EN    EN EN 
SANCO/569/2008 (POOL/E3/2008/569/569-EN.doc)  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2008) final 
Draft 
COMMISSION DIRECTIVE 
of 
amending Directive 96/77/EC laying down speci fic purity criteria on food additives other 
than colours and sweeteners 
(Memorandum from Ms A. VASSILIOU)  
EN 2   EN Draft  
COMMISSION DIRECTIVE 
of 
amending Directive 96/77/EC laying down speci fic purity criteria on food additives other 
than colours and sweeteners 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Council Directive 89/107/ EEC of 21 December 1988 on the approximation 
of the laws of the Member States concerning food additives authorised for use in foodstuffs 
intended for human consumption(1), and in particular Article 3(3)(a) thereof, 
After consulting the Scientific Committee on Food (SCF) and the European Food Safety 
Authority (EFSA), 
Whereas:  (1) Commission Directive 96/77/EC(
2) of 2 December 1996 laying down specific purity 
criteria on food additives othe r than colours and sweeteners sets out the pu rity criteria 
for the additives mentioned in European Pa rliament and Council Directive 95/2/EC of 
20 February 1995 on food additives ot her than colours and sweeteners(3). 
(2) The European Food Safety Authority (hereaf ter 'EFSA') concluded in its Opinion of 
20 October 2006(4) that nisin produced through a modi fied production process using a 
sugar-based medium is equivalent with re spect to health protection to the one 
produced by the original milk -based medium process. On the basis of that opinion, the 
existing specifications for E 234 nisin shou ld be amended in order to adapt the 
definition and the purity criteria set out for that additive. 
                                                 
1 OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
2 OJ L 339, 30.12.1996, p. 1. Directive as last ame nded by Directive 2006/129/EC (OJ L 346, 9.12.2006, 
p. 15). 
3 OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, 
p. 10). 
4 http://www.efsa.europa.eu/en/science/ afc/afc_opinions/ej314b_nisin.html  
EN 3   EN (3) Formaldehyde is used as a preservative du ring the manufacture of alginic acid, 
alginate salts and esters of alginic acid. It has been reported that residual 
formaldehyde, up to 50 mg/kg, may be present in the final gelling additives. At the 
request of the Commission, EFSA assessed the safety in use of  formaldehyde as a 
preservative during the manufacture and prepara tion of food additives5. EFSA in its 
Opinion of 30 November 2006 concluded that  the estimated exposure to gelling 
additives containing residual formaldehyde at the level of 50 mg/kg of additive would 
be of no safety concern. Therefore the exis ting purity criteria fo r E 400 alginic acid, E 
401 sodium alginate, E 402 potassium algi nate, E 403 ammonium alginate, E 404 
calcium alginate, and E 405 propane-1.2-diol alginate should be amended in such a 
way that the maximum level of formaldehyde is set at 50 mg/kg. 
(4) Formaldehyde is not currently used in th e processing of seaweeds for the production 
of E 407 carrageenan and E 407a processe d eucheuma seaweed. However, it may be 
naturally occurring in marine algae and be consequently pr esent as an impurity in the 
finished product. It is ther efore appropriate to  fix a maximum level of adventitious 
presence of the above substance in those food additives.  
(5) Guar gum is authorised as a food additive for use in foodstuffs by Directive 95/2/EC. 
In particular, it is used as thickener, em ulsifier, and stabiliser. A request to use a 
partially depolymerised guar gum as a f ood additive, produced from native guar gum 
by one of the three manufact uring processes consisting of heat treatment, acid 
hydrolysis or alkaline oxidation, was submitted to the Commission. EFSA assessed the safety in use of that additive  and, in its opinion of 4 July 2007
6, estimated that partially 
depolymerised guar gum has been shown to be  very similar to native guar gum with 
respect to the composition of the final prod uct. It also concluded that partially 
depolymerised guar gum is of no safety concer n for its use as thickener, emulsifier or 
stabiliser. However, in the same Opinion, EFSA recommended that the specifications 
for E 412 guar gum should be adjusted to ta ke into account the increased level of salts 
and the possible presence of undesirable by-products that may result from the 
manufacturing process. On the basis of the recommendations issued by EFSA, the 
specifications of guar gum should be amended. 
