Full text of Act No. 114 / 2004 Coll.
Full text of Act No. 91 / 1996 Coll., on Feed, as resulting from subsequent amendments
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17.03.2004
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114
PRESIDENT OF THE GOVERNMENT
Announces
full text of Act No. 91 / 1996 Coll., on Feed, as follows from amendments made by Act No. 244 / 2000 Coll., Act No. 147 / 2002 Coll., Act No. 320 / 2002 Coll. and Act No. 21 / 2004 Coll.
THE LAW
on feedingstuffs
Parliament has decided on this law of the Czech Republic:
GENERAL PROVISIONS
Subject matter
(1) That law lays down requirements for the production, import, use, packaging, labelling, transport and putting into circulation of feedingstuffs, additives and premixtures, as well as the powers and powers of professional supervision of compliance with the obligations laid down by that law, including the authorisation to impose penalties, in accordance with European Community law.
(2) This Act shall not apply to feed, additives and premixtures intended for export and which are safe. (1a)
(3) This law does not apply to veterinary products and medication.2)
Definition of terms
For the purposes of this Act:
(a) feed of products of plant or animal origin fresh or preserved and products of industrial processing, as well as organic and inorganic substances with the addition of additives or without addition which are intended for feeding to animals separately or in mixtures;
(b) feed materials intended for direct use in animals in their original state or after processing, for the manufacture of compound feedingstuffs or as carriers for the manufacture of premixtures,
(c) compound feedingstuffs of compound feed containing or without additives intended as complete or complementary feed for animals;
(d) complete feedingstuffs of compound feedingstuffs which, by their composition, cover the need for a daily ration;
(e) complementary feedingstuffs of a compound feed with a high content of certain nutrients which, when added to other feedingstuffs, cover the need for a daily ration;
(f) a daily ration of the average total amount of feed calculated on a moisture content of 12% required by the animal of the species, age category and utility to ensure all its needs;
(g) additive substance or preparation used in the manufacture of feed or animal nutrition for the purposes of:
1. beneficial influence on the characteristics of feedingstuffs or animal products;
2. satisfaction of animal nutrition or improvement of animal production, in particular by affecting gastro-intestinal flora or feed digestibility;
3. Addition of animal nutrition by elements which contribute to the achievement of specific nutritional objectives or which ensure specific animal nutrition requirements during a specific period;
4. preventing or mitigating harmful effects caused by animal feces;
5. improving the environment of animals,
(h) premixtures of a mixture of additives without carriers or a mixture of one or more additives with carriers, where appropriate with the addition of amino acids intended for the manufacture of feedingstuffs,
(i) an undesirable substance, a substance or a product, which is present on the surface or in products intended for animal feed and which present a potential risk to animal health, human health or the environment, or may have an adverse effect on animal production, except for pathogenic agents;
(j) a prohibited substance or a prohibited product which, by its essence, adversely affects the health of the animal or the health of the raw material or food of animal origin which must not be used in the manufacture of feed or, where appropriate, in animal nutrition;
(k) a withdrawal period of the minimum period which must elapse from the end of the feed containing a specific additive for which that period is fixed until the slaughter of the animal or the start of production of animal products intended for human consumption;
(l) a conditionally applicable feed, additive or premixtures feed, additive or premixtures which does not comply with any of the requirements laid down in this Law or with the legislation or regulations of the European Communities and which cannot be used for that purpose for the original purpose, provided that such feed, additive or premixture maintains its health,
(m) degraded feed, additive or premixtures feed, additive or premixtures unfit for use for animal feed,
(n) an livestock animal which is normally kept by man for economic purposes or fed for human consumption, and a fur animal;
(o) pet animals which are kept by man are not used and are not farmed animals, except fur animals (hereinafter referred to as "pet animals"),
(p) a specific protein feed material which constitutes direct or indirect protein sources and which has been produced by a specific technological process;
(r) the specific purpose of feeding to ensure specific nutritional and physiological requirements of a category of economic or domestic animal whose digestion, absorption or metabolism may be temporarily or irreversibly disturbed and which may therefore benefit from the intake of feed corresponding to its condition;
