.html Codex
Alimentarius Commission main website
http//www.codexalimentarius.net
32
(No Transcript)
33
A brief description of the situation Product or
commodity involved The values expected to be
placed at risk, (e.g. human health, economic
concerns) Potential consequences Consumer
perception of the risks The distribution of risks
and benefits
Risk Management
1. Assessment of effectiveness of measures
taken 2. Review risk management and / or
assessment as necessary
A. Risk Evaluation
1. Identification of a food safety problem 2.
Establishment of a risk profile 3. Ranking of the
hazard for risk assessment and risk management
priority 4. Establishment of risk assessment
policy for conduct of risk assessment 5.
Commitment of resources 6. Commissioning of risk
assessment 7. Consideration of risk assessment
result
D. Monitoring and review
Value judgements and policy choices for the risk
assessment process
C. Implementation of management decision
Risk Communication

• Hazard identification
• Hazard characterization
• Exposure assessment
• Risk characterization

B. Risk management option assessment
Risk Assessment

• Risk perception
• Value judgement
• Precautionary principle
• Benefits/costs
• Other technical factors

1. Identification of available management
options 2. Selection of preferred management
option, including consideration of an appropriate
safety standard 3. Final management decision
Regulatory or other control measures
34

EC Concerted Action

• (FOSIE)
• Food Safety in EuropeRisk Assessment of
  Chemicals in Food and Diet

35
The Risk Assessment Paradigm
Problem formulation

• Exposure Assessment
• Levels of substance in food and diet
• Amounts of food consumed
• Intake in individuals (max/min,
  regularly/occasionally)
• Intake in special population groups

• Hazard Identification
• Identification of adverse health effects
• human studies
• animal-based toxicology studies
• in vitro toxicology studies
• structure-activity considerations

• Hazard Characterisation
• Selection of critical data set
• Mode/mechanism of action
• Kinetic variability
• Dynamic variability
• Dose-response for critical effect
• Identification of starting point

Risk Characterisation
Advice to Risk Managers
Reconsideration due to unexpected data on
exposure or hazard
36
FOSIE Objectives

• Strengthen and develop science base and general
  understanding of RA of chemicals in food
• Identify gaps in knowledge leading to differences
  in interpretation of toxicological and exposure
  data, and research needs to reduce these
• Determine the nature and level of testing,
  relevant to the nature of the chemical, and its
  level of human exposure
• European contribution to international initiative
• Contribute towards international harmonisation
• To explore means of improving the principles
  applied to, and scientific basis of, risk
  assessment with respect to food additives and
  contaminants, micronutrients and nutritional
  supplements, macronutrients and whole foods
• To consider possible interactions between
  individual chemicals and effects of the food
  matrix

37
FOSIE Objectives

• To identify the gaps in knowledge that might lead
  to differences in interpretation of toxicological
  and exposure data, and the research needs to
  reduce these
• To determine the nature and level of testing
  needed for safety evaluation relevant to the
  nature of the chemical, level of use/occurrence
  in the diet and human exposure
• To add a European contribution to international
  initiatives to harmonise principles, terminology
  and methodology for risk assessment
• To contribute towards a consensus on risk
  assessment issues that is scientifically
  transparent and justifiable
• To assist risk managers in developing
  appropriate, defensible food standards that
  adequately protect the safety of the consumer
  while allowing for innovation in food production
  and processing.

38
FOSIE - ITG E Intake Assessment

• Main outcome
• Intake assessment to be seen in context of a
  tiered system, e.g. crude screening may conclude
• No significant intake (TTC)
• Expected exposure does not exceed Health Based
  Guidance Values (ADI)
• Research needs
• Pan-European food composition database taking
  into account e.g.
• Harmonisation of methods
• Significant local differences
• Harmonisation of food survey methods taking into
  account e.g.
• Food habit trends
• Determination of reasonable extremes
• Options for corrections for underreporting
• Evaluation of probabilistic models for intake
  assessment
• Aggregate and cumulative exposure assessment
  methodology

39

Probabilistic assessments can produce more
meaningful outputs that quantify the type,
magnitude and frequency of effects. They can
express risk in terms of the probability that
unacceptable effects will occur, and have more
ecological meaning than other measures of risk
(e.g. Toxicity-exposure ratios). Therefore, they
may contribute to providing a better basis for
deciding what is ecologically acceptable. If
communicated well, they should also be more
meaningful to decision-makers and the public.

