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,
After consulting the Scientific Committee on Food and the European Food Safety Authority,
Whereas:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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’
- (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’
- (a)
- (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’
- (c)
Part C is amended as follows:
- (i)
the entry concerning the additive E 234 is replaced by the following:
‘E 234
Nisin17Semolina 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’
- (i)
- (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)’
- (a)
- (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’
- (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’
- (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’
- (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’
- (a)
- (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’