The pace of regulatory development and change for food supplements, herbal remedies and other natural health products is relentless and it is the IHTA’s role to keep our Members updated with these developments, understand Member’s views on the legislation and represent those views to legislators and regulators in Ireland.

Food law covers the laws, regulations and administrative provisions governing food in general and food safety in particular at Community and National level. The laws cover all production stages from actual production (feed, methods of manufacturing etc), energy, nutrients, related substances used in processing (additives, enzymes, flavourings etc), as well as distribution (packaging and food contact material), labelling and advertising.

One of the first interests of the European Community to establish Food laws was to ensure efficient consumer protection and free movement of goods among its Member States.

With the very establishment of the EU, the need for harmonization of policies especially in the areas closely related to the common market of goods became evident. With the aim to address food safety the first EU White paper of food policy, was introduced back in 2000, followed by specific rules for each category of foodstuffs shortly afterwards.

Herbal Medicines

There are two routes available to license herbal medicinal products in Ireland:
(1) A Marketing Authorisation [MA] (as per article 8(3) for a full authorisation or article 10a for well-established use authorisation, of Directive 2001/83/EC as amended). Products in this case must be able to demonstrate appropriate standards of quality, safety and efficacy and be accompanied by the necessary information for safe use.

(2) A Certificate of Traditional-use Registration (as per article 16a of Directive 2001/83/EC as amended). Products in this category are registered under the Traditional Herbal Medicinal Products Registration Scheme and are known as traditional herbal medicines.

Qualifying products must be registered by April 30th 2011.

Current activity, the IHTA has established over the years a good working consultative relationship with IMB and FSAI personnel, representatives of both bodies have presented at IHTA AGMs.

Nutritional & Health Claims Regulation.

The FSAI compiled the list of Article 13 health claims submissions for Ireland. The List was collated using an on-line process. All claims submitted via the FSAI Article 13 online submissions process between June and December 2007 were included in the List. The claims on the List of Article 13 Health Claims Submissions for Ireland do not represent claims that are in any way endorsed or approved by the FSAI or the Department of Health and Children.

The List consists of 314 separate submissions

It is very clear that regulation is stepped up not only at EU level but at national level too. IHTA has worked very diligently to forge mutual and co-operative working relationships with the regulatory authorities and interested parties, our focus has been to encourage acceptance of our industry as responsible stakeholders in the natural health industry.

Members are kept up to date on all developments and afforded the opportunity to make known their views and concerns. Times are very challenging for the natural health trade industry at local, European and global level, the IHTA is embracing these challenges with energy and drive.

Food Supplements

The Food Supplements Directive 2002/46/EC came into force in July 2002 and
is implemented in Ireland by the Food Supplements Regulations, S.I. 506 of
2007.
Directive 2006/37/EC introduced amendments to Annex II of Directive
2002/46/EC as regards the inclusion of certain substances.

From June 2002 any person placing a food supplement product on the market in
Ireland, must notify the FSAI and in addition forward to them a model of the
label used for the product.

S.I. No. 506 of 2007 requires that the labelling, presentation and advertising of
food supplements must not attribute to food supplements the property of
preventing, treating or curing a human disease, or refer to such properties.

The S.I. also sets out specific labelling provisions which the labels of food
supplements must bear in addition to the general labelling provisions of
Directive 2000/13/EC

In Ireland, vitamins and minerals sold as food supplements are regulated as
food if the amounts of vitamin or mineral in the supplement is within the
Recommended Dietary Allowance (RDA) listed in the Health (Nutrition
Labelling for Foodstuffs) Regulations, 2005 (S.I. No.65 of 2005).
If the vitamin and minerals content of the food supplements are in excess of
100% RDA then they are classified as ” Medicines” and are under the
jurisdiction of the Irish Medicines Board (IMB).

The Food Supplements Directive 2002/46/EC came into force in July 2002 and
is implemented in Ireland by the Food Supplements Regulations, S.I. 506 of
2007.
Directive 2006/37/EC introduced amendments to Annex II of Directive
2002/46/EC as regards the inclusion of certain substances.

From June 2002 any person placing a food supplement product on the market in
Ireland, must notify the FSAI and in addition forward to them a model of the
label used for the product.

S.I. No. 506 of 2007 requires that the labelling, presentation and advertising of
food supplements must not attribute to food supplements the property of
preventing, treating or curing a human disease, or refer to such properties.

The S.I. also sets out specific labelling provisions which the labels of food
supplements must bear in addition to the general labelling provisions of
Directive 2000/13/EC

In Ireland, vitamins and minerals sold as food supplements are regulated as
food if the amounts of vitamin or mineral in the supplement is within the
Recommended Dietary Allowance (RDA) listed in the Health (Nutrition
Labelling for Foodstuffs) Regulations, 2005 (S.I. No.65 of 2005).
If the vitamin and minerals content of the food supplements are in excess of
100% RDA then they are classified as ” Medicines” and are under the
jurisdiction of the Irish Medicines Board (IMB).

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