COMMISSION REGULATION (EU) No 257/2010  
of 25 March 2010  
setting up a programme for the re-evaluation of approved food additives in accordance with 
Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives  
(Text with EEA relevance)  
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,  
After consulting the European Food Safety Authority,  
Whereas:  
(1) Regulation (EC) No 1333/2008 requires the Commission 
to set up a programme for the re-evaluation, by the 
European Food Safety Authority (hereinafter referred to 
as ‘EFSA’), of the safety of food additives that were 
already permitted in the Union before 20 January 2009.  
(2) In 2007, the Commission presented a report to the 
European Parliament and the Council on the progress 
of the re-evaluation of food additives (  2 ). That report 
provides a summary of the recent additive re-evaluations 
undertaken by the Scientific Committee on Food (‘SCF’) 
and EFSA and describes the related actions taken by the 
European Commission on the basis of the scientific 
opinions.  
(3) The re-evaluation of food colours has already been 
started with priority, since these food additives have 
the oldest evaluations by the SCF. The re-evaluation of 
certain colours (namely E 102 Tartrazine, E 104 
Quinoline Yellow, E 110 Sunset Yellow FCF, E 124 
Ponceau 4R, E 129 Allura Red AC and E 122 
Carmoisine, E 160d lycopene) has already been 
completed. In addition, some food additives such as E 
234 Nisin and E 214–219 Para-hydroxybenzoates were 
re-evaluated in recent years since new scientific data was requested or became otherwise available. As a conse ­
quence, those additives do not need to be re-evaluated 
again.  
(4) Taking into account that sweeteners have the most recent 
evaluations they should be re-evaluated the last.  
(5) The order of priorities for the re-evaluation of the 
currently approved food additives should be set on the 
basis of the following criteria: the time since the last 
evaluation of a food additive by the SCF or by EFSA, 
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 Report from the Commission on 
Dietary Food Additive Intake in the EU (  3 ) of 2001. 
The report ‘Food additives in Europe 2000 (  4 )’ 
submitted by the Nordic Council of Ministers to the 
Commission, provides additional information for the 
prioritisation of additives for re-evaluation.  
(6) For efficiency and practical purposes, the re-evaluation 
should, as far as possible, be conducted by group of 
food additives according to the main functional class to 
which they belong. EFSA should however be in a 
position to start the re-evaluation of a food additive or 
a group of food additives with higher priority, on a 
request from the Commission or on its own initiative, 
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.  
(7) Deadlines for the re-evaluation should be established in 
accordance with that order of priorities. In duly justified 
cases and only when such re-evaluation may delay 
substantially the re-evaluation of other food additives, 
the deadlines laid down in this Regulation may be 
revised.  
(8) More specific deadlines for individual food additives or 
groups of food additives may be set in the future, in 
order to allow the smooth running of the re-evaluation 
process or in case of emerging concern.EN 26.3.2010 Official Journal of the European Union L 80/19  
( 1 ) OJ L 354, 31.12.2008, p. 16.  
( 2 ) COM(2007) 418 final.  ( 3 ) COM(2001) 542 final.  
( 4 ) Food Additives in Europe 2000, Status of safety assessments of food 
additives presently permitted in the EU, Nordic Council of Ministers, 
TemaNord 2002:560.(9) In order for the re-evaluation procedure to be effective, it 
is important that EFSA acquires from the interested 
parties all data relevant to the re-evaluation and that 
the interested parties are informed well in advance 
when additional data is necessary for the completion of 
the re-evaluation of a food additive.  
(10) Business operators interested in the continuity of the 
approval of a food additive under re-evaluation should 
submit any data relevant to the re-evaluation of the food 
additive. Where possible, business operators should take 
steps to submit information collectively.  
(11) EFSA should 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 re-evaluation, in 
particular toxicological 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 set time limits.  
