Act No 174 / 2021 Coll.
Act amending Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, and other related laws
Valid
Law
Effective from 12.05.2021
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174
THE LAW
of 13 April 2021
amending Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, and other related laws
Parliament has decided on this law of the Czech Republic:
Amendment of the Food and Tobacco Products Act
Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws, as amended by Act No. 166 / 1999 Coll., Act No. 119 / 2000 Coll., Act No. 306 / 2000 Coll., Act No. 146 / 2002 Coll., Act No. 131 / 2003 Coll., Act No. 140 / 2003 Coll., Act No. 94 / 2004 Coll., Act No. 316 / 2004 Coll., Act No. 180 Coll., Act No. 26 / 2017 Coll., Act No. 183 / 2003 Coll.
1. In footnote 18, the first and ninth sentences are deleted.
2. footnote 19 shall read:
"(19) Council Regulation (EEC) No 2136 / 89 of 21 June 1989 laying down common marketing standards for preserved sardines and trade names for preserved sardines and sardine-type products, as amended. Council Regulation (EEC) No 2219 / 89 of 18 July 1989 on special conditions governing the export of food and feed following a nuclear accident or any other case of radiological emergency. COMMISSION REGULATION (EEC) No 2568 / 91 of 11 July 1991 on the characteristics of olive oil and olive-residue oil and on the relevant methods of analysis, as amended. COUNCIL REGULATION (EEC) No 1536 / 92 of 9 June 1992 laying down common marketing standards for preserved tuna and tuna. Council Regulation (EEC) No 315 / 93 of 8 February 1993 laying down Community procedures for contaminants in foodstuffs, as amended. Council Regulation (EC) No 2406 / 96 of 26 November 1996 laying down common marketing standards for certain fishery products, as amended. Regulation (EC) No 1760 / 2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820 / 97, as amended. Commission Regulation (EC) No 1825 / 2000 of 25 August 2000 laying down detailed rules for the application of Regulation (EC) No 1760 / 2000 of the European Parliament and of the Council as regards the labelling of beef and beef products, as amended. Regulation No 178 / 2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, as amended. Regulation (EC) No 1829 / 2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food, as amended. Regulation (EC) No 1830 / 2003 of the European Parliament and of the Council of 22 September 2003 on the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001 / 18 / EC, as amended. Regulation (EC) No 852 / 2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, as amended. Regulation (EC) No 853 / 2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin, as amended. Regulation (EC) No 854 / 2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption, as amended. Regulation (EC) No 1935 / 2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80 / 590 / EEC and 89 / 109 / EEC, as amended. Commission Decision 2005 / 1 / EC of 27 December 2004 approving methods for grading pig carcases in the Czech Republic, as amended. Commission Regulation (EC) No 37 / 2005 of 12 January 2005 on temperature monitoring in means of transport, storage and storage for quick-frozen foodstuffs intended for human consumption. Regulation (EC) No 396 / 2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91 / 414 / EEC, as amended. Commission Regulation (EC) No 2073 / 2005 of 15 November 2005 on microbiological criteria for foodstuffs, as amended. Commission Regulation (EC) No 2074 / 2005 of 5 December 2005 laying down implementing measures for certain products pursuant to Regulation (EC) No 853 / 2004 of the European Parliament and of the Council and for the organisation of official controls pursuant to Regulations (EC) No 854 / 2004 and (EC) No 882 / 2004 of the European Parliament and of the Council, as amended. Commission Regulation (EC) No 1635 / 2006 of 6 November 2006 laying down detailed rules for the application of Council Regulation (EEC) No 737 / 90 on the conditions for imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station, as amended. Commission Regulation (EC) No 1881 / 2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs, as amended. Commission Regulation (EC) No 1882 / 2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of nitrate levels in certain foodstuffs. 