(6) It is necessary to adopt sp ecifications for E 504i magnesium  carbonate authorised as a 
food additive for use in foodstuffs through Directive 95/2/EC. 
                                                 
5 Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact 
with food (AFC) on a request from the Commission related to use of formaldehyde as a preservative during the manufacture and preparation of food additives ; Question Nº EFSA Q-2005-032. 
 http://www.efsa.europa .eu/EFSA/efsa_locale-1178620753812_1178620766610.htm 
6 Opinion of the Scientific Panel on Food Additiv es, Flavourings, Processing Aids and Materials in 
Contact with Food on a request from the Commission related to an application on the use of partially 
depolymerised guar gum as a food additive ; Question N° EFSA-Q-2006-122. 
 http://www.efsa.europa .eu/EFSA/efsa_locale-1178620753812_1178638739757.htm  
EN 4   EN (7) On the basis of data provided by the Europe an Lime association, it appears that the 
manufacturing of lime products from availa ble raw materials does not permit them to 
comply with the existing purity criteria set for E 526 calcium hydroxide and E 529 
calcium oxide, as regards the level of magne sium and alkali salts. Taking into account 
that magnesium salts are of no safety concer n and the specifications as set out in the 
Codex Alimentarius as drafted by the Jo int FAO/WHO Expert Committee on Food 
Additives (hereafter JECFA), it is appropriate  to adjust the levels of magnesium and 
alkali salts for E 526 calci um hydroxide and E 529 calcium oxide to the lowest 
achievable values, which remain lower or equal to the levels set by JECFA. 
(8) In addition, it is necessary to take into account the specifications as set out in the 
Codex Alimentarius drafted by JECFA with regard to the level of lead for E 526 
calcium hydroxide and E 529 calcium oxide. However, due to the natural high 
background of lead contained in the raw material (calcium carbonate) extracted in 
some Member States, and from which thos e additives are derived, it appears difficult 
to align the level of lead contained in those food additiv es with the upper limit of lead 
set by JECFA. Therefore the le vel of lead should be fixe d at the lowest achievable 
threshold. 
(9) E 901 beeswax is authorised as a food additive in Directive 95/2/EC. EFSA in its 
Opinion of 27 November 20077 confirmed the safety in use of this food additive. 
However, it also indicated that the presence of  lead should be restricted to the lowest 
possible level. Taking into account the revise d specifications for beeswax as set out in 
the Codex Alimentarius as drafted by JECFA,  it is appropriate to amend the existing 
purity criteria for E 901 beeswax in order to lower the maximum permitted level of lead. 
(10) Highly refined waxes derivi ng from hydrocarbon feedstock (synthetic waxes) and 
from petroleum based feedstock were join tly evaluated by the Scientific Committee on 
Food (hereafter 'SCF')
8 and an opinion on mineral and synthetic hydrocarbons was 
issued on 22 September 1995. The SCF consid ered that sufficient data had been 
provided to allocate a full group ADI (accepta ble daily intake), covering both types of 
waxes, i.e. waxes deriving from petroleum based or hydrocarbon feed stocks. When purity criteria for E 905 microcrystalline  wax were established, the synthetic 
hydrocarbon waxes were omitted and not included in the specifications. The 
Commission considers it therefore necessary  to amend the purity criteria for E 905 
microcrystalline wax in order to also cove r waxes derived from synthetic hydrocarbon 
feedstocks. 
(11) It is necessary to take in to account the specifications and analytical techniques for 
additives as set out in the Codex Alimenta rius drafted by the JECFA. In particular 
where appropriate, the specific purity criteria need to be adapted to reflect the limits 
for individual heavy metals of interest. 
