COMMISSION DIRECTIVE 2010/67/EU
of 20 October 2010
amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 30(5) thereof,
After consulting the Scientific Committee on Food and the European Food Safety Authority,
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)
Under Article 30(4) of Regulation (EC) No 1333/2008 specifications of the food additives covered under paragraphs 1 to 3 of that Article, including additives authorised under Directive 95/2/EC, shall be adopted, in accordance with Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (4), at the moment when those food additives are entered in the respective Annexes in accordance with those paragraphs.
(3)
Since the lists have not yet been drawn up, and in order to ensure that the modification of the Annexes to Directive 95/2/EC pursuant to Article 31 is effective, and to ensure that additives so authorised comply with safe conditions of use, Directive 2008/84/EC should therefore be amended.
(4)
The entry related to carbon dioxide (E 290) should be revised with respect to the concentration level of ‘oil content’ to take into account Codex Alimentarius specifications drafted by the Joint Expert Committee on Food Additives (JECFA) and the documents of the International Organisation for Standardisation (ISO) (e.g. ISO 6141).
(5)
The European Food Safety Authority (hereinafter the Authority) has assessed the information on the safety of extracts of rosemary when used as an antioxidant in foodstuffs. Extracts of rosemary are derived from Rosmarinus officinalis L. and contain several compounds which exert antioxidative functions (mainly phenolic acids, flavonoids, diterpenoids and triterpenes). It is considered appropriate to adopt specifications for extracts of rosemary which is authorised as a new food additive for use in foodstuffs under Directive 95/2/EC and assigned E 392 as its E number. Several types of production process are described, using solvent extraction (ethanolic, acetone and hexane) and supercritical carbon dioxide extraction.
(6)
Soybean hemicellulose (E 426) was evaluated by the Scientific Committee on Food in 2003 (5) and is currently authorised within the EU under Directive 95/2/EC. A new variety of soybean hemicellulose is now produced and complies with all specifications set out in Directive 2008/84/EC for E 426 except that ethanol is technologically needed as precipitant for purifying the extract solution of that new variety of soybean hemicellulose. In consequence, the final E 426, which feature differs from a spray dried white powder, may also contain some ethanol as a residue at the maximum concentration of 2 %. Ethanol is authorised by Directive 2009/32/EC of the European Parliament and of the Council (6) as extraction solvent during the processing of raw materials, foodstuffs, food components, or food ingredients in compliance with good manufacturing practice.
(7)
The Authority assessed the information on the safety of cassia gum as a new food additive acting as gelling agent and thickener and expressed its opinion on 26 September 2006 (7). The Authority found the use of cassia gum as indicated under the conditions specified of no safety concern. It is therefore appropriate to adopt specifications for that new food additive which is assigned E number 427.
(8)
The entry relating to hydroxypropyl cellulose (E 463) should be modified in order to correct an error of the specifications in relation to the assay. Instead of ‘Content not less than 80,5 % of hydroxypropoxyl groups’, it should read ‘Content not more than 80,5 % of hydroxypropoxyl groups’. It is therefore appropriate to update the current specifications.
(9)
The entry relating to hydrogen (E 949) should be corrected so that the concentration levels indicated in the assay and purity sections can be compatible. Consequently, the concentration of nitrogen should be corrected.
(10)
The Authority assessed the information on the safety of the new food additive, polyvinyl alcohol (PVA), as a film-coating agent for food supplements and expressed its opinion on 5 December 2005 (8). The Authority found the use of PVA of no safety concern in the coating of food supplements that are in the form of capsules and tablets. It is therefore appropriate to adopt specifications for polyvinyl alcohol which is assigned E number 1203, and which is authorised as a food additive under Directive 95/2/EC.
(11)
The Authority assessed the information on the safety of six grades of polyethylene glycols (PEG 400, PEG 3000, PEG 3350, PEG 4000, PEG 6000, PEG 8000) as film coating agents for use in food supplement products and expressed its opinion on 28 November 2006 (9). The Authority found the use of those grades of polyethylene glycol as glazing agent in film-coating formulations of no safety concern for food supplement tablets and capsules under the intended conditions of use. All those grades of polyethylene glycols have been assigned a new E number, namely E 1521. It is therefore appropriate to adopt specifications for those six grades of polyethylene glycols and to group them together under a single entry. Consequently, it is necessary to update the current specifications already laid down in Directive 2008/84/EC for polyethylene glycol 6000.
(12)
EFSA assessed the safety of use of an enzyme preparation based on thrombin with fibrinogen derived from cattle and/or pigs as a food additive for reconstituting food and concluded in its opinion on 26 April 2005 that this use of the enzyme preparation when produced as outlined in the opinion is of no safety concern (10). However, the European Parliament in its Resolution of 19 May 2010 on the draft Commission Directive amending the Annexes to the European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners, considered that the inclusion in Annex IV to Directive 95/2/EC of this enzyme preparation as a food additive for reconstituting food was not compatible with the aim and content of Regulation (EC) No 1333/2008, as it does not meet the general criteria of Article 6 of Regulation (EC) No 1333/2008, especially in paragraph 1(c) of Article 6.
(13)
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.
(14)
Directive 2008/84/EC should therefore be amended accordingly.
(15)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS DIRECTIVE:
Article 1
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 31 March 2011 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, 20 October 2010.