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Council Directive 80/597/EEC of 29 May 1980 amending for the second time Directive 74/329/EEC on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs Official Journal L 155 , 23/06/1980 P. 0023 - 0025 Finnish special edition: Chapter 13 Volume 10 P. 0205 Greek special edition: Chapter 13 Volume 9 P. 0127 Swedish special edition: Chapter 13 Volume 10 P. 0205 Spanish special edition: Chapter 13 Volume 11 P. 0026 Portuguese special edition Chapter 13 Volume 11 P. 0026

COUNCIL DIRECTIVE of 29 May 1980 amending for the second time Directive 74/329/EEC on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (80/597/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 74/329/EEC (4), as last amended by Directive 78/612/EEC (5), lays down a single list of emulsifiers, stabilizers, thickeners and gelling agents which may be authorized for use in foodstuffs by the Member States; Whereas having regard to the most recent scientific and technical knowledge the reference to microcrystalline cellulose (E 460) in Annex I to Directive 78/612/EEC must be reworded ; whereas the use of tragacanth (E 413) should be re-evaluated after an enquiry by the Commission; Whereas Annex II to Directive 74/329/EEC indicates the designations of the substances which may be temporarily authorized by Member States for use in foodstuffs; Whereas Article 3 (1) of Directive 74/329/EEC authorizes this derogation for a period of five years from the date of notification of the Directive; Whereas having regard to the most recent scientific and technical knowledge the said Annex II must be revised ; whereas, therefore, for certain substances, the period of temporary authorization must be prolonged to permit the completion of certain toxicological investigations necessary in the light of present day requirements regarding the safety of their use in foodstuffs; Whereas other substances for which the necessary toxicological investigations have been completed cannot be accepted at Community level unless conditions of use and purity criteria are stipulated ; whereas their use may be authorized without limit in time by Member States; Whereas the scientific and technical knowledge on Xanthan gum is sufficient to allow its transfer to Annex I to Directive 74/329/EEC ; whereas Ghatti gum must no longer be used but nevertheless a temporary period must be provided to allow the sale of foodstuffs containing this substance which are already on the market; Whereas extract of quillaia is no longer covered by Directive 74/329/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 74/329/EEC is hereby amended as follows: 1. Paragraphs 2 and 3 of Article 2 shall be replaced by the following: "2. However, as regards the substances referred to in Annex I under E 413 and E 440b, the Council, acting in accordance with the procedure provided for in Article 100 of the Treaty, may decide, by 31 December 1982 and on the basis of a study by the Commission, to delete them from that Annex or otherwise change their status." 2. The following Article shall be inserted: "Article 2a 1. Notwithstanding Article 2 (1), Member States may authorize the use in foodstuffs of the substances listed below: Ammonium phosphatides, Polyglycerol polyricinoleate, (1)OJ No C 115, 8.5.1979, p. 10. (2)OJ No C 4, 7.1.1980, p. 64 (3)OJ No C 247, 1.10.1979, p. 1. (4)OJ No L 189, 12.7.1.1980, p. 64. (5)OJ No L 197, 22.7.1978, p. 22. Sorbitan monostearate, Sorbitan tristearate, Sorbitan monolaurate, Sorbitan monoleate, Sorbitan monopalmitate. 2. The Council may, in accordance with the procedure laid down in Article 100 of the Treaty, include in Annex I the substances mentioned in paragraph 1, at the same time stipulating the conditions for their use in foodstuffs, provided that in accordance with Article 7 (1) their purity criteria are established." 3. Paragraph 1 of Article 3 shall be replaced by the following: "1. Notwithstanding Article 2 (1), Member States may authorize until 31 December 1984 the use in foodstuffs of the substances listed in Annex II, and until 1 April 1981 the marketing of foodstuffs containing Ghatti gum. However, as regards Karaya gum, the Council, acting in accordance with the procedure provided for in Article 100 of the Treaty, may decide, by 31 December 1980 and on the basis of a study by the Commission, to delete it from that Annex or otherwise change its status." 4. Annex I is amended as follows: (a) Item E 460, Microcrystalline cellulose, is replaced by the following: >PIC FILE= "T9001228"> (b) The following is inserted: "E 415 Xanthan gum". 5. Annex II is replaced by the Annex to this Directive. Article 2 Article 1 shall take effect as from 21 June 1979. Article 3 Member States shall, within one year of the notification of this Directive, amend their laws in accordance with the preceding provisions, and shall forthwith inform the Commission thereof. The laws thus amended shall be implemented two years after notification of this Directive. Article 4 This Directive is addressed to the Member States. Done at Brussels, 29 May 1980. For the Council The President G. MARCORA ANNEX "ANNEX II DESIGNATION Karaya gum (synonym : sterculia gum) Polyoxyethylene (20) sorbitan monolaurate (synonym : polysorbate 20) Polyoxyethylene (20) sorbitan monopalmitate (synonym : polysorbate 40) Polyoxyethylene (20) sorbitan monostearate (synonym : polysorbate 60) Polyoxyethylene (20) sorbitan tristearate (synonym : polysorbate 65) Polyoxyethylene (20) sorbitan monooleate (synonym : polysorbate 80) Polyoxyethylene (8) stearate Polyoxyethylene (40) stearate Thermally oxidized soya bean oil interacted with mono- and di-glycerides of fatty acids Lactylated fatty acid esters of glycerol and propylene glycol Dioctyl sodium sulphosuccinate"