(s) by putting into circulation the holding, storage, sale of feed or, where appropriate, the additive or premixture with a view to their sale, offer for sale or any other way of transferring them to a third party for consideration or free of charge;
(t) by biological testing to determine the efficacy of the feed or additive under precisely specified conditions laid down in the Decree;
(u) the type of production of feed, the production of additives, the production of premixtures, the production of feed using additives or the production of feed using premixtures or the production of feed using feed;
(v) sampling for the official control of feed, feed additives, premixtures and undesirable substances in accordance with the procedure laid down in the Decree with the exception of pesticide residues and micro-organisms (hereinafter "sampling"),
(w) the manufacturing operation of the plant producing or processing feed, feed additives or premixtures;
(x) the date of minimum durability of the date by which the feed, additive or premixtures retain the quality-determining properties in the specified storage conditions;
(y) the supplier, the legal or natural person holding the feed, feed additive or premixtures, manipulates and puts them into circulation;
(z) by a distributor, a legal or natural person who makes the putting into circulation of feedingstuffs, additives or premixtures;
(aa) lots of feed, feed additive or premixture showing consistency with its external arrangements, labelling and local storage;
(bb) cross-contamination of two or more additives, undesirable substances, or the presence of prohibited substances, or products, where appropriate, which have mutual contrasting or inhibiting effects, undesirable or toxic effects, is contained in feed in a quantity higher than the limit of determination of the methods for detection or a specified tolerance value for their occurrence;
(cc) by professional supervision, official control including surveillance, inspections, verification, monitoring, sampling and analysis carried out by the professional surveillance authority;
(dd) the legal or natural person producing or processing feed, feed additives or premixtures holds those as suppliers before they are put into circulation or puts them into circulation, including the person operating the mobile feed production,
(ee) agricultural primary production of livestock farming, cultivation of agricultural crops, including harvesting, milk production, eggs and pre-slaughter livestock production,
(ff) any stage of production, production, storage, transport, supply, distribution, sale or import of feed products,
(gg) by an importer, a legal or natural person importing feed, feed additives or premixtures from third countries;
(hh) the traceability of the origin of the finding of origin of the feed or of a substance which is or might be processed into feed at all stages of production, processing and delivery;
(ii) the risk of adverse health effects and the severity of such effects as a result of the real existence of danger;
(j) the risk of biological, chemical or physical factors in feed products or the state of feed products which may adversely affect health;
(kk) the Contracting State is a State which is in contract with the States of the European Communities;
(ll) a third country of a country which is not in contractual relationship with the States of the European Communities or part of the European Communities,
(mm) checking documents for verification of documents accompanying the product or any other information relating to the product;
(nn) checking the identity of the verification of conformity between the document, the marking and the product by visual inspection;
(oo) physical inspection of the product itself, including sampling and laboratory testing where necessary.
Basic provisions
(1) In the manufacture, putting into circulation and use of feed, additives and premixtures, the content and the intended purpose of use of additives and certain protein feedingstuffs and the content and limits of undesirable substances must be respected in order to avoid damage to animal health and to ensure health (2a) and not to adversely affect the quality of animal products intended for human consumption.
(2) For the manufacture of feed, feed additives and premixtures, their putting into circulation and animal feed, no authorised protein feed or non-authorised additives or additives which do not comply with the conditions of their authorisation, and premixtures or feed containing such substances shall be used.
(3) Additives intended for animal nutrition may be used only as part of the feed.
(4) The use of feed marked with a withdrawal period shall respect the minimum period of withdrawal; This is without prejudice to the provisions of the Special Act (3).
(5) Feed, additives and premixtures which have undergone a minimum durability date or warranty period may not be used for production, put into circulation and used for feeding unless their declared quality and health is checked.
