350/2011 Sb.
LAW
of 27 June. October 2011
on chemical substances and chemical mixtures and amending some laws
(law)
Change: 279/Sb.
Change: 61/2014 Sb.
Change: 61/2014 Coll. (part)
Change: 350/2011 Sb.
Parliament has passed the following Act of the United States:
PART THE FIRST
CHEMICALS AND CHEMICAL MIXTURES
TITLE I OF THE
INTRODUCTORY PROVISIONS
§ 1
The subject of the edit
This law incorporates the relevant provisions of the European Union ^ 1), followed by
on the directly applicable European Union regulations ^ 2) and modifies the
and) the rights and obligations of legal entities and natural persons-entrepreneurs
(hereinafter referred to as "the person")
1. the production, classification, testing, packaging, dangerous properties
the labelling, placing on the market, use, export and import of chemical
substances ^ 3) (hereinafter referred to as "substance") or substances contained in mixtures or
articles,
2. the classification of the hazardous properties, testing, packaging, labelling and
placing on the market of chemical mixtures ^ 4) (hereinafter referred to as "mixture") on the territory of the United
Republic,
(b)) good laboratory practice,
(c)) the scope of the administrative authorities in providing protection against harmful
the effects of substances and mixtures.
§ 2
The scope of the law
(1) this law shall apply to substances, substances contained in the mixture or
the subject and the mixture.
(2) on plant protection products, auxiliary means to protect
plants ^ 5) and biocidal products ^ 6) from the obligations laid down in this
the Act only apply duties to the classification, packaging and labelling.
TITLE II
cancelled
§ 3
cancelled
§ 4
cancelled
§ 5
cancelled
§ 6
cancelled
§ 7
cancelled
§ 8
cancelled
§ 9
cancelled
§ 10
cancelled
§ 11
cancelled
the title launched
§ 12
cancelled
section 13 of the
cancelled
§ 14
cancelled
§ 15
cancelled
section 16 of the
cancelled
TITLE III
GOOD LABORATORY PRACTICE AND TESTING OF SUBSTANCES AND MIXTURES
§ 17
Good laboratory practice
(1) good laboratory practice for the purposes of this Act, the system
quality assurance relating to the organisational process and the conditions under
which are planned, performed, monitored, recorded, archived and
be notified to the non-clinical studies the safety of substances and mixtures for health and
the environment.
(2) the implementing legislation lays down the principles of good laboratory practice
(hereinafter "the policy").
Certificate of compliance with the principles
section 18
(1) for the purposes of this Act and the regulations directly applicable European
Union ^ 20) ^ 21) performs the testing of hazardous properties of the substance or
mixtures in the range of hazardous characteristics set out in parts 3 and 4
Annex I to the regulation of the European Parliament and of the Council (EC) no 1272/2008 ^ 21)
only a person who has a certificate of compliance with the policy (hereinafter referred to as
the "certificate").
(2) equivalent certificate issued by a Member State
The Organization for economic cooperation and development in accordance with the laws of the
The Organization for economic cooperation and development ^ 22).
(3) equivalent certificate issued by a Member State
Of the European Union.
§ 19
(1) a certificate issued by the Ministry of the environment on the basis of
the application of the person who intends to perform testing of the hazardous properties
the substance or mixture.
(2) in addition to the General requirements for issuing a certificate must contain
and) the name of the test facility,
(b)) the number of permissions to business activities and
(c) introduction of the) Declaration of good laboratory practice and the names and
surname of the natural person who is responsible for the implementation.
(3) the basis for issue of the certificate is a report on the progress of the input control
test equipment (hereinafter referred to as "input control"), performed by the
The Ministry of the environment established by the legal person for authentication
the policy.
(4) in the event that the input check shows that the person who intends to
perform testing of hazardous properties of the substance or the mixture adheres to the
policy, issues a certificate of her Ministry of the environment. In the opposite
case, shall issue a decision, which shall reject the application.
(5) when the input control in compliance with the principles identified
defects, which do not have a significant effect on the quality of the results of the testing
the hazardous properties of the substance or mixture, Ministry of
environment shall stay the proceedings and shall set a deadline to remove them.
section 20
(1) Ongoing verification of compliance with the policy holder of the certificate carried out
The Ministry of the environment established by the legal person for authentication
policy in the form of periodic checks of the test facility (hereinafter referred to as
"periodic inspection") or study audits.
(2) the person who requested the issue of the certificate, or the holder of the certificate
will allow the Ministry of the environment established by the legal entity for
When you input the policy validation check, periodic inspections and
study audits on the land, to the input objects and sites used to
testing and provide information on compliance with the principles to the extent
an implementing regulation.
(3) the information recorded in the entry check and periodic inspections
or study audits, in addition to the name of the laboratory, quality, compliance with the principles
and the date of the inspections carried out, shall be deemed confidential and can be
provided only to the authorities carrying out control activities,
The Ministry of the environment established by the legal person for authentication
policy, laboratory or study sponsor, covered by the specific inspection
or audit study.
(4) in the case of non-compliance with the principles established in the periodic inspection
or on request of the holder of the certificate may, Ministry of
environment decision to cancel the certificate.
(5) the certificate expires
and death or declaration) for the dead,
(b) dissolution of the legal person) or
(c) a decision on the cancellation of the certificate).
(6) the implementing law provides a range of information about compliance with the
the principles to be provided during the initial and periodic inspection and
study audit, a model certificate, the progress of the input checks, periodic
control and audit of studies and reports on their progress.
Testing of substances and mixtures
section 21
(1) the testing of the hazardous properties of the substance or mixture shall for the purposes of
This Act made for substances and mixtures in the State in which they are produced
or place on the market.
