EN    EN EN 
SANCO/11223/2010 EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final  
Draft 
COMMISSION DIRECTIVE 
of 
amending the Annexes to European Parliame nt and Council Directive 95/2/EC on food 
additives other than colours and sweeteners  
(Text with EEA relevance) EN 2   EN Draft 
COMMISSION DIRECTIVE 
of 
amending the Annexes to European Parliame nt and Council Directive 95/2/EC 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 31 thereof, 
Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the 
Council of 28 January 2002 laying down the genera l principles and requirements of food law, 
establishing the European Food Safety Authorit y and laying down procedures in matters of 
food safety2, and in particular Article 53 thereof, 
After consulting the Scientific Committee on Food and the European Food Safety Authority, Whereas: (1) European Parliament and Council Direct ive 95/2/EC on food additives other than 
colours and sweeteners
3 lays down a list of  food additives that may be used in the 
European Union and the conditions for their use. 
(2) There have been technical developments in the field of food additives since the 
adoption of Directive 95/2/EC.  This Directive should be adapted to take into account 
those developments. 
(3) In accordance with Article 31 of Regulation (EC) No 1333/2008 until the 
establishment of the Union lists of food additiv es as provided for in Article 30 of that 
Regulation is completed, the Annexes to Di rective 95/2/EC shall be amended, where 
necessary, by measures a dopted by the Commission.  
(4) The following stabilisers agar (E 406), carrageenan (E 407), locust bean gum (E 410), 
guar gum (E 412), xanthan gum (E 415), pect ins (E 440), cellulose  (E 460), carboxy 
methyl cellulose (E 466), oxidised starch  (E 1404), monostarc h phosphate (E 1410), 
distarch phosphate (E 1412), phosphated di starch phosphate (E 1413), acetylated 
                                                 
1 OJ L 354, 31.12.2008, p. 16. 
2 OJ L 31, 1.2.2002, p. 1.  
3  OJ L 61, 18.3.1995, p. 1. EN 3   EN distarch phosphate (E 1414), acetylated star ch (E 1420), acetylated distarch adipate 
(E 1422), hydroxyl propyl starch (E 1440), hydroxy propyl distarch phosphate 
(E 1442), starch sodium octenyl succinate  (E 1450), acetylated oxidised starch 
(E 1451) and emulsifier mono- and diglycerid es of fatty acids (E 471) are currently 
authorised under Directive 95/2/EC for a variety of uses. These food additives have been allocated an acceptable daily intake (ADI) ‘not sp ecified’ by th e Scientific 
Committee on Food (hereinafter SCF) and th erefore do not present any hazard to the 
health of consumers. There is a technologica l need to extend their uses to unflavoured 
live fermented cream products and substitute products with a fat c ontent of less than 
20 % to ensure the stability and integrity of the emulsion. This use would benefit the 
consumer by providing the choice of re duced fat fermented cream products with 
similar properties as to the ordinary product.  It is therefore appr opriate to authorise 
this additional use. 
(5) In 1990, the SCF evaluated sodium and potassi um salts of lactate (E 325 and E 326), 
potassium acetate (E 261), sodium acetat e (E 262i) and sodium hydrogen acetate 
(E 262ii) and came to the conclu sion that they are all naturally presen t as constituents 
in food and estimates of their intake are lik ely to be insignificant compared to the 
intake from natural sources. Therefore th ey were all allocated a ‘group ADI not 
specified’. Consequently, these food additives are generally permitted for use in all foodstuffs, other than those referred to in Ar ticle 2(3) of Directiv e 95/2/EC. There is a 
proposal to extend the use of these food additi ves into pre-packed preparations of fresh 
minced meat to control the growth of microbial pathoge ns, e.g. Listeria, E. coli  O157. 
Based on this technological jus tification, and taking into account  that this use raises no 
safety concern, it is appropriate to permit the additional use of these food additives in pre-packed preparations of fresh minced meat. 
(6) Sorbates (E 200, E 202, E 203) and benz oates (E 210, E 211, E 212, E 213) are 
currently permitted as food additives under Directive 95/2/EC. An additional use as 
preservative of these food additives is proposed in seaweed-based fish product analogues (caviar analogues ma de of seaweed) as topping on various foods in order to 
prevent the growth of moulds and yeasts a nd the formation of mycotoxins. These salts 
are allocated an ADI of 0-25 mg/kg bw and 0-5 mg/kg/ bw respectively. On the basis 
of a worst case scenario where the maximu m concentrations were used, the intake 
estimates are very low compared to the ADI. The exposure of the consumer as a result of this use does not give rise to safety con cern. It is therefore appropriate to permit the 
additional use of sorbates and benzoates in seaweed based fish analogue products, 
bearing in mind the technological justificat ion and the fact that  this new product 
represents a niche market. 
(7) The use of sorbates (E 200, E 202, E 203)  and benzoates (E 210, E 211, E 212, E 213) 
is requested for beers in keg to which more than 0,5 % ferm entable sugars and/or fruit 
juices or concentrates have been added and which are directly served on draft. These beers in keg may stay connected to the beer tap for a longer time. As the connection of the keg to the tap cannot be performe d under sterile conditions, microbiological 
contamination of the keg is possible. This is a problem for beers which still contain 
fermentable sugars because this may lead to the growth of hazardous microorganisms. 
Therefore antimicrobial agents are required in draft beers and to which fermentable 
sugars and/or fruit juices or concentrates have been added. From an intake point of 
view, the consumption on draft of such fruit beers remain s marginal and the intake 
estimates for sorbates and benzoates, on the grounds of a ‘wor st case approach’, EN 4   EN should be below their respective ADIs. Ther efore it is appropriate to permit the 
additional use of sorbates and benzoates in beer in kegs containing more than 0,5 % added fermentable sugar and/or fruit juices or concentrates. 
(8) To prevent the development of moulds on citr us fruit, their post harvest treatment with 
pesticides such as imazalil and thiabendazo le is authorised. Sorbates (E 200, E 202, 
E 203) could be used to replace these pesticid es partly or completely for the treatment 
of citrus fruit. Sorbates can be applied on the surface of the unpeeled fresh citrus fruit 
via the authorised waxes: beeswax, candel illa wax, carnauba wax and shellac (E 901, 
E 902, E 903 and E 904 respectiv ely). The exposure of the co nsumer to these additives 
due to this use is not a cause of safety con cern. It is therefore appropriate to authorise 
its additional use. 
(9) Consumers may choose to supplement their intake of some nut rients with food 
supplements. For that purpose, vitamin A an d combinations of vitamins A and D can 
be added to food supplements, as defined by Directive 2002/46/EC of the European 
Parliament and of the Council
4. For reasons of safe handling, vitamin A and 
combinations of vitamins A and D have to be formulated into preparations that may 
require high humidity and high temperature, in the presence of starches and sugars. 
Such processing may favour the development of microorganisms. In  order to prevent 
the growth of these microorganisms, th e addition of sorbates (E 200, E 202, E 203) 
and benzoates (E 210, E 211, E 212 and E 213) should be authorised  in vitamin A and 
in combinations of vitamins A and D when used in food supplements supplied in dried 
form. 
(10) Sulphur dioxide and sulphites (E 220, E 221, E 222, E 223, E 224, E 226, E 227, 
E 228) are food additives authorised under Di rective 95/2/EC which act primarily as 
antimicrobial agents and controlling chemi cal spoilage. Nowadays, transport of fresh 
fruit has become very important, in particul ar by sea freight. Such transport may be 
several weeks. The use of sulphur dioxide and sulphites will prot ect fresh blueberries 
against fungi growth. The additional use of sulphur dioxide and sulphites should be 
authorised in order to help preserve fresh blueberries against fungi growth, bearing in 
mind that this is likely to represent a nich e market. Taking also into consideration the 
sound technological reasons for including th ese new authorisations, the need to 
facilitate worldwide trade and its negligible  impact in term of sulphur and sulphite 
intake, it is therefore appropria te to authorise the additiona l use of sulphur dioxide in 
blueberries at the concentra tion level indicated in the Annex to this Directive. 
