Implementation in Scotland of European directive on additives
Monday 22 January 2007
Draft regulations implementing in Scotland European Parliament and Council Directive 2006/52/EC amending Directives 95/2/EC on food additives other than colours and sweeteners and 94/35/EC on sweeteners for use in foodstuffs.
All comments and views should be sent to:
Contaminant, Hygiene, Additives and Shellfish
Food Standards Agency Scotland
6th Floor, St Magnus House
25 Guild Street
Aberdeen AB11 6NJ
Tel: 01224 285158
Responses are requested by: 9 April 2007
Directive 2006/52/EC is available on the EU website.
The key proposals are:
- a reduction in the levels for nitrites and nitrates in meat and other food products, with exceptions for a number of traditional products
- the withdrawal of two preservatives
- the withdrawal of the authorisation for gelling agents for use in jelly mini-cups
- the authorisation of seven new food additives
- a number of additional uses of already permitted food additives
The Miscellaneous Food Additives Regulations 1995 have been amended five times to implement amendments to Directive 95/2/EC. The Sweeteners in Food Regulations have been amended twice to implement amendments to Directive 94/35/EC. The draft Miscellaneous Food Additives and the Sweeteners in Food Amendment (Scotland) Regulations 2007 will implement the provisions of Directive 2006/52/EC in Scotland.
Member States are required to implement the provisions of Directive 2006/52/EC into national legislation before 15 February 2008 and to prohibit products that do not comply with the Directive by 15 August 2008. In Scotland, the Agency is aiming to bring the Regulations into force in June 2007, in line with the proposed UK timetable. However, due to the Scottish elections in May this may not be possible, in which case the Regulations will be brought into force after summer recess. Transitional provisions have been included, permitting additives or uses of additives not conforming to Directive 2006/52/EC, but in line with Directive 95/2/EC and put on the market or labelled before 15 August 2008, to continue to be marketed until stocks are exhausted.
Details of the consultation
The main amendments to Directive 95/2/EC are:
1) A reduction in the authorised levels for nitrites and nitrates 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 while 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, will be based on added rather than residual amounts. However, during Brussels discussions on the Commission's original proposal, Member States recognised that a degree of compromise was required in order to achieve the objective of further controls on the use of nitrates and nitrites in most meat products, while allowing the continued production of certain traditional products. These compromises,which include provisions that will permit traditional UK meat products such as Wiltshire cured ham, bacon and similar products to be produced based on residual amounts, were agreed during the UK Presidency, and are contained within the new legislation.
2) 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) that 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.
3) 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.
4) The authorisation of seven new food additives - erythritol, 4-hexylresorcinol, soybean hemicellulose and starch aluminium octenyl succinate (following positive evaluations by the Scientific Committee on Food), and ethyl cellulose, pullulan and tertiary butyl hydroquinone (TBHQ) (following positive evaluations by the European Food Safety Authority).
5) 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, sulphites in cooked crustaceans, grapes and lychees and certain additives in traditional Hungarian products.
The main amendment to Directive 94/35/EC is 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. Although the SCF opinion noted that laxative effects from erythritol occur at higher intake levels than seen for other polyols, it was nevertheless agreed during Brussels discussions that erythritol should not be exempt from the labelling rule regarding laxative effects in table-top sweeteners containing polyols.
The purpose of this written consultation is to seek stakeholders' views on the attached document, which includes:
- The draft Miscellaneous Food Additives and the Sweeteners in Food Amendment (Scotland) Regulations 2007
- A Regulatory Impact Assessment (RIA) for the draft Regulations, setting out likely impact in terms of costs and benefits
Partial Regulatory Impact Assessments (RIA)
Specific questions for the consultation
- does the RIA accurately reflect the cost implications for businesses affected by the proposed regulations?
- are there other implications for consumers, enforcement officers and businesses, which should be taken into account?
- is there any other information you can provide that would better illustrate the effects of these proposals on consumers, enforcement officers and businesses?
The RIA already includes assessments of the impact of the proposals on small businesses. The Agency would particularly welcome any comments from small firms, or trade bodies that represent small firms, as to any further likely cost implications arising from the new regulations
This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.
We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.
Publication of personal data and confidentiality of responses
In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.
Data protection form (Word)
Data protection form (pdf)
Publication of response summary
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