EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/11368/2011 (POOL/E3/2011/11368/11368-EN.doc) 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
laying down specifications for food additives listed in Annexes II and III to Regulation 
(EC) No 1333/2008 of the European Parliament and of the Council  
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
laying down specifications for food additive s listed in Annexes II and III to Regulation 
(EC) No 1333/2008 of the European Parliament and of the Council  
(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 Articles 14 and 30(4) 
thereof, and Regulation (EC) No  1331/2008 of the European Parliament and of the Council of 
16 December 2008 establishing a common authoris ation procedure for food additives, food 
enzymes and food flavourings2, and in particular Ar ticle 7(5) thereof, 
Whereas:  (1) Specifications relating to origin, purity criteria and any other necessary information 
should be adopted for food additives listed in  the Union lists in Annex II and III to 
Regulation (EC) No 1333/2008.  
(2)  To that end, specifications previously developed for food additives in Commission 
Directive 2008/128/EC of 22 December 2008  laying down specific purity criteria 
concerning colours for use in foodstuffs
3, Commission Directive 2008/84/EC of 
27 August 2008 laying down specific purity criteria on food additives other than 
colours and sweeteners4 and Commission Directive 2008/60/EC of 17 June 2008 
laying down specific purity criteria conc erning sweeteners for use in foodstuffs5 
should be updated and taken over to this Regulation. As a consequence, those 
Directives should be repealed.  
(3) It is necessary to take into account the sp ecifications and analyti cal techniques as set 
out in the Codex Alimentarius drafted by the Joint FAO/WHO Expert Committee on 
Food Additives (hereafter JECFA). 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 OJ L 354, 31.12.2008, p. 1. 
3 OJ L 6, 10.1.2009, p. 20. 
4 OJ L 253, 20.9.2008, p. 1. 
5 OJ L 158, 18.6.2008, p. 17.  
EN 3   EN (4) The European Food Safety Authority (herei nafter "the Author ity") expressed its 
opinion on the safety of basic methacrylate copolymer6 as a glazing agent. That food 
additive has subsequently been authorised on the basis of specifi c uses and has been 
allocated the number E 1205. Therefore specifi cations should be adopted for that food 
additive. 
(5) Food colours E 160 f ethyl ester of beta-apo-8' -carotenic acid, and E 154 brown FK, as 
well as the aluminium containing carrier  E 558 bentonite are not used any more 
according to information submitted by f ood manufacturers. Therefore, current 
specifications for those food additives shoul d not be taken over to this Regulation. 
(6) On 10 February 2010 the Authority expresse d an opinion on the safety of E 473 
sucrose esters of fatty acids prepar ed from vinyl esters of fatty acids7. Current 
specifications should be adapted according ly in particular by reducing maximum 
limits for impurities of safety concern. 
(7) Specific purity criteria currently applicable  should be adapted by reducing maximum 
limits for individual heavy metals of interest where feasible and where the JECFA limits are lower than those currently in force. Pursuant to that approach maximum limits for the contaminant 4-methylimidazole in colour E 150 c ammonia caramel, 
sulphated ash in E 160 a (i) beta-caroten e, magnesium and alkali salts in E 170 
calcium carbonate, should be lowered. That a pproach should be departed from only for 
additives E 331 (iii) tricalci um citrate (lead content), E 407 carrageenan and E407a 
processed euchema seaweed (cadmium content) , as manufacturers have declared that 
compliance with stricter Union provisi ons, reflecting JECFA limits, would not be 
technically feasible. The cont ribution to the total intake of those two contaminants 
(lead and cadmium) in those three individua l food additives is not considered to be 
significant. On the contrary for phosphate s (E 338 – E 341 and E 450- E 452) new 
significantly lower values, compared to the ones indicated by JECFA, should be 
established due to new developments of th e manufacturing processes, by taking into 
account the recent recommendations of the Aut hority on a reduction of the intake of 
arsenic, especially in the inorganic form
8. In addition, a new provision on arsenic for E 
620 glutamic acid should be introduced for sa fety reasons. The total balance of those 
adaptations benefits the c onsumers as maximum limits for heavy metals are becoming 
stricter in general and in most of th e food additives. Detailed information on the 
production process and starting materials of a food additive  should be included in the 
specifications to facilitate any future decision pursuant to Article 12 of Regulation (EC) No 1333/2008. 
