EN    EN EN 
SANCO/2010/10036  
EN    EN  EUROPEAN COMMISSION 
Brussels,  
 
  
Draft 
COMMISSION DIRECTIVE 
of […] 
amending Directive 2008/84/EC laying down speci fic purity criteria on food additives other 
than colours and sweeteners  
 
 
  
EN 2   EN Draft 
COMMISSION DIRECTIVE 
of […] 
amending Directive 2008/84/EC laying down speci fic purity criteria on food additives other 
than colours and sweeteners  
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union Having regard to Regulation 1333/2008 of the Eur opean Parliament and of the Council of 16 
December 2008 on food additives and in particular art.30.5 thereof
1, 
After consulting the Scientific Committee on Food and the European Food Safety Authority, Whereas: (1) Commission Directive 2008/84/EC
2 of 27 August 2008 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 sweeteners3. 
(2) Regulation 1333/2008 provides u nder Art.30.4 that Specif ications of the food 
additives covered under paragraphs 1 to 3 of this Article which in clude also additives 
authorised under Directive 95/2/EC shall be adopted, in accordance with Regulation 
(EC) No 1331/2008 [establishing a common  authorisation procedure for food 
additives, food enzymes and food flavourings],  at the moment those food additives are 
entered in the Annexes in accordance with those paragraphs. 
(3) Since the lists are not yet been established and in order to ensure the modification of 
the annexes of Directive 95/2/EC  pursuant to art. 31 are eff ective and that additives so 
authorised are in accordance with safe conditions of use,  Directive 2008 /84/EC should 
therefore be amended. 
(4) The entry related to Carbon dioxide (E 290)  should be revised with respect to the 
concentration level of “oil content” to  take into account Codex Alimentarius 
specifications drafted by the Joint Expert Committee on Food Additives (JECFA) and 
the documents of International Organisa tion for Standardization (ISO) (e.g. ISO 
6141). 
(5) The European Food Safety Authority (herei nafter "the Author ity") assessed the 
information on the safety of extracts of rosemary when used as an antioxidant in 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 OJ L 253, 20.9.2008, p. 1. 
3 OJ L 61, 18.3.1995, p. 1.  
EN 3   EN foodstuffs. Extracts of ro semary are derived from Rosmarinus officinalis L . and 
contain several compounds which exert an tioxidative functions  (mainly phenolic 
acids, flavonoids, diterpenoids and triterpene s). It is considered appropriate to adopt 
specifications for extracts of rosemary which is authorised as a new food additive for 
use in foodstuffs under Directive 95/2/EC a nd assigned E 392 as E number. Few types 
of production process are desc ribed, using solvent extrac tion (ethanolic, acetone and 
hexane) and supercritica l carbon dioxide extraction. 
(6) Soybean hemicellulose (E 426) was evaluate d by the Scientific Committee on Food in 
20034 and is currently authorised within the EU under Directive 95/2/EC. A new 
variety of soybean hemicellulose is now pr oduced and complies with all specifications 
set out in Directive 2008/84/EC for E 426  except that ethanol  is technologically 
needed as precipitant for purifying the extrac t solution of that new variety of soybean 
hemicellulose. In consequence, the final E 426, which feature differs from a spray dried white powder, may also  contain some ethanol as a residue at the maximum 
concentration of 2%. Ethanol is authoris ed by Directive 2009/32/EC as extraction 
solvent during the processing of raw material s, of foodstuffs, of food components, or 
of food ingredients, in complian ce with good manufacturing practice. 
(7) The Authority assessed the information on the safety of cassia gum as a new food 
additive acting as gelling agent and thickener and expressed its opinion on 26 
September 2006
5. The Authority found the use of cassia gum as indicated under the 
conditions specified of no safety concern. It is therefore appropriate to adopt 
specifications for that new food additive which is assigned E number 427. 
(8) The entry related to hydroxypropyl cellulose  E 463 should be modi fied in order to 
correct an error of the specifications in re lation to the assay. In stead of “Content not 
less than 80,5 % of hydroxypropoxyl groups”,  it should be read “Content not more 
than 80,5 % of hydroxypropoxyl groups”. It is  therefore appropriate to update the 
current specifications. 
(9) The entry related to hydrogen (E 949) shoul d be corrected so th at the concentration 
levels indicated in the assay and purity sections can be compatible. Consequently, the concentration of nitroge n should be corrected. 
(10) The Authority assessed the information on th e safety of new food additive, polyvinyl 
alcohol (PVA), as a film-coating agent for food supplements and expressed its opinion 
on 5 December 2005
6. The Authority found the use of PV A of no safety concern in the 
coating of food supplement that are in the form  of capsules and tablet s. It is therefore 
appropriate to adopt specifications for pol yvinyl alcohol which is assigned E number 
1203, and which is authorised as a f ood additive under Directive 95/2/EC. 
                                                 
