Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version) (Text with EEA relevance)

32008L0128DirectiveJan 30, 2009

of 22 December 2008

laying down specific purity criteria concerning colours for use in foodstuffs

(Codified version)

(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 authorized for use in foodstuffs intended for human consumption 1 , and in particular Article 3(3)(a) thereof,

Whereas:

(1) Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs 2 has been substantially amended several times 3 . In the interests of clarity and rationality the said Directive should be codified.

(2) It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs 4 .

(3) It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.

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

(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in Annex I hereto.

Article 2

Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

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, 22 December 2008. For the Commission The President José Manuel BARROSO

1 OJ L 40, 11.2.1989, p. 27 .

2 OJ L 226, 22.9.1995, p. 1 .

3 See Annex II, Part A.

4 OJ L 237, 10.9.1994, p. 13 .

A. GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS

DefinitionAluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.
HCl insoluble matterNot more than 0,5 %
Ether extractable matterNot more than 0,2 % (under neutral conditions)
Specific purity criteria for the corresponding colours are applicable.

B. SPECIFIC CRITERIA OF PURITY

Purity
Subsidiary colouring mattersNot more than 0,5 %
Organic compounds other than colouring matters:
2-Amino-5-methylbenzenesulfonic acid, calcium saltNot more than 0,2 %
3-hydroxy-2-naphthalenecarboxylic acid, calcium saltNot more than 0,4 %
Unsulfonated primary aromatic aminesNot more than 0,01 % (expressed as aniline)
Ether extractable matterFrom a solution of pH 7, not more than 0,2 %
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg

1 Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

2 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

3 Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).

4 Benzene not more than 0,05 % v/v.

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 2)

Commission Directive 95/45/EC( OJ L 226, 22.9.1995, p. 1 )
Commission Directive 1999/75/EC( OJ L 206, 5.8.1999, p. 19 )
Commission Directive 2001/50/EC( OJ L 190, 12.7.2001, p. 14 )
Commission Directive 2004/47/EC( OJ L 113, 20.4.2004, p. 24 )
Commission Directive 2006/33/EC( OJ L 82, 21.3.2006, p. 10 )

PART B

List of time-limits for transposition into national law

(referred to in Article 2)

DirectiveTime-limit for transposition
95/45/EC1 July 1996 1
1999/75/EC1 July 2000
2001/50/EC29 June 2002
2004/47/EC1 April 2005 2
2006/33/EC10 April 2007

1 According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted.

2 According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted.

Correlation table

Directive 95/45/ECThis Directive
Article 1, first paragraphArticle 1
Article 1, second paragraph
Article 2
Article 2
Article 3Article 3
Article 4Article 4
AnnexAnnex I
Annex II
Annex III

Footnotes

  1. According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted. 2 3 4 5

  2. According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted. 2 3 4 5

  3. Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell). 2 3

  4. Benzene not more than 0,05 % v/v. 2 3

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