120/2002 Sb.
LAW
of 8 March. March 2002
on the conditions of marketing of biocidal products and active substances on the market and on the
amending certain related laws
Change: 120/2002 Coll. (part)
Change: 120/2002 Coll. (part)
Change: 120/2002 Coll. (part), 186/2004 Sb.
Change: 120/2002 Coll. (part)
Change: 125/2005 Sb.
Change: 120/2002 Coll. (part), 297/2008 Coll.
Change: 136/2010 Sb.
Change: 342/2006.
Change: 375/2007 Sb.
Modified: 18/2012 Sb.
Parliament has passed the following Act of the United States:
PART THE FIRST
CONDITIONS FOR THE MARKETING OF BIOCIDAL PRODUCTS AND ACTIVE SUBSTANCES ON THE MARKET
TITLE I OF THE
BASIC PROVISIONS
§ 1
The subject of the edit
(1) this Act incorporates the relevant provisions of the European Union ^ 1)
at the same time follows the directly applicable European Union regulations ^ 1a) and
regulates the rights and obligations of legal entities and individuals-entrepreneurs
people and the scope of the administrative offices of the marketing of biocidal products and
active substances on the market in the Czech Republic, the conditions for the issuance of permits to
the placing of biocidal products on the market, the method of evaluating the effectiveness
biocidal products and active substances and their protection
on human health, animals, plants, on the health of animal feedingstuffs,
animal and plant products and the environment and conditions
use of biocidal products.
(2) this Act does not apply to pharmaceuticals, veterinary products,
medical devices, foods, additives are added to
food, food flavourings, additives intended
for animal feed, feed, materials and articles intended to come into contact with
food, cosmetic products and plant protection products.
(3) this Act does not affect specific legal provisions on technical
requirements for products and on chemical substances and chemical preparations.
The requirements for the classification, packaging and labelling of biocidal products
provided for in this law shall not apply to the carriage of biocidal products in
rail, road, air, inland waterway and maritime transport.
§ 2
Definition of basic terms
(1) the active substance is a chemical substance or micro-organism, including viruses
and fungi that their specific or general effect on harmful acts
organisms.
(2) the biocidal product the active substance or preparation containing
one or more active substances, in the form in which they are supplied
the user, intended to control, repulsion, disposal, prevention effect
or to achieve a different effect on any harmful
the organism by chemical or biological means; list of types of biocidal
products with a brief description of each type is given in the annex to this
the law.
(3) the harmful organism is any organism that has an adverse
effect on humans or whose presence is unwanted, adversely
affects the activity of people or objects which they use or produce, or
adversely affects other living organisms, or the environment;
When the use of biocidal products is the target harmful organism
the organism.
(4) the low-risk biocidal product is a product, which
does not contain any substance and as active substance contains only
substances listed in the list of active substances with low risk; This
the medicine must, under the conditions of its use constitute only a low risk of
for the health of humans, animals, plants, health of animal feedingstuffs,
animal and plant products and of the environment.
(5) a substance is any substance that can its dangerous
characteristics of ^ 2) adversely affect the health of humans, animals, plants,
health of animal feedingstuffs, animal and plant products, and
the environment, with the exception of the active substance, and is present or is produced in the
the biocidal product at a concentration such that the entire product is
^ 3) classified as dangerous.
(6) basic substance is a substance, which the European Commission (hereinafter referred to as
"The Commission") shall be included in the list of basic substances as part of the regulation
Of the European Union concerning the placing of biocidal products on the market ^ 3a) which is not
substance and is not placed on the market for biocidal purpose primarily
referred to in § 2 (2). 2, but which may be used for this purpose either
directly or in a product containing the substance and a simple diluent.
(7) the frame formulation is the composition of the biocidal products
have the same use and the same user category; biocidal products
with the same frame formulation must contain the same active substances
identical properties and their composition may exhibit only such derogations
from the composition of authorised biocidal product from this group, which
do not reduce the efficacy of the biocidal product, and do not increase the risks related
with the presence of each of the components; deviation from the composition of the authorised
the biocidal product may include just such a reduction of the percentage
the content of the active substance, change the percentage composition of one or more
other than the active substance or replacement of one or several pigments,
colourings or aromatic substances, other substances that represent the same
or a lower risk, and do not reduce the efficacy of the biocidal product.
(8) the Residue is the rest of the one or more of the substances contained in biocidal
the product, including products of metabolism and degradation or
the reactions of these compounds, which remains after use of the biocidal product
for example, in soil, air, water, animal body fluids and tissues
or a human, food and feed, where the presence of these substances is not
desirable.
(9) for the purposes of this Act, import means a release of the biocidal
the product or active substance under the customs procedure of free circulation, or
inward processing with duty drawback.
(10) the indication of the biocidal product or active substance on the market, each
their surrender in return for payment or free, or subsequent storage other
than storage followed by consignment from the customs territory of the European
Union or for destruction. For the placing on the market also means imports
of the biocidal product or active substance.
TITLE II
THE PLACING OF THE BIOCIDAL PRODUCT, THE BASE AND THE ACTIVE SUBSTANCE ON THE MARKET AND
THE USE OF THE BIOCIDAL PRODUCT
§ 3
The basic conditions for the placing on the market and use of
(1) the active substance intended for use in a biocidal product may indicate
on the market of the legal person or the entrepreneurial natural persons under the conditions
laid down in section 8, and biocide such persons may place on the market
on the basis of the authorization of the Ministry of health (hereinafter referred to as
"the Ministry"), unless this Act provides otherwise.
(2) biocidal products may contain only active substances listed in
list of active substances and in the list of active substances with a low risk and
only the basic substance, while complying with all requirements.
For the fulfilment of specific conditions for authorisation and use of biocidal products
products and low-risk biocidal products containing the
the active substance is equivalent to a legal entity or individual entrepreneur,
that States the biocidal product on the market, with the exception of compliance with specific
conditions imposed by the holder of an authorization issued pursuant to section 7, for which
This corresponds to the holder, and the specific conditions that apply to
the use of the biocidal product, which conforms to the person referred to in section 3a
paragraph. 2. the list of active substances, list of active substances with a low risk of
and specific conditions for authorisation and use of biocidal products and
low-risk biocidal products containing the active substance
the Ministry shall determine by Decree.
(3) the legal person or the entrepreneurial natural persons that take
a biocidal product shall submit to the Customs Office of transit
the Declaration and the decision of the Ministry of the authorisation for placing the biocidal
product on the market or a written declaration of the importer that the biocidal product
It is designed exclusively for the needs of scientific research and development or for the
evaluation purposes.
(4) the provisions of paragraphs 1 and 2 shall not apply to biocidal products and
active substance intended exclusively for the needs of scientific research and development and
for testing purposes.
section 3a
(1) a legal entity or individual entrepreneur shall not use
a biocidal product which has not been notified under section 35, or allowed to
placing on the market, if not stipulated otherwise.
(2) the use of the biocidal product must a legal person or
nonentrepreneurial natural person-entrepreneur or comply with the information and instructions
listed on the packaging, label or package insert or warning
symbols, standard phrases indicating the special risks, or
standard instructions for safe handling of the chemical law
substances and chemical preparations ^ 3b), and specific conditions for the
the use of the biocidal product, modified by Decree. The biocidal product
may be the person referred to in the first sentence used in a strictly necessary extent.
section 3b
A legal entity or individual entrepreneur may without notification in accordance with
§ 35 or without the authorisation of the placing on the market for biocidal use or use
for these purposes, the basic substance or a biocidal product containing only
such basic substances.
Application for authorisation for placing on the market of a biocidal product
§ 4
(1) an application for authorisation for placing on the market of a biocidal product serves
the Ministry of the legal person that has its registered office, company or its
organizational folder ^ 4) on the territory of the Czech Republic, or doing business
a natural person who has a place of business in the territory of the Czech Republic (hereinafter referred to
"the applicant") prior to the placing on the market for the first time, or the first use,
If the biocidal product is intended to be placed on the market. The request must be
submitted in 1 original in paper form and in 4 copies to the
electronic data carriers and formats using a special set of
programmes according to the directly applicable European Union legislation on the programme
review active substances of biocidal products ^ 4a). Included in the request
the completed form is generated from the register for biocidal products
established by Commission decision No 2010/296/EU ^ 23) and bearing the signature of the
of the statutory representative of the applicant.
(2) the request referred to in paragraph 1 must, to the extent specified by Decree
ministries include
and) next to the requirements under the administrative code and the requirements of the
the specific conditions laid down by Decree, the data to identify
the manufacturer of the biocidal product and the active substance manufacturer and address space
production,
(b)) detailed quantitative and qualitative composition of the biocidal product,
(c)) the safety data sheet of the biocidal product, set up on the right
applicable European Union legislation on chemical substances and chemical
preparations ^ 5), if his development this directly applicable provision
The European Union imposes.
(3) an application for authorisation for placing the biocidal product on the market, with the exception of
low-risk biocidal product or a biocidal product with
frame-formulation, shall contain the information referred to in paragraph 2 and in
the scope of the Decree of the Ministry of these basic data on
active substances and the biocidal product: the name, identifying information,
physical, chemical and technical or biological properties, the type of
of the biocidal product, the analytical methods for the determination of the active substance,
toxicological and ecotoxicological data, effectiveness against target organisms and
recommended use, category of users, measures necessary for the protection of
humans, animals, plants, the environment, the health of the
feed, animal and plant products, the way of disposal of the waste,
the classification, packaging, labelling, the residues of active substances, the effects on the
non-target organisms, summary and evaluation of data.
(4) an application for authorization to place a low-risk biocidal product
or formulation of a biocidal product on the market must contain
the information referred to in paragraph 2 and to the extent provided for by Decree
the Ministry of basic information concerning the biocidal product: the name, the identification
details, physical and chemical properties, the type of biocidal product and
area of use, user categories, method of use, efficiency,
the analytical methods, the method of disposal of the waste, the classification, packaging and
the designation.
(5) the Ministry shall invite the applicant to submit in the case of an application referred to in
paragraph 3 in addition to the basic data on the active substance and the biocidal product
and supplementary physico-chemical, toxicological and ecotoxicological data
modified by Decree of the Ministry or some of them, if it is
needed for the assessment of the biocidal product with regard to the nature
active substances of a biocidal product type, method of use and the expected
exposure of humans, animals, plants, animal feed, animal and plant
products and the environment.
(6) data on the properties of the active substances and biocidal products
submitted pursuant to paragraphs 3, 4 and 5 must be accompanied by protocols with
a detailed and full description of the tests carried out and of the methods used or
literary references to these methods, together with a copy of the text of these methods.
These documents may be submitted in the English language. Active tests
substances and biocidal products must be made to set out the methods of ^ 6)
and under the conditions of compliance with good laboratory practice. ^ 7) use of other than
the methods must be laid down in the Protocol must entail a justified. The Ministry may
require that the information referred to in the request were added, if they are not
sufficient to perform the evaluation of the effectiveness and the properties of the biocidal
of the product in accordance with § 6.
(7) an application for authorisation for placing the biocidal product on the market may
the Ministry also natural person authorized to do business or legal
a person who has a domicile or permanent residence permit, residence, place of
business, Central Administration, principal place of business
or organizational folder in the territory of another Member State of the European Union
(hereinafter referred to as "Member State").