(6) For the manufacture of feed, feed additives and premixtures and for animal feeding
(a) prohibited substances and products, feed and premixtures containing prohibited substances and products, and degraded feedingstuffs, feed additives and premixtures,
(b) feed materials, feed, additives and premixtures containing undesirable substances if they exceed the limits laid down in the Decree;
(c) feed, additives and premixtures in which foreign objects are present which are liable to endanger animal health and live stock pests listed in the Decree.
(7) Feed and substances which, by their physical characteristics, do not ensure the homogeneity and stability of the additives in the premixture shall not be used as carriers for the manufacture of premixtures.
(8) Feed, additives and premixtures for which the level of radioactive contamination exceeds the limits laid down must not be used for the further manufacture of complete and complementary feed and premixtures and must not be put into circulation, fed, imported and exported.
(9) Additives of growth promoters, anti-coccidials, chemotherapeutic agents, vitamin A, vitamin D, copper and selenium groups may be used only in the form of premixtures with carriers and delivered only to authorised registered production establishments in accordance with Article 4 (3), unless the cases referred to in Article 4 (5) are concerned. Vitamin A, vitamin D, copper and selenium may be supplied directly for use in such mixtures by registered manufacturers of compound feedingstuffs for domestic animals.
(10) Premixes containing the feed additives referred to in paragraph 9 may be supplied only to registered feed manufacturers and suppliers meeting the requirements laid down in Section 4 and not added to feed of less than 0,2% by weight of feed. Where the authorised production operation technology on the basis of the examination allows a homogeneous incorporation in the premixture of the feed additives in the premixture, the percentage of premixture dosage may be reduced to 0,05% of the feed weight, provided that the manufacturing operation is authorised for that purpose.
(11) Paragraph 10 shall also apply to persons producing feed for the purpose of animal primary production which fulfil the conditions for the production of feed laid down by this Law. Additional feed containing the additives referred to in paragraph 9 may be added to feed in proportion to the proportion determined by the Ministry of Agriculture (hereinafter referred to as "the Ministry ') by decree.
(12) Feed or feed additives containing or produced by genetically modified organisms may be used for the production of feed, including production for the purpose of animal primary production, where appropriate for putting into circulation, only under the conditions laid down by a special act. 3a)
(13) The list of prohibited substances and products, the list of undesirable substances and products and the maximum limits on their content and use, the list of storage pests, the maximum levels of radioactive contamination and the withdrawal periods for certain additives shall be laid down by the Ministry by decree.
(1) Feed materials, feed materials and all other substances and products, additives and premixtures (hereinafter referred to as "feed products") intended for food-producing animals must not present a risk to animal health, human health or the environment and animal products derived from such animals must be safe and suitable for human consumption.
(2) The natural or legal person producing, importing, putting into circulation or using feed products, including feeding animals for the purpose of animal primary production, must at all stages of his activity ensure that feed products comply with the requirements laid down by law and implementing legislation.
(3) The person referred to in paragraph 2 shall ensure accurate traceability of the origin and data enabling the monitoring of the feed product which has been or should be incorporated into feed. This person must have a method and working procedure that allows identification of the persons who have supplied him or her with their products. This information must be provided at the request of the expert supervisor, which is the Central Audit and Examination Institute of the Agricultural Institute ("the Institute ').
(4) Where the person referred to in paragraph 2 has reasonable grounds for suspecting or finding that a feed product does not comply with the requirements laid down by law and implementing legislation pursuant to paragraph 1, he shall inform the Institute thereof and shall immediately take measures to prevent the further spread of the risk to animal health, human health and the environment, which shall suspend further production, suspend the further putting into circulation of the feed product, ensure its separate storage and, where appropriate, withdraw it from circulation.
