324/2016 Sb.
LAW
of 6 May 1999. September 2016
on biocidal products and active substances and amending certain
related laws (law on biocides)
Parliament has passed the following Act of the United States:
PART THE FIRST
BIOCIDAL PRODUCTS AND ACTIVE SUBSTANCES
TITLE I OF THE
THE SUBJECT OF THE EDIT
§ 1
This law regulates the following on directly applicable provisions of the European
Union governing of biocidal products on the market and their
use of ^ 1)
and legal and) certain obligations of individuals engaged in
biocidal products on the market in the territory of the United States and their
the use,
(b) providers of health services) the obligation to report data on poisonings
biocidal products and active substances into the national health
the information system,
(c)) the scope of the administrative organs in the performance of State administration in the field of
the supply and use of biocidal products, in the field of active substances and the
supply of treated articles,
d) penalties for infringement of obligations laid down directly applicable
European Union regulations governing the biocidal products on
marketing and use of "^ 1") and this Act.
TITLE II
ONE OF THE OBLIGATIONS OF LEGAL ENTITIES AND NATURAL PERSONS ENGAGED IN THE
BIOCIDAL PRODUCTS ON THE MARKET IN THE TERRITORY OF THE CZECH REPUBLIC
§ 2
(1) the Legal and entrepreneurial natural persons that supply the biocidal
product on the market in the territory of the Czech Republic
and on-demand) Ministry of health (hereinafter referred to as "the Ministry")
provide the model or design for packaging, labelling or package leaflet
information ^ 2)
(b)) shall ensure that the biocidal product has been marked in the Czech language, including
leaflet ^ 3),
(c)) shall ensure that the biocidal product has been classified, known and packed
According to the article. 69 European Parliament and Council Regulation (EU) No 528/2012 ^ 4)
(hereinafter referred to as the "regulation on biocides"), unless it is of the biocidal product
referred to in § 13 para. 1.
(2) the Legal and entrepreneurial natural persons submitted by the
the Ministry of a request for authorisation of a biocidal product or a request for
mutual recognition of a national authorisation of a biocidal product shall submit to the
the Ministry of
application for authorisation) of the biocidal product or application for mutual recognition
a national authorisation of the biocidal product in the Czech language ^ 5),
(b) the documentation presented by the application) in the Czech language; of the Charter, which
are part of the documentation, and have been prepared in a language other than English,
must be submitted in the original texts and at the same time in the translation into Czech
the language of the ^ 5),
(c) the summary of the biocidal product characteristics) in the Czech language ^ 6)
d) translation of biocidal product granted by the reference member
State, in any language, with respect to an application for mutual recognition of
a national authorisation of the biocidal product ^ 7).
(3) the Ministry may waive the requirement to allow documents to be submitted
referred to in paragraph 2 have been translated into the Czech language, and provided to the applicant,
that such a translation is not required. Such a measure may make Ministry
Declaration on their notice board for an indefinite number of proceedings in
the future.
TITLE III
REPORTS OF POISONING
§ 3
(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
products and active substances. Data provider of health services
passes the manner prescribed by law on health services ^ 8).
(2) information on biocidal products and active substances obtained pursuant to
the directly applicable European Union legislation governing the delivery of
biocidal products on the market and use of the ^ 1), which are necessary
for providing first aid or medical treatment, free of charge, provides in
cases of poisoning or other accidents caused by biocidal products and
active substances or to other persons executing medical
the profession of Toxicological information centre General faculty
Hospital in Prague.
TITLE IV
THE SCOPE OF THE ADMINISTRATIVE AUTHORITIES
§ 4
State administration in the field of active substances, supply and use of biocidal products
products and in the field of the supply of treated articles exercise
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 Administration) the authorities of the Czech Republic (hereinafter referred to as "Customs authorities
the Administration "),
g) Ministry of defence,
h) Ministry of the Interior.
