EN    EN EN 
SANCO/2009/10755 EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
 
  
 Draft 
COMMISSION DIRECTIVE 
of […] 
amending Directive 95/2/EC on food additives other than colours and sweeteners 
 
 
 EN 2   EN Draft 
COMMISSION DIRECTIVE  
of […] 
amending Directive 95/2/EC on food additives other than colours and sweeteners  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission, 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, 
After consulting the Scientific Committee on Food (SCF) and the European Food Safety 
Authority (EFSA), 
Whereas: (1) Directive 95/2/EC on food additives other than colours and sweeteners
2 lays down a 
list of food additives that may be used in the Community 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 Regulation (EC) No 1333/2008, until the establishment of the 
Community lists of food additives as provide d for in Article 30 of  that Regulation is 
completed, the Annexes to Directive 95/2/EC  shall be amended, where necessary, by 
measures, designed to amend non-essential elem ents of this Directive, adopted by the 
Commission in accordance with the regulatory procedure with scrutiny referred to in 
Article 28(4) of the above mentioned Regulation 
(4) The following stabilisers agar (E 406), ca rrageenan (E 407), xa nthan gum (E 415), 
cellulose (E 460), carboxy me thyl cellulose (E 466), locu st bean gum (E 410), guar 
gum (E 412), pectins (E 440), oxidized starch (E1404), monostarch phosphate 
(E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), 
acetylated distarch phosphate (E 1414), acetyl ated starch (E 1420), acetylated distarch 
                                                
