The competent authorities must be notified when these products are first put
on sale, as long as they do not come under a specific rule, or it is required
by their own regulations.
At present, the following categories of products must be notified:
- Food intended for special medical use (article 5 Royal Decree
1091/2000).
- preparations for newborns (article 13 Royal Decree 867/2008)
- food for premature babies
- dietetic food intended for gluten intolerant persons (NB: regulated
by Regulation 41/2009 on the composition and labelling of products suitable for
persons with an intolerance to gluten, but not included in the annex to
Directive 2009/39/EC).
- Food intended for high muscle depletion, especially sportspersons.
- very low-calorie diets (VLCD)
- Food low in salt and hyposodic salts
- food for persons with disorders of the glucoside metabolism
(diabetics)
- other products for special nutritional use, considered as dietetics, in
accordance with legislation by another member state of the EU
Procedure