§ 5
(1) the Ministry may require that the applicant provide, free of charge
a sample of the active substance or biocidal product in quantities necessary for
carrying out the examinations, as well as a sample of the packaging, label or enclosed
the flyer ^ 3b).
(2) before submitting an application for marketing authorisation of a biocidal product on the
the market, which requires testing on vertebrate animals, the applicant
shall inform the Department of, whether the biocidal product for which intends to bring
the request is not similar to a biocidal product already authorised and which is
name and address of the holder or holders of the authorisation. At the same time shall submit to the
a written declaration that it intends to apply for authorisation for placing the biocidal
product on the market in their own interest, and that is available to other
the information needed to submit a request. The Ministry shall provide the applicant
the information requested and the time inform the holders of the authorisations and invite them to
mutual cooperation in order to prevent repeated toxicological
testing on vertebrate animals.
(3) in the case of a biocidal product that is similar to the product already
permitted under section 7 and whose active ingredients are the same, including the degree
of purity and the nature of impurities, may accept the request of the Department in which the
the second and subsequent applicant replaces the information required pursuant to section 4, paragraph 4. 3, 4
or (5) a certified written consent with the use by the first applicant
the submitted data for the purpose of issue of the permit a second or further
to the applicant.
(4) if some of the information required under section 4, paragraph 4. 3, 4 or 5 are not
necessary with regard to the nature of the biocidal product or of its proposed
use or is not technically possible or not from a scientific
point of view, the applicant is required to provide these facts justify in
application submitted.
(5) the Ministry shall keep for a period of 15 years of application for authorisation for placing
of the biocidal product on the market, including the submitted data and other
of documents. These documents shall make available on request to the Commission and to the competent
authorities of the other Member States.
§ 6
Evaluation of the documentation of the biocidal product
(1) the Ministry, Ministry of environment and the Ministry of
Agriculture will ensure the evaluation of the data contained in the request submitted by the
pursuant to section 4 (hereinafter referred to as "documentation of the biocidal product").
(2) the evaluation of the dossier includes an assessment of the biocidal product
completeness and further evaluation of the data contained within it from the point of view of efficiency
the biocidal product on the target organisms, its effects on man,
animals, plants and the environment, as well as in terms of the measures
necessary for the protection of human, animal, plant, health certificate
feed, animal and vegetable products and environmental protection
as a whole, in conditions of normal use of the biocidal product and in
the conditions of real at least favourable conditions of preparation, use,
storage and disposal of the biocidal product and material by
treated.
(3) the Ministry, Ministry of environment and the Ministry of
Agriculture in the implementation of the evaluation and adoption of decisions on
the biocidal product shall be considered and the reasons of the applicant for
failure to provide certain data pursuant to § 5 para. 4.
(4) the Ministry shall determine the procedure and detailed specification of policy evaluation
documentation of biocidal products and active substances by Decree.
§ 7
Authorisation for placing on the market of a biocidal product
(1) the Ministry shall authorise the placing of the biocidal product on the market in
the case that
and) the active substances contained in it are listed in the list of active substances
or a list of low-risk active substances laid down by Decree, and
the requirements and specific conditions set forth therein,
(b)) is established on the basis of the latest scientific and technical knowledge
and it is clear from the evaluation of the documentation submitted to the biocidal product
pursuant to section 4, paragraph 4. 3, 4 or 5, that having regard to the normal conditions of use
of the biocidal product, usual terms of use with the treated
the material, the consequences of the use of the biocidal product and the possibilities of its
disposal of the biocidal product,
1. is sufficiently effective,
2. the recommended use not on target organisms
unacceptable effects such as resistance or cross-resistance or
unnecessary suffering and pain for vertebrates,
3. When does not have a recommended use, directly or indirectly, for example,
through drinking water, food or feed, indoor air or
consequences on the working environment, unacceptable effects itself or its
residues on the health of humans or animals,
4. does not have, with regard to its transformation and distribution in the environment,
unacceptable effects itself or its residues, on the environment, in particular
the contamination of surface waters, groundwater and drinking water,
(c)) it is possible to analytically determine according to the documentation of the biocidal product
the nature and quantity of its active substances and, if necessary, all
toxicologically or ecotoxicologically significant impurities and additives, and
their residues important in terms of the effect on humans, animals,
plants, health of animal feedingstuffs, animal and plant
products and the environment which are a result of authorised use
d) test results, physical and chemical properties of the biocidal
the product shall be deemed acceptable for the purposes of the permitted uses,
storage and transport.
(2) the Ministry shall lay down in the permit referred to in paragraph 1, the conditions for
the placing of the biocidal product on the market.
(3) the biocidal product classified according to special legal
regulations ^ 3) as highly toxic, toxic, carcinogen category 1 or
2, category 1 or 2 mutagen or toxic for reproduction
category 1 or 2 does not allow for the sale or use of
to the consumer.
(4) in cases where the directly applicable European Union regulation or
the specific conditions of the modified decree imposing the conditions for granting
authorisation of the biocidal product and for use of the biocidal product,
especially where these terms and conditions to protect the health of distributors,
users, employees and consumers, animals or the environment,
the Ministry shall authorise the placing on the market of a biocidal product, provided
compliance with these requirements.
(5) before issuing a decision on the authorisation for the placing of the biocidal product
on the market, the Ministry's requests a binding opinion of the Ministry of the
environment for the evaluation of dossiers of the biocidal product in the scope of § 6
paragraph. 2 in terms of protection of the environment and binding opinion
The Ministry of agriculture within the scope of § 6 (1). 2 in terms of efficiency for
veterinary purposes, protection of farm animals and plants and health
safety of animal feed, animal and vegetable products.
(6) the Ministry shall issue a decision on the authorisation for placing the biocidal
product on the market to 360 days and in the case of a biocidal product with low
risk or biocidal product complying with the requirements of the framework
the composition within 60 days from the date of initiation of the proceeding. The Ministry of the
the environment and the Ministry of agriculture shall send the Ministry of their views
the opinion referred to in paragraph 5, no later than 90 days and in the case of the biocidal
preparation of low-risk biocidal product or a qualifying
the requirements for a frame-formulation in 30 days after the receipt of the request from the
of the Ministry.
(7) the decision on authorisation for placing on the market of a biocidal product,
be issued for a maximum period of validity until the end of the inclusion of some of the effective
substances of a biocidal product in the list of active substances or a list of
the low-risk active substances laid down by Decree. The period of validity
However, shall not exceed a period of 10 years from first or renewed inclusion of the
active substances to the list of active substances or a list of active substances with
low-risk set out by decree for the type of biocidal product.
The decision on authorisation for placing on the market of a biocidal product can be
restored in compliance with the provisions of the first and second sentence of this paragraph and
After you verify that the conditions referred to in paragraphs 1 and 3 are fulfilled.
Restored the decision on authorisation for placing the biocidal
product on the market may, where appropriate, be restricted to the period,
that it is necessary that the Ministry should have the option of such verification
to do this.
(8) in parallel with the authorisation of the biocidal product, the Ministry provides
conceptual composition, if the applicant so requests; It may do so in the
If necessary, ex officio.
(9) the Ministry keeps records and notified to the authorised biocidal
products and publishes on an ongoing basis in electronic form on your
the Internet address, and at least once per calendar year, in the journal of the
The Ministry of health a list containing designations permit holders
and the people that have made the notification under section 35, the types and names of the biocidal
the names of the products and the active substances.
(10) the holder of the authorisation for placing the biocidal product on the market shall be obliged to
notify the Department of new information that could affect other duration
authorisation, soon as known; in particular, the following details
for the active substance or a biocidal product containing
substance:
and new insights into the effects) of the active substance or biocidal product on
humans, animals, plants, animal feed, animal and vegetable products or
on the environment,
(b)) change of manufacturer of the active substance,
(c) a change in the composition of the active substance),
(d)) change in the composition of the biocidal product
e) change the content and the type of impurity or co-Formulants
f) changing values of residues,
(g) the emergence of resistance in the target organism), or
Another significant change in), for example, the type of packaging.
(11) the Ministry shall immediately notify the other Member States and the Commission
the information referred to in paragraph 10.
§ 8
the title launched
A legal entity or individual entrepreneur may be placed on the market
active substance intended for use in a biocidal product which has not been
placed on the market before the date of 14. in May 2000, after the release of the consent to
by sending a summary to the active substance dossier to the competent authorities
the other Member States and the Commission thereof, issued by the Ministry or
the competent authority of another Member State. Consent under the first sentence is issued by
the Ministry pursuant to § 12 para. 2 on the basis of the proposal in accordance with § 12 para. 1 and
the attached written declaration that the active substance is intended for use in
the biocidal product. An active substance for use in biocidal
the product, which have been placed on the market before the date of 14. in May 2000, after
This date, the placing on the market subject to the conditions fixed by directly applicable
European Union regulations ^ 1a).
§ 9
Temporary authorisation for placing on the market of a biocidal product
(1) the Ministry of ex officio or at the request of the applicant enables to bring
on the market of a biocidal product which does not meet the requirements of this Act, the
a period not exceeding 120 days, if such a measure appears
necessary as a result of an unforeseen danger which cannot be
contained by other means. In the permit, the Ministry shall determine the conditions
the use of the biocidal product. With these conditions, the holder
the authorization shall be obliged to demonstrably meet the legal entity or business
a natural person, that the biocidal product shall be taken from him, and those persons
they are required to do in accordance with the facts on which they were
familiar.
(2) the Ministry shall authorise, at the request of the applicant temporarily to the placing on the market
a biocidal product containing an active substance not included in the list of
active substances or a list of active substances with low-risk set out
the Decree, which was not on the market on 14 January 1998. May 2000 to another use
than for research and development under Title IV, if
and based on the evaluation of the dossier) to the active substance, submitted pursuant to §
12 the applicant concludes that the active substance complies with the principles of
marshaling the substance to the list under section 13,
(b)) it can be expected that the biocidal product complies with the conditions laid down in §
7 (2). 1 (b). b) to (d)),
(c)), no other Member State on the basis of the summary sent under section 12
paragraph. 2 does not object to the completeness of the dossier for the active substance or
the case referred to in paragraph 3, the Commission issued a decision, according to which the
dossier is complete.
This authorization is valid until the date of inclusion of the active substances to a list
in the list of active substances or a list of active substances with
low-risk set out by Decree, but no longer than 3 years from the date of its
of enforceability. In the case of an active substance is not after this time
included in the list provided for in the list of active substances or a list
the low-risk active substances laid down by Decree, may be
at the request of the holder of the permit extended by a further year.
(3) if other Member States in the proceedings referred to in paragraph 2 shall apply to the
the completeness of the documentation to the active substance, the Department shall suspend the
the time of the decision of the Commission. If the Commission decides that the documentation is not
complete, the Ministry will invite the applicant to supplement the documentation.
(4) before issuing a decision on the authorisation for the placing of the biocidal product
on the market in accordance with paragraph 1 or 2, the Ministry will seek the binding
opinion pursuant to § 7 para. 5. The Ministry shall authorise the biocidal product
in accordance with paragraph 2, within the time limits referred to in § 7 para. 6.