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 445 / 2007 of 23 April 2007 laying down certain detailed rules for the application of Council Regulation (EC) No 2991 / 94 laying down standards for spreadable fats and Council Regulation (EEC) No 1898 / 87 on the protection of designations used in the marketing of milk and milk products. Regulation (EC) No 110 / 2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576 / 89, as amended. Commission Regulation (EC) No 282 / 2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with food and amending Regulation (EC) No 2023 / 2006, as amended. Commission Regulation (EC) No 543 / 2008 of 16 June 2008 laying down detailed rules for the application of Council Regulation (EC) No 1234 / 2007 as regards marketing standards for poultrymeat, as amended. Commission Regulation (EC) No 566 / 2008 of 18 June 2008 laying down detailed rules for the application of Council Regulation (EC) No 1234 / 2007 as regards the marketing of meat of bovine animals aged 12 months or less, as amended. Commission Regulation (EC) No 589 / 2008 of 23 June 2008 laying down detailed rules for the application of Council Regulation (EC) No 1234 / 2007 as regards marketing standards for eggs, as amended. Council Regulation (EC) No 733 / 2008 of 15 July 2008 on the conditions for imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station, as amended. Regulation (EC) No 1331 / 2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. Regulation (EC) No 1332 / 2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83 / 417 / EEC, Council Regulation (EC) No 1493 / 1999, Directive 2000 / 13 / EC, Council Directive 2001 / 112 / EC and Regulation (EC) No 258 / 97, as amended. Regulation (EC) No 1333 / 2008 of the European Parliament and of the Council of 16 December 2008 on food additives, as amended. Regulation (EC) No 1334 / 2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in or on foods and amending Council Regulation (EEC) No 1601 / 91, Regulations (EC) No 2232 / 96 and (EC) No 110 / 2008 and Directive 2000 / 13 / EC, as amended. Regulation (EC) No 470 / 2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377 / 90 and amending Directive 2001 / 82 / EC of the European Parliament and of the Council and Regulation (EC) No 726 / 2004 of the European Parliament and of the Council. Commission Regulation (EC) No 450 / 2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food. Commission Regulation (EC) No 669 / 2009 of 24 July 2009 implementing Regulation (EC) No 882 / 2004 of the European Parliament and of the Council as regards increased official controls on imports of certain feed and food of non-animal origin and amending Decision 2006 / 504 / EC, as amended. Commission Regulation (EU) No 115 / 2010 of 9 February 2010 laying down the conditions for the use of activated alumina to remove fluorides from natural mineral waters and spring waters. Commission Decision 2010 / 791 / EU of 20 December 2010 establishing the list of products referred to in the second subparagraph of point III (1) of Annex XII to Council Regulation (EC) No 1234 / 2007. Commission Implementing Regulation (EU) No 543 / 2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234 / 2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors, as amended. Commission Implementing Regulation (EU) No 931 / 2011 of 19 September 2011 on traceability requirements laid down in Regulation (EC) No 178 / 2002 of the European Parliament and of the Council for food of animal origin. 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 Implementing Regulation (EU) No 1333 / 2011 of 19 December 2011 laying down marketing standards for bananas, rules on compliance with those marketing standards and notification requirements in the banana sector, as amended. Commission Implementing Decision 2011 / 884 / EU of 22 December 2011 on emergency measures concerning unauthorised genetically modified rice in rice products originating in China and repealing Decision 2008 / 289 / EC. Commission Implementing Regulation (EU) No 29 / 2012 of 13 January 2012 on marketing standards for olive oil, as amended. Regulation (EU) No 1151 / 2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs. Commission Implementing Regulation (EU) No 208 / 2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts. Regulation (EU) No 609 / 2013 of the European Parliament and of the Council of 12 June 2013 on foodstuffs intended for infants and young children, foods for special medical purposes and total diet replacement for weight control and repealing Council Directive 92 / 52 / EEC, Commission Directives 96 / 8 / EC, 1999 / 21 / EC, 2006 / 125 / EC and 2006 / 141 / EC, Directive 2009 / 39 / EC of the European Parliament and of the Council and Commission Regulations (EC) No 41 / 2009 and (EC) No 953 / 2009, as amended. Regulation (EU) No 1379 / 2013 of the European Parliament and of the Council of 11 December 2013 on the common organisation