(11) For the production of cinnamon sticks ( Cinnamomum ceylanicum  only), also known as 
‘quills’, the fresh peels of th e inner bark of the cinnamon tree is used. The peel is 
exposed to microbial contamination and inse ct attacks, particularly under tropical and 
humid climatic conditions, in the produci ng country. Sulphur dioxide fumigation is an 
appropriate treatment against such microbial  contamination and in sect attacks. In 
1994, the SCF established an ADI of 0-0,7 mg/ kg bw and considered that the use of 
sulphur dioxide and other sulphiting agents should be limited in order to limit the 
occurrence of severe asthma tic reactions. Although the us e of sulphur dioxide and 
sulphites should be limited, th is specific use represents a negligible contributor in 
relation to the intake of sulphur dioxide and sulphites. It is ther efore appropriate to 
                                                 
4 OJ L 183, 12.7.2002, p. 51. EN 5   EN authorise the additional use of sulphur dioxide and sulphites (E 220, E 221, E 222, 
E 223, E 224, E 226, E 227, E 228) only in this  particular type of cinnamon. 
(12) The European Food Safety Authority (herei nafter EFSA) assessed the information on 
the safety of use of nisin in an additional food category of liquid eggs, and on the safety of nisin produced using a modified production process. Th e EFSA confirmed in 
its opinion on 26 January 2006
5 the previously established ADI of 0-0,13 mg/kg for 
the nisin produced using a new manufactur ing and extraction process based on 
fermentation of a sugar medium as a re placement for the traditionally milk-based 
medium. In this opinion, the EFSA also c onfirmed that the development of antibiotic 
resistance should not be expected from th e use of nisin in food. According to the 
EFSA, there are no reports of nisin resi stant bacterial muta nts showing cross-
resistance to therapeutic antibiotic. It considered that this is probably due to the differences between therapeutic antibiotics and nisin in terms of the antimicrobial 
mode of action. The EFSA furthermore confirmed in its opinion issued on 20 October 2006
6 that the additional use of nisin in pasteurised liquid eggs under the intended 
conditions of use (maximum limit at 6,25 mg/l) is not a safety concern and is justified 
from a technological point of view to exte nd the shelf life of the product and also to 
prevent the growth of food poisoning spore-forming species, like Bacillus cereus , 
which may survive from pasteurisation treatment. It is therefore appropriate to authorise this additional use of nisin in pasteuri sed liquid egg. 
(13) Dimethyl dicarbonate (DMDC, E 242) is a food additive permitted under Directive 
95/2/EC which acts as a preservative in non-alcoholic flavoured drinks, alcohol-free 
wine and liquid-tea concentrate. The authorisation of this additive was decided on the basis of a positive opinion issued by the SCF in 1990 and confirmed in 1996. The SCF was unable to set an ADI, as DMDC rapidl y decomposes into carbon dioxide and 
methanol. In 2001, the SCF was requested to i nvestigate the safety of use of DMDC in 
wine. At that time the SCF considered th at the formation of methanol and other 
reaction products, such as methylcarbamat e resulting from the use of DMDC for the 
treatment of alcoholic bevera ges and wine is similar to that formed in non-alcoholic 
beverages, and even a heavy consumption of wine would not pose any hazard from 
methanol and methylcarbamate. The use of DMDC has been requested in order to 
prevent spoilage as a result of fermentati on in unopened non-sterile filled bottles of 
cider, perry and fruit wines,  alcohol-reduced wine, wine-b ased drinks and all other 
products covered by Council Regulation (EEC) No 1601/91
7. These additional uses 
are not considered as being of safety con cern for the consumer. Moreover, the use of 
DMDC could contribute to the reduction of  the sulphur dioxide exposure. It is 
therefore appropriate to authorise the additional uses of DMDC in cider, perry and fruit wines, alcohol-reduced wine, wine-bas ed drinks and other products covered by 
Regulation (EEC) No 1601/91. 