(5) the authorisation for the placing of the biocidal product on the market referred to in paragraph 1
or 2 shall inform the Ministry without undue delay to the other Member
States and the Commission, together with a justification of acceptance; Similarly,
the Ministry proceeds in the case of renewal of the authorization. If
the Commission's decision, on the basis of which the Ministry is obliged to
authorisation issued under paragraph 1 or 2, change or cancel
the Ministry ex officio, amend or revoke the permit issued in accordance with the
the conditions laid down in the Commission decision.
(6) the request referred to in paragraph 1 or 2 may submit a Ministry and the person
referred to in section 4, paragraph 4. 7.
§ 10
Mutual recognition of authorisations for the placing on the market of a biocidal product
(1) placing on the market of a biocidal product which has been authorized or
^ 8) registered in a Member State shall authorise the Ministry on the basis of
request of the applicant or a person referred to in section 4, paragraph 4. 7 before his
the first placing on the market, to 120 days in the case of a biocidal product with
low risk within 60 days from the date on which the Ministry of the request
submitted, provided that the active substance of the biocidal product are
listed in the list of active substances or a list of active substances with a low
risk laid down by Decree and the requirements listed there.
The Ministry shall determine the conditions in the permit, to which it is bound by the placing
of the biocidal product on the market in another Member State.
(2) an application under paragraph 1 shall include a certified translation of the first
authorisation for placing on the market of a biocidal product issued in another
Member State into the Czech language, the information referred to in section 4, paragraph 4. 2, and a summary of the
and evaluation of the information referred to in section 4, paragraph 4. 3; in the case of the biocidal
of the product with a low risk of data referred to in section 4, paragraph 4. 4 with the exception of data
on the efficacy of the biocidal product, where is sufficient summary.
(3) if the Department determines that the conditions of use, such as climate
or conditions of reproduction of the target organism, differ substantially in
The Czech Republic from those in the Member State where the biocidal
the product was first authorised, or resistance of the target is demonstrated
of the organism to the biocidal product, and it intends to modify the conditions set out in
section 20 (2). 1 (b). (e)), f), (g)), i), and (b).) l) (2), it shall suspend the
on the application and inform its intention and the reasons for the other Member
States, the Commission and the person referred to in paragraph 1. Furthermore, the Ministry of
shall act in accordance with the decision of the competent authority of the European Union.
(4) in the event that the Ministry on the basis of examination of the application submitted by the
referred to in paragraph 1 comes to the conclusion that the biocidal product does not meet the
the requirements of section 7 (2). 1, and as a result, intends to permit the placing on the
the market to limit or refuse, interrupts the proceedings on the application and inform the
the other Member States, the Commission and the person referred to in paragraph 1. At the same time
sending them a justification of his opinion, the name of the biocidal product and
its specification. Furthermore, the Ministry shall act in accordance with the decision of
the competent authority of the European Union.
(5) in the event that the Ministry on the basis of examination of the application submitted by the
referred to in paragraph 1 comes to the conclusion that the biocidal product with low
risk does not conform to the provisions of § 2 (2). 4, a biocidal product shall not authorize the
and he will discuss this fact with the competent authority of the Member State which
biocidal product as the first. If it will not be achieved within 90
days of compliance, the Ministry shall transmit to the Commission the resulting conflict. If the competent
body of the European Union decides that the biocidal product conforms to the provisions of
§ 2 (2). 4, the Ministry shall authorise the biocidal product.
(6) the Ministry may not comply with the request referred to in paragraph 1 in the case of
biocidal product types 15, 17 and 23 referred to in the annex to this
the law. Their opinion together with reasons shall communicate to the other Member
States and the Commission.
(7) before a decision on authorisation for placing the biocidal product
on the market referred to in paragraph 1 or the opening of the procedure under paragraphs 3 to 6 of the
the Ministry will require binding opinions pursuant to § 7 para. 5. the Ministry of
the environment and the Ministry of agriculture shall inform their
binding opinions to the Ministry within 60 days and in the case of the biocidal
low-risk product within 30 days after receipt of the request.
§ 11
Amendment and revocation of authorisations for the placing on the market of a biocidal product
(1) the Ministry may permit the placing on the market of a biocidal product
change
a) on the basis of data reported under section 7 (2). 10,
(b)) with regard to the new knowledge in science and technology or new requirements on
protection of the health of humans, animals, plants, animal feed, animal and plant
the products and the protection of the environment, or
(c)) at the request of the authorisation holder, if the request shall state the reasons for the modification,
and even after the change will be subject to the conditions provided for in § 7 para. 1 and 3.
(2) if the change of authorisation for placing on the market of a biocidal product
modifies the range of use of the biocidal product, this must be a change in the
accordance with the specific terms and conditions for the active substance referred to in the
list of active substances or a list of active substances with a low risk of
laid down by Decree.
(3) if the amendment of an authorisation for the placing on the market of a biocidal product
It includes a change to the specific conditions for the active substance referred to in the
lists the modified Decree, may make such an amendment of an authorisation
only after the new evaluation of the active substance in accordance with § 12.
(4) the Ministry authorisation for placing on the market of a biocidal product shall cancel,
If
and the active substance) has been retired from the list of active substances or a list
the low-risk active substances laid down by decree or no longer
requirements or specific conditions set forth therein,
(b)) is not complied with any of the conditions referred to in § 7 para. 1 (b). (b)) to
(d)),
(c)) is determined that the submitted false or misleading information
concerning the facts on the basis of the authorisation of the biocidal
the product has been granted, or
(d)) on request to the holder of the authorisation.
(5) the revocation of the authorisation for the placing of the biocidal product on the market shall establish
the Ministry ex officio holder of the authorization period for the disposal,
storage, sale or use of existing stocks of biocidal
of the product. Similarly at the end of the validity of the residence permit
the placing of the biocidal product on the market, if the holder of the authorisation
so requests. With the cancellation of a permit or it expires, as well as the
deadlines for the disposal, storage, sale and use of existing
inventory is the holder of the authorisation of a biocidal product shall demonstrably
meet the legal entity or natural person-entrepreneur from him
the biocidal product shall be taken, and these persons are obliged to proceed in
accordance with the facts with which they were familiar.
(6) the Ministry may demand that he submit the permit holder
information necessary for the procedure under paragraph 1 or 4. In the case of
the needs of the Ministry, at the request of the authorisation holder to extend the
authorisation for the period necessary for its review; However, from the
ex officio, extend the validity of the authorisation for the period necessary for the
the provision of information in the first sentence.
(7) before a decision on the amendment or revocation of an authorisation to place the product
of the biocidal product on the market referred to in paragraph 1 or 4 of the Department's
requests a binding opinion pursuant to § 7 para. 5. The Ministry of the
the environment and the Ministry of agriculture shall inform their binding
the opinion of the Ministry within 30 days after receipt of the request. The Ministry of
shall issue a decision within 30 days from the date of delivery of binding opinions
the institutions concerned.
(8) the amendment or repeal of the authorisation for placing on the market of a biocidal product
the Ministry shall inform the Commission and the other Member States thereof, giving substantiated reasons.
TITLE III
MARSHAL OF THE ACTIVE SUBSTANCE TO A LIST
§ 12
How to marshal the active substances to a list
(1) on the basis of current scientific and technical knowledge, an active
substances shall be classified in the list of active substances, list of active substances with
list of low-risk and basic substances that are part of the laws of the
Of the European Union concerning the placing of biocidal products on the market, ^ 9). The proposal for the
the inclusion of the active substance in these lists is given to the Ministry.
The applicant, who shall submit to the Ministry a proposal according to the second sentence, it shall
the Ministry at the same time a request for consent from the Ministry of sending summary
the information referred to in subparagraphs a) and b) to the competent authorities of other Member States
and the Commission. The proposal in the first sentence is served in 1 original in the documentary
form and in 4 copies on electronic data carriers in the formats
and with the use of special programs according to the directly applicable legislation
The European Union on the review programme for biocidal active substances
preparations ^ 4a). For particulars of the proposal applies to section 4, paragraph 4. 2 Accordingly; further
the proposal must to the extent modified by the Decree of the Ministry include
and) basic and supplementary information on the active substance,
b) basic and supplementary details of at least one biocidal product,
containing the active substance, whose inclusion in the list, the applicant asks the
(hereinafter referred to as "active substance").
(2) the Ministry, Ministry of environment and the Ministry of
Agriculture will ensure the completeness of the documentation of the assessment of the active substance.
If the dossier is complete, the Ministry shall issue the applicant within 90 days
consent by sending a summary to the active substance dossier by the competent
authorities of the other Member States and the Commission and at the same time asks the applicant to the
submission of the proposal on the evaluation of the dossier for the active substance for the purposes of
the inclusion of the active substance to the list of active substances, list of active substances
low-risk or a list of basic substances.
(3) if the applicant shall submit to the Ministry a proposal for the evaluation of the dossier to the
the active substance referred to in paragraph 2, second sentence, Ministry, Ministry of
the environment and the Ministry of agriculture shall ensure the evaluation of the
aspects and according to the principles laid down in § 6 (1). 2 to 4 with the fact that the
the basis of the General evaluation of this documentation, the Ministry shall draw up
the final report within 12 months from the date of receipt of the proposal.
(4) the Ministry interrupts the reviews referred to in paragraph 3 and shall invite the applicant
to provide additional information, if it finds that the evaluation of the dossier to the
the active substance cannot be complete without this information. The time from the interruption of the
reviews to the receipt of the required information in the 12-month period
pursuant to paragraph 3 shall not be counted. The reasons for discontinuation of the trial
the Ministry shall inform the other Member States and the Commission.
(5) the Ministry will send a final report to the applicant, the other Member
States and the Commission, together with a proposal on the inclusion or non inclusion of the active
substances in the lists referred to in paragraph 1; in the drafting of the final report
advancing Ministry according to the principles laid down in section 13. With the decision
The Commission on the inclusion or non-inclusion of the active substance in the list of active
substances, list of active substances with a low risk or a list of base
substances, the Ministry of the applicant. get acquainted
(6) after the issue of the consent in accordance with paragraph 2 may request the Department
The Commission that reviews documentation to the active substance made by another Member
State. With the decision of the Commission, of the Member State dossier
the active substance of the applicant's Department, performs.
(7) the application for inclusion of an active substance to the list of active substances, list of
the low-risk active substances or a list of basic substances can
submit to the Ministry and the person referred to in section 4, paragraph 4. 7.
(8) the inclusion of active substances in the list of active substances, list of
the low-risk active substances or a list of basic substances in the framework of the
the programme of work for the systematic examination of the active substances,
follow the directly applicable European Union legislation ^ 1a).
(9) the Ministry adjusted by Decree the detailed specification of the data
concerning the identification of the active substance, organism and the preparation with
giving the common name, chemical name or taxonomic name and strain,
physical, chemical, technical and biological properties,
analytical methods for the detection and identification of the effectiveness and the intended
use, toxicological and metabolic studies, ecotoxicological
the data, of the measures necessary to protect humans, animals, plants and
the environment, residues of active substances, the effects on the target
organisms, classification, labelling, and rating summary.
