DIRECTIVES  
COMMISSION DIRECTIVE 2010/67/EU  
of 20 October 2010  
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 (EC) No 1333/2008 of the 
European 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 
other than colours and sweeteners (  2 ) sets out the 
purity criteria for the additives mentioned in European 
Parliament and Council Directive 95/2/EC of 20 February 
1995 on food additives other than colours and 
sweeteners (  3 ). 
(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 of 
the European Parliament and of the Council of 
16 December 2008 establishing a common authorisation 
procedure for food additives, food enzymes and food 
flavourings (  4 ), 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 been 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 with respect to the concentration level of ‘oil 
content’ to take into account Codex Alimentarius spec ­
ifications drafted by the Joint Expert Committee on Food 
Additives (JECFA) and the documents of the International 
Organisation for Standardisation (ISO) (e.g. ISO 6141).  
(5) The European Food Safety Authority (hereinafter the 
Authority) has assessed the information on the safety 
of extracts of rosemary when used as an antioxidant in 
foodstuffs. Extracts of rosemary are derived from  
Rosmarinus officinalis  L. and contain several compounds 
which exert antioxidative functions (mainly phenolic 
acids, flavonoids, diterpenoids and triterpenes). 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 
and assigned E 392 as its E number. Several types of 
production process are described, using solvent 
extraction (ethanolic, acetone and hexane) and super ­
critical carbon dioxide extraction.  
(6) Soybean hemicellulose (E 426) was evaluated 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 produced and complies with all specifications set 
out in Directive 2008/84/EC for E 426 except thatEN 21.10.2010 Official Journal of the European Union L 277/17  
( 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.  ( 5 ) Opinion of the Scientific Committee on Food on Soybean Hemicel ­
lulose expressed on 4 April 2003 (SCF/CS/ADD/EMU/185 Final).ethanol is technologically needed as precipitant for 
purifying the extract 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 authorised 
by Directive 2009/32/EC of the European Parliament 
and of the Council (  1 ) 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 (  2 ). 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 relation to the assay. Instead of ‘Content 
not less than 80,5 % of hydroxypropoxyl groups’, it 
should read ‘Content not more than 80,5 % of hydroxy ­
propoxyl groups’. It is therefore appropriate to update 
the current specifications.  
(9) The entry relating to hydrogen (E 949) should be 
corrected so that the concentration levels indicated in 
the assay and purity sections can be compatible. 
Consequently, the concentration of nitrogen 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 (  3 ). The Authority found 
the use of PVA of no safety 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 authorised as a food additive under 
Directive 95/2/EC.  
(11) The Authority assessed the information on the safety of 
six grades of polyethylene glycols (PEG 400, PEG 3000, 
PEG 3350, PEG 4000, PEG 6000, PEG 8000) as film coating agents for use in food supplement products and 
expressed its opinion on 28 November 2006 (  4 ). The 
Authority found the use of those grades of polyethylene 
glycol as glazing agent in film-coating formulations of no 
safety concern for food supplement tablets and capsules 
under the intended conditions of use. All those grades of 
polyethylene glycols have been assigned a new E number, 
namely E 1521. It is therefore appropriate to adopt spec ­
ifications for those six grades of polyethylene glycols and 
to group them together under a single entry. 
Consequently, it is necessary to update the current spec ­
ifications already laid down in Directive 2008/84/EC for 
polyethylene glycol 6000.  
(12) EFSA assessed the safety of use of an enzyme 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 that this use 
of the enzyme preparation when produced as outlined in 
the opinion is of no safety concern (  5 ). However, the 
European Parliament in its Resolution of 19 May 2010 
on the draft Commission Directive amending the 
Annexes to the European Parliament and Council 
Directive 95/2/EC on food additives other than colours 
and sweeteners, considered that the inclusion in Annex 
IV to Directive 95/2/EC of this enzyme preparation as a 
food additive for reconstituting food was not compatible 
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 into account the specifications and 
analytical techniques for additives as set out in the Codex 
Alimentarius 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 Directive are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health, and 
neither the European Parliament nor the Council has 
opposed them,EN L 277/18 Official Journal of the European Union 21.10.2010  
( 1 ) OJ L 141, 6.6.2009, p. 3.  
( 2 ) Scientific opinion of the Panel on Food Additives, 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.  
( 3 ) Scientific opinion of the Panel on Food Additives, 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.  ( 4 ) Scientific opinion of the Panel on Food Additives, 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.  
