244/2000 Sb.
LAW
of 29 April 2004. June 2000,
amending Act No. 91/1996 Coll., on feedstuffs
Parliament has passed the following Act of the United States:
Article. (I)
Act No. 91/1996 Coll., on feedstuffs, shall be amended as follows:
1. § 1, including title and footnotes # 1) and (2)):
"§ 1
The subject of the edit
(1) this Act provides the conditions for the manufacture, import, use, packaging,
labelling, transport and marketing of animal feedingstuffs, additives and
premixtures, the scope of the institutions of professional supervision of compliance with the obligations
provided for by this Act, including the authority to impose sanctions, as well as
conditions for the export of animal feed with upper levels of undesirable substances and
products.
(2) this Act does not apply to feed, additives and premixtures,
which are intended for the feeding of animals imported in the territory of the Czech Republic
for the purpose of Assembly ^ 1) in quantities corresponding to the length of the downspout and the type of
animals, and on the manufacture of animal feedingstuffs, additives and premixtures, which are
intended for export and are clearly marked.
(3) this law shall apply to veterinary medicinal products and
drugs. ^ 2)
1) § 3 (1). 1 (b). f) of Act No. 166/1999 Coll. on veterinary care and
changes to some related laws (health law).
2) Act No. 79/1997 Coll., on pharmaceuticals and on amendments and additions to some
related laws, as amended ".
2. section 2 including the title reads as follows:
"§ 2
Definition of terms
For the purposes of this Act, means the
and feed products) vegetable or animal origin, fresh or
preserved and products of their processing, as well as industrial
organic and inorganic substances, with or without the addition of additives
Add, which are intended for animal feeding singly or in mixtures,
b) straight feedingstuffs: feed, which are intended for direct use to
feeding of the animals in its original state or after treatment, in addition to the production of feed
mixtures or as carriers of premixtures, for the production
c) compound feedingstuffs mixtures of feed materials, with or without the addition of
the additives, which are intended as complete or complementary
feed for animal feed,
d) complete feedingstuffs compound feedingstuffs, that its composition cover
the need for daily ration,
e) complementary feedingstuffs compound feedingstuffs with a high content of certain substances,
that after filling to other feed cover the need for daily ration,
f) daily ration: the minimum amount of food an animal
of a given species, age category and yield, on average a day in order to ensure the overall
necessary nutrients, estimated at 12% moisture content,
g) additives substances used in animal nutrition in order to
the positive influence properties of feedingstuffs or animal products,
satisfy the requirements of animal nutrition, improve animal production, in particular,
affecting the digestibility of feed supplementation necessary nutrients to animals or
ensure the specific nutritional requirements of animals within a certain period and mitigation
harmful effects caused by animal feces or affecting the
environment, animals,
h) premixtures: mixtures of additives or mixtures of one without porters or more
additives with medium, where appropriate, with the addition of amino acids, which
they are intended for the manufacture of feedingstuffs,
I) undesirable substances and products, substances or products of organic or
inorganic origin, which negatively affect the health status of the animals
or the wholesomeness of the raw materials and foodstuffs of animal origin (hereinafter
"animal products"),
j) forbidden substances and products, substances or products which, by their
the essence of negatively affect animal health and health
the safety of animal products, and may not be in the manufacture of animal feedingstuffs and in
animal feed used,
k) withdrawal period is the minimum period which must elapse from the end
feed intake containing a specific additive for which this
time limit is set, the slaughter of the animal or early production animal
products intended for human food,
l) conditionally applicable by feed, additives and premixtures of feed,
additives and premixtures, that do not match any of the specified
requirements and which is therefore limited to the original use, if the
their wholesomeness,
m) deactivated feed, additives and premixtures to those that are
not eligible for animal feed,
n) livestock animals, which are usually kept man
for farming purposes and fed to the need for human nutrition, and fur
animals,
o) pet animals animals which are reared by humans, but
are not used, (hereinafter referred to as "pets"),
p) certain protein feedingstuffs, feed materials, which constitute direct
or indirect protein sources and were produced with a special technology
the procedure,
r) specific nutritional purposes purposes to ensure specific
physiological nutritional effect-physiological requirements of certain categories of
or domestic animals may be indigestion, or
metabolic,
with) putting into circulation the possession, storage, sale, import or export
feed additives or premixtures for sale,
offer for sale and any other method of transfer for a consideration or
without it, any other person,
t) biological testing the determination of the effectiveness of the feed or supplementary
substances under specific conditions laid down by Decree,
for the kind of production the production of feedingstuffs) or production of additives or the production of
premixtures or feedingstuffs production with the use of additives or the production of
feed with the use of premixtures,
in the sample feed) additives or premixtures of sampling in accordance with
the procedures laid down by Decree,
w) operation that the production site manufactures and to the circulation of feed
additives or premixtures,
x) date of minimum durability date, until which the feed additive
substance or premix shall retain in the specified storage conditions
properties that determine their quality,
s) contractor legal or natural person, in possession of feedingstuffs,
additives or premixtures, manipulates them and put them into circulation,
from) a distributor of legal or natural person who conveys
the placing of feed additives or premixtures to circulation,
AA) lots amount of feed additive or premixture, which
show consistency in its external design, sign and local
saving,
cross-contamination of BB) occurrence of two or more substances that
they have contradictory or mutually inhibitory effects and occur in the feed
in the content of higher than the limit of determination methods for their
demonstrate. ".
