32/2012 Sb.
DECREE
of 19 December 2003. January 2012
about products and other pesticides
326/2012: Sb.
The Ministry of agriculture shall establish, in cooperation with the Ministry of
of health and the Ministry of the environment under section 88 para. 3
Act No. 326/2004 Coll., on phytosanitary care and amendments
related laws, as amended by Act No. 245/2011 Coll. (hereinafter referred to as
the "Act"):
§ 1
This Decree follows on directly applicable provision of the European Union on the
the placing of plant protection products on the market, "^ 1") and the provisions
the law applicable to the jigs and other means to protect
plants.
§ 2
The conditions of the repackaging plant protection products
(To section 31 (6) of the Act)
(1) the Repackaging of the product intended for placing on the market must not affect the
the composition or physical and chemical properties of přebalovaného.
(2) the product is allowed to be placed on the market may be repacked only to
the package, whose properties and the risks of its use has been assessed
plant protection management in relation to this product and that is
listed in the decision on the authorisation of this product.
(3) when the repackaging must not lead to the mixing of different batches of přebalovaného
of the product.
(4) on the packaging of the product after repackaging must bear the same lot number
and the date of manufacture as the original packaging of the product přebalovaného.
(5) the dossier on the baby changing facilities includes:
and repackaging, date)
(b) the product name by repacking before) and after repackaging,
c) quantity supplied, the lot number and date of manufacture of the product intended for
repackaging, referred to in its original packaging.
(6) the dossier referred to in paragraph 5 shall be kept in accordance with regulation
The European Union governing the placing on the market of ^ 2).
§ 3
The criteria defining minority use of
(Section 37, paragraph 2, of the Act)
Use of the product is considered as a minority, if
the area under crops) in the Czech Republic is less than 10 000 ha in
year in which the request was made to extend the authorisation,
b) area of crop treated in the last three years prior to the application of
extend the authorisation was less than 10 000 ha per year,
(c)) the occurrence of the harmful organism irregular and needed less treatment
than once every three years, or
(d)) usable in organic farming product ^ 3).
§ 4
The area of testing and documentation requirements to demonstrate competence to
carrying out experiments and tests
(§ 45 para. 13 of the Act)
(1) the field testing are
and field crops and vegetables),
b) permanent crops including forest stands,
(c) the greenhouses and other indoor) spaces,
d) pickling seeds
e) laboratory tests and analysis.
(2) documentation to establish eligibility to conduct experiments and tests in
accordance with the requirements of good pokusnické practice includes
and documentation about) organizational and technical conditions, which
contains:
1. a description of the site and its activities in the field of agriculture,
2. the Organization of the workplace, including the delimitation of competences in the management
work and the conduct of his professional activities,
3. internal system of staff training in the field of quality assurance
work, work practices and safety at work,
4. a description of the structures, space and experimental plots, including space for
storage of samples of medicinal products,
5. Description of the way to ensure the safe collection and disposal of
the remnants of the preparations, the packaging of unfit after them, the remnants of the application
liquids and water after cleaning application techniques,
6. Description of how the handling of treated plants or plant
products,
7. Overview of machines, apparatus and other equipment to carry out the tests,
8. rules for the retention of documentation and
9. the rules of the internal quality control system,
b) standard operating procedures for all activities related to
carrying out the tests,
c) Metrology order, which lays down the rules for treatment, maintenance and
calibration of the measuring instruments used,
d) records of maintenance and calibration of used equipment and facilities and
e) records of education completed courses and training for performance
activity.
§ 5
The criteria on the points at which occurs when business activity to
preparations or other resources within the distribution
(Section 46a, paragraph 1, of the Act)
(1) the place in which the waste products or other
resources within the distribution, must correspond to the type and amount of
distributed products so as to allow for the safe handling of
preparations.
(2) the place in which occurs when business activity management
products or other resources within the distribution, must be protected
before the rain, mrazuprosté, must allow for the separate storage:
individual types of products or other means and must be
fitted with a device to measure the air temperature.
