Report from the Commission to the European Parliament and the Council on the progress of the re-evaluation of food additives {SEC(2007)998}
Date: 2007-07-18
Institutions: European Commission
Subjects: consumer information, consumer protection, food additive, food safety, foodstuff, foodstuffs legislation, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 18.7.2007 
COM(2007) 418 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

ON THE PROGRESS OF THE RE-EVALUATION OF FOOD ADDITIVES 

{SEC(2007)998} 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

ON THE PROGRESS OF THE RE-EVALUATION OF FOOD ADDITIVES 

EXECUTIVE SUMMARY 

Food  additives  are  subject  to  a  safety  evaluation  before  they  are  permitted  for  use  in  the 
European Community. It is also a requirement that they are re-evaluated whenever necessary 
in  light  of  changing  conditions  of  use  and  new  scientific  information.  European  Parliament 
and Council Directives 2003/114/EC and 2003/115/EC require the Commission to present a 
status  report  to  the  European  Parliament  and  the  Council  on  the  re-evaluations  of  food 
additives which have been carried out. 

This  report  provides  a  summary  of  the  recent  additive  re-evaluations  undertaken  by  the 
Scientific  Committee  on  Food  (SCF)  and  the  European  Food  Safety  Authority  (EFSA)  and 
describes the related actions taken by the European Commission on the basis of the scientific 
opinions. 

Some of the additive evaluations were undertaken when the SCF was first established in the 
1970’s. Therefore the Commission felt that it is timely to request that the EFSA undertake to 
review  the  evaluations  of  all  currently  permitted  food  additives.  This  report  additionally 
describes the rationale and priority setting for this review by the EFSA. 

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1. 

INTRODUCTION 

The authorisation of food additives for  use in foods is harmonised in the European 
Community. Framework Directive 89/107/EEC1 lays down the general principles for 
the  use  and  authorisation  of  food  additives,  whereas  three  specific  directives  on 
sweeteners  (Directive  94/35/EC2),  colours  (Directive  94/36/EC3)  and  on  additives 
other than colours and sweeteners (Directive 95/2/EC4) lay down the rules on which 
additives  may  be  used  in  which  foods  and  their  conditions  of  use.  This  legal 
framework  is  complemented  by  three  Commission  Directives  laying  down 
specifications  (specific  purity  criteria)  for  the  authorised  food  additives  (Directives 
95/31/EC5, 95/45/EC6 and 96/77/EC7). 

The authorisations are based on three criteria: 

• 

• 

• 

the food additive does not pose a safety risk to the health of the consumer,  

there is a technological need for the use and, 

the consumer is not mislead by the use of a food additive. 

According  to  the  framework  Directive  89/107/EEC,  the  Scientific  Committee  on 
Food (SCF), now replaced by the European Food Safety Authority (EFSA), must be 
consulted before the adoption of provisions likely to affect public health, such as the 
drawing  up  of  lists  of  additives  and  the  conditions  for  their  use.  Accordingly,  food 
additives  have  been  evaluated  for  their  safety  by  the  SCF  or  EFSA  prior  to  their 
authorisation. 

Directive  89/107/EEC  also  requires  that  food  additives  must  be  kept  under 
continuous observation and re-evaluated whenever necessary in the light of changing 
conditions of use and new scientific information. 

Accordingly some food additives have been re-evaluated in recent years when new 
scientific data had been requested or became otherwise available. 

There are a number of reasons why the Commission has considered it appropriate to 
start a systematic re-evaluation of food additives: 

(1)  The  Commission  has  recently  adopted  a  proposal  for  a  new  Regulation8  on 
food  additives  as  announced  in  the  White  Paper  on  Food  Safety.  In  this 
context, the Commission has proposed to formalise its intention and introduce 
a requirement for a systematic re-evaluation of all authorised food additives.  

1 
2 
3 
4 
5 
6 
7 
8 

Council Directive 89/107/EEC, OJ L 40, 11.2.1989, p. 27. 
European Parliament and Council Directive 94/35/EC, OJ L 237, 10.9.1994, p. 3. 
European Parliament and Council Directive 94/36/EC, OJ L 237, 10.9.1994, p. 13. 
European Parliament and Council Directive No 95/2/EC, OJ L 61, 18.3.1995, p. 1. 
Commission Directive 95/31/EC, OJ L 178, 28.7.1995, p. 1. 
Commission Directive 95/45/EC, OJ L 226, 22.9.1995, p. 1. 
Commission Directive 96/77/EC, OJ L 339, 30.12.1996, p. 1. 
COM(2006) 428 final. 