                                                
 
5 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 nisin (E 234) as a food 
additive, The EFSA Journal  (2006) 314, p. 1. 
6 Scientific opinion of the Panel on Food Additiv es, Flavourings, Processing Aids and Material in 
Contact with Food on the safety in use of nisin as a food additive in an additional category of liquid eggs and on the safety of nisin produced using a modified production process as a food additive, The 
EFSA Journal  (2006) 314b, p. 1. 
7 OJ L 149, 14.6.1991, p. 1. EN 6   EN (14) The EFSA assessed the information on the safety  of use of extracts of rosemary when 
used as an antioxidant in foodstuffs. Ex tracts of rosemary are derived from 
Rosmarinus officinalis L. and contain several compounds which exert antioxidative 
functions (mainly phenolic aci ds, flavonoids, diterpenoids and triterpenes). Although 
the toxicological data on extracts of rose mary were insufficient for the EFSA to 
establish a numerical ADI, the EFSA considered in its opinion on 7 March 20088 that 
the margin of safety was high enough to c onclude that dietary exposure resulting from 
the proposed uses and use levels were of no safety concern. Extracts of rosemary can 
therefore be authorised where there is a t echnological justification for their use. The 
proposed uses of extracts of rosemary as antioxidant should be authorised and E 392 
should be assigned as E number  for extracts of rosemary. 
(15) Whey is a by-product of cheese manufacturing.  Some whey protein containing drinks 
have been developed in order to provide a diet sufficiently rich in proteins. To keep 
the proteins in suspension during the heat  treatment of such drinks, the phosphates 
must be at levels that are higher than  for normal non-alcoholic flavoured drinks. 
Phosphates should be authorised in wh ey protein containing sport drinks. 
(16) Beeswax (E 901) is currently authorised as a glazing agent for use in small products of 
fine bakery wares coated with chocolate. This authorisation doe s not cover ice cream 
wafers that are not coated with chocolate. In addition to the fact that beeswax can be 
considered as an alternative to chocolate in pre-packed ice cream wafers, the coating 
of the wafers with beeswax would prevent the migration of water to the wafer and 
ensure its crunchiness and the extension of th e shelf life of the product and is therefore 
considered technologically ju stified. Therefore beeswax should be aut horised as a 
glazing agent to replace fully or partly the in-layer chocolate in pre-packed wafers 
containing ice-cream. 
(17) The EFSA assessed the information on the sa fety of use of beeswax considering its 
additional use as a carrier of flavourings in non-alcoholic flavour ed drinks. Although 
the available data on beeswax itself were insufficient to establish an ADI, the EFSA came to the conclusion that, due to the low toxicological prof ile of beeswax, the 
existing food uses and the pr oposed new use of beeswax do not  raise safety concern. It 
is therefore appropriate to authorise this additional use of beeswax as a carrier of 
flavourings in non-alcoho lic flavoured drinks. 
(18) Triethyl citrate (E 1505) is currently authorised within the EU under Directive 
95/2/EC as a carrier in flavourings, and in dried egg white. Its ADI was established by 
the SCF in 1990 at 0-20 mg/kg. An extension of use of triethyl  citrate has been 
proposed as glazing agent of food supplement tablets. Triethyl ci trate would increase 
the film resistance of the co ating, protecting the tablet fr om external environment and 
also increase the duration of release of the product. According to the worst case 
scenario, this additional source  of triethyl citrate intake is negligible (0,25 % of the 
ADI) compared to the full ADI. Therefore it is appropriate to authorise the additional use of triethyl citrate at EU level as a glazing agent for food supplement tablets.  
