EN    EN ENEN 1   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
setting the programme for the re-evaluation of  approved food additives in application of 
Regulation (EC) No 1333/2008 of the European  Parliament and of the Council on food 
additives 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the 
Council of 16 December 2008 on food additives
1, and in particular Article 32 thereof, 
Whereas: (1) The Commission should, after consultation with European Food Safety Authority 
(hereinafter referred to as EFSA), se t up an evaluation programme for the re-
evaluation by EFSA of the safety of the f ood additives that were already permitted in 
the Community before 20 January 2009. That programme should define the needs and 
the order of priorities according to which the approved food additives are to be examined. 
(2) The order of priorities for the re-evaluation of the approved food additives should be 
set on the basis of certain criteria such as the time since the last  evaluation of a food 
additive, the availability of new scientific evidence, the extent of use of a food additive 
in food and the human exposure to the food additive taking also into account the 
outcome of the 2001 Commission report
2 on food additive dietary intake at EU level 
and its subsequent follow up. A report  entitled “Food additi ves in Europe 20003” was 
submitted by the Nordic Council of Minist ers to the Commission, provides also 
additional information for the prioritisation of additives for re-evaluation. 
(3) It is important for this re-evaluation to be effective, that EFSA acquires from 
interested parties all data relevant to the re-evaluati on of food additives and that 
interested parties are informed on the time when additional data is necessary for the completion of the re-evaluation of a food additive. 
(4) A procedure should therefore be establishe d in which the relationship between the 
parties interested in the re-e valuated food additives, EFSA, the Member States and the 
                                                
 
1 OJ L 354, 31.12.2008, p. 16. 
2  COM(2001) 542 final 
3  Food Additives in Europe 2000, Status of safety assessments of food additives presently permitted in 
the EU, Nordic Council of Ministers, TemaNord 2002:560. EN 2   EN Commission and the obligations of each of the parties for the implementation of the 
procedure should be laid down. 
(5) Business operators interested in the continu ity of the approval of a food additive under 
re-evaluation should submit any data releva nt to the re-evaluation of  the food 
additive.  Business operators can take steps to submit information collectively. 
(6) EFSA will make public one or more open calls  for data on all food additives to be re-
evaluated. Any technical and scientific information about  a food additive which is 
necessary for its evaluation, in particular to xicological data and data relevant for the 
estimation of the human exposure to the relevant food additive, should be submitted by the interested parties to EFSA within the relevant time limits and to the extent 
possible in accordance with the applicable guidance on submissions for food additive 
evaluations (currently the guidance established by the Scientific Committee on Food  
(hereinafter referred to as  ‘SCF’ ) on 11 July 2001
4. 
(7) The information submitted should include existing data on which the previous 
evaluation of a food additive was based and an y new data relevant to the food additive 
made available since its last evaluation by the SCF. This information should be as 
comprehensive as possible in order to allow EFSA to complete its re-evaluation and form an up-to–date opinion. 
(8) Where necessary EFSA may require additiona l information in order to complete the 
re-evaluation of a food additive. In this ca se EFSA should request the necessary data 
in good time either by an open call for data or by contacting the parties that submitted 
data on the food additive. The interest ed parties should submit the requested 
information within a time period that is  set by EFSA having considered, where 
relevant, the views of interested  parties of the time required.  
(9) Food additives must be safe when used, th ere must be a technological need for their 
use and their use must not mislead the c onsumer and must be of benefit to the 
consumer. The approval of food additives s hould also take into account other factors 
relevant to the matter under consideration including societal, economic, traditional, 
ethical and environmental factors. Theref ore, at any time including during the re-
evaluation of food additives  interested parties should inform the Commission and 
EFSA of any information available relevant to any environmental risks from the production, use or waste of  the food additive.  
(10) The re-evaluation procedure of food additi ves must fulfil transparency and public 
information requirements while guarant eeing the confiden tiality of certain 
information. 
(11) The re-evaluation of food colours has alrea dy been started with priority, since these 
food additives have the oldest evaluations by the SCF. The re-evaluation of certain 
colours namely of E102 Tartrazine, E 104 Quinoline Yellow, E110 Sunset Yellow 
FCF, E124 Ponceau 4R , E129 Allura Red AC and E 122 Carmoisine, as well as of E
160d lycopene from all sources is therefore already completed at the time this re-
evaluation programme is established. In a ddition, some food addi tives such as E 234 
                                                 
4  Guidance on submissions for food additive evaluations by the Scientific Committee on Food.  Opinion 
expressed on 11 July 2001. SCF/CS/ADD/GEN/26 Final EN 3   EN Nisin and E214–219 Para-hydroxybenzoates have  been re-evaluated in recent years 
when new scientific data had been request ed or became otherwise available. In 2007, 
the Commission presented a report to the Eu ropean Parliament and the Council on the 
progress of the re-evaluation of food additives5. That report provides a summary of the 
recent additive re-evaluations undertaken  by the SCF and EFSA and describes the 
related actions taken by the European Co mmission on the basis of the scientific 
opinions. Overall, sweeteners have the most recent evaluations and therefore are to be 
re-evaluated the last.  