(10) for the management of the proposal to amend the inclusion of the active substances to a list
active substances, list of active substances with a low risk or list
basic substances or prolongation of this classification applies to paragraph 1 to 9
by analogy.
section 13 of the
The principle of active substances to the list of spool
(1) the Ministry on the basis of current scientific and technical knowledge
the Commission will propose the inclusion of the active substance to the list of active substances, list of
the low-risk active substances or a list of basic substances for the period
not exceeding 10 years, if it can be assumed that biocidal products,
where the active substance is contained, meets the requirements of section 7 (2). 1 (b). (b))
to (d)). In doing so, shall take into account any cumulative effects when
the use of biocidal products containing the same active substance.
(2) the Ministry may proposal on the inclusion of the active substance in the list referred to in
paragraph 1, subject to
and on request) a minimum degree of purity of the active substance,
(b) the definition of the maximum content of certain) impurities,
(c)) by specifying the type of the biocidal product, in which the active substance may
to use,
d) specifying how and area of use,
(e) defining the categories of users), for example, industrial, professional,
unprofessional,
f) by determining the acceptable levels of exposure in the work environment,
(g)) and by establishing an acceptable daily intake, maximum residue limit
(h)) by setting the data transformations and behaviour of the active substance in the
environment and the impact on animals, plants, health of animal feedingstuffs,
animal and vegetable products,
I) by fixing other special conditions that resulted from the evaluation
the documentation submitted.
(3) the Ministry shall propose to the Commission not to include into the list of active substances with
such low-risk active substance, which is under a special
the law on chemical substances and chemical preparations ^ 3b)
carcinogenic, mutagenic, toxic for reproduction or sensitising
or has the ability to accumulate in the environment and is not easily
biodegradable.
(4) the Ministry shall propose to the Commission, the inclusion of the active substance in the list referred to
paragraph 1 only for biocidal product types referred to in the annex to this
the law, which was submitted to the documentation referred to in § 12 para. 1 (b).
(b)). The proposal for the inclusion of the active substance to the list of active substances with a low
the risk may be subject to a range of concentrations, which may only be
to use.
(5) the Ministry may propose to the Commission repeatedly to make classification effective
the substance in the list referred to in paragraph 1 after the expiry of 10 years was renewed,
but no longer than for a period of the next 10 years. If the Ministry gets
the knowledge that one of the conditions referred to in paragraph 1 or 3 is not
complied with, the Commission may propose a review of the inclusion of the active substance in
the list.
(6) the Ministry may propose to the Commission that the inclusion of the active substance in
list of active substances, list of active substances with a low risk or
list of basic substances, or extend the period of enlistment was rejected
or inclusion in the list was cancelled, if
and) the assessment carried out pursuant to § 12 para. 3 shows that under normal
conditions of use of the biocidal product containing that active substance
This could cause danger to human, animal, plant, health
feed safety, animal or plant products or the environment
environment, or
(b)) in the list of active substances or a list of active substances with a low
risk is another effective substance for the same type of the biocidal
of the product (hereinafter referred to as "alternative substance"), which represents a substantially
less risk to humans, animals, plants, health safety
feed the animal or plant products or the environment.
(7) prior to the filing of the application referred to in paragraph 6, the Ministry shall ensure that an assessment of the
alternative substances that can be used with similar effect on the
the target organism without significant economic and application of drawbacks for
the user and without increasing the risks for health or for the environment.
This assessment shall send the Ministry of the other Member States and the Commission.
(8) the application of the procedure referred to in paragraphs 6 and 7 shall be complied with
the following terms and conditions:
and diversity will be maintained) active substances, so that the occurrence of resistance
the target organism was minimal,
(b)) this procedure will be applied only to active substances contained in the
biocidal products of the same type,
(c)) the vulnerability to humans, animals or the environment will be at the
the active substance of decommissioned or declined significantly higher under normal
conditions of use,
(d)) will be able to obtain knowledge of the practical application, if such a
the findings are not available.
TITLE IV
SCIENTIFIC RESEARCH AND DEVELOPMENT
§ 14
(1) for the purposes of research or development, including applied research or
development and for carrying out the tests necessary for submission of the application referred to in paragraph 4 of the
or § 9 para. 1 or a proposal under section 12 may be placed on the market of biocidal
medicine without permission and without completion of the active substance
the requirements referred to in section 8.
(2) a legal person or entrepreneurial natural persons conducting research,
development or testing required for an application under section 4 or § 9 para.
1 or for the submission of an application pursuant to section 12 shall at all times
experimentation lead and for a period of 15 years from the end of attempts to keep
records of the biocidal product or active substance, which contain
and) identification of the biocidal product and the active substances,
(b)), labelling data, quantities supplied, names, family names,
permanent residence and place of business of self-employed individuals or
names or commercial companies and the headquarters of the legal entities, which
biocidal product or active substance received,
c) all available data on possible effects on human health,
animals, plants, animal feed, animal and plant products and the
environment.
(3) the records referred to in paragraph 2 shall be submitted to the Ministry, if
of the latter.
(4) the legal person or the entrepreneurial natural persons carrying out
applied research or development are required to report to the Ministry of information
referred to in paragraph 2 (a). a) to (c)) prior to the placing of the active substance or
of the biocidal product on the market. These persons are also required to report
the Ministry of their applied research or development.
(5) in the event that when performing experiments or tests may cause
the leak of the biocidal product or active substance in the environment, it is
a legal entity or individual entrepreneur before starting,
shall apply to the Department for authorization of such experiments or tests; in
the application is required to include the information necessary for the assessment of experiments or tests
and the establishment of conditions that limit the negative impact on the
environment to acceptable levels.
(6) the Ministry may carried out experiments and tests of its own motion to prohibit
or lay down restrictive conditions for them, if it finds that the
the implementation might endanger the health of humans, animals, plants, health
feed safety, animal or plant products or the
environment.
(7) prior to issuing a decision on the authorisation of experiments or tests referred to in paragraph
5 and the release of the decision referred to in paragraph 6 requests the Ministry's binding
opinion pursuant to § 7 para. 5. the Ministry of the environment and
The Ministry of agriculture shall inform their binding opinions
the Ministry within 30 days after receipt of the request. The Ministry will issue a
decision within 30 days from the date of delivery of binding opinions of the concerned
authorities.
TITLE V OF THE
DATA PROTECTION
§ 15
Protection of the data of the applicant
(1) the applicant under sections 4, 9, 10 or 12, as well as the person responsible for placing on the market
of an active substance according to § 8, in the documentation to be submitted
the Ministry indicate the information that should not be disclosed to third parties
(hereinafter referred to as "confidential information"), and to submit a request on this matter, with a detailed
justification. On the request shall be decided by the Ministry. The Ministry always meet
a request that relates to data on the complete composition of the biocidal product.
(2) referred to in paragraph 1 cannot be marked
and) the data referred to in section 4, paragraph 4. 2 (a). and) and (b)),
(b)) names and the concentration of active substance in the biocidal product and the name of the
of the biocidal product,
(c)) the names of the substances contained in the biocidal product, which are
dangerous ^ 2) and contribute to the classification of the biocidal product,
d) physical and chemical data concerning the biocidal product or active substance,
e) methods of disposal of the biocidal product or active substance,
(f) a summary of the results of the tests required) in order to determine the effectiveness
of the active substance or preparation and their effect on humans, animals,
plants, animal feed, animal and plant products and the environment
g) precautions to reduce dangers from handling, storage, transport
and the use of the biocidal product or active substance,
h) safety data sheet
I) analytical methods,
j) methods of disposal packaging of the biocidal product or active substance,
k) procedures and measures in case of leakage of the biocidal product or active
the substance,
l) first aid in case of contact with people.
(3) the Ministry shall not divulge confidential information to persons other than
and persons carrying out evaluations of dossiers) of the biocidal product or
documentation to the active substance,
b) Toxicological information centre General teaching hospital
in Prague,
(c) the Ministry of the Interior) for the purpose of fire protection
(d)) to the Member States,
(e)) to the Commission.
(4) a person referred to in paragraph 3 (b). ) to c) confidential information shall not
to communicate to other people.
(5) If a person referred to in paragraph 1 shall publish any confidential information,
You cannot continue to be considered as such; This fact is a person
referred to in paragraph 1 shall be required to inform the Ministry.
section 16 of the
Provision of data to the other and the other applicants
(1) the Ministry may use the data submitted by the applicant pursuant to § 4, 9,
10 or 12 in favour of the second and the other applicants, if this
the applicant shall submit to the Ministry a written consent of the first applicant, certified as
such use of these data.
(2) the Ministry may not be used without the written consent of the first applicant
for the benefit of other applicants, the following information:
and) on the active substance, which was not on the market before the date of 14. in May 2000, and is
included in the list of active substances or a list of active substances with a low
risk laid down by decree for a period of 15 years from the date of its first
inclusion in these lists,
(b)) of the active substance that was on the market before the date of 14. in May 2000,
1. to 14. may 2014, with the exception of data protected under specific
laws on inventions, rationalization proposals and industrial
patterns and their protection ^ 10), which will continue the protection of the
information to the time specified by the special legislation,
up to 14. may 2014,
2. for a period of 10 years from the date of the first inclusion of the active substances to a list
active substances or a list of active substances with low-risk set out
by Decree, if the data which were submitted for the first time as
support of the first inclusion of either of the active substance or of an additional type
the biocidal product into these lists,
(c)) of a biocidal product containing an active substance not on the
the market before the date of 14. 15, 2000, from which an enforceable permit
placing on the market in any Member State are less than 10 years,
(d)) of a biocidal product containing an active substance that has been on the market
before the date of 14. May 2000
1. to 14. may 2014, with the exception of data protected under specific
laws on inventions, rationalization proposals and industrial
patterns and their protection ^ 10), which will continue the protection of the
information to the time specified by the special legislation,
up to 14. may 2014,
2. for a period of 10 years from the date of the first inclusion of the active substances to a list
active substances or a list of active substances with a low risk of modified
by Decree, if the data which were submitted for the first time as
support of the first inclusion of either of the active substance or of an additional type
the biocidal product into these lists,
(e)) that have been submitted for the purposes of the amendments to the conditions of the permit pursuant to section 11
or for the purpose of inclusion of the active substance changes to a list of active substances,
list of active substances with a low risk or a list of basic substances
or extension of the classification under section 12(1). 10 and from whose
the first submission of less than 5 years; This is without prejudice to the obligation to
observe the time limits referred to in points (a) to (d)).)
§ 17
The exchange of information
(1) within 30 days after the end of each quarter, the Department shall send to the other
the Member States and the Commission of any biocidal products information,
which have been authorised or for which authorization was refused, annulled,
were lost, altered or renewed, with the following details:
and the designation of the holder of the authorization,)
(b)) the name of the biocidal product,
(c)) the name and amount of active substances and of dangerous substances ' ^ 2 ') contained in the
biocidal product and their classification,
(d) the type of biocidal product), and the purpose for which it is enabled,
(e)) the form of the biocidal product, e.g. wettable powder, popraš,
emulsifiable concentrate, granules,
(f) the value of the specified residues)
g) permit conditions, or the reasons its restrictions, amendments or cancellation,
h) communication, whether it is a special type of biocidal product, for example, with
low-risk formulation.
(2) the Ministry shall prepare each year a list of biocidal products
permitted on the territory of the United States and send it to the other Member
States and the Commission.
