Full text of Act No. 45 / 2008 Coll.
Full text of Act No. 91 / 1996 Coll., on Feed, as resulting from subsequent amendments
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15.02.2008
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45
PRESIDENT OF THE GOVERNMENT
Announces
full text of Act No. 91 / 1996 Coll., on feedingstuffs, as follows from amendments made by Act No. 244 / 2000 Coll., Act No. 147 / 2002 Coll., Act No. 320 / 2002 Coll., Act No. 21 / 2004 Coll., Act No. 444 / 2005 Coll., Act No. 553 / 2005 Coll. and Act No. 214 / 2007 Coll.
THE LAW
on feedingstuffs
Parliament has decided on this law of the Czech Republic:
GENERAL PROVISIONS
Subject matter
(1) This Act implements the relevant provisions of the European Communities (1) and, following the directly applicable provisions of the European Communities (1a), lays down requirements for the production, import, use, packaging, labelling, transport and putting into circulation of feedingstuffs, supplementary substances (1b) and premixtures (1), as well as the competence and competence of the expert supervisor (1d) over compliance with the obligations laid down by this Act and directly applicable provisions of the European Communities (hereinafter the "European Communities").
(2) This law does not apply to feed, additives and premixtures intended for export and which are safe 1e).
(3) This law does not apply to veterinary products and medication2).
Definition of terms
(1) In this Act, the following definitions apply:
(a) feed a product of plant or animal origin, fresh or preserved, and a product of its industrial processing, an organic and inorganic substance, with or without the addition of an additive intended for animal feed, either alone or in mixtures,
(b) feed material, for direct feeding to animals in their original state or after processing, or feed intended for the manufacture of compound feedingstuffs or as a carrier for the manufacture of premixtures;
(c) a compound feed mixture of feed materials containing or without additives intended as complete or complementary feed for animal feed;
(d) a compound feed covering the need for a daily ration by its composition;
(e) complementary feed a mixture of feedingstuffs with a high content of certain nutrients which, when added to other feedingstuffs, covers 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 its nutritional needs;
(g) an undesirable substance, a substance or a product, present on the surface or in products intended for animal feed, which present a potential risk to animal health, human health or the environment, or which may have an adverse effect on animal production, with the exception of pathogenic agents;
(h) a prohibited substance or a prohibited product which, by its nature, 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 animal nutrition,
(i) a minimum period of protection which must elapse from the end of the feed intake 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 food, in order to ensure that they do not contain residues of additives in quantities exceeding the maximum levels laid down in specific legislation2a) and European Communities,
(j) 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, 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,
(k) degraded feed, additive or premixtures feed, additive or premixtures, unfit for animal feed,
(l) an farmed animal which is kept by man for economic purposes or fed for human consumption, and a fur animal;
(m) pet animals kept by man are not used and are not farmed animals, except fur animals;
(n) a specific protein feed material which constitutes direct or indirect sources of protein produced by a specific technological process;
(o) 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, which may benefit from the intake of feed corresponding to its condition;
(p) by putting into circulation the holding, storage, sale of feed or, where appropriate, the additive or premixture with a view to their sale or offer for sale, or any other way of transferring them to a third party free of charge or in return,
(r) biological testing for the determination of the efficacy and safety of feed or feed additive,
(s) 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"),
(t) the date of minimum durability of the time-limit in which the feed, additive or premixtures retain the quality-determining properties in the specified storage conditions;
(u) the supplier is a legal or natural person holding, handling or putting into circulation a feed, additive or premixtures;
(v) by a distributor, a legal or natural person which mediates the putting into circulation of feed, feed additive or premixture without holding the product.
(2) For the purposes of this Act:
(a) lots of feedingstuffs, additives (1b) or premixu1c) showing consistency with their external arrangements, labelling and local storage;
(b) cross-contamination
1. the presence of two or more additives, undesirable substances or the presence of prohibited substances, or products which have adverse or inhibitory effects,
2. the presence of an undesirable or prohibited substance in feed or the presence of an additive not intended for the species and category of animal,
(c) by professional supervision of official control2b),
(d) a legal or natural person who manufactures or processes feed, feed additives or premixtures shall hold them as a supplier before they are put into circulation or put into circulation; the manufacturer also means the person operating the mobile feed factory,
(e) by an importer, a legal or natural person importing feed, feed additives or premixtures from third countries,
(f) the Member State of the European Community shall also be the States of the European Economic Area and the Swiss Confederation (hereinafter referred to as the Member State);
(g) a third country of a country which is not a Member State;
(h) a carrier of feed material or water used in the manufacture of premixtures of which they are part;
(i) feed for particular nutritional purposes (hereinafter referred to as "dietary feed"), feed which, with its specific composition or method of manufacture, clearly distinguishes from normal feedingstuffs and is intended to provide specific nutritional and physiological purposes and is not veterinary products or medicinal products;
(j) a product intended for animal feed (hereinafter referred to as "feed product") of feed materials, premixtures, additives, feedingstuffs and all other products intended for use in or for animal feed.
