Act No. 316 / 2004 Coll.
Act amending Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, and certain other laws
Valid
Law
Effective from 27.05.2004
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316
THE LAW
of 29 April 2004
amending Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, and certain other 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 amending and supplementing certain related laws, as amended by Act No. 119 / 2000 Coll., Act No. 306 / 2000 Coll., Act No. 146 / 2002 Coll., Act No. 131 / 2003 Coll., Act No. 274 / 2003 Coll. and Act No. 94 / 2004 Coll., is amended as follows:
1. Article 1, including the title and footnotes 1), 1a) to 1e) shall read as follows:
Subject matter
(1) The purpose of the Act is to establish, in accordance with the law of the European Communities (1) and on the basis of the immediately binding provisions of the European Communities (1a), the obligations of food business operators and persons producing or putting into circulation tobacco products, (1b) and to regulate State supervision of compliance with the obligations arising from that Act and the immediately binding provisions of the European Communities. (1a)
(2) The purpose of this Act is also to provide for an obligation for business1b) to report stocks of 1c) food or agricultural products provided for in the immediately binding provisions of the European Community1d) (hereinafter referred to as "stocks") and to regulate state supervision of compliance with that obligation.
(3) This law does not apply to food and drinking water. The conditions for the production and supply of drinking water and the conditions for the production and putting into circulation of dishes shall be laid down in specific legislation. (e)
1) For example, Directive 2000 / 13 / EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, marketing and advertising of foodstuffs. Directive 2001 / 37 / EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the manufacture, presentation and sale of tobacco products. Directive 1999 / 2 / EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States relating to foodstuffs and additives in foodstuffs treated with ionisation. Commission Directive 2003 / 40 / EC of 16 May 2003 establishing a list of constituents of natural mineral waters, their concentration limits and labelling requirements and requirements for the use of ozone-enriched air in the treatment of natural mineral waters and spring waters.
(1a) For example, Regulation 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. 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. Commission Regulation (EC) No 1661 / 1999 of 27 July 1999 laying down more detailed rules for the implementation 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. Council Regulation (EEC) No 2759 / 75 of 29 October 1975 on the common organisation of the market in pigmeat, as amended. Council Regulation (EC) No 2529 / 2001 on the common organisation of the market in sheepmeat and goatmeat, as amended. COUNCIL REGULATION (EEC) No 1208 / 81 of 28 April 1981 determining the Community scale for the classification of carcases of adult bovine animals.
1b) § 2 of Act No. 513 / 1991 Coll., Commercial Code, as amended.
1c) § 9 of Decree No. 500 / 2002 Coll., implementing certain provisions of Act No. 563 / 1991 Coll., on Accounting, as amended, for entities that are entities accounting in the double accounting system.
1d) For example, Commission Regulation (EC) No 1972 / 2003 on transitional measures to be taken with regard to trade in agricultural products related to the accession of the Czech Republic, Estonia, Cyprus, Lithuania, Latvia, Hungary, Malta, Poland, Slovenia and Slovakia. Commission Regulation (EC) No 60 / 2004 laying down transitional measures in the sugar sector by reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia.
1e) Act No. 258 / 2000 Coll., on the Protection of Public Health and the Amendment of Related Acts, as amended. '
footnotes 18, 19 and 20 are deleted.
2. footnote (1a) shall be deleted and the references to footnote (1a) shall be renumbered as footnote (1e).
3. footnotes 1) and 2) shall be renumbered footnotes 2) and 2a), including the footnotes.
4. the following shall be added to Article 2 (c), including footnote 2b:
"(c) foods or food ingredients of a new type (hereinafter referred to as" novel food ") of foodstuffs or ingredients produced and put into circulation in accordance with the provisions of the immediately binding Regulation of the European Communities, 2b)
2b) Article 1 of Regulation (EC) No 258 / 97 of the European Parliament and of the Council. '
5. in § 2 (e), the word "game" is replaced by "game" and at the end of the sentence, the reference to footnote 2c is added.
Footnote 2c) reads as follows:
"(2c) Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended."
footnote 7 is deleted. The references to footnote 7 shall be replaced by those to footnote 2c.
6. in Article 2, the following point (j) is inserted after point (i):
"(j) food supplements intended for direct consumption which are distinguished from foods for normal consumption by a high level of vitamins, minerals or other substances with nutritional or physiological effect and which have been produced to supplement the standard diet of the consumer to a level which adversely affects his health,"
Points (j) to (u) shall be renumbered as points (k) to (v).