( 5 ) 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.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 comply with this 
Directive by 31 March 2011 at the latest. They shall 
forthwith communicate to the Commission 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 determine 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 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 20 October 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 21.10.2010 Official Journal of the European Union L 277/19ANNEX  
Annex I to Directive 2008/84/EC is amended as follows:  
1. in the section on E 290 Carbon dioxide 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 E 392 Extracts of rosemary 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 decolourised. Extracts may be 
standardised  
Identification  
Reference antioxidative compounds: phenolic 
diterpenes  Carnosic acid (C  20 H 28 O 4 ) and Carnosol (C  20 H 26 O 4 ) 
(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 %  
Arsenic  Not more than 3 mg/kg  
Lead  Not more than 2 mg/kg  
1. Extracts of rosemary produced from dried 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 liquidEN L 277/20 Official Journal of the European Union 21.10.2010Identification  
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 and 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 extraction of dried rosemary leaves by means of supercritical carbon dioxide  
Extracts of rosemary produced from dried rosemary 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 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 extracts may be further 
purified, for example by treatment with active carbon and/or molecular distillation. The extracts 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 Chromatography — Mass Spectrometry 
Detection, “GC-MSD”)  
Residual Solvents  Ethanol: not more than 500 mg/kg  
4. Extracts of rosemary decolourised and deodorised, 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 molecular 
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 
carnosolEN 21.10.2010 Official Journal of the European Union L 277/21Antioxidant/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 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 E 426 Soybean Hemicellulose:  
(a) the entries on ‘Definition’ and ‘Description’ are replaced by the following: 
‘Definition  Soybean Hemicellulose is a refined water-soluble polysac ­
charide obtained from natural strain soybean fibre by hot 
water extraction. No organic precipitant shall be used 
other than ethanol  
Description  Free flowing white or yellowish white powder’;  
(b) in the entry on ‘Purity’, the following subentry is added: 
‘Ethanol  Not more than 2 %’;  
4. after the section on additive E 426, the following section on E 427 Cassia gum is inserted:  
‘E 427 CASSIA GUM 
Synonyms  
Definition  Cassia gum is the ground purified endosperm of the seeds 
of Cassia tora  and  Cassia obtusifoli  (Leguminosae ) containing 
less than 0,05 % of  Cassia occidentalis . It consists mainly of 
high molecular 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 formedEN L 277/22 Official Journal of the European Union 21.10.2010Gel 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 °C 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 °C, 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) cor- 
responding 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 % (5 h, 105 °C)  
Total Anthraquinones  Not more than 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 25 g  
E. Coli  Absent in 1 g’;  
5. in the section on E 463 Hydroxypropyl cellulose, the subentry on ‘Assay’ is replaced by the following: 
‘Assay  Content not more than 80,5 % of hydroxypropoxyl 
groups (-OCH  2 CHOHCH  3 ) equivalent to not more than 
4,6 hydroxypropyl groups per anhydroglucose unit on 
the anhydrous basis’;  
6. in the section on E 949 Hydrogen, in entry on ‘Purity’, the subentry on ‘Nitrogen’ is replaced by the following: 
‘Nitrogen  Not more than 0,07 % v/v’;EN 21.10.2010 Official Journal of the European Union L 277/237. after the section on additive E 1201, the following section is inserted:  
‘E 1203 POLYVINYL ALCOHOL 
Synonyms  Vinyl alcohol polymer, PVOH  
Definition  Polyvinyl alcohol is a synthetic 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  2 H 3 OR)  n where R = H or COCH  3 
Description  Odourless, tasteless, translucent, white or cream-coloured 
granular powder  
Identification  
Solubility  Soluble in water; sparingly soluble in ethanol  
Precipitation reaction  Dissolve 0,25 g 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 solution leads to 
a white, turbid or flocculent precipitate  
Colour reaction  Dissolve 0,01 g 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 0,5 g 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 adding 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 26 000-30 000 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, 3 H)  
Residue in ignition  Not more than 1,0 %  
Lead  Not more than 2,0 mg/kg’;EN L 277/24 Official Journal of the European Union 21.10.20108. the section on ‘Polyethylene glycol 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-omega-hydroxypoly (oxy-1,2-ethanediol)  
Chemical formula  HOCH  2 - (CH  2 - O - CH  2 ) n - CH  2 OH 
Average molecular weight  380 to 9 000 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: 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 candidate substance in 
waterEN 21.10.2010 Official Journal of the European Union L 277/25Solubility  PEG 400 is miscible with water, very soluble in acetone, 
in alcohol and in methylene chloride, 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 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’.EN L 277/26 Official Journal of the European Union 21.10.2010