Irish Health Trade Association

To become a team member and caretaker of our industry sector,
join our Association now:

The Irish Health Trade Association is committed to co-operating in self
regulation of the natural health trade industry and as such has established a
good working relationship with the Irish Regulatory Authorities.

Legislative framework and self regulation go hand in hand ensuring that the
market is open to all natural health products that meet safety and quality
criteria.

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).

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.

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.

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.

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.

To become a team member and caretaker of our industry sector, join our Association now:

Ring Phil Costigan, General Secretary IHTA at 065 684 89 11 or E mail info@ihta.org

IHTA membership