7. in § 2 (v):
"(v) tobacco products manufactured from tobacco, including genetically modified tobacco;"
8. in Article 2, point (v) is deleted;
9. in § 2 (y):
'( y) the classification of carcases of animals for slaughter (hereinafter referred to as the "classification of animals for slaughter") means the classification of carcases of animals for slaughter in the quality classes as laid down in the immediately binding provisions of the European Communities (1a) and the implementing legislation, '.
10. in Article 2, footnote 5 shall be deleted;
11. Article 3, including the title and footnotes No 3a) to 3r) shall read as follows:
Obligations of food business operators
(1) Food business operator 3a) is obliged to:
(a) to comply with obligations arising from the provisions of the European Communities, 3b)
(b) comply with the health, quality, transport, storage and putting into circulation of foodstuffs or raw materials for their production (hereinafter referred to as "raw materials") and with the technological and hygienic requirements laid down by this Act and the specific legislation (1e), (2c) or decisions of the competent authorities (1e), (2c), (3c) at all stages of production and putting into circulation, and use only heat-treated egg contents for the manufacture of non-treated foodstuffs;
(c) separate premises intended for the production and handling of food from other premises;
(d) ensure, in the manufacture and handling of foodstuffs, the hygiene conditions and requirements laid down by this law and by specific legislation, 1e), 2c)
(e) use only technical or technological equipment and technology in the manufacture and handling of foodstuffs to ensure the safety of foodstuffs;
(f) use only those articles and materials in direct contact with foodstuffs which comply with the requirements laid down in specific legislation, 1e)
(g) when using substances approved by a decision of the competent administrative authority pursuant to Article 3a, comply with the approved scope of labelling of such substances on the packaging of foodstuffs;
(h) keep a record of the protective disinsectisation carried out and of the protective extermination aimed at the disposal of disease agents and the increased presence of carriers of infectious diseases and harmful and epidemiologically significant arthropods, rodents and other animals;
(i) adapt the focus, scope of production, import and export of foodstuffs under economic measures imposed in a state of crisis under specific legislation, 3d)
(j) identify, at all stages of production and putting into circulation, the technological sections (critical points) in which the greatest risk of a health breach is to be carried out in the manner laid down in the implementing act, 3e) carry out checks and records thereof,
(k) notify in writing or in a manner that allows the remote transmission of the dates of commencement and termination of the activity at the latest on the date of its commencement or termination, to the competent authority of the supervisory authority (2c), 3f), stating its name, surname and place of business, if any, of a natural person, or of a commercial firm and its registered office, if it is a legal person.
(2) The food business operator which produces food or raw materials (hereinafter referred to as "producer") is also obliged to:
(a) to obtain, for the production of packaged spring water, packed infant water and packaged natural mineral water, water from groundwater only and to adapt it in accordance with implementing legislation; 3g), 3h) Treatment of packaged spring water with ozone-enriched air by the food business operator intending to apply such treatment in the production of packaged spring water, shall report this to the competent authority of the State surveillance authority,
(b) use food supplements, additives and flavourings in the manufacture of foodstuffs so that their content, conditions and method of use in the product is consistent with the implementing legislation or decision of the competent administrative authority;
(c) use drinking water for direct technological processing or food preservation; (1e) other water, with the exception of the manufacture of foodstuffs of animal origin, may be used by the manufacturer for this purpose only with the consent of the public health authority. The request for consent shall indicate the results of the quality and health inspection of the water and the justification for its use. The obligation to use drinking water shall not apply to water used for the transport or washing of agricultural products and raw materials which are further heat treated. However, this water must not adversely affect the health of the food,
(d) ensure, for manufactured foodstuffs, regular control of compliance with the requirements laid down in implementing legislation and technical requirements (3i) on health and quality and, at the time of radiological emergency (3c) on compliance with the requirements for maximum permitted levels of radioactive contamination of foodstuffs laid down by specific legislation, 3j) in the manner and to the extent laid down in the implementing legislation, and keep records thereof;
(e) comply with the health, purity and identity requirements of raw materials and substances laid down by specific legislation, 2c) by implementing legislation or by decision of the competent administrative authority issued under this law;
(f) ensure the supervision of compliance with the health requirements laid down, conduct regular training of staff, familiarise them with the hygiene conditions and requirements according to their working activities and keep records thereof.