(2) a person who performs testing for hazardous properties of the substance or
the mixture is required when submitting the results of such testing in writing
confirm that the tests have been carried out in accordance with the principles.
TITLE IV
THE PROVISION OF INFORMATION
section 22
The obligation of notification
(1) the importer or downstream user ^ 23) who first placed on the market
The European Union on the territory of the Czech Republic, which has a dangerous mixture
physico-chemical properties or harmful properties that affect the
health, shall, within 45 days from the date on which this mixture for the first time said on
the market, the Ministry of health to provide information about its impact on
health, including information about its full composition and physico-chemical
properties in electronic form and to the extent provided for in the implementing
legal regulation.
(2) the supplier, which in the territory of the United States launches a mixture of
another Member State of the European Union, which has dangerous
physico-chemical properties or harmful properties that affect the
health, shall, within 45 days from the date on which this mixture for the first time said on
the market, the Ministry of health to provide information about its impact on
health, including information on its composition and physico-chemical
the properties contained in the safety data sheet is in electronic form and in
the scope of the implementing legislation.
(3) the manufacturer who places on the market of the European Union on the territory of the Czech Republic
a detergent, shall, within 45 days of the date when this detergent said on
the market for the first time, the Ministry of health to provide the information contained in the
According to the datasheet directly applicable European Union legislation
detergents ^ 24) in electronic form.
(4) a Distributor who in the territory of the United States launches a detergent
from another Member State of the European Union shall, within 45 days from the date
When this detergent on the market for the first time, provide to the Department of
health information published by the manufacturer according to the directly applicable
the European Union regulation on detergents ^ 24) in electronic form.
(5) the importer, downstream user or supplier pursuant to paragraphs 1 and 2, and
the manufacturer or distributor pursuant to paragraphs 3 and 4 shall be required to any amendment
the information provided by the Ministry of health to announce within 45
days of changes to the information.
(6) the implementing legislation sets out the information requested
in accordance with paragraphs 1 to 4.
TITLE V OF THE
PERFORMANCE OF STATE ADMINISTRATION
Article 23 of the
State administration bodies
State administration in the field of marketing of substances or substances contained in mixtures
and in the articles on the market and in the marketing of mixtures on the market under this Act
they perform
and the Ministry of the environment),
(b)), the Ministry of health,
(c)), the Ministry of industry and trade,
(d)) the Czech environmental inspection,
(e) the regional hygiene station),
f) Customs offices
g) State Office of labour inspection,
h) the central control and testing Institute of agriculture.
section 24
Ministry of the environment
(1) the Ministry of the environment
and) is the central body of State administration in the field of the protection of the
the environment from the harmful effects of substances, mixtures or substances contained in
mixtures and articles
(b)) is a central point of contact in accordance with the directly applicable
European Union regulations ^ 20) ^ 21) for the purpose of providing advice
manufacturers, importers, downstream users and other interested parties
regarding their duties and responsibilities in accordance with these regulations,
(c)) shall state supervision in the area of protection of the environment from the
the harmful effects of substances, mixtures or substances contained in mixtures or
articles manufactured, marketed or used,
(d)) to be issued and the certificate of compliance shall be deleted pursuant to § 7 para. 1 and §
20 (2). 4,
e) keeps a list of holders of a certificate of compliance with the principles and exposes it to
in the journal of the Ministry of the environment,
f) shall be the competent authority in accordance with the directly applicable
European Union regulations ^ 2) and represents the Czech Republic in the organs
The European Chemicals Agency,
g) permits the exemption in article 87(3)(c). 2 (2). 3 regulation of the European Parliament
and Council Regulation (EC) No 1907/2006 ^ 20) or article. 1 (1). 4 regulation of the European
Parliament and of the Council (EC) no 1272/2008 ^ 21),
h) informs the public about the risks of substances in accordance with the directly applicable
the EU regulation ^ 20).
(2) the Ministry of health Provides information about granting exceptions
According to § 14 para. 1, and article 15, paragraph 2. 1.
(3) the Ministry of the environment provides the competent authorities of the
The European Union and the European Chemicals Agency in the context of its
the scope of the reports and opinions in the scope, form and time intervals
in accordance with the requirements of European Union legislation in the field of the protection of the
the environment from the harmful effects of substances or substances contained in mixtures
and articles and mixtures.
(4) the Ministry of the environment shall cooperate with the competent authorities
The European Union, the European Chemicals Agency and the competent
authorities of the Member States of the European Union in the field of the protection of the
the environment from the harmful effects of substances or substances contained in mixtures
and articles and mixtures.
§ 25
The Ministry of health
(1) the Ministry of health
and) is the central body of State administration in the field of public health protection
from the harmful effects of substances, mixtures or substances contained in mixtures and
articles,
(b) be submitted) collects information according to § 22 para. 1 to 5 and article. 45
directly applicable European Union legislation on the classification, packaging and
labelling of substances and mixtures, ^ 21) and enables remote access to them
Toxicological information centre
(c)) shall represent the Czech Republic in the bodies of the European chemical Agency
the substance,
d) within its jurisdiction shall inform the public of the risks of substances or
substances contained in mixtures and articles of dangerous for health.
(2) the Ministry of health provides the competent authorities of the European
the Union and the competent authorities of the Member States of the European Union News and
views on the scope, form and time intervals in accordance with the
the requirements of European Union legislation in the field of the protection of public
health from the harmful effects of substances, mixtures or substances contained in
mixtures and articles.