§ 5
The Ministry of
(1) the Ministry of
and) decide on the authorisation of a biocidal product for simplified procedure
According to the article. 26 of the regulation on biocides,
(b)) according to art. 27 para. 1 Regulation on biocides receives the notification for the placing
on the market in the territory of the United States of a biocidal product authorised
a simplified procedure in another Member State, receives information about the
notification or application, filed in the reference Member State under art. 6,
7 and 8 of the implementing Commission Regulation (EU) No 354/2013 and adopts revised
a summary of the properties of the biocidal product according to the article. 9 of the implementing regulation
The Commission Regulation (EU) No 354/2013; the dispute referred to in article. 27 para. 2 regulation on biocides
proceed to the coordination group,
(c)) decides on acceptance, renewal or cancellation of the provisional restriction
or prohibit the supply or use of a biocidal product authorised
a simplified procedure in another Member State pursuant to article. 27 para. 2
Regulation on biocides,
(d)) under art. 30, 33, 34, 35, 36 and 37 of regulation on biocides decides on
the national authorisation of the biocidal product or of its renewal according to the
article. 31 of regulation on biocides or under art. 5 of the Regulation Commission
delegated Regulation (EU) No 492/2014
e) decide on the amendment and cancellation of the authorisation of a biocidal product in accordance
with the decision of the European Commission under art. 36 regulation on biocides,
f) according to art. 48, 49 and 50 of the biocides decides to change and
cancellation of an authorisation for a biocidal product; According to the article. 52 the regulation on
decides on the granting of the biocides standstill period for delivery on the market and
the use of existing stocks of the biocidal product,
g) according to art. 44 para. 5 of the regulation on biocides proposes to the European Commission
the conditions to enable the Union to be valid on the territory of the Czech Republic, or
proposal from the European Commission, in order to enable the Union, did not apply to the territory of the United
Republic; to this end, shall seek the binding opinion from the Ministry of
of the environment and Ministry of agriculture, which binding
opinion within the time limit laid down by the Ministry shall provide,
h) decide on the authorisation, amendment and revocation of authorisations for parallel trade
for the biocidal product according to the article. 53 the regulation on biocides,
I) decide on the provisional authorisation of a biocidal product on delivery
the market or its use in the territory of the Czech Republic pursuant to article. 55 of regulation
biocides and about the change and the cancellation of such permits,
j) pursuant to article 6(1). 56 para. 2 regulation on biocides receives notice of the
the proposed experiments or tests for research or development purposes,
which include an unauthorised biocidal product or an active non-approved
substance intended exclusively for use in a biocidal product and is
shall be entitled to require the submission of additional information to assess the impact of
an unauthorized biocidal product or active substance not approved for
human or animal health or on the environment,
k) according to art. 56 para. 3 regulation on biocides decides on the authorization or
the ban on carrying out experiments or tests for research or development purposes,
which include an unauthorised biocidal product or an active non-approved
substance intended exclusively for use in a biocidal product,
l) according to art. paragraph 81. 2 regulation on biocides provides applicants and
all other interested parties information on the obligations of
arising from this Act and the regulations directly applicable European
Union on biocidal products on the market and their
use of ^ 1)
m) represents the Czech Republic in the coordination group, the Committee for
biocidal products and in the Standing Committee on biocidal products established
Regulation on biocides ^ 9),
n) reports to and fulfil the information obligations with regard to the European Commission
According to the regulation on biocides ^ 10),
o) according to art. 3 (2). 3 the regulation shall submit to the European Commission on biocides
a request for a decision as to whether a substance is considered a Nanomaterial and whether
the given product or group of products considered biocidal product
or a treated subject; to that end, the Ministry shall be entitled to ask the
Ministry of the environment or the Ministry of Agriculture of
Support Center, which will provide technical assistance in the time limit set
the Ministry,
p) the European Commission presented a request to review the approval of an active substance
for one or more product types under the conditions set out in article. 15 paragraph 1.