of the markets in fishery and aquaculture products and amending Council Regulations (EC) No 1184 / 2006 and (EC) No 1224 / 2009 and repealing Council Regulation (EC) No 104 / 2000, as amended. Commission Implementing Regulation (EU) No 1337 / 2013 of 13 December 2013 laying down detailed rules for the application of Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council as regards the indication of the country of origin or place of provenance in fresh, chilled and frozen pigmeat, sheep, goats and poultry meat. Regulation (EU) No 1308 / 2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922 / 72, (EEC) No 234 / 79, (EC) No 1037 / 2001 and (EC) No 1234 / 2007, as amended. Commission Regulation (EU) No 579 / 2014 of 28 May 2014 derogating from certain provisions of Annex II to Regulation (EC) No 852 / 2004 of the European Parliament and of the Council as regards the sea transport of liquid oils and fats, as amended. Commission Implementing Regulation (EU) 2015 / 949 of 19 June 2015 approving pre-export controls carried out by certain third countries on certain foodstuffs as regards the presence of certain mycotoxins, as amended. 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. Regulation (EU) 2017 / 625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities carried out to ensure the application of food and feed law and rules relating to animal health and animal welfare, plant health and plant protection products, amending Regulations (EC) No 999 / 2001 and (EC) No 396 / 2005, (EC) No 1069 / 2009, (EC) No 1107 / 2009, (EU) No 1151 / 2012, (EU) No 652 / 2014, (EU) 2016 / 429 / EC and (EU) 2016 / 2031, Council Regulation (EC) No 1 / 2005 and (EC) No 1099 / 2009 and Council Directives 98 / 58 / EC, 1999 / 74 / EC, 2007 / 43 / EC, 2008 / 119 / EC and 2008 / 120 / EC and repealing Council Regulations (EC) No 854 / 2004, Council Directives 89 / 662 / 662 / EEC, 89 / 662 / 62 / EEC, 90 / 425 / EEC, (EC, (EC, (EC), (EC), (EC), (EC), (EC), (EC) and (96 / 96 / 96 / 96 / 96 / 96 / 96 / 96 Commission Delegated Regulation (EU) 2017 / 1182 of 20 April 2017 supplementing Regulation (EU) No 1308 / 2013 of the European Parliament and of the Council with regard to the Union scale for the classification of carcases of bovine, porcine and ovine animals and the reporting of market prices for certain categories of carcasses and live animals. Commission Implementing Regulation (EU) 2017 / 1184 laying down rules for the application of Regulation (EU) No 1308 / 2013 of the European Parliament and of the Council as regards the Union scale for the classification of carcases of bovine, porcine and ovine animals and the reporting of market prices for certain categories of carcasses and live animals. Commission Implementing Regulation (EU) 2017 / 2470 of 20 December 2017 establishing a Union list of novel foods in accordance with Regulation (EU) 2015 / 2283 of the European Parliament and of the Council on novel foods, as amended. Commission Implementing Regulation (EU) 2018 / 456 of 19 March 2018 on procedural steps of the consultation procedure for the determination of novel food status in accordance with Regulation (EU) 2015 / 2283 of the European Parliament and of the Council concerning novel foods. Commission Implementing Regulation (EU) 2018 / 574 of 15 December 2017 on technical standards for the establishment and operation of the traceability system for tobacco products. Commission Implementing Decision (EU) 2018 / 576 of 15 December 2017 on technical standards for safety features used on tobacco products. Commission Implementing Regulation (EU) 2018 / 775 of 28 May 2018 laying down rules for the application of Article 26 (3) of Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council on the provision of food information to consumers as regards the rules on the indication of the country of origin or place of provenance of the primary ingredient of the food. ';
3. In Article 1, at the end of the text of paragraph 2, the words "with the exception of drinking water placed on the market by the food business operator or used at any stage of the production, processing or distribution of foodstuffs as referred to in Article 3 (16) of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council 'shall be added.
4. in Article 2 (1) (a), the words "supplementary expert opinion" shall be replaced by the words "second expert opinion";
5. in Article 2 (1) (o), the words "and meat of crocodiles" shall be replaced by the words "meat of crocodiles and insects intended for human consumption and products obtained from the processing of such insects or further processing of such products."