(3) This law is without prejudice to the obligations to comply with the principles of personal and operational hygiene and the conditions for the performance of protective disinfection, disinsectisation and exertification laid down by specific legislation. 1e), 2c)
(4) The food business operator importing food or raw materials from third countries (the importer) shall:
(a) to submit to the customs authority a certificate for foodstuffs provided for in the immediately binding provisions of the European Community (3k) confirming that the food complies with those provisions; the certificate shall be issued by the competent authority in the country of origin of the food; This provision is without prejudice to requirements laid down in specific legislation, (2c)
(b) ensure control in the manner and under conditions provided that the immediately binding provisions of the European Communities (3) lay down additional requirements for the control of foodstuffs or raw materials in the country of destination;
(c) to submit a certificate to the customs authority at the time of radiological emergency (3c) in accordance with the provisions of the immediately binding regulation of the European Communities, 3l)
(d) to import the foodstuffs provided for in (a) only through the entry point which is the Office of the Customs Office of Prague D 5.
(5) On importation of food or raw materials from third countries referred to in paragraph 4, the customs authority shall:
(a) they shall not place such foodstuffs or raw materials under the customs procedure of free circulation unless the importer submits the relevant certificate issued in accordance with paragraph 4 which complies with the requirements of the immediately binding provisions of the European Communities, 3k)
(b) inform without delay the competent authority of State surveillance (§ 16) if the consignment, including its designation, does not correspond to the certificate submitted;
(c) request a binding opinion from the competent authorities of the State surveillance (3k), (3m) in the cases referred to in (a) and in the event of a reasonable suspicion that the consignment does not correspond to the certificate submitted;
(d) allow the competent authorities of the State surveillance to enter the customs territory where the importer requests a certificate from those authorities or the customs authority requests a binding opinion from the competent authorities of the State surveillance. 3m)
(6) The customs authority shall suspend the procedure for the release of foodstuffs or raw materials referred to in paragraph 4 or 5 for the customs procedure for free circulation and shall immediately request a binding opinion from the supervisory authorities, 3m) where the food or raw material has been reported in the rapid alert system; 3n) will subsequently take action in accordance with the Government Regulation (Paragraph 18 (2)).
(7) The food business operator shall:
(a) comply with the relevant conditions and the quality and health requirements of the food or raw material laid down by law, unless otherwise provided for by the rules in the country of destination or by an international treaty;
(b) notify the competent authority in the country of destination if the balanced food does not comply with the requirements of (a);
(c) to carry out exports of a foodstuff which does not comply with the quality requirements referred to in (a) only with the agreement of the competent authority in the country of destination; a food which does not comply with the health requirements referred to in point (a) and presents a risk to health cannot be exported even with the consent of the authority in the country of destination,
(d) submit to the customs authority at the time of radiological emergency (3c) a certificate in the territory of the Czech Republic that the exported food or raw material complies with the maximum permitted level of radioactive contamination; 3j) the certificate shall be issued on request by the competent supervisory authority (Section 16).
(8) Food or raw materials which do not comply with the maximum permitted radioactive contamination shall be handled in accordance with the decision of the supervisory authority (§ 16) in administrative management3o) issued on the basis of the opinion of the State Authority on Nuclear Safety. (c)
(9) In the case of the export or import of foodstuffs or raw materials referred to in paragraph 8, or foodstuffs or raw materials of unknown origin, the customs authority shall immediately notify the supervisory authority referred to in paragraph 8, which shall decide on the method of further handling of such foodstuffs or raw materials.
(10) A person who puts into circulation wild edible mushrooms 3p) intended for sale to the consumer or for further processing for food purposes must have a certificate proving knowledge of mushrooms and a business authorisation.
(11) Certificates proving knowledge of fungi are issued by the Regional Sanitary Station1e (e) on the basis of a successful examination of the knowledge of fungi. The applicant shall pay an administrative fee in accordance with specific legislation for issuing the certificate. 3r)
(12) Only an adult with a medical certificate for this activity may apply for a mushroom test. Medical fitness shall be certified by a practitioner with whom a person is registered for medical treatment; a specialist eye examination is included.
(13) The validity of certificates proving knowledge of mushrooms shall cease to exist.
