Draft Commission Decision (SANCO/362/2002) suspending the placing on the market and import of jelly confectionery containing food additive E 425 Konjac

A short paper follows which explains the issues behind this draft Commission Decision and the FSA position. In order to be aware of views before the issue is discussed at the meeting of the Standing Committee on the Food Chain and Animal Health on 19 March 2002, I would be grateful for your comments by 15 March.

Publication of responses

2. Please note that all responses will normally be made publicly available in full. If you would prefer your comments not to be made publicly available, please indicate this in your letter, explaining your reasons. A summary of the responses received will also be published on the Food Standards Agency website as soon as possible after the closing date of the consultation. Publication of responses in full may include personal data (such as your contact / address details). Please say whether or not you agree to such personal data being published as part of the response by returning the attached form to indicate your intention. If no objection is received, we will assume that you consent to full disclosure and we may publish the details.

Further information

3. This consultation has been prepared in accordance with the Cabinet Office's Code of Practice on Written Consultation, available at www.consultation.gov.uk If you need any further information about the issues covered in the attached paper letter, please contact me, Noel Griffin or Simon Renn . If the mailing information used to send you this letter has changed please let us have your new details. If you have any Data Protection concerns, please contact Kay Wolf (FSA Records Manager) (020 7276 8194, e-mail kay.wolf@foodstandards.gsi.gov.uk).

Purpose
1. This is a UK wide consultation on draft emergency legislation to ensure consistent action across Europe on the risk to consumers posed by the choking hazard presented by jelly mini-cups (mini fruit gel sweets) containing konjac.

2. The effect of the legislation will be to suspend the use, placing on the market and import of jelly confectionery, including jelly mini-cups, containing konjac (E425) in the European Community. The draft legislation aims to provide adequate protection of human health across Europe in light of the disparity of action by Member States on these products.

3. This proposal will be voted on at the meeting of the Standing Committee on the Food Chain and Animal Health on 19 March 2002 and if adopted will be enacted in UK legislation by emergency Regulation shortly thereafter. Comments from interested parties are therefore required by close on 15 March. In light of the timetable, the deadline cannot be extended.

Background
4. A number of deaths have been reported from around the world linked to jelly mini-cups containing konjac. We are also aware of the death of a young child in February in the UK. The cause of death is not yet known and is subject to an inquest which has not yet been held. However, the fact that a minicup gel sweet may have been a factor in the death cannot be excluded at this stage. These sweets are imported from the far East and we are not aware of manufacturers in the UK or the European Union. In the UK the FSA issued a Statement in August 2001 giving advice that parents should be alert to the potential risk from these sweets and that children should not buy or eat them.

5. Based on further information gathered and advice from the Department of Health, the FSA assessed these jelly mini-cups containing konjac as not being suitable for sale on the UK market because they present a choking hazard due to their size, shape, consistency and solubility. Some of these products contain a small piece of fruit that may also present a hazard. Subsequently, the FSA issued two Food Hazard Warnings (FHW) to local authorities (14 December 2001 and 6 March 2002). Enforcement Officials have taken action under existing legislation to remove this product from sale. This legislation is the General Product Safety Regulations 1994 (implementing the EU General Product Safety Directive) and the Food Safety Act 1990. A number of other countries, including a number of Member States, have taken action to address this risk.

6. Konjac (konjac glucomannane, konjac gum) is a permitted food additive (E 425), approved for safety by the EC Scientific Committee on Food. It has, since 1998/9, been permitted to be used in a wide range of foods under UK/EC miscellaneous additives legislation. Imports may also describe this ingredient as glucomannan, konyak, konjac gum, konyac, conjac, konnyaku or konnuyaku.

7. The FSA has been made aware that some of the jelly mini-cups containing konjac may still be on retail sale in the UK, particularly in smaller outlets such as corner shops, newsagents, market stalls etc. To counter this problem we have issued further advice in a second FHW to Local Authorities and more widely publicised this in the media. The fact that Member States have taken different food safety measures on this problem across the European Union means there is no certainty that this product has been stopped from coming into the European market. While Enforcement Officials are making every effort to stop the entry of product into the UK, the surest means is for a consistent approach across Europe. We have been pressing the European Commission to introduce measures to achieve this.

Issue
8. The Commission has concluded that jelly mini-cups containing konjac constitute a life-threatening risk. This risk to human health is presented by the size and shape, and the chemical and physical properties of the products.

9. In order to ensure a consistent approach across the Community, the European Commission has proposed to suspend the sale, production or import of jelly confectionery containing konjac. The measure aims to provide adequate protection of human health across the Community

10. The Commission can take action under Article 53 (1) of Regulation No 178/2002. This Regulation lays down the general principles and requirements of food law, and procedures in matters of food safety. Once adopted, the UK will enact an emergency Statutory Instrument shortly thereafter.

11. The FSA supports this proposal. Further action is likely by an amendment of Directive 95/2/EEC on food additives other than colours and sweeteners, in order to modify the authorisation for the use of E 425 konjac in line with this proposal.

Your views
12. We are inviting comments on this proposal and on the FSA position of support for it.

13. This proposal may have an economic impact on some sectors of the UK food industry. We would welcome comments to help us better assess what this impact is likely to be.

Reference Documents
14. The key document is the draft Commission Decision, reference number SANCO/362/2002, dated 4 March 2002. This is enclosed. Other European Regulations and Directives referred to in this paper are available online at www.europa.eu.

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.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

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)

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk