Act No. 91 / 1996 Coll.
Law on feedingstuffs
Valid
Law
Effective from 01.09.1996
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91
THE LAW
of 15 March 1996
on feedingstuffs
Parliament has decided on this law of the Czech Republic:
GENERAL PROVISIONS
Subject matter
(1) This law implements the relevant European Union1) and, following the directly applicable European Union1a (1), lays down certain requirements for the production, import, use, packaging, labelling, transport and placing on the market of feedingstuffs, complementary substances (1b) and premixtures (1), as well as the powers and powers of the authority carrying out official controls1d) for compliance with the obligations laid down by this law and directly applicable European Union rules (hereinafter "European Union rules").
(2) This Act shall not apply to feed, additives and premixtures intended for export and which are safe. (e)
(3) In addition, this Act does not apply to the requirements for prescribing medicated feed (31), the placing on the market of medicated feed for pet animals, the distribution of medicinal products to feed business operators, the advertising of medicated feed and intermediate products31), the use of medicated feed, the feeding of animals by medicated feed, the collection of data on sales and the use of medicinal products2) in the form of medicated feed or intermediate products and the requirements in the field of pharmacovigilance under the Drug Act.
Definition of terms
(1) In this Act:
(a) 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 and which may have an adverse effect on animal production, with the exception of pathogenic agents;
(b) 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 by veterinary law (1e) and European Union rules, or the period laid down for medicated feed by Regulation (EU) 2019 / 6 of the European Parliament and of the Council or, where appropriate, by veterinary legislation (hereinafter referred to as the "recipe"),
(c) biological testing for the determination of the efficacy and safety of feed or feed additive,
(d) by a supplier, a legal or natural person holding, handling or marketing feed, additive or premixtures;
(e) by a distributor, a legal or natural person who mediates the placing on the market of feed, additive or premixture without holding the product in question.
(2) For the purposes of this Act:
(a) by the manufacturer, a legal or natural person who produces or processes feed, feed additives or premixtures, holds them before they are placed on the market or places them on the market; the manufacturer also means the person operating the mobile feed factory,
(b) by an importer, a legal or natural person importing feed, feed additives or premixtures from third countries;
(c) the Member State of the European Union also states of the European Economic Area and the Swiss Confederation (hereinafter referred to as "the Member State");
(d) a third country of a country which is not a Member State;
(e) 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 regulated by European Union regulations, concepts whose content and meaning are not defined in this law but in those regulations are used in this law, the definition of those terms in those regulations shall be based, for the purposes of this law, on the definition of those terms.
Basic provisions
(1) In the manufacture, placing on the market and use of feed, the feed business operator (2c) (hereinafter referred to as "operator") must comply with the levels and limits of undesirable substances in order to ensure the health of 2d). 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) 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).
(3) For the production of feed, feed additives and premixtures and for animal feeding, the operator shall not use products for feeding containing undesirable substances if they exceed the limits laid down in European Union24), or containing foreign objects liable to endanger animal health, or live storage pests listed in the implementing legislation. Feed containing undesirable substances may only be used for feeding after decontamination carried out in accordance with directly applicable European Union25).
(4) 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.
(5) Importers of feed products subject to import control under European Union16), medicated feed or intermediate products, or any other person authorised by the importer, are required to notify the Central Control and Examination Institute (hereinafter referred to as "the Institute") in writing of the expected date of importation of such a lot of feed or consignment and of the documents accompanying the consignment or lot of feed as soon as it becomes aware of them. The data referred to in the first sentence shall also be notified by the importer to the customs office responsible for the place of import control at least 1 working day before the physical arrival of the consignment.
(6) The Ministry of Agriculture (hereinafter referred to as "the Ministry") provides by decree:
(a) the list of undesirable substances and products and the maximum levels for their content in feed products;
(b) a list of warehouse pests;
(c) the categories of feed materials used to label feed for non-food-producing animals;
(d) maximum cross-contamination limits for non-target feed of active substances (2), 31),
(e) the list, purpose and method of use of the additives and their withdrawal periods, other than those directly covered by European Union3b,
(f) the conditions for storage of bulk feedingstuffs on agricultural land.
