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)
Modified by
  • Commission Implementing Regulation (EU) 2021/148of 8 February 2021amending Regulation (EU) No 257/2010 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), 32021R0148, February 9, 2021
Commission Regulation (EU) No 257/2010of 25 March 2010setting 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)
Article 1Subject matter and scope1.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.
Article 2DefinitionsFor 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 foodstuffsOJ L 237, 10.9.1994, p. 3., Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffsOJ L 237, 10.9.1994, p. 13. 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 sweetenersOJ L 61, 18.3.1995, p. 1.;(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 3Priorities for the re-evaluation of approved food additives1.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 4Re-evaluation procedureWhen 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 in accordance with Articles 5, 6 and 7 of this Regulation;(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 5Call for data1.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.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 determination 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 6Submission of data1.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 evaluationsCurrently the Opinion expressed by the SCF on 11 July 2001. SCF/CS/ADD/GEN/26 Final..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 1333/2008OJ L 354, 31.12.2008, p. 16..
Article 7Other informationIn 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 7aFollow-up of EFSA opinions1.Where, on the basis of the information referred to in Article 4, EFSA cannot confirm the safety of a food additive, of its uses or levels of use or recommend changes to the specifications, the Commission may take or request EFSA to take further steps, including the organisation of calls for data, in order to complete the safety assessment.2.Where the data and information requested in accordance with paragraph 1 has not been submitted or where it does not allow to confirm the safety of the food additive, of its uses or levels of use or specifications, the food additive may be removed from the Union list in accordance with the procedure referred to in Article 10(3) of Regulation (EC) No 1333/2008.
Article 7bPre-submission adviceWhere EFSA is required or requested to deliver an opinion in accordance with this Regulation, the staff of EFSA shall, at the request of interested business operator(s) or any other interested, party provide advice on the rules applicable to, and the content required for the submission of information pursuant to Articles 4 to 7a. Such advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002 of the European Parliament and of the CouncilRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1)., which shall apply mutatis mutandis.
Article 7cNotification of studiesInterested business operators and other interested parties shall, without delay, notify EFSA of the title and the scope of any study commissioned or carried out by them to support the re-evaluation of an approved food additive in accordance with Articles 4 to 7a of this Regulation, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates.Laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by business operators and other interested parties, carried out by such laboratories or other testing facilities to support the re-evaluation of an approved food additive in accordance with Articles 4 to 7a of this Regulation, its starting and planned completion dates, as well as the name of the business operators or interested parties who commissioned such a study.Studies notified in accordance with this article shall be included by EFSA in the database referred to in Article 32b(1) of Regulation (EC) No 178/2002.
Article 7dFormat of submissionsPrior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, data submitted in accordance with this Regulation shall be submitted in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, data shall be submitted in accordance with those standard data formats.
Article 7eTransparencyWhere EFSA is required or requested to deliver an opinion in accordance with this Regulation, it shall consult stakeholders and the public on the basis of the non-confidential version of the data submitted pursuant to this Regulation, in accordance with Article 32c(2), of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
Article 8ConfidentialityUpon submission of data in accordance with this Regulation, the interested business operator or other interested party may submit a request to treat certain parts of the information or data as confidential. Such request shall be accompanied by verifiable justification. Such confidentiality requests shall be assessed in accordance with Article 12 of Regulation (EC) No 1331/2008, which shall apply mutatis mutandis.
Article 9Monitoring progressEvery year in December, EFSA shall inform the Commission and the Member States on the progress of the re-evaluation programme.