3. section 3, including title and footnote # 3):
"§ 3
Basic provisions
(1) the production, placing on the market and use of feed additives and
premixtures content must be maintained, and provided for the purpose of the use of additives
and certain protein feedingstuffs and the content and limits of undesirable substances and
the intended purpose of the products and the use of animal feed containing undesirable substances and
products so as to avoid damage to the health of animals and to
ensure the wholesomeness and has not been negatively influenced by the quality of the
animal products intended for human consumption. Feed materials
which the excess was detected level of undesirable substances and products may be
be marketed and used in the manufacture of compound feedingstuffs only in
conditions laid down.
(2) For the manufacture of feedingstuffs of additives and premixtures, putting them into
circulation and for animal feed must not be used by an unauthorized
protein feed, or the unauthorized additives or additive,
which do not comply with the conditions of their permits, and premixtures or feedingstuffs,
that such substances they contain.
(3) additives intended for animal nutrition shall be used only as a
part of the feed.
(4) the use of the feed marked withdrawal period must be complied with
the minimum period of the withdrawal period; This is without prejudice to the provisions of the Special
^ 3) of the Act.
(5) feed additives and premixtures, which has passed the date of minimum
durability or the warranty period, shall not be used for production, listed
the circulation and used to feed, if it is not checked their declared
health and safety.
(6) For the manufacture of feedingstuffs of additives and premixtures and animal feed
may not be used
and prohibited substances and products), feedingstuffs and premixtures containing disabled
substances and products, and impaired feed, additives and premixtures,
b) feed materials containing undesirable substances and products, if
exceed the limits set out by Decree, if the conditions are not fulfilled in
It laid down,
c) feed additives and premixtures, in which there are foreign
items which may endanger the health of the animals, and feed on storage pests
the list of which is given in the Decree.
(7) for the manufacture of the premixtures may be used as carriers for food and substances
their physical characteristics do not achieve homogeneity and
stability of additives in the premixture.
(8) feed additives and premixtures, for which the level of radioactive
contamination exceeds the specified limits, shall not be used for other
production of complete and supplementary feeding-stuffs and premixtures and may not be placed
into circulation, zkrmovány, imported and exported.
(9) the additive groups, growth promoters, coccidiostats,
chemotherapy agents, vitamin A, vitamin D, copper, and selenium may be used
only in the form of premixtures with carrier and delivered only to the enabled
registered manufacturing operations pursuant to § 4 paragraph 2. 3, if it is not a
the cases referred to in § 4, paragraph 4. 5. registered manufacturers of compound feedingstuffs for
Pets can be vitamin A, vitamin D, copper and selenium delivered
directly.
(10) Premixtures containing additives referred to in paragraph 9,
should be supplied only to registered manufacturers and suppliers of feed
meeting the requirements laid down in paragraph 4 and shall not be added to the feed in
the share of less than 0.2% by weight of the feed. If technology allowed
of traffic on the basis of the examination allows a homogeneous mixing in
premixture of additives contained in the compound feedingstuff may be share
the dosage of the premixture reduced to a 0.05% by weight of the feed provided
that the manufacturing operation is enabled for this purpose.
(11) the provisions of paragraph 10 shall also apply to the person producing the feed
for their own use which meet the conditions laid down for the manufacture of feedingstuffs
This Act.
(12) feed and feed additives that contain genetically modified
organisms or which have been acquired through them, may only be
used for the manufacture of feed including the production for their own use and for
placing on the market only on condition that they were authorized under a special
legal regulation.
(13) the list of prohibited substances and products, a list of undesirable substances and
products and the maximum limits of their content and the method of use, putting into
circulation of the feedingstuffs containing undesirable substances and products, the list of skladištních
pests, the maximum levels of radioactive contamination and withdrawal periods for
certain additives provides for the Ministry of agriculture (hereinafter referred to as
"the Ministry") by Decree.
3) § 19 para. 2 of the Act No. 168/1999 Coll. ".
4. the heading of part II and section 4, including the footnote # 4), 5), 5a) and
5B):
"THE MANUFACTURE, IMPORT AND PLACING ON THE MARKET OF FEED ADDITIVES AND PREMIXTURES
§ 4
(1) feed, feed additives and premixtures intended for marketing may
to produce people who are entrepreneurs ^ 4) and are registered under section 8,
(hereinafter referred to as "producers"). Registration obligation shall also apply to persons
referred to in § 3 (1). 11, to persons engaged in the production of equipment
mobile stations the supplier referred to in paragraph 4, on the importer ^ 5)
feed additives or premixtures, in addition to the import of the feedingstuffs referred to in article 1
paragraph. 2, and the distributors pursuant to section 8a.
(2) the obligations referred to in paragraph 1 are not subject to persons which manufacture
grains, oilseeds and livestock fodder roots and Brassicas, voluminous and watery
prepared animal feeds (pammene, yeast milk, whey,
mlékárensky modified milk, buttermilk, sugar, and starch
zdrtky, molasses, feed hydrolysates, waste šlempy, burnouts and lihovarské
feed). Also are not subject to this obligation, importers and suppliers
the listed feed, if not obtained from genetically modified
organisms.
