2006L0052 — EN — 15.08.2006 — 000.001

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DIRECTIVE 2006/52/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 5 July 2006

amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs







THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee ( 1 ), Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 2 ), Whereas: (1) Food additives may be approved for use in foodstuffs only if they comply with Annex II to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption ( 3 ). (2) Directive 95/2/EC ( 4 ) lays down a list of food additives that may be used in the Community and the conditions for their use. (3) Directive 94/35/EC ( 5 ) lays down a list of sweeteners that may be used in the Community and the conditions for their use. (4) There have been technical developments in the field of food additives since the adoption of Directives 95/2/EC and 94/35/EC. These Directives should be adapted to take account of those developments. (5) On the basis of an opinion of the European Food Safety Authority (EFSA), expressed on 26 November 2003, changes are made to current authorisations in order to keep the level of nitrosamines as low as possible by bringing down the levels of nitrites and nitrates added to food whilst maintaining the microbiological safety of food products. EFSA recommends that the levels of nitrite and nitrate are set in the legislation as ‘added amount’. EFSA is of the opinion that the added amount of nitrite rather than the residual amount contributes to the inhibitory activity against C. botulinum. The current provisions should be amended in such a way that the maximum levels permitted, as mentioned by EFSA, in non-heat-treated or heat‐treated meat products, in cheese and in fish are expressed as added amounts. Exceptionally, however, for certain traditionally manufactured meat products maximum residual levels should be set, on the condition that the products are adequately specified and identified. The levels set should ensure that the acceptable daily intake (ADI) established by the Scientific Committee on Food in 1990 is not exceeded. Products which are not specifically named in this Directive, but which are traditionally produced in a similar manner (i.e. similar products) can if necessary be categorised in accordance with Articles 5 and 6 of Directive 95/2/EC. For cheese, the level should be expressed as the amount added to the cheese milk. If a process is used where addition of nitrate follows removal of whey and addition of water, this should lead to levels identical to those which would have been obtained had the nitrate been added directly to the cheese milk. (6) Directive 2003/114/EC amending Directive 95/2/EC required the Commission and EFSA to review the conditions for the use of E 214 to E 219 p-hydroxybenzoates and their sodium salts before 1 July 2004. EFSA assessed the information on the safety of p‐hydroxybenzoates and expressed its opinion on 13 July 2004. EFSA established a full‐group ADI of 0 to 10 mg/kg body weight for the sum of methyl and ethyl p‐hydroxybenzoic acid esters and their sodium salts. EFSA considered that propyl paraben should not be included in this group ADI because propyl paraben, contrary to methyl and ethyl paraben, had effects on sex hormones and the male reproductive organs in juvenile rats. Therefore, EFSA was unable to recommend an ADI for propyl paraben because of the lack of a clear no-observed-adverse-effect-level (NOAEL). It is necessary to withdraw E 216 propyl p‐hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate from Directive 95/2/EC. In addition, it is necessary to withdraw the use of p-hydroxybenzoates in liquid dietary food supplements. (7) Commission Decision 2004/374/EC ( 6 ) suspended the placing on the market and import of jelly mini-cups containing gel-forming food additives derived from seaweed and certain gums due to the risk of choking on these products. Following a review of that Decision it is necessary to exclude the use of certain gel-forming food additives in jelly mini-cups. (8) The Scientific Committee on Food assessed the information on the safety of erythritol and expressed its opinion on 5 March 2003. The Committee concluded that the use of erythritol as a food additive is acceptable. The Committee also notes that erythritol has a laxative effect, but at a higher dose than other polyols. Erythritol has many technological non‐sweetening properties that are important in a wide range of foods, from confectionery to dairy products. These include functions such as flavour enhancer, carrier, humectant, stabiliser, thickener, bulking