Approval procedure
(1) A natural or legal person may perform activities 4) provided for in Regulation (EC) No 183 / 2005 of the European Parliament and of the Council or in Regulation (EU) 2019 / 4 of the European Parliament and of the Council only with the consent of 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 firm, the address of the place of permanent residence or, where applicable, another address for service, usually at the place of residence in the Czech Republic or in the place of business, the person's identification number (hereinafter referred to as the "identification number"), if 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) e-mail contact address or telephone, if any, if the applicant has it;
(d) the address of the operation, type of activity and its specification;
(e) data which are subject to the protection of patent rights and data which are classified as business 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 inspection or calibration of the scales and weighing systems used;
(e) the quality control plan;
(f) verification of the homogeneity of feed additives and premixtures,
(g) feed data from a third country;
(h) a written declaration by the importer that the product comes from operation which meets the requirements of Regulation (EC) No 183 / 20053c of the European Parliament and of the Council;
(i) proof of patent protection;
(j) a copy of the certificate of competence of the responsible person in accordance with Article 6 (2) or the decision to recognise the professional qualification in accordance with Article 6 (3);
(k) proof of business registration;
(l) a declaration by the distributor that the feed complies with Regulation (EC) No 183 / 20053c of the European Parliament and of the Council; and
(m) a written declaration on the processing of risk analysis and the setting of critical control points (HACCP) in accordance with the requirements of Regulation (EC) No 183 / 20053c of the European Parliament and of the Council.
(5) The applicant is obliged to pay an administrative fee for the acts carried out in the approval procedure under the special legislature22) and for the costs of professional and test actions linked to the approval procedure at the level laid down by the special legislation on reimbursement of costs for professional and test action23).
(6) The approval decision contains, in addition to the general requirements referred to in paragraph 3 (a), (b) and (d), the approval identification number of the operation and, where appropriate, other traffic information.
(7) The Institute shall enter in the Register (7) the identification of the approved operation referred to in paragraph 6.
(8) 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 Union8).
(9) 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.
(10) The Ministry shall determine by decree the details of the annexes to the application for approval in accordance with paragraph 4.
(11) Where an operator interrupts the activity approved for more than 1 year, it shall inform the Institute in writing without undue delay.
(12) If the operator notifies the Institute of an interruption, the operation of the activity shall be interrupted on the date of receipt of the notification of the interruption of the activity of the Institute or on a later date specified in the notification. The interruption of the operator's activities shall end on the date specified in the notification.
(13) Continuation of the operation before the expiry of the period for which the operation was interrupted in accordance with paragraph 12 shall be required by the operator to notify the Institute in writing in advance. The operation may be continued at the earliest on the date of receipt of the notice of continued operation of the Institute or at a later date specified in the notification.
(14) The operator shall, at the request of the Institute, communicate without undue delay whether he or she is carrying out the activity and provide evidence showing that he or she is operating the activity. 26).
Registration procedure
(1) An operator carrying out activities 9) established by Regulation (EC) No 183 / 2005 of the European Parliament and of the Council or by Regulation (EU) 2019 / 4 of the European Parliament and of the Council is required to apply to the Institute for the Registration of Operations (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) e-mail contact address or telephone, if any, if the applicant has it;
(d) the address of the operation, type of activity and its specification;
(e) data which are subject to the protection of patent rights and data which are classified as business 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 inspection or calibration of the scales and weighing systems used;
(e) the quality control plan;
(f) verification of the homogeneity of feed additives and premixtures,
(g) feed data from a third country;
(h) a written declaration by the importer that the product comes from operation which meets the requirements of Regulation (EC) No 183 / 20053c of the European Parliament and of the Council;
(i) a written declaration on the processing of risk analysis and the setting of critical control points (HACCP) or the use of good practice in accordance with the directly applicable European Union Regulation on feed hygiene requirements 3c);
(j) proof of patent protection;
(k) proof of business registration.
(5) The applicant is required to pay an administrative fee for the activities carried out in the registration proceedings under the special legislature22) and the costs of professional and test tasks linked to the registration proceedings at the level laid down by the special legislation on reimbursement of costs for professional and test tasks (23).
(6) The traffic registration decision contains, in addition to the general requirements referred to in paragraph 3 (a), (b) and (d), the traffic registration number and, where applicable, other traffic details.
(7) The Institute shall register (7) the identification of the registered operation referred to in paragraph 6.
(8) The Institute of Business Registration shall suspend, amend or revoke:
(a) at the operator's written request; or
(b) in cases provided for in European Union8).
(9) 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.
(10) The Ministry shall determine by decree the details of the annexes to the registration application referred to in paragraph 4.
(11) If the operator interrupts the operation of the registered activity for more than 1 year, it shall inform the Institute in writing without undue delay.