(3) for each site referred to in paragraph 1 must be handled by a separate
operating safety regulations for hygienic specifications, operational
safety and fire regulations.
(4) The points at which occurs when business activity management
products or other resources in the retail packaging and this
packaging standards are directly sold to users who are not
Professional users, subject to the requirements referred to in paragraph 1.
§ 6
The principles of good distribution practices
[To section 46a (6) (a)) of the Act]
(1) in the distribution of products or other resources distributor
and) creates and continuously and systematically applied during
the requirements referred to in paragraphs 2 and 3,
(b)) shall ensure that employees are trained to work
perform, and their jurisdiction is set out in writing, and
(c)) shall ensure that the premises and technical equipment intended for distribution
products or other resources match the type and extent of
distributed products or other means and to have these
premises and technical equipment are maintained and controlled so that
ensured proper handling of products or other resources.
(2) products or other resources stored at the distributor so that the
and storage conditions have been complied with) corresponding to the hazard
products or other resources and additional storage requirements
products provided for directly applicable EU regulation ^ 1) ^ 4),
law and other legislation ^ 5),
(b)) was introduced the system of rotation of stocks,
(c)) or other resources, whose shelf-life
expired, were placed separately and were not distributed,
d) products or other resources associated with impaired or preparations
or other resources, which is suspected of being contaminated or
counterfeited, or products or other measures which have been applied
claims were placed separately and were not distributed,
e) products or other devices intended for export to third countries have been
stored separately from products or other means which are intended to
placing on the market,
(f)) or other means referred to in subparagraphs (c) to (e)))
stored in a space that is significantly marked,
g) avoid contamination, damage, theft, depreciation and
confusion and
h) avoid divisions among the documentation conducted under section 7 and
the activities undertaken in the framework of the receipt, storage and delivery
products or other means. ".
(3) the transport of products or other resources will ensure the distributor so
in order to
and have not been exposed to adverse effects),
(b)) are not contamination, damage, theft, depreciation and
mix-ups.
(4) if the distributor product or other resource returned from
because of a suspicion of an unauthorised medicinal product or another means
unregistered into the official registry, the distributor of this fact leads
records and stores the documents referred to in section 7 of the analogy.
(5) a Distributor performed repeatedly, which validates the internal control
the implementation and observance of good distribution practices, and to adopt the necessary
the corrective measures. In the framework of internal controls performed by the distributor
at least once a year check in order to compare the status of accepted and
distributed products or other means with the current inventory
the status of preparations or other means. Any irregularities
identified in the context of this comparison must be recorded.
§ 7
The scope and method of storage of documentation and records of the distribution of products
or other resources and their origin
[To section 46a (6) (b)) law]
(1) a Distributor shall draw up and maintain written procedures for the current
activities that may affect the quality of the products, other resources
or distribution activities, such as the receipt, control procedures
supply, storage, cleaning and maintenance of premises, inspection conditions
storage, including the protection of products or other resources when
storage and transport, download products from circulation, ordering, refunds
and delivery, keep the record referred to in paragraph 4 and shall keep the documents referred to in
of paragraph 6.
(2) the management of the documentation about the product recall or other resource from the
circulation pursuant to section 46a of the Act is set out in the written procedures. This
the documentation includes
and the delimitation of competences of workers at) the implementation and coordination of the download,
(b) a description of the communication) with the relevant authorities, the holder of the authorization, the manufacturer of the
and with suppliers and customers of or in the course of the next resource
the download and after downloading,
(c) a description of the custom download procedure), including the procedure for immediate
identify and contact all purchasers of or further
resource,
(d)) the way the leadership and maintain records of all activities related
downloading the product, or other resource,
(e)) assessment of the product recall or other resource, and
measures carried out in cases where it is not possible, download and
(f) ensure the separate location) for a description of downloaded products or
other resources from other stored products or other
resources.