(3) in the event that the Department receives from another Member State a summary of the
documentation of the biocidal product or active substance and comes to the
the conclusion that the dossier is incomplete, it shall immediately notify the fact to the
the competent authority of the Member State responsible for the evaluation
documentation and shall inform the Commission and the other Member States about this
Affairs.
TITLE VI OF THE
TO THE CLASSIFICATION, PACKAGING AND LABELLING OF
section 18
Classification
Biocidal products shall be classified according to a special legal
^ 3) of the code.
§ 19
Packaging
Biocidal products shall be packaged in accordance with special legislation. ^ 11) on
packaging of biocidal products must comply with specific conditions
modified by Decree and those additional terms and conditions:
a) biocidal products, which could be considered a food,
drink or feedingstuff shall be packaged to minimize the likelihood of confusion,
for example, the choice of the shape and labelling of the packaging,
b) biocidal products intended for sale to consumers, which can be
mistaken for food, drink or feedingstuff shall contain the taste or
scent ingredients that discourage their consumption.
section 20
Labelling
(1) the Packaging of biocidal products shall be labelled according to a special legal
regulation; ^ 12) on the labelling of the packaging of biocidal products contain
These well legible and indelible details in Czech language:
and) the name and concentration of each active substance in metric units, ^ 13)
(b)) number, under which it has been authorised for the placing of the biocidal product on the
the market is granted,
(c)), for example, form, popraš, wettable powder, emulsifiable
concentrate, granules,
(d)) purpose of use for which the biocidal product is authorised, for example,
wood protection product, disinfectants,
e) directions for use and the dose rate, expressed in metric units, for
each use,
f) likely direct or indirect adverse side effects
g) first-aid measures,
(h)) the phrase "read attached instructions before use", if they are biocid
of attached written instructions,
I) directions for safe disposal of the biocidal product and its packaging
prohibition on reuse of packaging, including, where necessary,
j) batch number or designation of the biocidal product and the indication of the period
shelf life under normal conditions of storage,
k) time period needed for the biocidal effect; interval to be
be observed between applications of the biocidal product or between application and
the following use of the product treated, or the next input person
or animals to areas where the biocidal product has been used, including data
concerning decontamination means and measures and duration of necessary including
ventilation of treated areas; data for adequate cleaning of the equipment;
data on the provisional measures during use, storage and transport,
for example, personal protective equipment, measures for protection against
the fire, covering of furniture, removal of food and feed and instructions for
the protection of animals from exposure, and
l) other data, if this is necessary with regard to the characteristics and uses
product:
1. the categories of users to which the biocidal product
limited, for example, professional, industrial,
2. information on any specific danger to the environment,
especially when it comes to animals, and measures to prevent water pollution,
3. for biocidal products containing microorganisms the data necessary
for the protection of the health of workers against exposure to micro-organisms in
the working environment,
m) the data set out in the specific conditions of the modified Decree.
(2) the information referred to in paragraph 1 (b). (c)), e), (f)), i), (j)), k), (m) and in the
paragraph 1 (b). l) point 2 can be place on the packaging listed in the written
the guidelines, which must be passed at the same time with the biocidal product. The indication
referred to in paragraph 1 (b). (b)) only for biocidal products
allowed by the Ministry.
(3) on the packaging of biocidal products shall not be listed the inscriptions
as a "low-risk" product, ' non-toxic ', ' harmless '.
(4) biocidal products of type 14, 15, 16 and 18 for the classification,
packaging and labelling applies special legislation at the same time, ^ 14) may
be packed and labelled in accordance with this special legislation,
If this does not conflict with the terms of the authorisation for placing the biocidal
product on the market, issued under this Act.
(5) the obligation to indicate the packaging in the Czech language does not exclude the possibility of
simultaneous marking in other languages.
section 21
Promotion and advertising
(1) in promotional and advertising material of a biocidal product shall
always be reported sentence "Use biocides safely. Before
using, always read the packaging to the attached information about
product. " These sentences shall be compared with the other text significantly
distinguished. The words ' biocidal products ' may be replaced by a more precise
description of the biocidal product, such as a "disinfectant"
"protection of the wood".
(2) promotional and advertising materials must not contain the words
"low-risk biocidal product ', ' non-toxic ', ' harmless ' and
of a biocidal product shall not inform the way that is misleading in
view of the risks resulting from its characteristics and its use for
humans, animals, plants, animal feed, animal and plant products, and
the environment.
§ 21a
For the fulfilment of the obligations set out in sections 19 to 21 matches the legal person
or individual entrepreneur, which lists the biocidal product on the market.
§ 21b
The active substance placed on the market for use in a biocidal product,
classified, packaged and indicates under a special legal regulation concerning the
chemical substances and chemical preparations ^ 3b).
TITLE VII
REPORTS OF POISONING
section 22
(1) the provider of health services passes to the national health
information system, and to the national registry of hospitalized or
The national register of occupational diseases, the information about the poisonings in biocidal
medicinal products or active substances. Data provider of health services
passes the manner prescribed by law, which regulates health services and
their provision.
(2) the information on the active substances and the biocidal products obtained according to
This law, which are necessary for providing first aid or
healing, provides in cases of poisoning or other accidents caused by
active substances or biocidal products to doctors or others
executing health profession Poison Center
The General faculty hospital in Prague.
TITLE VIII
PERFORMANCE OF STATE ADMINISTRATION
Article 23 of the
Performance of State administration
State administration in the field of marketing of biocidal products and active substances
on the market and use of the exercises
and) the Ministry,
(b)), the Ministry of the environment,
(c)), the Ministry of agriculture,
(d) the regional hygiene station),
(e)) the Czech environmental inspection,
(f)), the Customs authorities,
g) Ministry of defence and the Ministry of the Interior.
section 24
The Ministry of
(1) the Ministry of
and receives notification of biocidal products), proposals for the inclusion of the active
substances in the list of active substances, list of active substances with a low
risk and basic substances list in accordance with § 12 para. 1, proposals for amendment of
and the extension of this status and the suggestions on the evaluation of the dossier to the
active substance for the purposes of inclusion of the active substance in these lists,
(b)) decides on matters under sections 7, 9, 10, 11, § 12 para. 2, § 14 para. 5
and 6, § 15 para. 1 and § 35 para. 4 and 5, shall submit proposals in matters of inclusion
active substances in the list of active substances, list of active substances with
low risk and basic substances list under section 13 and shall keep for a period of
15 years all documentation related thereto,
c) evaluates the documentation submitted for the issue of biocidal product,
change or cancellation of an authorisation for the placing of biocidal products on the market and
documentation for the active substance a proposal for the inclusion of active substances in the
list of active substances, list of active substances with a low risk and
basic substances from the perspective of the protection of man, as well as change and
the extension of this classification,
d) keeps records of authorized and notified of biocidal products and
exposes it in the scope of § 7 para. 9,
e) provides a framework of the composition of the biocidal product,
(f) the notification referred to in §) takes 14. 4,
I) ensures the international exchange of information with the Member States and the Commission
under this Act,
h) decide on appeals against decisions issued by regional health
the station,
I) performs tasks according to the section 4, paragraph 4. 5 and 6, § 5, section 7 (2). 11, § 14 para. 3, §
15 paragraph 1. 3 and 5, and section 16,
j) keeps records of checks carried out by the regional hygiene station,
The Czech environmental inspectorate or the Customs authorities containing
identification data of the person checked the amount of fines, the facts,
on the basis of an enforceable decision fines were imposed and the types of
enforceable decision imposed corrective measures,
k) by the directly applicable European Union legislation ^ 1a) receives and
evaluates the documentation for the inclusion of active substances in the list of active
substances, active substances with low risk and basic substances list
shall prepare a final report and adopt the related notification in
cases where the Czech Republic intended to ensure as rapporteur
implementation of the programme the examination of existing active substances
l) passes the Toxicological information centre for the provision of the first
help or healing information on the active substances and the biocidal
preparations.
(2) the Ministry may delegate activities referred to in paragraph 1 (b). (c)), and (e))
and assessing the documentation referred to in paragraph 1 (b). k) Organization
that performs the function of the founder or of the founder.
(3) in the performance of duties under this Act is the Ministry in the scope of their
the scope of the competent to adopt measures on the basis and within the limits of directly
applicable European Union legislation on biocidal products and active
substances ^ 1a). In matters of marketing of biocidal products and active substances on the
the market acts as the authority of the Ministry of the Chief Health Officer of the Czech
Republic. ^ 17)
(4) the Ministry cooperates with the Commission and the competent authorities of the Member
States within its jurisdiction in accordance with paragraph 1 and provides them with information
and the opinions in the scope, form and time intervals in accordance with this
law and directly applicable European Union legislation on biocidal
products and active substances ^ 1a).
(5) the Ministry shall be sent every third year to 30. November the Commission
a summary report on the examinations, enforceable decision
the corrective measures and penalties imposed and cases of poisoning
biocidal products or active substances on the territory of the Czech Republic
This period of time.
§ 25
Ministry of the environment
Ministry of the environment
and the institution concerned) is in proceedings for the issue, amendment or revocation of an authorisation to
the placing of the biocidal product on the market; binding opinion from the perspective of
protection of the environment,
(b)) evaluates the documentation for the proposal for the inclusion of active substances in the
list of active substances, list of active substances with a low risk and
list of basic substances in terms of its completeness and conservation
the environment, as well as the amendment and extension of this classification,
c) serves the Ministry of incentives to change or cancellation of the authorization to place
of the biocidal product on the market,
(d)) is the institution concerned in the authorisation procedure for experiments or tests pursuant to section
14. 5 and in proceedings relating to the prohibition of experiments or tests or the determination of
conditions referred to in section 14 para. 6; binding opinion from the point of view of the protection of
of the environment,
e) decides on appeals against a decision issued by the Czech inspections
of the environment.
section 26
The Ministry of agriculture
The Ministry of agriculture
and the institution concerned) is in proceedings for the issue, amendment or revocation of an authorisation to
the placing of the biocidal product on the market; binding opinion from the perspective of
the protection of animal and plant health and animal feedingstuffs
animal and vegetable products,
(b)) evaluates the documentation for the proposal for the inclusion of active substances in the
list of active substances, list of active substances with a low risk and
list of basic substances in terms of its completeness and conservation
farm animal and plant health and animal feedingstuffs
animal and vegetable products, as well as change, and the extension of this
the classification,
c) serves the Ministry of incentives to change or cancellation of the authorization to place
of the biocidal product on the market,
(d)) is the institution concerned in the authorisation procedure for experiments or tests pursuant to section
14. 5 and in proceedings relating to the prohibition of experiments or tests or the determination of
conditions referred to in section 14 para. 6; binding opinion from the point of view of the protection of
farm animal and plant health and animal feedingstuffs
animal and vegetable products.