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(2)  The  report  from  the  Commission  on  Dietary  Food  Additive  Intake  in  the 
European  Union9  published  in  2001  has  shown  that  the  intake  of  some  food 
additives has the potential to exceed the Acceptable Daily Intake (ADI). 

(3) 

In the context of the amendment of Directive 95/2/EC and Directive 94/35/EC 
on sweeteners (Directives 2003/114/EC10 and 2003/115/EC11), the Commission 
has  been  required  to  present  a  status  report  about  the  re-evaluation  of  food 
additives  to  the  European  Parliament  and  the  Council,  in  particular  for  those 
additives that were identified as possibly exceeding the ADI in the 2001 intake 
report. 

(4)  A  report  entitled  “Food  additives  in  Europe  200012”  was  submitted  by  the 
Nordic Council of Ministers to the Commission. This provides a good basis for 
the prioritisation of additives for re-evaluation. It examines whether the safety 
evaluations  on  food  additives  undertaken  by  the  SCF  are  still  valid  and 
adequate  in  the  light  of  present  day  standards  for  safety  assessments. 
Furthermore,  it  examines  whether  significant  new  toxicological  studies  have 
been published since the latest SCF evaluation of a substance. 

Consequently,  the  Commission  has  asked  the  EFSA  to  re-evaluate  all  currently 
permitted food additives in the EC. 

This  report  is  elaborated  as  a  response  to  the  requirements  laid  down  in  Directives 
2003/114/EC and 2003/115/EC. The European Commission’s mandate is to submit a 
report to the European Parliament and the Council outlining the progress made in the 
re-evaluations  of  additives  and  setting  a  provisional  calendar  for  future  re-
evaluations. 

This  report  describes  the  safety  evaluation  which  applies  to  food  additives  prior  to 
their  authorisation  and  lists  examples  of  recent  re-evaluations  of  authorised  food 
additives. It also gives an overview on the organisation of the on-going re-evaluation 
of food colours and describes other on-going re-evaluations. Further detail relating to 
recent re-evaluations is provided in an accompanying staff working paper. 

2. 

SAFETY EVALUATION 

Prior to their authorisation food additives are evaluated for safety by the independent 
scientific bodies that advise the Commission. The SCF, created in 1974, undertook 
this task until May 2003. The task of the SCF was to advise the 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,  in  particular  on  nutritional,  hygienic  and 
toxicological issues.  

9 
10 
11 
12 

COM(2001) 542 final. 
OJ L 24, 29.1.2004, p. 65. 
OJ L 24, 29.1.2004, p. 58. 
Food Additives in Europe 2000, Status of safety assessments of food additives presently permitted in 
the EU, Nordic Council of Ministers, TemaNord 2002:560. 

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Therefore, although the legislation on the authorisation and use of food additives was 
only fully harmonised and completed by 1995, there is a long history of evaluating 
the safety of food additives in the EC. 

Since  May  2003  the  SCF  was  replaced  by  the  EFSA  established  by  Framework 
Regulation (EC) No 178/2002 of 28 January 200213.  

Similarly to the SCF, the EFSA provides independent scientific advice on all matters 
linked to food and feed safety. EFSA’s risk assessments provide risk managers with 
a sound scientific basis for defining policy driven legislative or regulatory measures 
required to ensure a high level of consumer protection with regard to food safety.  

In addition to establishing technological need and value to consumers of a proposed 
food  additive,  it  is  necessary  to  evaluate  the  implications  for  the  health  of  the 
consumer due to the presence of that additive in food. 

Within  the  EFSA,  it  is  usually  the  Panel on  food additives,  flavourings, processing 
aids and materials in contact with food (AFC) which carries out the risk assessment 
in relation to food additives and issues the opinions on their safety. 