(5) The person referred to in paragraph 2 shall inform the Institute of the measures taken pursuant to paragraph 4 and shall inform the users to whom he has supplied the feed products effectively and accurately of the reason for the suspension of the supply of those feed products. It shall, if necessary, require them to supply products provided that other measures do not provide adequate protection for animal health, human health and the environment. In providing the activities referred to in paragraphs 4 and 5, the person referred to in paragraph 2 shall cooperate with the Institute in order to prevent the risks that the feed product supplied to him could cause, in particular by providing any data enabling his or her exact traceability and monitoring.
(6) Institute without delay
(a) verify the information received;
(b) examine the nature of the danger, the possible content of undesirable substances in the feed product, their possible origin or the cause of the hazard, or, where appropriate, take a decision on the measure referred to in Article 18.
(7) On the basis of the extent of the risk identified, the Institute shall assess other parts of the lot or supply of the same type or designation. If the danger is confirmed, the Institute shall proceed in accordance with Sections 16b and 18.
(8) The obligations laid down in paragraphs 4 and 5 in the case of the finding that a feed product does not comply with the requirements of paragraph 1 shall also apply to operators of laboratories referred to in Article 17 (2) who carry out the relevant analyses.
Safety requirements for feed products
(1) Feed products may not be put into circulation and may not be used for feeding livestock unless they are safe under the relevant Regulation (c).
(2) The safety assessment requirements for feed products are laid down in specific legislation. (c)
(3) Feed products from third countries may be put into circulation and may only be used if they are of sound, genuine and marketable quality and therefore do not present any risk to animal health, human health and the environment if properly used, or if they do not have an adverse effect on animal production.
PRODUCTION, IMPORTS AND INCOME INTO THE CIRCUMSTANCES, ADDITIONAL SUBSTANCES AND PREMIXES
(1) Feed, feed additives and premixtures intended for putting into circulation may be manufactured by producers that are enterprises4) and registered in accordance with Section 8. The obligation to register shall also apply to persons referred to in Article 3 (11), persons operating the production facilities of mobile feed mills, suppliers referred to in paragraph 4, importers of feed, additives or premixtures and distributors referred to in Article 8a. Entrepreneurs who produce feed using complementary feed and use it for the use of animal primary production but do not put it into circulation shall be obliged to report this in writing to the Institute, including the relevant production operations referred to in Section 8b.
(2) The obligations referred to in paragraph 1 shall not apply to persons producing grains, oilseeds and oilseeds, livestock-bulky fodder and watery industrial feed (brewing straw, yeast milk, whey, milk-treated milk, buttermilk, buttermilk, sugar pulp, starch grits, molasses, feed hydrolysates, waste cream, distillates and fodder pastes). This obligation shall also not apply to importers and suppliers of those feedingstuffs.
(3) Production plants in which they are produced
(a) antioxidants for which a maximum level of use is established, carotenoids and xanthophylls, enzymes and micro-organisms, growth promoters, anti-coccidic agents and chemotherapeutic agents, vitamins, trace elements or certain protein feed provided for in the Decree, with the exception of urea and its derivatives, and ammonium salts and yeasts cultured on substrates of plant or animal origin;
(b) premixtures containing growth promoters, anti-coccidic agents and chemotherapeutic agents, vitamin A, vitamin D, copper or selenium;
(c) compound feedingstuffs using premixtures containing growth promoters, anti-coccidic agents or chemotherapeutic agents, vitamin A, vitamin D, copper or selenium;
must comply with the requirements for manufacturing operations laid down in the Decree and must be authorised by the competent administrative authority.
(4) Suppliers holding and putting into circulation
(a) additives or certain protein feedingstuffs referred to in paragraph 3 (a) and premixtures containing those additives and certain protein feedingstuffs; or
(b) the premixtures referred to in paragraph 3 (b);
be competent in accordance with Section 6 and meet the requirements for suppliers laid down in the Decree.