section 27 of the
Regional hygiene station
The regional hygiene station
and supervised as they are) legal persons or individuals doing business with
compliance with the provisions of this Act persons, directly applicable
European Union legislation on biocidal products and active substances ^ 1a),
decision of the Ministry issued on the basis thereof and the decision issued by the
referred to in subparagraph (c)),
b) stores the legal persons or natural persons fines for doing business
breach of duties under this Act, directly applicable regulations
The European Union on biocidal products and active substances ^ 1a) and
decision of the Ministry issued on the basis thereof,
(c)) shall be entitled to legal persons or natural persons, doing business
that use the biocidal product or placing biocidal product or
an active substance on the market in contravention of this Act, a directly applicable
the EU regulation on biocidal products and active substances ^ 1a)
or by decision of the Ministry, impose a prohibition on the placing of the biocidal
product or an active substance on the market, to prohibit the use of the biocidal
preparation or implementation of remedial measures consisting in the download
of the biocidal product or active substance from the market or distribution or in the
their disposal,
d) hears misdemeanors under section 32a,
(e) the Ministry shall forward each year to) the date ' 30. September summary report on the
made of State inspections and the corrective measures referred to in point
(c)) and the penalties laid down in point (b) enforceable decision) saved,
for the previous 12 months at the date of 31. August of each calendar year.
section 28
cancelled
section 29
Czech environmental inspection
Czech environmental inspection
and supervised as they are) legal persons or individuals doing business with
people respected the provisions of section 19 to 21 and decisions issued by
subparagraph (b)),
(b)) is entitled to impose a prohibition on the placing on the market of a biocidal product or
the implementation of remedial measures consisting in the withdrawal of the biocidal
product from the market or distribution or its destruction when it detects when
supervisory activities in compliance with the provisions of § glitches 19 to 21,
c) stores doing business legal persons or natural persons, penalties for
violation of the provisions of paragraphs 19 to 21,
(d) the Ministry shall forward each year to) the date ' 30. September summary report on the
made of State inspections and the corrective measures referred to in point
(b)), and fines referred to in points (c) enforceable decision) saved,
for the previous 12 months at the date of 31. August of each calendar year.
section 30
The Customs authorities of the
(1) the Customs authorities
and they won't release the biocidal product) proposed customs procedure without
authorization, unless this Act provides otherwise, or without the written
Declaration by the importer that the biocidal product is intended exclusively for the needs of
scientific research and development or for testing purposes. In the case of
doubts may apply to the Ministry for technical assistance,
(b) the control on importation) that cover the biocidal product fulfils the
the conditions set out in sections 19 to 21,
(c)) won't be released for free circulation of biocidal product if it is found in the
the control activities in compliance with the provisions of paragraphs 19 to 21,
(d)) legal persons or natural persons engaged in the fine
to infringements of the provisions of section 19 to 21.
(2) the Directorate-General of customs
and) keeps records of the imported biocidal products, and will allow Ministry
The Czech environmental inspection, the Ministry of agriculture and
The Ministry of the environment, the village of delegated scope or
regional hygiene station in the register to inspect, take from it
copies, extracts or copies or allowing digital data transmission,
(b) shall be sent to the Ministry annually) the date ' 30. September summary report on the
State inspections carried out and the measures referred to in paragraph 1 (b). (c))
and fines referred to in point (d)) stored in an enforceable decision and under the
the previous 12 months at the date of 31. August of each calendar year.
section 31
The Ministry of defence and the Ministry of the Interior
The Ministry of defence and Ministry of Internal Affairs shall exercise State control
over compliance with this Act and shall perform the functions referred to in section 27 in the armed
the forces and security corps, with the exception of the prison service of the Czech
of the Republic.
§ 31a
Performance of State control
(1) the regional hygiene station progresses in the exercise of State control
According to the law on the protection of public health ^ 17a); Czech environmental inspection
environment and the Customs authorities shall, in the exercise of State control under
the law on State control ^ 17b). In the exercise of State control are County
hygiene stations, the Czech environmental inspection and customs authorities
Additionally entitled to
and) take samples of active substances and biocidal products and take
image documentation
(b) verify the identity of persons) and also the identity of the natural
people that when you check the controlled person, represent and permissions
These people to represent.
(2) the Controlled person and other persons involved in the performance of the State
the checks are required to create the conditions for the implementation of State control.
Who is considered to be a controlled person lays down the law on the State
control ^ 17b).
(3) the Permission and the obligations of the regional hygiene stations and the United
environmental inspection under this Act, or directly
applicable European Union legislation on biocidal products and active
substances ^ 1a) shall also apply to a dwelling which is used for business.
TITLE IX OF THE
ADMINISTRATIVE OFFENCES
§ 32
Administrative offences of legal entities and natural persons-entrepreneurs
(1) a legal entity or individual entrepreneur is committed by the administrative
tort by
and) contrary to section 3 (2). 1 to market the active substance are intended for
the use in a biocidal product in accordance with the conditions referred to in section 8 or
on the market of a biocidal product without permission according to § 7, § 9 para. 1
or 2 or § 10 para. 1, or without notice in accordance with § 35 or in conflict
with this authorization or notification,
(b)) in violation of § 3a paragraph 2. 1 it's a biocidal product which has not been
authorised for placing on the market or whose placing on the market was not notified
under section 35, or uses a biocidal product in violation of § 3a paragraph 2. 2,
(c)) has requested authorisation for placing on the market of a biocidal product, though
This plan has made a written declaration in accordance with § 5 para. 2, or indicate
active substance on the market in violation of a written declaration under section 8,
(d) fails to comply with a condition of use) of the biocidal product, which was in accordance with § 9
paragraph. 1 available
e) fails to comply with a time limit for the disposal, storage, sale or use of
existing stocks of the biocidal product, determined in accordance with § 11 para. 5
or § 35 para. 5,
(f)) as the person referred to in article 15, paragraph 2. 1 does not inform about the disclosure of confidential
information pursuant to § 15 para. 5,
(g) fails to comply with a request to packaging) of the biocidal product according to the § 19, his
labelling pursuant to section 20 or its promotion or advertising pursuant to § 21,
or
h) fail to comply with the obligation laid down-regulation of the European
the Union of the active substances and the biocidal products ^ 1a).
(2) a legal entity or individual entrepreneur, who uses a biocidal
product or lists the biocidal product or active substance on the market,
committing an administrative offense by that, contrary to a decision under section 27 of the
(a). (c)) or section 29 (b). (b)) it's a biocidal product, or fails to comply with
prohibition on the placing of the biocidal product or active substance on the market, or
biocidal product or an active substance from the market, will not download from the distribution
or is nezneškodní.
(3) a legal entity or individual entrepreneur, which lists the biocidal
product on the market or uses it, or the holder of the marketing authorisation
of the biocidal product on the market under section 7 is guilty of an administrative offense by
that contrary to section 3 (2). 2 fails to comply with a specific condition modified
by Decree.
(4) the holder of the authorisation for placing on the market of a biocidal product in accordance with § 7, 9
or 10 commits an administrative offense by that, contrary to section 11 para. 5
customer's acquaintance with the deadline for the disposal, storage, sale or
the use of existing stocks of biocidal product or, with the authorisation
to the placing of the biocidal product on the market has been cancelled or ended his
force.
(5) the holder of the authorisation for placing on the market of a biocidal product pursuant to section 7, the
committing an administrative offense that advertise new data according to § 7 (2).
10.
(6) the holder of a temporary authorisation for placing on the market of a biocidal product
According to § 9 para. 1 committing an administrative offense by acquaintance
the Subscriber with the terms of use of the biocidal product.
(7) the legal entity or individual entrepreneur carrying out research, development
or tests required for an application under section 4 or § 9 para. 1
or for the submission of an application pursuant to section 12 of the administrative offense committed by
and) contrary to § 14 para. 3 do not submit the record of the biocidal product
or the active substance, which is required to keep and maintain under § 14 paragraph 2.
2, or
(b)) carried out experiments or tests in violation of § 14 para. 5 or 6.
(8) a legal entity or individual entrepreneur carrying out applied
research or development of committing an administrative offense by that, contrary to section 14
paragraph. 4 notify details of the biocidal product or active substance or
their applied research or development.
(9) an administrative offense shall be fined in the
and 5 000 000 Czk), in the case of an administrative offence referred to in paragraph 1 (b). and), (b)),
d), (e)), g) or (h)), paragraphs 2, 3, 4, or 6, or paragraphs 7 (b). (b)),
(b) 2 000 000 Czk), in the case of an administrative offence referred to in paragraph 1 (b). (c)), or
paragraph 5 or 8,
(c) $ 1 000 000), in the case of an administrative offence under paragraph 7 (b). and)
d) 500 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (f)).
section 32a
Misdemeanors
(1) a natural person has committed the offence by using biocide
medicine in violation of § 3a paragraph 2. 2.
(2) for the offence referred to in paragraph 1 can be used to impose a fine of up to $ 50,000.
§ 33
(1) a legal person for an administrative offence is not liable if he proves that
made every effort, that it was possible to require that the infringement of the
a legal obligation is prevented.
(2) in determining the amount of the fine on a legal person shall take account of the seriousness of the
the administrative offense, in particular, the way a criminal offence and its consequences, and
the circumstances under which it was committed.
(3) the liability of a legal person for an administrative offense shall cease, if the
administrative authority about him has not initiated proceedings within 1 year from the date on which it
learned, but not later than within 3 years from the date on which it was committed.
(4) administrative offences under this law are heard at first instance
Czech environmental inspection, customs offices and the regional hygiene
station. Czech environmental inspection shall consult the administrative offence
According to § 32 para. 2, if the failure to comply with the decision which has been committed
released, and an administrative offence under § 32 para. 1 (b). (g)), did not detect the
breach of duty when checking import customs office. The customs authority shall consult
administrative offence under § 32 para. 1 (b). (g)), if it finds violations of the
When checking import duties. The regional hygiene station will discuss
administrative offence under § 32 para. 2, if it was committed non-compliance
the decision, released, and other administrative offences provided for in this
the law, which is not pending, the Czech environmental inspection or
the Customs authorities.
(5) The liability for the acts, which took place in the business
person ^ 18) or in direct connection with the applicable provisions of the Act
on the liability of legal persons and sanctions.
(6) the Fines collected and enforced by the authority that is saved.
(7) income from the fines imposed on the regional hygiene stations or
the Customs authorities shall constitute revenue of the State budget, income from the fines imposed
The Czech environmental inspectorate is the income of the State Fund of the
the environment of the Czech Republic ^ 19).
TITLE X
PROVISIONS COMMON, TRANSITIONAL AND FINAL
§ 34
The delivery of the communication, challenges and applications
When the delivery of the communication pursuant to § 5 para. 2, § 12 para. 5 and 6, challenges by
§ 12 para. 2 and 4 or a request pursuant to § 14 para. 3 legal persons or
doing business to individuals, the Ministry shall proceed according to the provisions
administrative regulations on the service of documents into your own hands ^ 20).
§ 34a
The procedure for the application of a person from another Member State
In the proceedings on the application of physical persons entitled to business or legal
persons who have their domicile or permanent residence permit, residence,
place of business, Central Administration, principal place of business
business or organizational folder on the territory of another Member State, the
section 4, paragraph 4 shall apply. 1 to 6, § 5, 6, paragraph 7 (1). 1 to 8, § 9 para. 1 sentence
the first and second, § 9 para. 2 to 4 and § 9 para. 5 the first sentence, section 15 and 16
by analogy; in proceedings on its proposal on the inclusion of the active substances to a list
active substances, list of active substances with a low risk or list
basic substances and to amend or extend this classification shall apply
Similarly, section 12 paragraph 1. 1 to 6 and 10, section 13, 15 and 16.