Article 10Entry into forceThis 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.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 NoSubstanceYear of latest evaluation by SCF or EFSAStatus of re-evaluation by EFSA
E 102Tartrazine2009Re-evaluation completed on 23 September 2009
E 104Quinoline Yellow2009Re-evaluation completed on 23 September 2009
E 110Sunset yellow FCF, Orange Yellow S2009Re-evaluation completed on 24 September 2009
E 122Azorubine, Carmoisine2009Re-evaluation completed on 24 September 2009
E 124Ponceau 4R, Cochineal Red A2009Re-evaluation completed on 23 September 2009
E 129Allura Red AC2009Re-evaluation completed on 23 September 2009
E 160dLycopene2008Re-evaluation completed on 30 January 2008
E 234Nisin2006Re-evaluation completed on 26 January 2006
E 173Aluminium2008Re-evaluation completed on 22 May 2008
E 214Ethyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 215Sodium ethyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 218Methyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 219Sodium methyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 235Natamycin2009Re-evaluation completed on 26 November 2009
E 473Sucrose esters of fatty acids2006Re-evaluation completed on 23 November 2004; revised on 26 January 2006
E 474Sucroglycerides2006Re-evaluation completed on 23 November 2004; revised on 26 January 2006
E 901Beeswax, white and yellow2007Re-evaluation completed on 27 November 2007
ANNEX IISpecific priorities for certain food additives within the functional classes of food additives as referred to in Article 3(1) and (2)PART I:FOOD COLOURSWithin 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 15.4.2010E 123Amaranth,E 151Brilliant Black BN, Black PNE 154Brown FK,E 155Brown HT andE 180Litholrubine BK2.The following food colours shall be evaluated by 31.12.2010E 100Curcumin,E 127Erythrosine,E 131Patent Blue V,E 132Indigotine, Indigo carmineE 133Brilliant Blue FCF,E 142Green S,E 150aPlain caramel,E 150bCaustic sulphite caramel,E 150cAmmonia caramel,E 150dSulphite ammonia caramel,E 161bLutein,E 161gCanthaxanthin,E 170Calcium carbonate,3.The following food colours shall be evaluated by 31.12.2015E 101(i) Riboflavin (ii) Riboflavin-5’-phosphate,E 120Cochineal, Carminic acid, CarminesE 140Chlorophylls and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins,E 141Copper complexes of Chlorophylls and Chlorophyllins: (i) Copper complexes of chlorophylls (ii) Copper complexes of chlorophyllins,E 153Vegetable carbon,E 160bAnnatto, bixin, norbixinE 160aCarotenes: (i) mixed carotenes, (ii) beta-carotene,E 160cPaprika extract, capsanthin, capsorubin,E 160eBeta-apo-8’-carotenal (C30),E 160fEthyl ester of beta-apo-8’, -carotenoic acid (C30),E 162Beetroot red, betanin,E 163Anthocyanins,E 171Titanium dioxide,E 172Iron oxides and hydroxides,E 174Silver,E 175GoldPART II:FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERSWithin 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 31.12.2015with higher priority within this group on:E 310-312GallatesE 320Butylated hydroxyanisole (BHA)E 321Butylated hydroxytoluene (BHT)E 220-228Sulphur dioxide and sulphitesE 304Fatty acid esters of ascorbic acid: (i) Ascorbyl palmitate (ii) Ascorbyl stearateE 200-203Sorbic acid and sorbatesE 284Boric acidE 285Sodium tetraborate (borax)E 239Hexamethylene tetramineE 242Dimethyl dicarbonateE 249Potassium nitriteE 250Sodium nitriteE 251Sodium nitrateE 252Potassium nitrateE 280-283Propionic acid and its sodium, calcium and potassium saltsE 306Tocopherol-rich extractE 307Alpha-tocopherolE 308Gamma-tocopherolE 309Delta-tocopherol2.Emulsifiers, stabilisers, gelling agents E 322, E 400-E 419; E 422-E 495; E 1401-E 1451 shall be evaluated by 31.12.2016With higher priority within this group on:E 483Stearyl tartrateE 491-495Sorbitan estersE 431Polyoxyethylene (40) stearateE 432-436PolysorbatesE 444Sucrose acetate isobutyrateE 481Sodium stearoyl-2-lactylateE 482Calcium stearoyl-2-lactylateE 414Acacia gum (gum arabic)All natural gums E 400-418 and E 425 could be evaluated at the same time.E 410Locust bean gumAll natural gums E 400-418 and E 425 could be evaluated at the same time.E 417Tara gumAll natural gums E 400-418 and E 425 could be evaluated at the same time.E 422GlycerolE 475Polyglycerol esters of fatty acids3.E 551 Silicon dioxide, E 620-625 Glutamates, E 1105 Lysozyme and E 1103 Invertase shall be evaluated by 31.12.20164.The remaining food additives other than colours and sweeteners shall be evaluated by 31.12.2018With higher priority onE 552Calcium silicateE 553aMagnesium silicate and trisilicateE 553bTalcE 558BentoniteE 999Quillaia extractE 338-343Phosphoric acid and phosphatesE 450-452Di-, tri- and polyphosphatesE 900Dimethyl polysiloxaneE 912Montan acid estersE 914Oxidised polyethylene waxE 902Candellila waxE 904ShellacE 626-629Guanylic acid, Disodium guanylate, Dipotassium guanylate and Calcium guanylateE 630-633Inosinic acid, Disodium inosinate; Dipotassium inosinate and Calcium inosinateE 634-635Calcium 5'-ribonucleotides and Disodium 5'-ribonucleotidesE 507-511Hydrochloric acid, Potassium chloride, Calcium chloride, Magnesium chlorideE 513Sulphuric acid
Article 1Subject matter and scope1.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.