(5) Growth promoters, anti-coccidiums and chemotherapeutic agents, vitamin A and vitamin D, copper and selenium may be processed directly into compound feedingstuffs provided that this method of processing is established by decree and provided that the production technology by examination ensures a homogeneous incorporation of the additive in the compound feed and that the production operation is authorised for that purpose.
(6) Manufacturers are obliged to use only feed materials complying with the requirements laid down in the Decree, certain protein feed and additives listed in the Decree and complying with the requirements laid down by the law and supplied from producers and importers registered under this Act. The provisions of this paragraph shall also apply to suppliers and distributors putting feed, feed additives and premixtures into circulation.
(7) The manufacturer of additives, premixtures and feedingstuffs using additives or premixtures and certain protein feedingstuffs shall be competent in accordance with Article 6 or shall designate a competent person responsible for production. This obligation also applies to persons producing feed for the purpose of agricultural primary production. Production facilities and equipment shall comply with the requirements set out in Section 7.
(8) Manufacturers of additives, premixtures and feedingstuffs covered by the provisions of paragraphs 3 and 5 are required to process written procedures in the production process in relation to quality control, including the definition of critical stages of the production process, to draw up a nominal list of staff with a responsibility heading, to designate the persons responsible for quality control and to ensure, on the basis of a written quality control plan, a check in their own laboratory or on a contract basis. For the additives referred to in point (a) of paragraph 3, manufacturers shall ensure quality control before putting the products into circulation.
(9) The manufacturer of additives, premixtures and feedingstuffs using additives or premixtures or feed with the use of feed supplements shall take a sample from each batch produced and ensure that it is kept for a minimum shelf life or a guarantee period, except for samples subject to destruction.
(10) Only feed, feed additives and premixtures which are of a healthy, unfalsified, marketable quality, not impaired, not containing prohibited substances and products and which are not labelled with false or misleading data may be put into circulation. They must not pose a risk to animal health, human health and the environment. These provisions shall also apply to feed intended for the feeding of wild game 5b) and feed put into circulation for that purpose.
(11) The feed additives, their species specification and certain protein feed authorised for the production and putting into circulation, the conditions for their use and processing into compound feed, the requirements for feed materials and the minimum requirements for compound feed and the limit values for their composition, the requirements for the manufacture of premixtures and the use of media, the particular nutritional and nutritional purposes, the requirements for suppliers and manufacturing operations, taking into account the type of production and the use of additives, certain protein feedingstuffs and the method of storage of samples from manufacturers, are laid down by the Ministry by decree.
Record keeping
(1) The manufacturer, importer and supplier of feed, feed additives and premixtures is required to keep an accurate record of their production, import, intake and supply.
(2) The records shall contain:
(a) for the manufacturer, importer and supplier of additives
1. the type and quantities of additives produced, imported, delivered or stored and the date of their manufacture;
2. name and surname (hereinafter referred to as "first name") and address or business name and registered office of the manufacturer, importer, supplier or consignee,
(b) for the manufacturer, importer and supplier of premixtures and feedingstuffs using additives or premixtures
1. the type and quantities of additives, premixtures and feedingstuffs produced, imported, delivered or stored using additives or premixtures and the date of their manufacture,
2. the name and address or business name of the establishment of the manufacturer, importer, supplier or consignee of premixtures or feedingstuffs using additives or premixtures;
(c) in the case of a producer putting into circulation feed or persons producing animal primary production or a feed mobile producer in the manufacture of compound feedingstuffs using complementary feedingstuffs for the purposes of animal production or of the operator of the mobile feed plant
1. the type and quantity of complementary feed and feed materials used, including own resources;
2. the name and address or business name and address of the establishment of the manufacturer, importer, supplier or consignee of the complementary feedingstuffs and feed materials used for the manufacture of complete feedingstuffs.
(3) The manufacturer of compound feedingstuffs shall also keep a record of their receptor composition as a percentage or weight of feed materials, additives and premixtures. The obligation shall also apply to persons referred to in Article 3 (11), to feed producers putting feed into circulation, to persons producing for the purpose of animal primary production and to operators of mobile feed production which produce feed using complementary feed.
