# L_2010279EN.01002201.xml

| 23.10.2010 | EN | Official Journal of the European Union | L 279/22 |
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23.10.2010

EN

Official Journal of the European Union

L 279/22

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COMMISSION DIRECTIVE 2010/69/EU

of 22 October 2010

amending the Annexes to European Parliament 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 general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2), 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 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. |
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(1)

European Parliament and Council 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. |
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(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 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. |
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(3)

In accordance with Article 31 of Regulation (EC) No 1333/2008 until the establishment of the Union 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), pectins (E 440), cellulose (E 460), carboxy methyl cellulose (E 466), oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (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 diglycerides 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) 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 and substitute products with a fat content of less than 20 % to ensure the stability and integrity of the emulsion. This use would benefit the consumer by providing the choice of reduced fat fermented cream products with similar properties as to the ordinary product. It is therefore appropriate to authorise this additional use. |
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(4)

The following stabilisers agar (E 406), carrageenan (E 407), locust bean gum (E 410), guar gum (E 412), xanthan gum (E 415), pectins (E 440), cellulose (E 460), carboxy methyl cellulose (E 466), oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (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 diglycerides 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) 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 and substitute products with a fat content of less than 20 % to ensure the stability and integrity of the emulsion. This use would benefit the consumer by providing the choice of reduced fat fermented cream products with similar properties as to the ordinary product. It is therefore appropriate to authorise this additional use.

| (5) | In 1990, the SCF evaluated sodium and potassium salts of lactate (E 325 and E 326), potassium acetate (E 261), 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 estimates of their intake are likely to be insignificant compared to the intake from natural sources. Therefore they 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 Article 2(3) of Directive 95/2/EC. There is a proposal to extend the use of these food additives into pre-packed preparations of fresh minced meat to control the growth of microbial pathogens, e.g. Listeria, E. coli O157. Based on this technological justification, 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. |
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(5)

In 1990, the SCF evaluated sodium and potassium salts of lactate (E 325 and E 326), potassium acetate (E 261), 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 estimates of their intake are likely to be insignificant compared to the intake from natural sources. Therefore they 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 Article 2(3) of Directive 95/2/EC. There is a proposal to extend the use of these food additives into pre-packed preparations of fresh minced meat to control the growth of microbial pathogens, e.g. Listeria, E. coli O157. Based on this technological justification, 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 benzoates (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 made of seaweed) as topping on various foods in order to prevent the growth of moulds and yeasts and 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 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 does not give rise to safety concern. It is therefore appropriate to permit the additional use of sorbates and benzoates in seaweed based fish analogue products, bearing in mind the technological justification and the fact that this new product represents a niche market. |
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(6)

Sorbates (E 200, E 202, E 203) and benzoates (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 made of seaweed) as topping on various foods in order to prevent the growth of moulds and yeasts and 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 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 does not give rise to safety concern. It is therefore appropriate to permit the additional use of sorbates and benzoates in seaweed based fish analogue products, bearing in mind the technological justification 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 performed 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 remains marginal and the intake estimates for sorbates and benzoates, on the grounds of a ‘worst case approach’, should be below their respective ADIs. Therefore 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. |
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(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 performed 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 remains marginal and the intake estimates for sorbates and benzoates, on the grounds of a ‘worst case approach’, should be below their respective ADIs. Therefore 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 citrus fruit, their post harvest treatment with pesticides such as imazalil and thiabendazole is authorised. Sorbates (E 200, E 202, E 203) could be used to replace these pesticides 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, candelilla wax, carnauba wax and shellac (E 901, E 902, E 903 and E 904 respectively). The exposure of the consumer to these additives due to this use is not a cause of safety concern. It is therefore appropriate to authorise its additional use. |
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(8)

To prevent the development of moulds on citrus fruit, their post harvest treatment with pesticides such as imazalil and thiabendazole is authorised. Sorbates (E 200, E 202, E 203) could be used to replace these pesticides 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, candelilla wax, carnauba wax and shellac (E 901, E 902, E 903 and E 904 respectively). The exposure of the consumer to these additives 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 nutrients with food supplements. For that purpose, vitamin A and 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, the 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. |
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(9)