1 Regulation on biocides,
q) informs the public about the benefits and risks of biocidal products and the
ways to minimize their use, in accordance with article 3(1). Article 17(1). 5
Regulation on biocides; to that end, the Ministry shall be entitled to ask the
Ministry of the environment or the Ministry of Agriculture of
Support Center, which will provide technical assistance in the time limit set
the Ministry,
r) performs tasks in the field of the protection of the confidentiality of information pursuant to article. 66
Regulation on biocides,
with) according to art. 88 of regulation on biocides is entitled to take appropriate
provisional measures in respect of authorised biocidal product for the purpose of
protection of human health, in particular for vulnerable groups, such as pregnant
women and children, or animal health or the environment, if it has
Ministry of justifiable grounds; Next, decide on the continuation or
the cancellation of the provisional measures,
t) holds the other tasks of the competent authority in accordance with the directly applicable
European Union legislation concerning biocidal products on
marketing and use of "^ 1"), unless otherwise provided by this Act,
u) decide on the conditions of use of the biocidal product or the prohibition of the
the delivery of the biocidal product on the market in the territory of the United States pursuant to section
in article 13(3). 2.
(2) the Ministry on
and assessing the completeness of the request) of the biocidal product
the simplified procedure laid down in article 4(1). 26 of the regulation on biocides, requests for
national authorisations pursuant to article 4(1). 29 regulation on biocides, requests for
national authorisations pursuant to article 4(1). 34 para. 1 Regulation on biocides,
applications for mutual recognition of the authorisation referred to in article. 33 or article. 34 para. 2
Regulation on biocides, applications for the authorisation of the Union referred to in article. 43 the regulation on
biocides, change requests the authorisation referred to in article. 50 of regulation on biocides,
the application for approval of an active substance according to article. 7 regulation on biocides,
requests for the subsequent amendments to the conditions of the approval of the active substance
According to the article. 7 regulation on biocides and the request for renewal of a permit under
article. 2 the Commission delegated Regulation (EU) No 492/2014
(b) the assessment of the application of the) performs the authorisation of a biocidal product
the simplified procedure laid down in article 4(1). 26 of the regulation on biocides, requests for
national authorisations pursuant to article 4(1). 29 regulation on biocides, requests for
national authorisations pursuant to article 4(1). 34 para. 1 Regulation on biocides,
application for renewal of a national authorisation in accordance with article 3(1). 31 of regulation
biocide, a request for renewal of a national authorisation in accordance with article 3(1). 4
the Commission delegated Regulation (EU) No 492/2014, requests for
enable the Union referred to in article. 43 regulation on biocides, renewal requests
enable the Union referred to in article. 45 regulation on biocides, change requests
the authorisation referred to in article. 50 of regulation on biocides, application for approval of an active
substances referred to in article 14(2). 7 regulation on biocides, requests for subsequent
changes to the terms of the approval of an active substance according to article. 7 regulation on biocides and
application for renewal of the approval of an active substance according to article. 13 of regulation
biocides; in the context of the evaluation, carried out a comparative assessment,
If provided for by the regulation on biocides,
c) handles the draft assessment report in respect of the application of national
the authorisation referred to in article. 29 regulation on biocides, applications for national
the authorisation referred to in article. 34 para. 1 Regulation on biocides, renewal requests
a national authorisation referred to in article. 31 of regulation on biocides, requests for
renewal of a national authorisation in accordance with article 3(1). 4 Commission Regulation in the
delegated Regulation (EU) No 492/2014, applications for the authorisation of the Union referred to in article.