§ 34b
Reimbursement of costs
Costs arising from the obligations of the placing of biocidal
products and active substances on the market and use of biocidal products shall be borne by
a legal entity or natural person that is the obligation imposed on it. Carry
and payment of the costs incurred in the exercise of State control, lays down the law on the
State control ^ 17b).
§ 35
Transitional provisions
(1) a legal person or entrepreneurial natural persons that have indicated
the biocidal product on the market and intend to continue to be available on the market, shall notify the
not later than 1 year after the entry into force of this Act, the Ministry of
the following information:
and) name, surname, permanent residence or place of business, if
notification is submitted by a natural person; the name or business name and registered place of
If the notification is submitted by a legal person,
(b)) name, surname, permanent residence or place of business of the manufacturer
of the biocidal product and the active substance manufacturer if the manufacturer of natural
the person; the name or business name and address of the manufacturer, if the legal
person,
(c)) the name of the biocidal product,
(d)) the chemical name and international identification numbers of active substances,
If these numbers are available, and their concentrations,
(e) the names of the other) the chemical substances contained in the biocidal product
including international identification numbers if these numbers
available, and their concentrations,
(f) the type of biocidal product) according to the annex to this Act,
g) category of users, for example, for professional use only, for
the public,
h) the Protocol on determination of the effectiveness,
I) text labelling,
j) instructions for use, if it is not listed on the packaging,
k) the approximate amount of the biocidal product on the market provided for
the calendar year,
l) safety data sheet
m) date of placing of the biocidal product on the market.
(2) a legal person or natural person conducting business after the acquisition of the
the effectiveness of this law they intend to place on the market of a biocidal product shall notify the
the Ministry of information referred to in paragraph 1 (b). and) to l) prior to the placing
of the biocidal product on the market, if you have not submitted an application in accordance with section 4.
(3) a legal person or entrepreneurial natural persons placing on the market
biocidal product under the conditions of paragraph 1 or 2 are obliged to meet the
the requirements of § 3 para. 1
and in the case of a biocidal product) of a specific type that contains
only existing active substance for that product type to
program review ^ 21), which has not been decided by directly
of the applicable legislation of the European Union ^ 22) or this act otherwise,
until 14 June. may 2014,
(b)) to 31. August 2006, if the biocidal product contains exclusively
active substances which are listed in the list of identified active
substances or contains their mixture with active substances referred to in the list of
the notified active substances,
(c)) to 1. January 2004 if the biocidal product contains other active
substances than those specified in (a)), or (b)).
(4) the Ministry may for a biocidal product placed on the market in accordance with
paragraphs 1, 2 or 3 to provide for the terms of use or placing on
disable the market biocidal product does not meet the requirements of § 7 para.
1 (b). (b)), 1, 2, 3, or 4 or § 7 para. 1 (b). c) or (d)).
(5) the prohibition of the placing of the biocidal product on the market referred to in paragraph 4
the Ministry provides notice of the disposal, storage, sale or
the use of existing stocks of the biocidal product.
section 36
cancelled
PART TWO
Amendment of the Act on the protection of public health
§ 37
Act No. 258/2000 Coll., on the protection of public health and amendment to certain
related laws, as amended by Act No. 254/2001 Coll., Act No.
274/2001 Coll. and Act No. 13/2002, is amended as follows:
1. In paragraph 25, the following shall be added at the end of paragraph 2 the words including notes
footnote # 29a) shall be added: "or a biocidal product ^ 29a)
29A) Law No 120/2002 Coll., on conditions for the placing of biocidal products and
active substances on the market and amending certain related laws. ".
2. In section 56 (a). and) the words "approved by the competent authority
the protection of public health "shall be replaced by ' products, whose entry
on the market were allowed to ^ 29a) ".
3. In article 77, paragraph 1 reads:
"(1) a natural person who is an entrepreneur, and a legal person are
required to submit for approval to the competent authority to protect public
the health proposals for production and imports of the foodstuffs for children aged under 3 years. ".
4. In § 80 para. 1 (b). (g)), the words "(a). a) and b) "before the semicolon
shall be deleted.
PART THREE
Amendment to the veterinary Act
§ 38
In section 39 of the Act No. 167/1999 Coll., on health care and on amendments to certain
related laws (health law), including paragraph 4 notes
footnote # 5 ^ ^) and 5a):
"(4) for disinfection, disinsectization and dezodorizaci, according to this
the law can only use registered ^ 5) preparations and procedures or
products whose placing on the market was enabled. ^ 5a)
5) Act No. 79/1997 Coll.
5A) Law No 120/2002 Coll., on conditions for the placing of biocidal products and
active substances on the market and amending certain related laws. ".
PART FOUR
Amendment of the Act on administrative fees
§ 39
Act No. 368/1992 Coll., on administrative fees, as amended by Act No.
10/1993 Coll., Act No. 72/1994 Coll., Act No. 85/1994 Coll., Act No.
273/1994 Coll., Act No. 36/1995 Coll., Act No. 118/1995 Coll., Act No.
160/1995 Coll., Act No. 301/1995 Coll., Act No. 151/1997 Coll., Act No.
305/1997 Coll., Act No. 148/1998 Coll., Act No. 157/1998 Coll., Act No.
167/1998 Coll., Act No. 63/1999 Coll., Act No. 167/1999 Coll., Act No.
167/1999 Coll., Act No. 222/1999 Coll., Act No. 326/1999 Coll., Act No.
353/1999 Coll., Act No. 359/1999 Coll., Act No. 360/1999 Coll., Act No.
363/1999 Coll., Act No. 62/2000 Coll., Act No. 121/2000 Coll., Act No.
133/2000 Coll., Act No. 151/2000 Coll., Act No. 155/2000 Coll., Act No.
154/2000 Coll., Act No. 155/2000 Coll., Act No. 155/2000 Coll., Act No.
227/2000 Coll., Act No. 242/2000 Coll., Act No. 242/2000 Coll., Act No.
307/2000 Coll., Act No. 367/2000 Coll., Act No. 143/2001 Coll., Act No.
231/2001 Coll. and Act No. 76/2002 Coll., is amended as follows:
In Tariff administrative fees for item 131 c inserted 131d,
to read as follows:
"131d Entry
1. Submission of the request
and) on authorisation for placing the biocidal product
$ 35000.0 to the market-
(b)) of the authorisation for placing the biocidal product
low-risk or formulation on the market for $ 20000.0-
(c)) the amendment of the authorisation for placing the biocidal product
on the market, the extension of the permit or
the renewal of $ 2500.0-
d) authorisation for the placing on the market of a biocidal product,
that has already been authorised in another Member State
The European Union Eur 4500.0-
2. The request for the inclusion of the active substance
biocidal products to the list of active substances,
list of active substances with a low risk or
list of basic substances Czk 45000.0-
Notes
1. the administrative authority shall levy the fee referred to in point 1 (a)) of this item
for an application for an authorisation pursuant to § 4 paragraph 2. 3 or § 9 para. 2 of law No.
120/2002 Coll., on conditions for placing biocidal products and active
substances on the market and amending certain related laws, and by the letter
(b)) this item for an application for an authorisation pursuant to § 4 paragraph 2. 4 of the same Act.
2. the administrative authority shall levy the fee referred to in point 1 (c)) for this item
for requests submitted pursuant to section 11 (1) 1 (b). (c)), § 9 para. 2 or § 7
paragraph. 7 of law No 120/2002 Coll., on conditions for the placing of biocidal
products and active substances on the market and amending some related
laws.
3. the administrative authority shall levy the fee referred to in point 1 (d)) of this item
the application is served under section 10 of the Act No 120/2002 Coll., on conditions for
placing of biocidal products and active substances on the market and amending
some related laws.
4. the administrative authority shall levy the fee referred to in point 2 of this item for the suggestion
filed pursuant to section 12 of the Act No 120/2002 Coll., on conditions for the placing
biocidal products and active substances on the market and amending certain
related laws.
PART FIVE
The EFFECTIVENESS of the
section 40
This Act shall take effect on 1 January 2000. July 2002, with the exception of
the provisions of the
§ 3 (1)). 2, § 7 (2). 1 (b). and, § 7 (1)). 7, § 11 (1) 2 and 3, §
11 (1) 4 (b). and section 16, paragraph 1). 2 (a). and section 16, paragraph 1). 2 (a). (b))
2 and § 16 para. 2 (a). (d)), point 2, which will become effective on 1 January 2004.
in January 2009,
(b)) § 8 para. 1, 2, 3 and 5, which will become effective on 1 January 2004. January 2004,
(c) section 2 (2).) 11, § 4, paragraph 4. 8, § 5 para. 5 the second sentence of § 7 para. 4, § 7
paragraph. 11, § 8 para. 4, § 9 para. 4 and 5, § 10, section 11 (1) 7, 12, 13, § §
15 paragraph 1. 3 (b). e) and (f)), section 17 and section 22 paragraph 1. 5, which will become effective
the date of entry of the Treaty of accession of the Czech Republic to the European Union in
entry into force,
d) section 14, which shall take effect on the expiry of 1 year from the date on which the
the effectiveness of this law,
(e) section 19 (a)). (b)), section 20 (2). 1 (b). a) to (l)), section 20 (2). 2 and § 21,
which shall take effect at the end of 2 years from the date of entry into force of
of this Act.
Klaus r.
Havel, v. r.
Zeman in r.