(a) after a period of 10 years from the date of its issue, for persons under the age of 60;
(b) 5 years after the date of issue for persons between 60 and 65 years of age;
(c) two years after the date of issue for persons over 65 years of age,
(d) the death of the person who acquired it.
(3a) Article 3 (3) of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council.
3b) Article 11, 12, 14, 16, 17, 18, 19 of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council.
3c) Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionizing Radiation (Atomic Act) and on the amendment and addition of certain laws, as amended.
3d) Act No. 240 / 2000 Coll., on crisis management and amending certain laws (Crisis Act), as amended by Act No. 320 / 2002 Coll. Act No. 239 / 2000 Coll., on Integrated Rescue System and on the amendment of certain laws, as amended by Act No. 320 / 2002 Coll. Act No. 241 / 2000 Coll., on economic measures for crisis situations and amending certain related laws, as amended by Act No. 320 / 2002 Coll.
3e) Decree No. 147 / 1998 Coll., on the method of determining critical points in production technology, as amended by Decree No. 196 / 2002 Coll.
3f) Act No. 146 / 2002 Coll., on State Agricultural and Food Inspection and on the amendment of certain related laws, as amended.
3g) Decree No. 292 / 1997 Coll., on health requirements for packaged waters and on how to adapt them, as amended.
3h) Act No. 164 / 2001 Coll., on Natural Medical Resources, Natural Mineral Water Resources, Natural Spa and Spa Places and on the Change of Certain Related Laws (Spa Act), as amended.
3i) § 2 (h) of Act No. 22 / 1997 Coll., on technical requirements for products and amending and supplementing certain laws, as amended.
3j) Decree No. 307 / 2002 Coll., on Radiation Protection.
3k) Commission Regulation (EC) No 1148 / 2001 on checking the conformity of fresh fruit and vegetables with marketing standards. Commission Decision 97 / 830 / EC of 11.12.1997 imposing special conditions on imports of pistachios and products thereof or consigned from Iran. Commission Decision 2002 / 79 / EC of 4 February 2002 imposing special conditions governing imports of peanuts and certain products derived from peanuts originating in or consigned from China. Commission Decision 2002 / 80 / EC of 4 February 2002 introducing special conditions for imports of figs, hazelnuts and pistachios and certain products thereof originating in or consigned from Turkey. Commission Decision 2002 / 75 / EC of 1 February 2002 laying down special conditions for imports of star anise from third countries. Commission Decision 2002 / 679 / EC of 22 August 2002 amending Decision 2002 / 80 / EC imposing special conditions governing imports of figs, hazelnuts and pistachios and certain products derived thereof originating in or consigned from Turkey. Commission Decision 2002 / 678 / EC of 22 August 2002 amending Decision 2002 / 79 / EC imposing special conditions governing imports of peanuts and certain products derived from peanuts originating in or consigned from China. Commission Regulation (EC) No 1661 / 1999. Commission Regulation (EC) No 1627 / 2000. Commission Regulation (EC) No 1621 / 2001.
3l) Article 3 of Commission Regulation (EC) No 1661 / 1999 / EC.
3m) Act No. 102 / 2001 Coll., on general product safety and amending certain laws (Act on general product safety), as amended.
3n) Article 50 of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council.
3o) Act No. 71 / 1967 Coll., on Administrative Procedure (Administrative Regulations), as amended.
3p) Decree No. 157 / 2003 Coll., laying down requirements for fresh fruit and fresh vegetables, processed fruit and processed vegetables, dry nuts, mushrooms, potatoes and their products, and other means of labelling them.
3r) Act No. 368 / 1992 Coll., on Administrative Charges, as amended. '
footnotes 8, 9, 9a, 9b, 9c, 9d, 9e, 10 and 10b are deleted.
12.
Obligations of manufacturers and importers of certain additives
(1) The Ministry of Health may, at the request of the manufacturer or importer of an additive intended for the manufacture of foodstuffs and not covered by the implementing legislation, 3s or the food business operator, issue consent to its manufacture or use. The consent of the Ministry of Health shall be issued for a maximum period of 2 years.
(2) Without the consent of the Ministry of Health referred to in paragraph 1, additives other than those mentioned in Implementing Legislation (3s) may not be used for the manufacture of foodstuffs or put into circulation.
