Message 001
Communication from the Commission - TRIS/(2024) 2054
Directive (EU) 2015/1535
Notification: 2024/0430/CZ
Notification of a draft text from a Member State
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Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20242054.EN
1. MSG 001 IND 2024 0430 CZ EN 30-07-2024 CZ NOTIF
2. Czechia
3A. Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
Biskupský dvůr 1148/5
110 00 Praha 1
tel: 221 802 212
e-mail: eu9834@unmz.cz
3B. Ministerstvo zemědělství České republiky
Oddělení pro úřední kontroly v potravinovém řetězci
Těšnov 65/17; 110 00 Praha 1
tel: 221 812 068
4. 2024/0430/CZ - C00A - AGRICULTURE, FISHING AND FOODSTUFFS
5. Decree of............ 2024 amending Decree No 58/2018 on food supplements and on the composition of foodstuffs
6. food supplements, foodstuffs, narcotics, composition of foodstuffs, psychotropic substances, addictive substances
7.
8. The main reason for amending the Decree is the adaptation of the text in Section 5. The current wording of Section 5 does not cover the situation where a substance is present in one of the ingredients of a food. The use of such an ingredient in the manufacture of foodstuffs may subsequently bring the dangerous substance into the final foodstuff, which has not been used in isolated form. For this reason, it is problematic to prove how the substance has reached the food and thus any breach of Section 5. The proposed legislation will regulate this 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 the production of foodstuffs and/or are regulated by other legislation and, in order to maintain clarity and predictability 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 of the laws of the Member States relating to food supplements, as amended by Commission Regulation (EC) No 1170/2009, Commission Regulation (EU) No 1161/2011, Commission Regulation (EU) No 119/2014 and Commission Regulation (EU) No 2015/414.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, as amended by Commission Directive 2006/37/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 on nutrition 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 the addition 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 the European 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 and their 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 the European 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 the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods.
Commission Regulation (EU) 2015/414 of 12 March 2015 amending Directive 2002/46/EC of the European Parliament and of the Council as regards (6S)-5-methyltetrahydrofolic acid, glucosamine salt used in the manufacture of food supplements.
Commission Regulation (EU) 2017/1203 of 5 July 2017 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council 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 in the 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 the European Parliament and of the Council as regards ferric hydroxide adipate tartrate used in the manufacture of food supplements.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision 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 repealing Commission 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 and 2008/5/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 novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (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 drug precursors, as amended.
Government Regulation No 454/2009 laying down, for the purposes of the Criminal Code, what is considered to be substances with anabolic and other hormonal effects and what is considered, for the purposes of the Criminal Code, as a method of increasing the transfer of oxygen in the human body and as other methods with doping effect, as amended.
Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services
The draft does not include references to international recommendations, company standards, harmonised or international standards, technical documents and technical standards. The proposal does not refer to national technical standards or European standards.
Basic regulation – Decree No 58/2018 on food supplements and on the composition of foodstuffs does not contain references to international recommendations, company standards, harmonised or international standards, 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 the following European legislation:
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, as amended by Commission Regulation (EC) No 1170/2009, 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 on nutrition 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 the addition 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 the European 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 and their 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 the European 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 the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods.
Commission Regulation (EU) 2015/414 of 12 March 2015 amending Directive 2002/46/EC of the European Parliament and of the Council as regards (6S)-5-methyltetrahydrofolic acid, glucosamine salt used in the manufacture of food supplements.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC)
No 1924/2006 and (EC) No 1925/2006, and repealing Commission 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 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 concerning novel foods and novel food ingredients, as amended.
Regulation No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors.
The basic regulations are:
Act No 110/1997 on foodstuffs and tobacco products and amending and supplementing certain related acts, as amended (text provided under notification 2023/0436/CZ).
Decree No 58/2018 on food supplements and on the composition of foodstuffs (text provided under notification 2016/0257/CZ).
9. The proposed legislation will replace the current Decree 58/2018 on food supplements and on the composition of foodstuffs. This legislation is a response to the ever-evolving market for food supplements and novel foods. It is proposed to update the text of Decree No 58/2018, including its annexes, in order to increase consumer protection and restore market conditions for foodstuffs, namely food supplements.
The main point of the amendment is the change to § 5. The current wording of § 5 prohibits the addition to foodstuffs of substances of narcotics or psychotropic substances, precursors of substances listed in category I of directly applicable European Union legislation, steroids, i.e. substances with anabolic and other hormonal effects, substances of a hormonal nature and other substances that have been shown to be toxic, genotoxic, teratogenic, hallucinogenic, narcotic or having other adverse effects on the human body, individually or in a mixture. As it stands, the situation where a substance is part of an ingredient used in food production is not covered. For this reason, it is important to adapt the text of the § to cover the situation where an undesirable substance is part of an ingredient, such as the plants from which food is produced, including food supplements. In practice, it is now difficult for the supervisory authority to withdraw food containing these undesirable substances from the market if they have been introduced into a food as part of one of its ingredients.
Certain substances and certain plants are being removed from the prohibited lists in the annexes to the Decree because they may be used in the production of foodstuffs and/or are regulated by other legislation. For some plant genera, the text concerning the use of part of the plant body has been amended.
10. References to basic texts: 2023/0436/CZ, 2016/0257/CZ
the basic texts were forwarded within an earlier notification:
2023/0436/CZ
2016/0257/CZ
11. No
12.
13. No
14. No
15. No
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