Consumers may choose to supplement their intake of some nutrients with food supplements. For that purpose, vitamin A and 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, the 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 Directive 95/2/EC which act primarily as antimicrobial agents and controlling chemical spoilage. Nowadays, transport of fresh fruit has become very important, in particular by sea freight. Such transport may be several weeks. The use of sulphur dioxide and sulphites will protect 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 niche market. Taking also into consideration the sound technological reasons for including these new authorisations, the need to facilitate worldwide trade and its negligible impact in term of sulphur and sulphite intake, it is therefore appropriate to authorise the additional use of sulphur dioxide in blueberries at the concentration level indicated in the Annex to this Directive. |
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(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 Directive 95/2/EC which act primarily as antimicrobial agents and controlling chemical spoilage. Nowadays, transport of fresh fruit has become very important, in particular by sea freight. Such transport may be several weeks. The use of sulphur dioxide and sulphites will protect 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 niche market. Taking also into consideration the sound technological reasons for including these new authorisations, the need to facilitate worldwide trade and its negligible impact in term of sulphur and sulphite intake, it is therefore appropriate to authorise the additional use of sulphur dioxide in blueberries at the concentration 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 insect attacks, particularly under tropical and humid climatic conditions, in the producing country. Sulphur dioxide fumigation is an appropriate treatment against such microbial contamination and insect 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 asthmatic reactions. Although the use of sulphur dioxide and sulphites should be limited, this specific use represents a negligible contributor in relation to the intake of sulphur dioxide and sulphites. It is therefore appropriate to 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. |
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(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 insect attacks, particularly under tropical and humid climatic conditions, in the producing country. Sulphur dioxide fumigation is an appropriate treatment against such microbial contamination and insect 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 asthmatic reactions. Although the use of sulphur dioxide and sulphites should be limited, this specific use represents a negligible contributor in relation to the intake of sulphur dioxide and sulphites. It is therefore appropriate to 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 (hereinafter 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. The 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 manufacturing and extraction process based on fermentation of a sugar medium as a replacement for the traditionally milk-based medium. In this opinion, the EFSA also confirmed that the development of antibiotic resistance should not be expected from the use of nisin in food. According to the EFSA, 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 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 extend 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 pasteurised liquid egg. |
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(12)

The European Food Safety Authority (hereinafter 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. The 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 manufacturing and extraction process based on fermentation of a sugar medium as a replacement for the traditionally milk-based medium. In this opinion, the EFSA also confirmed that the development of antibiotic resistance should not be expected from the use of nisin in food. According to the EFSA, 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 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 extend 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 pasteurised 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 rapidly decomposes into carbon dioxide and methanol. In 2001, the SCF was requested to investigate the safety of use of DMDC in wine. At that time the SCF considered that the formation of methanol and other reaction products, such as methylcarbamate resulting from the use of DMDC for the treatment of alcoholic beverages 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 fermentation in unopened non-sterile filled bottles of cider, perry and fruit wines, alcohol-reduced wine, wine-based drinks and all other products covered by Council Regulation (EEC) No 1601/91 (7). These additional uses are not considered as being of safety concern 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-based drinks and other products covered by Regulation (EEC) No 1601/91. |
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(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 rapidly decomposes into carbon dioxide and methanol. In 2001, the SCF was requested to investigate the safety of use of DMDC in wine. At that time the SCF considered that the formation of methanol and other reaction products, such as methylcarbamate resulting from the use of DMDC for the treatment of alcoholic beverages 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 fermentation in unopened non-sterile filled bottles of cider, perry and fruit wines, alcohol-reduced wine, wine-based drinks and all other products covered by Council Regulation (EEC) No 1601/91 (7). These additional uses are not considered as being of safety concern 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-based drinks and other products 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. Extracts of rosemary are derived from Rosmarinus officinalis L. and contain several compounds which exert antioxidative functions (mainly phenolic acids, flavonoids, diterpenoids and triterpenes). Although the toxicological data on extracts of rosemary were insufficient for the EFSA to establish a numerical ADI, the EFSA considered in its opinion on 7 March 2008 (8) that the margin of safety was high enough to conclude 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 technological 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. |
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(14)