 
1 OJ L 354, 31.12.2008, p. 16  
2 2 OJ L 61, 18.3.1995, p.1. EN 3   EN adipate (E 1422), hydroxyl propyl starch (E 1440), hydr oxy 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 
permitted under Directive 95/2/EC for a vari ety of uses. These food additives have 
been allocated an Acceptable Daily Inta ke (ADI) “not specified” by the SCF and 
therefore do not present any hazard to the health of consumers. There is a technological need to extend their uses to  unflavoured live fermented cream products 
with fat content less than 20% and substitute  dairy products to ensu re the stability and 
integrity of the emulsion. This use would be nefit the consumer by providing the choice 
of reduced fat fermented cream products with  closely the same properties compared to 
the ordinary product. It is therefore ap propriate to permit 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) as well as sodium acetate (E 262i) and sodium hydrogen 
acetate (E 262ii) and came to the conclusion  that they are all naturally present as 
constituents in food and their intake estimat es are likely to be insignificant compared 
to the intake from natural sources. Therefor e they were all allocated a “group ADI not 
specified”. Consequently these food additi ves 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 mi crobial pathogens, e.g. Listeria, EColi O157. 
On the grounds of the technol ogical justifications provide d by the petitioner, taking 
into account that this use is of no safety concern, it is appropriate to permit the additional use of these food additives into pre-packed preparations of fresh minced 
meat. 
(6) Sorbates (E200, E 202, E203) and benzoate s (E 210, E 211, E212, E213) 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 products analogues (caviar 
analogues made of seaweed) as topping on various foods in order to prevent the growth of moulds and yeasts and formati on of mycotoxins. These salts are allocated 
respectively an ADI of 0-25 mg/kg bw and 0-5 mg/kg/ bw. On the basis of a worst 
case scenario where the maximum concentrations were used, the intake estimates are very low compared to the ADI. The exposure of the consumer as  a result of this use is 
of no safety concern. It is therefore appropriate to permit the additional use of  sorbates and benzoates in seaweed based fi sh products analogues, bearing in mind the 
technological justifica tion and the fact that this new product represents a niche market. 
(7) Sorbates (E200, E 202, E203) and  benzoates (E 210, E 211, E212, E213) are 
authorised food additive under Directive 95/2/EC. The use of those food additives is requested for beers in keg to which more than 0.5% fermentable sugars and/or fruit 
juices or concentrates have been added and that are directly served on draft. These 
beers in keg may stay for a longer time connect ed to the beer tap. As the connection of 
the keg to the tap can not 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  concentrates have been added (like the 
“Lambic”). From an intake point of view, th e consumption on draft of such fruit beers 
should remain marginal and the intake estim ates for sorbates and benzoates, on the 
grounds of “worst case approach”, should be below their respective ADIs. Therefore it EN 4   EN is appropriate to permit the additional use of  sorbates and benzoates in beer in kegs 
with added fermentable sugar and/or  fruit juices or concentrates. 
(8) To prevent the development of moulds on citr us fruits, post harv est treatment of the 
fruits with pesticides such as imazalil a nd thiabendazole is authorised.  Sorbates 
(E200, E202, E203) could be used to replace thes e pesticides partly are completely for 
the treatment of citrus fruits.  Sorbates can be applied on the surface of the unpeeled 
fruits via the authorised waxes: beeswa x, candilla wax, carnauba wax 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 of concer n. It is therefore appr opriate to permit his 
additional use.  
(9) Consumers, because of their particular life styles or for other reasons, may choose to 
supplement their intake of some nutrients through food supplements. For that purpose, 
Vitamins A and combinations of vitamin A and D can be added to food supplements, 
as defined by the directive 2002/46/EC. For reasons of st ability and safe handling, 
vitamin A and combinations of vitamin A and D have to be formulated into 
preparations that may require high humidity and temperature, in presence of starches and sugars. These processings may favour th e development of micro-organisms. In 
order to prevent such micr o-organism growth, the addi tion of sorbates (E200, E202, 
E203) and benzoates (E210, E211, E212 and E213)  should be authorised in vitamin A 
and in combinations of vitamin A and D when  used in food supplements, as defined by 
the Directive 2002/46/EC. 
(10) Sulphur dioxide and sulphites (E220, E221, E222, E223, E224, E226, E227, E228) are 
permitted food additives under Directive 95/2/EC acting primarily as antimicrobial agents and to control chemical spoilage. Tran sport of fresh fruits between countries is 
becoming more and more important nowaday s, in particular via the sea freight. 
Transport times may take several weeks. The use of sulphur dioxide  and sulphites will 
protect fresh blueberries against fungi grow th. The additional use of sulphur dioxide 
and sulphites should be permitted to assist in the preservation of fresh blueberries 
against fungi growth, bearing in  mind that this sector is likely to represent a niche 
market. Taking into consideration also the sound technological ju stifications for the 
inclusion of these new author isations, the need to facili tate worldwide trade and its 
negligible impact in term of sulphur and sulp hite intake, it is therefore appropriate to 
permit the additional use of sulphur dioxide in blueberries at the concentration level 
indicated in this Annex. 
(11) For the production of cinnamon sticks ( cinnamomum ceylanicum  only), also known as 
“quills”, the fresh peels of the inner bark of the cinnam on tree is used. The peels are 
exposed to microbial contamination and inse ct attacks particular ly under tropical and 
humid climatic conditions in the produc ing country. Sulphur dioxide fumigation 
constitutes an appropriate treatment agains t these microbial contamination and insect 
attacks. In 1993, the Scientific Committee on Food established an ADI to 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 asthmatic reactions. Although the 
European community is of the opinion that the use of Sulphur dioxide and sulphites 
should be limited, bearing in mind the potenti al ADI exceedance, th is specific use   
should represent a negligible contributor in relation to the intake of sulphur dioxide 
and sulphites. It is therefor e appropriate to permit the addi tional use of sulphur dioxide EN 5   EN and sulphites (E220, E221, E222, E223, E224, E226, E227, E228) only in this 
particular type of cinnamon. 
(12) The European Food Safety Authority (herei nafter referred to as the Authority) 
assessed the information on the safety in use of nisin in an additional food category of liquid eggs, and on the safety  of nisin produced using a modified production process. 
The Authority confirmed in its opinion on 26 January 2006
3 the previously established 
ADI of 0-0.13 mg/kg for the nisin produced via a new manufactur ing and extraction 
process based on fermentation of a sugar medi um as a replacement for the traditionally 
milk based medium. In this opinion, th e Authority also confirmed that the 
development of antibiotic resistance should not  be expected from the use of nisin in 
food. According to the Authority, there are no reports of nisin resistant bacterial 
mutants showing cross-resistance to therapeutic antibiotic. It considered that this is probably due to the differences in the antimicrobial mode of action between 
therapeutic antibiotics and nisin. The Author ity confirmed furtherm ore in its opinion 
issued by 20 October 2006
4 that the additional use of ni sin in pasteurised liquid eggs 
under the intended conditions of use (maximum limit at 6.25 mg/l) is not of safety concern. It is therefore appropriate to permit this additional use of nisin in pasteurised 
liquid egg. 
(13) Dimethyl dicarbonate (DMDC, E 242) is a food additive permitted under Directive 
95/2/EC acting as a preservati ve in non-alcoholic flavoured  drinks, alcohol-free wine 
and liquid-tea concentrate. Its authorisation was set on the basis of a positive opinion issued by SCF in 1990 and confirmed in 1996. The SCF was unable to set an ADI as 
the DMDC rapidly decomposes into carbon dioxide and methanol. In 2001, the SCF 
was requested to investigate on the safety in  use of DMDC in wine. At that time the 
SCF considered that the formation of me thanol and other reaction products like 
alkylcarbamate resulting from the use of DMDC for the treatment of alcoholic 
beverages and wine is similar to that fo rmed in non alcoholic beverages, and even 
large consumption of wine would not pose any hazard from methanol and 
alkylcarbamate. The use of DMDC has been requested to prevent fermentative spoilage in unopened non-sterile filled bottles of cider, pe rry and fruit wines, alcohol-
reduced wine, and wine based drinks a nd products covered by Regulation (EEC) No 
1601/91. These additional uses are not consid ered as of safety concern for the 
consumer. Moreover, the use of DMDC co uld contribute to the reduction of the 
sulphur dioxide exposure. It is therefore a ppropriate to permit the additional uses of 
DMDC in cider, perry and fruit wines, al cohol-reduced wine, and wine based drinks 
and products covered by Regulation (EEC) No 1601/91 
(14) The Authority assessed the information on the sa fety in use of ethyl lauroyl arginate as 
a new food additive acting as a food pr eservative. In its opinion on 17 April 2007
5, the 
                                                 
