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EN

SANCO/569/2008 Rev. 6 (POOL/E3/2008/569/569R6-EN.doc)



COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels,

C(2008) final

Draft

COMMISSION DIRECTIVE

of

amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (codified version)

(Text with EEA relevance)

Draft


COMMISSION DIRECTIVE

of

amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (codified version)

(Text with EEA relevance)

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 (SCF) and the European Food Safety Authority (EFSA),

Whereas:



  1. Commission Directive 2008/84/EC(2) of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (codified version) sets out the purity criteria for the additives mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners(3).

  2. The European Food Safety Authority (hereafter 'EFSA') concluded in its Opinion of 20 October 2006(4) that nisin produced through a modified production process using a sugar-based medium is equivalent with respect to health protection to the one produced by the original milk-based medium process. On the basis of that opinion, the existing specifications for E 234 nisin should be amended in order to adapt the definition and the purity criteria set out for that additive.

  3. Formaldehyde is used as a preservative during the manufacture of alginic acid, alginate salts and esters of alginic acid. It has been reported that residual formaldehyde, up to 50 mg/kg, may be present in the final gelling additives. At the request of the Commission, EFSA assessed the safety in use of formaldehyde as a preservative during the manufacture and preparation of food additives5. EFSA in its Opinion of 30 November 2006 concluded that the estimated exposure to gelling additives containing residual formaldehyde at the level of 50 mg/kg of additive would be of no safety concern. Therefore the existing purity criteria for E 400 alginic acid, E 401 sodium alginate, E 402 potassium alginate, E 403 ammonium alginate, E 404 calcium alginate, and E 405 propane-1.2-diol alginate should be amended in such a way that the maximum level of formaldehyde is set at 50 mg/kg.

  4. Formaldehyde is not currently used in the processing of seaweeds for the production of E 407 carrageenan and E 407a processed eucheuma seaweed. However, it may be naturally occurring in marine algae and be consequently present as an impurity in the finished product. It is therefore appropriate to fix a maximum level of adventitious presence of the above substance in those food additives.

  5. Guar gum is authorised as a food additive for use in foodstuffs by Directive 95/2/EC. In particular, it is used as thickener, emulsifier, and stabiliser. A request to use a partially depolymerised guar gum as a food additive, produced from native guar gum by one of the three manufacturing processes consisting of heat treatment, acid hydrolysis or alkaline oxidation, was submitted to the Commission. EFSA assessed the safety in use of that additive and, in its opinion of 4 July 20076, estimated that partially depolymerised guar gum has been shown to be very similar to native guar gum with respect to the composition of the final product. It also concluded that partially depolymerised guar gum is of no safety concern for its use as thickener, emulsifier or stabiliser. However, in the same Opinion, EFSA recommended that the specifications for E 412 guar gum should be adjusted to take into account the increased level of salts and the possible presence of undesirable by-products that may result from the manufacturing process. On the basis of the recommendations issued by EFSA, the specifications of guar gum should be amended.

  6. It is necessary to adopt specifications for E 504i magnesium carbonate authorised as a food additive for use in foodstuffs through Directive 95/2/EC.

  7. On the basis of data provided by the European Lime Association, it appears that the manufacturing of lime products from available raw materials does not permit them to comply with the existing purity criteria set for E 526 calcium hydroxide and E 529 calcium oxide, as regards the level of magnesium and alkali salts. Taking into account that magnesium salts are of no safety concern and the specifications as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA), it is appropriate to adjust the levels of magnesium and alkali salts for E 526 calcium hydroxide and E 529 calcium oxide to the lowest achievable values, which remain lower or equal to the levels set by JECFA.

  8. In addition, it is necessary to take into account the specifications as set out in the Codex Alimentarius drafted by JECFA with regard to the level of lead for E 526 calcium hydroxide and E 529 calcium oxide. However, due to the natural high background of lead contained in the raw material (calcium carbonate) extracted in some Member States, and from which those additives are derived, it appears difficult to align the level of lead contained in those food additives with the upper limit of lead set by JECFA. Therefore the current level of lead should be reduced to the lowest achievable threshold.