4  Opinion of the Scientific Committee on Food on So ybean Hemicellulose expr essed on 4 April 2003 
(SCF/CS/ADD/EMU/185 Final). 
5 Scientific opinion of the Panel on Food Additives, Fla vourings, Processing Aids and Material in Contact with 
Food on a request from the Commission related to an application on the use of cassia gum as a food 
additive, The EFSA Journal (2006) 389, 1-16. 
6 Scientific opinion of the Panel on Food Additives, Fla vourings, Processing Aids and Material in Contact with 
Food on a request from the Commission related to the use of polyvinyl alcohol as a coating agent for 
food supplement, The EFSA Journal (2005) 294, 1-15.  
EN 4   EN (11) The Authority assessed the information on th e safety of six grades of polyethylene 
glycols (PEG 400, PEG 3000, PEG 3350, PE G 4000, PEG 6000, PEG 8000) as film 
coating agents for use in food supplemen t products and expre ssed its opinion on 28 
November 20067. The Authority found the use of thos e grades of polyethylene glycol 
as glazing agent in film-coating formulations of no safety concern for food supplement tablets and capsules under the intended co nditions of use. Al l those grades of 
polyethylene glycols have been assigne d a new E number, namely E 1521. It is 
therefore appropriate to adopt  specifications for those six grades of polyethylene 
glycols and gather them under a single entr y. Consequently, it is necessary to update 
the current specifications already establishe d in Directive 2008/84/ EC for polyethylene 
glycol 6000. 
(12) The Authority assessed the safety of an en zyme preparation based on thrombin with 
fibrinogen isolated from bovine and/or por cine blood plasma as a food additive for 
recombining food and concluded in its opinion on  26 April 2005
8 that such use of the 
enzyme preparation when produced as outlined in the opinion is of no safety concern. 
It is therefore appropriate to adopt specifi cations for the two components thrombin and 
fibrinogen of that enzyme preparation. 
(13) 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. 
(14) Directive 2008/84/EC should therefore be amended accordingly. 
(15) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health, and neither the European 
Parliament nor the Council has opposed them, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
The Annex I to Directive 2008/8 4/EC is amended in accordanc e with the Annex to this 
Directive. 
                                                 
