The EU re-evaluation programme

Most additives on the EU list were approved on evaluations made by the Scientific Committee on Food, some of them in the 1970s and 1980s. Article 32 of Regulation (EC) No 1333/2008 required the Commission to put all of them back through the European Food Safety Authority, and Commission Regulation (EU) No 257/2010 is the programme that does it: an order of priority, and a deadline for each class and for certain additives by name.

This page is the Regulation, not a scoreboard. It records what was required and by when. It does not record which re-evaluations EFSA has since published, because this site imports EFSA's reference values rather than its opinion register — so an additive that says nothing here is one this site holds nothing for, which is a fact about this site and not a finding that the work was not done.

What it covers

A food additive authorised before 20 January 2009 and listed in Directive 94/35/EC (sweeteners), Directive 94/36/EC (colours) or Directive 95/2/EC (additives other than colours and sweeteners).

An additive authorised on or after 20 January 2009 was approved under Regulation (EC) No 1333/2008 itself, on a current EFSA opinion, and is outside the programme. Additives whose re-evaluation EFSA had already completed when the programme was made were exempted by Article 1(2) and listed in Annex I; they are below.

Adopted: 25 March 2010
Published: OJ L 80, 26.3.2010, p. 19
Made under: Article 32 of Regulation (EC) No 1333/2008
CELEX: 32010R0257

Article 9: every year in December, EFSA informs the Commission and the Member States of the programme's progress.

Where the information the Regulation asks for is not supplied within the deadlines set, Article 6(5) provides that the additive may be removed from the Union list under the procedure in Article 10(3) of Regulation (EC) No 1333/2008.

The three deadlines

Article 3(1) sets one deadline per functional class, in the order the Commission judged the evaluations to be oldest. Colours first, sweeteners last, because their evaluations were the most recent.

Class	Deadline	As drafted	Article
Colours	2015-12-31	all approved food colours listed in Directive 94/36/EC	Article 3(1)(a)
Additives other than colours and sweeteners	2018-12-31	all approved food additives other than colours and sweeteners listed in Directive 95/2/EC	Article 3(1)(b)
Sweeteners	2020-12-31	all approved sweeteners listed in Directive 94/35/EC	Article 3(1)(c)

Article 3(3) lets EFSA start on any additive at any time, on the Commission's request or its own initiative, where new evidence indicates a possible risk or otherwise bears on the assessment. A re-evaluation is an opinion, and what follows it is a separate decision: the Commission removed titanium dioxide (E 171) from the Union list in 2022, by a regulation of its own.

Already done when the programme began

Annex I lists the 17 additives EFSA had re-evaluated by March 2010. Article 1(2) provides that they are not to be re-evaluated again under this programme. The wording in the last column is the Regulation's own.

E number	Substance	Year	Status of re-evaluation
E102	Tartrazine	2009	Re-evaluation completed on 23 September 2009
E104	Quinoline Yellow	2009	Re-evaluation completed on 23 September 2009
E110	Sunset yellow FCF, Orange Yellow S	2009	Re-evaluation completed on 24 September 2009
E122	Azorubine, Carmoisine	2009	Re-evaluation completed on 24 September 2009
E124	Ponceau 4R, Cochineal Red A	2009	Re-evaluation completed on 23 September 2009
E129	Allura Red AC	2009	Re-evaluation completed on 23 September 2009
E160d	Lycopene	2008	Re-evaluation completed on 30 January 2008
E234	Nisin	2006	Re-evaluation completed on 26 January 2006
E173	Aluminium	2008	Re-evaluation completed on 22 May 2008
E214	Ethyl p-hydroxybenzoate	2004	Re-evaluation completed on 13 July 2004
E215	Sodium ethyl p-hydroxybenzoate	2004	Re-evaluation completed on 13 July 2004
E218	Methyl p-hydroxybenzoate	2004	Re-evaluation completed on 13 July 2004
E219	Sodium methyl p-hydroxybenzoate	2004	Re-evaluation completed on 13 July 2004
E235	Natamycin	2009	Re-evaluation completed on 26 November 2009
E473	Sucrose esters of fatty acids	2006	Re-evaluation completed on 23 November 2004; revised on 26 January 2006
E474	Sucroglycerides	2006	Re-evaluation completed on 23 November 2004; revised on 26 January 2006
E901	Beeswax, white and yellow	2007	Re-evaluation completed on 27 November 2007

Colours: by 31 December 2015

Within the overall deadline, Annex II sets earlier dates for these, and provides that they are evaluated first among the additives of the same class.