43 regulation on biocides, application for renewal of an authorisation of the Union referred to in article. 45
Regulation on biocides, change requests the authorisation referred to in article. 50 of the
biocides, requests for approval of an active substance according to article. 7 of the regulation on
biocide, a request for subsequent changes to the terms of approval
of the active substance according to article. 7 regulation on biocides and renewal requests
approval of an active substance according to article. 13 of regulation on biocides; further
recommendations for renewal of the approval of an active substance, in respect of the application
on the renewal of the approval of an active substance according to article. 13 of regulation on biocides and
recommendations for the renewal of a permit in respect of the application for renewal
enable the Union referred to in article. 45 regulation on biocides; and carries out
the assessment of the applicant's comments on the draft of the assessment report in accordance with
Regulation on biocides,
(d)) shall conduct an assessment and approved the summary of the biocidal product characteristics
proposed by the reference Member State for the purposes of mutual recognition
a national authorisation referred to in article. 33 and 34 of regulation on biocides,
e) performs an assessment of whether it should be released by the authorisation of a biocidal product
change or cancel on the basis of information obtained from the holder of the authorization
and information from the official activities,
(f)) performs an assessment of whether the information obtained from the notice of proposed
experiments or tests for research or development purposes may have
unreasonable adverse effect on human or animal health or the
the environment,
g) on the basis of notifications under article 14(1). 27 of regulation on biocides performs
to assess whether the biocidal product is authorised by a simplified procedure
the authorisation on the market in another Member State complies with the criteria laid down in
article. 25 regulation on biocides,
(h) prepares the request presented by the) European Commission on adjustments
some of the conditions enabling the Union referred to in article. 44 para. 5 of the regulation on
biocides,
I) carried out an assessment of whether, on the basis of new evidence, it is appropriate to adopt a
the provisional measures referred to in article 14(2). 88 of regulation on biocides,
j) passes the Toxicological information centre General faculty
Hospital in Prague for first aid or treatment of information about
approved active substances and biocidal products authorised or notified
preparations,
the notification referred to in §) receives 14, keeps records of reported biocidal
products and keep it publishes on its website,
l) manages electronic information system for the purposes of record keeping
the biocidal products notified under section 14, the BPD
products authorised for marketing in the territory of the Czech Republic and
Furthermore, concerning applications for authorisation of biocidal products,
m) receives messages about the checks carried out by the authorities referred to in section 8 and
from the authorities of the customs administration, pursuant to section 9,
n) is authorized to require the production of the model or design of the packaging,
the labelling or package leaflet of the biocidal product,
about) selects administrative charges in accordance with the regulation on biocides and
This Act and decides on the amount of the reimbursement of the costs of professional acts.
(3) the Ministry may delegate the activities referred to in paragraph 2 (a). a) to i)
The National Health Institute or another organization that performs the function of
the founder or the founder.
(4) the Ministry under the activities referred to in paragraph 2 (a). a) to i)
requests a binding opinion of the Ministry of the environment in terms of
protection of the environment and binding opinion of the Ministry of
Agriculture in terms of the protection of animal health. Ministry in the request for
issue binding opinions shall set a reasonable time limit for sending the
the written statement in the first sentence.
(5) the Ministry may, on request, issue to the applicant a certificate of
the consent of the Ministry, adding that the assessment by the competent authority in the
respect of the application pursuant to article. 7, 13, 26, 43, 45 or 50 of regulation on biocides.
The Ministry of the certificate referred to in the first sentence shall not issue, especially if it is
completely obvious that the active substance or biocidal product as referred to in the request
According to the article. 7, 13, 26, 43, 45 or 50 of the biocides has a negative
effects on human or animal health or the environment, or if the
It would not be possible for capacity reasons the request. 7, 13, 26, 43, 45
or 50 of regulation on biocides evaluate within 365 days from the date of
approval of the application under art. 7, 13, 26, 43, 45 or 50 of the
biocides. The Ministry will issue on request of the applicant a certificate of
acceptance of the fact that the assessment by the competent authority, if the application
a change pursuant to article. 50 of regulation on biocides and if it is the competent authority,
which follow up the initial application for authorisation to the European Union for the concerned
of the biocidal product. On the issue of the certificate referred to in the first sentence is not
a legal claim. The Ministry shall notify the applicant that the nevydalo confirmation
referred to in the first sentence.
§ 6
Ministry of the environment
(1) the Ministry of the environment
and at the request of the Ministry) according to § 5 para. 4 issuing binding
opinion from the perspective of environmental protection; in the opinion of whether or not
the number of hours spent on activities referred to in paragraph 2 for the purposes of
determine the amount of reimbursement of the costs of professional acts performed pursuant to section 16,
(b)), the Ministry of incentives to change or cancellation of permit
of the biocidal product, the mutual recognition of national authorisations or
review of the approval of the active substance in terms of environmental protection,
(c)) works with the Ministry referred to in § 5 para. 1 (b). o) and (q))
point of view of environmental protection,
d) cooperates with the Ministry in representing the United States in
the bodies referred to in § 5 para. 1 (b). m) in the field of the protection of the
environment.