                                                
 
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 rosemary extracts as a food 
additive, The EFSA Journal  (2008) 721, p. 1. EN 7   EN (19) The EFSA assessed the information on the sa fety of polyvinyl alcohol (PVA) as a 
film-coating agent for food supplements and expressed its opinion on 5 December 2005
9. The EFSA found the use of PVA in the co ating of food supplements that are in 
the form of capsules and tablets to be of no safety concern. The EFSA considered that 
the potential human exposure to PVA under the intended conditions of use is expected to be low. PVA is reported to be minima lly absorbed following oral administration. 
The maximum limit of use has been fixed at  18 g/kg based on the worst case scenario 
and on the basis of which the EFSA has undertaken its risk assessment. Due to the good adhesion qualities and film strength of polyvinyl alcohol, this new food additive 
is expected to play a technological role as  film coating agent for food supplements, in 
particular in applicat ions where moisture barrier and moisture protection properties are 
required. It is therefore appropr iate to authorise this use at EU level. This new food 
additive should be assigned the E number E 1203. 
(20) The EFSA assessed the information on the safe ty of use 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 2006
10. The EFSA found the use of thes e grades of polyethylene glycol 
as a glazing agent in film -coating formulations for food supplement tablets and 
capsules under the intended c onditions of use of no safety concern. The EFSA has also 
taken into consideration in its risk assessment the additi onal source of exposure to 
these PEGs originating from the use of pharmaceutical products and considered that only a limited additional intake may result from the already approved use of PEG 6000 as carrier for sweeteners, as well as from the use of PEG in food contact materials. It is 
therefore appropriate to authorise this new use at EU level. In addition, due to the 
limited intake from PEG 6000 as carrier of sweeteners and its similar toxicological 
profile with respect to the other PEG grades (the six PEGs have b een allocated a group 
tolerable daily intake (TDI), it is also a ppropriate to authorise the use of the PEGs 
evaluated by the EFSA as an alternatives  to PEG 6000 as carrier of sweeteners. All 
these PEGs should be assigned E 1521 as E number. 
(21) The EFSA assessed the information on the safe ty of use of cassia gum as a new food 
additive acting as gelling agent and thickener and expressed its opinion on 
26 September 2006
11. The EFSA found the use of cassia gum as indicated under the 
conditions specified raised no safety c oncern. Although the EFSA considered the 
available toxicological data on cassia gum as  insufficient to derive an ADI, they did 
not consider that the existing data gave cau se for concern. In particular the EFSA 
highlighted the specific low absorption of ca ssia gum and the fact th at, if hydrolysed at 
all, cassia gum would be degraded to com pounds that will enter the normal metabolic 
pathways. There is a technological justific ation for the use of cassia gum through its 
synergistic gelling effects when added to other regular food gums. It is therefore 
                                                 
9 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. 
10 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. 
11 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, p. 1. EN 8   EN appropriate to authorise thes e uses at EU level and to assign E 427 as E number for 
cassia gum. 
(22) The EFSA evaluated the safety  of neotame as a flavour enhancer and expressed its 
opinion on 27 September 200712. The EFSA concluded that neotame is of no safety 
concern with respect to the proposed uses as a flavour enhancer and established an 
ADI of 0-2 mg/kg bw/day. Therefore it is nece ssary to authorise the use of neotame as 
a flavour enhancer. 
(23) The EFSA assessed the information on the sa fety of use of L-cysteine (E 920) in 
certain foodstuffs intended for infants and young children. The EFSA concluded in its opinion on 26 September 2006
13 that its proposed use in processed cereal-based foods 
and foods (specifically baby biscuits) for in fants and young children  is of no safety 
concern. Biscuits for infants and young chil dren are required to have a suitable 
composition, including a controlled content of sugar and fat. However, biscuits with a 
low fat content have increased brittleness with an associated risk of choking and suffocation due to the biscuit breaking in the child’s mouth. The function of the L-
cysteine is to act as a dough improver to co ntrol the texture of the final product. It is 
therefore appropriate to authorise the use of  L-cysteine in biscuits for infants and 
young children at EU level. 