(12) The prioritisation of the re-evaluation of the particular food additives is done on the 
basis of the criteria set in this Regulation.  For efficiency and practical purposes, the 
re-evaluation will, as far as possible,  be conducted by group of food additives 
according to the main functional class to wh ich they belong. However, when necessary 
these priorities may change and on re quest from the Commission or on its own 
initiative EFSA, after the agreement of the Commission, may commence the re-
evaluation of a food additive or  a group of food additives wi th higher priority, if new 
scientific evidence emerges that indicates a possible risk for human health or which in 
any way may affect the assessment of  the safety of a food additive.  
(13) Where the requested information which is n ecessary for the re-evaluation of a food 
additive is not provided and as a result EFSA can not conclude on the safety of a 
particular food additive, a measure may be a dopted to change the conditions of use or 
remove the food additive from the Community list of approved food additives. 
(14) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Scope  
1. This Regulation lays down the criteria, the procedure and the order of priorities for a 
new risk assessment (here in after referre d to as "re-evaluation") by EFSA of food 
additives which were permitted before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on 
sweeteners for use in foodstuffs6, Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs7 and in Directive 
95/2/EC of the European Parliament and of the Council of 20 February 1995 on food 
additives other than colours and sweeteners8  (here in after referred to as “currently 
approved additives”.   
2. By the time of publication of this Regul ation, the Commission shall make available 
to the public a list of the cu rrently approved food additives under consideration in the 
re-evaluation together with the date of their latest evaluation by the SCF or EFSA. 
                                                
 
5  COM(2007) 418 final 
6  OJ L 237, 10.9.1994, p. 3. 
7  OJ L 237, 10.9.1994, p. 13. 
8  OJ L 61, 18.3.1995, p. 1. EN 4   EN 3. Those currently approved food additives, for which the re-evaluation by EFSA is 
already completed at the time of the adoption of this Regulation, are listed in Annex I 
and shall not be re-evaluated again.  
Article 2 
Definitions  
For the purposes of this Regulation: 
(a) 'Business operator' means the natural or le gal persons responsible for ensuring that the 
requirements of Regulation (EC)  No 1333/2008 and of this Re gulation are met within the 
food business under their control; 
(b) ‘Original dossier’, in relati on to a food additive, means the dossier on the basis of which 
the food additive was evaluated and permitted for use in food before 20 January 2009. 
Article 3 
Criteria for setting priorities  in the re-evaluation progr amme of currently approved 
food additives  
1. The order of priority under wh ich currently approved food additi ves will be evaluated is set 
in Article 4 and Annex II on the basis of the following criteria: 
(a)  The time since the last evaluation of  a food additive by the SCF, or by EFSA; 
(b) The existence of new scientif ic evidence or technical inform ation made available since the 
last evaluation which may affect the asse ssment of the safety of a food additive; 
(c) The extent of the use of a group of food additives or a partic ular food additive in foods and 
concerns over the human exposure to  the specific food additive(s); 
(d) The case where for a food additive an A cceptable Daily Intake (ADI) could not be 
established or a temporary ADI was establ ished by the SCF or the basis for the ADI 
established by the SCF was unclear; 
(e) The existence of diverging views on the risk  assessment of the same food additive between 
SCF and Joint FAO/WHO Expert Committee on F ood Additives (hereinafter referred to 
as JECFA), leading for example to the setting of different ADIs; 
(f) The search for efficiency of the re-evalua tion process and the nee d, for practical reasons, 
for a food additive to be re-evaluated at the same time as others belonging to the same functional group. 
