# COMMISSION DIRECTIVE 2006/129/EC

of 8 December 2006

amending and correcting Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners

(Text with EEA relevance)

## Preamble

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 [^1] , and in particular Article 3(3)(a) thereof,

After consulting the Scientific Committee on Food and the European Food Safety Authority,

Whereas:

**(1)** Commission Directive 96/77/EC [^2] of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners sets out the purity criteria for the additives mentioned in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners [^3] .

**(2)** It is appropriate to withdraw the purity criteria for E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate which are no longer permitted for use as food additives.

**(3)** A number of language versions of Directive 96/77/EC contain errors regarding the following substances: E 307 alpha-tocopherol, E 315 erythorbic acid, E 415 xanthan gum. Those errors need to be corrected. In addition it is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In particular where appropriate, the specific purity criteria have been adapted to reflect the limits for individual heavy metals of interest. For reasons of clarity the whole text concerning those substances should be replaced.

**(4)** The level of sulphated ash in the purity criteria for E 472c citric acid esters of mono- and diglycerides of fatty acids should be amended in order to cover partially or wholly neutralised products.

**(5)** It is necessary to ensure that E 559 aluminium silicate is produced from raw kaolinitic clay which is free from unacceptable dioxin contamination. The presence of dioxin in the raw kaolinitic clay should therefore be restricted to the lowest possible level.

**(6)** It is necessary to adopt specifications for the new food additives authorised through 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: E 319 tertiary-butylhydroquinone (TBHQ), E 426 soybean hemicellulose, E 462 ethyl cellulose, E 586 4-hexylresorcinol, E 1204 pullulan and E 1452 starch aluminium octenyl succinate.

**(7)** Directive 96/77/EC should therefore be amended and corrected accordingly.

**(8)** The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

## **Article 1**

The Annex to Directive 96/77/EC is amended and corrected in accordance with the Annex to this Directive.

## **Article 2**

**1.** Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

## **Article 3**

This Directive shall enter into force on the 20th day following that of its publication in the *Official Journal of the European Union* .

## **Article 4**

This Directive is addressed to the Member States.

## Final provisions

Done at Brussels, 8 December 2006. *For the Commission* Markos KYPRIANOU *Member of the Commission*

[^1] [OJ L 40, 11.2.1989, p. 27](http://publications.europa.eu/resource/oj/JOL_1989_040_R_TOC) . 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](http://publications.europa.eu/resource/oj/JOL_2003_284_R_TOC) ).

[^2] [OJ L 339, 30.12.1996, p. 1](http://publications.europa.eu/resource/oj/JOL_1996_339_R_TOC) . Directive as last amended by Directive 2004/45/EC ( [OJ L 113, 20.4.2004, p. 19](http://publications.europa.eu/resource/oj/JOL_2004_113_R_TOC) ).

[^3] [OJ L 61, 18.3.1995, p. 1](http://publications.europa.eu/resource/oj/JOL_1995_061_R_TOC) . Directive as last amended by Directive 2006/52/EC ( [OJ L 204, 26.7.2006, p. 10](http://publications.europa.eu/resource/oj/JOL_2006_204_R_TOC) ).

The Annex to Directive 96/77/EC is amended and corrected as follows:

**1.** The texts concerning E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate are deleted.

| 2. | \| Purity \| \|; \| --- \| --- \|; \| Refractive index \| n D 20 1,503 to 1,507 \|; \| Specific absorption E 1 % 1 cm in ethanol \| E 1 % 1 cm (292 nm) 72 to 76<br>(0,01 g in 200 ml of absolute ethanol) \|; \| Sulphated ash \| Not more than 0,1 % \|; \| Specific rotation \| [α] 25 D 0° ± 0,05° (1 in 10 solution in chloroform) \|; \| Lead \| Not more than 2 mg/kg’ \| |
| --- | --- |

| 3. | \| Purity \| \|; \| --- \| --- \|; \| Loss on drying \| Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours \|; \| Sulphated ash \| Not more than 0,3 % \|; \| Specific rotation \| [α] 25 D 10 % (w/v) aqueous solution between – 16,5° to – 18,0° \|; \| Oxalate \| To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear \|; \| Lead \| Not more than 2 mg/kg’ \| |
| --- | --- |

| 4. | \| Purity \| \|; \| --- \| --- \|; \| *Tertiary* -Butyl- *p* -benzoquinone \| Not more than 0,2 % \|; \| 2,5- *Di-tertiary* -butyl hydroquinone \| Not more than 0,2 % \|; \| Hydroxyquinone \| Not more than 0,1 % \|; \| Toluene \| Not more than 25 mg/kg \|; \| Lead \| Not more than 2 mg/kg’ \| |
| --- | --- |

