EN    EN EN 
SANCO/2010/10035  
EN    EN  EUROPEAN COMMISSION 
Brussels,  
 
  
 Draft 
COMMISSION DIRECTIVE 
of […] 
amending the Annexes to European Parliament  and Council  Directive 95/2/EC on food 
additives other than colours and sweeten ers and repealing  D ecision 2004/374/EC 
 
 
  
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 sweeten ers  and repealing D ecision 2004/374/EC 
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) Directive 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 30 of Regulation (EC) No 1333/2008 until the 
establishment of the Community lists of food additives as provided for in Article 30 of 
that Regulation is completed, the Annexes to Directive 95/2/EC shall be amended, 
where necessary, by measures adopted 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), oxidized star ch (E1404), monostarch 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 specified” by the Scientific Committee on Food (hereinafter – 'SCF') a nd therefore do not present any hazard to 
the health of consumers. Th ere is a technological need  to extend their uses to 
unflavoured live fermented cream products and substitute dairy products with a fat content of less than 20% to ensure the stab ility and integrity of the emulsion. This use 
would benefit the consumer by providing th e choice of reduced fat fermented cream 
products with similar properties as to the or dinary product. It is therefore appropriate 
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 they were all allocated a “group ADI not 
specified”. Consequently, these food additiv es 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 gr owth of microbial pathogens, 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% fermentable 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 as post-pr oduction antimicrobial agents in draft beers and to which 
fermentable sugars and/or fruit juices or c oncentrates have been added. From an intake 
point of view, the consumpti on on draft of such fruit beers remains marginal and the 
intake estimates for sorbates and benz oates, on the grounds of a “worst case 
approach”, should be below their respective ADIs. Therefore it is appropriate to permit  
EN 4   EN the additional use of  sorbates and benzoa tes 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. So rbates (E 200, E 202, E 
203) could be used to replace these pesticides partly or co mpletely for the treatment of 
citrus fruit. Sorbates can be applied on the surface of the unpeeled fresh citrus fruit via 
the authorised waxes: bees wax, candilla wax, carnauba wa x and shellac (E 901, E 902, 
E 903 and E 904 respectively). The exposure of  the consumer to the additive due to 
this use is not a cause of safety concern. 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 define d by Directive 2002/46/EC. For reasons of 
safe handling, vitamin A and combinations of vitamins A and D have to be formulated into preparations that may require high hum idity and high temperature, in the presence 
of starches and sugars. Such processi ng may favour the development of micro-
organisms. In order to prevent the growth of these micro-organisms, the addition of 
sorbates (E 200, E 202, E 203) and benzoa tes (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 the 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 
1993, the SCF established an ADI of 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 
authorise the additional use of sulphur dioxide and su lphites (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 add itional food category of liquid eggs, and on the  
EN 5   EN safety of nisin produced using a modified production process. Th e EFSA confirmed in 
its opinion on 26 January 20064 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 repl acement 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
5 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 alkylcarbamate 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 alkylcarbamate. 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-redu ced wine, wine based drinks and products 
covered by Regulation (EEC) No 1601/91. These additional uses are not considered as 
being of safety concern for the consum er. Moreover, the use of DMDC could 
contribute to the reduction of the sulphur diox ide exposure. It is therefore appropriate 
to authorise the additional uses of DMDC in cider, perry and fruit wines, alcohol-
reduced wine, wine based drinks and pr oducts covered by Regulation (EEC) No 
1601/91. 
(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 
                                                