(3) production plant in which it is produced
and antioxidants which) is determined by the maximum content limit use,
carotenoids and xanthophylls, enzymes and micro-organisms, growth promoters,
coccidiostats and other, vitamins, trace elements or certain
protein feed laid down by Decree, with the exception of urea and its
derivatives, ammonium salts and yeasts cultivated on substrates
vegetable or animal origin,
b) premixtures containing growth promoters, antikokcidik and chemotherapy
Vitamin A, vitamin D, selenium, copper, or
c) compound feedingstuffs using
1. premixtures containing growth promoters, antikokcidik or
chemotherapeutic agents, vitamin A, vitamin D, selenium, copper, or
2. feed materials with the upper tier levels of undesirable substances and products,
must meet the requirements laid down by a decree on production sites and must
be authorized by the competent administrative authority.
(4) the suppliers, who have held and the circulation of
and certain additives or) protein feed referred to in paragraph 3
(a). and premixtures containing) and these additional substances and certain
protein feed, or
b) premixtures referred to in paragraph 3 (b). (b)),
must be professionally competent pursuant to § 6 and meet the vendors
laid down by Decree.
(5), growth promoters, coccidiostats and other medicinal, vitamin A and
Vitamin D, copper and selenium can be processed directly to compound feedingstuffs,
If this way of handling established by Decree, and on condition that the
production technology on the basis of the examination ensures a homogeneous
mixing of those additives in the compound feedingstuff additives and manufacturing operation is behind it
the purpose is allowed.
(6) if the person engaged in agricultural production, producing only
for the need to own livestock feed mixtures, that the raw material,
She wants to use, has the excess level of undesirable substances and
products, of the fact, notify the competent authority of the animal health
Administration. ^ 5a)
(7) manufacturers are required to use in the manufacture of feeds for farm and
Pets only feed materials complying with the requirements laid down
the Decree, certain protein feedingstuffs and additives that are
listed in the notice and meet the requirements prescribed by law and are supplied
manufacturers and importers who are registered under this Act.
The provisions of this paragraph shall also apply to suppliers and distributors,
who report feed, additives and premixtures.
(8) the producer of the additives, premixtures and feedingstuffs with the use of supplementary
substances or premixtures and certain protein feedingstuffs must be professionally
to be eligible under section 6, or by a competent person must establish
responsible for production. This obligation also applies to persons producing
feed for their own use. The production premises and equipment must correspond to the
the requirements set out in section 7.
(9) the manufacturers of additives, premixtures and feedingstuffs covered by
the provisions of paragraphs 3 and 5, are required to process the written procedures in the
the production process in relation to the control of the quality, including the definition of
the critical phases of the production process, to draw up a list
workers with the delimitation of responsibility, appoint a person responsible
for quality control and to ensure, on the basis of a processed plan in writing
quality control, control in your own lab or made to order. U
the additives referred to in paragraph 3 (b). and manufacturers are required to)
to ensure quality control before putting the product into circulation.
(10) the producer of the additives, premixtures and feedingstuffs with the use of supplementary
substances or premixtures is obliged to remove the sample from each lot produced, and
keep it for a period of minimum durability or the warranty period in addition to the
samples of perishable produce. This obligation shall also apply to the manufacturer
processing of feed with upper levels of undesirable substances and
products.
(11) may be put into circulation only feed, additives and
premixtures, which are safe, they are not rendered useless,
contain banned substances and products and are not marked with the indications
untrue or misleading. This provision shall also apply to the feed
intended for the feeding of wild game ^ 5b) and feed referred to this
the purpose of the circulation.
(12) the additive, and certain protein feedingstuffs authorised for the production and
putting into circulation, the conditions for their use and processing into feed
mixtures of feed materials requirements and minimum requirements for compound feedingstuffs
limit values and their composition, the requirements for the manufacture of premixtures and the use of
carriers, particular nutritional purposes and requirements, requirements for
vendor and manufacturing operations, taking into account the type of production and
products and the use of additives of certain protein feedingstuffs, and
feed materials with the upper tier levels of undesirable substances and products, and
the method of storage of samples for producers shall lay down by Decree of the Ministry.
4) § 2 (2). 2 of the Act No. 513/1991 Coll., the commercial code, as amended by
amended.
5) § 2 (2). 1 (b). d) of Act No. 634/1992 Coll. on consumer protection,
in the wording of later regulations.
5A) § 49 paragraph 1. 1 (b). j) Act No. 167/1999 Coll.
5B) § 19 para. 1 of law No 23/1962 Coll., on game management, as
amended. ".
5. section 5, including the title reads as follows:
"§ 5
Record keeping
(1) the manufacturer, importer and supplier of feed additives and premixtures is
required to keep accurate records of their manufacture, import, receipt and issue.