3 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, 1-16 
4 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, 1-8 
5 Scientific opinion of the Panel on Food Additives, Fla vourings, Processing Aids and Material in Contact with 
Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as 
a food additive, The EFSA Journal (2007) 511, 1-27 EN 6   EN Authority established an ADI of 0-0.5 mg/ kg bw. On the basis of the intended uses 
requested by the petitioner, the Authority concluded that the consumption of ethyl 
lauroyl arginate could reach, and even ex ceed the ADI for both children and adults. 
Consequently, the list of proposed used has been restricted in order to bring the 
estimated intake with in the limit of the ADI. Ethyl la uroyl arginate can under certain 
condition be used as a efficient alternative to  the currently authorised preservatives. It 
is therefore appropriate to permit these us es at Community level and to assign E 243 
as E number for ethyl lauroyl arginate. 
(15) The Authority assessed the information on the safety in use of rosemary extracts when 
used as an antioxidant in foodstuffs. Rosemary extracts are derived from Rosmarinus 
officinalis L . and contain several compounds wh ich exert antioxidative functions 
(mainly phenolic acids, flavonoids, dite rpenoids and triterp enes). Although the 
toxicological data on the rosemary extracts were insufficient for the Authority to establish a numerical ADI, the Authority considered in its opinion on 7 March 2008
6 
that the margin of safety was high enough to conclude that dietary exposure resulting 
from the proposed uses and use levels were not of safety concern. Rosemary extracts can thus be authorised where there is a te chnological justification for its use. The 
following uses of rosemary extracts as an tioxidant should be authorised and E 392 
should be assigned as E number for rosemary extracts. 
(16) Whey is a by product of cheese manufacturi ng. Some whey protei n containing drinks 
have been developed to help providing a diet sufficiently rich in proteins. To that end 
whey protein containing drinks have been de veloped. In order to keep the proteins in 
suspension during the heat treatment of the drinks phosphates are required at levels 
higher than for normal non-alcoholic fl avoured drinks. Phosphates should be 
authorised in such whey protein containing drinks. 
(17) Beeswax (E 901) is currently authorised as 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 justified. Th erefore Beeswax should be permitted as a 
glazing agent to replace fully or partly the in-layer chocolate in pre-packed wafers 
containing ice cream. 
(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 Scientific Committee on Food (SCF) in 1990 at 20 mg/kg. An extension of use of triethyl citrate has been propos ed as glazing agent of food supplement tablets. Triethyl 
citrate would increase the film resistance of  the coating, protecting the tablet from the 
external environment as well as well as increasing the duration of release of the 
product. This additional source of triethyl citrate intake according to the worst case 
scenario proposed by the petitioner is neg ligible (0.25 % of the ADI) compared to the 
                                                