(4) The producer of additives, premixtures and feedingstuffs using additives and premixtures covered by the provisions of Section 4 (9) is also required to keep a record of the results of quality control.
(5) The producer, importer, supplier and distributor or person producing feed for the use of animal primary production or the operator of the mobile feed plant in possession, own or imported feed, premix or additive with an excessive content of undesirable substances and products is required to keep a separate register.
(6) The manufacturer, importer, supplier or distributor who manufactures, processes or puts into circulation the additives, premixtures or feedingstuffs referred to in Article 4 (3) and compound feedingstuffs containing them is required to keep a record of the processing of claims allowing, where necessary, the withdrawal of products. The withdrawn products may be re-put into circulation provided that they have been examined from a quality perspective by the manufacturer, importer, supplier or distributor and from a health perspective by the competent veterinary authority. (c)
(7) Records shall be kept for a period of 3 years from the end of the calendar year in which they were acquired.
(8) The Ministry shall determine the further requirements for keeping records of manufacturers, importers and suppliers of additives, premixtures and feedingstuffs, including the records of quality control results, by decree.
Professional competence
(1) Professional competence for the production, processing, import and entry into circulation of additives, certain protein feed, premixtures, feedingstuffs using additives or premixtures (hereinafter referred to as "professional competence") means a set of professional and practical knowledge relating to the production of feed, feed additives and premixtures, knowledge of the foundations of livestock nutrition and feed technology and of the legislation on feed production.
(2) Professional competence shall be demonstrated by a certificate issued by the Institute to persons who fulfil the following conditions:
(a) legal capacity;
(b) the nature, degree of education and professional practice of the production of feed.
(3) The type, degree and field of education and the duration of professional practice are defined by the Ministry by decree.
Requirements for production facilities and installations
(1) In production plants where feed, feed additives and premixtures are produced or processed, the premises and production facilities shall be such as to allow safe production and ensure that during production there are no undesirable changes in the characteristics of feed used and produced, additives and premixtures.
(2) Production facilities intended for the manufacture of feed, additives and premixtures shall ensure that during production there is no confusion or omission of certain parts of the production process or contamination of products and cross-contamination with other substances or products, in particular the introduction of additional or prohibited substances or products into the product subsequently mixed. During and after manufacture, sampling, quality verification and health shall be technically possible.
(3) The provisions of paragraphs 1 and 2 also apply to production plants and establishments producing compound feedingstuffs using complementary feedingstuffs.
(4) Production plants and equipment intended for the production and processing of additives, premixtures or feedingstuffs referred to in Article 4 (3) and compound feed containing them must comply with the requirements for production facilities and production processes following quality control and storage, as laid down by the Ministry by decree.
(5) Production plants covered by paragraph 4 must have weighing, mixing and removal equipment complying with the requirements laid down by the Ministry by decree for each type of production.
(6) The manufacturer shall demonstrate that the products meet the required characteristics, namely:
(a) for premixtures, the content or efficacy and homogeneity of amino acids and additives,
(b) for feedingstuffs using additives and premixtures, the content or efficacy and homogeneity of additives.
(7) The operator of the mobile feed plant shall report to the Institute before the start of the production of the place and period of operation and the timetable for the production of the feed.
Registration of producers, importers and suppliers
(1) The person covered by Paragraph 4 (1) ("the applicant") is required to apply for import before the start of manufacture (8) or for registration. The customs authority shall not release the goods on importation unless the importer provides evidence that the importation is justified under Article 9 (1) (c) and (e) by a registration decision.
(2) The Institute shall decide on the registration upon request. The conditions for initiating the registration procedure for the production, processing, import and entry into circulation of additives, premixtures, feedingstuffs using additives or premixtures and certain protein feedingstuffs shall be those laid down in Article 6.