(12) The food additives to be re-evaluated by EFSA have been 
previously assessed for their safety by the SCF and many 
of them have been used since long time. The information 
to be submitted for their re-evaluation should include 
existing data on which the previous evaluation of a 
food additive was based and any new data relevant to 
the food additive made available since its last evaluation 
by the SCF. That information should be as compre ­
hensive as possible in order to allow EFSA to complete 
its re-evaluation and form an up-to-date opinion and 
should be submitted following to the extent possible 
the applicable guidance on submissions for food 
additive evaluations (currently the guidance established 
by the SCF on 11 July 2001 (  1 )). 
(13) EFSA may require additional information in order to 
complete the re-evaluation of a food additive. In that 
case 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 interested parties should submit the requested 
information within a time period that is set by EFSA 
having considered, where relevant, the views of the 
interested parties.  
(14) Regulation (EC) No 1333/2008 provides that the 
approval of food additives should also take into account environmental factors. Therefore, in the 
framework of the re-evaluation of a food additive the 
interested parties should inform the Commission and 
EFSA of any information relevant to any environmental 
risks from the production, use or waste of that additive.  
(15) Where the requested information necessary for the 
completion of the re-evaluation of a particular food 
additive is not provided, the food additive may be 
removed from the Union list of approved food additives.  
(16) The re-evaluation procedure of food additives must fulfil 
transparency and public information requirements while 
guaranteeing the confidentiality of certain information.  
(17) By the date of entry into force of this Regulation, the 
Commission will make available to the public a list of 
approved food additives that are being re-evaluated with 
the date of their latest evaluation by the ‘SCF’ or EFSA.  
(18) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council 
opposed them,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Subject matter and scope  
1. This Regulation sets up a programme for the re-evaluation 
by the European Food Safety Authority (hereinafter referred to 
as ‘EFSA’) of approved food additives, as provided for in 
Article 32 of Regulation (EC) No 1333/2008.  
2. Approved food additives, for which the re-evaluation by 
EFSA is already completed at the time of the adoption of this 
Regulation, shall not be re-evaluated again. Those food additives 
are listed in Annex I.EN L 80/20 Official Journal of the European Union 26.3.2010  
( 1 ) 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.Article 2  
Definitions  
For the purposes of this Regulation, the following definitions 
shall apply:  
(a) ‘approved food additive’ means a food additive authorised 
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 foodstuffs (  1 ), Directive 
94/36/EC of the European Parliament and of the Council 
of 30 June 1994 on colours for use in foodstuffs (  2 ) or in 
Directive 95/2/EC of the European Parliament and of the 
Council of 20 February 1995 on food additives other than 
colours and sweeteners (  3 ); 
(b) ‘business operator’ means any natural or legal person 
responsible for ensuring that the requirements of Regulation 
(EC) No 1333/2008 are met within the food business under 
its control;  
(c) ‘interested business operator’ means a business operator 
interested in the continuity of the authorisation of one or 
more approved food additives;  
(d) ‘original dossier’ means a dossier on the basis of which the 
food additive was evaluated and permitted for use in food 
before 20 January 2009.  
Article 3  
Priorities for the re-evaluation of approved food additives  
1. Approved food additives shall be re-evaluated in the 
following order and within the following deadlines:  
(a) the re-evaluation of all approved food colours listed in 
Directive 94/36/EC shall be completed by 31 December 
2015;  
(b) the re-evaluation of all approved food additives other than 
colours and sweeteners listed in Directive 95/2/EC shall be 
completed by 31 December 2018;  
(c) the re-evaluation of all approved sweeteners listed in 
Directive 94/35/EC shall be completed by 31 December 
2020.  2. For certain food additives within the functional classes 
referred to in paragraph 1 more specific deadlines are set out 
in Annex II to this Regulation. Those food additives shall be 
evaluated first among the other food additives of the same 
functional class.  