| 5. | \| Purity \| \|; \| --- \| --- \|; \| Loss on drying \| Not more than 15 % (105 °C, 2 1 / 2 hours) \|; \| Total ash \| Not more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours \|; \| Pyruvic acid \| Not less than 1,5 % \|; \| Nitrogen \| Not more than 1,5 % \|; \| Ethanol and propan-2-ol \| Not more than 500 mg/kg singly or in combination \|; \| Lead \| Not more than 2 mg/kg \|; \| Total plate count \| Not more than 5 000 colonies per gram \|; \| Yeast and mould \| Not more than 300 colonies per gram \|; \| *E. coli* \| Absent in 5 g \|; \| *Salmonella* spp. \| Absent in 10 g \|; \| *Xanthomonas campestris* \| Viable cells absent in 1 g’ \| |
| --- | --- |

| 6. | \| Purity \| \|; \| --- \| --- \|; \| Loss on drying \| Not more than 7 % (105 °C, 4 h) \|; \| Protein \| Not more than 14 % \|; \| Total ash \| Not more than 9,5 % (600 °C, 4 h) \|; \| Arsenic \| Not more than 2 mg/kg \|; \| Lead \| Not more than 5 mg/kg \|; \| Mercury \| Not more than 1 mg/kg \|; \| Cadmium \| Not more than 1 mg/kg \|; \| Standard plate count \| Not more than 3 000 colonies per gram \|; \| Yeast and mould \| Not more than 100 colonies per gram \|; \| *E. Coli* \| Negative in 10 g’ \| |
| --- | --- |

| 7. | \| Purity \| \|; \| --- \| --- \|; \| Loss on drying \| Not more than 3 % (105 °C, 2 h) \|; \| Sulphated ash \| Not more than 0,4 % \|; \| pH of a 1 % colloidal solution \| Neutral to litmus \|; \| Arsenic \| Not more than 3 mg/kg \|; \| Lead \| Not more than 2 mg/kg \|; \| Mercury \| Not more than 1 mg/kg \|; \| Cadmium \| Not more than 1 mg/kg’ \| |
| --- | --- |

| 8. | \| Purity \| \|; \| --- \| --- \|; \| Acids other than citric and fatty acids \| Not detectable \|; \| Free glycerol \| Not more than 2 % \|; \| Total glycerol \| Not less than 8 % and not more than 33 % \|; \| Total citric acid \| Not less than 13 % and not more than 50 % \|; \| Sulphated ash (determined at 800 ± 25 °C) \| Non-neutralised products: not more than 0,5 %<br>Partially or wholly neutralised products: not more than 10 % \|; \| Lead \| Not more than 2 mg/kg \|; \| Free fatty acids \| Not more than 3 % estimated as oleic acid \|; \| *Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).* ’ \| \| |
| --- | --- |

| 9. | \| Purity \| \|; \| --- \| --- \|; \| Loss on ignition \| Between 10 and 14 % (1 000 °C, constant weight) \|; \| Water soluble matter \| Not more than 0,3 % \|; \| Acid soluble matter \| Not more than 2 % \|; \| Iron \| Not more than 5 % \|; \| Potassium oxide (K 2 O) \| Not more than 5 % \|; \| Carbon \| Not more than 0,5 % \|; \| Arsenic \| Not more than 3 mg/kg \|; \| Lead \| Not more than 5 mg/kg \|; \| Mercury \| Not more than 1 mg/kg’ \| |
| --- | --- |

| 10. | \| Purity \| \|; \| --- \| --- \|; \| Acidity \| Not more than 0,05 % \|; \| Sulphated ash \| Not more than 0,1 % \|; \| Resorcinol and other phenols \| Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced \|; \| Nickel \| Not more than 2 mg/kg \|; \| Lead \| Not more than 2 mg/kg \|; \| Mercury \| Not more than 3 mg/kg’ \| |
| --- | --- |

| 11. | \| Purity \| \|; \| --- \| --- \|; \| Loss on drying \| Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 h) \|; \| Mono-, di- and oligosaccharides \| Not more than 10 % expressed as glucose \|; \| Viscosity \| 100 to 180 mm 2 /s (10 % w/w aqueous solution at 30 °C) \|; \| Lead \| Not more than 1 mg/kg \|; \| Yeast and moulds \| Not more than 100 colonies per gram \|; \| Coliforms \| Absent in 25 g \|; \| Salmonella \| Absent in 25 g’ \| |
| --- | --- |

| 12. | \| Purity \| \|; \| --- \| --- \|; \| (all values expressed on an anhydrous basis except for loss on drying) \| \|; \| Loss on drying \| Not more than 21 % \|; \| Octenylsuccinyl groups \| Not more than 3 % \|; \| Octenylsuccinic acid residue \| Not more than 0,3 % \|; \| Sulphur dioxide \| Not more than 50 mg/kg for modified cereal starches<br>Not more than 10 mg/kg for the other modified starches unless otherwise specified \|; \| Arsenic \| Not more than 1 mg/kg \|; \| Lead \| Not more than 2 mg/kg \|; \| Mercury \| Not more than 0,1 mg/kg \|; \| Aluminium \| Not more than 0,3 %’ \| |
| --- | --- |

[^1]: . Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council ().
[^2]: . Directive as last amended by Directive 2004/45/EC ().
[^3]: . Directive as last amended by Directive 2006/52/EC ().