(3) the Ministry of Health cooperates with the competent authorities
The European Union and the competent authorities of the Member States of the European Union on the
protection of public health against the harmful effects of substances, mixtures or
substances contained in mixtures and articles.
section 26
The Ministry of industry and trade
The Ministry of industry and trade
and he represents the Czech Republic) in the organs of the European Agency for chemical
the substance,
b) cooperates with the Ministry of environment in the provision of
advice to manufacturers, importers, downstream users and other
the persons concerned on their responsibilities and accountability by directly
applicable European Union legislation ^ 20) ^ 21),
(c)) shall inform the public about the risks of the substances referred to in article. 123 directly
of the applicable legislation of the European Union concerning the registration, evaluation, authorisation
and restriction of chemicals ^ 20).
section 27 of the
Czech environmental inspection
Czech environmental inspection
and as) checks the suppliers of substances, mixtures or articles
compliance with the provisions of this Act, the legislation adopted for its
implementation, the directly applicable European Union legislation ^ 2) and decision of the
the administrative authorities referred to in this Act,
b) stores the fines for infringement of the obligations under this law, legal
the rules adopted for its implementation, the directly applicable provisions
The European Union ^ 2) and decision of the administrative authorities under this Act.
section 28
The regional hygiene station
The regional hygiene station
and as) checks the suppliers of substances, mixtures or articles
compliance with the provisions of this Act, the legislation adopted for its
implementation, the directly applicable European Union legislation ^ 2) and decision of the
the administrative authorities referred to in this law, from the point of view of health protection,
(b)) checks the compliance with the provisions of this Act, legal
the rules adopted for its implementation, the directly applicable provisions
The European Union ^ 2) and decision of the administrative authorities issued under this
the law, if the govern the content of substances in articles intended to come into contact with
food, toys, cosmetics, products for children
the age of 3 years and in products intended for direct contact with drinking, hot
or raw water in their collecting, collection, transport, treatment, divorce,
the collection, measurement, delivery and other similar purposes,
c) stores the fines for infringement of the obligations under this law, legal
the rules adopted for its implementation, the directly applicable provisions
The European Union ^ 2) and decision of the administrative authorities under this Act.
section 29
The State Labour Inspection Office
The State Labour Inspection Office
and as) checks the suppliers of substances, mixtures or articles
compliance with the provisions of this Act, the legislation adopted for its
implementation, the directly applicable European Union legislation ^ 2) and decision of the
the administrative authorities referred to in this law, in terms of safety at work,
b) stores the fines for infringement of the obligations under this law, legal
the rules adopted for its implementation, the directly applicable provisions
The European Union ^ 2) and decision of the administrative authorities under this Act.
section 30
The Customs Office
The Customs Office
and keeps records of all) of substances and mixtures, exported from the territory of the Czech Republic
and imported on the territory of the Czech Republic. This registration will allow
workers of the Ministry of the environment, Ministry of
health, the Czech environmental inspection, the Central
control and testing Institute of agricultural and regional health
stations to inspect, take excerpts or copies,
(b)) are checked as exporters and importers to compliance with the provisions of this
law, legal regulations issued for its implementation, the directly applicable
European Union legislation ^ 2) and decision of the administrative authorities referred to in this
the law,
c) stores the fines for infringement of the obligations under this law, legal
the rules adopted for its implementation, the directly applicable provisions
The European Union ^ 2) and decision of the administrative authorities under this Act.
section 31
The central control and testing Institute of agricultural
The central control and testing Institute of agricultural
and as) checks the suppliers of substances and mixtures complied with the provisions of the
This Act, legislation issued for its implementation, directly
applicable European Union legislation and decisions of administrative authorities referred to in
This Act, as they relate to the classification, packaging and labelling of
of plant protection products,
b) stores the fines for infringement of the obligations under this law, legal
the rules adopted for its implementation, the directly applicable provisions
The European Union ^ 2) and decision of the administrative authorities under this Act, and
It gives the Ministry of the environment to exercise State supervision
from the harmful effects of the manufactured, marketed or used
of plant protection products or other means to protect
plants.
§ 32
cancelled
TITLE VI OF THE
CORRECTIVE MEASURES AND ADMINISTRATIVE OFFENCES
§ 33
Corrective measures
(1) the competent administrative authorities referred to in article 23 (a). d) to (h)) are entitled to
to order the
a) to the person who stated on the market a substance or mixture is contrary to the requirements of the
their classification, packaging or labelling laid down directly
applicable to the EU regulation on classification, labelling and
^ 21) labelling, to suspend their placing on the market by the time
before stating their classification, packaging and labelling in accordance with the following
requirements,
(b)) to the person who said the substance or the substance in the mixture or subject on the market,
without the obligation to register in accordance with fulfilled directly applicable legislation
The European Union on the registration, evaluation, authorisation and restriction of
chemicals ^ 20), its withdrawal from the market,
(c) the person who has infringed) prohibition or restrictions on the placing on the market a substance
alone or in a mixture or article under Titles VII and VIII
directly applicable European Union regulation concerning the registration, evaluation,
authorisation and restriction of chemical substances ^ 20), its withdrawal from the market,
(d)) to remove the infringement in the placing of substances, mixtures or
items on the market for the disposal of a hazardous substance, mixture or article on the
the cost of their owner, or of the holder, if the owner is not known,
If there is damage to the health or life of man, the
environment or, if it occurred,
(e)) to remove the infringement in the area of import and export of substances,
mixtures or articles for the disposal of a hazardous substance, mixture or article
at the expense of their owner, or of the holder, if the owner is not known,
If there is damage to the health or life of man, the
environment or, if it occurred,
(f)) to remove the infringement in the placing of
plant protection products or other means of plant protection products on the market
disposal of hazardous plant protection product or an additional
resource on plant protection products or simultaneous protection
plants at the expense of their owner, or of the holder, unless the
I know the owner, if there is a risk of damage to human or animal health or the
damage to the environment or if it has already occurred,
(g))
cancelled
(h)) to the person who launched the surfactant or detergent
containing surfactants that meet the criteria of biological
the biodegradability of a directly applicable provision provided for the European Union of
^ 28) detergents, their withdrawal from the market, or
I) to the person who stated detergent on the market that does not meet the content restrictions
phosphates and other phosphorus compounds provided for directly applicable
the EU regulation on detergents ^ 28), its withdrawal from the market.
