State Institute for Drug Control

 

Who and how approves dietary supplements in the Czech Republic?

The regulation of dietary supplements falls within the powers of the Ministry of Health of the Czech Republic. It is governed by Act No 110/1997 Coll., on Foodstuffs and Tobacco Products and on Amendments to Some Related Acts, as amended (hereinafter referred to as the “Act on Foodstuffs”; its full version is available from the Collection of Acts where it has been published under No. 224/2008 Coll.) and Decree No 225/2008 Coll., on the requirements for dietary supplements and fortification of foodstuffs (hereinafter referred to as the implementing legal regulation). The procedure which the manufacturer or importer has to comply with in placing the dietary supplement into circulation depends on the composition of the product

Dietary supplements containing substances listed under the implementing legal regulation: pursuant to Section 3d of the Act on Foodstuffs, manufacturers as well as importers are obliged to send to the Ministry of Health of the Czech Republic the Czech text which will be presented on the labelling of the product prior to the first marketing of the dietary supplement (so called notification).

Dietary supplements containing substances other than those listed under the implementing legal regulation:  pursuant to Section 11, paragraph 2, letter b) of the Act on Foodstuffs these products may be marketed only after a prior approval of the Ministry of Health of the Czech Republic is obtained (i.e. the Ministry of Health of the Czech Republic must authorise the products before they may be marketed). The base for the approval is an expert position issued by the National Institute of Public Health (NIPH) on the health safety of the product.

 

Pharmacies offer a whole range of dietary supplements and over-the-counter medicinal products. What is the difference between these types of products and how can they be distinguished from each other?

It is often difficult for the consumer to navigate in the deluge of products available in pharmacies as “over-the-counter” (OTC) products, and, in particular, distinguish the two basic types of these products – dietary supplements and medicinal products - with confidence. For better orientation please refer to the SÚKL position regarding distinction between dietary supplements and medicinal products.
This section describes only the major difference between the said types of products, and information regarding their labelling as implied by effective legal regulations (Act No 110/1997 Coll. on Foodstuffs and Tobacco Products, as amended, Decree No 225/2008 Coll., on the requirements for dietary supplements and fortification of foodstuffs (hereinafter referred to as the implementing legal regulation), Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), Decree No 228/2008 Coll. on marketing authorisation of medicinal products):

• Efficacy is assessed only for medicinal products. 
• In dietary supplements, only safety and not efficacy is assessed. This means that the statements on the labelling and package inserts for dietary supplements are not expertly assessed (e.g. whether the plant contained in the dietary supplement truly has the effects declared by the manufacturer or whether the product may indeed have beneficial effects on the problems specified by the manufacturer). Effective legislation stipulates that the labelling of dietary supplements must not attribute properties relevant to the prevention, treatment or cure of human diseases to dietary supplements nor refer to these properties (Section 3, paragraph 5of Decree No 225/2008 Coll.)
• The labelling of dietary supplements bears the statement “dietary supplement” as part of the name (Section 4 , paragraph 1, letter a) of Decree No 225/2008 Coll.).
• The labelling of medicinal products bears so called authorisation number in a predefined format (e.g. 95/312/99-C) (Annex 4 and 5 to Decree No  288/2004 Coll. refers).

 

What are foodstuffs intended for particular nutritional uses?

Foodstuffs intended for particular nutritional uses are defined by Decree No 54/2004 Coll.,  on foodstuffs intended for particular nutritional uses and on the method of their use, as amended. This involves foodstuffs which are intended for nutrition use stipulated by this Decree and which are marketed with a specified purpose of use (Section 1, paragraph 2 of the Decree). Section 2 of the Decree defines categories of foodstuffs intended for particular nutritional uses:

1. Infant formulae and follow-on formulae and foodstuffs for young children  
2. Foodstuffs for cereal nutrition and other than cereal nutrition foodstuffs for infants and young children
3. Low-energy foodstuffs intended for body weight loss (so called foodstuffs for weight-reduction diets)
4. Foods for special medical purposes
5. Phenylalanine-free foodstuffs  
6. Gluten-free foodstuffs
7. Foodstuffs intended for persons with saccharide-metabolism disorders (diabetic patients)
8. Foodstuffs with low content of lactose or lactose-free foodstuffs
9. Low-protein foodstuffs
10. Foodstuffs with low and very low content of sodium or sodium-free foodstuffs
11. Foodstuffs intended for sportsmen and persons with increased physical activity

 

Who and how authorises foodstuffs intended for particular nutritional uses in the Czech Republic? 

