1. © 2005 Food Supplements Guidance Note Dr. Muireann Cullen Technical Executive 21.04.05

2. © 2005 Working Group FSAI Environmental Health Officers (EHOs) Irish Medicines Board Irish Health Trade Association Irish Association of Health Stores

3. © 2005 Scope Information on implementation, enforcement & compliance with Statutory Instrument No. 539 of 2003 (& Directive 2002/46/EC). Guidance note on the European Communities (Food Supplements Regulations) 2003, S.I. No. 539 of 2003 and the notification of food supplements.

4. © 2005 Who would find it useful? For food supplement manufacturers , importers , distributors  & retailers  as well as EHOs.  Includes website sales, company mail order sales and network marketing.

5. © 2005 Example of areas dealt with (1) Definitions e.g. food supplement, medicine, market etc. Key dates Food supplement v. medicine Food supplement labels

6. © 2005 Example of areas dealt with (2) Notification When to notify Ingredients listed/not listed How to notify Responsibility to notify Products notified in another Member State Processing of notification

7. © 2005 Example of areas dealt with (3) Warranty through the chain Marketing without notification Enforcement of the Directive offences

8. © 2005 Notification procedure to FSAI Notification to FSAI of intent to bring new product onto market for first time required Submit: Completed notification form** Product Label Associated literature (advertising, leaflets etc.) Relevant certificates e.g. TSE certificates

9. © 2005 Summary of Notification form** Manufacturer Contact Details: Name, Address, Phone & Fax, E mail Importer Details: Name, Address, Phone & Fax, E mail Product details Product Name Product Description What is the function of this product? A model of the product label and accompanying product literature should be provided to the FSAI. Signature: ______________________ Name in block letters: _____________Date:___________ www.fsai.ie/legislation/notif_forms/food_supp_not_form.pdf. www.fsai.ie/legislation/notif_forms/food_supp_not_form.doc

10. © 2005 Processing of notification Acknowledgement of receipt of all required information Product and literature assessed Notifier informed of outcome within 8 weeks* of completed submission *additional time required

11. © 2005 Notification Outcomes Positive : applicant company will receive a letter stating compliance with the legislation. Negative: applicant company is informed by letter, detailing reasons of same and advised how to become compliant with the legislation.

12. © 2005 Product Classification unclear Liaison FSAI IMB Representatives of business in question (specific) Representatives of trade (general) IMB classification committee Decision made is final* * More information becomes available, requiring review

13. © 2005 Derogation Ireland has taken full derogation 31 st December 2009 Products with submitted ingredient dossiers No unfavourable EFSA opinion

14. © 2005 Where is it at? Final drafting stages Public consultation on website (6 weeks) www.fsai.ie/consultations/index.asp Collate comments Final document published

15. © 2005