                                                
 
7 Beeswax (E 901) as a glazing agent and as carrier for flavours ; Scientific Opinion of the Panel on Food 
additives, Flavourings, Processing aids and Materials in Contact with Food (AFC) ; Question No EFSA-Q-2006-021. 
 http://www.efsa.europa .eu/EFSA/efsa_locale-1178620753812_1178672652158.htm 
8 http://ec.europa.eu/food/fs/sc/sc f/reports/scf_reports_37.pdf  
EN 5   EN (12) Directive 96/77/EC should ther efore be amended accordingly. 
(13) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
The Annex to Directive 96/77/EC is amended in accordance with the Annex to this Directive. 
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by [one year after the date of adoption] at the latest. They shall forthw ith communicate to the Commission the text 
of those provisions and a correlation table between those provisions and this 
Directive. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Co mmission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU 
 Member of the Commission  
EN 6   EN ANNEX  
The Annex to Directive 96/77/EC is amended as follows: 
1. The text concerning E 234 nisin is replaced by the following: 
“E 234 NISIN 
Definition Nisin consists of se veral closely related 
polypeptides produced during the 
fermentation of a milk or sugar medium 
by certain natural strains of Lactococcus 
lactis subsp.lactis .  
Einecs 215-807-5 
Chemical formula C 143 H230 N42 O37 S7  
Molecular weight 3 354,12 
Assay Nisin concentrate contains not less than 
900 units per mg in a mixture of non-fat milk proteins
 or fermented solids  and a 
minimum sodium chloride content of 50 % 
Description White powder  
Purity  
Loss on drying Not more than 3% when dried to constant 
weight at 102 °C to 103 °C 
Arsenic Not more than 1 mg/kg 
Lead  Not more than 1mg/kg 
Mercury Not more than 1 mg/kg"  
EN 7   EN 2. The text concerning E 400 Alginic Ac id is replaced by the following: 
“E 400 ALGINIC ACID 
Definition Linear glycuronoglycan consisting 
mainly of β-(1-4) linked D-mannuronic 
and α-(1-4) linked L- guluronic acid units 
in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali fr om natural strains of 
various species of brown seaweeds (Phaeophyceae ) 
Einecs 232-680-1 
Chemical formula (C 6H8O6)n 
Molecular weight 10 000—600 000 (typical average) 
Assay Alginic acid yields, on the anhydrous 
basis, not less than 20 % and not more than 23 % of carbon dioxide (CO
2), 
equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C
6H8O6)n (calculated on equivalent 
weight basis of 200) 
Description Alginic acid occurs in filamentous, 
grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless 
Identification  
A. Solubility  Insoluble in water a nd organic solvents, 
slowly soluble in so lutions of sodium 
carbonate, sodium hydroxide and trisodium phosphate 
B. Calcium chloride precipitation test  To a 0,5 % solution of the sample in 1 M 
sodium hydroxide so lution, add one fifth 
of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum  
EN 8   EN C. Ammonium sulphate precipitation 
test To a 0,5 % solution of the sample in 1 M 
sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test di stinguishes alginic 
acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch 
D. Colour reaction  Dissolve as completely as possible 0,01 g 
of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple 
Purity  
pH of a 3 % suspension Between 2,0 and 3,5 
Loss on drying Not more than 15 % (105 °C, 4 hours) 
Sulphated ash Not more than 8 % on the anhydrous 
basis 
Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous 
basis insoluble matter 
Formaldehyde  Not more than 50 mg/kg  
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium  Not more than 1 mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 500 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 9   EN 3. The text concerning E 401 Sodium Al ginate is replaced by the following: 
“E 401 SODIUM ALGINATE 
Definition  
Chemical name Sodium salt of alginic acid 
Chemical formula (C 6H7NaO 6)n 
Molecular weight 10 000-600 000 (typical average) 
Assay Yields, on the anhydrous basis, not less 
than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium algina te (calculated on 
equivalent weight  basis of 222) 
Description Nearly odourless, white to yellowish 
fibrous or granular powder 
Identification  
Positive test for sodium and alginic acid   
Purity  
Loss on drying Not more than 15 % (105 °C, 4 hours) 
Water-insoluble matter Not more than 2 % on the anhydrous 
basis 
