EN    EN EN 
SANCO/11236/2010 EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION DIRECTIVE 
of 
amending Directive 2008/84/EC laying down specific purity criteria on food additives 
other than colours and sweeteners 
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION DIRECTIVE 
of 
amending Directive 2008/84/EC laying down specific purity criteria on food additives 
other than colours and sweeteners 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation 1333/2008, of the Eu ropean Parliament and of the Council of 
16 December 2008 on food additives
1, and in particular Article 30(5) thereof, 
After consulting the Scientific Committee on Food and the European Food Safety Authority, Whereas: (1) Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity 
criteria on food additives othe r than colours and sweeteners
2 sets out the purity 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) Under Article 30(4) of Regulation (EC)  No 1333/2008 specifications of the food 
additives covered under paragraphs 1 to 3 of that Article, including additives 
authorised under Directive 95/2/EC, shall be adopted, in accordance with Regulation 
(EC) No 1331/2008 establishing a common auth orisation procedure for food additives, 
food enzymes and food flavourings4, at the moment when those food additives are 
entered in the respective Annexes in  accordance with those paragraphs. 
(3) Since the lists have not yet b een drawn up, and in order to ensure that the modification 
of the Annexes to Directive 95/2/EC pursuant to Article 31 is effective, and to ensure that additives so authorised comply 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 wi th 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 
                                                
 
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. 
4  OJ L 354, 31.12.2008, p. 1.  EN 3   EN the documents of the International Organi sation for Standardisation (ISO) (e.g. ISO 
6141). 
(5) The European Food Safety Authority (herei nafter "the Authority") has assessed the 
information on the safety of extracts of rosemary when used as an antioxidant in foodstuffs. Extracts of rosemary are deri ved 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 its E number. Several 
types of production process are described, us ing solvent extraction (ethanolic, acetone 
and hexane) and supercritical  carbon dioxide extraction. 
(6) Soybean hemicellulose (E 426) was evaluate d by the Scientific Committee on Food in 
2003
5 and is currently authorised within the EU under Directive 95/2/EC. A new 
variety of soybean hemicellulose is now produ ced 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 materials, foodstuffs , food components, or food 
ingredients in compliance 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
6. 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 relating to hydroxypropyl cellulose (E  463) should be modified 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 read “Content not more than 
80,5 % of hydroxypropoxyl groups”. It is theref ore appropriate to update the current 
specifications.  
(9) The entry relating 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 the safety of the new food additive, 
polyvinyl alcohol (PVA), as a film-coating agent for food supplements and expressed 
its opinion on 5 December 2005
7. The Authority found the use of PVA of no safety 
                                                 
5 Opinion of the Scientific Committee on Food on So ybean Hemicellulose expr essed on 4 April 2003 
(SCF/CS/ADD/EMU/185 Final). 
6 Scientific opinion of the Panel on Food Additiv es, Flavourings, 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. 
7 Scientific opinion of the Panel on Food Additiv es, Flavourings, 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, p. 1. EN 4   EN concern in the coating of food supplements that  are in the form of capsules and tablets. 
It is therefore appropriate to adopt specifications for polyvinyl alcohol which is 
assigned E number 1203, and which is authoris ed as a food additi ve under Directive 
95/2/EC. 
(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 supplement  products and expressed its opinion on 
28 November 20068. The Authority found the use of those grades of polyethylene 
glycol as glazing agent in film-coating form ulations of no safe ty concern for food 
supplement tablets and capsules  under the intended  conditions of use. All those grades 
of polyethylene glycols have been assi gned a new E number, namely E 1521. It is 
therefore appropriate to adopt  specifications for those six grades of polyethylene 
glycols and to group them together under a si ngle entry. Consequent ly, it is necessary 
to update the current specifications alrea dy laid down in Directive 2008/84/EC for 
polyethylene glycol 6000. 
(12) EFSA assessed the safety of use of an en zyme preparation based on thrombin with 
fibrinogen derived from cattle and/or pigs as a food additive for reconstituting food and concluded in its opinion on 26 April 2005 th at this use of the enzyme preparation 
when produced as outlined in th e opinion is of no safety concern
9. However, the 
European Parliament in its Resoluti on of 19 May 2010 on the draft Commission 
Directive amending the Annexes to the Eu ropean Parliament and Council Directive 
95/2/EC on food additives other than colour s and sweeteners, c onsidered that the 
inclusion in Annex IV to Di rective 95/2/EC of this enzyme preparation as a food 
additive for reconstituting food was not co mpatible with the aim and content of 
Regulation (EC) No 1333/2008, as it does not meet the general criteria of Article 6 of 
Regulation (EC) No 1333/2008, especially in paragraph 1(c) of Article 6. 
(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, 
                                                 