agent and sequestrant. It is necessary to permit the use of erythritol in the same food applications as the other currently permitted polyols. In addition, it is necessary to amend Directive 94/35/EC, as erythritol can also be used for sweetening purposes like the other currently permitted polyols. (9) The Scientific Committee on Food assessed the information on the safety of soybean hemicellulose and expressed its opinion on 4 April 2003. The Committee concluded that the use of soybean hemicellulose is acceptable in certain foods in respect of which the request was made and at certain inclusion levels. It is therefore appropriate to permit such use for certain purposes. In order to facilitate matters for allergy sufferers, however, such use should not be permitted for unprocessed foods in which soybean is not expected to be found. At all events, consumers should be informed when products contain hemicellulose derived from soybean in accordance with the provisions of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs ( 7 ). (10) EFSA assessed the information on the safety of ethyl cellulose and expressed its opinion on 17 February 2004. EFSA decided to include ethyl cellulose in the group ADI ‘not specified’ for modified celluloses established by the Scientific Committee on Food. The main application of ethyl cellulose is in food supplements and encapsulated flavourings. The use of ethyl cellulose should therefore be permitted in a way similar to that for other celluloses. (11) EFSA assessed the information on the safety of pullulan and expressed its opinion on 13 July 2004. EFSA found the use of pullulan acceptable in the coating of food supplements that are in the form of capsules and tablets as well as in breath fresheners in the form of films. It is therefore appropriate to permit these uses. (12) EFSA assessed the information on the safety of tertiary butyl hydroquinone (TBHQ) and expressed its opinion on 12 July 2004. EFSA established an ADI of 0 to 0,7 mg/kg body weight for this antioxidant and found that its use would be acceptable in certain foodstuffs at certain inclusion levels. It is therefore appropriate to permit this additive. (13) The Scientific Committee on Food assessed the information on the safety of starch aluminium octenyl succinate and expressed its opinion on 21 March 1997. The Committee found that the use of this additive as a component of micro encapsulated vitamins and carotenoids may be regarded as acceptable. It is therefore appropriate to permit this use. (14) During the manufacture of sour milk cheese, E 500ii sodium hydrogen carbonate is added to the pasteurised milk in order to buffer the acidity caused by the lactic acid to an appropriate pH value, thereby creating the necessary growth conditions for the ripening cultures. It is, therefore, appropriate to permit the use of sodium hydrogen carbonate in sour milk cheese. (15) Currently, the use of a mixture of sorbates (E 200, E 202 and E 203) and benzoates (E 210 to E 213) is authorised in cooked shrimps for preservation. It is appropriate to extend that authorisation to its use in all cooked crustaceans and molluscs. (16) E 551 silicon dioxide is permitted as a carrier for food colours at the maximum level of 5 %. The use of silicon dioxide as a carrier for food colours E 171 titanium dioxide and E 172 iron oxides and hydroxides should also be permitted at the level of maximum 90 % relative to the pigment. (17) Directive 95/2/EC limits the use of additives listed in Annex I to that Directive in traditional French bread ‘Pain courant français’. The same limitation should apply to similar traditional Hungarian bread. It is also appropriate to authorise use of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium disodium EDTA (E 385) in Hungarian liver patés. (18) It is necessary to update the current provisions regarding the use of sulphites (E 220 to E 228) in cooked crustaceans, table grapes and lychees. (19) In accordance with a request from a Member State and the opinion of the Scientific Committee on Food of 5 March 2003, 4-hexylresorcinol, which was authorised at national level under Directive 89/107/EEC, should be authorised at Community level. (20) The terminology used in Directive 95/2/EC should be adapted to take into account Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses ( 8 ), Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( 9 ) and Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes ( 10 ). (21) Directives 95/2/EC and 94/35/EC should, therefore, be amended accordingly, Whereas: HAVE ADOPTED THIS DIRECTIVE:







Article 1

Directive 95/2/EC is hereby amended as follows:

1. Article 1(3)(c) shall be replaced by the following: ‘(c) “carriers”, including carrier solvents, are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive or flavouring without altering its function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use;’;

2. in Article 3(2) ‘weaning foods’ shall be replaced by ‘processed cereal-based foods and baby foods’;

3. the Annexes shall be amended in accordance with Annex I to this Directive.

Article 2

The Annex to Directive 94/35/EC shall be amended in accordance with Annex II to this Directive.

Article 3

1. Member States shall bring into force by 15 February 2008 the laws, regulations and administrative provisions necessary to comply with this Directive in order to:

(a) permit trade in and the use of products complying with this Directive by 15 February 2008;

(b) prohibit trade in and use of products which do not comply with this Directive by 15 August 2008.

However, products placed on the market or labelled before 15 August 2008 which do not comply with this Directive may be marketed until stocks are exhausted.

Member States shall forthwith communicate to the Commission the text of such laws, regulations and administrative provisions, together with a correlation table between them and this Directive.

2. When Member States adopt the laws, regulations and administrative provisions referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

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.









ANNEX I

The Annexes to Directive 95/2/EC are amended as follows:

(1) Annex I is amended as follows: (a) in the introductory note, the following note is added: ‘4. The substances listed under numbers E 400, E 401, E 402, E 403, E 404, E 406, E 407, E 407a, E 410, E 412, E 413, E 414, E 415, E 417, E 418 and E 440 may not be used in jelly mini-cups, defined, for the purpose of this Directive, as jelly confectionery of a firm consistence, contained in semi-rigid mini-cups or mini-capsules, intended to be ingested in a single bite by exerting pressure on the mini-cups or mini-capsule to project the confectionery into the mouth.’; (b) in the table, the following row is inserted:



‘E 462 Ethyl cellulose’;

(2) Annex II is amended as follows: (a) the row for ‘ripened cheese’ is replaced by the following:



‘Ripened cheese E 170 Calcium carbonate E 504 Magnesium carbonates E 509 Calcium chloride E 575 Glucono-delta-lactone quantum satis E 500ii Sodium hydrogen carbonate quantum satis (only for sour milk cheese)’; (b) in the row for ‘Pain courant français’ after the words ‘Pain courant français’ the following words are added: ‘Friss búzakenyér, fehér és félbarna kenyerek’; (c) in the row for ‘Foie gras, foie gras entier, blocs de foie gras’ after the words ‘Foie gras, foie gras entier, blocs de foie gras’ the following words are added: ‘Libamáj, libamáj egészben, libamáj tömbben’;

(3) Annex III is amended as follows: (a) Part A is amended as follows: (i) in the table ‘Sorbates, benzoates and p-hydroxybenzoates’, the rows for ‘E 216 Propyl p-hydroxybenzoate’ and ‘E 217 Sodium propyl p‐hydroxybenzoate’ are deleted; (ii) the table for foodstuffs is amended as follows: — the following rows are deleted: —



‘Shrimps, cooked 2 000 Crayfish tails, cooked, and pre‐packed marinated cooked molluscs 2 000 Liquid dietary food supplements 2 000’; — the following rows are added: —



‘Crustaceans and molluscs, cooked 1 000 2 000 Food supplements as defined in Directive 2002/46/EC (1) supplied in liquid form 2 000 (1) Directive 2002/46/EC of the European Parliament and of the Council (OJ L 183, 12.7.2002, p. 51).’ — the words ‘Dietetic food intended for special medical purposes’ are replaced by the words ‘Dietary foods for special medical purposes as defined in Directive 1999/21/EC ( 11 ) (b) in Part B the table for foodstuffs is amended as follows: — the row for ‘crustaceans and cephalopods’ is replaced by the following: —