 
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, 1-29 EN 7   EN full ADI. Therefore it is appropriate to perm it the additional use of triethyl citrate at 
community level as glazing agen t for food supplement tablets. 
(19) The Authority assessed the information on th e safety of polyvinyl alcohol (PVA) as a 
film-coating agent for food supplements and expressed its opinion on 5 December 2005
7. The Authority found the us e of PVA in the coating of  food supplement that are 
in the form of capsules and tablets of no sa fety concern. The Authority 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 
provided by the petitioner and on the basis of which the Au thority 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 supplement, especially in applications where moisture barrier and 
protection properties are required. It is ther efore appropriate to permit this use at 
Community level. This new food additiv e should be assigned E 1203 as E number. 
(20) The Authority assessed the information on the safety in use 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
8. The Authority found the use of these grades of 
polyethylene glycol  as glazi ng agent in film-coating form ulations for food supplement 
tablets and capsules under the intended condi tions of use of no safety concern. The 
Authority has also taken into considerati on within its risk assessment the additional 
source of exposure to these PE Gs 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 sweeten ers, as well as from the use of PEG in 
food contact materials. It is therefore appr opriate to permit this new use at Community 
level. In addition, due to the limited inta ke 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 TD I), it is also appropriate to  authorise the use of the 
PEGs evaluated by the Authority as an alternatives to PEG 6000 as carrier of 
sweeteners. All these PEGs should be assigned a new E number, namely E 1521. 
(21) The Authority assessed the information on the safety in use of cassia gum as a new 
food additive acting as gelling agent and thickener and expressed its opinion on 26 September 2006
9. The Authority found the use of cassia gum as indicated under the 
conditions specified of no safety concer n. Although the Authority considered the 
available toxicological data on cassia gum as  insufficient to derive an ADI, they did 
not consider that the existing data gave r eason for concern. In particular the Authority 
highlighted the specific low absorption of ca ssia gum and the fact th at, if hydrolysed at 
all, cassia gum would be degraded to co mpounds that will enter normal metabolic 
                                                 
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, 1-15 
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, 1-22 
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, 1-16 EN 8   EN 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 permit these uses at Community level a nd to assign E 427 for cassia 
gum 
(22) The Authority evaluated the safety of neotam e as a flavour enhanc er and expressed its 
opinion of 27 September 200710. The Authority concluded that neotame is not of 
safety concern with respect to the proposed uses as a flavour enha ncer and established 
an ADIof 0-2 mg/kg bw/day. Therefore it is necessary to permit the use of neotame as 
flavour enhancer. 
(23) Beeswax (E 901) is already an  authorised food additive und er the Directive 95/2/EC. 
The Authority assessed the information on the safety in use of Beeswax considering an 
additional use of this food addi tive as a carrier of flavour ings in non al coholic cloudy 
flavoured drinks. Although the available data  on Beeswax itself were insufficient to 
establish an ADI, the Authority Panel came to the conclusion that, due to the low toxicological profile of B eeswax, the existing food uses and the proposed new use of 
beeswax are not of safety conc ern. It is therefore appropriat e to permit this additional 
use of Beeswax as carrier of flavouri ngs in non alcoholic  flavoured drinks. 
(24) The Authority assessed the information on the safety in use of L- cysteine (E 920) in 
certain foodstuffs intended for infants a nd young children. The Au thority concluded in 
its opinion on 26 September 2006
11 that the proposed use of  this food additive in 
processed cereal based foods and foods (s pecifically baby biscuits) for infants and 
young children is not of safety concern. Bi scuits for infants and young children are 
required to have a suitable composition, in cluding 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 breakage of the biscuit in the 
child’s mouth. The function of the L-cysteine is to act as a dough improver to control 
the texture of the final product. It is th erefore appropriate to  permit the use of L-
cysteine in biscuits for infants and young children at Community level. 
(25) The 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 of these 
products. The Directive 95/2/EC wa s amended accordingly by Directive 
2006/52/EC
13. Therefore Commission Decision 2004/ 374/EC should be repealed as its 
provisions have adequately been taken into  consideration in the Directive 95/2/EC. 
(26) The Authority assessed the safety in use of an enzyme preparation based on thrombin 
with fibrinogen derived from cattle and/or pigs as a food additive for reconstituting 
                                                 
