COMMON POSITION (EC) No 26/98 adopted by the Council on 23 March 1998 with a view to adopting Directive 98/. . ./EC of the European Parliament and of the Council of . . . amending Directive 95/2/EC on food additives other than colours and sweeteners (98/C161 /03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social Committee (2),

Acting in accordance with the procedure referred to in Article 189b of the Treaty (3),

Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (4), and in particular Article 3(2) thereof,

Whereas there have been technical developments in the field of food additives since the adoption of Directive 95/2/EC (5);

Whereas Directive 95/2/EC should be adapted to take account of these developments;

Whereas the Scientific Committee for Food, set up by Decision 74/234/EEC (6), was consulted before the adoption of provisions liable to have an effect on public health;

Whereas specific provisions on thiabendazole have been laid down in Council Directive 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels (7); whereas the entry on thiabendazole should now be repealed,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

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

1. Article 1(1) shall be replaced by the following:

'1. This Directive is a specific Directive forming a part of the comprehensive Directive, within the meaning of Article 3 of Directive 89/107/EEC, and applies to additives other than colours and sweeteners. It does not apply to enzymes other than those mentioned in the Annexes,`;

2. Article 2(1) shall be replaced by the following:

'1. Only substances listed in Annexes I, III, IV and V may be used in foodstuffs for the purposes mentioned in Article 1(3) and Article 1(4),`;

3. Article 2(2) shall be replaced by the following:

'2. Food additives listed in Annex I are permitted in foodstuffs, for the purposes mentioned in Article 1(3) and Article 1(4), with the exception of those foodstuffs listed in Annex II, following the "quantum satis" principle,`;

4. The fifth indent of Article 2(3)(a) shall be replaced by:

'- pasteurised and sterilised (including UHT) milk (including plain, skimmed and semi-skimmed) and plain pasteurised cream,`;

5. The eleventh indent of Article 2(3)(a) shall be replaced by:

'- dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 89/398/EEC,`;

6. The tables of the Annexes shall be amended in accordance with the provisions contained in the Annex to this Directive.

Article 2

1. Member States shall, where necessary, amend their laws, regulations and administrative provisions in order to:

- authorise trade in products conforming with this Directive, by . . . (8) at the latest,

- prohibit trade in products not conforming with this Directive from . . . (9). However, products placed on the market or labelled before that date which do not comply with the Directive may be marketed until stocks are exhausted.

They shall forthwith inform the Commission thereof.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

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

Article 3

This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, . . .

For the European Parliament

The President

For the Council

The President

(1) OJ C 76, 11.3.1997, p. 34, and OJ C 77, 12.3.1998, p. 7.

(2) OJ C 75, 10.3.1997, p. 1.

(3) Opinion of the European Parliament of 23 October 1997 (OJ C 339, 10.11.1997, p. 1), Council common position of 23 March 1998 and Decision of the European Parliament of . . . (not yet published in the Official Journal).

(4) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Directive 94/34/EC of the European Parliament and of the Council (OJ L 237, 10.9.1994, p. 1).

(5) OJ L 61, 18.3.1995, p. 1. Directive as amended by Directive 96/85/EC (OJ L 86, 28.3.1997, p. 4).

(6) OJ L 136, 20.5.1974, p. 1.

(7) OJ L 197, 22.8.1995, p. 14.

(8) 18 months after the entry into force of this Directive.

(9) 24 months after the entry into force of this Directive.

ANNEX

1. In Annex I, the following additives shall be added:

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2. In Annex II:

(a) the list of additives and the maximum level for 'Jam, jellies and marmalades as defined in Directive 79/693/EEC and other similar fruit spreads including low-calorie products` shall be supplemented as follows:

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(b) the table concerning 'Sterilised, pasteurised and UHT cream, low-calorie cream and pasteurised low-fat cream` shall be replaced by the following:

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(c) the designation 'Frozen and deep-frozen unprocessed fruit and vegetables` shall be amended as follows:

'Frozen and deep-frozen unprocessed fruit and vegetables; prepacked, refrigerated unprocessed fruit and vegetables ready for consumption and prepacked unprocessed and peeled potatoes.`;

(d) the following table shall be inserted after the table concerning 'Non-emulsified oils and fats of animal or vegetable origin`:

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(e) the list of additives and the maximum level for 'Mozzarella and whey cheese` shall be supplemented as follows.

