General information on changes of notification process of food supplements, infant formulas and foods for special medical purposes

National Institute of Pharmacy and Nutrition (OGYÉI) is going to change the notification process of food supplements, infant formulas and foods for special medical purposes. The procedure to be introduced from 20th November, 2017 will be simpler, the confirmations will be prepared with shorter deadlines. This modification will facilitate the market surveillance activity of our partner authorities.

What will be the same?

There isn’t any change in the data sheet and documents required for submission, producers and distributors can notify their products as before.

What will be changed?

After 20th November, 2017 the applicants will get a confirmation on their submission in case of food supplements, infant formulas and foods for special medical purposes within 30 days.

What will happen to the applications submitted earlier?

In case of products applied for notification before 20th November, 2017 OGYÉI will send the same confirmation complying with the new procedure. Products will appear on the list of notified products of OGYÉI website in 30 days; the confirmations are issued continuosly.

What is written in the confirmation?

The confirmation confirms that the product has been notified in accordance with the relevant legislation but is doesn’t include product evaluation. In the future the label attached to the application is an inseparable annex of the confirmation.

What to know about risk assessment?

In order to ensure the efficiency of market surveillance and to protect consumers OGYÉI keeps on its risk assessment activity. First of all the evaluation will refer to those products which can be of public health risk based on their composition or labelling.To enhance market surveillance activity OGYÉI sends the evaluation on products bearing public health risk to the authorities of market surveillance. At the same time the company who has launched the notification will get information on this and on the evaluation as well.

What does the lists of food supplements, infant formulas and foods for special medical purposes contain available on OGYÉI website?

1. Food supplement

On OGYÉI website we publish a table of the notified food supplements and another one of those products which are affected by market surveillance measures (withdrawal from the market, suspension of marketing). The pictograms like „green tick” or „red exclamation mark” and „black star” will disappear.

2. Infant formulas and foods for special medical purposes

The notified infant formulas and foods for special medical purposes are still available on OGYÉI website. Those products which are affected by market surveillance measures (withdrawal from the market, suspension of marketing) like in case of food supplements are listed separately.

The above measures result a faster and more transparent procedure, support the activity of market surveillance authorities and strengthen the responsibility of producers or distributors on product safety.

In order to widen the knowledge of food business operators and apply correctly the legal requirements OGYÉI elaborates and publishes professional studies and grants free consultation possiblity (one day semi-annually).

Information regarding the notification procedure and notified products is available on OGYÉI website:

· regarding food supplements: https://ogyei.gov.hu/etrend kiegeszitok/

· regarding foods for special groups: https://ogyei.gov.hu/Specifikus csoportoknak szant elelmiszerek/

Normative legislation:

· Decree No. 37/2004. (IV.26.) on food supplements emitted by the Health Ministry

· Decree No. 36/2004 (IV.26.) on foods for special nutritional purposes emitted by the Health Ministry

· Decree No. 24/2003 (V.9.) on foods for special medical purposes emitted by the Health Ministry

· Decree No. 20/2008 (V.14.) on infant formulas emitted by the Health Ministry

For more detailed information please contact: ektf.ugyfelszolgalat@nngyk.gov.hu