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EUROPEAN ECONOMIC COMMUNITY (EEC) LEGISLATION 625 European Economic Community (EEC) REVISED DRAFT DIRECTIVE ON ANTIOXIDANTS The text of the revised draft directive on antioxidants has been published in the Journal O~ciel des CommunauMs Europ~ennes of 13 April 1965 and supersedes the original draft directive (Cited in F.C.T. 1964, 2, 51). There are several minor changes in the text of the Articles in the original draft directive, but the only major change is the addition of another Article (No. 2) concerned with the uses of propyl gallate and the esters of l-ascorbic acid with C14-Cts straight-chain fatty acids. This Article reads as follows: As a departure from Article 1 the Member States may, for a period of 3 yr after notifi- cation of this directive, retain the national regulations governing the use of propyl gallate and the esters of l-ascorbic acid and the C~4-C1s straight-chain fatty acids in foodstuffs. Before the end of the period named in sentence 1 the Council may, in accordance with Article 100 of the Treaty, decide on a draft directive by which the substances specified in sentence I are included in the Annex; the inclusion of those substances in the Annex may only be decided upon if it has been proved by scientific investigations that those sub- stances are not injurious to health and if their use is necessary on economic grounds. To the list of 13 permitted substances constituting Appendices A and B of the original draft directive, 25 substances (marked with an asterisk) have been added to and one (propyl gallate) omitted from the Annex to the revised draft directive. The Annex is divided into two parts: (1) substances which are primarily used as anti- oxidants, including certain substances which are now on the EEC permitted list of preserva- tives (e.g. sulphur dioxide and sodium sulphite) and which can also be employed as anti- oxidants; and (2) substances like lactic and tartaric acid, used for other purposes but whose antioxidant effects are incidental. One notable absentee from the lists of both draft directives is butylated hydroxytoluene. The reason underlying the omission of propyl gallate from the revised draft list is based on the effect the antioxidant is known to exercise on the nutritive value of fats. A temporary provision has, however, been laid down (Article 2 of the revised draft directive) which permits member states to enforce their regulations on this antioxidant for a period of 3 yr by which time the antioxidant may be incorporated in the Annex, providing satisfactory evidence of safety-in-use and necessary economy is forthcoming. A similar provision laid down in the same Article extends to esters of l-ascorbic acid and C14-C18 straight-chain fatty acids. So far satisfactory toxicological data are available only for ascorbyl palmitate and at least short-term tests will have to be conducted on the other compounds before their use can be authorized. Annex Part I. Substances primarily used as antioxidants E 220 Sulphur dioxide*; E 221 Sodium sulphite*; E 222 sodium bisulphite*; E 223 sodium metabisulphite*; E 224 potassium metabisulphite*; E 225 calcium metabisul- phite*; E 300 l-ascorbic acid, E 301 sodium l-ascorbate*; E 302 calcium l-ascorbate*; E 303 l-ascorbyl acetate*; E 304 /-ascorbyl palmitate; E 306 concentrated tocopherol extracts of natural origin; E 307 DL-~-tocopherol; E 308 DL-V-tocopherol; E 309 DL-t~- tocopherol; E 311 octyl gallate; E 312 dodecyl gallate; E 320 butylated hydroxyanisole; E 322 lecithins*.

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Page 1: European Economic Community (EEC)

EUROPEAN ECONOMIC COMMUNITY (EEC) LEGISLATION 625

European Economic Community (EEC) REVISED DRAFT DIRECTIVE ON ANTIOXIDANTS

The text of the revised draft directive on antioxidants has been published in the Journal O~ciel des CommunauMs Europ~ennes of 13 April 1965 and supersedes the original draft directive (Cited in F.C.T. 1964, 2, 51).

There are several minor changes in the text of the Articles in the original draft directive, but the only major change is the addition of another Article (No. 2) concerned with the uses of propyl gallate and the esters of l-ascorbic acid with C14-Cts straight-chain fatty acids. This Article reads as follows:

As a departure from Article 1 the Member States may, for a period of 3 yr after notifi- cation of this directive, retain the national regulations governing the use of propyl gallate and the esters of l-ascorbic acid and the C~4-C1s straight-chain fatty acids in foodstuffs. Before the end of the period named in sentence 1 the Council may, in accordance with Article 100 of the Treaty, decide on a draft directive by which the substances specified in sentence I are included in the Annex; the inclusion of those substances in the Annex may only be decided upon if it has been proved by scientific investigations that those sub- stances are not injurious to health and if their use is necessary on economic grounds. To the list of 13 permitted substances constituting Appendices A and B of the original

draft directive, 25 substances (marked with an asterisk) have been added to and one (propyl gallate) omitted from the Annex to the revised draft directive.