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, 1-43 
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, 1-7 
12 OJ L 118; 23.4.2004, p.70 
13 OJ L 204, 26.7.2006, p.10 EN 9   EN food and concluded in it s opinion of 26 April 200514 that this use of the enzyme 
preparation when produced as outlined in th e opinion is not of concern from the safety 
point of view. The enzyme preparati on consists of thro mbin (EC 3.4.21.5) and 
fibrinogen, both obtained from blood plasma. The thrombin-fibrinogen preparation is 
applied to meat where thrombin transforms fibrinogen to fibrin that interacts with 
collagen enabling the binding of meat pieces  for the production of portion controlled 
and standardised products with a uni form shape, thickness and quality. The 
preparation is also used to upgrade raw mate rials by binding togeth er small pieces of 
meat to new size products. However, in th e case of binding meat  pieces into products 
of new size, the use of this enzyme prepar ation could mislead the consumer as to the 
state of the final food which could be mistak en for an integral piece of meat. It is 
therefore appropriate to restri ct the use of thrombin with fibrinogen in combined meat 
preparations which are pre-packed and inte nded for the final consumer only, in order 
to ensure that the consumer is informed by labelling about the true nature of the reconstituted food. The food enzyme "cat tle and/or porc thrombin" should be 
permitted as a food additive under Directiv e 95/2/EC to be used together with 
fibrinogen which will be added as an ingredient to the meat  preparation. "Cattle and/or 
porc thrombin" and its conditions of use shoul d 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
15. The use of "cattle and/or porc th rombin" when used with fibrinogen 
in meat products is considered as a proce ssing aid because of the inactivation of the 
food enzyme by thermal processing during th e manufacturing of the meat product. 
This use will be regulated under Regulation (EC) No 1332/2008. 
(27) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
The Annex to Directive 95/2/EC is amended in acco rdance with the Annex to this Directive.  
Article 2 
 
The following act is repealed: 
Commission Decision 2004/374/EC of 13 Apri l 2004 suspending the placing on the market 
and import of jelly mini-cups containing the food additives 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 and/or E 418 
                                                 
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, 1-8 
15 OJ L 354, 31.12.2008, p.7 EN 10   EN Article 3 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by […] at the latest. They shall 
forthwith communicate to the Commission th e text of those provisions and a 
correlation table between those pr ovisions and th is Directive. 
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 4 
This Directive shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union . 
Article 5 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission EN 11   EN ANNEX  
The Annexes to Directive 95/2/EC are amended as follows: 
1. Annex II is amended as follows:   (a) in the table, the following row is added: 
 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 
E1404 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  
      “Unflavoured live  
Fermented cream products with fat and substitute products content less than 20%  
E 1442 Hydroxy propyl distarch 
phosphate  
 E 1450 Starch sodium octenyl 
succinate  
 E 1451 Acetylated oxidised starch  EN 12   EN   (b) in the table, the row on “Pre-packe d preparations of fresh minced meat” is 
replaced by: 
Pre-packed 
preparations of fresh minced meat  “E 261 Potassium acetate Quantum satis” 
 E 262i Sodium acetate  
 E262ii 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  
 
2. Annex III is amended as follows:   (a) Part A is amended as follows:    (i) at the end of the table, the following row is inserted: 
“Seaweed 
based fish products analogues  1000 500     
Beer in kegs 
containing 
more than 
0.5% added fermentable sugar and/or fruit juices or concentrates 200 200  400   
Unpeeled 
fresh citrus  20”      EN 13   EN fruit (surface 
treatment only) 
Food supplements as defined in Directive 2002/46/EC containing Preparations of vitamin A and of combinations of vitamin A and D    
1000 mg/kg in 
the product ready for consumption”
   