Annex
Biocidal product-types
+---------+-----------------------------+------------------------------------------------+
| Type | The name of the product type | Area of application |
| of | | |
+---------+-----------------------------+------------------------------------------------+
| Disinfectants and products for general use |
| |
| (Does not include the cleaning products that are not intended for use as biocidal products |
guaranteed efficiency, including | washing liquids, powders and similar cleaning products |
|) |
+---------+-----------------------------+------------------------------------------------+
| 1 | Biocidal products personal | Products used in personal hygiene |
| | | for the purposes of general hygiene, disinfection with the exception of |
| | products with medicinal effect ' | ' and products |
| | the primary effect, and || purpose purpose, |
| | the beauty and effect of biocidal | is a complementary, |
| | | such as. antimicrobial soaps, shampoos |
| | | dandruff and mouthwash. |
+---------+-----------------------------+------------------------------------------------+
| 2 | Disinfectants | Preparations for the disinfection of air, |
| private and professional | | surfaces, materials, equipment and furniture |
| and other biocidal | | that are not used in direct contact |
| | | food or feed in the field |
| | | & private, public, industrial, as well as |
| | products used as algaecides |. |
| | | |
| | | Preparations against fungi and algae in |
| | structures such as ' | '. greenhouses |
| | | that are not applied to plants |
| | but on the window, ' | ' equipment, tables, knife, etc. |
| | | |
| | | Preparations for disinfection of empty |
| | storage facilities, containers | sacks and barrels. |
| | | |
| | | Products used for the adjustment of the river beds. |
| | | |
| | | Algicidní products used on the desktop |
| | formed by other than soil | substrates on |
| | playgrounds, parking lots, | sidewalks, |
| | | pomnících, below. |
| | | |
| | | The area of application includes, inter alia, swimming pools, |
| | | aquariums, bathing waters and other water |
| | air conditioning, | systems walls and floors in |
| | medical and other institutions, |, |
| | disinfection of medical instruments | chemical |
| | toilets, waste water, |, hospital waste. |
| | | |
| | | Does not include herbicides for agricultural and |
| | non-agricultural use, | algaecides applied |
| | on soil, desktop | consisting of other soil |
| | substrates in water or ' | ' for plant protection products |
| | | (for example on the race track, golf |
| | | in aquariums and courses, etc.). and products |
| | | in the disinfection of surfaces in greenhouses against |
| | | that may attack the microorganisms |
| | plants and then on the ' | ' them to grow. |
+---------+-----------------------------+------------------------------------------------+
| 3 | Biocidal products for | Products used for veterinary hygiene |
| veterinary hygiene | | purposes including products used in areas |
| | | in which they behave, present or |
| | transporting animals. | Includes products |
| | intended for General disinfection, |, |
| | | does not include products which have a healing effect. |
+---------+-----------------------------+------------------------------------------------+
| 4 | Disinfectants | Products used for the disinfection of equipment, |
| Food and feed area | | containers, consumption utensils, surfaces and |
| | | pipework associated with the production, transport, |
| | | storage or consumption of food, feed |
| | | or drink (including drinking water) for humans and |
| | | animals. |
+---------+-----------------------------+------------------------------------------------+
| 5 | Disinfectants | Products used for the disinfection of drinking |
| drinking water water | | (for humans and animals). |
+---------+-----------------------------+------------------------------------------------+
| Preservatives |
+---------+-----------------------------+------------------------------------------------+
| 6 | Preservatives for | Products used for the preservation of |
| | | packages products other than food and feed |
| | suppress microbial contamination and | secure |
| | shelf life including preservatives | |
| | | photographic film. |
+---------+-----------------------------+------------------------------------------------+
| 7 | Preservatives for | Preparations by the control of microbial |
| | | contamination coatings protect the initial properties of the surface |
| | | materials or articles (films, paints, plastics, |
| | | jointing materials, wall adhesives, binders, |
| | paper, artwork, |). |
+---------+-----------------------------+------------------------------------------------+
| 8 | Preservatives for | Products used for the preservation of wood, |
| | | including timber or wood products |
| | | by destroying or wood |
| | |-disfiguring organisms. |
+---------+-----------------------------+------------------------------------------------+
| 9 | Preservatives for | Preparations inhibiting microbial |
| | fibre, leather, rubber and contamination for fibrous and | polymer |
| | polymeric materials | materials (leather, rubber, paper, plastic |
| | | mass or textile products). |
+---------+-----------------------------+------------------------------------------------+
| 10 | Preservatives for | Suppressive effect of preparations of micro-organisms |
| | | and algae in the masonry conservation and renovation of masonry and other |
| | | except building materials and wood. |
+---------+-----------------------------+------------------------------------------------+
| 11 | Preservatives for | Suppressing the growth of harmful products |
| | |-cooling and processing of such organisms as microbes, algae and |
| | | systems using the molluscs in the water or other technological |
| | fluids used in chladírenstvínebo | |
| | | industrial processes. Does not include products |
| | ' | ' used for the preservation of drinking water. |
+---------+-----------------------------+------------------------------------------------+
| 12 | Preservatives against | Products used for disease prevention and control |
| | | slimicides slime growth on materials, zařízenícha |
| | structures used in industrialized | |
| | |: processes (such as paper, pulp, porous |
| | materials used for the extraction of | of oil). |
+---------+-----------------------------+------------------------------------------------+
| 13 | Preservatives for | Products used for Suppression of microbial |
| the liquid used in | | contaminating liquids used in machining |
| Metalworking metal | |. |
+---------+-----------------------------+------------------------------------------------+
| Products for the control of animal pests |
+---------+-----------------------------+------------------------------------------------+
| 14 | Rodenticides | Preparations for the regularization of the status of mice, rats or |
| | | other rodents. Does not include products used |
| | exclusively for plant protection | on agricultural |
| | the fields and plant products | stored |
| | temporarily in the fields. | |
+---------+-----------------------------+------------------------------------------------+
| 15 | Avicides | Products used for the control of stavuptactva |
| | | except for products used to protect |
| | | plants or plant products. |
+---------+-----------------------------+------------------------------------------------+
| 16 | Molluscicides | Products used as prevention |
| | |-borne animal and human diseases, molluscs and |
| | against the clogging plumbing | molluscs. |
| | | Does not include products used to protect |
| | ' | ' plants and plant products in front of the molluscs. |
+---------+-----------------------------+------------------------------------------------+
| 17 | Piscicides | Products used for the control of počturyb. |
| | | Do not include preparations for treatment of the diseases of fish. |
+---------+-----------------------------+------------------------------------------------+
| 18 | Insecticides, acaricides and | Products used for the control of the State |
| on the regulation of the status of preparations | | arthropods (e.g. insects, mites, ticks, |
| | | other arthropods Arachnids and crustaceans), including products used |
| | external parasitů to | in areas where |
| | |, or behave in the present transport animals |
| | | except for the situation where the animals in the treated |
| | present premises at the time | when medicine |
| | | still active. |
| | | |
| | | Preparations for treatment of empty storerooms or |
| | containers, bags, | barrels, showers, etc. |
| | | except those that are intended solely for |
| | | storage plants and plant products. |
| | | |
| | | Preparations for killing dust mites and other arthropods |
| | | in textiles. |
| | | |
| | | Does not include products intended for direct contact |
| | the human organism and | for the treatment of the animals, |
| | including bath containing insecticides | and |
| | |-containing products insecticides or other |
| | active substances intended for | pest |
| | | organisms (collars, signs to the ears, etc.) |
| | or halt their growth | or reproduction |
| | | (growth regulators). Further excludes |
| | |-protection of plants and plant |
| | | products. |
+---------+-----------------------------+------------------------------------------------+
| 19 | Repellents and Attractants | Preparations used for repelling (repellents) |
| | snapping individuals | or opposite sex |
| | | (Attractants) harmful organisms (invertebrates |
| | such as fleas and | mosquitoes, vertebrates as |
| | | are birds), without them it should |
| | lethal effect or decreased | their |
| | reproduction, including |, |
| | | are used directly or indirectly for human |
| | veterinary hygiene and | or products containing |
| | | repellents (collars, signs to the ears, etc.) |
| | products permanent | and dogs and cats. |
| | | |
| | | It does not include plant protection products |
| | |, and plant products, food and feed. |
+---------+-----------------------------+------------------------------------------------+
| Other products |
+---------+-----------------------------+------------------------------------------------+
| 20 | Preservatives for | Products used for the preservation of food |
| | | food or feed or feed from harmful micro-organisms |
| | | that are not intended for direct contact |
| | | food or feed (e.g. fumigants |
| | |-used in food storage rooms |
| | | such as cheese and meat). |
+---------+-----------------------------+------------------------------------------------+
| 21 | Antifouling products | Products used to control the growth and |
| | | settlement of fouling organisms (microorganisms |
| | |, and higher forms of plant or animal species) |
| | on vessels, aquaculture equipment for water sports |
| | ' | ' or other structures used in water. |
+---------+-----------------------------+------------------------------------------------+
| 22 | Embalming and taxidermist | Products used for the disinfection and preservation |
| | | human and animal corpses, or parts thereof. |
+---------+-----------------------------+------------------------------------------------+
| 23 | The regulation of the status of the other | Preparations for the regularization of the status of the side |
| | | vertebrates except vertebrates preparations intended |
| | | to protect plants and plant products. |
+---------+-----------------------------+------------------------------------------------+
Annex 2
cancelled
Annex 3
cancelled
Selected provisions of the novel
Article. (II) Act No. 297/2008 Coll.
Transitional provision
The proceedings to a final unfinished until the date of entry into force of this Act shall be
completes in accordance with the existing legislation.
1) European Parliament and Council Directive 98/8/EC of 16 December 2002. February 1998
concerning the placing of biocidal products on the market.
European Parliament and Council directive 2009/107/EC of 16 December 2002. September 2009,
amending Directive 98/8/EC concerning the placing of biocidal products on the market,
as regards the extension of certain time limits.
1A) Commission Regulation (EC) no 1896/2000 of 7 September. September 2000 on the first phase
programme referred to in article 14(2). Article 16(1). 2 of the directive of the European Parliament and of the Council
98/8/EC on biocidal products, as amended.
Commission Regulation (EC) no 1451/2007 on the second phase of the 10-year work
programme referred to in article 14(2). Article 16(1). 2 of the directive of the European Parliament and of the
Directive 98/8/EC concerning the placing of biocidal products on the market.
2) § 2 (2). 8 of Act No. 157/1998 Coll., on chemical substances and
chemical preparations and amending some other acts.
3) section 3 of the Act No. 157/1998 Coll.
3A) Annex IB to Directive 98/8/EC.
3B) Act No. 356/2003 SB., on chemical substances and chemical
preparations and amending certain laws, as amended.
4) Act No. 513/1991 Coll., the commercial code, as amended
regulations.
4A) Annex III to Regulation (EC) no 1451/2007.
5) annex II to the regulation of the European Parliament and of the Council (EC) No. 1907/2006
of 18 May. December 2006 concerning the registration, evaluation, authorisation and
restriction of chemicals, establishing a European Chemicals Agency
the substance of amendment of Directive 1999/45/EC and repealing Council Regulation (EEC) No.
793/93 and Commission Regulation (EC) No 1488/94, Council Directive 76/769/EEC and
Commission directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
6) § 4 paragraph 2. 1 of Act No. 157/1998 Coll.
7) section 5 of the Act No. 157/1998 Coll.
8) Article. 2 (2). 1 (b). I) and k) directive of the European Parliament and the Council
98/8/EC.
9) annexes I, IA or IB to Directive 98/8/EC.
Commission Directive 2006/140/EC.
Commission Directive 2007/20/EC.
Commission Directive 2007/69/EC.
Commission Directive 2007/70/EC.
10) Act No. 527/1990 Coll., on inventions, industrial designs and
rationalization proposals, as amended.
Act No. 207/2000 Coll., on the protection of industrial designs and the amendment of the Act No.
527/1990 Coll., on inventions, industrial designs and rationalization
the proposals, as amended.
11) section 11 of Act No. 157/1998 Coll.
12) section 12 of Act No. 157/1998 Coll.
13) Act No. 506/1990 Coll., on weights and measures, as amended.
14) Act No. 147/1996 Coll., on phytosanitary care and amendments to certain
related laws, as amended.
17) § 80 para. 4 Act No. 258/2000 Coll., as amended.
17A) Act No. 258/2000 Coll., on the protection of public health and amending
some related laws, as amended.
17B) Act No. 553/1991 Coll. on State control, as amended
regulations.
18) § 2 (2). 2 of the commercial code.
19) Act No. 389/1991 Coll., on the State Environmental Fund of the Czech
Republic, as amended.
20) Act No. 500/2004 Coll., the administrative code, as amended by law no 413/2005 Sb.
21) annex II to Regulation (EC) no 1451/2007.
22) Article. 4 Regulation (EC) no 1451/2007.
23) Commission decision No 2010/296/EC of 21 June 1999. May 2010 on the establishment of
Register for biocidal products.