(24) 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 the opinion is of no safety concern
14. 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.  
(25) Commission Decision 2004/374/EC15 suspended the placing on the market and import 
of jelly mini-cups containing gel-forming food additives derived from seaweed and 
certain gums (E 400, E 401, E 402, E 403, E 404, E 405, E 406, E 407, E 407a, E 410, 
E 412, E 413, E 414, E 415, E 417, E 418) due to the risk of choking posed by these 
products. Directive 95/2/EC was amended accordingly by Directive 2006/52/EC of the 
                                                 
12 Scientific opinion of the Panel on Food Additiv es, Flavourings, Processing Aids and Material in 
Contact with Food on a request from the Commission on neotame as a sweetener and flavour enhancer, 
The EFSA Journal  (2007) 581, p. 1. 
13 Scientific opinion of the Panel on Food Additiv es, Flavourings, Processing Aids and Material in 
Contact with Food on a request from the Commission re lated to the use of L-cysteine in foods intended 
for infants and young children, The EFSA Journal  (2006) 390, p. 1. 
14  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. 
15 OJ L 118, 23.4.2004, p. 70. EN 9   EN European Parliament and of the Council16. Commission Decision 2004/374/EC should 
therefore be repealed as it s provisions have been incl uded in Directive 95/2/EC. 
(26) 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 
Annexes II to VI to Directive 95/2/EC are ame nded in accordance with the Annex to this 
Directive.  
Article 2 
1. Member States shall adopt and publish, by 31 March 2011 at th e latest, the laws, 
regulations and administrative provisions neces sary to comply with Article 1 of this 
Directive. They shall forthwith communicat e to the Commission the text of those 
provisions. 
They shall apply those provisions from 1 April 2011 at the latest. 
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 
Commission Decision 2004/ 374/EC is repealed. 
Article 4 
This Directive shall enter into force on the twentieth  day following its publication in the 
Official Journal of the European Union . 
Article 5 
This Directive is addressed to the Member States. 
                                                
 
16 OJ L 204, 26.7.2006, p. 10. EN 10   EN Done at Brussels,  
 For the  Commission on behalf of its President 
Mr Dalli  Member of the Commission EN 11   EN ANNEX  
Annexes II to VI to Directive 95/2/EC are amended as follows: 
(1) Annex II is amended as follows: 
(a) the entry concerning ‘Pre-packed prep arations of fresh minced meat’ is 
replaced by the following: 
Pre-packed 
preparations of fresh minced meat  ‘E 261 Potassium acetate quantum satis 
 E 262i Sodium acetate  
 E 262ii Sodium hydrogen acetate  
 E 300 Ascorbic acid  
 E 301 Sodium ascorbate  
 E 302 Calcium ascorbate  
 E 325  Sodium lactate  
 E 326 Potassium lactate  
 E 330 Citric acid  
 E 331 Sodium citrates  
 E 332 Potassium citrates  
 E 333 Calcium citrates  EN 12   EN (b) at the end of the Annex, th e following entry is added: 
‘Unflavoured live  
fermented cream products and substitute products with a fat content of less than 20 %  E 406 Agar quantum satis ’ 
 E 407 Carrageenan  
 E 410 Locust bean gum   
 E 412 Guar gum   
 E 415 Xanthan gum  
 E 440  Pectins  
 E 460 Cellulose  
 E 466 Carboxy methyl cellulose   
 E 471 Mono- and diglycerides of 
fatty acids  
 E 1404 Oxidised starch  
 E 1410 Monostarch phosphate   
 E 1412 Distarch phosphate   
 E 1413 Phosphated distarch 
phosphate   
 E 1414 Acetylated distarch phosphate  
 E 1420 Acetylated starch   