7 Scientific opinion of the Panel on Food Additives, Fla vourings, Processing Aids and Material in Contact with 
Food on a request from the Commission related to the use of polyethylene glycol (PEG) as a film coating agent for use in food supplement products, The EFSA Journal (2006) 414, 1-22. 
8 Opinion of the Scientific Panel on Food Additives, Fl avourings, Processing Aids and Materials in Contact with 
Food on a request from the Commission related to the use of an enzyme preparation based on thrombin:fibrinogen derived from cattle and/or pigs as a food additive for reconstituting food. The 
EFSA Journal (2005) 214, 1-8.  
EN 5   EN Article 2  
 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by […] at the latest. They shall 
forthwith communicate to the Commissi on the text of those provisions. 
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 Commission 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 on behalf of the President 
Mr Dalli Member of the Commission  
EN 6   EN ANNEX  
Annex I to Directive 2008/84/ EC is amended as follows: 
1. In the section on Carbon dioxide (E290) the subentry on “oil content” is replaced by 
the following 
Oil content Not more than 5 mg/kg 
2. After section on additive E 385, the following section on Extracts of rosemary (E 
392) is inserted: 
E 392 Extracts of rosemary 
GENERAL SPECIFICATION  
Synonym Extract of rosemary leaf (antioxidant) 
Definition  Extracts of rosemary contain several components, 
which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. 
Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable 
material specifically defined in the following 
specification. 
 EINECS 283-291-9 
 Chemical name  Rosemary extract ( Rosmarinus officinalis ) 
Description  Rosemary leaf extract antioxidant is prepared by 
extraction of the leaves of Rosmarinus officinalis  using 
a food approved solvent system . Extracts may then be 
deodorised and decolouris ed. Extracts may be 
standardised. 
Identification  
Reference antioxidative 
compounds: phenolic diterpenes Carnosic acid (C 20H28O4) and Carnosol (C 20H26O4) 
(which comprise not less than 90% of the total phenolic diterpenes) 
Reference key volatiles Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, 
Verbenone 
Density > 0.25 g/ml 
Solubility Insoluble in water 
Purity:  
Loss on Drying < 5%  
EN 7   EN Arsenic Not more than 3 mg/kg 
Lead Not more than 2 mg/kg 
 
1 - Extracts of rosemary produced from dr ied rosemary leaves by acetone extraction. 
 
Description  Extracts of rosemary are produced from dried rosemary 
leaves by acetone extraction, filtration, purification and 
solvent evaporation, followed  by drying and sieving to 
obtain a fine powder or a liquid.  
Identification  
Content of reference antioxidative 
compounds ≥ 10 % w/w, expressed as the total of carnosic acid and 
carnosol 
Antioxidant / Volatiles – Ratio  (Total % w/w of carnosic acid / carnosol) ≥ 15  
(% w/w of reference key volatiles) * (* as a percentage of total volatiles in the extract, measured by 
Gas Chromatography - Mass Spectrometry 
Detection, "GC-MSD" )) 
Residual Solvents  Acetone : Not more than 500 mg/kg 
 
2 – Extracts of rosemary prepared by extrac tion of dried rosemary leaves by means of 
supercritical carbon dioxide. 
Extracts of rosemary produced from dried rosema ry leaves extracted by means of supercritical 
carbon dioxide with a small amount of ethanol as entrainer.  
Identification  
Content of reference antioxidative 
compounds ≥13 % w/w, expressed as the to tal of carnosic acid and 
carnosol 
Antioxidant / Volatiles – Ratio (Total % w/w of carnosic acid / carnosol) ≥ 15  
(% w/w of reference key volatiles) * (* as a percentage of total volatiles in the extract, measured by 
Gas Chromatography - Mass Spectrometry 
Detection, "GC-MSD" )) 
Residual Solvents Ethanol: not more than 2% 
 
3 – Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary. 
Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The 
extract may be further purified, for example by treatment with active carbon and/or molecular 
distillation. They may be suspended in suit able and approved carri ers or spray dried.  
EN 8   EN Identification  
Content of reference antioxidative 
compounds ≥5 % w/w, expressed as the total of carnosic acid and 
carnosol 
Antioxidant / Volatiles – Ratio (Total % w/w of carnosic acid / carnosol) ≥ 15  
(% w/w of reference key volatiles) * (* as a percentage of total volatiles in the extract, measured by 
Gas Chromatography - Mass Spectrometry 
Detection, "GC-MSD" )) 
Residual Solvents Ethanol : not more than 500 mg/kg 
 