‘Crustaceans and cephalopods: — fresh, frozen and deep-frozen 150 (1) — crustaceans, Penaeidae, Solenoceridae, Aristaeidae family: — up to 80 units 150 (1) — between 80 and 120 units 200 (1) — over 120 units 300 (1) Crustaceans and cephalopods — cooked 50 (1) — cooked crustaceans, Penaeidae, Solenoceridae, Aristaeidae family: — up to 80 units 135 (1) — between 80 and 120 units 180 (1) — over 120 units 270 (1) (1) In edible parts.’ — the entry ‘Starches (excluding starches for weaning foods, follow-on formulae and infant formulae)’ is replaced by ‘Starches (excluding starches in infant formulae, follow-on formulae and processed cereal‐based foods and baby foods)’; — the following rows are added: —



►C1 ‘Salsicha fresca ◄ 450 Table grapes 10 Fresh lychees 10 (measured on edible parts)’; (c) in Part C the table for E 249, E 250, E 251 and E 252 is replaced by the following:



‘E No Name Foodstuff Maximum amount that may be added during manufacture (expressed as NaNO2) Maximum residual level (expressed as NaNO2) E 249 Potassium nitrite ((x)) Meat products 150 mg/kg E 250 Sodium nitrite ((x)) Sterilised meat products (Fo > 3,00) ((y)) 100 mg/kg Traditional immersion cured meat products (1): Wiltshire bacon (1.1); ►C1 175 mg/kg ◄ Entremeada, entrecosto, chispe, orelheira e cabeça (salgados) Toucinho fumado (1.2); and similar products Wiltshire ham (1.1); and similar products 100 mg/kg Rohschinken, nassgepökelt (1.6); and similar products 50 mg/kg Cured tongue (1.3) ►C1 50 mg/kg ◄ Traditional dry cured meat products (2): Dry cured bacon (2.1); ►C1 175 mg/kg ◄ and similar products Dry cured ham (2.1); Jamón curado, paleta curada, lomo embuchado y cecina (2.2); Presunto, presunto da pá and paio do lombo (2.3); and similar products 100 mg/kg Rohschinken, trockengepökelt (2.5); and similar products 50 mg/kg Other traditionally cured meat products (3): Vysočina Selský salám Turistický trvanlivý salám Poličan Herkules Lovecký salám Dunajská klobása Paprikáš (3.5); and similar products 180 mg/kg Rohschinken, trocken-/nassgepökelt (3.1); and similar products Jellied veal and brisket (3.2) 50 mg/kg



E No Name Foodstuff Maximum amount that may be added during manufacture ►C1 (expressed as NaNO3) ◄ Maximum residual level ►C1 (expressed as NaNO3) ◄ E 251 E 252 Potassium nitrate ((z)) Sodium nitrate ((z)) Non-heat-treated meat products 150 mg/kg Traditional immersion cured meat products (1): Kylmäsavustettu poronliha/ Kallrökt renkött (1.4); 300 mg/kg Wiltshire bacon and Wiltshire ham (1.1); Entremeada, entrecosto, chispe, orelheira e cabeça (salgados), Toucinho fumado (1.2); Rohschinken, nassgepökelt (1.6); and similar products 250 mg/kg Bacon, Filet de bacon (1.5); and similar products 250 mg/kg without added E 249 or E 250 Cured tongue (1.3) 10 mg/kg Traditional dry cured meat products (2): Dry cured bacon and Dry cured ham (2.1); ►C1 250 mg/kg ◄ Jamón curado, paleta curada, lomo embuchado y cecina (2.2); Presunto, presunto da pá and paio do lombo (2.3); Rohschinken, trockengepökelt (2.5); and similar products Jambon sec, jambon sel sec et autres pièces maturées séchées similaires (2.4) 250 mg/kg without added E 249 or E 250 Other traditionally cured meat products (3): Rohwürste (Salami and Kantwurst) (3.3); ►C1 300 mg/kg (without added E 249 or E 250) ◄ Rohschinken, trocken-/nassgepökelt (3.1); and similar products 250 mg/kg Salchichón y chorizo tradicionales de larga curación (3.4); Saucissons secs (3.6); and similar products 250 mg/kg (without added E 249 or E 250) Jellied veal and brisket (3.2); 10 mg/kg Hard, semi-hard and semi-soft cheese 150 mg/kg in the cheese milk or equivalent level if added after removal of whey and addition of water Dairy-based cheese analogue Pickled herring and sprat 500 mg/kg (x) When labelled “for food use”, nitrite may be sold only in a mixture with salt or a salt substitute. (y) Fo-value 3 is equivalent to 3 minutes heating at 121 oC (reduction of the bacterial load of one billion spores in each 1 000 cans to one spore in a thousand cans). (z) Nitrates may be present in some heat-treated meat products resulting from natural conversion of nitrites to nitrates in a low-acid environment. (d) Part D is amended as follows: (i) the Note is replaced by: ‘The * in the table refers to the proportionality rule: when combinations of gallates, TBHQ, BHA and BHT are used, the individual levels must be reduced proportionally.’; (ii) row E 310 to E 321 and row E 310 to E 320 are replaced by the following: ▼C1