 
4 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 nisin (E 234) as a food additive, The 
EFSA Journal (2006) 314, p. 1. 
5 Scientific opinion of the Panel on Food Additives, Fla vourings, 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.  
EN 6   EN establish a numerical ADI, the EFSA considered in its opinion on 7 March 20086 that 
the margin of safety was high enough to c onclude that dietary exposure resulting from 
the proposed uses and the used levels were of no safety concern. Extracts of rosemary 
can therefore be authorised where there is a technological justific ation 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 20 mg/kg. An extension of  use of triethyl citr ate has been proposed 
as glazing agent of food supplement tablets.  Triethyl citrate w ould increase the film 
resistance of the coating, protecting the ta blet from external environment and also 
increase the duration of release of the pr oduct. 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 a ppropriate to authorise the additional use of 
triethyl citrate at EU le vel as a glazing agent for food supplement tablets.  
(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
7. The EFSA found the use of PVA in the co ating of food supplements that are in 
                                                 
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 rosemary extracts as a food additive, The 
EFSA Journal (2008) 721, p. 1. 
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 polyvinyl alcohol as a coating agent for 
food supplement, The EFSA Journal (2005) 294, p. 1.  
EN 7   EN 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  18g/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 applications where moisture barrier and protection pr operties are required. 
It is therefore appropriate to  authorise this use at EU le vel. 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 supplemen t products and expre ssed its opinion on 28 
November 2006
8. The EFSA found the use of these gr ades of polyethylene glycol as a 
glazing agent in film-coating formulations  for food supplement tablets and capsules 
under the intended conditions of use of no sa fety concern. The EFSA has also taken 
into consideration in its risk assessment the additional 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 ap proved use of PEG 6000 as 
carrier for sweeteners, as well as from the us e 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 been allocated a group 
TDI), it is also appropriate to authorise th e 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 20069. The EFSA found the use of ca ssia 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 
appropriate to authorise thes e uses at EU level and to assign E 427 as E number for 
cassia gum. 
                                                 
8 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, p. 1. 
9 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, p. 1.  
EN 8   EN (22) The EFSA evaluated the safety  of neotame as a flavour enhancer and expressed its 
opinion on 27 September 200710. 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 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
11 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) Commission Decision 2004/374/EC
12 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 amende d accordingly by Directive 2006/52/EC. 
Decision 2004/374/EC should th erefore be repealed as its provisions have been 
included in Directive 95/2/EC. 
(25) The EFSA assessed the safety of use of an enzyme preparation ba sed 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
13 that this use of the enzyme 
preparation when produced as outlined in the opinion is of no safety concern. The 
enzyme preparation consists of thromb in (EC 3.4.21.5) and fibrinogen, both of which 
are obtained from blood plasma. The thromb in-fibrinogen preparation is applied to 
meat where the thrombin transforms fibrinoge n to fibrin which interacts with collagen 
enabling the binding of meat pieces in  order to produce portion-controlled and 
standardised products with a uniform shape,  thickness and quality. The preparation is 
also used to upgrade raw materials by binding  together small pieces  of meat into new 
size products. However, in some cases, the use of this enzyme preparation could mislead the consumer as to the state of th e final food. It is ther efore appropriate to 
restrict the use of thrombin with fibrinogen  in combined meat preparations and meat 
products which are pre-packed and intended for the final consumer only, in order to 
                                                
 
10 Scientific opinion of the Panel on Food Additives, Fl avourings, 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. 
11 Scientific opinion of the Panel on Food Additives, Fl avourings, Processing Aids and Material in Contact with 
Food on a request from the Commission related to the use of L-cysteine in foods intended for infants 
and young children, The EFSA Journal (2006) 390, p. 1. 
12 OJ L 118; 23.4.2004, p.70 
13 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 9   EN ensure that the consumer is informed by mean s of the labelling about the true nature of 
the combined food. The food enzyme "bovine  and/or porcine thrombin" should be 
authorised as a food additive to be used t ogether with fibrinogen  which will be added 
as an ingredient to the meat preparati on or meat product. "Bovine and/or porcine 
thrombin" and its conditions of use should be carried over to the Community list of food enzymes when this is established in accordance with Regulation (EC) No 
1332/2008 of the European Parliament and of the Council of 16 December 2008 on 
food enzymes
14. 
(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 V to Directive 95/2/EC are ame nded in accordance with the Annex to this 
Directive.  
Article 2 
 