(2) an appeal against a decision to withdraw the substance, mixture or article from
market or the disposal of a hazardous substance, mixture or article does not have
suspensory effect.
§ 34
Administrative offences of legal entities and natural persons-entrepreneurs
(1) a person who carries out testing the properties of substances or mixtures
dangerous for health and the environment, for the purposes of this Act,
committing an administrative offense, by
and testing of the hazardous properties) is a substance or mixture for the purposes
This law and the directly applicable European Union legislation ^ 20) ^ 21)
without a certificate pursuant to § 18 para. 1, or
b) contrary to section 21 para. 2 in writing does not confirm that testing of dangerous
properties of the substance or the mixture was done in accordance with the principles.
(2) the manufacturer or importer is guilty of an administrative offense, by
and produces or imports the substance) or the substance in the mixture or article without
registration or notification in accordance with regulation directly applicable European
Union on the registration, evaluation, authorisation and restriction of chemicals
substances ^ 20), or
b) contrary to the directly applicable EU regulation on classification,
labelling and packaging of substances and mixtures ^ 21) does not notify the details of the classification.
(3) the manufacturer is guilty of an administrative offense by that, contrary to directly
applicable to the EU regulation on detergents ^ 28) launches on
the territory of the Czech Republic
and) surfactant or detergent containing surface active
substance which does not meet the criteria biodegradability established
directly applicable EU regulation on detergents ^ 28), or
b) detergent or detergent intended for the consumer for
for consumers, the automatic dishwasher.
(4) the manufacturer, importer or downstream user is guilty of an administrative
tort by
and) contrary to the directly applicable European Union regulation concerning the registration,
evaluation, authorisation and restriction of chemicals ^ 20) launches
or uses the substance without permission,
b) contrary to the directly applicable European Union law
persistent organic pollutants ^ 25) produced, shall appear on the
market or uses the substance, or
c) contrary to the directly applicable EU regulation on classification,
labelling and packaging of substances and mixtures ^ 21) classified the substance or mixture
before placing them on the market or is classified differently than the
This prescription.
(5)
cancelled
(6) the manufacturer, importer, downstream user or distributor commits
the administrative offense by
and) contrary to the directly applicable European Union regulation concerning the registration,
evaluation, authorisation and restriction of chemicals) does not provide the 20 ^ ^
information in the supply chain
(b)) in violation of title VIII directly applicable European Union legislation
the registration, evaluation, authorisation and restriction of chemicals ^ 20)
be constructed, to market or it's the substance or the substance in the mixture or
the subject,
(c)) shall appear on the market a substance or mixture classified as hazardous, without
ensure its labelling and packaging according to the directly applicable legislation
The European Union on the classification, labelling and packaging of substances and mixtures ^ 21),
(d))
cancelled
(e))
cancelled
(f))
cancelled
(g))
cancelled
h) contrary to the directly applicable EU regulation on classification,
labelling and packaging of substances and mixtures ^ 21) does not retain the evidence of compliance with the
the requirements for the classification and labelling of the substance or mixture as long
that is the substance or mixture is placed on the market, and for the next 10 years
Since the last launch, or otherwise on request to the competent
administrative authorities,
I) contrary to the directly applicable EU regulation on classification,
labelling and packaging of substances and mixtures ^ 21) is mentioned in the menu of the dangerous
the substance or mixture that allows the purchase contract without knowledge
the information provided on the label or packaging of substances or mixtures, information about
its hazards,
j) contrary to the directly applicable European Union regulation concerning the registration,
evaluation, authorisation and restriction of chemicals) does not retain the 20 ^ ^
all information that it requires for the performance of their duties, for a period,
This is a substance or mixture is placed on the market, and for a period of 10 years from the
the last entry on the market.
(7) the exporter or importer is guilty of an administrative offense, by
and) contrary to the directly applicable EU regulation concerning the export and
import of dangerous chemicals ^ 26) imports or export the substance, or
b) contrary to the directly applicable EU regulation concerning the export and
imports of hazardous chemicals the Ministry does not provide ^ 26)
environmental information on imports and exports.
(8) the exporter is committing an administrative offense by that, contrary to directly
applicable to the EU regulation on the banning of exports of metallic mercury and
some of the compounds and mixtures of mercury ^ 27) Mercury, its compounds or
the mixture.
(9) the manufacturer engaged in the production of chlorine and chlor-alkali industry is
committing an administrative offense by that, contrary to the directly applicable
the EU regulation on the banning of exports of metallic mercury and certain
compounds and mixtures of mercury ^ 27) does not provide the Ministry of the environment
provided for information.
(10) the downstream user is guilty of an administrative offense by that, contrary to
directly applicable EU regulation on registration, evaluation,
authorisation and restriction of chemical substances ^ 20)
and) a chemical safety report is not produced or does not provide the European
Chemicals Agency certain information, or
(b)) unless the or not apply appropriate measures to adequately control risks
identified
1. the safety data sheet supplied to him,
2. in his own chemical safety assessment, or
3. any information on risk management measures, that have been
provided.
(11) the registrant is committed by the administrative offense to the fact that
contrary to the directly applicable European Union regulation concerning the registration,
evaluation, authorisation and restriction of chemicals ^ 20)
and does not provide the European Agency for the) chemical substances set out information,
(b) it provides for or does not apply), appropriate measures to adequately control the risks
identified in the chemical safety assessment or is not in
the safety data sheets
(c)) does not maintain a chemical safety report or it does not update, or
(d)) does not update your registration data by adding information that the newly
found, or does not submit the European Chemicals Agency.