‘E 310 Propyl gallate Fats and oils for the professional manufacture of heat-treated foodstuffs 200*(gallates, TBHQ and BHA, individually or in combination) E 311 Octyl gallate Frying oil and frying fat, excluding olive pomace oil 100*(BHT) E 312 Dodecyl gallate E 319 Tertiary-butyl hydroquinone (TBHQ) Lard; fish oil; beef, poultry and sheep fat both expressed on fat E 320 Butylated hydroxyanisole (BHA) Cake mixes Cereal-based snack foods Milk powder for vending machines 200 (gallates, TBHQ and BHA, individually or in combination) E 321 Butylated hydroxytoluene (BHT) Dehydrated soups and broths Sauces Dehydrated meat Processed nuts Pre-cooked cereals expressed on fat Seasonings and condiments 200 (gallates and BHA, individually or in combination) expressed on fat Dehydrated potatoes 25 (gallates, TBHQ and BHA, individually or in combination) Chewing gum Food supplements as defined in Directive 2002/46/EC 400 (gallates, TBHQ, BHT and BHA, individually or in combination) Essential oils 1 000 (gallates, TBHQ and BHA, individually or in combination) Flavourings other than essential oils 100 * (gallates, individually or in combination) 200 * (TBHQ and BHA, individually or in combination)’; ▼B (iii) the following row is added:



‘E 586 4-Hexylresorcinol Fresh, frozen and deep-frozen crustaceans 2 mg/kg as residues in crustacean meat’;

(4) Annex IV is amended as follows: (a) the row for E 385 is replaced by the following:



‘E 385 Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA) Emulsified sauces 75 mg/kg Canned and bottled pulses, legumes, mushrooms and artichokes 250 mg/kg Canned and bottled crustaceans and molluscs 75 mg/kg Canned and bottled fish 75 mg/kg Spreadable fats as defined in Annexes B and C to Regulation (EC) No 2991/94 (1) , having a fat content of 41 % or less 100 mg/kg Frozen and deep‐frozen crustaceans 75 mg/kg ►C1 Libamáj, egészben és tömbben ◄ 250 mg/kg (1) OJ L 316, 9.12.1994, p. 2.’; (b) the following row is inserted after the row for E 967:



‘E 968 Erythritol Foodstuffs in general (except drinks and those foodstuffs referred to in Article 2(3)) quantum satis Frozen and deep-frozen unprocessed fish, crustaceans, molluscs and cephalopods quantum satis Liqueurs quantum satis For purposes other than sweetening’; (c) the following row is added: ▼C1