The EFSA assessed the information on the safety of use of extracts of rosemary when used as an antioxidant in foodstuffs. Extracts of rosemary are derived from Rosmarinus officinalis L. and contain several compounds which exert antioxidative functions (mainly phenolic acids, flavonoids, diterpenoids and triterpenes). Although the toxicological data on extracts of rosemary were insufficient for the EFSA to establish a numerical ADI, the EFSA considered in its opinion on 7 March 2008 (8) that the margin of safety was high enough to conclude 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 technological 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 whey protein containing sport drinks. |
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(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 whey 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 does 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 the shelf life of the product and is therefore considered technologically justified. Therefore beeswax should be authorised as a glazing agent to replace fully or partly the in-layer chocolate in pre-packed wafers containing ice-cream. |
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(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 does 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 the shelf life of the product and is therefore considered technologically justified. Therefore beeswax should be authorised 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 safety of use of beeswax considering its additional use as a carrier of flavourings in non-alcoholic flavoured 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 profile of beeswax, the existing food uses and the proposed 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-alcoholic flavoured drinks. |
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(17)

The EFSA assessed the information on the safety of use of beeswax considering its additional use as a carrier of flavourings in non-alcoholic flavoured 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 profile of beeswax, the existing food uses and the proposed 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-alcoholic 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 citrate would increase the film resistance of the coating, protecting the tablet from 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. |
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(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 citrate would increase the film resistance of the coating, protecting the tablet from 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.

| (19) | The EFSA assessed the information on the safety 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 coating 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 minimally 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 applications where moisture barrier and moisture protection properties are required. It is therefore appropriate to authorise this use at EU level. This new food additive should be assigned the E number E 1203. |
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(19)

The EFSA assessed the information on the safety 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 coating 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 minimally 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 applications where moisture barrier and moisture protection properties are required. It is therefore appropriate 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 safety of 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 (10). The EFSA found the use of these grades 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 safety 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 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 been allocated a group tolerable daily intake (TDI), it is also appropriate 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. |
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(20)

The EFSA assessed the information on the safety of 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 (10). The EFSA found the use of these grades 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 safety 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 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 been allocated a group tolerable daily intake (TDI), it is also appropriate 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 safety 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 concern. 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 cause for concern. In particular the EFSA highlighted the specific low absorption of cassia gum and the fact that, if hydrolysed at all, cassia gum would be degraded to compounds that will enter the normal metabolic pathways. There is a technological justification for the use of cassia gum through its synergistic gelling effects when added to other regular food gums. It is therefore appropriate to authorise these uses at EU level and to assign E 427 as E number for cassia gum. |
| --- | --- |

(21)

The EFSA assessed the information on the safety 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 concern. 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 cause for concern. In particular the EFSA highlighted the specific low absorption of cassia gum and the fact that, if hydrolysed at all, cassia gum would be degraded to compounds that will enter the normal metabolic pathways. There is a technological justification for the use of cassia gum through its synergistic gelling effects when added to other regular food gums. It is therefore appropriate to authorise these 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 2007 (12). 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 necessary to authorise the use of neotame as a flavour enhancer. |
| --- | --- |

(22)

The EFSA evaluated the safety of neotame as a flavour enhancer and expressed its opinion on 27 September 2007 (12). 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 necessary to authorise the use of neotame as a flavour enhancer.

| (23) | The EFSA assessed the information on the safety 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 infants and young children is of no safety concern. Biscuits for infants and young children 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 control 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. |
| --- | --- |

(23)