Article 2DefinitionsFor 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 foodstuffsOJ L 237, 10.9.1994, p. 3., Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffsOJ L 237, 10.9.1994, p. 13. 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 sweetenersOJ L 61, 18.3.1995, p. 1.;(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 3Priorities for the re-evaluation of approved food additives1.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 4Re-evaluation procedureWhen 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 in accordance with Articles 5, 6 and 7 of this Regulation;(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 5Call for data1.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.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 determination 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 6Submission of data1.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 evaluationsCurrently the Opinion expressed by the SCF on 11 July 2001. SCF/CS/ADD/GEN/26 Final..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 1333/2008OJ L 354, 31.12.2008, p. 16..
Article 7Other informationIn 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 7aFollow-up of EFSA opinions1.Where, on the basis of the information referred to in Article 4, EFSA cannot confirm the safety of a food additive, of its uses or levels of use or recommend changes to the specifications, the Commission may take or request EFSA to take further steps, including the organisation of calls for data, in order to complete the safety assessment.2.Where the data and information requested in accordance with paragraph 1 has not been submitted or where it does not allow to confirm the safety of the food additive, of its uses or levels of use or specifications, the food additive may be removed from the Union list in accordance with the procedure referred to in Article 10(3) of Regulation (EC) No 1333/2008.
Article 7bPre-submission adviceWhere EFSA is required or requested to deliver an opinion in accordance with this Regulation, the staff of EFSA shall, at the request of interested business operator(s) or any other interested, party provide advice on the rules applicable to, and the content required for the submission of information pursuant to Articles 4 to 7a. Such advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002 of the European Parliament and of the CouncilRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1)., which shall apply mutatis mutandis.
Article 7cNotification of studiesInterested business operators and other interested parties shall, without delay, notify EFSA of the title and the scope of any study commissioned or carried out by them to support the re-evaluation of an approved food additive in accordance with Articles 4 to 7a of this Regulation, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates.Laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by business operators and other interested parties, carried out by such laboratories or other testing facilities to support the re-evaluation of an approved food additive in accordance with Articles 4 to 7a of this Regulation, its starting and planned completion dates, as well as the name of the business operators or interested parties who commissioned such a study.Studies notified in accordance with this article shall be included by EFSA in the database referred to in Article 32b(1) of Regulation (EC) No 178/2002.
Article 7dFormat of submissionsPrior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, data submitted in accordance with this Regulation shall be submitted in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, data shall be submitted in accordance with those standard data formats.
Article 7eTransparencyWhere EFSA is required or requested to deliver an opinion in accordance with this Regulation, it shall consult stakeholders and the public on the basis of the non-confidential version of the data submitted pursuant to this Regulation, in accordance with Article 32c(2), of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.
Article 8ConfidentialityUpon submission of data in accordance with this Regulation, the interested business operator or other interested party may submit a request to treat certain parts of the information or data as confidential. Such request shall be accompanied by verifiable justification. Such confidentiality requests shall be assessed in accordance with Article 12 of Regulation (EC) No 1331/2008, which shall apply mutatis mutandis.
Article 9Monitoring progressEvery year in December, EFSA shall inform the Commission and the Member States on the progress of the re-evaluation programme.