(3) Where, in the context of legal relations governed by the regulations of the European Communities, concepts whose content and meaning are not defined in that law but in those regulations are used in that law, the definition of those terms shall be based on those rules for the purposes of that law.
Basic provisions
(1) In the manufacture, putting into circulation and use of feedingstuffs, the feed business operator (s) (c) (hereinafter referred to as "operator") must comply with the content and intended purpose of the use of additives and certain protein feed and the content and limits of undesirable substances in order to avoid harm to animal health and to ensure the health of 2d) and not adversely affect the quality of animal products intended for human consumption. Products for feeding containing an undesirable substance higher than the maximum level for their content shall not be mixed by the operator for dilution with the same or other feed products.
(2) For the production, putting into circulation and feeding of feed, the operator shall not use unauthorised certain protein feed or unauthorised additives or additives which do not comply with the conditions of their authorisation and premixtures or feed containing such substances.
(3) When using feed marked with a withdrawal period, the operator shall comply with the withdrawal period; This is without prejudice to the provisions of the Special Act (3).
(4) Feed, additives and premixtures for which the date of minimum durability or warranty period has been passed, the operator must not use for production, putting into circulation and use for feeding unless their declared quality and health is checked.
(5) For the manufacture of feed, feed additives and premixtures and for animal feeding, the operator shall not use:
(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.
(6) For the production of premixtures, the operator shall not use feed and substances as carriers which, by their physical characteristics, do not ensure the achievement of the homogeneity and stability of the additives in the premixture.
(7) Feed for which the level of radioactive contamination exceeds the limits laid down must not be used by the operator for the further production of complete and complementary feed, put into circulation, feed, import or export.
(8) Feed or feed additives containing, consisting of, or produced from genetically modified organisms may be put into circulation, used for the production of feed, including production for the purpose of agricultural primary production, or fed only under the conditions laid down in European Community Regulation (3a).
(9) The Ministry of Agriculture (hereinafter referred to as "the Ministry") provides by decree:
(a) a list of prohibited substances and products;
(b) the list of undesirable substances and products and the maximum levels for their content in feed products;
(c) a list of warehouse pests and their depictions;
(d) a list of certain protein feedingstuffs, their specifications, their composition, the conditions for their use and processing into compound feedingstuffs and other provisions, in particular mandatory particulars on the packaging or labelling;
(e) maximum levels for radioactive contamination of feed intended for direct animal feeding;
(f) the requirements for feed materials, their list, description, conditions of use, method of adaptation and the quality characteristics declared by them,
(g) requirements for complete and complementary feedingstuffs and the concentration of additives in feed additives;
(h) particular nutritional purposes, their main nutritional characteristics, destination, recommended use time and mandatory labelling including declaration and use;
(i) the list, purpose and method of use of additives, including analytical and technological tolerances and their withdrawal periods.
Expired
Safety requirements for feed products
(1) Products for feeding, including products for feeding from third countries, may only be imported, put into circulation and used by the operator if they are of sound, genuine and marketable quality, do not pose any risk to animal health, human health and the environment, have no adverse effect on animal production and are safe under European Community rules.
(2) Further conditions for the import of products for feeding are laid down in the provisions of the European Community (3).
Approval procedure
(1) A natural or legal person may carry out the activities provided for in Article 10 (1) of Regulation (EC) No 183 / 20054 of the European Parliament and of the Council only with the agreement of the Central Control and Examination Institute of Agriculture (hereinafter referred to as the Institute).
(2) The approval of the operation is decided by the Institute on the basis of an application for approval of the operation (5) (hereinafter referred to as the "application for approval") submitted on a form issued by the Institute. The Institute shall publish the form in a way that allows remote access.
(3) The application for approval contains:
(a) in the case of natural persons, the name and surname, the date of birth or, where applicable, the business name, the address of the place of permanent residence and, where applicable, another address for service, usually at the place of residence in the Czech Republic or at the place of business, the identification number, if any, has been assigned; in the case of legal persons, the business firm or the name, registered office or any other address intended for delivery or, where applicable, the location of the organisational component in the Czech Republic, and the identification number, if assigned,
(b) for natural persons established in a third country, the name and surname, date of birth and residence of the person responsible in the Czech Republic; in the case of legal persons established in a third country, the seat of the organizational component in the Czech Republic or the name, date of birth and residence of the person responsible in the Czech Republic,
(c) the address of the operation, the type of activity and its specification;
(d) data which are subject to the protection of patent rights and data which are classified as trade secrets (6).