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(f) the list of additives and the maximum level for 'Canned and bottled fruit and vegetables` shall be supplemented as follows:

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(g) the list of additives and the maximum level for 'Gehakt` shall be supplemented as follows:

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(h) the following table shall be added at the end of the Annex:

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3. In Annex III, Part A:

(a) the maximum levels for 'Olives and olive-based preparations`, 'Emulsified sauces with a fat content of 60 % or more` and 'Emulsified sauces with a fat content less than 60 %` shall be replaced by the following:

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(b) at the end of this part, the following table shall be added:

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4. In Annex III, Part B:

(a) the presentation of the following foodstuffs and maximum levels:

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shall be as follows:

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(b) the maximum level for the entry 'Sugars as defined in Directive 73/437/EEC except glucose syrup, whether or not dehydrated` shall be replaced by the following:

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(c) the following foodstuffs and maximum levels:

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shall be replaced by the following:

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(d) at the end of this Part, the following foodstuffs and maximum levels shall be added:

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5. In Annex III, Part C:

(a) the following foodstuff and maximum level shall be added to E 234:

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(b) the following foodstuffs and maximum levels shall be added to E 251 and E 252:

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(c) the following foodstuffs and maximum levels shall be added to E 280, E 281, E 282 and E 283:

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(d) the following table shall be deleted:

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6. The designation 'Dehydrated granulated potatoes` contained in the table in Annex III parts B and D in the foodstuffs column shall be replaced by 'Dehydrated potatoes`.

7. In Annex IV:

(a) the designation 'Instant tea powder` concerning E 297 Fumaric acid and the maximum level of 1 g/l shall be replaced by 'Instant products for preparation of flavoured tea and herbal infusions with the maximum level: 1 g/kg`.

(b) the table concerning E 338 to E 452 shall be replaced by the following:

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(c) the following additive shall be added:

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(d) the designation 'Minarine` concerning E 385 shall be amended as follows:

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(e) the following foodstuff and maximum level shall be added to E 405:

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(f) the designation in the 12th section, third column, concerning E 442, shall be amended as follows:

'Cocoa and chocolate products as defined in Directive 73/241/EEC including fillings`

'Confectionary based on these products`;

(g) the following foodstuff and maximum level shall be added to E 445:

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(h) the following foodstuffs and maximum levels shall be added to E 473 and E 474:

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(i) the designation 'Low and very low fat spreads and dressings` concerning E 476 shall be amended as follows:

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(j) the following foodstuffs and maximum levels concerning E 551 to E 559 shall be added:

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(k) the designation 'Sliced hard cheese and sliced processed cheese` concerning E 551 to E 559 shall be amended as follows:

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(l) the following foodstuff and maximum level shall be added to E 900:

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(m) the following foodstuffs and maximum levels shall be added to E 901, E 902, E 903 and E 904:

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(n) the following foodstuffs and maximum levels shall be added to E 912 and E 914:

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(o) the following foodstuffs and maximum levels shall be added to E 957:

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(p) the designation 'Margarine` and 'Minarine` concerning E 959 shall be amended as follows:

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(q) the following foodstuff and maximum level shall be added to E 999:

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(r) the following table shall be added:

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(s) the following table shall be added:

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8. In Annex V, the following tables shall be added:

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9. In Annex VI:

(a) the first subparagraph of the introductory note shall be replaced by the following:

'Formulae and weaning foods for infants and young children may contain E 414 (acacia gum, gum arabic) and E 551 (silicon dioxide) resulting from the addition of nutrient preparations containing not more than 150 g/kg of E 414 and 10 g/kg of E 551, as well as E 421 (mannitol) when used as a carrier for vitamin B12 (not less than 1 part vitamin B12 to 1 000 parts mannitol). The carry over of E 414 in the product ready for consumption should not be more than 10 mg/kg.

Formulae and weaning foods for infants and young children may contain E 301 (sodium L-ascorbate), used at QS level in coatings of nutrient preparations containing polyunsaturated fatty acids. The carry over of E 301 in the product ready for consumption should not be more than 75 mg/l.`;

(b) in Part 1, note 2 shall be replaced by the following:

'2. If more than one of the substances E 322, E 471, E 472c and E 473 are added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is present of the other substances together in that foodstuff.`;

(c) in Part 1, the following table shall be added:

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(d) in Part 2, note 2 shall be replaced by the following:

'2. If more than one of the substances E 322, E 471, E 472c and 473 is added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is present of the other substances together in that foodstuff.`;

(e) in Part 2, the following table shall be added:

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(f) in Part 3, the following table shall be added:

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(g) in Part 4, the following table shall be added:

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 4 September 1996, the Commission submitted to the Council a proposal for a Directive of the European Parliament and of the Council based on Article 100a of the EC Treaty amending Directive 95/2/EC of the European Parliament and of the Council on food additives other than colours and sweeteners (1).

2. Further to the European Parliament's opinion delivered at first reading on 23 October 1997 (2), the Commission submitted an amended proposal (3) to the Council on 16 January 1998.

3. The Economic and Social Committee delivered its opinion on 18 December 1996 (4).

4. The Council adopted on 23 March 1998 its common position in accordance with Article 189b of the Treaty.

II. PURPOSE

5. The aim of the draft Directive is to adapt Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (5) to recent scientific and technical developments taking account of the requirements of both industry and consumers.