3. By way of derogation from paragraphs 1 and 2, EFSA may 
at any moment start the re-evaluation of a food additive or a 
group of food additives with priority, on a request from the 
Commission or on its own initiative, if new scientific evidence 
emerges that  
(a) indicates a possible risk for human health or  
(b) may in any way affect the safety assessment of that food 
additive or group of food additives.  
Article 4  
Re-evaluation procedure  
When re-evaluating an approved food additive, EFSA shall:  
(a) examine the original opinion and the working documents of 
the Scientific Committee on Food (‘SCF’) or EFSA;  
(b) examine, where available, the original dossier;  
(c) examine the data submitted by the interested business 
operator(s) and/or any other interested party;  
(d) examine any data made available by the Commission and 
Member States;  
(e) identify any relevant literature published since the last 
evaluation of each food additive.  
Article 5  
Call for data  
1. In order to acquire the data from the interested business 
operators and/or other interested parties, EFSA shall make open 
call(s) for data for the food additives under re-evaluation. In 
specifying the timetable for data submission, EFSA shall allow 
a reasonable time period after the entry into force of this 
Regulation, to allow the interested business operator and/or 
any other interested party to meet this duty.EN 26.3.2010 Official Journal of the European Union L 80/21  
( 1 ) OJ L 237, 10.9.1994, p. 3.  
( 2 ) OJ L 237, 10.9.1994, p. 13.  
( 3 ) OJ L 61, 18.3.1995, p. 1.2. The data referred to in paragraph 1 may comprise among 
others:  
(a) study reports from the original dossier as evaluated by the 
SCF or EFSA or the Joint FAO/WHO Expert Committee on 
Food Additives (JECFA),  
(b) information on the data on the safety of the food additive 
concerned not previously reviewed by the SCF or the JECFA,  
(c) information on the specifications of the food additives 
presently in use, including information on particle size 
and relevant physicochemical characteristics and properties,  
(d) information on the manufacturing process,  
(e) information on analytical methods available for deter ­
mination in food,  
(f) information on the human exposure to the food additives 
from food (e.g. consumption pattern and uses, actual use 
levels and maximum use levels, frequency of consumption 
and other factors influencing exposure),  
(g) reaction and fate in food.  
Article 6  
Submission of data  
1. The interested business operator(s) and any other 
interested party shall submit the data related to the re-evaluation 
of a food additive as referred to in Article 5(2), within the 
period set by EFSA in its call for data. In the submission the 
interested business operator and the other interested parties 
shall include the data requested by EFSA by following, to the 
extent possible, the applicable guidance on submissions for food 
additive evaluations (  1 ). 
2. Where there are several interested business operators they 
may, when possible, submit the data collectively.  
3. If during the re-evaluation additional information 
considered to be relevant for the re-evaluation of a particular 
food additive is needed, EFSA shall request from the interested 
business operators, and shall invite other interested parties, to submit this information by an open call for data. It shall set a 
deadline within which that information shall be submitted 
having considered, where relevant, the interested business 
operator's and/or other interested parties' view of the time 
required. In such cases, EFSA shall make the request for the 
additional information well in advance so that the overall 
deadlines for the re-evaluation as set out in Article 3(1) and 
in Annex II are not affected.  
4. Information which has not been submitted within the 
deadline 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 account 
information submitted after the deadline, if that information is 
significant for the re-evaluation of a food additive.  
5. Where the requested information has not been submitted 
to EFSA within the set deadlines, the food additive may be 
removed from the Union list in accordance with the 
procedure laid down in Article 10.3 of Regulation (EC) 
No 1333/2008 (  2 ). 
Article 7  
Other information  
In the framework of the re-evaluation of a food additive, the 
interested business operator(s) or any other interested party 
shall inform EFSA and the Commission of any information 
available in relation to any environment risks from the 
production, use or waste of that food additive.  
Article 8  
Confidentiality  
1. Confidential treatment may be given to information the 
disclosure of which might significantly harm the competitive 
position of business operators or other interested parties.  