 Article 4 
Priorities for the re-evaluation of  currently approved food additives 
1. Food additives shall be re-evaluated with the following order and within the following 
deadlines taking also into acc ount the specific deadlines as referred to in paragraph 2: 
– The re-evaluation of all currently approved food colours liste d in Directive 
94/36/EC shall be completed by 30.06.2011.  EN 5   EN – The re-evaluation of all currently approve d food additives other than colours and 
sweeteners listed in Directive 95 /2/EC shall be completed by 31.12.2018 
– The re-evaluation of all currently a pproved sweeteners listed in Directive 
94/35/EC  shall be completed by 31.12.2020 
2. For certain food additives within the functiona l classes of food additives referred to in 
paragraph 1 more specific deadlines are set in  Annex II to this Regulation on the basis of 
the criteria set in Article 3. Those food add itives shall be evaluated first among the other 
food additives of the same func tional class of food additives re ferred to in paragraph 1 and 
within the specific deadlines set in Annex II.  
3. By way of derogation from paragraphs 1 a nd 2, EFSA may at any moment, on the request 
from the Commission or on its own initiativ e, commence the re-e valuation of a food 
additive or a group of f ood additives with priority, if new scientific evidence emerges that 
indicates a possible risk for hu man health or which in any way may affect the assessment 
of the safety of a food additive. In duly jus tified cases and only when such re-evaluation 
may delay substantially the re-evaluation of other food additives, the deadlines laid down 
under paragraph 1 and in Annex II of this  Regulation may be revised accordingly. 
4. The Commission may establish more specific deadlines within t hose laid down under 
paragraph 1 and in Annex II, fo r individual food additives or groups of food additives, in 
order to allow the smooth running of the re-e valuation process or in case of emerging 
concern. 
 Article 5 
Data gathering and submission  
1. Business operators, or their representatives, interested in the continuity of the authorisation 
of one or more currently approved food additives after the re-evaluation process, shall  make 
the necessary effort to gather and submit the data referred to in Article 6(2) which are 
necessary for the re-evaluation of these food additive(s). Such a bu siness operator, or 
representative, is hereinafter referred to as 'the  submitter'.  
2. Data shall be submitted following the procedure laid down in Article 6. 3. Where the requested informati on which is necessary for the re -evaluation of a food additive 
has not been submitted to EFSA within the set d eadlines referred to in Article 6 (4) and 6 (6) 
and as a result EFSA cannot conc lude on the safety of  a particular food additive, a measure 
may be adopted to change the conditions of use or remove the food additive from the Community list in accordance  with the procedure laid down in Regulation (EC) No 
1331/2008
9 
Article 6 
Re-evaluation procedure 
1. In re-evaluating each food additive EFSA shall: 
                                                 
9  OJ L354, 31.12.2008, p.1 EN 6   EN • Examine the original SCF opinion and SCF working documents;  
• Examine, where available, the original dossier; 
• Examine the data provided by the submitters or other interested parties as referred to in 
paragraph 4; 
• Examine any data made available by the Commission and Member States;  
• Identify any relevant literature published si nce the last evaluation of each food additive. 
 2. In order to acquire data from submitters and other interested parties, EFSA shall make one 
or more open calls for data for the food additives under re -evaluation. These data may 
comprise among others: 
• study reports from the original dossier as evaluated by the SCF or EFSA and JECFA,  
• information on data on the safety of the food additives concerned not previously 
reviewed in the scientific opinions by SCF and JECFA, 
• Information on the specifications of the food additives presently in use, including 
information on particle size and releva nt physicochemical characteristics and 
properties, 
• Information on the manufacturing process,  
• Information on analytical methods available for determination in food,  
• Information on the human exposure to the food additive from food (e.g. consumption 
pattern and uses, actual us e levels and maximum use levels, frequency and other 
factors influencing exposure). 
• Reaction and fate in the food 
3. The submitter(s) or any other in terested party shall submit data  related to the re-evaluation 
of a food additive within the submission period defined by EFSA in its call for data. In the 
submission the submitter shall include the data re quested by EFSA as referred to in paragraph 
2 by following, to the extent possible, the applicable guidance document on submissions for food additive evaluations. The guidance document applicable at the time of entry into force of this Regulation is the guidance on submissions for food additive evaluations by the Scientific 
Committee on Food
10.  
4. Where for a food additive there are several subm itter(s) they shall take  all reasonable steps 
to submit the data collectively. In specifying the timetable for data submission, EFSA shall allow a reasonable period of time following publication of this Regulation, to allow 
submitters to meet this duty. 
5. During the re-evaluation, EFSA may request from the submitter(s) and/or by an open call 
for data additional information considered to be relevant for the re-evaluation of a particular 
                                                
 
10  Opinion expressed on 11 July  2001. SCF/CS/ADD/GEN/26 Final EN 7   EN food additive setting a time limit within which this information shall be provided having 
considered, where relevant, the submitter’s view of the time required. In those cases, EFSA 
shall make the request for the additional informa tion in good time so that the overall deadlines 
set for the re-evaluation in Article 4( 1) and in Annex II are not affected. 