(3) records of receipt and delivery of products or other resources
contain
and the name of the medicine or other) resource
(b)) date of receipt or shipment,
(c)) the name, or name, last name, place of business of a natural person,
that is a vendor or customer, and its identification number,
If it was allocated for the customer or vendor that is a legal
person, its commercial name, where appropriate, the name, registered office and identification
number, if assigned,
(d)) the address for service,
e) details of the quantity of the purchased or sold and the identification of the supplied
products or other resources to track the path of the distribution
each product or other resource, including details of the time of their
usability and
f) batch number and date of manufacture;
in the management of these records, the distributor shall ensure that each item
by letter a) to (f)) were not interchangeable.
(4) evidence of purchase of the product, or additional resource include
and) order,
(b)) and waybill, delivery
(c)) Declaration on dangerous goods and safety data sheet
d) invoice.
(5) documents of the subsequent distribution of the product, or other resource
include
and) order,
(b)) and waybill, delivery
(c)) Declaration on dangerous goods and safety data sheet
d) invoice
(e)) the book of incoming and outgoing invoices.
(6) a Distributor shall keep the documentation in accordance with the regulation of the European
Union governing the placing on the market of ^ 2).
§ 8
Additional resource requirements for registration of plant protection products into the official
the registry and the technical requirements of the application for such registration
(§ 54 paragraph 3 and 4 of the Act)
(1) the application for registration of an additional resource into the official registry, the applicant
showing that there are
and the auxiliary data resource) and related documents, provided for in
the annexes 1 and 3 of this decree or bioagens and related data
the documents set out in annexes 2 and 3 to this Decree,
(b) observations on the possible use) in the gardens that are not being used to
business, to attend a public school, green land and children's
courses, indoor and balcony of ornamental plants, on recreational
areas, sports fields and other areas outside the agricultural or forestry
land.
(2) the applicant shall, on request of the phytosanitary administration of the next sample
the resource that corresponds to its standard production, along with proof of
its composition.
§ 9
Labelling other means
(Section 55 of the Act)
On the cover of the next resource directly, in addition to the requirements laid down
the applicable law of the European Union ^ 5) and other legislation ^ 6)
lists
and the business name or name) of the holder of the registration in the official
the registry and its registered office for legal persons, for natural persons, the name or
name, last name, home address and place of business if different from the
residence,
(b)) the composition of the next resource according to the conditions laid down in the decision
his entry in the official registry,
(c) the decision on registration number) into the official registry,
(d)) for more information set out in decision on registration in the official registry.
§ 9a
The method of keeping records of used products professional
the user
(Section 60, paragraph 5, of the Act)
(1) professional users are performing in accordance with regulations of the European Union
governing the placing on the market of ^ 2) records for the use of
or other resources when doing business in a special book with the continuously
numbered pages, or in electronic form, under the current
the security of their preservation. The records shall be carried out without delay,
no later than the following working day after application of or further
resource on plant protection products.
(2) the records in electronic form must be routed so that it is possible and
subsequent electronic data processing.
(3) a record of the used preparations or other resources on
plant protection products shall include:
and the identification of the application site)
1. the land is devoted cadastral areas, municipalities, district parcelním
number, or the number of the soil block registration of agricultural land according to the
user relations, in the case of forest land unit 3-d
the distribution of forest,
2. the UK plant products is determined by the municipality, marking, warehouse,
3. greenhouse is determined by the municipality, the designation of the greenhouse,
4. wash station is determined by the municipality, marking the pickling station
5. in other cases, keeping records of the used preparations or
additional resources on the plant protection product is to identify
the object to be treated in accordance with points 1 to 4 apply mutatis mutandis,
(b) the identification of the object)
1. the type of crop,
2. type, where appropriate, a genus of fruit, ornamental trees or ornamental
plants grown in the greenhouse,
3. the type of plant product, seed and propagating material,
4. for additional information, such as unit of solid wood, split rail
housing, stubble after olejce Winter Canola, wheat,
(c)) the volume or quantity to be treated, with a record object with the
If the treated area does not empty the greenhouse or the warehouse cannot be
State, or if it is a different application than areal,
(d)) date of application (in the format day, month, year)
(e)) the full name of the plant protection product or an additional resource on
plant protection products,
(f) the dose of the drive)
(g) the identification of the target harmful organism) in accordance with the designation
listed on the packaging of the product, or other resource, which was
the application is made, or
h) purpose of use, especially the pickling, desiccation, defoliation, regulation
biological processes, wound closure of plants, customize the appearance of the plant,
soil disinfection, fumigation of soil.