Information  that  should  be  submitted  in  order  to  carry  out  a  safety  evaluation  of  a 
food  additive  is  laid  down  in  the  guidance  document14  that  was  developed  by  the 
SCF (adopted in July 2001). Subsequently this guidance document was endorsed by 
the AFC panel in its second meeting on 9 July 2003. The SCF first issued guidelines 
for  the  safety  assessment  of  food  additives15  in  1980.  Since  that  time,  a  number  of 
other  guidance  documents  have  been  published  on  the  principles  for  assessment  of 
food additive safety, including by the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA),16
 and there is now considerable international consensus on these 
general principles.  

to 

In  accordance  with  the  SCF  guidelines,  the  aim  of  toxicological  testing  is  to 
determine  whether  the  substance,  when  used  in  the  manner  and  in  the  quantities 
proposed, would pose any appreciable risk to the health of consumers. Such testing 
should  provide  not  only  information  relevant  to  the  average  consumer,  but  also 
those  population  groups  whose  pattern  of  food  consumption, 
relevant 
physiological  status  or  health  status  may  make  them  vulnerable,  e.g.  young  age, 
pregnancy, diabetes, etc. A general framework covering core tests and other tests is 
given  in  the  guidelines.  Core  tests  include  tests  on  metabolism  and  toxicokinetics, 
subchronic  toxicity,  genotoxicity,  chronic  toxicity  and  carcinogenicity  as  well  as 
tests  on  reproduction  and  developmental  toxicity.  Other  tests  include  studies  on 
immunotoxicity, allergenicity, food intolerance, neurotoxicity and in vitro studies as 
alternatives to in vivo studies. 

13 
14 

15 

16 

Regulation (EC) No 178/2002 of the European Parliament and of the Council, OJ L 31, 1.2.2002, p. 1. 
Guidance on submissions for food additive evaluations by the Scientific Committee on Food (opinion 
expressed on 11 July 2001). http://europa.eu.int/comm/food/fs/sc/scf/out98_en.pdf 
Guidelines  for  the  Safety  Assessment  of  Food  Additives  (Opinion  expressed  on  22  February  1980, 
10th Series). http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_10.pdf 
IPCS/JECFA  (1987)  Environmental  Health  Criteria  70:  Principles  for  the  Safety  Assessment  of  Food 
Additives and Contaminants in Food. World Health Organization, Geneva. 

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As stated in the guidelines, the studies required will depend on the chemical nature of 
the additive, its intended uses and levels of use in food, whether it is a new additive 
or a re-examination of an existing additive. In addition to laboratory tests, it may be 
possible to use human data  derived from medical  use, epidemiologic studies, or on 
critically  exposed  groups.  However,  it  is  recognised  that  for  new  food  additives,  a 
safety  evaluation  generally  relies  on  experimental  data  largely  derived  from 
investigations in laboratory animals. If the biological action of a substance has been 
ascertained qualitatively and quantitatively in a range of tests on laboratory animals, 
the  likely  effects  on  man  can  then  be  estimated  by  careful  extrapolation  by 
toxicologists. 

3. 

PRIORITY SETTING 

3.1. 

Colours 

Synthetic colours were among the first additives to be evaluated, therefore, many of 
the evaluations date back to the 1970’s and 1980s’. For some of these colours many 
new  studies  have  become  available  and  the  results  of  these  studies  should  be 
included in the evaluation. 

The report of the Nordic Council (Food Additives in Europe 2000) draws the same 
conclusion  by  giving  some  natural  colours  priority.  The  report  concludes  that  they 
have  only  been  tested  to  a  very  limited  extent  and  that  the  evaluations  were  based 
more on assumptions. For instance some were considered acceptable as long as they 
were  derived  from  food  and  that  consumption  as  a  colour  would  not  significantly 
differ  from  that  which  could  be  expected  from  consuming  the  foods  in  question. 
However, since the specifications for these colours also allow for other sources and 
there is a tendency by food producers to replace synthetic colours by natural ones, it 
is  not  certain  that  these  conditions  are  still  met.  So  a  new  safety  assessment  is 
needed. The report gives a low to medium priority for the re-evaluation of synthetic 
colours.  

The  report  of  the  Nordic  Council  therefore  suggested  that  most  natural  colours  are 
given a higher priority re-evaluation than the synthetic colours. 