                                                
 
6 EFSA Panel on Food Additives and Nutrient Sources  added to Food (ANS); Scientific Opinion on the 
use of Basic Methacrylate Copolymer as a food additive on request from the European Commission. 
EFSA Journal 2010; 8(2):1513. 
7 EFSA Panel on Food Additives and Nutrient Sources  added to Food (ANS); Scientific Opinion on the 
safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of 
use of sucrose esters of fatty acids in flavourings on request from the European Commission. EFSA Journal 2010; 8(3):1512.  
8 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opin ion on Arsenic in Food. 
EFSA Journal 2009; 7(10):1351.  
EN 4   EN (8) Specifications should not make reference to or ganoleptic tests related to the taste as it 
cannot be expected by the cont rol authorities to take the risk to taste a chemical 
substance, 
(9) Specifications should not make reference to cl asses as there is no added value in this 
reference.  
(10) Specifications should not make reference to  the general paramete r "Heavy metals" as 
this parameter does not relate with toxicity, but rather with a generic analytical method 
but only, if needed, to an individual elemen t. Parameters related to individual heavy 
metals are toxicity related and are included in the specifications. 
(11) Some food additives are currently listed  under various names (E 466, carboxy methyl 
cellulose, E 468 cross-linked sodium car boxymethylcellulose, E 469 enzymatically 
hydrolised carboxymethylcellulose and E 901 beeswax, white and ye llow) in various 
provisions of Directive 95/2/EC9. Therefore the specifica tions established by this 
Regulation should refer to those various names.  
(12) Current provisions on Polycyclic Aromatic  Hydrocarbons (PAHs) are too generic and 
not relevant to safety and should be repl aced by maximum limits for individual PAHs 
of concern for food additives E 153 vegeta ble carbon and E 905 micr ocrystalline wax. 
Similar maximum limits should be established for formaldehyde in E 407 carageenan and E 407a processed euchema seaweed, for pa rticular microbiologi cal criteria in E 
406 agar gum and for salmonella spp. conten t in E 421 (ii) mannitol manufactured by 
fermentation.  
(13) The use of isopropanol (isopropyl alcohol) s hould be allowed for manufacturing the 
additives E 100 curcumin and E 160 c pa prika extract, in line with JECFA 
specifications, as this particular use has been considered safe by the Authority
10. The 
use of ethanol in replacement of isopropa nol in the manufacturi ng of E 418 gellan gum 
should be permitted where the final product still  complies with all ot her specifications 
and ethanol is considered to  be of less safety concern. 
(14) The percentage of the colouring principle in E 120 cochineal, carminic acid, carmines 
should be specified, as maximum limits are to  apply to quantities of  that principle.  
(15) The numbering system for subcategories of  E 160 a carotenes should be updated in 
order to bring it in line with the C odex alimentarius numbering system.  
(16) The solid form of E 270 lactic acid should al so be included in the specifications, as it 
can now be manufactured in the solid form and there is no safety concern. 
(17) The current temperature value in loss of drying for E 331 (i) monosodium citrate, 
anhydrous form should be adjusted as und er the currently listed conditions the 
substance decomposes. Drying conditions for E 331 (iii) trisodium citrate should also 
be adjusted to improve the reproducibility of the method. 
                                                 
9 OJ L 61, 18.3.1995, p. 1. 
10 EFSA Panel on Food Additives and Nutrient Sources  added to Food (ANS); Scientific Opinion on the 
re-evaluation of curcumin (E 100) as a fo od additive. EFSA Journal 2010; 8(9):1679.  
EN 5   EN (18) The current specific absorption value for E 307 alpha-tocopherol should be corrected 
and the sublimation point for E 200 sorbic ac id should be replaced by a "solubility 
test" as the former is not relevant. The specification of bacterial sources for the manufacturing of E 234 nisin and E 235 natamycin should be  updated according to the 
current taxonomic nomenclature. 