Article 10Entry into forceThis 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.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 NoSubstanceYear of latest evaluation by SCF or EFSAStatus of re-evaluation by EFSA
E 102Tartrazine2009Re-evaluation completed on 23 September 2009
E 104Quinoline Yellow2009Re-evaluation completed on 23 September 2009
E 110Sunset yellow FCF, Orange Yellow S2009Re-evaluation completed on 24 September 2009
E 122Azorubine, Carmoisine2009Re-evaluation completed on 24 September 2009
E 124Ponceau 4R, Cochineal Red A2009Re-evaluation completed on 23 September 2009
E 129Allura Red AC2009Re-evaluation completed on 23 September 2009
E 160dLycopene2008Re-evaluation completed on 30 January 2008
E 234Nisin2006Re-evaluation completed on 26 January 2006
E 173Aluminium2008Re-evaluation completed on 22 May 2008
E 214Ethyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 215Sodium ethyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 218Methyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 219Sodium methyl p-hydroxybenzoate2004Re-evaluation completed on 13 July 2004
E 235Natamycin2009Re-evaluation completed on 26 November 2009
E 473Sucrose esters of fatty acids2006Re-evaluation completed on 23 November 2004; revised on 26 January 2006
E 474Sucroglycerides2006Re-evaluation completed on 23 November 2004; revised on 26 January 2006
E 901Beeswax, white and yellow2007Re-evaluation completed on 27 November 2007
ANNEX IISpecific priorities for certain food additives within the functional classes of food additives as referred to in Article 3(1) and (2)PART I:FOOD COLOURSWithin 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 15.4.2010E 123Amaranth,E 151Brilliant Black BN, Black PNE 154Brown FK,E 155Brown HT andE 180Litholrubine BK2.The following food colours shall be evaluated by 31.12.2010E 100Curcumin,E 127Erythrosine,E 131Patent Blue V,E 132Indigotine, Indigo carmineE 133Brilliant Blue FCF,E 142Green S,E 150aPlain caramel,E 150bCaustic sulphite caramel,E 150cAmmonia caramel,E 150dSulphite ammonia caramel,E 161bLutein,E 161gCanthaxanthin,E 170Calcium carbonate,3.The following food colours shall be evaluated by 31.12.2015E 101(i) Riboflavin (ii) Riboflavin-5’-phosphate,E 120Cochineal, Carminic acid, CarminesE 140Chlorophylls and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins,E 141Copper complexes of Chlorophylls and Chlorophyllins: (i) Copper complexes of chlorophylls (ii) Copper complexes of chlorophyllins,E 153Vegetable carbon,E 160bAnnatto, bixin, norbixinE 160aCarotenes: (i) mixed carotenes, (ii) beta-carotene,E 160cPaprika extract, capsanthin, capsorubin,E 160eBeta-apo-8’-carotenal (C30),E 160fEthyl ester of beta-apo-8’, -carotenoic acid (C30),E 162Beetroot red, betanin,E 163Anthocyanins,E 171Titanium dioxide,E 172Iron oxides and hydroxides,E 174Silver,E 175GoldPART II:FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERSWithin 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 31.12.2015with higher priority within this group on:E 310-312GallatesE 320Butylated hydroxyanisole (BHA)E 321Butylated hydroxytoluene (BHT)E 220-228Sulphur dioxide and sulphitesE 304Fatty acid esters of ascorbic acid: (i) Ascorbyl palmitate (ii) Ascorbyl stearateE 200-203Sorbic acid and sorbatesE 284Boric acidE 285Sodium tetraborate (borax)E 239Hexamethylene tetramineE 242Dimethyl dicarbonateE 249Potassium nitriteE 250Sodium nitriteE 251Sodium nitrateE 252Potassium nitrateE 280-283Propionic acid and its sodium, calcium and potassium saltsE 306Tocopherol-rich extractE 307Alpha-tocopherolE 308Gamma-tocopherolE 309Delta-tocopherol2.Emulsifiers, stabilisers, gelling agents E 322, E 400-E 419; E 422-E 495; E 1401-E 1451 shall be evaluated by 31.12.2016With higher priority within this group on:E 483Stearyl tartrateE 491-495Sorbitan estersE 431Polyoxyethylene (40) stearateE 432-436PolysorbatesE 444Sucrose acetate isobutyrateE 481Sodium stearoyl-2-lactylateE 482Calcium stearoyl-2-lactylateE 414Acacia gum (gum arabic)All natural gums E 400-418 and E 425 could be evaluated at the same time.E 410Locust bean gumAll natural gums E 400-418 and E 425 could be evaluated at the same time.E 417Tara gumAll natural gums E 400-418 and E 425 could be evaluated at the same time.E 422GlycerolE 475Polyglycerol esters of fatty acids3.E 551 Silicon dioxide, E 620-625 Glutamates, E 1105 Lysozyme and E 1103 Invertase shall be evaluated by 31.12.20164.The remaining food additives other than colours and sweeteners shall be evaluated by 31.12.2018With higher priority onE 552Calcium silicateE 553aMagnesium silicate and trisilicateE 553bTalcE 558BentoniteE 999Quillaia extractE 338-343Phosphoric acid and phosphatesE 450-452Di-, tri- and polyphosphatesE 900Dimethyl polysiloxaneE 912Montan acid estersE 914Oxidised polyethylene waxE 902Candellila waxE 904ShellacE 626-629Guanylic acid, Disodium guanylate, Dipotassium guanylate and Calcium guanylateE 630-633Inosinic acid, Disodium inosinate; Dipotassium inosinate and Calcium inosinateE 634-635Calcium 5'-ribonucleotides and Disodium 5'-ribonucleotidesE 507-511Hydrochloric acid, Potassium chloride, Calcium chloride, Magnesium chlorideE 513Sulphuric acid