3.2.  Miscellaneous food additives 

The  re-evaluation  of  nitrites  and  nitrates  was  set  as  a  priority  following  the 
judgement  of  the  Court  of  Justice  in  case  C-3/00  Denmark  against  Commission17. 
Additionally,  Directive  2003/114/EC  lays  down  as  a  matter  of  priority  the  re-
evaluation of polysorbates.  

Moreover,  the  report  of  the  Nordic  Council  has  given  a  medium  priority  to  some 
additives 
the 
categorisations are less homogeneous than those concerning colours or sweeteners. 

the  group  of  antioxidants  and  preservatives.  However, 

in 

17 

C-3/00 Judgment of 20/03/2003, Denmark / Commission (Rec.2003, p.I-2643). 

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3.3. 

Sweeteners 

The  safety  evaluation  of  most  sweeteners  is  recent.  Therefore,  sweeteners  should 
have the lowest priority for re-evaluation. However, due to recent studies published 
on the safety of aspartame, the EFSA has recently re-evaluated aspartame with high 
priority. 

4. 

OUTCOME AND STATUS OF RECENT AND ONGOING RE-EVALUATIONS 

The  outcomes  and  status  of  some  recent  and  ongoing  re-evaluations  is  provided 
below,  further  details  relating  to  these  and  other  re-evaluations  is  available  in  a 
Commission Staff Working Paper18. 

4.1. 

Nisin (E 234) and Natamycin (E 235) 

Nisin is authorised for food preservation by Directive 95/2/EC. Nisin is permitted in 
ripened  cheese  and  processed  cheese,  certain  puddings,  clotted  cream  and 
mascarpone.  

Natamycin is also authorised for food preservation by Directive 95/2/EC. Natamycin 
is permitted for the surface treatment on cheese and on dried cured sausages. 

The Scientific Steering Committee adopted an opinion on antimicrobial resistance in 
28  May  199919.  On  the  basis  of  this  opinion,  the  Commission  adopted  on  20  June 
2001 a Communication on a Community strategy against antimicrobial resistance20. 
Action  9  listed  in  the  Communication  is  to  review  the  use  of  two  authorised 
antimicrobial agents in food: nisin and natamycin.  

The  re-evaluation  of  nisin  was  completed  by  January  2006  and  the  AFC  Panel 
adopted an opinion on nisin with the following conclusions21: 

Nisin has a double mode of antimicrobial action; binding to lipid II and subsequent 
inhibition  of  cell  wall  synthesis  as  well  as  forming  pores  in  the  cytoplasmic 
membrane. Nisin is used as a food preservative and has currently no therapeutic use. 
There  are  no  reports  of  sporadic  nisin  resistant  bacterial  mutants  showing  cross-
resistance to therapeutic antibiotics. The Panel considered that this is probably due to 
the  differences  in  the  antimicrobial  mode  of  action  between  therapeutic  antibiotics 
and nisin and that antibiotic resistance to nisin is not likely to be an issue in relation 
to its use in food.’  

Similarly  to  nisin,  the  Commission  has  asked  the  EFSA  to  issue  an  opinion  on  the 
safety  of  using  natamycin  as  a  food  additive  and  also  to  address  the  issue  of 
antimicrobial  resistance  and  the  use  of natamycin.  This  re-evaluation  should  be 
completed by mid 2007. 

18 
19 

20 
21 

[reference to be added]. 
Opinion  of  the  Scientific  Steering  Committee  on  Antimicrobial  Resistance  28  May  1999  (available 
from http://ec.europa.eu/food/fs/sc/ssc/out50_en.pdf) 
COM(2001) 333 final. 
The EFSA Journal (2006) 314, 1-16. 

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4.2. 

Para-hydroxybenzoates (E 214 – 219) 

Para-hydroxybenzoates are permitted for use as preservatives in some meat coatings, 
potato and cereal based snacks, coated nuts, certain confectionery items and dietary 
food supplements in liquid form by Directive 95/2/EC.  

The  SCF  evaluated  para-hydroxybenzoates  (parabens)  in  199422  and  established  a 
temporary  ADI  of  0-10  mg/kg  bw,  as  the  sum  of  methyl,  ethyl  and  propyl  p-
hydroxybenzoic  acid  esters  and  their  sodium  salts..  The  ADI  was  made  temporary 
because  the  SCF  considered  that  the  toxicological  information  available  showed 
some  inadequacies  and  uncertainties.  The  SCF  therefore  requested  a  new  oral 
teratogenicity study in the rat. 