The EFSA assessed the information on the safety 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 infants and young children is of no safety concern. Biscuits for infants and young children 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 control 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 enzyme preparation based on thrombin with fibrinogen derived from cattle and/or pigs as a food additive for reconstituting food and concluded in its opinion on 26 April 2005 that this use of the enzyme preparation when produced as outlined in the opinion is of no safety concern (14). However, the European Parliament in its Resolution of 19 May 2010 on the draft Commission Directive amending the Annexes to the European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners, considered that the inclusion in Annex IV to Directive 95/2/EC of this enzyme preparation as a food additive for reconstituting food was not compatible with the aim and content of Regulation (EC) No 1333/2008, as it does not meet the general criteria of Article 6 of Regulation (EC) No 1333/2008, especially in paragraph 1(c) of Article 6. |
| --- | --- |

(24)

EFSA assessed the safety of use of an enzyme preparation based on thrombin with fibrinogen derived from cattle and/or pigs as a food additive for reconstituting food and concluded in its opinion on 26 April 2005 that this use of the enzyme preparation when produced as outlined in the opinion is of no safety concern (14). However, the European Parliament in its Resolution of 19 May 2010 on the draft Commission Directive amending the Annexes to the European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners, considered that the inclusion in Annex IV to Directive 95/2/EC of this enzyme preparation as a food additive for reconstituting food was not compatible with the aim and content of Regulation (EC) No 1333/2008, as it does not meet the general criteria of Article 6 of Regulation (EC) No 1333/2008, especially in paragraph 1(c) of Article 6.

| (25) | Commission Decision 2004/374/EC (15) 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 European Parliament and of the Council (16). Commission Decision 2004/374/EC should therefore be repealed as its provisions have been included in Directive 95/2/EC. |
| --- | --- |

(25)

Commission Decision 2004/374/EC (15) 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 European Parliament and of the Council (16). Commission Decision 2004/374/EC should therefore be repealed as its provisions have been included in Directive 95/2/EC.

| (26) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council has opposed them, |
| --- | --- |

(26)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II to VI to Directive 95/2/EC are amended in accordance with the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish, by 31 March 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with Article 1 of this Directive. They shall forthwith communicate 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 determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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.

Done at Brussels, 22 October 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 31, 1.2.2002, p. 1.

2

(3)  
  OJ L 61, 18.3.1995, p. 1.

3

(4)  
  OJ L 183, 12.7.2002, p. 51.

4

(5)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on a request from the Commission related to the use of nisin (E 234) as a food additive, The EFSA Journal (2006) 314, p. 1.

5

The EFSA Journal

(6)  Scientific opinion of the Panel on Food Additives, 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.

6

The EFSA Journal

(7)  
  OJ L 149, 14.6.1991, p. 1.

7

(8)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on a request from the Commission related to the use of rosemary extracts as a food additive, The EFSA Journal (2008) 721, p. 1.

8

The EFSA Journal

(9)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on a request from the Commission related to the use of polyvinyl alcohol as a coating agent for food supplement, The EFSA Journal (2005) 294, p. 1.

9

The EFSA Journal

(10)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on a request from the Commission related to the use of polyethylene glycol (PEG) as a film coating agent for use in food supplement products, The EFSA Journal (2006) 414, p. 1.

10

The EFSA Journal

(11)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on a request from the Commission related to an application on the use of cassia gum as a food additive, The EFSA Journal (2006) 389, p. 1.

11

The EFSA Journal

(12)  Scientific opinion of the Panel on Food Additives, 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.

12

The EFSA Journal

(13)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Material in Contact with Food on a request from the Commission related to the use of L-cysteine in foods intended for infants and young children, The EFSA Journal (2006) 390, p. 1.

13

The EFSA Journal

(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.

14

The EFSA Journal

(15)  
  OJ L 118, 23.4.2004, p. 70.

15

(16)  
  OJ L 204, 26.7.2006, p. 10.