Colours to be evaluated first — by 15 April 2010

Annex II, Part I, point 1

Colours to be evaluated next — by 31 December 2010

Annex II, Part I, point 2

The remaining colours — by 31 December 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
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

Annex II, Part I, point 3

Additives other than colours and sweeteners: by 31 December 2018

Within the overall deadline, Annex II sets earlier dates for these, and provides that they are evaluated first among the additives of the same class.

Preservatives and antioxidants — by 31 December 2015

The group as the Annex defines it: E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321 and E 586. The additives named below are those it singles out for higher priority within it.

E 310-312 Gallates — a group, not a single additive
E 320 Butylated hydroxyanisole (BHA)
E 321 Butylated hydroxytoluene (BHT)
E 220-228 Sulphur dioxide and sulphites — a group, not a single additive
E 304 Fatty acid esters of ascorbic acid: (i) Ascorbyl palmitate (ii) Ascorbyl stearate
E 200-203 Sorbic acid and sorbates — a group, not a single additive
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 — a group, not a single additive
E 306 Tocopherol-rich extract
E 307 Alpha-tocopherol
E 308 Gamma-tocopherol
E 309 Delta-tocopherol

Annex II, Part II, point 1

Emulsifiers, stabilisers and gelling agents — by 31 December 2016

The group as the Annex defines it: E 322, E 400-E 419; E 422-E 495; E 1401-E 1451. The additives named below are those it singles out for higher priority within it.

E 483 Stearyl tartrate
E 491-495 Sorbitan esters — a group, not a single additive
E 431 Polyoxyethylene (40) stearate
E 432-436 Polysorbates — a group, not a single additive
E 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

Annex II, Part II, point 2 — * All natural gums E 400-418 and E 425 could be evaluated at the same time.

Silicon dioxide, glutamates, lysozyme and invertase — by 31 December 2016

E 551 Silicon dioxide
E 620-625 Glutamates — a group, not a single additive
E 1105 Lysozyme
E 1103 Invertase

Annex II, Part II, point 3

The remaining additives other than colours and sweeteners — by 31 December 2018

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 — a group, not a single additive
E 450-452 Di-, tri- and polyphosphates — a group, not a single additive
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 — a group, not a single additive
E 630-633 Inosinic acid, Disodium inosinate; Dipotassium inosinate and Calcium inosinate — a group, not a single additive
E 634-635 Calcium 5'-ribonucleotides and Disodium 5'-ribonucleotides — a group, not a single additive
E 507-511 Hydrochloric acid, Potassium chloride, Calcium chloride, Magnesium chloride — a group, not a single additive
E 513 Sulphuric acid

Annex II, Part II, point 4

Sweeteners: by 31 December 2020

The Regulation sets no specific priorities within this class. Every approved sweetener fell under the single deadline in Article 3(1)(c).

How to read this

A deadline is a deadline for EFSA's opinion, not for any change to the law. An opinion may confirm the existing intake, revise it, find the data insufficient, or lead the Commission to amend or withdraw an authorisation — and each of those is a separate step, taken by a different body. Where the Union list has since changed for an additive on this page, the change is on that additive's own page with the instrument that made it.

This is EU law, and the deadlines on this page are the EU's. Great Britain kept the substance of the EU additives regime as assimilated law and now authorises additives by its own procedure; what it does about re-evaluating the additives it inherited is not something this site records. See Great Britain, and reference values for what an intake is and is not.

Source: Commission Regulation (EU) No 257/2010 (OJ L 80, 26.3.2010, p. 19), consolidated text on EUR-Lex, © European Union — reuse authorised under Commission Decision 2011/833/EU. Deadlines, names and the Annex I statuses are transcribed from it; 73 additives are named individually across the Annex II lists. A consolidated text is an editorial convenience and is not legally authentic.