(3) The registrant for the production and processing of additives, premixtures and feedingstuffs is required to apply at the same time for the registration of production operations. Where the applicant has more than one production facility, he shall submit the particulars set out in the registration application for each production operation separately.
(4) The registrant for the production and processing of additives, premixtures and feed covered by the provisions of Article 4 (3) and (5) is required to apply at the same time for the authorisation of production operations intended for such production. The Institute shall verify that the production operation complies with the requirements laid down in the Decree.
(5) For the registrant for the placing into circulation of additives, premixtures and feedingstuffs referred to in Article 4 (3), subject to the provisions of § 4 (1) and (4), the Institute shall verify that the applicant complies with the requirements for suppliers laid down in the Decree before issuing the marketing authorisation.
(6) The manufacturer, importer and supplier of feed, feed additives and premixtures must notify the Institute without delay of changes to the information contained in the application for registration.
(7) An applicant intending to produce, import or put into circulation feed materials or products which have been obtained or modified by new technological processes or which do not yet have the character of feed and silage additives may be registered only after the positive result of the biological testing carried out. If it is not possible to terminate the biological testing no later than 3 years after the registration, the final date for the end of the biological testing shall be determined by the Ministry on a proposal from the applicant by a decision.
(8) The biological testing for registration proceedings is carried out by the Institute. The cost of biological testing shall be borne by the applicant, who shall deliver free of charge to the Institute feed material, product or additive intended for silage in the quantity required to carry out the biological testing. The biological testing carried out on an animal shall be carried out under the conditions laid down in a specific legislation. (a)
(9) The Institute may, subject to the approval of the State Veterinary Administration (9), refrain from biological testing of feed material or product or additives intended for silage subject to biological testing in cases where the applicant submits, together with the application for registration, the results of biological testing required by this Law. The Institute may request additional special expertise.
(10) The Institute shall draw up a summary dossier on the biological testing carried out which is a condition for granting the marketing authorisation of the applicant in accordance with paragraph 7. The relevant monographs form an integral part of the summary dossier for feed additives.
(11) Data submitted for registration subject to the protection of patent rights shall not be published by the Institute. The documents submitted during the registration of feed, feed additives and premixtures shall be kept by the Institute for a period of 10 years from the issue of the marketing authorisation or the extension of the marketing authorisation or withdrawal of the marketing authorisation.
(12) The requirements of the application for registration of manufacturers, suppliers and importers of feed, feed additives and premixtures and for the registration and authorisation of production facilities and the technical parameters and methods for carrying out biological testing, including methods for testing the efficacy of feed preservatives, methods for testing the quality of animal products, methods for testing the safety of the use of feed or feed additive, and the method for processing the monograph of the additive and the summary dossier shall be laid down by the Ministry by decree.
Registration of distributors
(1) Distributors which put into circulation additives or premixtures or feed referred to in Article 4 (3) (a) and (b) must apply for registration with the Institute.
(2) The application for registration of a distributor shall include a written declaration by the applicant to ensure that the documentation and registration of the products it provides for the placing into circulation comply with the applicable legislation.
(3) The Institute will issue a decision to register the distributor. The decision shall include the registration number and address of the distributor and the group of additives or premixtures or feed referred to in Article 4 (3) (a) and (b) which are put into circulation.
(4) In the event of a change to the groups of additives, premixtures or feedingstuffs referred to in paragraph 1 and put into circulation and other changes to the data contained in the application for registration, the distributor shall request a change to the marketing authorisation. Where the information relating to the application for an amendment is part of the marketing authorisation issued, the Institute shall issue a decision amending the marketing authorisation.
(5) The Institute shall issue a decision to cancel the registration of a distributor if it finds a serious breach of the obligations laid down in paragraph 2, § 3 (2), § 3 (6) (a) and (b), § 3 (8), (10) and (12), § 11 and 18. Upon written request by the distributor, the Institute shall cancel the registration by decision.