Formaldehyde  Not more than 50 mg/kg  
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium  Not more than 1 mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 500 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 10   EN 4. The text concerning E 402 Potassium Alginate is replaced by the following: 
“E 402 POTASSIUM ALGINATE 
Definition  
Chemical name Potassium salt of alginic acid 
Chemical formula (C 6H7KO 6)n 
Molecular weight 10 000-600 000 (typical average) 
Assay Yields, on the anhydrous basis, not less 
than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate  (calculated on an 
equivalent weight  basis of 238) 
Description Nearly odourless, white to yellowish 
fibrous or granular powder 
Identification  
Positive test for potassium and for alginic 
acid  
Purity  
Loss on drying Not more than 15 % (105 °C, 4 hours) 
Water-insoluble matter Not more than 2 % on the anhydrous 
basis 
Formaldehyde  Not more than 50 mg/kg  
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium  Not more than 1 mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 500 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 11   EN 5. The text concerning E 403 Ammonium Al ginate is replaced by the following: 
“E 403 AMMONIUM ALGINATE 
Definition  
Chemical name Ammonium salt of alginic acid 
Chemical formula (C 6H11NO 6)n 
Molecular weight 10 000-600 000 (typical average) 
Assay Yields, on the anhydrous basis, not less 
than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an 
equivalent weight  basis of 217) 
Description White to yellowi sh fibrous or granular 
powder 
Identification  
Positive test for ammonium and alginic 
acid  
Purity  
Loss on drying Not more than 15 % (105 °C, 4 hours) 
Sulphated ash Not more than 7 % on the dried basis 
Water-insoluble matter Not more than 2 % on the anhydrous 
basis 
Formaldehyde  Not more than 50 mg/kg  
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium  Not more than 1 mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 500 colonies per gram  
EN 12   EN E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 13   EN 6. The text concerning E 404 Calcium Al ginate is replaced by the following: 
“E 404 CALCIUM ALGINATE 
Synonyms Calcium salt of alginate 
Definition  
Chemical name Calcium salt of alginic acid 
Chemical formula (C 6H7Ca1/2O6)n 
Molecular weight 10 000-600 000 (typical average) 
Assay Yields, on the anhydrous basis, not less 
than 18 % and not more than 21 % 
carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight  basis of 219) 
Description Nearly odourless, white to yellowish 
fibrous or granular powder 
Identification  
Positive test for calcium and alginic acid   
Purity  
Loss on drying Not more th an 15,0 % (105 °C, 4 hours) 
Formaldehyde  Not more than 50 mg/kg  
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium  Not more than 1 mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 500 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 14   EN 7. The text concerning E 405 Propane-1.2-diol Alginate is replaced by the following: 
“E 405 PROPANE-1.2-DIOL ALGINATE 
Synonyms Hydroxypropyl alginate  
1,2-propanediol ester of alginic acid Propylene glycol alginate 
Definition  
Chemical name Propane-1,2-d iol ester of alginic acid; 
varies in composition according to its 
degree of esterification and the 
percentage of free  and neutralised 
carboxyl groups in the molecule 
Chemical formula (C 9H14O7)n (esterified) 
Molecular weight 10 000—600 000 (typical average) 
Assay Yields, on the anhydrous basis, not less 
than 16 % and not more than 20 % of CO
2 of carbon dioxide 
Description Nearly odourless, white to yellowish 
brown fibrous or granular powder 
Identification  
Positive test for 1,2-propanediol and 
alginic acid after hydrolysis   
Purity  
Loss on drying Not more than 20 % (105 °C, 4 hours) 
Total propane-1,2-diol content Not less than 15 % and not more than 
45 % 
Free propane-1,2-diol content Not more than 15 % 
Water-insoluble matter Not more than 2 % on the anhydrous 
basis 
Formaldehyde  Not more than 50 mg/kg  
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg  
EN 15   EN Mercury Not more than 1 mg/kg 
Cadmium  Not more than 1 mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 500 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 16   EN 8. The text concerning E 407 Carrageen an is replaced by the following: 
“E 407 CARRAGEENAN 
Synonyms Products of commerce are sold under 
different names such as: 
Irish moss gelose Eucheuman (from Eucheuma spp.) 