(12) If the operator notifies the Institute of an interruption, the operation of the activity shall be interrupted on the date of receipt of the notification of the interruption of the activity of the Institute or on a later date specified in the notification. The interruption of the operator's activities shall end on the date specified in the notification.
(13) Continuation of the operation before the expiry of the period for which the operation was interrupted in accordance with paragraph 12 shall be required by the operator to notify the Institute in writing in advance. The operation may be continued at the earliest on the date of receipt of the notice of continued operation of the Institute or at a later date specified in the notification.
(14) The operator shall, at the request of the Institute, communicate without undue delay whether he or she is carrying out the activity and provide evidence showing that he or she is operating the activity. 26).
Professional competence
(1) Professional competence for the production, processing, import and placing on the market of additives, premixtures, feedingstuffs using additives or premixtures, medicated feed or intermediate products (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 knowledge of feed production legislation.
(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, place on the market, on the territory of the Czech Republic, feedingstuffs, additives or premixtures on the basis of a verification of professional qualifications in accordance with a specific legal provision 9b), provided that they are entitled 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 the European Union Regulation, 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 content of undesirable substances or the presence of prohibited materials have been stored separately;
(d) medicated feed has been placed on the market in accordance with the conditions laid down in the recipe for medicated feed issued under the Drug Act (2);
(e) medicated feed or intermediate product with an expiry date or medicated feed not consumed for the treatment specified in the recipe has been removed in accordance with the Waste Act;
(f) for the manufacture of medicated feed or intermediate products, a medicinal product authorised or authorised by the Medicines Act and obtained from a distributor of medicinal products under the conditions laid down by the Medicines Act has been used;
(g) medicated feed intended exclusively for pet animals has been made available for marketing only to persons established by the Law on Medicines and under the conditions laid down by the Law on Medicines; and
(h) the unused medicinal products have been disposed of in accordance with the Drug Act.
(2) An operator operating a mobile feed production plant is required to notify the Institute at least 3 working days before the start of production of the type of feed produced, instead of and at the time 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 Hazard Analysis and Critical Control Points System (HACCP) in writing.
(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 materials or radioactive contamination, is obliged to notify the Institute of this fact and to comply with the European Union9e Code).
(5) An operator is required to keep records kept under the European Union3c Code for a period of 3 years, unless otherwise specified by the European Union Regulation (32).
(6) An operator, as a manufacturer or distributor of medicated feed or intermediate products, shall notify the Institute for State Control of Veterinary Bioprafts and Medicines of the consumption of medicinal products under the Drug Act.
(7) 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).
Publication of the list of approved and registered establishments
(1) The Institute shall publish, in accordance with European Union17, a list of approved and registered establishments in a way that allows remote access.
(2) The Institute shall indicate in the list of approved and registered establishments the information set out in Sections 4 (6) and 5 (6).
(3) The list of approved establishments must conform to the model in the Regulation of the European Union9h).
Storage
(1) The operator is required to store feed, feed additives and premixtures in warehouses or handling premises, where appropriate, on production premises or on agricultural land in such a way that, in accordance with European Union Regulation (c) and implementing legislation, the maintenance of their quality, health and protection against:
(a) abuse;
(b) rodents and birds;
(c) moisture and substances which may degrade or produce products harmful to animal and human health and to the environment.
(2) The operator is required to ensure that disinfectant, disinfectant and deratization are carried out and that adequate microclimatic conditions and cleans10 are maintained in storage areas.
OFFICIAL CONTROL AND OTHER OFFICIAL ACTIVITIES
(1) The Institute shall carry out official controls in accordance with other European Unionlegislation and regulations (12) on compliance with the obligations laid down by this law and European Union rules on animal feed and nutrition; In particular, they shall monitor compliance by operators with the conditions laid down for the production, import, transport, storage, use or placing on the market of feed, additives or premixtures.
(2) The Institute shall keep a record of irregularities detected in the performance of official control.
(3) The Institute is required to keep samples of feed, feed additives and premixtures intended for laboratory testing, other than those subject to destruction, for a period of 60 days from the date of notification of the result of their evaluation to the person checked.
(4) If the Institute finds that the deficiencies identified during the routine check have not been remedied within the time limit set, the operator shall be obliged to reimburse the costs of the additional control12a).
(5) The Ministry shall determine by decree the flat-rate amount of the costs of the additional checks paid by the operator.
(6) The Institute will decide on the reimbursement of the costs of additional checks. This compensation is the income of the state budget, chosen by the Institute.
(7) The operator shall reimburse the Institute for the cost of analysing samples of feed, feed additives and premixtures taken under Implementing Legislation (23) if their analysis shows that the samples do not comply with the requirements of this Act and other legislation.