In  2000,  the  SCF  reiterated  its  wish  to  review  the  safety  of  parabens.  At  its  last 
meeting in April 2003, the SCF noted that no data had been submitted by the food 
industry  in  support  of  the  parabens  and  drew  attention  to  its  statement  of  October 
2000, that the temporary ADI should be withdrawn if no further data were submitted.  

In addition, Directive 2003/114 requested the Commission and the EFSA to review 
the conditions for the use of E 214 – 219 p-hydroxybenzoates and their sodium salts 
before 1 July 2004. 

The  re-evaluation  was  completed  in  July  2004  when  the  AFC  Panel  adopted  an 
opinion23 with the following conclusions: 

‘The Panel established a full group ADI of 0-10 mg/kg bw for the sum of methyl and 
ethyl  p-hydroxybenzoic  acid  esters  and  their  sodium  salts….  The  Panel  considered 
that  propyl  paraben  should  not  be  included  in  this  group  ADI  because  propyl 
paraben, contrary to methyl and ethyl paraben, had effects on sex hormones and the 
male reproductive organs in juvenile rats. 

The Panel is unable to recommend an ADI for propyl paraben because of the lack of 
a clear NOAEL.’ 

Consequently, the Commission proposed in October 2004 to withdraw E 216 propyl 
p-hydroxybenzoate  and  E  217  sodium  propyl  p-hydroxybenzoate  from  Directive 
95/2/EC24.  The  amendment  to  Directive  95/2/EC  was  adopted  by  the  European 
Parliament and the Council on 5 July 200625.  

4.3. 

Nitrites and nitrates (E 249 – E 252) 

Sodium  and  potassium  salts  of  nitrite  and  nitrate  are  permitted  for  preservation  of 
meat products, cheese and certain fish products by Directive 95/2/EC. 

In  light  of  the  judgement  of  the  Court  of  Justice  in  Case  C-3/00,  Denmark  v. 
Commission,  the  Commission  consulted  the  EFSA  for  advice  on  the  current 

22 

23 
24 
25 

Opinion  on  p-hydroxybenzoic  acid  alkyl  esters  their  sodium  salts.  Expressed  on  25  February  1994. 
Reports of the Scientific Committee for Food, Thirty-Fifth Series. CEC, Luxembourg. p. 9-12. 
The EFSA Journal (2004) 83, 1- 26. 
(COM(2004) 650 final). 
Directive 2006/52/EC, OJ L 204, 26.7.2006 p. 10. 

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authorisations of nitrite and nitrate in meat products in relation to the effect of nitrites 
and  nitrates  on  the  microbiological  safety  of  meat  products,  in  particular  related  to 
Clostridium botulinum. 

The  re-evaluation  was  completed  in  November  2003  and  the  Scientific  Panel  on 
Biological Hazards adopted an opinion26 . 

The Panel confirmed that nitrite contributes to microbiological safety and also to the 
flavour, colour and anti-oxidative stability of meat products. Levels up to 100 mg/kg 
of  added  nitrite  might  suffice  for  preservation  of  many  products,  but  some  might 
require up to 150 mg/kg. The Panel noted that nitrate provides no direct protection 
against  the  growth  of  Clostridium  botulinum  in  most  meat  products.  However,  the 
use of nitrate as a reservoir of nitrite appears necessary, in particular, in traditionally-
cured meat products.  

The  Panel  recommended  that  the  levels  of  nitrite  and  nitrate  are  set  down  in  the 
legislation as “added amount”. It was of the opinion that the added amount of nitrite 
rather  than  the  residual  amount  contributes  to  the  inhibitory  activity  against  C. 
botulinum. 

In order to keep the level of nitrosamines as low as possible by lowering the levels of 
nitrites  and  nitrates  added  to  food  whilst  maintaining  the  microbiological  safety  of 
food  products,  the  European  Parliament  and  the  Council  have  adopted  Directive 
2006/52/EC  amending  Directive  95/2/EC  to  change  the  current  authorisations  for 
nitrates  and  nitrites.  In  this  amendment  the  general  principle  of  controlling  ingoing 
amounts  of  nitrates  and  nitrites  applies,  however  for  certain 
traditionally 
manufactured products the use is controlled by residual amounts.  