Iridophycan (from Iridaea spp.) 
Hypnean (from Hypnea spp.) 
Furcellaran or Danish agar (from 
Furcellaria fastigiata ) 
Carrageenan (from Chondrus and 
Gigartina spp.) 
Definition Carrageenan is obtained by aqueous 
extraction of natural strains of seaweeds of Gigartinaceae , Solieriaceae , 
Hypneaeceae and Furcellariaceae , 
families of the class Rhodophyceae (red 
seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carr ageenan consists 
chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded. Formaldehyde may be present 
as an adventitious impurity up to a 
maximum level of 3 mg/kg .  
Einecs  232-524-2 
Description Yellowish to colourless, coarse to fine 
powder which is practically odourless 
Identification  
Positive tests for galactose, for 
anhydrogalactose and for sulphate    
EN 17   EN Purity  
Methanol, ethanol, propane-2-ol conten t Not more than 0,1 % singly or in 
combination 
Viscosity of a 1,5 % solution at  75 °C Not less than 5 mPa.s 
Loss on drying  Not more than 12 % (105 °C, four hours)  
Sulphate Not less than 15 % and not more than 
40 % on the dried basis (as SO 4) 
Ash Not less than 15 % and not more than 
40 % determined on the dried basis at 
550 °C 
Acid-insoluble ash Not more than 1 % on the dried basis 
(insoluble in 10 % hydrochloric acid) 
Acid-insoluble matter Not more than 2 % on the dried basis 
(insoluble in 1 % v/v sulphuric acid) 
Low molecular weight carrageenan 
(Molecular weight fraction below 
50 kDa) Not more than 5 % 
Arsenic Not more than 3 mg/kg 
Lead  Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium  Not more than 2  mg/kg 
Total plate count  Not more than 5 000 colonies per gram 
Yeast and moulds  Not more than 300 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 18   EN 9. The text concerning E 407a Processed Eucheuma Seaweed is replaced by the 
following:  
“E 407a PROCESSED E UCHEUMA SEAWEED 
Synonyms PES (acronym for processed eucheuma 
seaweed) 
Definition Processed eucheuma seaweed is obtained 
by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma 
cottonii  and Eucheuma spinosum , of the 
class Rhodophyceae  (red seaweeds) to 
remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15% algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded. Formaldehyde may be present as an 
adventitious impurity up to a maximum 
level of 3 mg/kg.  
Description  Tan to yellowish, coarse to fine powder 
which is practically odourless 
Identification  
A. Positive tests for galactose, for 
anhydrogalactose and for sulphate Forms cloudy viscous suspensions in 
water. Insoluble in ethanol 
B. Solubility  
Purity  
Methanol, ethanol, propane-2-ol conten t Not more than 0,1 % singly or in 
combination 
Viscosity of a 1,5 % solution at  75 °C Not less than 5 mPa.s 
Loss on drying Not more than 12 % (105 °C, four hours)  
EN 19   EN Sulphate Not less than 15 % and not more than 
40 % on the dried basis (as SO 4) 
Ash Not less than 15 % and not more than 
40 % determined on the dried basis at 550°C 
Acid-insoluble ash Not more than 1 % on the dried basis 
(insoluble in 10 % hydrochloric acid) 
Acid-insoluble matter Not less than 8 % and not more than 
15 % on the dried basis (insoluble in 1 % 
v/v sulphuric acid) 
Low molecular weight carrageenan 
(Molecular weight fraction below 
50 kDa) Not more than 5 % 
Arsenic Not more than 3 mg/kg 
Lead Not more than 5 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium Not more than 2  mg/kg 
Total plate count Not more th an 5 000 colonies per gram 
Yeast and moulds Not more than 300 colonies per gram 
E. coli  Absent  in 5 g 
Salmonella spp. Absent  in 10 g”  
EN 20   EN 10. The text concerning E 412 guar gum is replaced by the following: 
“E 412 GUAR GUM 
Synonyms  Gum cyamopsis 
Guar flour 
Definition Guar gum is the ground endosperm of the 
seeds of natural strain s of the guar plant, 
Cyamopsis tetragonolobur  (L.) Taub. 