(2) the register shall include
and) for a manufacturer, importer and supplier of additives
1. the type and quantity of manufactured, imported, supplied or stored
the additives and the date of their manufacture,
2. first and last name ("name") and the name and residence or business
the seat of the establishment, the manufacturer, importer, supplier or recipient,
(b)) by the manufacturer, importer and supplier of premixes and feedingstuffs, using
additives or premixtures
1. the type and quantity of manufactured, imported, supplied or stored
additives, premixtures and feedingstuffs using feed additives or
premixtures and the date of their manufacture,
2. the name and residence or business name and address of the establishment of the manufacturer,
the importer, supplier or recipient premixtures or feedingstuffs with the use of
additives or premixtures.
(3) the manufacturer of compound feedingstuffs is also required to keep records of their
recepturálním composition in revenue or mass representation
feed materials, additives and premixtures. Obligation also applies
the persons referred to in section 3, paragraph 3. 11.
(4) the manufacturer of additives, premixtures and feedingstuffs with the use of supplementary
substances and premixtures, which are covered by the provisions of § 4 para. 9, it is also
required to keep records of the results of quality control.
(5) the manufacturer, importer, supplier and distributor who processes or
the circulation of the feed with upper levels of undesirable substances and
products shall keep separate registers of such feedingstuffs.
(6) the manufacturer, importer, distributor or supplier, producing,
handles or puts into circulation additives, premixtures or feedingstuffs
referred to in section 4, paragraph 4. 3 and compound feedingstuffs that contain them, is required to keep
records of complaints to allow, if necessary, downloads
products out of circulation. Downloaded products can be put into circulation again for
provided that these products have been examined from the viewpoint of quality
a manufacturer, importer, or distributor and supplier in terms of
health certificate by the competent authority of the veterinary service. 5a)
(7) the registration records must be kept for a period of 3 years from the expiry of the
the calendar year in which they were taken.
(8) the other essentials of keeping records on manufacturers, importers and suppliers
additives, premixtures and feedingstuffs, including records of the results of the checks
quality, provides for the Ministry by Decree. "
6. In paragraph 6 of paragraph 1 reads:
' (1) competence for the manufacture, processing, importation and marketing to
circulation of feed additives, certain protein feedingstuffs, premixtures of feed with
the use of additives or premixtures and feedingstuffs establishments contents
undesirable substances (hereinafter referred to as "competence") means the file
Professional and practical knowledge relating to the manufacture of feedingstuffs,
additives and premixtures, knowledge of the foundations of nutrition marketing
animals and feeding techniques and knowledge of the legal instruments relating to production
feed. ".
7. section 7, including the title reads as follows:
"section 7 of the
Requirements for production plant and equipment
(1) manufacturing, in which it is produced or processed
feed additives and premixtures shall be premises and manufacturing
devices that allow you to clean production and ensure that, in the course of the
production of adverse changes in the properties of the used and produced
feed additives and premixtures.
(2) the production equipment for the manufacture of animal feedingstuffs, additives and
premixtures must ensure that during production, there is no confusion or
the omission of some parts of the manufacturing process or product pollution
and cross-contamination by other substances, in particular to the introduction of additional
substances in the product the product subsequently. During and after its
their must be technically allowed sampling, verification of the quality and
health certificate.
(3) the provisions of paragraphs 1 and 2 shall also apply to production sites and
establishments manufacturing compound feedingstuffs using feed additives.
(4) production plant and equipment designed for the production and processing
of additives, premixtures or feedingstuffs referred to in section 4, paragraph 4. 3 and feed
mixtures that contain them must meet the requirements of production and
the production procedures in following up on quality control and storage,
that provides Ministry decree.
(5) manufacturing operations, which are subject to the provisions of paragraph 4,
have a weighing and mixing equipment and equipment for the removal of foreign
the subjects corresponding to the requirements they set for each type of
the production Ministry decree.
(6) the manufacturer must provide proof that the products meet the required properties, and
It
and) for premixtures content or efficacy and the homogeneity of the amino acids and
additives,
(b)) for feedingstuffs with the use of additives and premixtures content or efficacy and
the homogeneity of the additives.
(7) the operator of a mobile production of feedingstuffs must report the Institute before the
start of manufacture, the place and the period of operation and timetable for the production of animal feed. ".
8. section 8 including title and footnote 8) and (9)):
"section 8
Registration of manufacturers, importers and suppliers
(1) a person that is subject to section 4, paragraph 4. 1, (hereinafter referred to as "the applicant") is
shall apply before the start of manufacture, the import of ^ 8) or putting into circulation
about registration. The customs authority releases goods at importation, if the importer
they can demonstrate the legitimacy of the imports referred to in § 9 para. 1 (b). (c)), and (e)) by decision
about registration.
(2) the register shall be decided by the Department upon request. The condition for
begin the registration procedure for the manufacture, processing, importation and marketing
into circulation additives, premixtures of feed by using additives
or, certain protein feedingstuffs and feed upper content
undesirable substances and products is qualifications pursuant to section 6.
(3) the applicant for a marketing authorisation for manufacture and processing additives
premixtures and feedingstuffs is obliged to request at the same time of the registration of the
operation. If the applicant has multiple manufacturing plants, the set
the elements in the request for registration for each operation separately.
(4) the applicant for a marketing authorisation for manufacture and processing additives
premixtures and feedingstuffs, that is subject to the provisions of § 4 para. 3 and 5,
at the same time obliged to request for the authorisation of the operation specified for this
the production. The Department verifies that the operation meets the requirements
by Decree.