  (b) Part B is amended as follows: 
   (i) at the end of the table, the following rows are added: 
“Blueberries (Vaccinium corymbosum only)  10 mg/kg 
Cinnamon ( cinnamomum ceylanicum only)  150 mg/kg” 
  (c) Part C is amended as follows: 
   (i) in the table, the row fo r 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) in the table, the row fo r E 242 is replaced by the following: 
“E 242 Dimethyl 
dicarbonate Non-alcoholic 
flavoured drinks 250 mg/l ingoing 
amount, residues non detectable EN 14   EN   Alcohol free-wine  
  Liquid-tea 
concentrate  
  Cider, Perry, fruit 
wines,  
Alcohol-reduced 
wine 
Wine based drinks 
and products covered by Regulation EC No 1601/91  250 mg/l ingoing 
amount, residues non detectable 
   (iii) in the table, after the row for E 242, and additiona l row is added as 
follows: 
“E 243 Ethyl lauroyl 
arginate High energy drink 
 55 mg/kg 
  Flavourings for 
flavoured water 250 mg/kg in the 
flavourings with a maximum limit of 5 mg/kg in the finished product 
  Dried salted fish of 
the “Gadidae” species/salted, dried fish 225 mg/kg 
  Rehydrated legumes 225 mg/kg 
expressed on the basis of rehydrated legumes 
  Meat products (heat-
treated, marinated or dried) 225 mg/kg 
  Fish roe products 225 mg/kg  
  Prepared salads 225 mg/kg 
  Savoury toppings or 
fillings 225 mg/kg EN 15   EN   Surface treatment of 
hard, semi-hard and semi-soft cheese 1 mg/cm
2 (not 
present at a depth of 3 mm)” 
 
  (d) Part D is amended as follows: 
(i) in the table, the following row is inserted after the row for E 316: 
“E 392 Extract 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 
and sheep fat 
  
  Fats and oils for the 
professional manufacture of heat-treated foodstuffs  
  Frying oil and 
frying fat, excluding olive oil and olive pomace oil  EN 16   EN   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 
condiments  
  Processed nuts  
  Dehydrated soups 
and broths 50 mg/kg 
(expressed as the sum of 
carnosol and
carnosic acid)  EN 17   EN   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 
 
  Flavourings 1000 mg/kg 
(expressed as the sum of 
carnosol and
carnosic acid)  
  Dried milk (as 
ingredients in manufactured foods) 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 table on phosphates, E3 38, E339, E340, E341, E343, E450, E451 and 
E452, an additional row is added  under the row for vegetable protein drinks: 
  “Whey protein drinks 
for senior nutrition and whey protein containing sport drink 4 g/kg “ 
 
(b) in the list of foodstu ffs and maximum levels for E 901 to E 904, the entry: 
‘E 901 Beeswax, white and yellow’ sha ll be deleted and the following entry 
concerning E 901 shall be added after the entry ‘E 900 Dimethyl polysiloxane’: 
“E 901 Beeswax, white and 
yellow As glazing agents only 
for : 
- Confectionary Quantum satis EN 18   EN (including chocolate) 
- Small products of 
fine bakery wares coated with chocolate 
- Snacks - Nuts - Coffee beans - Pre-packed wafers 
containing ice cream ” 
  Flavourings in non 
alcoholic flavoured drinks  0.2 g/kg in the 
flavoured drinks ”  
  Food supplements as 
defined in Directive 2002/46/EC Quantum satis  
  Fresh citrus fruits, 
melons, apples and pears (surface treatment only) Quantum satis  
  Peaches and 
pineapples (surface treatment only) Quantum satis”  
 
(c) in the table,  an additional row is added for E 1505 as follows: 
    
“E 1505 Triethyl citrate Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 3.5 g/kg” 
 
(d) in the table, the following row is inserted after the row for E 1202: 
“E 1203  Polyvinyl alcohol Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 18 g/kg in food 
supplement” 
   
(e) in the table, the following rows are inserted after the row for E 1452: EN 19   EN “E 1521  Polyethylene glycol Food supplements as 
defined in Directive 2002/46/EC in capsule and tablet form 10 g/kg in food 
supplement” 
- Cattle and/or porc 
thrombin Prepacked meat 
preparations indented 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. 
(f) in the table, the following row is  inserted before the row for E 432: 
“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” 
(g) in the table, the following row is  inserted after the row for E 959 as 
follows: 
“E961 Neotame Water-based flavoured 
drinks, energy-reduced 2 mg/l as flavour EN 20   EN or with no added sugar  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, 
prepacked, 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  
 
4. Annex V is amended as follows: EN 21   EN (a) in the table, the row for “Pol yethyleneglycol 6000” is deleted and 
replaced by : 
“E 1521  Polyethylene glycol Sweeteners” 
 
5. Annex VI is amended as follows: 
(a) in part 3, the following entr y is added after the row for E 526: 
“E 920 L-cysteine Biscuits for infants and 
young children 1g/kg