‘E 426 Soybean hemicellulose Dairy-based drinks intended for retail sale 5 g/l Food supplements as defined in Directive 2002/46/EC 1,5 g/l Emulsified sauces 30 g/l Pre-packaged fine bakery wares intended for retail sale 10 g/kg Pre-packaged ready to eat oriental noodles intended for retail sale 10 g/kg Pre-packaged ready to eat rice intended for retail sale 10 g/kg Pre-packaged processed potato and rice products (including frozen, deep-frozen, chilled and dried processed products) intended for retail sale 10 g/kg Dehydrated, concentrated, frozen and deep-frozen egg products 10 g/kg Jelly confectionery, except jelly mini-cups 10 g/kg’; ▼B (d) in row E 468 the words ‘Solid dietary supplements’ are replaced by the words ‘Food supplements as defined in Directive 2002/46/EC supplied in solid form’; (e) in row E 338 to E 452 the words ‘Dietary supplements’ are replaced by the words ‘Food supplements as defined in Directive 2002/46/EC’; (f) in row E 405, row E 416, row E 432 to E 436, row E 473 and E 474, row E 475, row E 491 to E 495, row E 551 to E 559, and row E 901 to E 904, the words ‘Dietary food supplements’ are replaced by the words ‘Food supplements as defined in Directive 2002/46/EC’; (g) in row E 1201 and E 1202 the words ‘Dietary food supplements in tablet and coated tablet form’ are replaced by the words ‘Food supplements as defined in Directive 2002/46/EC in tablet and coated tablet form’; (h) in row E 405, row E 432 to E 436, row E 473 and E 474, row E 475, row E 477, row E 481 and E 482, row E 491 to E 495 the words ‘Dietetic food intended for special medical purposes’ are replaced by the words ‘Dietary foods for special medical purposes as defined in Directive 1999/21/EC’; (i) Row E 1505 to E 1520 is replaced by the following: ▼C1



‘E 1505 Triethyl citrate Flavourings 3 g/kg from all sources in foodstuffs as consumed or as reconstituted according to the instructions of the manufacturer; individually or in combination. In the case of beverages, with the exception of cream liqueurs, the maximum level of E 1520 shall be 1 g/l.’; E 1517 Glyceryl diacetate (diacetin) E 1518 Glyceryl triacetate (triacetin) E 1520 Propan-1,2-diol (propylene glycol) ▼B (j) the following rows are added: ▼C1



‘E 1204 Pullulan Food supplements as defined in Directive 2002/46/EC in capsule and tablet form quantum satis Breath freshening micro-sweets in the form of films quantum satis E 1452 Starch Aluminium Octenyl Succinate Encapsulated vitamin preparations in food supplements as defined in Directive 2002/46/EC 35 g/kg in food supplement’; ▼B

(5) Annex V is amended as follows: (a) the following row is inserted after the row for E 967:



‘E 968 Erythritol’; (b) the following row is inserted after the row for E 466:



‘E 462 Ethyl cellulose’; (c) in the third column of the row for E 551 and E 552 the following sentence is added: ‘For E 551: in E 171 titanium dioxide and E 172 iron oxides and hydroxides (max. 90 % relative to the pigment).’;

(6) Annex VI is amended as follows: (a) in the first, second and third paragraph of the introductory note ‘weaning foods’ are replaced by ‘processed cereal-based foods and baby foods’; (b) in Part 3, in the title, in row E 170 to E 526, row E 500, E 501 and E 503, row E 338, row E 410 to E 440, row E 1404 to E 1450 and row E 1451 ‘weaning foods’ are replaced by ‘processed cereal-based foods and baby foods’; (c) in Part 4, the following is inserted after row E 472c:



‘E 473 Sucrose esters of fatty acids 120 mg/l Products containing hydrolysed proteins, peptides and amino acids’.









ANNEX II

The Annex to Directive 94/35/EC is amended as follows:

(1) in the first column of the row for E 420 to E 967, ‘E 968’ is added;

(2) in the second column of the row for E 420 to E 967, ‘Erythritol’ is added.





(x) When labelled “for food use”, nitrite may be sold only in a mixture with salt or a salt substitute.

(y) Fo-value 3 is equivalent to 3 minutes heating at 121 oC (reduction of the bacterial load of one billion spores in each 1 000 cans to one spore in a thousand cans).