Decision 2004/374/EC is repealed. 
Article 3  
 
1. Member States shall adopt and publish, by [… ] at the latest, the laws, regulations and 
administrative provisions necessary to comply w ith Article 1 of this Directive. They shall 
forthwith communicate to the Commissi on the text of those provisions. 
They shall apply those provisions from […]. 
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the o ccasion of their official publication. Member 
States shall determine how such  reference is to be made. 
2. Member States shall communicate to the Co mmission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 4 
This Directive shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of  the European Union . 
                                                 
14 OJ L 354, 31.12.2008, p.7  
EN 10   EN Article 5 
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 11   EN ANNEX  
Annexes II to V  to Directive 95/2/EC are amended as follows: 
(1) Annex II is amended as follows: 
(a) the entry concerning “Pre-packed prepar ations 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  
(b) at the end of the Annex, the following entry is added: 
“Unflavoured live  
fermented cream products and substitute dairy 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   
EN 12   EN E 460 Cellulose 
E 466 Carboxy methyl cellulose  
E 471 Mono- and diglycerides of 
fatty acids 
E 1404 Oxidized 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  
(2) Annex III is amended as follows: 
 (a) at the end of Part A, the following entries are added: 
“Seaweed 
based fish analogue products 1000 500     
Beer in kegs 
containing more than 0.5% added fermentable sugar and/or fruit juices or concentrates 200 200  400   
Unpeeled 20”       
EN 13   EN fresh citrus  
fruit (surface treatment only) 
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    1000 mg/kg 
in the product ready for consumption
”   
 (b) at the end of Part B, the following entries are added: 
“Blueberries (Vaccinium corymbosum only)  10 mg/kg 
Cinnamon ( cinnamomum ceylanicum only)  150 mg/kg” 
 (c) Part C is amended as follows: 
(i) the  entry concerning the additiv e 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 additiv e E 242 is replaced by the following: 
“E 242 Dimethyl 
dicarbonate Non-alcoholic 
flavoured drinks 250 mg/l ingoing 
amount, residues not  
EN 14   EN 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” 
(d) In Part D the following entry is insert ed after the entry co ncerning 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   
EN 15   EN   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 
  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   
EN 16   EN 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) 
  Meat and fish 
products 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  additives   E338, E339, E340, E341, E343, E450, E451 and 
E452,  the following row is  inserted after the row concerning  vegetable protein drinks: 
  “Whey protein 
containing sport drinks 4 g/kg”   
EN 17   EN (b) the following entry is inserted before the entry concerning additives E 432, E 433, 
E 434, E 435 and E 436: 
“E 427 Cassia gum Edible ices 2500 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 
product 1500 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 following 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 tre atment only) ", the following entry is added  
  “Flavourings in non 
alcoholic flavoured drinks (only for E 901) 0.2 g/kg in the 
flavoured drinks” 
(e) the following entry is inserted after the  entry concerning the 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, 2 mg/l as flavour 
enhancer
  
EN 18   EN energy-reduced or with 
no added sugar  
  ‘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 no 
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  
  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 afte r the entry concerni ng additive E 1202: 
“E 1203  Polyvinyl alcohol Food supplements as 
defined in Directive 
2002/46/EC in capsule and tablet form 18 g/kg”  
EN 19   EN (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 entries are inserted afte r the entry concerning the additive E 1452: 
“E 1521  Polyethylene glycol Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 10 g/kg 
- Bovine and/or porcine 
thrombin Pre-packed meat 
preparations and pre-packed meat products intended for the final consumer only  
 1 mg/kg expressed as 
thrombin.  
To be used together 
with fibrinogen 
The food shall bear 
the information "combined meat parts" in the proximity of its sales name.” 
(4) In Annex V,  
the entry concerning the additive “Polye thyleneglycol 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: 
“E 920 L-cysteine Biscuits for infants and 
young children 1g/kg”