FSA Consultation Letter, 28 October 2004

ADDITIVES - Proposal for a Directive to amend Directive 95/2/EC and Directive 94/35/EC from the European parliament and council

The FSA is seeking views on a European Commission proposal for a European Parliament and Council Directive amending Directive 95/2/EC on food additives other than colours and sweeteners for the sixth time and Directive 94/35/EC on sweeteners for use in foodstuffs for the third time. Responses are requested by: 21 January 2005

[Note: the Proposal is available in COM (2004) 0650 - see also EU News Item 11 October 2004]

Consultation details

Although the standard twelve week consultation period will be allowed, the FSA understand that the Dutch Presidency will be holding initial discussions on the proposal at the end of November so early responses would be appreciated in order to inform their negotiating position.

Summary

The key points of the proposal are as follows:

Amendments to Directive 95/2/EC

• Induction in the authorised levels for nitrites and nitrites in meat and other food products, which takes account of the opinion of the European Food Safety Authority (EFSA), published on 26 November 2003, and aims to keep levels of nitrosamines as low as possible whilst maintaining the microbiological safety of food products. In addition, in line with EFSA's recommendations, controls on the level of nitrites and nitrates in non-heat treated or heat treated meat products, in cheese and in fish, are based on added amounts.

  However, at the request of the UK, supported by Ireland, the existing system of control, based on maximum residual levels of nitrites/nitrates in the food as sold, have been maintained for certain traditional UK meat products, such as Wiltshire cured ham, bacon and similar products. The UK meat products industry claim that it would be impossible to produce these speciality foods which use a 'live' brine in the curing process by controlling added amounts of nitrite/nitrate as it is impossible to specify in-going amounts. The products do however comply with the current controls on residual amounts of nitrite/nitrate.

• The withdrawal of two preservatives E 216 (propyl p-hydroxybenzoate) and E 217 (sodium propyl p-hydroxybenzoate) following an EFSA evaluation of E 214 - 219 parahydroxybenzoates (parabens) which concluded that an Acceptable Daily Intake level could not be established for E 216 and E 217. There will be no change as regards the use of the other parabens.
• The withdrawal of the authorisation for gelling agents for use in jelly mini-cups, which are a single, pre-packed sweet or confectionery and which are considered a choking risk because of their consistency, shape and form. This makes permanent an earlier Commission Decision suspending the marketing in the EU of jelly mini-cups containing certain food additives derived from seaweed and/or certain gums.
• The authorisation of four new food additives - erythritol, 4-Hexylresorcinol, and soybean hemicellulose (following positive evaluations by the Scientific Committee on Food), and ethyl cellulose (following a positive evaluation by the European Food Safety Authority).
• A number of additional uses of already permitted food additives - sodium hydrogen carbonate in sour milk cheese, sorbates and benzoates in crustaceans, silicon dioxide as a carrier in certain colours, and authorisation of the use of certain additives in traditional Hungarian products.

 

Amendment to Directive 94/35/EC

• The authorisation of a new sweetener, erythritol, following a positive evaluation by the Scientific Committee on Food. As well as requiring authorisation under Directive 95/2/EC as a flavour enhancer, erythritol can also be used as a sweetener and therefore requires authorisation under Directive 94/35/EC for such uses. As with other polyols, erythritol can exhibit a laxative effect, but the SCF opinion noted that this occurs at higher levels of intake than seen for other polyols. It is proposed therefore that erythritol will be exempt from the labelling rule regarding laxative effects in table-top sweeteners containing polyols.

Background

European Parliament and Council Directive 95/2/EC harmonised the use of food additives other than colours and sweeteners (referred to in UK legislation as miscellaneous food additives) throughout the EU. It has been amended on five previous occasions. European Parliament and Council Directive 94/35/EC harmonised the use of sweeteners for use in foodstuffs throughout the EU. It has been amended twice.

The proposed amendment (COM (2004) 650 final) has three main purposes. The first is to amend Directive 95/2/EC to take account of EFSA's opinions on nitrites and nitrates and on parabens. The second is to make permanent the suspension of gelling agents in jelly mini-cups in Commission Decision 2004/374/EC. The third is to update existing entries in Directives 95/2/EC and 94/35/EC to take account of SCF and EFSA opinions on new additive approvals, and to extend the uses of existing additives in line with industry's requests and that of a new Member State, Hungary.

The proposed amendments have previously been discussed at European Commission Working Groups on food additives. The Commission's formal proposal will be discussed at a Council Working Group chaired by the Dutch Presidency, possibly at the end of November 2004.

Procedure

In the UK, this proposal will be examined by the House of Commons European Scrutiny Committee and the House of Lords Select Committee on the European Communities.

The adoption of this measure is subject to the EU co-decision procedure. The proposal will therefore be considered both by the European Parliament and the Council of Ministers.

Once the amending Directive is agreed by both the European Parliament and the Council of Ministers, it will need to be implemented in the UK.

Coming into force

Member States are required to implement the new Directive into national legislation within 18 months of its coming into force. Industry will be allowed 24 months from its coming into force date to trade in and use products not complying with the Directive's provisions. A provision for using up old stocks of products marketed or labelled before the period of 24 months has elapsed and which are no longer permitted by the Directive has also been included.

The Directive will be implemented in England by further amendments to the Miscellaneous Food Additives Regulations 1995 and the Sweeteners in Food Regulations 1995 and will also be implemented separately in Scotland, Wales and Northern Ireland. Before new regulations are implemented in the UK, they will be subject to separate consultation exercises in England, Scotland, Wales and Northern Ireland.