(3) The application referred to in paragraph 1 must contain:
(a) the specification of the additive and, where appropriate, the nature of the non-traditional source;
(b) technological justification;
(c) a dossier containing the elements necessary for the health assessment of the additive, in particular the results of toxicological testing, showing that the cumulative, synergistic or enhancer effect and the manifestations of intolerance of the organism to foreign substances, toxicity data with evidence that the additive does not affect the health of the food itself or the reaction or interaction with food, packaging or other substances and raw materials contained in the food, and data on the purity of the additive,
(d) the types of food to which the additive may be added and the conditions of its use, including the quantity in the resulting food and the justification for the extent of use of the additive in the manufacture of the food.
(4) In agreement, the Ministry of Health shall determine the types of food, including food intended for particular nutritional uses, to which the additive may be added and the conditions for its use; the method and extent of labelling of the additive on the packaging may also be specified in the consent. When deciding to give consent, the Ministry of Health shall take into account that the quantity of the additive is limited to the minimum necessary to achieve the desired effect and shall take into account the acceptable daily dose or estimate the likely intake of the additive from all sources.
(5) The Ministry of Health shall inform the Commission of the European Communities and the other Member States of the European Union of the consent on behalf of the Czech Republic within 2 months of the date of enforcement. Before the expiry of 2 years, the Ministry of Health may, on behalf of the Czech Republic, request the Commission of the European Communities to include a new additive in the list of authorised additives. The application shall state the supporting documents supporting the inclusion of the substance in the list and the use of the additive. If the Commission of the European Communities forward the proposal of the Czech Republic to the Council of the European Communities, the period of validity of the consent of the Ministry of Health shall be extended by the period necessary for the Council of the European Communities to decide, but for a maximum period of 18 months. If the Council of the European Communities accepts the proposal of the Czech Republic for the inclusion of the additive in the list, the consent period of the Ministry of Health shall be extended for an additional 18 months. If the Commission of the European Communities does not submit a proposal from the Czech Republic to a decision to the competent authority of the European Communities or decide to be included in the list within a specified time limit, the consent of the Ministry of Health, granted or extended under this provision, shall cease to exist on the date on which the Ministry of Health informs the person who has been given the consent pursuant to paragraph 1. For the same additive for which approval has been withdrawn, new consent may not be granted unless justified by scientific and technical progress since the expiry of the consent.
(6) The manufacturer or importer of an additive to which approval has been given in accordance with paragraph 1 shall be required to inform the food business operators and the food service operators, 1e) who are taking the additive from it, the types of food to which the additive may be added, the conditions of its use and the manner and extent of labelling on the packaging as well as the cessation of the consent granted; food business operators and food service operators shall comply with these conditions and terminate the use of the additive when the consent is terminated.
(7) Addendum substances shall be continuously monitored and, if necessary, reassessed in the light of changing conditions of use and new scientific information.
3s) Decree No. 53 / 2002 Coll., laying down the chemical health requirements for each type of food and food raw material, the conditions of use of additives, auxiliary and food supplements, as amended by Decree No. 233 / 2002 Coll. '.
footnote 10c is deleted.
13.
(1) Entrepreneur pursuant to § 1 (2) is obliged to report to the local inspector of the State Agricultural and Food Inspectorate
(a) stocks recorded under special legislation21) on 1 May 2004;
(b) stocks for 2001, 2002 and 2003, on 1 May;
(c) the stocks of sugar, isoglucose, fructose and processed products also on 1 May 2000.
(2) The reporting obligation referred to in paragraph 1 (a) to (c) must be fulfilled by the entrepreneur referred to in Paragraph 1 (2) by 31 July 2004 at the latest; This does not apply to the stocks of sugar, isoglucose, fructose or processed products referred to in paragraph 1 (a) for which the trader must fulfil the reporting obligation within 10 days of the entry into force of this Act.
(3) In addition to the obligations referred to in paragraphs 1 and 2, the entrepreneur referred to in Article 1 (2) shall, by 31 July 2004 at the latest, notify the locally competent inspectorate of the State Agricultural and Food Inspection of the quantities of sugar, isoglucose, fructose and processed products which the entrepreneur:
(a) imported;
(b) exported,
(c) purchased on the domestic market,
(d) sold on the domestic market,
for the period 2000, 2001, 2002, 2003 and 2004, from 1 May to 30 April of the following year.
(4) The scope of the stocks, their formation and movements subject to reporting obligations under paragraphs 1 to 3 and the model form is determined by the Ministry of Agriculture (hereinafter referred to as "the Ministry") by decree.