(5) the applicant for a marketing authorisation for putting into circulation the additives,
premixtures and feedingstuffs as referred to in section 4, paragraph 4. 3, which is subject to
the provisions of § 4 para. 1 and 4, before the issue of the marketing authorisation
verifies whether the applicant meets the requirements set out by Decree of the vendor.
(6) the manufacturer, importer and supplier of feed additives and premixtures is
shall be obliged to immediately notify the Institute changes to the data referred to in the application for
registration.
(7) an applicant who wishes to manufacture, import or place into circulation a
protein feed and additives which are not listed in the Decree
or to be used otherwise than is provided for by Decree, may be
registered to perform biological testing feed additive
substances or new use. If you cannot exit the biological testing
within 3 years from the submission of application for registration, on the deadline for
their biological testing on the applicant's suggestion to the Ministry of
by decision.
(8) the provisions of paragraph 7 shall also apply to the manufacture, placing on the market or
imports of premixtures containing a carrier substance or not
allowed, and it also applies to raw materials or products that have been
acquired or modified using new technological processes or that
do not yet have the character of a feed.
(9) the biological testing for registration for control carried out by the Institute. The cost of
for biological testing shall be borne by the applicant, which is obliged to deliver free of charge
Institute a feed additive or premixture in the desired quantity to
perform biological testing.
(10) the Institute shall refrain on the basis of the consent of the State Veterinary Administration ^ 9) from
biological testing feed additive or a premixture or
subjected to biological testing in cases where the applicant shall submit to the
together with the application for registration of the results of the biological testing of feed,
the additive or premixture or new use of an additive
required by this law. The Institute may require other necessary
special expertise.
(11) the Institute processes of biological testing summary
documentation, which is a condition for granting marketing authorisation
the manufacturer or importer pursuant to the provisions of paragraphs 7 and 8. Part of the summary
documentation for the additive process of a monograph.
(12) the data submitted to applications for registration which are subject to
protection of patent rights, shall be published by the Institute. Papers,
that were submitted during registration of feed, additives and
premixtures, Archives Department for 10 years since the release of decision
registration or on the extension of the registration.
(13) the requirements for an application for registration of manufacturers, suppliers and importers
feed additives and premixtures and the registration and authorisation of production
operations and technical parameters, and the methods of implementation of biological testing,
including the methods of testing the effectiveness of additives intended for the
manufacture of animal feed, to methods of testing the quality of animal products, methods
testing the safety of use of the feed or additives and method
processing of the monograph of the additive and the summary dossier sets out the
Ministry decree.
8) § 128 et seq.. and § 163 (a). (b)) of the Act No. 13/1993 Coll. Customs law,
in the wording of later regulations.
9) § 48 (b). I) Act No. 167/1999 Coll. ".
9. in paragraph 8, the following new section 8a, which including the title reads as follows:
"§ 8a
Distributors registration
(1) distributors, who place into circulation additives or premixtures
or feed referred to in § 4, paragraph 4. 3 (b). a) and b) or grains and oilseeds
obtained through genetically modified organisms, or
containing genetically modified organisms, must apply for registration
at the Institute.
(2) the application for registration of a Distributor is a written statement
the applicant shall ensure that the management of the documentation and registration of products
the putting into circulation of brokers, in accordance with the applicable legal
regulations.
(3) the Institute shall issue the Distributor's registration decision. Part of the
the decision is the registration number and address of the Distributor, and the Group
additives or premixtures or feedingstuffs referred to in § 4, paragraph 4. 3 (b).
a) and b), and grains and oilseeds obtained through genetically
GMOs or containing genetically modified
organisms that are the subject of marketing.
(4) in the case of changes to the categories of additives, premixes, feed, grain and
of oil referred to in paragraph 1 and put into circulation, the distributor will ask
for change of registration. About the change of registration issues Department of the decision.
(5) the Institute shall issue a decision on the cancellation of the registration of the Distributor, if it finds
a serious breach of the obligations laid down in paragraph 2, section 3, paragraph 3. 2, in the
§ 3 para. 6 (a). a) and b), in section 3, paragraph 3. 8, 10 and 12, in articles 11 and 18. On
the written request, the Institute shall cancel the registration decision Distributor.
(6) the requirements for an application for registration of the Distributor and the requirements for
documentation and registration of products referred to in paragraph 2 shall set out the Ministry of
by Decree. "
10. section 9, including the title reads as follows:
"section 9
The decision on the registration of manufacturers, importers and suppliers
(1) the Institute shall issue a decision on the registration of the manufacturer for the production and
registration of importers for imports of feed additives and premixtures and the
the registration of vendors for putting into circulation of feed additives and feed
referred to in section 4, paragraph 4. 3 and premixtures and compound feedingstuffs which contain them,
If the requirements of this Act. If the applicant fails to comply with these
requirements within the time limit or when prompted to complete the request, Institute of management
stops the registration decision. The decision on the registration contains
in particular, the
and the registration number of the manufacturer) and address, registration number and address
of operation, type of production and the range of activities and by the manufacturer of the feed with the
the use of premixtures limit dosage of premixtures, in the feedingstuffs; in the case that
the applicant submitted an application for the registration of more manufacturing operations (§ 8 paragraph.