To that end, draft amended Directive 95/2/EC aims to authorise:

- the use of certain additives, which are already authorised, in certain new categories of foodstuffs not yet included in the Directive,

- certain foodstuffs manufactured with certain additives in the 'new` Member States, which are not covered by the existing Directive,

- certain new food additives at present prohibited which, following assessment by the Scientific Committee for Food, have been deemed fit for human consumption.

As a result the draft Directive constitutes a necessary measure to help ensure proper operation of the internal market in the foodstuffs sector.

III. ANALYSIS OF THE COMMON POSITION

A. General comments

6. In the light of the amended Commission proposal, the Council endorsed the Commission's approach with respect to the European Parliament's amendments by:

- taking over as they stand or in principle amendments 13, 20, 21, 23 to 25, 28, 33 and 34,

- rejecting amendments 1 to 5, 15, 16, 18, 26, 29 and 42.

On the other hand, the Council departed from the Commission's amended proposal by:

- accepting amendments 8, 9, 17 and 19 (in part) which the Commission had rejected,

- endorsing two of the three parts of amendment 10 only one part of which the Commission had accepted,

- accepting partially amendment 14 which the Commission had adopted as it stood.

In addition, the Council made a number of other amendments to the Commission proposal which concerned both the substance and the form of the text. The Commission accepted all these amendments.

The amendments made by the Council to the amended Commission proposal require the following specific comments:

B. Specific comments

7. Amendments accepted (as they stood or in part) by the Council and rejected (as they stood or in part) by the Commission

- Amendment 8 (point 2(e) of the Annex to the common position): the Council accepted this amendment as it thought there was no technological need for the use of hydrochloric acid to be permitted in the manufacture of Mozzarella.

- Amendment 9 (point 4(b)): given that practice in the sugar industry is to use not more than 10 mg of SO2 per kg of sugar, the Council agreed with the European Parliament and reduced the maximum level for this additive, where sugar is concerned, to 10 mg.

- Amendment 10 (point 4(d)): only the third part of this amendment (addition of alcoholic beverages containing whole pears) was accepted by the Commission. The Council adopted that part as well as another point, namely the deletion of dehydrated apples and pears with a moisture content of more than 12 %; however, the Council did not see fit also to delete the reference to marinated nuts.

- Amendment 17 (point 7(o)): the Council agreed with the European Parliament and authorised two new uses for thaumatin as a flavour enhancer (water-based flavoured drinks and desserts) although it reduced the maximum level permitted in desserts to 5 mg (amendment 17: 10 mg).

- Amendment 19 (point 7(r)): the Council agreed with the European Parliament and deleted glazed rice from the list of foods which may be treated with microcrystalline wax; however, it went along with the Commission where triacetin was concerned and did not delete that heading as the European Parliament wished.

8. Amendment adopted by the Commission and accepted in part by the Council

- Amendment 14 (point 7(f)): the Council considered that it was justifiable to extend the use of ammonium phosphatides to fillings of cocoa and chocolate products, but not to all confectionery.

9. Other amendments made to the Commission proposal

The Council introduced other changes to the Commission proposal, in particular to take account of new technological developments and the needs of the food industry. These amendments include:

- the inclusion of flour treatment agents in the scope of the Directive and the exclusion of enzymes (Article 1(1), (2) and (3)); the Commission undertook to examine the problems connected with the latter and to submit appropriate proposals,

- repeal of the entry on thiabendazole which is now covered by Council Directive 95/38/EC on pesticide residues (6) (fourth recital and point 5(d)),

- authorisation to treat Mascarpone with nisin (point 5(a)) and peaches and pineapples with wax (point 7(m)).

10. Comments on a number of the European Parliament's other amendments

Of the amendments accepted by the Commission and the Council, with respect to amendment 28 on additives authorised in food products for infants and young children for particular medical purposes (Annex VI, Part 4) the following comment seems required: the Council accepted this amendment while adopting, as did the Commission, the maximum level recommended by the Scientific Committee on Food for the first three substances; it also followed the advice of that Committee in laying down more specific special conditions for the use of the additives concerned (point 9(g)).

IV. CONCLUSIONS

The Council considers that the common position at one and the same time substantially meets the wishes expressed by the European Parliament and takes sufficient account of recent technological requirements and developments. The Council is of the opinion that the common position reflects a sound balance between the technological requirements of the industry and consumer expectations.

(1) OJ C 76, 11.3.1997, p. 34.

(2) OJ C 339, 10.11.1997, p. 136.

(3) OJ C 77, 12.3.1998, p. 7.

(4) OJ C 75, 10.3.1997, p. 1.

(5) OJ L 61, 20.2.1995, p. 1.

(6) OJ L 197, 22.8.1995, p. 14.