(family Leguminosae ). Consists mainly 
of a high molecular weight hydrocolloidal polysacc haride composed 
of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan . The gum 
may be partially hydrolysed by either 
heat treatment, mild acid or alkaline 
oxidative treatment for viscosity 
adjustment.  
Einecs 232-536-0 
Molecular weight Consists mainly of a high molecular 
weight hydrocolloidal polysaccharide
(50 000 – 8 000 000)   
Assay  Galactomannan content not less than 
75 %  
Description A white to yellowish-white, nearly 
odourless powder 
Identification  
A. Positive tests for galactose and for 
mannose  
B. Solubility Soluble in cold water 
Purity  
Loss on drying Not more than 15 % (105 °C, 5 hours) 
Ash Not more than 5,5  % determined at 
800 °C  
EN 21   EN Acid-insoluble matter Not more than 7 % 
Protein (N x 6,25) Not more than 10 %  
Starch Not detectable by the following method: 
to a 1 in 10 solution of the sample add a few drops of iodine solution (No blue colour is produced) 
Organic peroxides  Not more than 0,7 meq active oxygen/kg 
sample  
Furfural  Not more than 1 mg/kg  
Lead  Not more than 2 mg/kg  
Arsenic Not more than 3 mg/kg 
Mercury Not more than 1 mg/kg 
Cadmium Not more than 1 mg/kg”  
EN 22   EN 11. After the entry E 503(ii), the followi ng text concerning E 504i is added : 
“E 504i Magnesium carbonate 
Synonyms Hydromagnesite 
Definition Magnesium carbonate is a basic hydrated 
or a normal hydrated magnesium carbonate or a mixture of the two 
Chemical name Magnesium carbonate 
Chemical formula MgCO 3.nH 2O 
Einecs 208-915-9 
Assay Not less than 24% and not more than 
26,4% of Mg 
Description Odourless, light , white friable masses or 
as a bulky white powder 
Identification  
A. Solubility Practically insoluble both in water or 
ethanol  
B. Positive tests for magnesium and for 
carbonate  
Purity  
Acid insoluble matter Not more than 0.05 % 
Water soluble matter Not more than 1 % 
Calcium Not more than 0.4 % 
Arsenic Not more than 4 mg/kg 
Lead  Not more than 2 mg/kg 
Mercury Not more than 1 mg/kg”  
EN 23   EN 12. The text concerning E 526 calcium h ydroxide is replaced by the following: 
“E 526 CALCIUM HYDROXIDE  
Synonyms Slaked lime, hydrated lime 
Definition  
Chemical name Calcium hydroxide 
Einecs 215-137-3 
Chemical formula Ca(OH) 2 
Molecular weight 74,09 
Assay Content not less than 92 %  
Description White powder 
Identification  
A. Positive tests for alkali and for 
calcium  
B. Solubility Slightly soluble in water. Insoluble in 
ethanol. Soluble in glycerol 
Purity  
Acid insoluble ash Not more than 1,0 % 
Magnesium and alkali salts Not more than 2,7  % 
Barium Not more than 300 mg/kg 
Fluoride Not more than 50 mg/kg 
Arsenic Not more than 3 mg/kg 
Lead  Not more than 6  mg/kg”  
EN 24   EN 13. The text concerning E 529 calcium oxide is replaced by the following: 
“E 529 CALCIUM OXIDE 
Synonyms Burnt lime 
Definition  
Chemical name Calcium oxide 
Einecs 215-138-9 
Chemical formula CaO 
Molecular weight 56,08 
Assay  Content not less than 95 % on the ignited 