4.4. 

Benzoic acid and its salts (E 210 – E213) 

Benzoic acid and its salts are widely used as food preservatives and permitted for use 
by Directive 95/2/EC. 

The  SCF  first  evaluated  the  safety  of  benzoic  acid  and  its  salts  in  1994.  In  this 
opinion27,  the  Committee  raised  questions  about  developmental  toxicity  and 
genotoxicity  and asked for further studies in these two areas.  In  view of these data 
requests, the Committee set only a temporary ADI of 0 – 5 mg/kg bw based on an 
overall NOAEL of 500 mg/kg bw/day from long-term and multigeneration studies. 

In September 2002, the SCF had completed the re-evaluation of its earlier opinion in 
the  light  of  new  information  and  adopted  an  opinion28  with  the  following 
conclusions: 

On the basis of these data and the other types of study previously evaluated by the 
Committee,  the  Committee  can  establish  a  full  Group  ADI  of  0  -  5  mg/kg  bw  for 

26 
27 

28 

The EFSA Journal (2003) 14, 1-31. 
Opinion  on  benzoic  acid  and  its  salts.  Expressed  on  24  February  1994.  Reports  of  the  Scientific 
Committee for Food, Thirty-Fifth Series. CEC, Luxembourg. p. 33-39. 
Opinion of the Scientific Committee on Food on Benzoic acid and its salts (expressed on 24 September 
2002). 

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benzoic  acid  and  its  salts  including  benzyl  alcohol  and  related  benzyl  derivatives 
used as flavourings.’ 

4.5. 

Cyclamic acid and its sodium and calcium salts (E 952) 

Cyclamic  acid  and  its  sodium  and  calcium  salts  are  intense  sweeteners,  with  a 
sweetness  approximately  30  times  that  of  sucrose.  They  are  permitted  for  use  in 
several low calorie foods and beverages by Directive 94/35/EC. 

The SCF evaluated the safety of cyclamate, cyclohexylamine and dicyclohexylamine 
in 198429 and established a temporary ADI of 0-11 mg/kg bw, expressed as cyclamic 
acid,  for  cyclamic  acid  and  its  sodium  and  calcium  salts.  The  Committee  reviewed 
cyclamate again in 1988, 1991 and 1995 and confirmed the temporary ADI. 

In  March  2000,  the  SCF  revised  its  opinion30  on  cyclamate  again.  The  Committee 
concluded  that  a  full  ADI  for  cyclamate  could  now  be  established.  However, 
although the new epidemiological data revealed no indications of harmful effects of 
cyclamate  on  humans,  the  Committee  decided  to  lower  the  ADI  for  this  substance 
from  11  to  7  mg/kg  bw.  The  reason  for  this  was  that  new  scientific  evidence  had 
shown the conversion rate of cyclamate to cyclohexylamine and dicyclohexylamine 
in the body to be higher than was previously thought. 

Consequently, the authorisations for the use of cyclamates were revised in Directive 
2003/115/EC to reflect the change in the acceptable daily intake.  

4.6. 

Aspartame (E 951) 

Aspartame is an intense sweetener with a sweetness approximately 200 times that of 
sucrose.  It  is  permitted  for  use  in  several  low  calorie  foods  and  beverages  by 
Directive  94/35/EC.  Salt  of  aspartame  acesulfame  (E  962)  is  also  permitted  by 
Directive  94/35/EC.  Owing  to  the  phenylalanine  content  of  aspartame,  persons 
suffering from the genetic disease phenylketonuria (PKU) must take into account the 
consumption  of  aspartame  into  their  daily  intake  of  phenylalanine,  therefore  under 
EU  legislation  products  containing  aspartame  must  contain  the  warning  ‘contains  a 
source of phenylalanine’.  

29 

30 

Commission  of  the  European  Communities  (1985).  Report  of  the  Scientific  Committee  for  Food  on 
Sweeteners (opinion expressed on 14 September 1984). Reports of the Scientific Committee for Food 
(Sixteenth Series). CEC, Luxembourg, EUR 10210 EN. 
Revised opinion on cyclamic acid and its sodium and calcium salts (Expressed on 9 March 2000). 