21) Sections 29 and 30 of Act No. 563 / 1991 Coll., on Accounting, as amended. § 7b of Act No. 586 / 1992 Coll., on Income Tax, as amended. '
14. The following Sections 3c and 3d are inserted after Article 3b, including the headings and footnotes 3t:
Obligations of manufacturers and importers of certain foodstuffs intended for particular nutritional uses
(1) A manufacturer putting into circulation, for the first time, a food intended for particular nutritional uses, not covered by the implementing legislation, 3t) or an importer of a food for particular nutritional uses, not covered by an implementing legislation originating in third countries, is required to notify the Ministry of Health of its putting into circulation without delay by means of a sample of the label used for the labelling of such food.
(2) Where the same food for particular nutritional uses is not provided for in the implementing legislation, subsequently placed on the market in another Member State of the European Union, the manufacturer or importer shall provide the same information to the competent authority of that State at the same time as the addressee of the first communication referred to in paragraph 1.
(3) The Ministry of Health shall be entitled to require from the manufacturer or importer who has made the notification referred to in paragraph 1 professional verification of the food notified, including indications that it is suitable for labelled nutritional purposes, complies with the labelled nutritional requirements, shall be identified in a manner specified by the implementing act or decision of the competent administrative authority and shall be placed on the market with a designation of the purpose of use. Where such professional verification is included in the available publication, it shall be sufficient for the manufacturer or importer to provide a reference to that publication.
(4) The Ministry of Health shall be entitled to prohibit or restrict the putting into circulation of food for particular nutritional uses not covered by an implementing act which does not meet the labelling of nutritional purposes, is not marked by the procedure laid down by the implementing act or by the decision of the competent administrative authority, is not put into circulation with the designation of the purpose of use or endangers health, although it is in circulation in one or more Member States of the European Union, and shall decide to repeal the measure. This procedure and its reasons shall be immediately communicated to the other Member States of the European Union and to the Commission of the European Communities.
Obligations of manufacturers and importers of food supplements and food supplements for special medical purposes
(1) In order to facilitate effective monitoring of food supplements, manufacturers and importers of food supplements are required to inform the Ministry of Health by sending a sample of the label used for the labelling of such food. A sample of the label shall be sent before the food supplement is put into circulation.
(2) In order to facilitate the monitoring of compliance with the obligations laid down by this Act (Article 16) for the production and putting into circulation of foodstuffs for special medical purposes, the manufacturer or importer, if the food is produced in third countries, is required to notify their entry into circulation by means of a model of the label used for the labelling of that food. The notification shall be submitted by the State Agricultural and Food Inspection.
(3) The importer shall not have the obligation referred to in paragraph 1 or 2 if the re-import of the same food and the label sample are not modified.
3t) Decree No. 54 / 2004 Coll., on foodstuffs intended for particular nutritional uses and their method of use. '
15. Paragraph 4 (1), including footnote 4, reads:
"(1) Ultraviolet rays or ionising radiation may only be irradiated by food or raw materials provided for in the implementing legislation, 4) and only by sources of ionising radiation approved for the irradiation of foodstuffs under specific legislation. 3c), 3j) The irradiation of food and raw materials must comply with the conditions laid down in the implementing legislation.4) Foodstuffs or raw materials not covered by the implementing legislation4) can only be irradiated with the consent and under the conditions laid down by the Ministry of Health.
4) Decree No. 297 / 1997 Coll., on the conditions for irradiation of foodstuffs, on the maximum permitted dose of radiation and on the method of labelling. '
16. in Article 4 (2), the word "food" shall be deleted from the introductory part of the text.
17. in Article 4 (2) (a) and (b):
"(a) to designate the natural person responsible for compliance with the conditions for irradiation laid down in the implementing legislation, 4)
(b) keep, for each source of ionising radiation, documentation containing the method of exposure to food or raw material by species, their irradiated quantity, batch marking, name of the client and consignee of the irradiated food or raw material, date of exposure, type of packaging material used during the exposure, data necessary to control the radiation process, including data on continuous dosimetric control of the dose used, details including the limit, lowest and highest absorbed dose of radiation and its nature, reference to validation measurements, indication of specific conditions for exposure, '.