COUNCIL DIRECTIVE of 29 May 1980 amending for the second time Directive 74/329/EEC on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (80/597/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

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

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

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas Directive 74/329/EEC (4), as last amended by Directive 78/612/EEC (5), lays down a single list of emulsifiers, stabilizers, thickeners and gelling agents which may be authorized for use in foodstuffs by the Member States;

Whereas having regard to the most recent scientific and technical knowledge the reference to microcrystalline cellulose (E 460) in Annex I to Directive 78/612/EEC must be reworded ; whereas the use of tragacanth (E 413) should be re-evaluated after an enquiry by the Commission;

Whereas Annex II to Directive 74/329/EEC indicates the designations of the substances which may be temporarily authorized by Member States for use in foodstuffs;

Whereas Article 3 (1) of Directive 74/329/EEC authorizes this derogation for a period of five years from the date of notification of the Directive;

Whereas having regard to the most recent scientific and technical knowledge the said Annex II must be revised ; whereas, therefore, for certain substances, the period of temporary authorization must be prolonged to permit the completion of certain toxicological investigations necessary in the light of present day requirements regarding the safety of their use in foodstuffs;

Whereas other substances for which the necessary toxicological investigations have been completed cannot be accepted at Community level unless conditions of use and purity criteria are stipulated ; whereas their use may be authorized without limit in time by Member States;

Whereas the scientific and technical knowledge on Xanthan gum is sufficient to allow its transfer to Annex I to Directive 74/329/EEC ; whereas Ghatti gum must no longer be used but nevertheless a temporary period must be provided to allow the sale of foodstuffs containing this substance which are already on the market;

Whereas extract of quillaia is no longer covered by Directive 74/329/EEC,

HAS ADOPTED THIS DIRECTIVE:

Directive 74/329/EEC is hereby amended as follows: 1. Paragraphs 2 and 3 of Article 2 shall be replaced by the following:

"2. However, as regards the substances referred to in Annex I under E 413 and E 440b, the Council, acting in accordance with the procedure provided for in Article 100 of the Treaty, may decide, by 31 December 1982 and on the basis of a study by the Commission, to delete them from that Annex or otherwise change their status."

2. The following Article shall be inserted:

"Article 2a 1. Notwithstanding Article 2 (1), Member States may authorize the use in foodstuffs of the substances listed below:

Ammonium phosphatides,

Polyglycerol polyricinoleate, (1)OJ No C 115, 8.5.1979, p. 10. (2)OJ No C 4, 7.1.1980, p. 64 (3)OJ No C 247, 1.10.1979, p. 1. (4)OJ No L 189, 12.7.1.1980, p. 64. (5)OJ No L 197, 22.7.1978, p. 22.

Sorbitan monostearate,

Sorbitan tristearate,

Sorbitan monolaurate,

Sorbitan monoleate,

Sorbitan monopalmitate.

2. The Council may, in accordance with the procedure laid down in Article 100 of the Treaty, include in Annex I the substances mentioned in paragraph 1, at the same time stipulating the conditions for their use in foodstuffs, provided that in accordance with Article 7 (1) their purity criteria are established."

3. Paragraph 1 of Article 3 shall be replaced by the following:

"1. Notwithstanding Article 2 (1), Member States may authorize until 31 December 1984 the use in foodstuffs of the substances listed in Annex II, and until 1 April 1981 the marketing of foodstuffs containing Ghatti gum. However, as regards Karaya gum, the Council, acting in accordance with the procedure provided for in Article 100 of the Treaty, may decide, by 31 December 1980 and on the basis of a study by the Commission, to delete it from that Annex or otherwise change its status."

4. Annex I is amended as follows: (a) Item E 460, Microcrystalline cellulose, is replaced by the following:

>PIC FILE= "T9001228"> (b) The following is inserted:

"E 415 Xanthan gum".

5. Annex II is replaced by the Annex to this Directive.

Article 2

Article 1 shall take effect as from 21 June 1979.

Article 3

Member States shall, within one year of the notification of this Directive, amend their laws in accordance with the preceding provisions, and shall forthwith inform the Commission thereof. The laws thus amended shall be implemented two years after notification of this Directive.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 29 May 1980.

For the Council

The President

G. MARCORA

ANNEX

"ANNEX II

DESIGNATION

Karaya gum (synonym : sterculia gum)

Polyoxyethylene (20) sorbitan monolaurate (synonym : polysorbate 20)

Polyoxyethylene (20) sorbitan monopalmitate (synonym : polysorbate 40)

Polyoxyethylene (20) sorbitan monostearate (synonym : polysorbate 60)

Polyoxyethylene (20) sorbitan tristearate (synonym : polysorbate 65)

Polyoxyethylene (20) sorbitan monooleate (synonym : polysorbate 80)

Polyoxyethylene (8) stearate

Polyoxyethylene (40) stearate

Thermally oxidized soya bean oil interacted with mono- and di-glycerides of fatty acids

Lactylated fatty acid esters of glycerol and propylene glycol

Dioctyl sodium sulphosuccinate"