(4) According to the type of activity referred to in paragraph 1, the Institute shall, as part of the application for approval, request the following annexes and copies of the documents:
(a) feed data;
(b) the production process;
(c) a technological diagram of the production facility describing and planning the production operation;
(d) proof of working accuracy of the mixing equipment used in the manufacture of finished products;
(e) evidence of inspection or calibration of the scales and weighing systems used;
(f) quality control plan,
(g) verification of the homogeneity of feed additives and premixtures,
(h) feed data imported from a third country;
(i) a written declaration by the importer that the product comes from operation which complies with the requirements of Regulation (EC) No 183 / 20053c of the European Parliament and of the Council;
(j) proof of patent protection;
(k) a copy of the certificate of competence of the responsible person in accordance with Article 6 (2) or the decision on recognition of professional qualifications in accordance with Article 6 (3);
(l) proof of business registration;
(m) a declaration by the distributor that the feed complies with Regulation (EC) No 183 / 20053c of the European Parliament and of the Council.
(5) The approval decision contains, in addition to the general requirements referred to in points (a) to (c) of paragraph 3, the approval identification number of the operation and, where applicable, other traffic related data.
(6) The Institute shall enter in Registr7) the identification of the approved operation in accordance with paragraph 5.
(7) The Institute will suspend, amend or revoke the decision approving the operation
(a) at the operator's written request; or
(b) in cases provided for by European CommunityRegulation (8).
(8) The operator shall notify, on a form issued by the Institute, changes to the information specified in the application for approval within 30 days of the change.
(9) The Ministry shall determine by decree the details of the annexes to the application for approval in accordance with paragraph 4.
Registration procedure
(1) An operator carrying out the activities provided for in Articles 9 (2) and 18 (2) of Regulation (EC) No 183 / 20059 of the European Parliament and of the Council shall be required to apply to the Institute for Traffic Registration (hereinafter referred to as the "registration application").
(2) The registration of operations shall be decided by the Institute on the basis of an application for registration by the operator using a form issued by the Institute. The Institute shall publish the form in a way that allows remote access.
(3) The application contains
(a) in the case of natural persons, the name and surname, the date of birth or, where applicable, the business name, the address of the place of permanent residence and, where applicable, another address for service, usually at the place of residence in the Czech Republic or at the place of business, the identification number, if any, has been assigned; in the case of legal persons, the business firm or the name, registered office or any other address intended for delivery or, where applicable, the location of the organisational component in the Czech Republic, and the identification number, if assigned,
(b) for natural persons established in a third country, the name and surname, date of birth and residence of the person responsible in the Czech Republic; in the case of legal persons established in a third country, the seat of the organizational component in the Czech Republic or the name, date of birth and residence of the person responsible in the Czech Republic,
(c) the address of the operation, the type of activity and its specification;
(d) data which are subject to the protection of patent rights and data which are classified as trade secrets (6).
(4) According to the type of activity referred to in paragraph 1, the Institute shall, as part of the application for registration, request the following annexes and copies of the documents:
(a) feed data;
(b) the production process;
(c) a technological diagram of the production facility describing and planning the production operation;
(d) proof of working accuracy of the mixing equipment used in the manufacture of finished products;
(e) evidence of inspection or calibration of the scales and weighing systems used;
(f) quality control plan,
(g) verification of the homogeneity of feed additives and premixtures,
(h) feed data imported from a third country;
(i) a written declaration by the importer that the product comes from operation which complies with the requirements of Regulation (EC) No 183 / 20053c of the European Parliament and of the Council;
(j) an operator's declaration that it has prepared, implemented and followed the procedures of the risk analysis system and critical control points;
(k) proof of patent protection;
(l) proof of business registration.
(5) The traffic registration decision contains, in addition to the general requirements referred to in points (a) to (c) of paragraph 3, the traffic registration number and, where appropriate, other traffic details.
(6) The Institute shall register (7) the identification of the registered operation referred to in paragraph 5.
(7) The Institute of Business Registration shall suspend, amend or revoke:
(a) at the operator's written request; or
(b) in cases provided for by European CommunityRegulation (8).
(8) An operator shall notify, on a form issued by the Institute, of changes to the information contained in the registration application within 30 days of the change.