4 - Extracts of rosemary decolourised and de odorised extracts obtained by a two-step 
extraction using hexane and ethanol.  
Extracts of rosemary which are prepared from  a deodorised ethanolic extract of rosemary, 
undergone a hexane extraction. The extract may be  further purified, for example by treatment 
with active carbon and/or mol ecular distillation. They may be  suspended in suitable and 
approved carriers or spray dried. 
Identification:  
Content of reference antioxidative 
compounds ≥5 % w/w, expressed as the total of carnosic acid and 
carnosol 
Antioxidant / Volatiles – Ratio  (Total % w/w of carnosic acid / carnosol) ≥ 15  
(% w/w of reference key volatiles) * (* as a percentage of total volatiles in the extract, measured by 
Gas Chromatography - Mass Spectrometry 
Detection, "GC-MSD" )) 
Residual solvents Hexane : not more than 25 mg/kg 
Ethanol : not more than 500 mg/kg 
3. In the section on  Soybean Hemicellulose (E426), entries on "Definition" and 
"Description" are repl aced by the following: 
 
Definition Soybean Hemicellulose is a refined water-soluble 
polysaccharide obtained from natural strain soybean fibre by hot water extraction. No organic pr ecipitant shall be used other 
than ethanol 
Description Free flowing white or yellowish white powder 
In the entry on “Purity ” of the section on Soybean Hemi cellulose (E426), the following 
subentry is added: 
Ethanol Not more than 2% 
4. After the section on additive E 426, the following section on Cassia gum (E 427)  is 
inserted::  
EN 9   EN E 427 Cassia gum 
Synonyms   
Definition  Cassia gum is the ground purifie d  endosperm of the seeds o f 
Cassia tora  and Cassia obtusifoli (Leguminosae ) containing 
less than 0.05 % of Cassia occidentalis . It consists mainly o f 
high molecular weight polysaccharides composed  primarily o f 
a linear chain of 1,4- β-D-mannopyranose units with 1,6 linked 
α-D-galactopyranose units. The ra tio of mannose to galactose 
is about 5:1. 
In the manufacture the seeds are dehusked and degermed by 
thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with isopropanol. 
 Assay Not less than 75% of Galactomannan 
Description  Pale yellow to off-white, odourless powder 
Identification   
Solubility Insoluble in ethanol. Disperses well in cold water forming a 
colloidal solution. 
Gel formation with borate To an aqueous dispersion of the sample add sufficient sodium borate 
TS to raise the pH to above 9; a gel is formed.  
Gel formation with xanthan gum Weigh 1.5 g of the sample and 1.5 g of xanthan gum and blend them. 
Add this blend with (rapid stirring) into 300 ml water at 80° in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for 
an extra 30 min after dissolution (maintain the temperature above 60° 
during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h. 
A firm, viscoelastic gel forms after the temperature drops below 40°, 
but no such gel forms in a 1% control solution of cassia gum or 
xanthan gum alone prepared in a similar manner.  
Viscosity Less than 500 mPa (25 °C , 2h, 1% solution) corresponding to 
an average molecular weight of 200 000-300 000 D 
Purity    
Acid insoluble matter Not more than 2.0% 
pH 5.5-8 (1% aqueous solution) 
Crude fat Not more than 1%  
EN 10   EN Proteins Not more than 7 % 
Total ash Not more than 1.2% 
Loss on drying Not more than 12 % (5h, 105 °C) 
Total Anthraquinones Not more th an 0.5 mg/kg(detection limit) 
Solvent residues Not more than 750 mg/kg Isopropyl alcohol 
Lead Not more than 1 mg/kg 
Microbiological criteria  
Total plate count Not more than 5 000 colony forming unit per gram 
Yeast and mould Not more than 100 colony forming unit per gram 
Salmonella Absent in 25g 
E Coli Absent in 1g 