The Annex is divided into two parts: (1) substances which are primarily used as anti- oxidants, including certain substances which are now on the EEC permitted list of preserva- tives (e.g. sulphur dioxide and sodium sulphite) and which can also be employed as anti- oxidants; and (2) substances like lactic and tartaric acid, used for other purposes but whose antioxidant effects are incidental.

One notable absentee from the lists of both draft directives is butylated hydroxytoluene. The reason underlying the omission of propyl gallate from the revised draft list is based

on the effect the antioxidant is known to exercise on the nutritive value of fats. A temporary provision has, however, been laid down (Article 2 of the revised draft directive) which permits member states to enforce their regulations on this antioxidant for a period of 3 yr by which time the antioxidant may be incorporated in the Annex, providing satisfactory evidence of safety-in-use and necessary economy is forthcoming.

A similar provision laid down in the same Article extends to esters of l-ascorbic acid and C14-C18 straight-chain fatty acids. So far satisfactory toxicological data are available only for ascorbyl palmitate and at least short-term tests will have to be conducted on the other compounds before their use can be authorized.

Annex

Part I. Substances primarily used as antioxidants

E 220 Sulphur dioxide*; E 221 Sodium sulphite*; E 222 sodium bisulphite*; E 223 sodium metabisulphite*; E 224 potassium metabisulphite*; E 225 calcium metabisul- phite*; E 300 l-ascorbic acid, E 301 sodium l-ascorbate*; E 302 calcium l-ascorbate*; E 303 l-ascorbyl acetate*; E 304 /-ascorbyl palmitate; E 306 concentrated tocopherol extracts of natural origin; E 307 DL-~-tocopherol; E 308 DL-V-tocopherol; E 309 DL-t~- tocopherol; E 311 octyl gallate; E 312 dodecyl gallate; E 320 butylated hydroxyanisole; E 322 lecithins*.

Page 2: European Economic Community (EEC)

626 CANADIAN, IRANIAN LEGISLATION

Part 11. Substances mainly intended for other purposes but having a secondary antioxidant effect

E 270 Lactic acid*; E 325 sodium lactate*; E 326 potassium lactate*; E 327 calcium lactate*; E 330 citric acid; E 331 sodium citrates*; E 332 potassium citrates*; E 333 calcium citrates*; E 334 tartaric acid; E 335 sodium tartrates*; E 336 potassium tar- trates*; E 337 potassium sodium tartrate*; E 338 orthophosphoric acid; E 339 sodium orthophosphates*; E 340 potassium orthophosphates*; E 341 calcium orthophosphates*; E 345 sorbitol*; E 346 glycerol*.

DIRECTIVE ON PRESERVATIVE SPECIFICATIONS The Journal Officiel des Communautds Europdennes of 9 February 1965 contains the text

of a Directive on the establishment of specific criteria of purity for preservatives permitted for use in foodstOaffs and listed in Parts I and II of the Directive on Preservatives (Cited in F.C.T. 1964 2, 468). The substances covered are:

E200 Sorbic acid; E 201 sodium sorbate; E 202 potassium sorbate; E 203 calcium sorbate; E 210 benzoic acid; E 211 sodium benzoate; E 212 potassium benzoate; E 213 calcium benzoate; E214 ethyl p-hydroxybenzoate; E215 ethyl p-hydroxybenzoate sodium salt; E216 n-propyl p-hydroxybenzoate; E217 n-propyl p-hydroxybenzoate sodium salt; E220 sulphur dioxide; E221 sodium sulphite; E222 sodium hydrogen sulphite; E 223 sodium metabisulphite; E 224 potassium metabisulphite; E 225 calcium metabisulphite; E 250 sodium nitrite; E 251 sodium nitrate; E 252 potassium nitrate; E260 acetic acid; E261 potassium acetate; E262 sodium diacetate; E263 calcium acetate; E 270 lactic acid; E 280 propionic acid; E 281 sodium propionate; E 282 calcium propionate; E 290 carbon dioxide.

Canada PROPOSED ANTIOXIDANT AMENDMENTS

A trade information letter (No. 251) has been sent out by the Department of National Health and Welfare, proposing a modification to the regulations on antioxidants which provides for the use of butylated hydroxyanisole, butylated hydroxytoluene, prop)l gallate and nordihydroguaiaretic acid at permitted levels based on the amount of fat or oil present in the food. Provided evidence can be produced to support their continued use in non-fat type food products, such as dry cereals, dry .beverage mixes, etc., it is proposed that the necessary exemptions be incorporated in the regulations.

I r a n

PERMITTED FOOD COLOURINGS The list of permitted food colourings, which came into effect on 22 March 1965, is as

follows (C.I. (1956) Nos. are given in brackets): Natural colouring matters, organic and inorganic. Cochineal carmine (75470); alkanet

(75520); orchil (75200); carotene (75130); annatto or bixin (75120); turmeric (75300); crocetin (75100); caramel; chlorophyll (75810); carbon black (77266); iron oxide (77492); titanium dioxide (77891); ultramarine (77007).