food supplements, foodstuffs, narcotics, composition of foodstuffs, psychotropic substances, addictivesubstances

Decree of............ 2024 amending Decree No 58/2018 on food supplements and on the composition of foodstuffs

The main reason for amending the Decree is the adaptation of the text in Section 5. The current wording ofSection 5 does not cover the situation where a substance is present in one of the ingredients of a food. Theuse of such an ingredient in the manufacture of foodstuffs may subsequently bring the dangerous substanceinto the final foodstuff, which has not been used in isolated form. For this reason, it is problematic to prove howthe substance has reached the food and thus any breach of Section 5. The proposed legislation will regulatethis situation and substances belonging to the groups referred to in Section 5 will not be present in foodstuffs.

Certain substances and plants are removed from the Annexes to the Decree and thus may be used in theproduction of foodstuffs and/or are regulated by other legislation and, in order to maintain clarity andpredictability of food law, it is appropriate to remove them from this Decree.
Keywords: food supplements, foodstuffs, narcotics, composition of foodstuffs, psychotropic substances,addictive substances
The draft decree refers to the following European legislation:
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation ofthe laws of the Member States relating to food supplements, as amended by Commission Regulation (EC) No1170/2009, Commission Regulation (EU) No 1161/2011, Commission Regulation (EU) No 119/2014 andCommission Regulation (EU) No 2015/414.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation ofthe laws of the Member States relating to food supplements, as amended by Commission Directive2006/37/EC, Commission Regulation (EC) No 1170/2009, Commission Regulation (EU) No 1161/2011,Commission Regulation (EU) No 119/2014, Commission Regulation (EU) 2015/414, Commission Regulation(EU) 2017/1203 and Commission Regulation (EU) 2021/418 and Commission Regulation (EU) 2024/248.
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 onnutrition and health claims made on foods, as amended.
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on theaddition of vitamins and minerals and of certain other substances to foods, as amended.
Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of theEuropean Parliament and of the Council and Regulation (EC)
No 1925/2006 of the European Parliament and of the Council as regards lists of vitamins and minerals andtheir forms that may be added to foods, including food supplements.
Commission Regulation (EU) No 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of theEuropean Parliament and of the Council, Regulation (EC) of the European Parliament and of the Council
No 1925/2006 and Commission Regulation (EC) No 953/2009 as regards the lists of minerals that may beadded to foods.
Commission Regulation (EU) No 119/2014 of 7 February 2014 amending Directive 2002/46/EC of theEuropean Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament andof the Council as regards chromium enriched yeast used for the manufacture of food supplements andchromium(III) lactate tri-hydrate added to foods.
Commission Regulation (EU) 2015/414 of 12 March 2015 amending Directive 2002/46/EC of the EuropeanParliament and of the Council as regards (6S)-5-methyltetrahydrofolic acid, glucosamine salt used in themanufacture of food supplements.
Commission Regulation (EU) 2017/1203 of 5 July 2017 amending Directive 2002/46/EC of the EuropeanParliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of theCouncil as regards organic silicon (monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) added to foods and used in the manufacture of food supplements.
Commission Regulation (EU) 2021/418 of 9 March 2021 amending Directive 2002/46/EC of the European Parliament and of the Council as regards nicotinamide riboside chloride and magnesium citrate malate used inthe manufacture of food supplements and as regards the units of measurement used for copper.
Commission Regulation (EU) 2024/248 of 16 January 2024 amending Annex II to Directive 2002/46/EC of theEuropean Parliament and of the Council as regards ferric hydroxide adipate tartrate used in the manufacture offood supplements.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on theprovision of food information to consumers, amending Regulations (EC)
No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealingCommission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC,Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and2008/5/EC and Commission Regulation (EC) No 608/2004, as amended.
Commission Regulation (EC) No 1170/2009 and Commission Regulation (EU) 2021/418.
Decree No 417/2016 on certain methods of labelling foodstuffs, as amended
Regulation (EC) No 1924/2006 of the European Parliament and of the Council.
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novelfoods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealingRegulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC)No 1852/2001, as amended.
Regulation (EC) No 1925/2006 of the European Parliament and of the Council.
Government Regulation No 463/2013 on schedules of addictive substances, as amended
Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drugprecursors, as amended.
Government Regulation No 454/2009 laying down, for the purposes of the Criminal Code, what is consideredto be substances with anabolic and other hormonal effects and what is considered, for the purposes of theCriminal Code, as a method of increasing the transfer of oxygen in the human body and as other methods withdoping effect, as amended.
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down aprocedure for the provision of information in the field of technical regulations and of rules on InformationSociety services
The draft does not include references to international recommendations, company standards, harmonised orinternational standards, technical documents and technical standards. The proposal does not refer to nationaltechnical standards or European standards.
Basic regulation – Decree No 58/2018 on food supplements and on the composition of foodstuffs does notcontain references to international recommendations, company standards, harmonised or internationalstandards, technical documents and technical standards, national technical standards or European standards.
Decree No 58/2018 on food supplements and on the composition of foodstuffs [contains references] to thefollowing European legislation:
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation ofthe laws of the Member States relating to food supplements, as amended by Commission Regulation (EC) No1170/2009, Regulation (EU) No 1161/2011, Regulation (EU) No 119/2014 and Regulation (EU) No 2015/414.
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 onnutrition and health claims made on foods, as amended.
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on theaddition of vitamins and minerals and of certain other substances to foods, as amended.
Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of theEuropean Parliament and of the Council and Regulation (EC)
No 1925/2006 of the European Parliament and of the Council as regards lists of vitamins and minerals andtheir forms that may be added to foods, including food supplements.
Commission Regulation (EU) No 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of theEuropean Parliament and of the Council, Regulation (EC) of the European Parliament and of the Council
No 1925/2006 and Commission Regulation (EC) No 953/2009 as regards the lists of minerals that may be added to foods.
Commission Regulation (EU) No 119/2014 of 7 February 2014 amending Directive 2002/46/EC of theEuropean Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament andof the Council as regards chromium enriched yeast used for the manufacture of food supplements andchromium(III) lactate tri-hydrate added to foods.
Commission Regulation (EU) 2015/414 of 12 March 2015 amending Directive 2002/46/EC of the EuropeanParliament and of the Council as regards (6S)-5-methyltetrahydrofolic acid, glucosamine salt used in themanufacture of food supplements.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on theprovision of food information to consumers, amending Regulations (EC)
No 1924/2006 and (EC) No 1925/2006, and repealing Commission Directive 87/250/EEC, Council Directive90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of theCouncil, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004.
Commission Regulation (EC) No 1170/2009.
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerningnovel foods and novel food ingredients, as amended.
Regulation No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drugprecursors.
The basic regulations are:
Act No 110/1997 on foodstuffs and tobacco products and amending and supplementing certain related acts, asamended (text provided under notification 2023/0436/CZ).
Decree No 58/2018 on food supplements and on the composition of foodstuffs (text provided under notification2016/0257/CZ).