6. Information which has not been submitted within the period set by EFSA shall not be taken 
into account in the re-evaluation. However, in exceptional cases, EFSA may decide with the 
agreement of the Commission, to take into acco unt information submitted after the original 
period, if this information is significant for the re-evaluation of a food additive. 
Article 7 
Other information  
During the re-evaluation of a food additive, the su bmitter(s) or any other interested party shall 
inform EFSA and the Commission of any in formation available in relation to any 
environment risks from the production, use or waste of the food additive. 
Article 8 
Confidentiality  
1. Confidential treatment may be given to in formation the disclosure of which might 
significantly harm the competitive position of business operators or other interested parties, 
Information relating to the following shall not,  in any circumstances, be regarded as 
confidential: 
(a) the name and address of the submitter; (b) the name and a clear description of the substance; (c) information for the use of the substance in  or on specific foodstuffs or food categories; 
(d) information that is relevant to the as sessment of the safety of the substance; 
(e) where applicable, the analysis method(s). 2. For the purposes of implementing paragraph 1, the submitter(s) shall indicate which of the 
information provided they wish to be treated as confidential. Verifiable justification must be 
given in such cases. 
3. EFSA shall decide after consulting the submitter(s) which information can remain 
confidential and shall notify them the Commission and th e Member States accordingly. 
4. The Commission, EFSA and the Member States  shall, in accordance with Regulation (EC) 
No 1049/2001
11, take the necessary measures to ensure appropriate confidentiality of the 
information received by them under this Regul ation, except for information which must be 
made public if circumstances so require in order to protect human health, animal health or the 
environment. 
                                                 
11  OJ L 145, 31.5.2001, p. 43. EN 8   EN 5. The implementation of paragraphs 1 to 4 sha ll not affect the circulation of information 
between the Commission, EFSA  and the Member States. 
Article 9 
Monitoring progress 
Every year on the date of entry into force of this Regulation, EFSA shall inform the 
Commission and the Member States on progress with th e re-evaluation programme. 
Article 10 
Entry into force 
This Regulation shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 The PresidentEN 9   EN ANNEX I  
List of food additives which were approve d before 20 January 2009 and of which the re-
evaluation by EFSA is completed at the time of adoption of this Regulation as referred 
to in Article 1  
E No  SUBSTANCE  Year of latest 
evaluation by 
SCF or EFSA  Status of re-
evaluation by 
EFSA 
E 102 Tartrazine 2009 Re-evaluation 
completed on 24 
September 2009 
E 104 Quinoline Yellow 2009 Re-evaluation 
completed on 24 
September 2009 
E 110 Sunset yellow FCF, Orange Yellow S 2009 Re-evaluation 
completed on 24 
September 2009 
E 120 Cochineal, Carminic acid, Carmines 2009 Re-evaluation 
completed on 24 September 2009 
E 122 Azorubine, Carmoisine 2009 Re-evaluation 
completed on 24 
September 2009 
E 124 Ponceau 4R, Cochineal Red A 2009 Re-evaluation 
completed on 24 
September 2009 
E 129 Allura red AC 2009 Re-evaluation 
completed on 24 September 2009 
E 160d Lycopene 2008 Re-evaluation 
completed on 30 
January 2008 
E 234 Nisin 2006 re-evaluation 
completed on 26 
January 2006  
E 173 Aluminium  2008 Re-evaluation 
completed on 22 
May 2008 as part 
of the opinion on 
the safety of 
aluminium from 
dietary intake 
E 214 Ethyl p-hydroxybenzoate 2004 Re-evaluation 
completed on 13 
July 2004 
E 215 Sodium ethyl p-hydroxybenzoate 2004 Re-evaluation 
completed on 13 
July 2004 
E 218 Methyl p-hydroxybenzoate 2004 Re-evaluation 
completed on 13 
July 2004 
E 219 Sodium methyl p-hydroxybenzoate 2004 Re-evaluation 