(6) The formalities for the application for registration of a distributor and the requirements for documentation and registration of products referred to in paragraph 2 are laid down by the Ministry by decree.
Registration of production plants
(1) Entrepreneurs who, pursuant to the last sentence of Article 4 (1), produce feed using complementary feed which they use for the purpose of animal primary production without putting into circulation must ask the Institute to register such production operations.
(2) The application for registration referred to in paragraph 1 shall include a written declaration by the applicant to ensure that the documentation and registration of feed is kept using supplementary feed as referred to in Article 5 (2) (c).
(3) The Institute will issue a decision on the registration of production operations. The decision shall include the registration number of the production operation and the business address.
(4) In the event of changes to the information contained in the registration application referred to in paragraph 1, the entrepreneur shall apply for an amendment to the registration decision.
(5) The Institute shall issue a decision on the cancellation of the registration of the business of production where it finds a serious breach of the obligations laid down in paragraphs 2, 3 (2), 3 (6) (a) and (b) and 18. At the written request of the entrepreneur, the Institute shall cancel the registration by decision.
(6) The formalities for registration referred to in paragraph 1 shall be determined by the Ministry by a decree.
Registration of producers, importers and suppliers
(1) The Institute shall issue a marketing authorisation for the manufacturer for the production and registration of the importer for the import of feed, feed additives and premixtures and for the registration of suppliers for the putting into circulation of additives and feed referred to in Article 4 (3) and premixtures and compound feed containing them, provided that the requirements of this Law are met. If the applicant fails to comply with these requirements within a time limit following the request to supplement the application, the registrant shall stop by decision. In particular, the marketing authorisation shall contain:
(a) in the case of a manufacturer, the registration number and address, the registration number and the address of the manufacturing plant, the type of production and the scope of the activities and, in the case of a feed manufacturer using premixtures, the dosage limit for feed premixtures; where the applicant has submitted an application for registration of multiple production plants (Section 8 (3)), the manufacturer's marketing authorisation shall specify those establishments individually,
(b) for the manufacturer for the production and processing of additives and feedingstuffs referred to in Article 4 (3) and premixtures and compound feedingstuffs containing them, the registration number and address of the authorised production operation; where the applicant has submitted an application for registration of multiple production plants (Section 8 (3)), the manufacturer's marketing authorisation shall specify those establishments individually,
(c) with the supplier and importer, the registration number, address, type and scope of the activity;
(d) for the supplier, the group of additives, feed and premixtures referred to in Article 4 (3) (a) and (b);
(e) for the importer, the types of feed, additives and premixtures.
(2) In case of introduction of a different type of production or import of feed types, additives and premixtures other than those for which a marketing authorisation is granted, the manufacturer, supplier and importer shall apply for an extension of the marketing authorisation. Paragraph 8 shall apply to the extension procedure. The Institute shall take a decision on the extension of the registration.
(3) Extension of registration is not necessary in the case of supplies from Member States of the European Union.
(4) If the data covered by the notified change pursuant to Article 8 (6) are part of the marketing authorisation, the Institute shall issue a decision to change the data in the marketing authorisation. This is also the case if the Institute finds, in the exercise of professional supervision, that the data included in the marketing authorisation is changed, even if the manufacturer, importer or supplier has not notified the change of the data contained in the application.
(5) The Institute will issue a decision to cancel the production operation register of the manufacturer, to register the supplier or importer if, in the exercise of supervision, it finds a serious breach of the obligations laid down in Sections 3 (1) and (2), § 3 (6) (a), (b), § 3 (8) to (12), § 4 (3), (4), (5) and (7), § 7, 11 and 18.
(6) The decision to revoke the registration shall also be taken by the Institute at the written request of the manufacturer, supplier or importer.
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Regulation Information
| Citation | Full text of Act No. 114 / 2004 Coll., Act No. 91 / 1996 Coll., on Feed, as resulting from subsequent amendments |
|---|---|
| Regulation Type | Declared full text |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.03.2004 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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