6. In Paragraph 2 (1), the dot is replaced by a comma at the end of paragraph 1 and the following point (after) is added:
"(za) a nicotine tobacco-free product containing nicotine for oral use which is not covered by the directly applicable European Union74).";
Footnote 74 reads as follows:
"(74) Regulation (EC) No 178 / 2002 of the European Parliament and of the Council."
7. footnote 24 reads as follows:
"(24) Article 11 of Commission Regulation (EC) No 669 / 2009, as amended."
8. In Article 3 (1), the words "and to comply with the specific import conditions for selected foodstuffs, provided that the European Union Regulation directly applicable to the special import conditions (61), are added at the end of the text in point (h)."
Footnote 61 reads as follows:
"61) For example, Commission Regulation (EC) No 669 / 2009, as amended, Commission Implementing Regulation (EU) No 884 / 2014 of 13 August 2014 laying down specific conditions for imports of certain feed and food from certain third countries due to the risk of contamination of aflatoxins and repealing Regulation (EC) No 1152 / 2009, as amended, Commission Implementing Regulation (EU) 2018 / 1660 of 7 November 2018 imposing specific conditions for imports of certain non-animal products from certain third countries, laying down specific conditions for the introduction into the Union of consignments from certain third countries as a result of microbiological contamination and amending Commission Implementing Regulation (EU) No 885 / 2014, Commission Implementing Regulation (EU) 2017 / 186 of 2 February 2017 imposing special conditions applicable to imports of guar gum originating in India, with a view to the contamination of the Union.
9. in Article 3 (1) (i):
"(i) notify the competent supervisory authority in paper form or in electronic form by means of remote transmission of the dates of commencement, modification or termination of the subject-matter under this law at the latest on the date on which these events occurred, and indicate in the notification and update on the date of amendment:
1. its name, surname or business name, registered office and address of the establishment, if it is a natural person, or a commercial company or name, registered office and address of the establishment, if it is a legal person;
2. person identification number,
3. the subject matter of the activity or business; and
4. the specific activities which the food business operator operates;
such data shall be notified to the competent public health authority when providing food services, which shall transmit them without delay to the other supervisory authorities referred to in Article 16, ';
10. in Article 3 (1) (l), the words "record the date of unpacking the food" shall be inserted after the words "food safety."
11. in § 3 (1) (q) of the introductory part of the provision, the words "separate placement and attachment of the disposal information" shall be inserted after the word "market."
12. in Article 3 (1) (q) (1), the words "(e)" shall be replaced by the words "(f) and foodstuffs with an expired date of minimum durability which are not safe."
13. in Paragraph 3 (1) (q), at the end of the text in point 2, the words "or in packages which do not protect food from degradation" shall be added.
14. in Article 3 (1), point (s) is deleted;
Point (t) shall be renumbered as point (s).
15. in Article 3 (4) (b), the words "designated points of entry or designated points of import provided for in the implementing legislation" shall be replaced by the words "border inspection post 62" designated by the Ministry of Agriculture ("Ministry") or through inspection points other than border inspection posts referred to in Article 53 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council ";
Footnote 62 reads:
"(62) Article 3 (38) of Regulation (EU) 2017 / 625 of the European Parliament and of the Council. ';
16. In Article 3, at the end of paragraph 4, the dot is replaced by "a 'and the following point (d) is added:
"(d) in the case of foodstuffs referred to in Article 47 (1) of Regulation (EU) 2017 / 625 of the European Parliament and of the Council, complete and transmit to the competent supervisory authority part of the common health entry document referred to in Article 56 of this Regulation.";
17. in Article 3d (1) of the final part of the provision, the words "the Ministry of Agriculture (" the Ministry ")" shall be replaced by the words "the Ministry."
18. Paragraph 3d (3), including footnote 63, reads as follows:
"(3) An operator of a food business which, at the place of destination, receives food defined by an implementing legislation from another Member State of the European Union or from a third country shall inform the supervisory authority responsible pursuant to Article 16 (4) or (5) of their arrival under the implementing legislation which, on the basis of the risk analysis referred to in Article 3 of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council to the extent strictly necessary for the organisation of official controls, sets out the type of the food, the date, extent and manner of information (63).