(2) the Ministry of the environment in the context of a binding opinion from the
for the protection of the environment
and assessing the completeness of the request) of the biocidal product
the simplified procedure laid down in article 4(1). 26 of the regulation on biocides, requests for
national authorisations pursuant to article 4(1). 29 regulation on biocides, requests for
national authorisations pursuant to article 4(1). 34 para. 1 Regulation on biocides,
applications for mutual recognition of the authorisation referred to in article. 33 or article. 34 para. 2
Regulation on biocides, applications for the authorisation of the Union referred to in article. 43 the regulation on
biocides, change requests the authorisation referred to in article. 50 of regulation on biocides,
the application for approval of an active substance according to article. 7 regulation on biocides,
requests for the subsequent amendments to the conditions of the approval of the active substance
According to the article. 7 regulation on biocides and the request for renewal of a permit under
article. 2 the Commission delegated Regulation (EU) No 492/2014
(b) the assessment of the application of the) performs the authorisation of a biocidal product
the simplified procedure laid down in article 4(1). 26 of the regulation on biocides, requests for
national authorisations pursuant to article 4(1). 29 regulation on biocides, requests for
national authorisations pursuant to article 4(1). 34 para. 1 Regulation on biocides,
application for renewal of a national authorisation in accordance with article 3(1). 31 of regulation
biocide, a request for renewal of a national authorisation in accordance with article 3(1). 4
the Commission delegated Regulation (EU) No 492/2014, requests for
enable the Union referred to in article. 43 regulation on biocides, renewal requests
enable the Union referred to in article. 45 regulation on biocides, change requests
the authorisation referred to in article. 50 of regulation on biocides, application for approval of an active
substances referred to in article 14(2). 7 regulation on biocides, requests for subsequent
changes to the terms of the approval of an active substance according to article. 7 regulation on biocides and
application for renewal of the approval of an active substance according to article. 13 of regulation
biocides; in the context of the evaluation, carried out a comparative assessment,
If provided for by the regulation on biocides,
c) handles the draft assessment report in respect of the application of national
the authorisation referred to in article. 29 regulation on biocides, applications for national
the authorisation referred to in article. 34 para. 1 Regulation on biocides, renewal requests
a national authorisation referred to in article. 31 of regulation on biocides, requests for
renewal of a national authorisation in accordance with article 3(1). 4 Commission Regulation in the
delegated Regulation (EU) No 492/2014, applications for the authorisation of the Union referred to in article.
43 regulation on biocides, application for renewal of an authorisation of the Union referred to in article. 45
Regulation on biocides, change requests the authorisation referred to in article. 50 of the
biocides, requests for approval of an active substance according to article. 7 of the regulation on
biocide, a request for subsequent changes to the terms of approval
of the active substance according to article. 7 regulation on biocides and renewal requests
approval of an active substance according to article. 13 of regulation on biocides; further
recommendations for renewal of the approval of an active substance, in respect of the application
on the renewal of the approval of an active substance according to article. 13 of regulation on biocides and
recommendations for the renewal of a permit in respect of the application for renewal
enable the Union referred to in article. 45 regulation on biocides; and carries out
the assessment of the applicant's comments on the draft of the assessment report in accordance with
Regulation on biocides,
(d)) shall conduct an assessment summary of the biocidal product characteristics proposed
the reference Member State for the purposes of mutual recognition of national
the authorisation referred to in article. 33 and 34 of regulation on biocides,
e) performs an assessment of whether it should be released by the authorisation of a biocidal product
change or cancel on the basis of information obtained from the holder of the authorization
and information from the official activities,
(f)) performs an assessment of whether the information obtained from the notice of proposed
experiments or tests for research or development purposes may have
an unacceptable adverse impact on the environment,
g) on the basis of notifications under article 14(1). 27 of regulation on biocides performs
to assess whether the biocidal product is authorised by a simplified procedure
the authorisation on the market in another Member State complies with the criteria laid down in
article. 25 regulation on biocides,
(h) prepares the request presented by the) European Commission on adjustments
some of the conditions enabling the Union referred to in article. 44 para. 5 of the regulation on
biocides,
I) carried out an assessment of whether, on the basis of new evidence, it is appropriate to adopt a
the provisional measures referred to in article 14(2). 88 of regulation on biocides.