(12) the importer, downstream user or vendor, who, as first reported by
on the market in the territory of the Czech Republic, which has a dangerous mixture
physico-chemical properties or harmful properties that affect the
health, committing an administrative offense that does not provide the Ministry of
health information pursuant to section 22 paragraph 1. 1 or 2.
(13) the manufacturer or distributor who places on the market in the territory of the United
Republic of detergent, is guilty of an administrative offense, by
and) launches a detergent without ensuring its name according to directly
applicable European Union legislation on detergents ^ 28),
(b)) launches a detergent that does not meet the restriction of phosphate content
and other compounds of phosphorus by directly applicable regulation
Union of detergents ^ 28), or
(c)) does not provide the Ministry of health information pursuant to section 22 paragraph 1. 3
or 4.
(14) the importer, downstream user, vendor, manufacturer or distributor
committing an administrative offense that change has not notified the information provided by the
The Ministry of health, pursuant to section 22(1) of the 5.
(3) the person who launched the substance or mixture that does not meet the
the requirements for the classification, packaging or labelling laid down directly
the applicable law of the European Union ^ 21), is guilty of an administrative offense
by not further marketing of the substance or preparation on the market pursuant to §
33 para. 1 (b). and).
(16)
cancelled
(5) the person who said the substance or the substance in the mixture or subject to
market, without the obligation to register in accordance with fulfilled directly applicable
Regulation of the European Union ^ 20), is guilty of an administrative offense to the fact that
contrary to the decision of the competent administrative authority according to § 33 para. 1
(a). (b)) does not download such a substance, mixture or article from the market.
(6) a person who has infringed the prohibition or restriction of the placing on the market of substances
alone or in a mixture or article under Titles VII and VIII
directly applicable European Union legislation ^ 20), is guilty of an administrative
offense by that, contrary to the decision of the competent administrative authority
According to § 33 para. 1 (b). (c)) does not download such a substance, mixture or article
the market.
(19)
cancelled
(20) the person who launched the surfactant or detergent
containing surfactants that meet the criteria of biological
the biodegradability of a directly applicable provision provided for the European Union of
detergents ^ 28), is guilty of an administrative offense that does not download such
surfactant or detergent containing surface active
substance from the market in accordance with § 33 para. 1 (b). (h)).
(21) a person who launched the detergent that does not meet the restrictions
phosphates and other phosphorus compounds provided for directly
applicable to the EU regulation on detergents ^ 28), is guilty of an
the administrative offense that does not download such detergent from the market in accordance with § 33
paragraph. 1 (b). I).
(22) For administrative offences is fined
to 5 000 000 Czk), in the case of an administrative offence referred to in paragraph 2 (a). and)
paragraph 4 (b). and) or (c)), paragraph 6 (a). (b)), or (c)), or paragraph
15, 17 or 18
(b))
cancelled
(c)) to $ 3 000 000, in the case of an administrative offence referred to in paragraph 4 (b). (b)),
paragraph 6 (a). a), h), (i)) or (j)), paragraph 7 (b). a), paragraph 8,
paragraph 10 (a). (b)), paragraph 11 (a). (b) paragraph 13 (a)). and) or
(b)) or paragraphs 20 or 21,
(d)) to 2 500 000 CZK in the case of an administrative offence under paragraph 11 (b). and)
or (d)),
(e))
cancelled
(f)) to 1 000 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). and)
paragraph 2 (a). (b)), paragraph 3, paragraph 7 (b). (b)), paragraph 9,
paragraph 10 (a). and paragraph 11 (a)). and), (c)) or (d)), paragraph 12
or (b) of paragraph 13. (c)),
g) to 500 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (b))
or paragraph 14.
§ 35
Provisions common to administrative offences
(1) a person for administrative offence is not liable if he proves that the intervener
all the effort that it was possible to require that the infringement of the legal
the obligation to prevent.
(2) when deciding on the imposition of fines and the determination of its amount,
taking into account the severity of the administrative offense, in particular, to the way its
having committed and its consequences, and the circumstances under which it was committed.
(3) the liability of a 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,
not later than 3 years from the date on which it was committed.
(4) administrative offences under this Act from the administrative authorities referred to in
section 23 (a). d) to (h)) in the first instance hearing the one committing the
the administrative offense found out first.
(5) the income from the fines imposed on the Czech environmental inspectorate is
income the State Environmental Fund and income from the fines imposed
in other administrative authorities of the State budget revenue.
TITLE VII
TRANSITIONAL, ENABLING AND CANCELLATION PROVISIONS
section 36
Transitional provisions
(1) the proceedings initiated and the unfinished until the date of entry into force of this Act
shall be completed according to the existing legislation.
(2) the authorization for use of an alternative name in the marking of the mixture, with the consent
the exception of the requirements for the labelling of mixtures and the certificate of compliance with the principles
issued by the Ministry of the environment in accordance with the existing laws,
the regulations remain in effect.
(3) the information duty according to § 22 para. 1 to 5 of mixtures and
detergents, which at the time of entry into force of this Act on the market
on the territory of the Czech Republic, must be met by 1. December 2012.
§ 37
The issue of the implementing legislation
(1) the Ministry of industry and trade will issue a decree to implement paragraph 6 (1).
3, § 11 (1) 3 and § 12 para. 6.
(2) the Department of health will issue a decree to implement section 22(2). 6.
(3) the Ministry of the environment shall issue a decree to implement section 14
paragraph. 5, § 17 para. 2 and article 20 (2). 6.