 E 1422 Acetylated distarch adipate  
 E 1440 Hydroxyl propyl starch  
 E 1442 Hydroxy propyl distarch 
phosphate  
 E 1450 Starch sodium octenyl 
succinate  
 E 1451 Acetylated oxidised starch  EN 13   EN (2) Annex III is amended as follows: 
(a) at the end of Part A, the following entries are added: 
‘Seaweed-
based fish analogue products 1 000 500     
Beer in kegs 
containing more than 0,5 % added fermentable sugar and/or fruit juices or concentrates 200 200  400   
Unpeeled 
fresh citrus fruit (surface treatment only) 20      
Food 
supplements as defined in Directive 2002/46/EC supplied in dried form 
containing 
preparations of vitamin A and of combinations of vitamin A and D    1 000 in the 
product ready for consumption’   
(b) at the end of Part B, the following entries are added: 
‘Blueberries ( Vaccinium corymbosum  only) 10 
Cinnamon ( Cinnamomum ceylanicum  only) 150’ EN 14   EN (c) Part C is amended as follows: 
(i) the entry concerning the additive E 234 is replaced by the following: 
  Semolina and 
tapioca puddings and similar products 3 mg/kg 
  Ripened cheese and 
processed cheese 12,5 mg/kg 
‘E 234 Nisin (1) Clotted cream 10 mg/kg 
  Mascarpone 10 mg/kg 
  Pasteurised liquid 
egg (white, yolk or whole egg) 6,25 mg/l 
(1) This substance may be present in certain cheeses as a result of fermentation process.’ 
(ii) the entry concerning the additive  E 242 is replaced by the following: 
‘E 242 Dimethyl 
dicarbonate Non-alcoholic 
flavoured drinks 250 mg/l ingoing 
amount, residues not detectable 
  Alcohol-free wine  
  Liquid-tea 
concentrate  
  Cider, perry, fruit 
wines 
Alcohol-reduced 
wine 
Wine-based drinks 
and products covered by Regulation (EEC) No 1601/91  250 mg/l ingoing 
amount, residues not detectable’ EN 15   EN (d) in Part D the following entry is inse rted after the entry concerning additive 
E 316: 
‘E 392 Extracts of rosemary Vegetable oils 
(excluding virgin oils and olive oils) and fat where content of polyunsaturated fatty acids is higher than 15 % w/w of the total fatty acid, for the use in non heat treated food products 30 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
Expressed on fat 
basis 
 
  Fish oils and algal 
oil 50 mg /kg 
(expressed as the 
sum of carnosol and carnosic acid) 
Expressed on fat 
basis 
  Lard, beef, poultry, 
sheep and porcine fat  
  Fats and oils for the 
professional manufacture of heat-treated foodstuffs  
  Frying oil and frying 
fat, excluding olive 
oil and olive pomace oil  
  Snack foods (snack 
based on cereals, potatoes or starch)  
  Sauces 100 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
Expressed on fat 
basis EN 16   EN   Fine bakery wares 200 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
Expressed on fat 
basis 
  Food supplements as 
defined in Directive 2002/46/EC  400 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
  Dehydrated potatoes 200 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
  Egg products  
  Chewing gum  
  Milk powder for 
vending machines 200 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
Expressed on fat 
basis 
  Seasoning and 
condiments  
  Processed nuts  
  Dehydrated soups 
and broths 50 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
  Dehydrated meat  150 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) EN 17   EN   Meat and fish 
products, excluding dehydrated meat and dried sausage 150 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
Expressed on fat 
basis 
  Dried sausage 100 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
  Flavourings 1000 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid) 
  Dried milk for the 