(4) for the common record-keeping on the use of plant protection
plants and fertilizers, paragraph 3 shall apply mutatis mutandis.
§ 10
Regulation (EEC)
Shall be deleted;
1. Decree No. 329/2004 Coll., on preparations and additional resources on
plant protection products.
2. Decree No. 371/2006 Coll., amending Decree No. 329/2004 Coll.
products and other pesticides.
3. Decree No. 146/2009 Coll., amending Decree No. 329/2004 Coll.
products and other means of plant protection products, as
Decree No. 371/2006 Coll.
§ 11
The effectiveness of the
This Decree shall enter into force on 1 January 2000. February 2012.
Minister:
Ing. Sarah b in r.
Annex 1
Details of the additional resource and related documents, which must include:
application for the registration of the auxiliary device into the official registry.
And data on auxiliary instrument (hereinafter referred to as "resource")
1 identification of the resource
1.1 information on the applicant
1.2 details of manufacturer:
and) business name and registered office, in the case of a legal person, or
(b)) the name or names, and last names, address of residence
or place of business, if it is not the same as the place of permanent residence, if it is
a natural person
1.3. Trade name or proposed trade name resource
1.4 the function and purpose of use
1.5 mechanism of action
1.6 active ingredient
1.7. Qualitative and quantitative composition of the resource
1.8 safety data sheet prepared in accordance with the directly applicable resource
European Union legislation ^ 1)
1.9 safety data sheets resource components, processed by directly
of the applicable legislation of the European Union ^ 2)
1.10 the resource tag suggestion text labels/label or text
enclosed leaflet,
1.11 Classification resource ^ 3) in terms of its chemical properties and
physical, toxicological, ecotoxicological (including existing
Studies)
2 data on the use
2.1. Field of use envisaged
2.2 the details of the proposed use of the
2.3. application rate
2.4. Method of application
2.5 the number of applications and the terms of use,
2.6 risks to plants or plant products
2.7 procedures for cleaning application equipment, if used
2.8 form of combination with another treatment plant protection products,
If it is assumed
3 for more information about the resource
3.1 packaging size, type of packaging, etc.
3.2 proposals for conservation and other periods or other precautions to protect
people, livestock and the environment
4 analytical methods
4.1. Analytical method for determining the composition of the resource
4.2. Methods to determine the standardnosti resource and its purity
5 risks for human health
5.1 the risk when dealing with a resource
5.2 license, that the use of the device in combination with protection
plants do not increase the risk to the health
5.3 Suggestions on minimizing the risk to human health when dealing with
a means of
5.4 proposals to minimise the risk of use of the resource in the areas of
used by the general public or by vulnerable groups
6 the risk of use of the device, in particular for the bees, animals and water
organisms, for animal health and the environment
(B)
Related documents-in particular
1 a document certifying authorisation for the placing of the product on the market in
other countries,
2 documents confirming the fulfillment of specific requirements pursuant to section 58 of the Act,
3 a declaration conforming to the model in annex 3 to this Decree, that
an auxiliary resource meets the special requirements of § 38 c and section 58
the law.
4 proof of the consent of the first applicant for the registration of an additional resource to
the official registry, which is the holder of the registration, with the
using the information provided by him for the benefit of another applicant for entry in the
the official registry, if it is not itself the first applicant.
5 for information about using the next resource in other Member States
The European Union and other States.
_______________
1) European Parliament and Council Regulation (EC) No 1107/2009 of 21 December.
October 2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC.