§ 38
Regulation (EEC)
Shall be repealed:
1. Act No. 356/2003 SB., on chemical substances and chemical preparations
and amending certain laws.
2. Act No. 346/2005 Coll., amending Act No. 356/2003 SB., on
chemical substances and chemical preparations and amending certain laws,
in the wording of later regulations.
3. Law No 371/2008 Coll., amending Act No. 356/2003 SB., on
chemical substances and chemical preparations and amending certain laws,
in the wording of later regulations.
4. Decree No. 222/2004 Coll., on principles of good laboratory practice.
5. Decree No. 232/2004 Coll., which implements certain provisions of
the law on chemical substances and chemical preparations and amending
Some laws, relating to the classification, packaging and labelling of
hazardous chemical substances and chemical preparations.
6. Decree No. 235/2004 Coll., on the possible use of alternative or
another different name of hazardous chemicals in the designation
hazardous chemical product and the granting of exemptions to the packaging and
labelling of dangerous chemical substances and chemical preparations.
7. Decree No. 279/2005 Coll., amending Decree No 219/2004 Coll., on
the principles of good laboratory practice.
8. Decree No. 369/2005 Coll., amending Decree No. 232/2004 Sb.
by implementing some provisions of the Act on chemical substances and
chemical preparations and amending certain acts relating to
to the classification, packaging and labelling of dangerous substances and
chemical products.
9. Decree No. 28/2007 Coll., amending Decree No. 232/2004 Sb.
by implementing some provisions of the Act on chemical substances and
chemical preparations and amending certain acts relating to
to the classification, packaging and labelling of dangerous substances and
chemical preparations, as amended by Decree No. 369/2005 Sb.
10. Decree No 389/2008 Coll., amending Decree No. 232/2004 Sb.
by implementing some provisions of the Act on chemical substances and
chemical preparations and amending certain acts relating to
to the classification, packaging and labelling of dangerous substances and
chemical preparations, as amended.
11. Decree No. 139/2009 Coll. on restriction of hazardous substances and
hazardous chemical products.
12. Decree No. 265/2010 Coll., on providing information about some of the
hazardous chemical products.
PART TWO
Amendment of the Act on labour inspection
§ 39
Act No. 251/2005 Coll., on labour inspection, as amended by law no 230/2006
Coll., Act No. 262/2006 Coll., Act No. 213/2007 Coll., Act No. 362/2007
Coll., Act No. 294/2008 Coll., Act No. 382/2008 Coll., Act No. 281/2009
Coll. and Act No. 73/2010 Coll., shall be amended as follows:
1. In article 3, paragraph 3. 3, the words "special legislation" ^ 9) "are replaced by
the words "special legislation" ^ 9) ".
Footnote 9 is added:
"9) Law No 59/2006 Coll. on the prevention of major accidents caused by
selected hazardous chemicals or chemical products and
Amendment of the Act No. 258/2000 Coll., on the protection of public health and amending
some related laws, as amended, and the Act
No. 320/2002 Coll., amending and repealing certain acts in connection with the
the termination of the activities of the district offices, as amended,
(law on the prevention of major accidents), as amended.
Law No. 350/2007 Coll., on chemical substances and chemical mixtures and
amendments to certain laws (legislation). ".
2. In paragraph 17, the dot at the end of paragraph 1 is replaced by a comma and the following
Letter zb) including footnote # 75:
"the zb) does not follow the measures to prevent risks in the workplace, as provided for
the law governing the obligations of legal entities and
entrepreneurial natural persons in the use of chemicals or substances
contained in mixtures ^ 75).
75) Law No 350/2011 Sb. ".
3. in section 17(2). 2 (a). (d)), the words ") and u)" shall be replaced by "), u) and
zb) ".
4. in section 30 is at the end of paragraph 1, the period is replaced by a comma and the following
Letter zb), which read as follows:
"the zb) does not follow the measures to prevent risks in the workplace, as provided for
the law governing the obligations of legal entities and
entrepreneurial natural persons in the use of chemicals or substances
contained in mixtures ^ 75). ".
5. in section 30 paragraph 2. 2 (a). (d)), the words ") and u)" shall be replaced by "), u) and
zb) ".
PART THREE
Amendment of the Act on fire protection
section 40
Act No. 133/1985 Coll., on fire protection, as amended by Act No. 425/1990
Coll., Act No. 41/1994 Coll., Act No. 209/1994 Coll., Act No. 167/1998
Coll., Act No. 71/2000 Coll., Act No. 242/2000 Coll., Act No. 320/2002
Coll., Act No. 413/2005 Coll., Act No. 186/2006 Coll., Act No. 262/2006
Coll. and Act No. 281/2009 Coll., is amended as follows:
1. In section 4, paragraph 4. 2 (a). a), the words "hazardous substances and preparations
are classified as oxidizing, extremely flammable, highly flammable and
flammable ^ 1b), in a total quantity exceeding 1 000 kg of these substances, and
products in solid form or 250 liters of such substances and preparations in the
liquid state "shall be replaced by" substances and mixtures classified in accordance with
special legislation governing chemicals area ^ 1b)
as oxidising, extremely flammable, highly flammable and flammable substances, or
and mixtures that meet the hazard class and category criteria 2.3; 2.6
and 2.7; 2.8 types A to F; 1.8 to 2.14 and 2.15 types A to F as set out in
directly applicable European Union legislation ^ 13), if the total amount of
These substances and mixtures exceeds 1 000 kg in solid form or 250 liters in
liquid state ".
Footnote 1b and 13 shall be added:
"1b) Law No 350/2007 Coll., on chemical substances and chemical mixtures and
amending some laws (legislation).