basis 
Description Odourless, har d, white or greyish white 
masses of granules, or white to greyish powder 
Identification  
A. Positive test for alkali and for 
calcium  
B. Heat is generated on moistening the 
sample in water  
C. Solubility Slightly soluble in water. Insoluble in 
ethanol. Soluble in glycerol 
Purity  
Loss on ignition Not more than 10 % (ca 800 ºC to 
constant weight) 
Acid insoluble matter Not more than 1 %  
Barium Not more than 300 mg/kg 
Magnesium and alkali salts Not more than 3,6  % 
Fluoride Not more than 50 mg/kg 
Arsenic Not more than 3 mg/kg 
Lead  Not more than 7  mg/kg”  
EN 25   EN 14. The following text concerning E 901 Beeswax is replaced by the following: 
“E 901 BEESWAX 
Synonyms White wax, yellow wax 
Definition Yellow bees wax is the wax obtained by 
melting the walls of the honeycomb made by the honey bee, Apis mellifera L. , with 
hot water and removing foreign matter 
White beeswax is obtained by bleaching 
yellow beeswax 
Einecs 232-383-7 (beeswax) 
Description Yellowish white (white form) or 
yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour 
Identification  
A. Melting range Between 62 °C and 65 °C 
B. Specific gravity About 0,96 
C. Solubility Insoluble in water 
Sparingly soluble in alcohol Very soluble in chloroform and ether 
Purity  
Acid value Not less than 17 and not more than 24 
Saponification value  87-104 
Peroxide value Not more than 5 
Glycerol and other polyols Not more than 0,5 % (as glycerol) 
Ceresin, paraffins and certain other waxes Absent 
Fats, Japan wax, rosin and soaps Absent 
Arsenic Not more than 3 mg/kg  
EN 26   EN Lead Not more than 2 mg/kg 
Mercury Not more than 1 mg/kg”  
EN 27   EN 15. The following text concerning E 905 micr ocrystalline wax is replaced by the 
following: 
“E 905 MICROCRYSTALLINE WAX 
Synonyms Petroleum wax, hydrocarbon wax, 
Fischer-Tropsch wa x, synthetic wax, 
synthetic paraffin  
Definition Refined mixtur es of solid, saturated 
hydrocarbons, obtained from petroleum 
or synthetic feedstocks  
Description White to amber, odourless wax 
Identification  
A. Solubility Insoluble in water, very slightly soluble 
in ethanol 
B. Refractive Index nD100 1,434-1,448 
Alternative : nD120 1,426-1,440  
Purity  
Molecular weight Aver age not less than 500 
Viscosity  Not less than 1,1 x 10-5 m2 s-1 at 100°C  
Alternative: Not less than 0,8 x10-5 m2 s-1 
at 120°C, if solid at 100°C  
Residue on ignition Not more than 0,1 wt  % 
Carbon number at 5 % distil lation point Not more than  5 % of molecules with 
carbon number less than 25 
Colour Passes test 
Sulphur Not more than 0,4 wt  %  
Arsenic Not more than 3 mg/kg 
Lead Not more than 3 mg/kg  
EN 28   EN Polycyclic aromatic compounds The polycyclic aromatic hydrocarbons, 
obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits: 
Nm
 Maximum absorbance
 per cm path length  
280-289 0,15 290-299 0,12 300-359 0,08 360-400 0,02 Alternative, if solid at 100°C
 
PAC method as per 21 CFR& 175.250 ;  
Absorbency at 290 nm in 
decahydronaphthalene at 88°C : Not 
exceeding 0.01”