(19) As new innovative manufacturing techniques resulting in less contaminated food 
additives are now available, the presence of aluminium in food additives should be 
restricted .In order to enhance legal certain ty and non-discrimination it is appropriate 
to provide the manufacturers of food additives with a transitional period to adapt gradually to those restrictions.   
(20) Maximum limits for aluminium should be established for food additives where 
relevant, and particularly for E 341 (i)-(iii ) calcium phosphates intended to be used in 
food for infants and young children
11, according to the relevant  opinion of Scientific 
Committee on Food expressed on 7 June 199612. In this framework a maximum limit 
for aluminum in E 333 calcium citr ate should also be established. 
(21) The maximum limits for aluminium in E 341  (i)-(iii) calcium phosphates, E 450 (i) 
disodium diphosphate and E 450 (vii) should be in accordance with the opinion of the 
Authority of 22 May 200813. Current limits should be reduced, where this is 
technically feasible, and where the contri bution to the total aluminium intake is 
significant. In this framework aluminium la kes of individual f ood colours should be 
authorised only if technically needed.  
(22) Provisions on maximum limits for aluminiu m in E 341 (ii) dicalcium phosphates, 
E 341 (iii) tricalcium phosphate  and E 450 (vii) should not cause any disruption of the 
market, due to a possible lack of supplies. 
(23) According to Regulation (EC) No 258/2010 of 25 March 2010 imposing special 
conditions on the imports of guar gum origin ating in or consigne d from India due to 
contamination risks by pent achlorophenol and dioxins,14maximum limits should be set 
for the contaminant pentachlorophenol in E 412 guar gum. 
(24) According to recital 48 of Regulation (EC) No 1881/2006 of 19 December 2006 
setting maximum levels for certain contaminants in foodstuffs15 Member States are to 
examine other foodstuffs than the ones incl uded in that Regulation for the occurrence 
of contaminant 3-MCPD in order to consider  the need to set maximum levels for that 
substance French authorities have submitted data on high concentrations of 3-MCPD 
in the food additive E 422 gl ycerol and the average use le vel of this food additive in 
various food categories. Maximum limits for 3-MCPD in this part icular food additive 
                                                 
11 As defined in Commission Directive 2006/125/EC  of 5 December 2006 on processed cereal-based 
foods and baby foods for infants and young children (Codified version), OJ L 339, 6.12.2006, p. 16. 
12 Opinion on Additives in nutrient preparations for use in infant formulae, follow-on formulae and 
weaning foods. Reports of the Scientific Committee on food (40th Series), p.13-30, (1997). 
13 Scientific opinion of the panel on Food Additiv es, Flavourings, Processing Aids and Materials in 
Contact with Food on a request from European Commission to provide a scientific opinion on the safety of aluminium from dietary intake. The EFSA Journal (2008) 754, 1-34. 
14 OJ L 80, 26.3.2010, p. 28. 
15 OJ L 364, 20.12.2006, p. 5.  
EN 6   EN should be set in order to avoid contamin ation of the final food at a higher than 
permissible level, taking into account the dilu tion factor.  
(25) Due to the development of analytical met hods certain current specifications should be 
updated. The current limit value "non detectable" is linked to the evolution of analytical methodologies and should be re placed by a specific number for additives 
E 472 Acid esters of mono- and di-glycerides , E 475 polyglycerol este rs of fatty acids 
and E 477 Propane-1,2-diol esters of fatty acids. 
(26) Specifications relating to the manufacturi ng procedure should be updated for E 472 c 
citric acid esters of fatty acids, as the us e of alcalic bases is replaced today by the use 
of their milder acting salts. 
(27) The current criterion "free fatty acids" for a dditives E 472 c citric acid esters of mono- 
and diglycerides and E 472 e mono and dia cetyltartaric acid esters of mono- and 
diglycerides is not appropria te. It should be replaced by the criterion "acid value" as 
the latter expresses better the titrimetric esti mation of the free acidic groups. This is in 
accordance with the 71
st report on food additives from JECFA16 where such change 
was adopted for E 472 e mono and diacety ltartaric acid esters of mono- and 
diglycerides. 