16

---

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 preparations 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 |

(1)

Annex II is amended as follows:

(a)

the entry concerning ‘Pre-packed preparations 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 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 |

(b)

at the end of the Annex, the 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

| (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’ | | |

(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 ’ |

(b)

at the end of Part B, the following entries are added:

‘Blueberries (Vaccinium corymbosum only)

10

Cinnamon (Cinnamomum ceylanicum only)

150 ’

| (c) | Part C is amended as follows:






  (i) | the entry concerning the additive E 234 is replaced by the following:








  ‘E 234 | Nisin (*1) | Semolina and tapioca puddings and similar products | 3  mg/kg |
| --- | --- | --- | --- | --- | --- |
| Ripened cheese and processed cheese | 12,5  mg/kg |
| Clotted cream | 10  mg/kg |
| Mascarpone | 10  mg/kg |
| Pasteurised liquid egg (white, yolk or whole egg) | 6,25  mg/l |

(c)

Part C is amended as follows:

(i)

the entry concerning the additive E 234 is replaced by the following:

‘E 234

Nisin (*1)

Semolina and tapioca puddings and similar products

3  mg/kg

Ripened cheese and processed cheese

12,5  mg/kg

Clotted cream

10  mg/kg

Mascarpone

10  mg/kg

Pasteurised liquid egg (white, yolk or whole egg)

6,25  mg/l

| (ii) | the entry concerning the additive E 242 is replaced by the following:








  ‘E 242 | Dimethyl dicarbonate | Non-alcoholic flavoured drinks
  Alcohol-free wine
  Liquid-tea concentrate | 250 mg/l ingoing amount, residues not detectable |
| --- | --- | --- | --- | --- |
| 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’ |

(ii)

the entry concerning the additive E 242 is replaced by the following:

‘E 242

Dimethyl dicarbonate

Non-alcoholic flavoured drinks

Alcohol-free wine

Liquid-tea concentrate

250 mg/l ingoing amount, residues not detectable

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 inserted 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 |
| 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
  Egg products
  Chewing gum | 200 mg/kg
  (expressed as the sum of carnosol and carnosic acid) |
| Milk powder for vending machines
  Seasoning and condiments
  Processed nuts | 200 mg/kg
  (expressed as the sum of carnosol and carnosic acid)
  Expressed on fat basis |
| 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, 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 | 1 000  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)’ |

(d)

in Part D the following entry is inserted 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

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

Egg products

Chewing gum

200 mg/kg

(expressed as the sum of carnosol and carnosic acid)

Milk powder for vending machines

Seasoning and condiments

Processed nuts

200 mg/kg

(expressed as the sum of carnosol and carnosic acid)

Expressed on fat basis

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, 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

1 000  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 E 338, E 339, E 340, E 341, E 343, E 450, E 451 and E 452, the following row is inserted after the row concerning ‘vegetable protein drinks’: | | ‘Whey protein containing sport drinks | 4  g/kg’ |
| --- | --- | --- | --- | --- | --- |

(3)

Annex IV is amended as follows:

(a)

in the entry concerning additives E 338, E 339, E 340, E 341, E 343, E 450, E 451 and E 452, the following row is inserted after the row concerning ‘vegetable protein drinks’:

‘Whey protein containing sport drinks

4  g/kg’

| (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 | 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’ |

(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

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 following entry is added: | | ‘— | Pre-packed wafers containing ice cream (only for E 901) |
| --- | --- | --- | --- | --- |

(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 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’ |
| --- | --- | --- | --- | --- |

(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’

| (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, 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 |
| 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’ |

(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, 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

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 after the entry concerning additive E 1202:








  ‘E 1203 | Polyvinyl alcohol | Food supplements as defined in Directive 2002/46/EC in capsule and tablet form | 18  g/kg’ |
| --- | --- | --- | --- | --- |

(f)

the following entry is inserted after the entry concerning 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’ |

(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 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’ |
| --- | --- | --- | --- | --- |

(h)

the following entry is inserted after 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’

| (4) | In Annex V, the entry concerning the additive ‘Polyethyleneglycol 6000’ is replaced by the following:







  ‘E 1521 | Polyethylene glycol | Sweeteners’ |
| --- | --- | --- | --- |

(4)

In Annex V, the entry concerning the additive ‘Polyethyleneglycol 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 | 1  g/kg’ |
| --- | --- | --- | --- | --- |

(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

1  g/kg’

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(*1)  This substance may be present in certain cheeses as a result of fermentation process.’

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