2) Article. 67 European Parliament and Council Regulation (EC) No 1107/2009,
the placing of plant protection products on the market and repealing Council directives
79/117/EEC and 91/414/EEC.
3) Act 242/2000 Coll., on organic farming and on the amendment of Act No.
368/1992 Coll., on administrative fees, as amended, in
as amended.
4) Eg. Act 350/2011 Coll., on chemical substances and chemical
mixtures and amending some laws (legislation) and the implementing
the regulations issued for its implementation.
5) European Parliament and Council Regulation (EC) no 1272/2008 of 16 May.
December 2008 on classification, labelling and packaging of substances and mixtures, amending
and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No.
1907/2006, as amended.
Annex 2
Information on bioagens and related documents, which must include a request for
write bioagens to the official registry
And
Information about bioagens
1 identification of the bioagens
1.1 information on the applicant
1.2 details of manufacturer:
and) business name and registered office, in the case of a legal person, or
(b)) the name or names, and last names, address of residence
or place of business, if it is not the same as the place of permanent residence, if it is
a natural person
1.3. Trade name or proposed trade name, and the development code number
bioagens
1.4 Biological functions (in particular against insects, mites)
1.5. Physical State and rewording bioagens
1.6 Effective makroorganismus
1.7 additional folders for data bioagens
1.8 the draft text labels/label, where appropriate, of the text of the leaflet
2 technical characteristics bioagens
2.1 the appearance bioagens
2.2 Storage stability and shelf-life of bioagens
2.3 methods of determining the stability and durability of the active macro-organisms in
storage
2.4. Technical characteristics of the formulation and content of effective macro-organisms
in bioagens
2.5 Compatibility with other substances, preparations or resources and
mixtures of ^ 3)
2.6 the application bioagens after the previous use of the protection
plants
2.7 Application of plant protection product after the previous use
bioagens
2.8 form of combination, if possible
3 data on the use
3.1 field of use envisaged
3.2 details of proposed use and in particular to target harmful species
organisms, plants, or plant products which are the subject
protective intervention
3.3 application rate of application per unit bioagens
3.4 number of macro-organisms of application per unit
3.5 the conditions under which it can be bioagens used
3.6. Method of application
3.7 number of applications, terms of use, the duration of the protective effect of
(the maximum number of applications during the season, the timing of applications, the minimum
the interval between applications)
2.4 duration of effect for each application
2.4 risks to plants or plant products
4 for more information about bioagens
4.1 packaging size
4.1.1 description of packaging
4.1.2 the test results in terms of packaging, transportation and normal handling
4.1.3 the resistance of the material of the packaging
4.2 procedures for cleaning application equipment, if the device uses
4.3 Recommended measures in case of accidental spillage
4.4 the recommended precautions when handling and storage
4.5 Procedures when disposing of the bioagens and the decontamination of packaging
5. analytical and diagnostic methods
5.1 analytical methods for determining the composition of the bioagens
5.2 Determination methods for determining the type of makroorganismu in bioagens
5.3 methods of determining the purity of bioagens and its standardnosti
6 data on biological activity
6.1 preliminary tests
6.2 Field, greenhouse, laboratory and field tests
6.3 the risk of reducing the effectiveness of
6.4 Effects on treated plants or plant products
6.5. Side effects on non-target organisms
4.1 Sensitivity of effective macro-organisms on the previous use of the
the plant protection product, used for the same crops, the time between the
the use of those preparations, in order to avoid the threat of active
macro-organisms.