manufacturing of ice cream  30 mg/kg 
(expressed as the 
sum of carnosol and carnosic acid)” 
(3) Annex IV is amended as follows: 
(a) in the entry concerning add itives E 338, E 339, E 340, E 341, E 343, E 450, 
E 451 and E 452, the following row is in serted after the row concerning 
‘vegetable protein drinks’: 
  ‘Whey protein 
containing sport drinks 4 g/kg’  EN 18   EN (b) the following entry is inserted befo re the entry concerni ng additives E 432, 
E 433, E 434, E 435 and E 436: 
‘E 427 Cassia gum Edible ices 2 500 mg/kg 
  Fermented milk 
products with the exception of unflavoured live fermented milk products  
  Dairy-based dessert 
and similar products  
  Filling, topping and 
coating for fine bakery wares and dessert  
  Processed cheese  
  Sauces and salads 
dressing  
  Dehydrated soups 
and broths  
  Heat-treated meat 
products 1 500 mg/kg’ 
(c) in the entry for E 901, E 902, and E 904, in the third column, under the use ‘As 
glazing agent only for’, the fo llowing entry is added: 
  ‘— Pre-packed 
wafers containing ice 
cream (only for E 
901) quantum satis ’ 
(d) in the entry for E 901, E 902, and E 904, in  the third column, below the use as 
‘Peaches and pineapples (surface treatment only)’, the following entry is added: 
  ‘Flavourings in non-
alcoholic flavoured drinks (only for E 901) 0,2 g/kg in the 
flavoured drinks’ EN 19   EN (e) the following entry is inserted after the entry concerning th e additive E 959: 
‘E 961 Neotame Water-based flavoured 
drinks, energy-reduced or with no added sugar 2 mg/l as flavour 
enhancer 
  Milk- and milk-
derivative-based or fruit-juice-based drinks, energy-reduced or with no added sugar 2 mg/l as flavour 
enhancer 
  “Snacks”: certain 
flavours of ready-to-eat, pre-packed, dry, savoury starch products and coated nuts 2 mg/kg as flavour 
enhancer 
  Starch-based 
confectionery, energy-reduced or with no added sugar 3 mg/kg as flavour 
enhancer 
  Breath-freshening 
micro-sweets, with no added sugar 3 mg/kg as flavour 
enhancer 
  Strongly flavoured 
throat pastilles with no added sugar 3 mg/kg as flavour 
enhancer 
  Chewing gum with  
added sugar 3 mg/kg as flavour 
enhancer 
  Energy-reduced jams, 
jellies and marmalades 2 mg/kg as flavour 
enhancer 
  Sauces 2 mg/kg as flavour 
enhancer 
  Food supplements as 
defined in Directive 2002/46/EC supplied in a liquid form 2 mg/kg as flavour 
enhancer EN 20   EN   Food supplements as 
defined in Directive 2002/46/EC supplied in a solid form 2 mg/kg as flavour 
enhancer 
  Food supplements as 
defined in Directive 2002/46/EC based on vitamins and/or mineral elements and supplied in a syrup-type or non-chewable form 2 mg/kg as flavour 
enhancer’ 
(f) the following entry is inserted af ter the entry concer ning additive E 1202: 
‘E 1203  Polyvinyl alcohol Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 18 g/kg’ 
(g) after the entry concerning the additive E 1202, the entry concerning only the 
food additive E 1505 is replaced by the following:  
‘E 1505 Triethyl citrate Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 3,5 g/kg 
  Dried egg white quantum satis ’ 
(h) the following entry is inserted after the entry concerning th e additive E 1452: 
‘E 1521  Polyethylene glycol Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 10 g/kg 
(4) In Annex V,the entry con cerning the additive ‘Polyeth yleneglycol 6000’ is replaced 
by the following: 
‘E 1521  Polyethylene glycol Sweeteners’ 
(5) In Part 3 of Annex VI, the following entry is added after the entry concerning 
additive E 526: EN 21   EN ‘E 920 L-cysteine Biscuits for infants 
and young children 1 g/kg’