63) Decree No. 172 / 2015 Coll., on the information obligations of the food recipient at the place of destination, as amended. '
19. Paragraph 4 (4) reads as follows:
"(4) The application referred to in paragraph 3 shall contain, in addition to the general requirements of the application under the administrative rules:
(a) the name, surname, date of birth and place of residence of the natural person responsible, if any;
(b) the name, surname and place of residence of the person who is the statutory authority of the legal person or its member;
(c) the address of the irradiation plant and the officially certified signature of the applicant;
(d) the subject matter and scope of the activity for which approval is sought and the means of securing it;
(e) justification for the technological need for food irradiation;
(f) an analysis of the risks and critical control points of a potential food health breach under Regulation (EC) No 852 / 2004 of the European Parliament and of the Council, as amended; and
(g) the specification of sources of ionising radiation, the sanitary procedure and the documentation referred to in paragraph 2 (b).
The State Agricultural and Food Inspection shall request from the State Office on Nuclear Security a copy of the authorisation for the treatment of the source of ionising radiation and a copy of the decision approving the source of ionising radiation, if required, for the application referred to in paragraph 3. ';
20. Paragraph 4 (8) reads:
"(8) Foods irradiated by ionising radiation in the Member States of the European Union which are not intended for the final consumer or for the operator of a food business which operates a food service shall be accompanied, when marketed in the Czech Republic, by documentation containing the name and address of the authorised irradiation facility which has carried out the exposure, or by data on the reference number and the mode of exposure of each food species. '
21.
"(27) Article 10 of Regulation (EU) No 1308 / 2013 of the European Parliament and of the Council. Commission Delegated Regulation (EU) 2017 / 1182. Commission Implementing Regulation (EU) 2017 / 1184. '
22. in Article 6 (2), the words "Symbol" e "to indicate the quantity of a foodstuff may appear on the packaging" may be replaced by the words "The food business operator referred to in paragraph 1 may indicate the symbol" e "to indicate the quantity of a foodstuff on the packaging."
23. In Article 8, at the end of paragraph 1, the dot is replaced by a comma and the following point (e) is added:
"(e) the particulars referred to in Article 9 (1) (b) and (c) of Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council if the food offered for sale is sold in a self-service manner.";
24. in Article 9a (1) (d), the words "or the date of minimum durability" shall be inserted after the words "applicable."
25. in Article 9b (1) (a), the words "birth, breeding," shall be inserted after the words "primary production 48" and the words "or" shall be deleted at the end of the letter.
26. In Paragraph 9b, at the end of paragraph 1, the dot is replaced by "or 'and the following point (c) is added:
"(c) it is a food provided for in the implementing legislation, the production of which took place in the Czech Republic."
27. A new Section 9c is inserted after Section 9b.
(1) When placing a food on the market, information on its manufacturer may be provided by the expression "manufacturer: 'or by the expression having the same meaning for the consumer, provided that such information is followed by the name and surname or name or business name and address of the food business operator who made the food.
(2) Where the head office of the food business operator referred to in paragraph 1 and its establishment in which the food was produced are located in different countries, the name of the country in which the establishment is situated shall also be given, as given by the expression "establishment: '.
28. In Paragraph 10, the dot is replaced by a comma at the end of paragraph 1 and the following points (f) and (g) are added:
"(f) containing substances contrary to the requirements for the composition of food supplements or substances prohibited in the manufacture of foodstuffs under the Food Supplements and Food Additives Ordinance (64); and
(g) seemingly identical to the food placed on the market in other Member States of the European Union, although the food placed on the market in the Czech Republic has a substantially different composition or characteristics, unless justified by legitimate and objective facts and provided that the food is not easily accessible and has sufficient information on that different composition or characteristics.
64) Decree No. 58 / 2018 Coll., on food supplements and food composition. '
29. in Paragraph 11 (2), the sentence "This obligation shall not apply to beverages with an alcoholic strength of more than 0,5% vol." shall be inserted after the first sentence.
