EN Official Journal of the European Union L 44/62

COMMISSION DIRECTIVE 2009/10/EC

of 13 February 2009

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

(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 of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (2) 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 (hereinafter 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 E234 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 additives (5). 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 E400 alginic acid, E401 sodium alginate, E402 potassium alginate, E403 ammonium alginate, E404 calcium alginate, and E405 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 E407 carrageenan and E407a 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 2007 (6), 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 E412 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 E504(i) 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 E526 calcium hydroxide and E529 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 E526 calcium hydroxide and E529 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 E526 calcium hydroxide and E529 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 2007 (7) 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 E901 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 (hereinafter 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 E905 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 E905 microcrystalline wax in order to also cover waxes derived from synthetic hydrocarbon feedstocks.

(11) E230 (biphenyl) and E233 (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 13 February 2010 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 its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 13 February 2009. For the Commission Androulla VASSILIOU Member of the Commission

(1) OJ L 40, 11.2.1989, p. 27.

(2) OJ L 253, 20.9.2008, p. 1.

(3) OJ L 61, 18.3.1995, p. 1.

(4) http://www.efsa.europa.eu/en/science/afc/afc_opinions/ej314b_nisin.html

(5) Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request from the Commission related to use of formaldehyde as a preservative during the manufacture and preparation of food additives; Question No EFSA Q-2005-032.

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620766610.htm

(6) Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food on a request from the Commission related to an application on the use of partially depolymerised guar gum as a food additive; Question No EFSA-Q-2006-122.

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178638739757.htm

(7) Beeswax (E 901) as a glazing agent and as carrier for flavours; Scientific Opinion of the Panel on food additives, flavourings, processing aids and materials in contact with food (AFC); Question No EFSA-Q-2006-021.

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178672652158.htm

(8) http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_37.pdf