13) Annex I to the European Parliament and Council Regulation (EC) no 1272/2008
of 16 December 2002. December 2008 on classification, labelling and packaging of substances and
mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC and amending
Regulation (EC) No 1907/2006, as amended. ".
2. In section 4, paragraph 4. 3 (b). a), the words "hazardous substances and preparations
are classified as oxidizing, extremely flammable, highly flammable and
flammable ^ 1b), in a total quantity greater than 5 000 tonnes ' is replaced by
"substances and mixtures classified under special legislation
governing the area ^ 1b chemicals) as oxidizing, extremely
flammable, highly flammable and flammable, or substances and mixtures that meet the
hazard class and category criteria 2.3; 2.6 and 2.7; 2.8 types A to
(F); 1.8 to 2.14 and 2.15 types A to F as set out in the applicable directly
Regulation of the European Union ^ 13), if the total amount of these substances and mixtures
exceeds 5 000 tonnes ".
3. In section 4, paragraph 4. 3 (b). (c)), the words "secures transport of dangerous
substances and preparations in liquid or gaseous state that are
classified as extremely flammable, highly flammable and flammable, in
pipe internal diameter 0.8 m and larger "are replaced by the words" in the
internal diameter of 0.8 m and more secures transport of liquid or
gaseous substances and mixtures classified under a special legal
the rules relating to a range of chemicals as an extremely ^ 1b)
flammable, highly flammable and flammable, or liquid or gaseous substances
and mixtures that meet the hazard class and category criteria 2.2 to
2.4; 2.6; 2.8 type A to F; 2.9; 2.11 to 2.13 2.15 type A to F
laid down in the applicable legislation of the European Union directly ^ 13) ".
PART FOUR
Amendment of the Act on administrative fees
§ 41
In the annex to the Act No 634/2004 Coll., on administrative fees, as amended by
Act No. 217/2005 Coll., Act No. 228/2005 Coll., Act No. 361/2005 Coll.
Act No 444/2005 Coll., Act No. 545/2005 Coll., Act No. 553/2005 Coll.
Act No. 48/2006 Coll., Act No. 56/2006 Coll., Act No. 57/2006 Coll.
Act No. 81/2006 Coll., Act No. 109/2006 Coll., Act No. 112/2006 Coll.
Act No. 130/2006 Coll., Act No. 137/2006 Coll., Act No. 137/2006 Coll.,
Act No. 159/2006 Coll., Act No. 179/2006 Coll., Act No. 186/2006 Coll.
Act No 215/2006 Coll., Act No. 227/2006 Coll., Act No. 227/2006 Coll.
Act No. 235/2006 Coll., Act No. 309/2006 Coll., Act No. 575/2006 Coll.
Act No. 106/2007 Coll., Act No. 261/2007 Coll., Act No. 261/2007 Coll.
Act No. 374/2007 Coll., Act No. 379/2007 Coll., Act No. 38/2008 Coll.,
Act No. 130/2008 Coll., Act No. 140/2008 Coll., Act No. 182/2008 Coll.,
Act No. 189/2008 Coll., Act No. 230/2008 Coll., Act No. 239/2008 Coll.,
Act No. 254/2008 Coll., Act No. 297/2008 Coll., Act No. 297/2008 Coll.,
Act No 301/2008 Coll., Act No. 309/2008 Coll., Act No 312/2008 Coll.,
Act No. 382/2008 Coll., Act No. 9/2009 Coll., Act No. 41/2009, Coll.,
Act No. 141/2009 Coll., Act No. 197/2009 Coll., Act No. 207/2009 Coll.,
Act No. 227/2009 Coll., Act No. 281/2009 Coll., Act No. 291/2009 Coll.,
Act No. 301/2009 Coll., Act No. 346/2009 Coll., Act No. 420/2009 Coll.,
Act No. 132/2010 Coll., Act No. 148/2010 Coll., Act No. 153/2010 Coll.,
Act No. 160/2010 Coll., Act No. 343/2010 Coll., Act No. 427/2010 Coll.,
Act No. 30/2011 Coll., Act No. 105/2007 Coll., Act No. 133/2007 Coll.
Act No. 134/2007 Coll., Act No. 152/2007 Coll., Act No. 188/2007 Coll.
Law No 245/2007 Coll., Act No. 249/2011 Coll., Act No. 255/2011 Sb.
and Act No. 262/2006, item 102, including footnotes.
61 repealed.
PART FIVE
Amendment to the Trade Licensing Act
§ 42
In annex No. 2 TRADES the BOUND in Act No. 455/1991 Coll., on the
trades (Trade Act), as amended by Act No.
200/1994 Coll., Act No. 283/1995 Coll., Act No. 147/1996 Coll., Act No.
280/1997 Coll., Act No. 82/1998 Coll., Act No. 157/1998 Coll., Act No.
159/1999 Coll., Act No. 359/1999 Coll., Act No. 27/2000 Coll., Act No.
29/2000 Coll., Act No. 128/2000 Coll., Act No. 151/2000 Coll., Act No.
247/2000 Coll., Act No. 247/2000 Coll., Act No. 258/2000 Coll., Act No.
308/2000 Coll., Act No. 406/2000 Coll., Act No. 458/2000 Coll., Act No.
100/2001 Coll., Act No. 120/2001 Coll., Act No. 164/2001 Coll., Act No.
273/2001 Coll., Act No. 483/2001 Coll., Act No. 174/2002 Coll., Act No.
86/2002 Coll., Act No. 130/2003 Coll., Act No. 441/2003 Coll., Act No.
167/2004 Coll., the Act No. 326/2004 Coll., Act No. 695/2004 Coll., Act No.
58/2005 Coll., Act No. 95/2005 Coll., Act No. 76/2006 Coll., Act No.
131/2006 Coll., Act No. 191/2006 Coll., Act No. 216/2006 Coll., Act No.