30. in Article 11 (2) and (3), the words "humanitarian or charitable organisations" are replaced by the words "public-service legal persons."
31. In § 11 (2), first sentence and (3), first sentence, the words "social services clients" shall be deleted.
32. in Article 11 (2) and (3), the words "intended for social services clients" are replaced by the words "according to the first sentence."
33. in Article 11 (2) and (3), the word "non-profit" shall be inserted after the word "these."
34. in Article 11 (4) (c), the words "to the client of social services" shall be replaced by the words "to the person to whom the food is provided."
35. In Article 11, the following paragraph 5 is added:
"(5) In the case of the distribution of foodstuffs, the promotion of a person other than a non-profit organisation, a food business operator providing free food or a public-service legal person as referred to in paragraphs 2 and 3 shall be prohibited. ';
36. in Paragraph 12c (1):
"(1) The manufacturer, importer, retailer and distributor of tobacco products shall:
(a) request, in the cases referred to in Article 9, 10, 14, 16 and 18 of Commission Implementing Regulation (EU) 2018 / 574, the State Price Printer, p. (hereinafter referred to as the State Price Printer) to assign a unique identifier, a unique identifier at group packaging level and an economic operator, equipment and machine identification code; and
(b) ensure that the unit packaging of cigarettes and tobacco intended for the manual packaging of cigarettes is marked with a unique identifier issued by the State Printer of Prices in the manner laid down in the implementing legislation. ';
37. in Article 12c (3), the words "issued by the State Price Printer" shall be inserted after the word "Identifier."
38. in Article 12c, paragraphs 5 and 6 are added:
"(5) The manufacturer and the importer of tobacco products shall provide samples of the tobacco products placed on the market by the State Agricultural and Food Inspection, upon request. The samples shall be provided in unit packaging format and shall contain the safety element used. State agricultural and food inspection shall pay compensation for the samples provided; it is carried out in accordance with § 11 (2) and (3) of the Control Regulations.
(6) Where the integrity of the verification element of the safety component is jeopardised pursuant to Article 6 (2) of Commission Implementing Decision (EU) 2018 / 576, the Central Inspectorate of the State Agricultural and Food Inspection shall order the replacement or modification of the safety element by the manufacturer of tobacco products, importers of tobacco products and providers of the safety component. The replacement regulation or changes to the safety component may be the first act in the proceedings. ';
39. in § 12h (2) of the introductory part of the provision, the words "or external" shall be replaced by "and external."
40. in Article 12h (2) (a), "to (d)" is replaced by "and (c); the net quantity may be indicated in ml '.
41. in Article 12h (3) of the introductory part of the provision, the word "attached" shall be inserted after the word "containing."
42.In Article 12h (7), "3" is replaced by "2."
43. In Article 12i (3), the word "may" shall be replaced by the words "or regional health centres shall be entitled."
44. The following Section 12k is inserted after Section 12j, which includes the title:
Tobacco-free nicotine sachets
(1) The manufacturer, importer, retailer and distributor of nicotine tobacco-free bags are required to ensure that these products meet the compositional, appearance, quality and characteristics requirements laid down in the implementing legislation.
(2) The manufacturer, importer, retailer and distributor of nicotine tobacco-free bags are required to ensure, in the form laid down in the implementing legislation, the presentation on the unit pack of:
(a) the data referred to in Article 12d (1) (a) to (d);
(b) a list of all ingredients contained in the product;
(c) nicotine content of the product,
(d) the quantity of nicotine in the dose;
(e) the lot number or equivalent information enabling the place and time of manufacture to be determined;
(f) data on the keeping out of reach of persons under the age of 18; and
(g) health warnings.
(3) The manufacturer, importer, retailer and distributor of tobacco-free nicotine bags are required to ensure that their unit packs contain:
(a) instructions for the use and storage of the product;
(b) information that non-smokers are not recommended for use,
(c) information on contraindications;
(d) warnings for specific risk groups;
(e) information on possible adverse effects,
(f) information on addiction and toxicity;
(g) contact details of the manufacturer or importer; and
(h) details of a legal or natural contact person having its registered office in a Member State of the European Union.