• Can quantify variability
• Can quantify uncertainty
• Can make better use of the available information
• Can help identify which factors have most
  influence on risk
• Promote better science

40
(No Transcript)
41
Integrated Document on Risk Characterisation

• Risk characterisation
• Introduction
• Prior use/exposure Future use/exposure
• Integrating exposure assessment and hazard
  characterisation into risk characterisation
• Matching the exposure assessment with the hazard
  characterisation
• Considerations related to exposure assessment
• Matching the duration of intake measurement to
  the toxicity of concern
• The use of biomarkers to define the relationship
  between external and internal dose, and to bridge
  the gap between exposure assessment and hazard
  characterisation
• The influence of the nature of the hazard and
  hazard characterisation on risk characterisation.

42
The iterative nature of risk characterisation
examples of questions/information that can
effect the outcome
HAZARD CHARACTERISATION
EXPOSURE ASSESSMENT
RISK CHARACTERISATION
Is the exposure sufficient to warrant full hazard
characterisation? Is the hazard relevant to the
exposed individuals? Do the hazard
characterisation data match the human
exposure? Integration of new data on hazard
identification or characterisation Integration of
new data on the nature of the distribution within
food
43
Integrated Document on Risk Characterisation

• The nature of advice to risk managers
• Advice concerning individuals at increased risk
  simultaneous exposure to different chemicals in
  food different duration and patterns of human
  exposure exposure exceeds the health-based
  guidance value uncertainties and sensitivity
  analyses very low risks for irreversible hazards
  such as cancer when data are sparse but indicate
  serious hazard.
• Special considerations for particular food
  categories
• Defined single chemical entities of low molecular
  weight
• Micronutrients
• Macronutrients
• Whole foods
• Food processing

44
Decision tree for consideration of all classes of
food chemicals
45
Public Concerns About the Safety of Food Additives

• The public believes chemical food additives can
  represent a significant health risk - media
  dossier
• BUT Food is comprised of chemicals
• Exposure isnt toxicity paraphrase of
  Paracelsus
• Safety evaluations are very conservative, no
  known health issues with additives, except
  occassional hypersensitivity not hyperactivity!
• THEREFORE
• Need to provide independent, factual advice to
  reassure the public -gt EFSA ?