(3) if the Ministry of the environment, in order to implement the activities of the
in accordance with paragraph 2, it is necessary to request from the applicant additional
for information, requests for supplementary information Ministry, which is
the applicant may request. The time limit for issuing binding opinions provided for by
§ 5 para. 4 to build up to that time, than the Ministry of the Ministry shall forward the
the environment additional information provided by the applicant.
§ 7
The Ministry of agriculture
(1) the Ministry of agriculture
and at the request of the Ministry) according to § 5 para. 4 issuing binding
opinion from the perspective of the protection of animal health; the opinion also indicate
the number of hours spent on activities referred to in paragraph 2 for the purposes of
determine the amount of reimbursement of the costs of professional acts performed pursuant to section 16,
(b)), the Ministry of incentives to change or cancellation of permit
of the biocidal product, the mutual recognition of national authorisations or
review of the approval of the active substance in terms of the protection of animal health,
(c)) works with the Ministry referred to in § 5 para. 1 (b). o) and (q))
regard to the protection of animal health,
d) cooperates with the Ministry in representing the United States in
the bodies referred to in § 5 para. 1 (b). m) in the field of health protection
animals.
(2) the Ministry of agriculture in the context of a binding opinion from the perspective of
protection of animal health
and assessing the completeness of the request) of the biocidal product
the simplified procedure laid down in article 4(1). 26 of the regulation on biocides, requests for
national authorisations pursuant to article 4(1). 29 regulation on biocides, requests for
national authorisations pursuant to article 4(1). 34 para. 1 Regulation on biocides,
applications for mutual recognition of the authorisation referred to in article. 33 or article. 34 para. 2
Regulation on biocides, applications for the authorisation of the Union referred to in article. 43 the regulation on
biocides, change requests the authorisation referred to in article. 50 of regulation on biocides,
the application for approval of an active substance according to article. 7 regulation on biocides,
requests for the subsequent amendments to the conditions of the approval of the active substance
According to the article. 7 regulation on biocides and the request for renewal of a permit under
article. 2 the Commission delegated Regulation (EU) No 492/2014
(b) the assessment of the application of the) performs the authorisation of a biocidal product
the simplified procedure laid down in article 4(1). 26 of the regulation on biocides, requests for
national authorisations pursuant to article 4(1). 29 regulation on biocides, requests for
national authorisations pursuant to article 4(1). 34 para. 1 Regulation on biocides,
application for renewal of a national authorisation in accordance with article 3(1). 31 of regulation
biocide, a request for renewal of a national authorisation in accordance with article 3(1). 4
the Commission delegated Regulation (EU) No 492/2014, requests for
enable the Union referred to in article. 43 regulation on biocides, renewal requests
enable the Union referred to in article. 45 regulation on biocides, change requests
the authorisation referred to in article. 50 of regulation on biocides, application for approval of an active
substances referred to in article 14(2). 7 regulation on biocides, requests for subsequent
changes to the terms of the approval of an active substance according to article. 7 regulation on biocides and
application for renewal of the approval of an active substance according to article. 13 of regulation
biocides; in the context of the evaluation, carried out a comparative assessment,
If provided for by the regulation on biocides,
c) handles the draft assessment report in respect of the application of national
the authorisation referred to in article. 29 regulation on biocides, applications for national
the authorisation referred to in article. 34 para. 1 Regulation on biocides, renewal requests
a national authorisation referred to in article. 31 of regulation on biocides, requests for
renewal of a national authorisation in accordance with article 3(1). 4 Commission Regulation in the
delegated Regulation (EU) No 492/2014, applications for the authorisation of the Union referred to in article.