3), in the marketing authorisation, the manufacturer, these operations shall
individually,
(b)) by the manufacturer for the manufacture and processing of feed additives and feed
referred to in section 4, paragraph 4. 3 and premixtures and compound feedingstuffs which contain them,
registration number and address of the authorised production site; in the case that
the applicant submitted an application for the registration of more manufacturing operations (§ 8 paragraph.
3), in the marketing authorisation, the manufacturer, these operations shall
individually,
(c)) at the supplier and importer registration number, address, the type and extent of
activities,
(d)) at the vendor further groups of additives, feedingstuffs and premixtures
referred to in section 4, paragraph 4. 3 (b). and) and (b)),
(e) the importer further species) of feed additives and premixtures.
(2) in the case of the introduction of a different kind manufacture or import other species
feed additives and premixtures than those for which it is the decision of the
the registration is issued, the manufacturer, the supplier and the importer is obliged to request the
the extension of the registration. On the procedure for extension of registration applies
the provisions of § 8. On the extension of the Institute shall issue a registration decision.
(3) if data are affected by the change announced pursuant to § 8 para. 6
part of the marketing authorisation, it shall issue a decision on changing the data Institute in
of the marketing authorisation. This also applies, if it finds in the performance Institute
professional supervision change of information, which are part of the decision on the
the registration, although the manufacturer, importer or supplier of data change
provided in the request did not report.
(4) the Institute shall issue a decision on the cancellation of registration of the production site of the manufacturer,
registration of the supplier or importer, if it is found in the exercise of supervision, serious
violation of the obligations provided for in § 3 (1). 1 and 2, section 3, paragraph 3. 6 (a).
and), (b)), in section 3, paragraph 3. 8 to 12, in section 4, paragraph 4. 3, 4, 5 and 7, in section 7, 11 and 18.
(5) a decision on the cancellation of registration shall issue a written request to the Institute
the manufacturer, importer or vendor. ".
11. section 10 including the title reads as follows:
"§ 10
The publication of the registration of manufacturers, suppliers and distributors
(1) the list and registration numbers of manufacturers of additives, premixtures, and
feed using additives or premixtures, list and registration
the number of allowed manufacturing plants and a list and registration numbers
suppliers and distributors who have been issued or revoked registration,
exposes the Ministry every 6 months, always according to the status to 1. January and to
July 1 of the calendar year in the journal of the Department of agriculture.
(2) the list shall be indicated, for what kind of production, or a group of
additives and certain protein feedingstuffs and premixtures referred to in § 4
paragraph. 3 (b). a) and b), registration was granted or cancelled. ".
12. In article 11, paragraphs 1 and 2 shall be added:
"(1) feed additives and premixtures produced or placed into circulation
they must bear, showing, in particular,
and the name of the feed) of the additive and the premixture,
(b)) business name, registration number of the manufacturer or supplier, or
the importer or the Distributor, registered office and registration number of the operation,
(c)), the quantities (weight, volume, number of pieces),
(d)) date of manufacture,
(e) the purpose of the use and recommendation) for proper use,
(f) the date of minimum durability or) end date of the warranty period,
g) composition, content of nutrients, additives, undesirable substances content
energy, declared characters and special nutritional purpose within the scope of
the Decree,
(h) the length of the withdrawal period), if prescribed,
even the presence of a warning) of genetically modified organisms, if
These were in the manufacture of animal feedingstuffs, additives or the premixture used,
j) warning if it is prescribed.
(2) the marking must be placed on each individual package, container or
they attached the label of the feedingstuffs in bulk, on an accompanying document.
The mark must be in the English language, clearly visible, legible, durable,
indelible and unmistakable. ".
13. in paragraph 11 (1) 3 at the end of the second sentence the words "and feed for
the specific purposes of animal nutrition ".
14. in article 11 the following paragraphs 4 and 5 are added:
"(4) on the packaging, on the label or in an accompanying document may be given other
information than the information provided for in paragraph 1 and in the Decree just in case
If they are clearly separated, and if it is a measurable or verifiable
information in relation to the consumer.
(5) feed additives and premixtures, which are put into circulation
distributors must also bear a marking provided for in paragraphs 1 to
4. ".
15. sections 12 and 13 shall be added:
"section 12
(1) the additive, a certain protein feedingstuffs, premixtures and compound feedingstuffs,
In addition to the cases referred to in paragraph 2, and feed of
properties may be placed on the market only in packages or containers,
that must be closed so that when you open a breach of
the original closure and this closure could not be re-used.
(2) compound feedingstuffs may be marketed in bulk or in also
unsealed packages or containers, and only when the supply of
and) from one manufacturer other producers or persons Pack,
b) compound feedingstuffs compound from whole seeds or fruits,
c) blocks and licks,
d) small quantities, whose weight does not exceed 50 kg, and which are
supplied to the final consumer, and if they come directly from the packaging
or containers which have been concluded in accordance with paragraph 1.
