On The Conditions Of Placing Of Biocidal Products And Active Substances On The Market

Original Language Title: o podmínkách uvádění biocidních přípravků a účinných látek na trh

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=53278&nr=120~2F2002~20Sb.&ft=txt

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.