(9) The Ministry shall determine by decree the details of the annexes to the registration application referred to in paragraph 4.
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 certificate referred to in paragraph 2 may be replaced by a decision on the recognition of professional qualifications under the Law on the recognition of professional qualifications 9b).
(4) The type, degree and field of education and the duration of professional practice are defined by the Ministry by decree.
(1) Nationals of the Member States may, on an occasional or temporary basis, put into circulation in the territory of the Czech Republic feed, feed additives or premixtures on the basis of the verification of professional qualifications under special legislation (9b), provided that they are authorised to carry out this activity on a continuous basis in another Member State. The provisions of this Act shall apply mutatis mutandis to such persons, except for Sections 4 and 5.
(2) Nationals of Member States authorised in another Member State to operate the mobile feed plant on a continuous basis are required to notify the Institute at least 3 working days before the start of production in the Czech Republic instead of and at the time of the production of feed.
Requirements for operations and operators
(1) An operator shall ensure that:
(a) the operation complies with the requirements laid down in Regulation 9c of the European Communities, this Act and the implementing legislation;
(b) in service intended for the production of feed, feed additives or premixtures, safe access to samples for quality and health verification has been technically granted before, during and after manufacture;
(c) feed, additives or premixtures with an excessive level of undesirable substances or the presence of prohibited substances and products have been stored separately.
(2) An operator operating a mobile feed plant is required to notify the Institute at least 3 working days before the start of production of the place and timing of production of the feed.
(3) Operators (9d) are obliged to demonstrate to the Institute that they have prepared, implemented and followed the procedures of the risk analysis system and critical control points.
(4) An operator holding, holding, or importing feed, additive or premixture with an excessive content of undesirable substances and products, or the presence of prohibited substances and products or radioactive contamination, is required to notify the Institute of this fact and to comply with the European Community Regulation (EC) 9e).
(5) The operator shall keep records kept under the European Communities9f for a period of 3 years.
(6) The Ministry provides by decree
(a) the requirements for operations and production facilities of operations according to the activities laid down in the European CommunityRegulation (4), (9);
(b) details of the location designation and details of the timetable for the production of feed referred to in paragraph 2;
(c) risk control requirements for primary products9g).
repealed
repealed
repealed
repealed
Publication of the list of approved and registered establishments
(1) The Institute will publish a list of approved and registered establishments in the Bulletin of the Central Audit and Examination Institute of the Agricultural Institute on 1 September of the calendar year.
(2) The Institute shall enter in the list of approved and registered establishments the information set out in Sections 4 (5) and 5 (5).
(3) The list of approved establishments must conform to the model in the Regulation of the European Communities (9h).
Labelling and packaging
(1) An operator is required, when producing and putting into circulation feed, additives and premixtures, to indicate these in accordance with the provisions of the European Community (9i), this Act and the implementing legislation.
(2) The operator shall indicate the label on each individual packaging, container or label affixed thereto, in the case of bulk feedingstuffs in the accompanying document. The marking must be in the Czech language, clearly visible, legible, durable, indelible and unmistakable.
(3) The labelling shall not contain indications which may give the impression that the product removes or relieves diseases or prevents diseases in animals which are not due to inadequate nutrition. This prohibition does not concern data on the content of substances used on the surface to prevent parasitic invasions in animals and feed for particular purposes of animal nutrition.
(4) Data other than those provided for in paragraph 1 and in the Order may be entered on the packaging, on the label or on the accompanying document only if they are clearly separated and are measurable or verifiable and not misleading.
(1) Certain protein feed and compound feed, except in the cases referred to in paragraph 2, and feed with hygroscopic properties may only be put into circulation in packages or containers which must be sealed in such a way that, when opened, the original seal is breached and this seal cannot be re-used.
(2) Feed mixtures may also be put into circulation in bulk or in unsealed packages or in containers only when supplied
(a) from one manufacturer to other manufacturers or packing agents;
(b) compound feedingstuffs consisting of whole seeds or fruits;
(c) feed blocks and lizards,
(d) small quantities weighing not more than 50 kg which are delivered to the final consumer and which come directly from packaging or containers which have been sealed in accordance with paragraph 1.
(3) Compound feed may also be put into circulation in bulk or in unsealed containers, but not in unsealed packages, only when supplied
(a) from the producer of compound feedingstuffs to the immediate final consumer;
(b) molasses feed consisting of not more than 3 feed materials;
(c) pelleted compound feed.
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Regulation Information
| Citation | Full text of Act No. 45 / 2008 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 | 15.02.2008 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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