  9. E 901 beeswax is authorised as a food additive in Directive 95/2/EC. EFSA in its Opinion of 27 November 20077 confirmed the safety in use of this food additive. However, it also indicated that the presence of lead should be restricted to the lowest possible level. Taking into account the revised specifications for beeswax as set out in the Codex Alimentarius as drafted by JECFA, it is appropriate to amend the existing purity criteria for E 901 beeswax in order to lower the maximum permitted level of lead.

  10. Highly refined waxes deriving from synthetic hydrocarbon feedstock (synthetic waxes) and from petroleum based feedstock were jointly evaluated by the Scientific Committee on Food (hereafter 'SCF')8 and an opinion on mineral and synthetic hydrocarbons was issued on 22 September 1995. The SCF considered that sufficient data had been provided to allocate a full group ADI (acceptable daily intake), covering both types of waxes, i.e. waxes deriving from petroleum based or synthetic hydrocarbon feed stocks. When purity criteria for E 905 microcrystalline wax were established, the synthetic hydrocarbon waxes were omitted and not included in the specifications. The Commission considers it therefore necessary to amend the purity criteria for E 905 microcrystalline wax in order to also cover waxes derived from synthetic hydrocarbon feedstocks.

  11. E 230 (biphenyl) and E 233 (thiabendazole) are no longer permitted as food additives in the EU legislation. These substances have been removed respectively by Directive 2003/114/EC and Directive 98/72/EC. Consequently, the Annex I to Directive 2008/84/EC should be updated accordingly and the specifications to E230 and E233 should be withdrawn.

  12. It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius drafted by the JECFA. In particular where appropriate, the specific purity criteria need to be adapted to reflect the limits for individual heavy metals of interest.

  13. Directive 2008/84/EC should therefore be amended accordingly.

  14. 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 I to Directive 2008/84/EC is amended 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 [one year after the date of adoption] at the latest. They shall forthwith communicate to the Commission the text of those provisions.

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.

Done at Brussels,

For the Commission

Androulla VASSILIOU

Member of the Commission

ANNEX

The Annex I to Directive 2008/84/EC is amended as follows:

1. The text concerning E 234 nisin is replaced by the following:

E 234 NISIN



Definition

Nisin consists of several closely related polypeptides produced during the fermentation of a milk or sugar medium by certain natural strains of Lactococcus lactis subsp.lactis.

Einecs

215-807-5

Chemical formula

C143 H230 N42 O37 S7

Molecular weight

3 354,12

Assay

Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk proteins or fermented solids and a minimum sodium chloride content of 50 %

Description

White powder

Purity




Loss on drying

Not more than 3% when dried to constant weight at 102 °C to 103 °C

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1mg/kg

Mercury

Not more than 1 mg/kg"

2. The text concerning E 400 Alginic Acid is replaced by the following:

E 400 ALGINIC ACID



Definition

Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L- guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)

Einecs

232-680-1

Chemical formula

(C6H8O6)n

Molecular weight

10 000—600 000 (typical average)

Assay

Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculated on equivalent weight basis of 200)

Description

Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless

Identification




A. Solubility

Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate

B. Calcium chloride precipitation test

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum

C. Ammonium sulphate precipitation test

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch

D. Colour reaction

Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple

Purity




pH of a 3 % suspension

Between 2,0 and 3,5

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Sulphated ash

Not more than 8 % on the anhydrous basis

Sodium hydroxide (1 M solution)

Not more than 2 % on the anhydrous basis insoluble matter

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g”

3. The text concerning E 401 Sodium Alginate is replaced by the following:

E 401 SODIUM ALGINATE



Definition




Chemical name

Sodium salt of alginic acid

Chemical formula

(C6H7NaO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification




Positive test for sodium and alginic acid




Purity




Loss on drying

Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g”

4. The text concerning E 402 Potassium Alginate is replaced by the following:

E 402 POTASSIUM ALGINATE



Definition




Chemical name

Potassium salt of alginic acid

Chemical formula

(C6H7KO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification




Positive test for potassium and for alginic acid




Purity




Loss on drying

Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g”
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