2. Information relating to the following shall not, in any 
circumstances, be regarded as confidential:  
(a) the name and address of the interested business operator;  
(b) the chemical name and a clear description of the substance;  
(c) information for the use of the substance in or on specific 
foodstuffs or food categories;EN L 80/22 Official Journal of the European Union 26.3.2010  
( 1 ) Currently the Opinion expressed by the SCF on 11 July 2001. 
SCF/CS/ADD/GEN/26 Final.  (  2 ) OJ L 354, 31.12.2008, p. 16.(d) information that is relevant to the assessment of the safety 
of the substance;  
(e) the method(s) of analysis in food.  
3. For the purposes of paragraph 1, the interested business 
operator(s) and the other interested parties shall indicate which 
of the information provided they wish to be treated as confi ­
dential. Verifiable justification shall be given in such cases.  
4. On a proposal from EFSA, the Commission shall decide 
after consulting the interested business operator and/or the 
other interested parties which information may remain confi ­
dential and shall notify the EFSA and the Member States 
accordingly.  
5. The Commission, EFSA and the Member States shall, in 
accordance with Regulation (EC) No 1049/2001 of the 
European Parliament and of the Council of 30 May 2001 
regarding public access to European Parliament, Council and 
Commission documents (  1 ), take the necessary measures to 
ensure appropriate confidentiality of the information received under this Regulation, except for information which must be 
made public if circumstances so require in order to protect 
human health, animal health or the environment.  
6. The implementation of paragraphs 1 to 5 shall not affect 
the circulation of information between the Commission, EFSA 
and the Member States.  
Article 9  
Monitoring progress  
Every year in December, EFSA shall inform the Commission and 
the Member States on the progress of the re-evaluation 
programme.  
Article 10  
Entry into force  
This Regulation shall enter into force on the twentieth 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, 25 March 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 26.3.2010 Official Journal of the European Union L 80/23  
( 1 ) OJ L 145, 31.5.2001, p. 43.ANNEX I  
A list of approved food additives which were approved before 20 January 2009 and for which the re-evaluation 
by EFSA is completed at the time of adoption of this Regulation  
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 23 September 
2009  
E 104  Quinoline Yellow  2009  Re-evaluation completed on 23 September 
2009  
E 110  Sunset yellow FCF, Orange Yellow S  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 23 September 
2009  
E 129  Allura Red AC  2009  Re-evaluation completed on 23 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  
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  2009  Re-evaluation completed on 26 November 
2009  
E 473  Sucrose esters of fatty acids  2006  Re-evaluation completed on 23 November 
2004; revised on 26 January 2006  
E 474  Sucroglycerides  2006  Re-evaluation completed on 23 November 
2004; revised on 26 January 2006  
E 901  Beeswax, white and yellow  2007  Re-evaluation completed on 27 November 
2007EN L 80/24 Official Journal of the European Union 26.3.2010ANNEX II  
Specific priorities for certain food additives within the functional classes of food additives as referred to in 
Article 3(1) and (2)  
PART I: FOOD COLOURS  
Within the overall deadline of 31.12.2015 set for the re-evaluation of food colours in Article 3(1) the following specific 
deadlines are set for the following food colours:  
1. The following food colours shall be evaluated by 15.4.2010  
E 123 Amaranth,  