(28) The current erroneous description of additive E 530 magnesium oxide should be 
corrected according to information submitted by  the manufacturers, in order to bring it 
in line with the Pharmacopoeia Europea17. The current maximum value for the 
reducing matter in additive E 574 gluconic acid  should also be updated as this limit is 
not technically feasible. For the estimation of the water content of E 967 xylitol the current method based on "loss of drying", s hould be replaced by a more appropriate 
method. 
(29) Some current specifications for additive E 902 Candellilla wax should not be taken 
over to this Regulation since they are erratic. For E 450 vii calcium dihydrogen 
diphosphate the current entry concerning P
2O5 content should be corrected.  
(30) In the current entry "assay" for E 957 th aumatin a calculation factor should be 
corrected. That factor is to be used in the Kjeldhal me thod for the estimation of the 
total content of the substance based on th e measurement of nitrogen. The calculation 
factor should be updated according to the relevant published literature for E 957 
thaumatin.  
(31) The Authority evaluated the safety of stevio l glycosides, as a sweetener and expressed 
its opinion of 10 March 201018. The use of steviol glyc osides, which have been 
allocated number E 960, has subsequently been permitted on the basis of well defined conditions of use. Therefore specifications should be adopted for this food additive. 
(32) Due to a taxonomic change source, current specifications for ye asts used in the 
manufacturing of E 968 eryt hritol should be updated. 
                                                
 
16 WHO Technical Report Series, No 956, 2010. 
17 European Pharmacopoeia is in EP 7.0 volume 2, p. 2415, 2416. 
18 Scientific Opinion of the Panel on Food Additives an d Nutrient Sources added to food on the safety of 
steviol glycosides for the proposed uses as a food additive. The EFSA Journal (2010); 8(4):1537.  
EN 7   EN (33) For E 999 quillaia extract the current specifi cation relating to the pH range should be 
adjusted in order to bring it in line with JECFA. 
(34) The combination of citric acid and phos phoric acid (which are currently both 
individually authorised for use in the manufacturing of a dditive E 1200 polydextrose), 
should be allowed, where the final product sti ll complies with the purity specifications, 
as it improves yields and re sults to more controllable reaction kinetics. There is no 
safety concern involved in such amendment. 
(35) Unlike for small molecules, the molecular ma ss of a polymer is not one unique value. 
A given polymer may have a distribution of  molecules with different masses. The 
distribution may depend on the way the polymer is produced. Polymer physical 
properties and behaviors are re lated to the mass and distribution of molecules with a 
certain mass in the mixture. A group of math ematical models describe the mixture in 
different ways in order to clarify the dist ribution of molecules in the mixture. Among 
the different models available, it is recommended in scientific literature to use the weight average molecular weight (Mw) to describe polymers. The specifications for 
E 1201 polyvinylpyrrolidone should be adjusted accordingly. 
(36) The criterion "Distillation range" referred to in current specifications for E 1520 
propane-1,2 diol leads to c ontradictory conclusions compared to results from the 
assay. That criterion should therefore not  be taken over in this Regulation.  
(37) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee and neither the European Parlia ment nor the Council has opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Specifications for food additives  
Specifications for food additives including colours and sweetene rs listed in A nnex II and III 
to Regulation (EC) No 1333/2008 are laid dow n in the Annex to this Regulation.  
Article 2 
Repeals 
Directives 2008/60/EC, 2008/84/EC and 2008/128/EC  are repealed with effect from 
1 December 2012 
Article 3 
Transitional measures 
Foodstuffs containing food additives that have been lawfully placed on the market before 
1 December 2012, but do not comply with this Regul ation, may continue to be marketed until 
stocks are exhausted .  
EN 8   EN Article 4 
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 .  
It shall apply from 1 December 2012. However, the specifications laid down in the Annex for additive E 960 steviol glycosides and 
E 1205 basic methacrylate copolymer shall apply fr om the date of entry into force of this 
Regulation.  
This Regulation shall be binding in  its entirety and directly applicable in the Member States. 
Done at Brussels,  
 For the Commission 
 José Manuel BARROSO  The President