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The  SCF initially  evaluated aspartame during 198431 and established an ADI of 40 
mg/kg bodyweight. Subsequently the SCF re-examined aspartame in 198832, 199733 
and  most  recently  in  2001  the  Committee  reviewed  the  safety  of  aspartame  by 
considering  over  500  papers  published  in  the  scientific  literature  since  the  earlier 
SCF  assessment  (papers  published  between  1988  and  2001).  As  a  result  of  this 
review in 200234 the Committee concluded that after reviewing the data available to 
date there was no evidence to suggest a need to revise the outcome of the earlier risk 
assessment or the ADI previously established for aspartame. 

In June 2005, the European Commission became aware of a new study carried out at 
the Ramazzini research centre in Italy by Soffritti et al.35  36 The Commission asked 
the  EFSA  to  urgently  assess  the  new  study  and  advise  whether  it  is  necessary  to 
revise the previous opinion on aspartame carried out by the SCF in 2002.  

After considering the data provided by the research institute in December 2005 and 
April 2006 the EFSA adopted an opinion on 3rd May 200637. This opinion concluded 
that,  on  the  basis  of  the  data  provided,  there  is  no  reason  to  further  review  the 
previous  scientific  opinion  on  the  safety  of  aspartame  nor  to  revise  the  ADI 
established by the SCF.  

5. 

ON-GOING RE-EVALUATION OF FOOD COLOURS 

As  mentioned  above,  the  Commission  requested  the  EFSA  to  re-evaluate  food 
colours  as  a  priority.  There  are  46  currently  permitted  colours  which  can  be 
subdivided  into  three  groups;  natural,  synthetic  and  mineral  colours.  In  order  to 
collate and summarise the existing information on the colours, the EFSA published 
in November 2004 two calls for tenders; one for gathering information on synthetic 
colours38 and one for natural colours39. In its call for tenders the EFSA also outlined 
its strategy for re-evaluation of the safety assessments. 

31 

32 

33 

34 

35 

36 

37 
38 
39 

SCF (1985). Sweeteners. Reports of the Scientific Committee for Food (Sixteenth Series), EUR 10210 
EN, Commission of the European Communities, Luxembourg. 
SCF  (1989).  Sweeteners.  Reports  of  the  Scientific  Committee  for  Food  (Twenty-first  Series),  EUR 
11617 EN, Commission of the European Communities, Luxembourg. 
SCF (1997). Minutes of the 107th Meeting of the Scientific Committee for Food, held on 12-13 June 
1997 in Brussels. Available at: 
http://europa.eu.int/comm/food/fs/sc/oldcomm7/out13_en.html 
Opinion  of  the  Scientific  Committee  on  Food:  Update  on  the  Safety  of  Aspartame  (expressed  on 
4 December 2002). 
Soffritti, M., Belpoggi, F., Esposti D.D, and Lambertini, L. (2005). Aspartame induces lymphomas and 
leukaemias in rats. Eur. J. Oncol., 10, 107-116. 
Soffritti,  M.,  Belpoggi,  F.,  Esposti,  D.D.,  Lambertini,  L.,  Tibaldi,  E.,  and  Rigano,  A.  (2006).  First 
Experimental Demonstration of the Multipotential Carcinogenic Effects of Aspartame Administered in 
the Feed to Sprague-Dawley Rats. Env. Health Perspect., 114, 379 – 385. 
The EFSA Journal (2006) 356, 1-44. 
Call for tender No EFSA/AFC/ADD/Tender/02/2004. 
Call for tender No EFSA/AFC/ADD/Tender/01/2004. 

EN 

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   EN 

 
                                                 
 
In  2005,  the  EFSA  selected  a  contractor  to  prepare  summary  reports,  including 
toxicity  and  non-toxicity  data,  to  be  used  in  the  re-evaluation  of  the  currently 
permitted  natural  and  synthetic  colours.  During  the  first  year  of  the  contract  the 
contractor  will  prepare  summary  reports  for  ten  natural  colours  and  ten  synthetic 
colours.  

The  actual  re-evaluation  is  being  undertaken  by  the  AFC  Panel  and  commenced  in 
2006.  

EN 

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   EN