8 Scientific opinion of the Panel on Food Additiv es, Flavourings, 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, p. 1. 
9  Opinion of the Scientific Panel on Food Additives, Flavourings, 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, p. 1. EN 5   EN HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 2008/84/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 comp ly with this Directive by 31 March 2011 at the latest. 
They shall forthwith communicate to the Co mmission 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 tw entieth 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 its 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 the 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 th an 90% of the total phenolic 
diterpenes) 
Reference key volatiles Borneol, Bo rnyl Acetate, Camphor, 1,8-Cineol, 
Verbenone 
Density > 0.25 g/ml 
Solubility Insoluble in water EN 7   EN Purity  
Loss on Drying < 5% 
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 th e total of carnosic acid and 
carnosol 
Antioxidant / Volatiles – Ratio (Total  % w/w of carnosic acid and carnosol)  ≥ 15
(% w/w of reference key volatiles)*(* as a percentage of total volatiles in the extract, measured by Gas Chromat ography - 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 total of carnosic acid and 
carnosol 
Antioxidant / Volatiles – Ratio (Total  % w/w of carnosic acid and carnosol)  ≥ 15 
(% w/w of reference key volatiles)*(* as a percentage of total volatiles in the extract, measured by Gas Chromat ography - Mass Spectrometry 
Detection, "GC-MSD" )) EN 8   EN 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 etha nolic extract of rosemary. The 
extracts may be further purified, for exam ple by treatment with active carbon and/or 
molecular distillation. The extracts may be su spended in suitable an d 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 and carnosol)  ≥ 15 
(% w/w of reference key volatiles)*(* as a percentage of total volatiles in the extract, measured by Gas Chromat ography - Mass Spectrometry 
Detection, "GC-MSD" )) 
Residual Solvents Ethanol: not more than 500 mg/kg 
 
4 – Extracts of rosemary decolourised and de odorised, 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 and carnosol)  ≥ 15 
(% w/w of reference key volatiles)*(* as a percentage of total volatiles in the extract, measured by Gas Chromat ography - Mass Spectrometry 
Detection, "GC-MSD" )) 
Residual solvents Hexane: not more than 25 mg/kg 
Ethanol: not more than 500 mg/kg” EN 9   EN (3) In the section on Soyb ean Hemicellulose (E426): 
 (a) the entries on "Definition" and "D escription" are replaced by the following: 
“Definition Soybean Hemicellulose is a refined water-soluble 
polysaccharide obtained from natural strain soybean fibre by hot water extraction. No or ganic precipitant shall be 
used other than ethanol 
Description Free flowing white or yellowish white powder” 
(b) in the entry on “Purity”, th e 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: 
“E 427 Cassia gum 
Synonyms   
Definition  Cassia gum is the ground purif ied endosperm of the seeds 
of Cassia tora  and Cassia obtusifoli (Leguminosae ) 
containing less than 0.05 % of Cassia occidentalis . It 
consists mainly of high mol ecular weight polysaccharides 
composed primarily of a linear chain of 1,4- β-D-
mannopyranose units linked with 1,6- α-D-galactopyranose 
units. The ratio 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 test solution (TS) to raise the pH to above 9; a gel is formed.
 EN 10   EN 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°  C 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.s (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% 
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 units per gram 
Yeast and mould Not more than 100 colony forming units per gram 
Salmonella spp Absent in 25g 
E Coli Absent in 1g” EN 11   EN (5) In the section on hydroxypropyl cellulose (E463), 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 anhyd roglucose unit on the 
anhydrous basis” 
(6) In the section on hydrogen (E949), in entr y on “Purity”, 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 synt hetic resin prepared by the 
polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis. 
 Chemical name Ethenol homopolymer 
 Chemical formula (C 2H3OR) n where R = H or COCH 3 
Description  Odourless, tasteless, translucen t, 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 of 10 ml of ethanol to this soluti on leads to a white, turbid or 
flocculent precipitate. 
Colour reaction Dissolve 0.01g of the sample 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 solution) one 
drop of iodine test solution (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 EN 12   EN blue colour is produced after a dding one drop of iodine TS to 
5 ml of solution. 
Viscosity 4.8 to 5.8 mPa.s (4% solution 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 glyc ol 6000” is replaced by the following: 
“E 1521 Polyethylene glycols 
Synonyms  PEG, Macrogol, Polyethylene oxide 
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 EN 13   EN  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: 105 to 130 mPa.s at 20 °C  
PEG 3000: 75 to 100 mPa.s at 20 °C PEG 3350: 83 to 120 mPa.s at 20 °C PEG 4000: 110 to 170 mPa.s at 20 °C PEG 6000: 200 to 270 mPa.s at 20 °C PEG 8000: 260 to 510 mPa.s at 20 °C For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined 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 chlori de, practically insoluble 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, practically insoluble in alcohol and in fatty oils and in mineral oils. 
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 th an 0.1 ml of 0.1 M sodium 
hydroxide is required to change th e colour of the indicator to 
blue. EN 14   EN 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”