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Document 02010R0257-20210327
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02010R0257 — EN — 27.03.2021 — 001.001
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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 (OJ L 080 26.3.2010, p. 19) |
Amended by:
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/148 of 8 February 2021 |
L 44 |
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9.2.2021 |
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)
Article 1
Subject matter and scope
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘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 );
‘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;
‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives;
‘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
Approved food additives shall be re-evaluated in the following order and within the following deadlines:
the re-evaluation of all approved food colours listed in Directive 94/36/EC shall be completed by 31 December 2015;
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;
the re-evaluation of all approved sweeteners listed in Directive 94/35/EC shall be completed by 31 December 2020.
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
indicates a possible risk for human health or
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:
examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA;
examine, where available, the original dossier;
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;
examine any data made available by the Commission and Member States;
identify any relevant literature published since the last evaluation of each food additive.
Article 5
Call for data
The data referred to in paragraph 1 may comprise among others:
study reports from the original dossier as evaluated by the SCF or EFSA or the Joint FAO/WHO Expert Committee on Food Additives (JECFA),
information on the data on the safety of the food additive concerned not previously reviewed by the SCF or the JECFA,
information on the specifications of the food additives presently in use, including information on particle size and relevant 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 additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure),
reaction and fate in food.
Article 6
Submission of data
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 7a
Follow-up of EFSA opinions
Article 7b
Pre-submission advice
Where 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 Council ( 6 ), which shall apply mutatis mutandis.
Article 7c
Notification of studies
Interested 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 7d
Format of submissions
Prior 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 7e
Transparency
Where 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 8
Confidentiality
Upon 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 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.
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 2007 |
ANNEX 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:
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 |
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, |
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), |
E 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:
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 |
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 |
Polysorbates |
E 444 |
Sucrose acetate isobutyrate |
E 481 |
Sodium stearoyl-2-lactylate |
E 482 |
Calcium stearoyl-2-lactylate |
E 414 |
Acacia gum (gum arabic) ( *1 ) |
E 410 |
Locust bean gum (*1) |
E 417 |
Tara gum (*1) |
E 422 |
Glycerol |
E 475 |
Polyglycerol esters of fatty acids |
E 551 Silicon dioxide, E 620-625 Glutamates, E 1105 Lysozyme and E 1103 Invertase shall be evaluated by 31.12.2016
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 acid |
( 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.
( 4 ) Currently the Opinion expressed by the SCF on 11 July 2001. SCF/CS/ADD/GEN/26 Final.
( 5 ) OJ L 354, 31.12.2008, p. 16.
( 6 ) Regulation (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).
( *1 ) All natural gums E 400-418 and E 425 could be evaluated at the same time.