(4) The manufacturer and importer of nicotine tobacco-free bags shall notify the Ministry of Health, in electronic form, by remote transmission of the data within the time limits and to the extent specified in the implementing legislation
(a) information on nicotine tobacco-free bags which it intends to place on the market or import; and
(b) information on the tobacco-free nicotine bags market.
(5) A new notification as referred to in paragraph 4 (a) shall be submitted for each substantial change of product.
(6) The manufacturer, importer and distributor of nicotine tobacco-free bags are required to:
(a) establish and maintain a system for collecting information on all suspected adverse effects of these products on human health;
(b) take without delay the corrective measures necessary to comply with the product with this law or implementing legislation or, where appropriate, to withdraw it from the market, provided that it can reasonably be assumed that nicotine tobacco-free bags which have been or are intended to be placed on the market are not of safe or of adequate quality or otherwise contrary to that law or implementing legislation;
(c) in the case referred to in point (b), immediately inform the Ministry of Health, in electronic form, by remote transmission of the data, giving details, in particular, of the risk to human health and safety and of the corrective action taken and its outcome. ';
45. Paragraph 13e, including the title, reads:
Placing on the market of tobacco products and tobacco products
(1) Where a tobacco product or a tobacco product or a nicotine tobacco-free bag is marketed on the territory of the Czech Republic, the data referred to in § 12d to 12f, § 12h paragraphs 2 and 3, § 12g paragraphs 1 and 3, § 12j paragraph 2 and § 12k paragraphs 2 and 3 shall be entered in the Czech language.
(2) In the case of tobacco products, tobacco products and nicotine tobacco-free bags offered for sale by means of distance communication, all the information referred to in Articles 12d (1) (a) to (d) and (f) to (h), 12e (a) and (b), 12f (a) and (b), 12h (2) (a) to (d), (f) and (g), 12h (3), 12j (2) (a) and (b) and 12k (2) (a) to (d) shall be provided to the final consumer before the purchase is completed. '
46. The heading "Traceability of tobacco products' is inserted above the designation of Section 13f.
47. The heading § 13f is deleted.
48. in Article 13f (1), (2) and (7), "importer and distributor" is replaced by "importer, distributor and retailer."
49. in Article 13f (4) (a), "importers and distributors" shall be replaced by "importers, distributors and retailers."
50. in Article 13f, the following paragraphs 8 and 9 are added:
"(8) The obligations of the retailer of tobacco products referred to in paragraphs 1, 2 and 7 and the obligation of the manufacturer of tobacco products to the retailer of tobacco products referred to in paragraph 4 (a) shall not apply to the place of retail sale of tobacco products where he places tobacco products on the market.
(9) The manufacturer and the importer of tobacco products, at the request of the State Agricultural and Food Inspection Authority, will provide full access to the record of the verification procedure established by the means of verifying unauthorised manipulation pursuant to Article 7 of Commission Implementing Regulation (EU) 2018 / 574. '
51. the following Section 13g is inserted after Section 13f:
(1) The national agricultural and food inspection is the national data repository administrator for the traceability of tobacco products pursuant to Article 25 of Commission Implementing Regulation (EU) 2018 / 574.
(2) According to Article 3 of Commission Implementing Regulation (EU) 2018 / 574 on the territory of the Czech Republic, the State Price Printer is the only publisher
(a) a unique identifier at unit packaging level as referred to in Article 6 of Commission Implementing Regulation (EU) 2018 / 574;
(b) a unique identifier at group packaging level as referred to in Article 10 of Commission Implementing Regulation (EU) 2018 / 574;
(c) the operator identification code referred to in Article 14 of Commission Implementing Regulation (EU) 2018 / 574;
(d) the installation identification code referred to in Article 16 of Commission Implementing Regulation (EU) 2018 / 574; and
(e) the machine identification code referred to in Article 18 of Commission Implementing Regulation (EU) 2018 / 574.