E 151 Brilliant Black BN, Black PN  
E 154 Brown FK,  
E 155 Brown HT and  
E 180 Litholrubine BK  
2. The following food colours shall be evaluated by 31.12.2010  
E 100 Curcumin,  
E 127 Erythrosine,  
E 131 Patent Blue V,  
E 132 Indigotine, Indigo carmine  
E 133 Brilliant Blue FCF,  
E 142 Green S,  
E 150a Plain caramel,  
E 150b Caustic sulphite caramel,  
E 150c Ammonia caramel,  
E 150d Sulphite ammonia caramel,  
E 161b Lutein,  
E 161g Canthaxanthin,  
E 170 Calcium carbonate,  
3. The following food colours shall be evaluated by 31.12.2015  
E 101 (i) Riboflavin (ii) Riboflavin-5’-phosphate,  
E 120 Cochineal, Carminic acid, Carmines  
E 140 Chlorophylls and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins,  
E 141 Copper complexes of Chlorophylls and Chlorophyllins: (i) Copper complexes of chlorophylls (ii) Copper 
complexes of chlorophyllins,  
E 153 Vegetable carbon,  
E 160b Annatto, bixin, norbixin  
E 160a Carotenes: (i) mixed carotenes, (ii) beta-carotene,  
E 160c Paprika extract, capsanthin, capsorubin,  
E 160e Beta-apo-8’-carotenal (C30),EN 26.3.2010 Official Journal of the European Union L 80/25E 160f Ethyl ester of beta-apo-8’, -carotenoic acid (C30),  
E 162 Beetroot red, betanin,  
E 163 Anthocyanins,  
E 171 Titanium dioxide,  
E 172 Iron oxides and hydroxides,  
E 174 Silver,  
E 175 Gold  
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 3(1), the following specific deadlines are set for certain food additives and groups of food additives:  
1. Preservatives and antioxidants E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321 and E 586 shall be 
evaluated by 31.12.2015  
with higher priority within this group on:  
E 310-312 Gallates  
E 320 Butylated hydroxyanisole (BHA)  
E 321 Butylated hydroxytoluene (BHT)  
E 220-228 Sulphur dioxide and sulphites  
E 304 Fatty acid esters of ascorbic acid: (i) Ascorbyl palmitate (ii) Ascorbyl stearate  
E 200-203 Sorbic acid and sorbates  
E 284 Boric acid  
E 285 Sodium tetraborate (borax)  
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, calcium and potassium salts  
E 306 Tocopherol-rich extract  
E 307 Alpha-tocopherol  
E 308 Gamma-tocopherol  
E 309 Delta-tocopherol  
2. Emulsifiers, stabilisers, gelling agents E 322, E 400-E 419; E 422-E 495; E 1401-E 1451 shall be evaluated by 
31.12.2016  
With higher priority within this group on:  
E 483 Stearyl tartrate  
E 491-495 Sorbitan esters  
E 431 Polyoxyethylene (40) stearate  
E 432-436 PolysorbatesEN L 80/26 Official Journal of the European Union 26.3.2010E 444 Sucrose acetate isobutyrate  
E 481 Sodium stearoyl-2-lactylate  
E 482 Calcium stearoyl-2-lactylate  
E 414 Acacia gum (gum arabic) (*)  
E 410 Locust bean gum (*)  
E 417 Tara gum (*)  
E 422 Glycerol  
E 475 Polyglycerol esters of fatty acids  
3. E 551 Silicon dioxide, E 620-625 Glutamates, E 1105 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 552 Calcium silicate  
E 553a Magnesium silicate and trisilicate  
E 553b Talc  
E 558 Bentonite  
E 999 Quillaia extract  
E 338-343 Phosphoric acid and phosphates  
E 450-452 Di-, tri- and polyphosphates  
E 900 Dimethyl polysiloxane  
E 912 Montan acid esters  
E 914 Oxidised polyethylene wax  
E 902 Candellila wax  
E 904 Shellac  
E 626-629 Guanylic acid, Disodium guanylate, Dipotassium guanylate and Calcium guanylate  
E 630-633 Inosinic acid, Disodium inosinate; Dipotassium inosinate and Calcium inosinate  
E 634-635 Calcium 5'-ribonucleotides and Disodium 5'-ribonucleotides  
E 507-511 Hydrochloric acid, Potassium chloride, Calcium chloride, Magnesium chloride  
E 513 Sulphuric acidEN 26.3.2010 Official Journal of the European Union L 80/27  
(*) All natural gums E 400-418 and E 425 could be evaluated at the same time.