The regulation of foodstuffs intended for particular nutritional uses falls within the powers of the Ministry of Health of the Czech Republic and the Czech Agriculture and Food Inspection Authority (CAFIA). It is governed by Act No 110/1997 Coll. on Foodstuffs and Tobacco Products an on Amendments to Some Related Acts, as amended ((hereinafter referred to as the "Act on Foodstuffs") and Decree No 54/2004 Coll., on foodstuffs intended for particular nutritional uses and on the method of their use, as amended. The procedure which the manufacturer or importer has to comply with in placing the foodstuffs into circulation depends on whether the product is governed by the implementing legal regulation (Decree No 54/2004 Coll., as amended) or not. Foods for special medical purposes (Section 3d of the Act on Foodstuffs):
Manufacturers from the Czech Republic and importers from third countries are obliged to notify CAFIA of the placement into circulation by submitting specimen labelling. Other categories of foodstuffs intended for particular nutritional uses (Section 3c of the Act on Foodstuffs):

• Foodstuffs intended for particular nutritional uses which are not listed under the implementing legal regulation: pursuant to Section 3c of the Act on Foodstuffs, the manufacturer or importer is obliged  to send to the Ministry of Health of the Czech Republic the Czech text which will be presented on the labelling of the product prior to the first marketing;
• Infant formulae: pursuant to Section 3d, paragraph 1 of the Act on Foodstuffs, the manufacturer or importer is obliged  to send to the Ministry of Health of the Czech Republic the Czech text which will be presented on the labelling of the product prior to the first marketing;
• Foods for special medical purposes: pursuant to Section 3d, paragraph 2 of the Act on Foodstuffs, the manufacturer or importer is obliged to send to the Czech Agriculture and Food Inspection Authority (CAFIA) the Czech text which will be presented on the labelling of the product prior to the marketing of the product.  

 

Annex 13 of Decree No 54/2004 Coll. defines a list of substances which may be added to foodstuffs intended for particular nutritional uses. The list contains also those substances which form the base of some medicinal products. Is it possible to use the same substances which are contained in an authorised medicinal product, also in foodstuffs intended for particular nutritional uses or in dietary supplements?

Substances listed in Annex 13 apply only to foodstuffs intended for particular nutritional uses. These are vitamins, minerals, amino acids, and other substances which are present in regular foodstuffs, in fruit, vegetables, etc. Although they are contained also in medicinal products, it is not a reason for prohibiting their inclusion in foodstuffs intended for particular nutritional uses (furthermore, their amounts in medicinal products are usually larger).

Dietary supplements are a separate category of foodstuffs and are governed by Decree No 225/2008 Coll.; Requirements governing their composition are stipulated in the annexes to this Decree. Decree No54/2004 Coll. does not apply to dietary supplements.

 

May foodstuffs intended for particular nutritional uses contain also substances which are not listed in Annex 13 to Decree No 54/2004 Coll.?

Yes, but the assessment and authorisation of foodstuffs intended for particular nutritional uses is not within the powers of SÚKL and it is necessary to contact the Ministry of Health of the Czech Republic, department of Public Health Protection. The marketing of these foodstuffs is regulated by Act No 110/1997 Coll., as amended, and by Decree No 54/2004 Coll., as amended. The quoted legal regulations, furthermore, stipulate the obligations of the manufacturer or importer prior to the marketing of these foodstuffs (see above).

 

How are cosmetic products regulated in the Czech Republic?

The regulation of cosmetic products is governed by Act No 258/2000 Coll., on the Protection of Public Health and Amendments to Some Related Acts, as amended (Section 25 - Section 29), and Decree No 26/2001 Coll. on hygienic requirements governing cosmetic products, as amended.

Annex 1, the cited Decree, provides lists examples of cosmetic products (i.e. what types of products are considered cosmetic products with a view to the definition of the cosmetic product stipulated by the Act). Annex 2 stipulates a list of substances which must not be included as ingredients in cosmetic products. Annex 3 provides a list of substances permissible in cosmetic products with a restriction, incl. the maximum permissible concentrations of selected substances and conditions of use. If a cosmetic product contains a substance which is not included in the list of substances permissible for use in cosmetic products, the decision on the permissibility of such substance shall be taken, upon the proposal of the manufacturer or importer, by the concerned public health protection authority (Section 26, paragraph 4 of the Act).

The manufacturer or importer shall be obliged to ensure that the cosmetic products manufactured or imported thereby are, upon their placement on the market, safe, particularly do not compromise the health of persons and comply with hygienic requirements stipulated by the Decree. Before the cosmetic product is placed on the market, the manufacturer or importer must ensure that the safety of the product with a view to the health of individuals is assessed by an authorised (qualified) person (Section 26, paragraph 1 and 3; Section 29, paragraph 2 of the Act).

Before a cosmetic product is marketed, the manufacturer or importer is obliged to carry out so called notification, i.e. to notify to the concerned public health protection authority (regional public health authority), apart from other, the start date of manufacture or import, incl. a list of cosmetic products which he/she intends to manufacture or import, and the site where mandatory product documentation is stored (Section 27, paragraph 1 of the Act).

At the address specified on the labelling of the cosmetic product the public must gain an easy access to data about the qualitative composition of the cosmetic product, its quantitative composition in terms of the contents of hazardous chemical substances, and on the adverse reactions to the cosmetic product arising from its use (Section 3 of the Decree).