Authorization procedure for functional indications
Regulation No. 1924/2006 provided that Member States shall submit to the European Commission (Commission) a list of functional (Article 13) health claims by 31 January 2008 together with the conditions applicable to the claims with reference to the relevant scientific substantiation.
In order to be included in the list of health claims in Latvia, entrepreneurs had to submit an application form or a free-form application together with a scientific justification.
By 31 January 2008, 321 applications had been received from 22 food and 24 food supplement production or distribution companies.
On 31 January 2008, the Commission received lists of EU Member States with a total of more than 44,000 health claims, including about 500 Latvian health claims. Komisija, sadarbojoties ar Eiropas Pārtikas nekaitīguma iestādi (EFSA), iesniegtos datus izvērtē un pieņem ES sarakstu ar atļautajām norādēm.
- The consolidated health claim database is available from the European Food Safety Authority homepage. Database of health claims submitted to EFSA for evaluation.
- EFSA opinions on the scientific substantiation of specific health claims (see section "NDA opinions on Article 13").
The Commission has announced that the adoption of the list of permitted claims will take place in 2 stages:
1. functional indications for non-botanical substances,
2. functional indications for botanical substances.
Authorization procedure for the indications referred to in Articles 13.5 and 14
Compared to the functional authorization procedure for Article 13 claims, some health claims are subject to a different authorization procedure.
A different procedure applies to indications:
-
on reduced risk of disease (guidance in Article 14.1.b),
-
on the development and health of children (references in Article 14.1a),
-
based on the latest scientific knowledge (guidance in Article 13.5),
-
which include a requirement for the protection of proprietary data (guidance in Article 13.5).
The authorization procedure for these claims is based on individual applications from operators.A separate application must be submitted for each health claim, in each application indicates the relationship between the food and only one route of exposure.
Description of the authorization procedure
The main stakeholders in the Article 13.5 and Article 14 authorization procedure for health claims are the applicant, the competent authority, EFSA and the Commission..
1. The applicant shall submit the application to the competent authority, which shall examine it (14 days) before forwarding it to EFSA..
2. EFSA informs the competent authorities of the EU Member States and the Commission of the receipt of the application and gives an opinion (5-7 months).
3. The applicant or members of the public may make comments to the Commission within 30 days of the date of publication of this opinion.
4. The Commission prepares a draft decision and submits it to the Standing Committee on the Food Chain and Animal Health (SCFCAH) (2 months).
5. Following the favorable opinion of the SCFCAH, the European Parliament and the Council have the right to examine the draft Commission decision.
6.If there are no objections, the Commission shall take a decision.
Schematic representation of the authorization procedure
Guidelines for applicants
The Commission has provided general guidelines for the preparation and presentation of applications for health claims (Regulations No. 353/2008 of 18.04.2008 and Regulations No. 1169/2009 of 30.11.2009).
In order to make it easier for economic operators to prepare applications for a health claim, EFSA has developed a number of guidelines, including on the scientific and technical requirements of the application, on the principles for evaluating health claims, on the scientific requirements for health claims in certain areas.scientific and technical guidelines