7 bioagens Risk to human health
7.1 Risk when dealing with bioagens
7.2 proposals to minimise the risks to human health when dealing with
bioagens
7.3. the proposals to minimise the risk of the use of the bioagens in the areas of
used by the general public or by vulnerable groups
7.4 proposals for conservation and other time limits which must be respected for
the proposed use or pick plant product after use
bioagens
8 the behavior of bioagens in the environment
8.1 relationship of the type and quantity of macro-organisms to the environment for which it is
bioagens designed
8.2 the trade Proposals and other periods or other precautions to protect
livestock and the environment
9 ecotoxicological studies
9.1. Effects on aquatic organisms
9.2. Effects on beneficial and other non-target organisms, if their
exposure maybe
10 additional information-in particular
10.1. Information about the extent of authorisation and registration in other countries
10.2 information about restrictions on use of bioagens in other countries
10.3 for more information and suggestions
(B) Effective makroorganismus is characterized by the following
1 identification of the effective makroorganismu
1.1 particulars of the manufacturers:
and) business name and registered office, in the case of a legal person, or
(b)) the name or names, and last names, address of residence
or place of business, if it is not the same as the place of permanent residence, if it is
a natural person
1.2 the name of makroorganismu (the scientific name, the Czech name, synonym)
1.3 Reference indication of breeding makroorganismu and its place
1.4. Determination of the characters and other criteria for the identification of makroorganismu
2 biological properties of makroorganismu
2.1 the target harmful organism, the kind of antagonism to a malicious
the organism
2.2 existing knowledge about the use of the makroorganismu, its natural occurrence,
geographic distribution
2.3 Circuit possible hosts and effects on other species outside the target
harmful organism, makroorganismu outside the extension options
the use for which it is intended
2.4 relationship to climatic conditions, characteristics of the autekologická
the species, ecological valence
3 for more information about makroorganismu
3.1 Biological functions (in particular against insects, mites)
3.2 mechanism of action on harmful organisms
3.3 restriction of use
3.4 description of the production method of effective makroorganismu
3.5 risk of loss of biological activity of makroorganismu
3.6 best practices and measures for treatment of makroorganismem, its
storage and transport
4 Analytical and diagnostic methods
4.1 method of determining the identity, life and activities, makroorganismu
determination of the characters
5 makroorganismu Risk to human health
5.1 the risk when dealing with makroorganismem
5.2 Suggestions on minimizing the risk to human health when dealing with
makroorganismem
6 behavior of makroorganismu in the environment
6.1 the spread, mobility, multiplication and the ability of wintering in the conditions
The United States
7 ecotoxicological data
7.1. effects on non-target organisms, if their exposure maybe
(C)
Related papers
1 documents confirming the fulfillment of specific requirements pursuant to section 59 of the Act,
2 of the Declaration, in accordance with the model in annex 3 to this
Notice that the bioagens meets the specific requirements pursuant to section 59 of the Act.
3 proof of the consent of the first applicant for the registration of an additional resource to
the official registry, which is the holder of the registration, with the
using the information provided by him for the benefit of another applicant for entry in the
the official registry, if it is not itself the first applicant.
_______________
3) Eg. Act 350/2011 Coll., on chemical substances and chemical
mixtures and amending some laws (legislation) and the implementing
the regulations issued for its implementation.
Regulation of the European Parliament and of the Council (EC) No. 1272/2008 of 16 December.
December 2008 on classification, labelling and packaging of substances and mixtures, amending
and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No.
1907/2006, as amended.
Annex 3
Model of the certificate of compliance with the specific requirements
1) European Parliament and Council Regulation (EC) No 1107/2009 of 21 December.
October 2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC.
2) Article. 67 European Parliament and Council Regulation (EC) No 1107/2009 of the
on 21 February 2006. October 2009 concerning the placing of plant protection products on the market and on the
annulment of Council Directives 79/117/EEC and 91/414/EEC.
3) Act 242/2000 Coll., on organic farming and on the amendment of Act No.
368/1992 Coll., on administrative fees, as amended, in
as amended.
4) European Parliament and Council Regulation (EC) no 1272/2008 of 16 May.
December 2008 on classification, labelling and packaging of substances and mixtures, amending
and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No.
1907/2006, as amended.
5) for example, Act 258/2000 Coll., on the protection of public health and
changes to some related laws, as amended,
Decree 268/2000 Coll. on technical requirements for construction.
6) for example, Act 350/2011 Coll., on chemical substances and chemical
mixtures and amending some laws (legislation).
