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

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

Preamble

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,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

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

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.

Final provisions

Done at Strasbourg, 5 July 2006. For the European Parliament The President J. BORRELL FONTELLES For the Council The President P. LEHTOMÄKI

¹ OJ C 255, 14.10.2005, p. 59 .

² Opinion of the European Parliament of 26 October 2005 (not yet published in the Official Journal). Council Decision of 2 June 2006.

³ OJ L 40, 11.2.1989, p. 27 . Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council ( OJ L 284, 31.10.2003, p. 1 ).

⁴ OJ L 61, 18.3.1995, p. 1 . Directive as last amended by Directive 2003/114/EC ( OJ L 24, 29.1.2004, p. 58 ).

⁵ OJ L 237, 10.9.1994, p. 3 . Directive as last amended by Directive 2003/115/EC ( OJ L 24, 29.1.2004, p. 65 ).

⁶ OJ L 118, 23.4.2004, p. 70 .

⁷ OJ L 109, 6.5.2000, p. 29 . Directive as last amended by Directive 2003/89/EC ( OJ L 308, 25.11.2003, p. 15 ).

⁸ OJ L 186, 30.6.1989, p. 27 . Directive as last amended by Regulation (EC) No 1882/2003 .

⁹ OJ L 183, 12.7.2002, p. 51 .

¹⁰ OJ L 91, 7.4.1999, p. 29 . Directive as amended by the 2003 Act of Accession.

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

(1) Annex I is amended as follows:

(2) Annex II is amended as follows:

(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:

(4) Annex IV is amended as follows:

(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’;

(5) Annex V is amended as follows:

(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’;

Commission Directive 1999/21/EC ( OJ L 91, 7.4.1999, p. 29 ).’ ’

Directive 2002/46/EC of the European Parliament and of the Council ( OJ L 183, 12.7.2002, p. 51 ).’

¹ In edible parts.’

¹

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

²

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

³

( z ) Nitrates may be present in some heat-treated meat products resulting from natural conversion of nitrites to nitrates in a low-acid environment.

OJ L 316, 9.12.1994, p. 2 .’;

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.

Footnotes

1. In edible parts.’ ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³ ↩²⁴ ↩²⁵ ↩²⁶ ↩²⁷ ↩²⁸ ↩²⁹ ↩³⁰

2. Opinion of the European Parliament of 26 October 2005 (not yet published in the Official Journal). Council Decision of 2 June 2006. ↩ ↩² ↩³ ↩⁴

3. . Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (). ↩ ↩² ↩³ ↩⁴ ↩⁵

4. . Directive as last amended by Directive 2003/114/EC (). ↩ ↩²

5. . Directive as last amended by Directive 2003/115/EC (). ↩ ↩²

6. . ↩ ↩²

7. . Directive as last amended by Directive 2003/89/EC (). ↩ ↩²

8. . Directive as last amended by Regulation (EC) No 1882/2003. ↩ ↩²

9. . ↩ ↩²

10. . Directive as amended by the 2003 Act of Accession. ↩ ↩²