46
Soft drinks 'full of chemicals' By Jonathan
Prynn and Jack Doyle, Evening Standard 10 May
2004 The hidden hazards in children's favourite
soft drinks are exposed today. An Evening
Standard investigation reveals that the top 10
bestsellers contain more than 70 additives, many
linked to potential health problems. Although
all the ingredients have been certified safe in
small quantities, almost no research has been
done on how they react with each other. As a
result, Britain's children are being exposed to
an "additive cocktail", experts say. Dr Vyvyan
Howard, a senior toxicologist at Liverpool
University, said "All the additives are tested
one at a time. Little or nothing is known about
how they interact in mixtures." Six of the 10
top drinks contain the controversial sweetener
aspartame, a factory-made product 200 times
stronger than sugar. Linked to brain cancer, it
has been called a "neurotoxin" by some critics.
Every drink in the top 10 contains several
artificial colours, flavours or preservatives. At
least four of the additives used in many of the
drinks have been linked to cancer, while others
are associated with behavioural problems, asthma
and diabetes. The analysis found that although
manufacturers have to disclose some of the
additives, there is no requirement to list the
hundreds of "flavourings" authorised for use.
The survey also uncovered loopholes in the rules
on additives which "improve" taste or appearance.
For example, the size of the dose does not have
to be revealed. Toxicologist Adam Woolley said
"Dose is a vital component. One paracetamol
clears a headache but too many will kill you."
47
Robinson's Orange Fruit Squash, Fanta, Tango,
Panda Pops, Robinson's Fruit Shoot and Sunny
Delight all contain either saccharin or
acesulfame k, linked to cancer in some research.
Panda Pops contains carmoisine (E122), an
artificial colouring banned in Sweden, America,
Austria and Norway over fears it can trigger
asthma attacks. Dr Howard said "Many of the
flavour enhancers are related to transmitter
substances in the brain. It is not surprising
very that they have been linked with behaviour
problems." Procter Gamble, maker of Sunny
Delight, which has at least 10 artificial
colours, flavourings, stabilisers and
preservatives, insists it is sold chilled,
creating the impression it is fresh. Given the
Food Commission's Additive Nightmare Award in
2002, "Sunny D" contains artificial thickeners,
giving a false impression it contains a lot of
fruit. A spokesman for the British Soft Drinks
Association said "There is a wide range of soft
drinks available from which consumers can choose.
All ingredients are approved as safe for the
purpose by the Food Standards Agency. The
ingredients list on the label enables consumers
to choose which drinks they prefer." Coca-Cola,
Britvic, which makes Tango and owns the
Robinson's brand, GlaxoSmithKline, which makes
Lucozade, and Procter Gamble all refused to
disclose what artificial flavourings are in their
products - citing "commercial confidentiality".
48
Side effects By Evening Standard Reporters 10
May 2004 Phosphoric acid - tooth erosion,
weakens bones Citric acid - tooth erosion
Sunset yellow - hyperactivity, may exacerbate
asthma Carmoisine - as above Sodium Benzoate
(E211) - may exacerbate asthma Aspartame - brain
cancer, migraines, dizziness, blurred vision
Saccharin - bladder cancer Glucose fructose
syrup - obesity and diabetes Acesulfame k -
cancer links Caffeine - behavioural problems,
insomnia Sodium metabisulphate - intestinal
irritation Caramel colour - behavioural problems
What the drinks contain By Jonathan Prynn and
Jack Doyle, Evening Standard 10 May 2004 1.
Robinson's Orange Squash 89p/1 litre Calories 53
Sugar Additives Glucose-fructose syrup,
citric acid, trisodium citrate, potassium
sorbate, sodium metabisulphate, aspartame,
saccharin, flavourings, stabiliser E466, beta
carotene 2. Tango 1.28p/2 litres Calories 29
Sugar Glucuse-fructose syrup, citric acid,
flavouring, sodium citrate, stabiliser, E1450,
ascorbic acid, aspartame, saccharin, potassium
sorbate, beta-carotene 3. Coca-Cola 55p/330ml
Calories 43 Sugar 10.7g Caramel E150d,
phosphoric acid, flavourings, caffeine 4. Pepsi
55p/330ml Calories 42 Sugar 11g Caramel,
E150d, acid E338, caffeine 5. Lucozade 62p/380ml
Calories 73 Sugar 17.9g Glucose syrup, citric
acid, lactic acid, flavourings (including
caffeine), sodium benzoate, sodium bisulphate,
ascorbic acid, sunset yellow colouring 6. Fanta
55p330ml Calories 43 Sugar 10.4g Citric acid,
acidity regulator E331, preservative E211,
flavourings, sodium saccharin, aspartame,
stabiliser E412, beta-carotene 7. Panda Pops
29p/330ml Calories 25 Sugar 6g Citric acid,
flavourings, aspartame, aceulfame k, sodium
benzoate, carmoisine colouring 8. Robinson's
Fruit Shoot 1.53p/200ml Calories 35 Sugar
Citric acid, trisodium citrate, preservatives
E202, E242 and E211, xanthan gum, aspartame,
acesulfame k, flavouring 9. SunnyD 94p/500ml
Calories 10 Sugar 1.4gCitric acid, vegetable
oil, polyphosphate, modified starch, guar gum,
potassium sulsorbate, acesulfame k, aspartame,
xanthan gum, gellun gum, beta-carotene 10.
Ribena 99p/330ml Calories 57 Sugar 14g Glucose
fructose syrup, citric acid, sodium benzoate,
anthocyanins Manufacturers will not reveal
contents
49
Public Concerns About the Safety of Food Additives

• The public believes chemical food additives can
  represent a significant health risk - media
  dossier
• BUT Food is comprised of chemicals
• Exposure isnt toxicity paraphrase of
  Paracelsus
• Safety evaluations are very conservative, no
  known health issues with additives, except
  occassional hypersensitivity not hyperactivity!
• THEREFORE
• Need to provide independent, factual advice to
  reassure the public -gt EFSA ?