(8) For control samples taken, compensation shall be granted to the person checked at the price at which the feed, additive or premixtures are normally sold on the market at the time of removal; if it is not possible to determine this price, the refund at the price at which the control samples were taken and, where appropriate, at the cost effectively incurred if the refund is requested within a period of six months from the date on which it was known that the feed, additive or premixtures had complied with the requirements laid down by specific legislation or directly applicable European Union24). The refund shall be granted to the person checked within 60 days of the date on which he requested it.
(9) In the context of other official activities carried out, the Institute shall, in the cases and under the conditions referred to in Articles 87 to 89 and 91 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council, issue official certificates and official certificates. The applicant for the issue of an official certificate and an official certificate shall be obliged to reimburse the Institute for the costs of issuing them under the implementing legislation27).
Rapid Alert System
(1) The Institute is the point of contact for the Rapid Alert System, processing contingency operational plans for this purpose, setting out measures to ensure that the product for feeding is not safe and presents a direct or indirect risk to human health, determining the powers, responsibilities and means of transmission of information within the Institute.
(2) The occurrence of a feed product which cannot be considered safe under the European Union3c Regulation must be notified immediately to the National Contact Point 12c).
Control of imports of feed from third countries and its place of implementation
(1) The Institute shall, in accordance with European Union rules, monitor imports of feed from third countries (28). The first sentence shall be checked at border inspection posts (hereinafter referred to as "posts') designated in accordance with the European Union Regulation on the territory of the Czech Republic. 29 The updated list of habitats in the Czech Republic will be determined by the Institute, published on its website and sent to the European Commission and other Member States of the European Union.
(2) On importation of products for feeding, the customs office shall also check the decision to authorise the operation of the importer pursuant to § 4 or the registration of operations of the importer pursuant to § 5 and the documents accompanying the consignment required by European Union16).
Sampling and laboratory testing
(1) Sampling and laboratory testing of the quality of feed, feed additives and premixtures shall be carried out by the Institute in the framework of official controls or on request.
(2) The Institute may authorise certain laboratory tests to be carried out by persons who so request (hereinafter referred to as "laboratory operators").
(3) The list of laboratories of the Institute carrying out laboratory tests on the quality of feedingstuffs, additives and premixtures in the framework of official control and the list of persons authorised to carry out laboratory tests will be published on their website by the Institute.
(4) The request for delegation must include:
(a) the name and surname and, where applicable, the business name, place of business, residence and identification number, if any, if any, if it is a natural person, or if it is a business name, seat and identification number, if it is a legal person;
(b) data on laboratory instrumentation;
(c) information on the training of laboratory staff;
(d) the scope of the activities for which the delegation is to be granted.
(5) The Institute shall grant the mandate referred to in paragraph 2 no later than 6 months after the application has been lodged if:
(a) the laboratory equipment complies with the intended scope and type of activity requested;
(b) laboratory tests shall be carried out by persons with at least a secondary education of chemical or biological focus;
(c) the results of the laboratory tests in the verification test have been found to be within the tolerances specified for those tests.
(6) The Institute shall ensure that the conditions under which the mandate referred to in paragraph 5 has been granted remain.
(7) The Institute may amend or withdraw the mandate if the conditions under which the mandate was granted have changed or ceased to exist. At the written request of the laboratory operator, the laboratory operator shall revoke the mandate.
(8) The Institute and laboratory operators are required to follow the sampling requirements and to use methods of analysis in accordance with European Union Regulation (13) to ensure objectivity and comparability of the control results.
(9) The Institute will publish on its website the methods and procedures of analysis for the official control of feed products, as far as these are not the methods and procedures laid down in European Union18).
Specific measures
(1) Where, in the performance of official control, the Institute finds that feed, feed, additive or premixtures do not comply with the requirements of this Law, Implementing legislation or European Union provisions, it shall, by decision or measure of a general nature, impose measures on the operator in accordance with Article 138 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council.
(2) Where the Institute finds, by its own investigation or on the basis of a communication from a legal or natural person, that there has been or is likely to be a threat to the safety of feed, feed additive or premixture, it shall proceed in accordance with Article 15 of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council, as amended, and Articles 137 and 138 of Regulation (EU) 2017 / 625 of the European Parliament and of the Council.
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Regulation Information
| Citation | Act No. 91 / 1996 Coll., on Feed |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 25.04.1996 |
|---|---|
| Effective from | 01.09.1996 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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