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Food Supplements Guidance Note

Dr. Muireann CullenTechnical Executive

21.04.05

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Working Group

FSAI

Environmental Health Officers (EHOs)

Irish Medicines Board

Irish Health Trade Association

Irish Association of Health Stores

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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.

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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.

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Example of areas dealt with (1)

• Definitions e.g. food supplement, medicine,

market etc.

• Key dates

• Food supplement v. medicine

• Food supplement labels

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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

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Example of areas dealt with (3)

• Warranty through the chain

• Marketing without notification

• Enforcement of the Directive

• offences

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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

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Summary of Notification form**Manufacturer Contact Details: Name, Address, Phone & Fax, E mail

Importer Details: Name, Address, Phone & Fax, E mail

Product detailsProduct NameProduct DescriptionWhat 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

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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

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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.

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Product Classification unclear

LiaisonFSAIIMBRepresentatives of business in question (specific)Representatives of trade (general)

IMB classification committeeDecision made is final*

* More information becomes available, requiring review

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Derogation

• Ireland has taken full derogation 31st December

2009

• Products with submitted ingredient dossiers

• No unfavourable EFSA opinion

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Where is it at?

Final drafting stages

Public consultation on website (6 weeks)

www.fsai.ie/consultations/index.asp

Collate comments

Final document published

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