5.  In the section on hydroxypropyl cellulose (E 463) the subentry on “Assay” is replaced 
by the following 
Assay Content not more  than 80,5 % of hydroxypropoxyl groups 
(-OCH 2CHOHCH 3) equivalent to not more than 4,6 
hydroxypropyl groups per anhydroglucose unit on the anhydrous basis 
6. In the entry on “Purity” of  the section on hydrogen (E949) the subentry on "Nitrogen" 
is replaced by the following:  
Nitrogen Not more than 0.07 % v/v 
7. After the section on additive E 1201, the following sect ion is inserted: 
E 1203 Polyvinyl Alcohol 
Synonyms  Vinyl alcohol polymer, PVOH 
Definition  Polyvinyl alcohol is a synthe tic resin prepared by the 
polymerization of vinyl acetate, followed by partial hydrolysis 
of the ester in the presence of an alkaline catalyst. The physical 
characteristics of the pr oduct depend on the degree o f 
polymerization and the degree of hydrolysis. 
 Chemical name Ethenol homopolymer 
 Chemical formula (C 2H3OR) n where R = H or COCH 3  
EN 11   EN Description  Odourless, tasteless, translu cent, white or cream-coloured 
granular powder 
Identification   
Solubility Soluble in water ; sparingly soluble in ethanol 
Precipitation reaction Dissolve 0.25g of the sample in 5 ml  of water with warming 
and let the solution cool to room temperature. The addition o f 
10 ml of ethanol to this solutio n leads to a white, turbid or 
flocculent precipitate. 
Colour reaction Dissolve 0.01g of the samp le in 100 ml of water with warming 
and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml so lution) one drop of iodine TS 
and a few drops of boric acid solution 
Dissolve 0.5g of the sample in 10 ml of water with warming 
and let the solution cool to room temperature. A dark red to 
blue colour is produced after addi ng one drop of i odine TS to 5 
ml of solution. 
Viscosity 4.8 to 5.8 mPa (4% soluti on at 20°C) corresponding to an 
average molecular weight of 26000-30000 D 
Purity    
Water insoluble matter Not more than 0.1% 
Ester Value Between 125 and 153 mg KOH/g 
Degree of hydrolysis 86.5 to 89.0% 
Acid value Not more than 3.0 
Solvent residues Not more than 1.0 % Methanol, 1.0 % Methyl acetate,  
pH 5.0 to 6.5 (4% solution) 
Loss on drying Not more than 5.0 % (105°C, 3H) 
Residue in ignition Not more than 1.0% 
Lead Not more than 2.0 mg/kg 
8. The section on “polyethylene glycol  6000” is replaced by the following: 
E 1521 Polyethylene glycols 
Synonyms  PEG, Macrogol, Polyethylene oxyde  
EN 12   EN Definition  Addition polymers of ethylene oxide and water usually 
designated by a number roughly corresponding to the molecular weight. 
 Chemical name alpha-Hydro-om ega-hydroxypoly (oxy-1,2-ethanediol) 
 Chemical formula HOCH2 - (CH2 - O - CH2)n - CH2OH  
 Average Molecular weight 380 to 9000 D 
 Assay PEG 400 : Not less than 95% and not more than 105 % 
PEG 3000 : Not less than 90% and not more than 110 % PEG 3350 : Not less than 90% and not more than 110 % PEG 4000 : Not less than 90% and not more than 110 % PEG 6000 :Not less than 90% and not more than 110 % PEG 8000 : Not less than 87.5% and not more than 112.5 % 
Description  PEG 400 is a clear, viscous, colourless or almost colourless 
hygroscopic liquid 
PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 
are white or almost white solids with a waxy or paraffin-like appearance 
Identification   
Melting point PEG 400 : 4-8°C 
PEG 3000 : 50-56°C PEG 3350 : 53-57°C PEG 4000 : 53-59°C PEG 6000 :55-61°C PEG 8000 : 55-62°C 
Viscosity PEG 400 : 0.105 to 0.130 mPa.s at 20 °C  
PEG 3000 : 0.075 to 0.100 mPa.s at 20 °C PEG 3350 : 0.083 to 0.120 mPa.s at 20 °C PEG 4000 : 0.11 to 0.17 mPa.s at 20 °C PEG 6000 : 0.20 to 0.27 mPa.s at 20 °C PEG 8000 : 0.26 to 0.51 mPa.s at 20 °C For polyethylene gycols having a average molecular weight greater than 400, the vi scosity is determin ed on a 50 per cent 
m/m solution of the candida te substance in water 
Solubility PEG 400 is miscible with water,  very soluble in acetone, in 
alcohol and in methylene chloride , practically inso luble in fatty 
oils and in mineral oils PEG 3000 and PEG 3350 : very soluble in water and in methylene chloride, very slightly  soluble in alcohol, practically 
insoluble in fatty oils and in mineral oils PEG 4000, PEG 6000 and PEG 8000 : very soluble in water and in methylene chloride, practic ally insoluble in alcohol and 
in fatty oils and in mineral oils.  
EN 13   EN Purity   
Acidity or alkalinity Dissolve 5.0 g in 50 ml of carbon dioxide-free water and add 
0.15 ml of bromothymol blue solution . The solution is yellow or green. Not more than 0.1 ml of 0.1 M sodium hydroxide is required to change the colour of the indicator to blue. 
Hydroxyl value PEG 400 : 264-300 
PEG 3000 : 34-42 PEG 3350 : 30-38 PEG 4000 : 25-32 PEG 6000 : 16-22 PEG 8000 : 12-16 
Sulphated ash Not more than 0.2% 
1.4-Dioxane Not more than 10 mg/kg 
Ethylene oxide Not more than 0.2 mg/kg 
Ethylene glycol and diethylene glycol Total not more than 0.25% °w/w individually or in 
combination 
Lead Not more than 1 mg/kg 
9. After the section on additive E 1521, the following section is added:  
EN 14   EN Thrombin 
Definition  
Synonyms Fibrinogenase; thrombase; thro mbofort; topical; thrombin-C; 
tropostasin; activated blood-co agulation factor II; blood-
coagulation factor IIa; factor IIa; E thrombin; β-thrombin; γ-
thrombin 
Definition Thrombin (EC 3.4.21.5) is a serine proteinase involved in the
final step of blood coagulation. This enzyme consists of twochains and has an apparent molecular mass of about 36.5 kD
a 
and an isoelectric point of 7.5. Thrombin has a highly specific
proteolytic activity, cleaving onl y arginine-gly cine peptide 
bonds such as those found in fibrinogen, which is cleaved into fibrin. 
Thrombin and fibrinogen are isolated from bovine and/o
r 
porcine blood plasma. 
The enzyme thrombin is used in a preparation with fibrinogen
as the substrate which are mixed together just before use.  
Enzyme Commission No 3.4.21.5 
Description Colourless solution with a neutral smell. 
Identification  
Density 1,04 kg/l 
pH Between 6 and 9 
Purity   
Ash Not more than 7% 
Water 92-94 % (w/w) 
Lead Not more than 0.1 mg/kg 
Microbiological criteria   
Total bacterial count Not more than 100 000 colony forming unit per gram 
Salmonella sp Absent in 25g 
Enterobacteriaceae Not more than  1000 colony forming unit per gram 
Staphylococcus aureus Not more th an 1000 colony forming unit per gram  
EN 15   EN Moulds Not more than 1000 colony forming unit per gram 
Yeasts Not more than 100 co lony forming unit per gram 
Total coliforms Not more than 30 colony forming unit per gram 
  
Fibrinogen  
Definition Fibrinogen is a plasma protein wh ich can be used for the cross
linking of the amino acids lysine and glutamine 
Description Viscous orange / red solution  
Identification   
Density 1,04 kg/l 
pH 7-9 
Purity   
Fat 0.3 % (w/w) 
Proteins 9.5 % (w/w) includ ing Fibrinogen (5% (w/w)) 
Citrate 0.5 % (w/w) 
water 86 – 90% (w/w) 
Arsenic Not more than 0.2 mg/kg 
Lead Not more than 0.1 mg/kg 
Microbiological criteria   
Total bacterial count Not more than 100 000 colony forming unit per gram 
Salmonella sp Absent in 25g 
Enterobacteriaceae Not more than  1000 colony forming unit per gram 
Staphylococcus aureus Not more th an 1000 colony forming unit per gram 
Moulds Not more than 1000 co lony forming unit per gram 
Yeasts Not more than 100 co lony forming unit per gram 
E coli Absent in 25g  
EN 16   EN Total coliforms Not more than 30 colony forming unit per gram