225/2006 Coll., Act No. 130/2008 Coll., Act No. 189/2008 Coll., Act No.
145/2010 Coll. and Act No. 155/2010 Coll., on business "Production
hazardous chemical substances and hazardous chemical products and
sale of chemical substances and chemical preparations classified as
very toxic and toxic *) *) "in the first column, the words ' chemical
preparations "shall be replaced by the words" chemical mixtures "in the second column, the
the words "chemical products" shall be replaced by the words "chemical mixtures", in
the third column, the words "§ 2 (2). 2 Act No. 356/2003 SB., on
chemical substances and chemical preparations and amending certain laws,
as amended, "shall be replaced by the words" § 5 para. 1 (b). (f)), and
g) Act No. 350/2007 Coll., on chemical substances and chemical mixtures and
amending some laws (legislation) ", the words" chemical
the product "shall be replaced by the words" chemical mixtures "and at the end of the text
the words "Act No. 145/2010 Coll. and Act No. 155/2010 Sb.".
PART SIX
Changing the law amending certain laws in connection with the adoption of the
the law on the customs administration of the Czech Republic
§ 43
Act No. 186/2004 Coll., amending certain laws in relation to
the adoption of the law on the customs administration of the Czech Republic, as amended by Act No.
189/2006 Coll., section 17 is repealed.
PART SEVEN
Amendment of the Act, amending Act No 120/2002 Coll., on conditions for
placing of biocidal products and active substances on the market and amending
some related laws, as amended by Act No. 186/2004 Coll., and
some other laws
§ 44
In the law No 125/2005 Coll., amending Act No 120/2002 Coll., on
terms of placing of biocidal products and active substances on the market and on the
changes to some related laws, as amended by Act No. 186/2004 Coll.
and some other laws, is part of the second deleted.
PART EIGHT
Amendment of the Act amending the Act No. 76/2002 Coll. on integrated
pollution prevention and control, on the integrated pollution registry and
on amendments to certain acts (the Act on integrated prevention), as amended by
amended, and certain other laws
§ 45
In Act No. 222/2006 Coll., amending Act No. 76/2002 Coll., on
integrated pollution prevention and control, on the integrated registry
pollution and on amendments to certain acts (the Act on integrated pre-
Abigail), as amended, and some other laws, is part of the
12 repealed.
PART NINE
Changing the law amending certain laws in connection with the adoption of the
the law on basic registers
§ 46
In Act No 227/2009 Coll., amending certain laws in relation to
the adoption of the law on basic registers, part of the one hundred and forty repealed.
PART TEN
Changing the law amending certain laws in connection with the adoption of the
the tax code
§ 47
In Act No 281/2009 Coll., amending certain laws in relation to
the adoption of the tax code, as amended by law No 153/2010 Coll., shall be part of the one hundred
twenty-four deleted.
PART ELEVEN
Amendment of the Act, amending Act No 326/2004 Coll., on phytosanitary
care and amending certain related laws
§ 48
In the law No 245/2007 Coll., amending Act No 326/2004 Coll., on
plant health care and amending certain related laws, in
as amended, and other related laws, part two
repealed.
PART TWELVE
The EFFECTIVENESS of the
§ 49
1. this Act shall come into effect on the first day of the second calendar month
following the date of its publication.
2. The provisions of title II and § 33 para. 1 (b). (g)), section 34 para. 5, § 34
paragraph. 6 (a). d) to (g)), section 34 para. 16, § 34 paragraph 1. 19 and § 34 paragraph 1. 22
(a). (b)), and (e)) shall expire on the expiry of 31 March 2004. may 2015.
Němcová in r.
Klaus r.
Nečas in r.
Annex 1
The minimum concentrations of dangerous substances contained in the mixture, which is
taken into account in the classification of mixtures
--------------------------------------------- -------------------------------
Concentration, which is
taken into account for the
Hazard category gas mixtures mixtures of different
% by volume than gas
% by weight
--------------------------------------------- -------------------------------
Highly toxic 0.02 0.1
--------------------------------------------- -------------------------------
Toxic 0.02 0.1
--------------------------------------------- -------------------------------
Carcinogenic category 1 or 2 0.02 0.1
--------------------------------------------- -------------------------------
Mutagen category 1 or 2 0.02 0.1
--------------------------------------------- -------------------------------
Toxic for reproduction, category 1 or 2 0.02 0.1
--------------------------------------------- -------------------------------
Harmful 0.2 1
--------------------------------------------- -------------------------------
Corrosive 0.02 1
--------------------------------------------- -------------------------------
Irritating 0.2 1
--------------------------------------------- -------------------------------
Sensitizing 0.2 1
--------------------------------------------- -------------------------------
Carcinogenic, category 3 0.2 1
--------------------------------------------- -------------------------------
Mutagenic category 3 0.2 1
--------------------------------------------- -------------------------------
Toxic for reproduction, category 3 0.2 1
--------------------------------------------- -------------------------------
Dangerous for the environment and assigned the 0.1
the symbol N
--------------------------------------------- -------------------------------
Dangerous for the ozone layer of the Earth 0.1 0.1
--------------------------------------------- -------------------------------
Dangerous for the environment without 1
assigned the symbol N
--------------------------------------------- -------------------------------
Annex 2
The limit concentrations of dangerous substances to change the classification
hazardous mixtures
-------------------------------------------------------------------
The default range of concentrations (c) Permissible change in the default
the substance contained in a mixture, the concentration of the substance contained in the
the mixture
-------------------------------------------------------------------
c =< 2,5 % +/- 30 %
2,5 % < c =< 10 % +/- 20 %
10 % < c =< 25 % +/- 10 %
25% c = 100 <