(3) compound feedingstuffs may be marketed in bulk or also
in unsealed containers, but not in unsealed packages,
only when the supply of
and the manufacturer of compound feedingstuffs) directly to the final consumer,
b) molassed feedingstuffs which are composed of a maximum of 3 feed materials,
c) pelleted snacks of compound feedingstuffs.
section 13 of the
The details of the labelling of feed materials, additives, premixtures, and
compound feedingstuffs, feed materials with the upper tier levels of undesirable substances
and products and feedingstuffs for particular nutritional purposes and method declaration
quality features, including their tolerances specification composition data,
way of placing warnings, the labelling of compound feedingstuffs and feed
raw materials supplied in small packages up to 10 kg, including the labelling of feed
for pets and details of their package provides the Ministry of
by Decree. "
16. in § 14 para. 1 to the beginning of the letter d), the words "moisture
and ".
17. in § 14 paragraph 2 reads as follows:
"(2) additives, premixtures and certain protein feedingstuffs shall be
stored in lockable spaces so that unauthorized persons to them
do not have access. Conditionally applicable fodder and raw materials with
upper tier content of certain undesirable substances and products laid down by the
the decree must be stored separately. ".
18. Footnote. ^ 10) reads as follows:
"10) section 39 of the Act No. 167/1999 Coll., Act No. 20/1966 Coll., on health care
the people, as amended. sections 23 and 24 of the Decree No. 91/1984 Coll.,
on the measures against communicable diseases. Act No. 157/1998 Coll., on
chemical substances and chemical preparations and amending and supplementing
certain other acts, as amended. ".
19. section 16 reads:
"section 16 of the
(1) the Institute shall see whether the conditions laid down by the law and its implementing
comply with regulations
and) producers, importers, suppliers and distributors who feed additive
substances and premixtures manufacture, import, transport or circulation,
(b)) people who use feed additives and premixtures.
(2) the Institute performs specialized supervision of production operations, facilities and
areas intended for the storage, transport, marketing and
the use of feed additives and premixtures and ensures their subscription
samples, laboratory testing and evaluation of the quality.
(3) the Institute performs professional supervision at regular intervals, particularly when the
the suspicion of breach of the provisions of the Act and its implementing regulations. In
If defects are found and the final method will save to remove them.
(4) the Technical supervision includes all stages of production, marketing,
including imports and use of feed additives and premixtures, and
focused on the monitoring of the occurrence of undesirable substances and products, and on the occurrence of
prohibited substances and products.
(5) the Technical supervision is carried out without prior notice.
(6) the Institute keeps records of performance failures identified in the professional supervision.
(7) the staff of the Institute delegation of professional supervision (hereinafter referred to as
"the staff of the Institute") must be professionally competent for the performance of professional
surveillance, which exhibit a written mandate, and the staff ID card.
The results of these activities are captured in the Protocol.
(8) the staff of the Institute are authorized to enter after the notification to the
areas where feed additives and premixtures produced
transported, marketed or used, and to require from manufacturers
importers, suppliers and distributors, who is producing, transporting and
the circulation, and from business owners who feed, additives and
pre-mixes are used, the necessary documents, information and necessary assistance to
smooth and quick performance of supervision, including the provision of technical
AIDS for free sampling.
(9) the producers, importers, suppliers and distributors who feed,
additives and premixtures produced, transported and put into circulation, and
entrepreneurs who use them, are required to allow employees
the Institute, after the notification entry to premises where animal feed, additives and
premixes are produced, transported, marketed and used, and
to provide the necessary documents, information and necessary assistance to
smooth and quick performance of supervision, including the provision of technical
AIDS for free sampling.
(10) the Institute is obliged to retain samples of animal feed, additives and
premixtures intended for laboratory testing, in addition to the samples subject to the
the destruction, for a period of 6 months from the date of receipt of the sample to the lab.
(11) the Technical supervision Institute at his own expense. In the case that
samples of feed additives and premixtures removed during performance of vocational
supervision do not meet after the analysis of the requirements of this Act and
the implementing regulations, shall bear the costs of their analysis of the controlled
body. ".
20. in article 16, the following paragraph 16a is inserted:
"§ 16a
(1) the staff of the Institute may, when defects are found in the production, quality,
packaging, labelling, transportation, putting into circulation and use of feed
additives and premixtures Save method and deadline for elimination of deficiencies,
in particular, save the necessary measures, including putting into the desired state.
Of the defects and the measures taken to make a written record.
(2) against the imposition of remedies provided for in paragraph 1 may submit a
controlled by the person not later than 3 working days in writing of the objections
professional supervision of the authority that carried out the inspection. The deadline for the submission of
the opposition is maintained, if the opposition is the last day of the period are disposed of in
the mail transport. Lodged objections do not have suspensory effect. About submitted
opposition, the Institute without delay.
(3) The procedure referred to in paragraphs 1 and 2 shall not apply the administrative code 13) ".
21. section 17 including the title reads as follows:
"§ 17
Sampling and laboratory testing
(1) the sampling and laboratory testing of the quality of feed additives
and premixtures, the Institute performs under professional supervision or on demand; It
also applies for the examination in accordance with § 3 (1). 5.
(2) the Institute may appoint to perform some laboratory tests
persons at their request be granted credentials (hereinafter referred to as "operator
the lab ").
(3) the list of laboratories of the Institute conducting laboratory testing of the quality
feed additives and premixtures in the performance of professional supervision and
the list of persons responsible for carrying out the laboratory tests shall publish
in the journal of the Department of the Ministry of agriculture.