(3) The State agricultural and food inspection is entitled to conclude further service level agreements with the secondary repository provider in accordance with Article 27 of Commission Implementing Regulation (EU) 2018 / 574.
(4) In the case of the dispatch and transhipment of unit or group packaging of tobacco products with a total weight of less than 10 kg intended outside the European Union, the obligations referred to in Article 32 (1) (c) to (e) of Commission Implementing Regulation (EU) 2018 / 574 may be fulfilled by providing access to records of the mail monitoring system belonging to the logistics or postal service operator.
(5) An independent third party that has supplied and installed a means of verifying tampering shall, upon installation, submit a declaration to the State Agricultural and Food Inspection and to the European Commission in accordance with Article 7 of Commission Implementing Regulation (EU) 2018 / 574 without undue delay.
(6) In the event of a serious breach of the requirements for the production, import, distribution or marketing of tobacco products laid down by this Act or by a directly applicable European Union regulation, the Central Inspectorate of the State Agricultural and Food Inspection shall decide on the de-activation of:
(a) the operator identification code referred to in Article 15 of Commission Implementing Regulation (EU) 2018 / 574;
(b) the installation identification code referred to in Article 17 of Commission Implementing Regulation (EU) 2018 / 574; or
(c) the machine identification code referred to in Article 19 of Commission Implementing Regulation (EU) 2018 / 574
and the price printer shall immediately deactivate the identification code referred to in (a), (b) or (c) and inform the State Agricultural and Food Inspection of the deactivation of the code.
(7) The State Agricultural and Food Inspection shall inform the manufacturer, importer, distributor, retailer or operator of the first retail store whose code has been deactivated, and shall inform the manufacturer or importer of the deactivation of the code referred to in paragraph 6 (c).
(8) The decision referred to in paragraph 6 may be the first act in the proceedings. ';
52. footnote 52 is deleted, including the footnote references.
53. In Article 15, at the end of paragraph 4, the sentence "The Ministry shall transmit and update contact details of liaison points in accordance with Article 103 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council to the European Commission and the Member States of the European Union. 'shall be added.
54. Paragraph 15 (7) reads:
"(7) The Ministry shall be the contact point, coordinate the preparation, processing and publication and ensure the submission of a multiannual national control plan pursuant to Article 109 to 111 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council and the annual report on the checks carried out pursuant to Article 113 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council. ';
55. in Article 15 (8) (d):
"(d) on the determination of novel food status pursuant to Article 4 of Regulation (EU) 2015 / 2283 of the European Parliament and of the Council,"
56. footnote 15c is deleted, including the footnote reference.
57. in Article 15 (12), the words "manufacturers, importers, retailers and distributors of tobacco and tobacco products and related products" shall be added at the end of point (b); and "
58. In Article 15 (13), at the end of the first sentence, the words "including information on non-safe foods, other than quality foods and falsified foods whose characteristics are adapted to the detriment of the consumer and which are marketed in a misleading manner 'shall be added.
59.In Article 15a (1) (a), "7" is replaced by "8."
60. In Article 15a, at the end of paragraph 1, the dot is replaced by a comma and the following points (e) to (s) are added:
"(e) designate a border inspection post in accordance with the procedure referred to in Article 59 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council on a proposal from the competent supervisory authority referred to in Article 14;
(f) withdraw the designation of a border inspection post pursuant to Article 62 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council on a proposal from the competent supervisory authority pursuant to Article 14;
(g) inform the European Commission and the other Member States of the European Union, in accordance with Article 62 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council, that the designation of the border inspection post has been cancelled and the reasons for the revocation;
(h) suspend, on a proposal from the competent supervisory authority pursuant to Article 14, the designation of a border inspection post, inform the European Commission and the other Member States of the European Union thereof, indicate the suspension in the list of border inspection posts on the territory of the Czech Republic and, under the conditions laid down, abolish such suspension in accordance with Article 63 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council;
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Regulation Information
| Citation | Act No. 174 / 2021 Coll., amending Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, and other related laws |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.04.2021 |
|---|---|
| Effective from | 12.05.2021 |
| Effective until | - |
| Status | Valid |
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