completed on 13 
July 2004 
E 235 Natamycin 1979 ongoing 
E 901 Beeswax, white and yellow 2007 Re-evaluation 
completed on 27 
November 2007 EN 10   EN ANNEX II  
Specific priorities for certain food additive s within the functional classes of food 
additives as referred to in Article 4 (1) and (2)  
PART I: FOOD COLOURS 
Within the overall deadline of 30.06.2011 set for th e re-evaluation of food colours in Article 
4(1) the following specific deadlines ar e set for the following food colours: 
1) The following food colours shall be evaluated by 15.04 2010 
E123 Amaranth,  
E151 Brilliant Black BN E154 Brown FK,  E155 Brown HT and  E180 Litholrubine BK  
2) E160b Annatto, bixin, norbixin shall be evaluated by 31.03. 2010 
3) The following food colours shall be evaluated by 31.12.2010  
E100 Curcumin ,  E101 (i) Riboflavin (ii) Riboflavin-5'-phosphate,  
E127 Erythrosine,  E131 Patent blue V,  E132 Indigotine,  E133 Brilliant blue FCF,  E140 Chlorophylls and chlorophyllins,  E141 Copper complexes of chlorophylls and chlorophyllins  E142 Green S,  E150a Plain caramel,  E150b Caustic sulphite caramel,  E150c Ammonia caramel,  
E150d Sulphite ammonia caramel,  
E153 Vegetable carbon,  E160a Carotenes (i) mixed carotenes, (ii) beta-carotene,  E160c Paprika extract, capsanthin, capsorubin,  E160e Beta-apo-8'-carotenal (C30),  E160f Ethyl esters of beta-apo-8', -carotenoic acid,  EN 11   EN E161b Lutein,  
E161g Canthaxanthin,  E162 Beetroot red, betanin,  E163 Anthocyanins,  E170 Calcium carbonate,  
4) The following food colours shall be evaluated by 30.06.2011   
E171 Titanium dioxide,  E172 Iron oxides and hydroxides,  E174 Silver,  E175 Gold  EN 12   EN PART II: FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERS  
Within the overall deadline of 31.12.2018 set for the re-evaluation of food additives other 
than colours and sweeteners in Article 4(1), th e following specific deadlines are set for certain 
food additives and groups of food additives: 
1) Preservatives and antioxidants  E200-203; E210-215, E218-252, E280-285; E300-E321, 
E586 and E1105 shall be evaluated by 31.12.2013   
with higher priority wi thin this group on: 
– E310-312 Gallates 
– E320  Butylated hydroxyanisole (BHA) 
– E321  Butylated hydroxytoluene (BHT) 
– E220-228 Sulphur dioxide and sulphites 
– E304   Ascorbyl palmitate and stearate 
– E200-203  Sorbates 
– E 284  Boric acid  
– E 285 Sodium tetraborate 
– E 239  Hexamethylene tetramine 
– E 242  Dimethyl dicarbonate 
– E 249  Potassium nitrite 
– E 250  Sodium nitrite 
– E 251  Sodium nitrate 
– E 252  Potassium nitrate 
– E 280-283 Propionic acid and its sodium and calcium salts 
– E306-309 Tocopherols EN 13   EN 2) Emulsifiers, stabilisers , gelling agents E322, E400- E 419; E422-E 495; E1401-E 1451; 
E1103 shall be evaluated by 31.12.2016   
With higher priority within this group on: 
– E 483 Stearyl tartrate 
– E491-495 Sorbitan esters 
– E 431 Polyoxyethylene (40) stearate 
– E432-436 Polysorbates  
– E 444 Sucrose acetate isobutyrate 
– E 481 Sodium stearoyl-2-lactylate 
– E 482 Calcium stearoyl-2-lactylate 
– E 414 Acacia gum* 
– E 410 Locust bean gu m (carob bean gum)* 
– E417  Tara gum* 
– E422  Glycerol 
– E475  Polyglycerol esters of fatty acids 
* All natural gums E 400-418 and E425 c ould be evaluated at the same time. 
3) E620-625 Glutamates, E1105 Lysozyme and E 1103 Invertase shall be evaluated by 
31.12.2016 
4) The remaining food additives other than colours and sweeteners  shall be evaluated by 
31.12.2018  
With higher priority on 
 E 551 Silicon dioxide – E 553b Magnesium trisilicate (talc) 
– E 558 Bentonite  
– E 999 Quillaia extract 
– E338-343 Phosphates 
– E450-452 Di-, tri- and polyphosphates 
– E900  Polydimethylsiloxane 
– E 912 Montan acid esters 
– E 914 Oxidised polyethylene wax 
– E902  Candellila wax 
– E904  Shellac 
– E626-629 Inosinates 
– E634-635 5' Ribonucleotides 
– E 507-511 Hydrochloric acid, Potassium ch loride, Calcium chloride, Magnesium 
chloride 
– 
E513  Sulphuric acid EN 14   EN