(4) an application for the granting of credentials must contain
and the name of the operator) laboratory, the place of business and residence,
If it is a physical person or business name and address, in the case of a person
legal,
b) data on the equipment of the laboratory,
(c) the education workers) information about the lab,
(d)) range of activities for which authorization is sought.
(5) the Institute shall grant credentials referred to in paragraph 2 no later than 6 months from the
submission of the application, if
and laboratory equipment) corresponds to the anticipated scope and type
activities by which the requests,
(b)) laboratory tests will be carried out by persons at least secondary
education of chemical or biological,
(c) the results of the laboratory tests at) certification test were found to be in
the range of tolerances laid down for these tests.
(6) the Institute has overseen, that the last conditions under which accreditation has been given
in accordance with paragraph 5.
(7) the Institute may change or revoke the credentials if you have changed or
have ceased to apply the conditions under which accreditation has been granted. At the written request
the lab operator, the Institute shall cancel the credentials.
(8) the Institute and the operators are required to ensure the laboratories
objectivity and comparability of the results of the checks follow
requirements for sampling and use methods of laboratory testing,
the understanding provides for the Ministry by Decree.
(9) the Ministry shall lay down by Decree the types of laboratory tests that
can be carried out on the basis of a mandate issued by the Institute. ".
22. section 18 including title and footnotes # 10a) is inserted:
"section 18
Special measures
(1) the Institute saves the decision of producers, importers, suppliers,
distributors or entrepreneurs, 4) who feed, additives or
premixes are produced or put into circulation or used, special
the measures, in particular the prohibition of the manufacture, placing on the market prohibition, the ban on imports,
a ban on feeding, the obligation to separate storage of feed additive
of the substance or the premixture, if it detects a danger to human health or the
animals or the environment.
(2) in the case of deactivated feed additives and premixtures saves the Institute
by decision of the measures for their disposal. ^ 10a)
(3) in the case of conditionally applicable animal feed, additives or premixtures
the Institute provides for special measures in the decision to use the replacement
and shall determine the conditions of use.
(4) an appeal against a decision on the measures referred to in paragraphs 1 to
3 does not have suspensory effect.
10A) Act No. 125/1997 Coll., on waste, as amended.
Act No. 157/1998 Coll., on fertilisers, soil conditioners,
auxiliary plant products and substrates and agrochemical
testing of agricultural soils (fertilizers). ".
23. in section 19 para. 1, the words "or importers or suppliers" shall be replaced by
the words "importer, supplier or distributor".
24. in section 19 para. 1, letter a) is added:
"and produces, imports or) puts into circulation of feed additive and
premixtures with data that are misleading, untrue or which
do not conform to the requirements provided by this Act, ".
25. in section 19 para. 1 (b). (b)), after the word "produced", the word "or" is replaced by
the comma and the word "takes" the words "or States into circulation".
26. in section 19 para. 3, the words "and produced" the word "or" is replaced by
the comma after the word "imported", the words "or States into circulation" and
the word "importation" shall be inserted the words "or putting into circulation".
27. in section 19 para. 4, after the word "producers", and the word "importer" Word
"or" is replaced by a comma and the word "suppliers" shall be inserted after
"or the reseller".
28. in section 19 para. 5, after the word "produced", the word "or" is replaced by a comma
and after the word "imported", the words "or States into circulation".
29. in section 19 para. 6, after the word "producers", and the word "importer" Word
"or" is replaced by a comma and the word "suppliers" shall be inserted after
"or the reseller".
30. In § 19 para. 7, after the word "producer" and the word "importer" Word
"or" is replaced by a comma and the word "supplier" shall be inserted the words "or
Distributor ".
31. in paragraph 8 of section 19 reads as follows:
"(8) in determining the fine, account shall be taken of the seriousness, the way time
the duration and consequences of the infringement. The fine can be producers, importers,
the supplier or distributor who feed, additives and premixtures
produced, imported and puts into circulation, save to one year from the date on which the
the Institute has found a breach of duty, but within 3 years from the date on which the
breach of an obligation has occurred. ".
32. In paragraph 22, the words "general rules on administrative řízení13)" are replaced by
the words "administrative procedure, 13) unless otherwise provided for in this law".
Article II
Transitional provisions
1. Registration of producers and importers, made before the effective date of this Act,
does not lose validity if within 18 months from the entry into force of this
the law, the manufacturer or importer shall request registration under section 8 and, if
This time will meet the requirements under sections 4 to 7. In this case, is not subject to
registration administrative fee.
2. suppliers and distributors, covered by the obligation to register
pursuant to section 8 and 8a are required to apply for registration within 3 months from the date of
entry into force of this Act.
3. products in packages marked in accordance with the existing legislation
may be put into circulation, but within 6 months from the date of acquisition
the effectiveness of this Act.
Article. (III)
The Prime Minister shall be empowered, in the collection of laws promulgated the full text
Act No. 91/1996 Coll., on feedstuffs, as a consequence of changes made to
This Act.
Article IV
The effectiveness of the
This Act shall take effect on 1 January 2000. January 1, 2001.
Klaus r.
Havel, v. r.
Zeman in r.