18. in Paragraph 4 (3):
"(3) The irradiation of food and raw materials by ionising radiation may be performed only if the procedure and method of irradiation have been decided upon at the request of the irradiation operator (hereinafter referred to as the" irradiation approval decision ') by the State Agricultural and Food Inspection. (f) the application for a decision shall be subject to an administrative fee. 3r)'.
19. In Article 4, paragraphs 4 to 8 are added:
"(4) The application referred to in paragraph 3 shall include the name, surname, date of birth and place of residence of the applicant, if any, if the natural person, surname, date of birth and place of residence of the representative of the applicant, if any, or business name and registered office, name, surname and place of residence of the person who is the statutory authority of the legal person or persons who are its members, if the legal person, address of the irradiation facility and officially certified signature of the applicant. The application referred to in paragraph 3 shall be supported by the authorisation of the State Office for Nuclear Safety to handle the source of ionising radiation, including type approval of the source of ionising radiation, documentation setting out the critical points of the maximum permissible risk of potential food harm, the specification of sources of radiation and the sanitation rules. The details and model of the application referred to in paragraph 3 shall be laid down in the implementing legislation.
(5) A decision on the approval of the irradiation plant may be taken provided that the conditions for irradiation laid down by specific legislation have been fulfilled. 3c), 3j) The decision on the application referred to in paragraph 3 shall be governed by a special law. 3o) The State agricultural and food inspection may suspend or revoke the decision approving the irradiation plant if it ascertains the facts which are liable to threaten or threaten its proper performance, or if it ascertains that the conditions and conditions for the proper execution of the irradiation approval decision are not met.
(6) The State agricultural and food inspection shall immediately inform the competent authority of the Commission of the European Communities of this fact after the decision on the approval of the irradiation plant has been taken and shall at the same time forward the documentation necessary for its approval for publication in the Official Journal of the European Communities. The national agricultural and food inspection shall also inform the competent authority of the Commission of the European Communities of any suspension or withdrawal of approval decisions.
(7) Imports of food or raw materials irradiated by ionising radiation from third countries may only be made on condition that:
(a) irradiated foodstuffs or raw materials meet the conditions and requirements laid down by law and implementing legislation, 4)
(b) have been irradiated in an irradiation facility approved by the competent authority of the Commission of the European Communities and appearing on the list of irradiation plants published in the Official Journal of the European Communities;
(c) the irradiated food shall be accompanied by documentation showing the name and address of the irradiation plant and other particulars referred to in paragraph 2.
(8) Foodstuffs or raw materials irradiated by ionising radiation in the Member States of the European Communities shall be accompanied, when put into circulation in the Czech Republic, by documentation indicating the name and address of the authorised irradiation facility which has carried out the irradiation, by an indication of the mode of exposure of the different types of food or raw materials and their quantities. '
20.
Classification of carcasses
(1) The food business operator operating a slaughterhouse (4a) (hereinafter referred to as "slaughterhouse operator") which slaughters slaughter animals for slaughter is required to ensure the classification and labelling of carcases of animals for slaughter in the manner and to the extent provided for by immediately binding European Community4b) and implementing legislation.
(2) Paragraph 1 shall not apply to operators of slaughterhouses which slaughter:
(a) an annual average of up to 100 pigs per week,
(b) only pigs born and fattened in their own breeding establishments and which have all been slaughtered;
(c) adult bovine animals with an annual average of up to 20 head per week.
(3) The classification referred to in paragraph 1 does not apply to:
(a) sows, cryptorchids and boars serving for breeding purposes;
(b) adult bovine animals for slaughter which, at the applicant's request and account, are only delivered for slaughter.
(4) The classification of the carcasses of animals for slaughter is carried out by natural persons in the manner and to the extent specified by the immediately binding provisions of the European Communities (4b) and by implementing legislation on the basis of a certificate of competence issued by the Ministry. The classifier shall issue a report on the classification carried out; the implementing legislation sets out a model of the classification protocol.
(5) The certificate referred to in paragraph 4 shall be subject to medical fitness, complete secondary education or full secondary vocational education and 2 years of experience, or to basic education and 6 years of experience in the field, training and examination; the order specifies the manner and extent of training, the composition of the examinations and the issue of the certificate, its duration and the extension of the certificate. Recognition of qualifications of citizens of the European Union is governed by this law and by specific legislation. (c)
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Regulation Information
| Citation | Act No. 316 / 2004 Coll., amending Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, and certain other laws |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 27.05.2004 |
|---|---|
| Effective from | 27.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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