43 regulation on biocides, application for renewal of an authorisation of the Union referred to in article. 45
Regulation on biocides, change requests the authorisation referred to in article. 50 of the
biocides, requests for approval of an active substance according to article. 7 of the regulation on
biocide, a request for subsequent changes to the terms of approval
of the active substance according to article. 7 regulation on biocides and renewal requests
approval of an active substance according to article. 13 of regulation on biocides; further
recommendations for renewal of the approval of an active substance, in respect of the application
on the renewal of the approval of an active substance according to article. 13 of regulation on biocides and
recommendations for the renewal of a permit in respect of the application for renewal
enable the Union referred to in article. 45 regulation on biocides; and carries out
the assessment of the applicant's comments on the draft of the assessment report in accordance with
Regulation on biocides,
(d)) shall conduct an assessment summary of the biocidal product characteristics proposed
the reference Member State for the purposes of mutual recognition of national
the authorisation referred to in article. 33 and 34 of regulation on biocides,
e) performs an assessment of whether it should be released by the authorisation of a biocidal product
change or cancel on the basis of information obtained from the holder of the authorization
and information from the official activities,
(f)) performs an assessment of whether the information obtained from the notice of proposed
experiments or tests for research or development purposes may have
an unacceptable adverse impact on the health of the animals,
g) on the basis of notifications under article 14(1). 27 of regulation on biocides performs
to assess whether the biocidal product is authorised by a simplified procedure
the authorisation on the market in another Member State complies with the criteria laid down in
article. 25 regulation on biocides,
(h) prepares the request presented by the) European Commission on adjustments
some of the conditions enabling the Union referred to in article. 44 para. 5 of the regulation on
biocides,
I) carried out an assessment of whether, on the basis of new evidence, it is appropriate to adopt a
the provisional measures referred to in article 14(2). 88 of regulation on biocides.
(3) if the Ministry of agriculture, to implement activities under the
paragraph 2, it is necessary to request from the applicant additional information
requests for supplementary information Ministry, which is from the applicant's
will require. The time limit for issuing binding opinions provided for pursuant to § 5 para.
4 to build up to that time, than the Ministry of the Ministry shall forward the
Agriculture, additional information provided by the applicant.
§ 8
Review
(1) the checking of compliance with the obligations arising from the directly applicable
European Union legislation concerning biocidal products on
the market and use of the ^ 1), of this law and of the decisions taken by the
the basis of this exercise
and the regional hygiene station),
(b)) the Czech environmental inspection,
(c)) the Ministry of defence,
(d) the Ministry of the Interior).
(2) the regional hygiene station
and) checks that are legal and natural persons, doing business
that market on the territory of the Czech Republic of biocidal products,
an active substance and treated articles, compliance with the regulation on biocides,
the Commission implementing Regulation (EU) No 354/2013, the European Commission decision
issued pursuant to the regulation on biocides, this law and the decision of the administrative
authorities issued under this Act,
b) stores the fines for infringement of obligations under the regulation on biocides,
the implementing Commission Regulation (EU) No 354/2013, decision of the European
the Commission issued in accordance with the regulation on biocides, this law and the decision of the
administrative bodies issued in accordance with this Act,
c) handles the message on the examinations for each calendar year, and
submit them to the Ministry not later than 31 December 2006. be forwarded to the
calendar year; included in the reports are to be submitted to the date information
the inspections carried out, trade name or other identification
controlled the biocidal product, trade name or other
identification of the treated article, the name of controlled controlled
person, the size and type of packaging, the name or names of the active substances
contained in the biocidal product or active substance names, which was
treated material is treated, the quantity of the active substances in
the biocidal product, the declared type of use of the biocidal product,
the lot number of the biocidal product, broken any law or
Regulation on biocides, information about the amount of the punitive provisions and
the penalties imposed, information about detected damage to human and animal health,
the environment and the number of registered poisoning caused by sealant
medicinal products or active substances.
(3) the Czech environmental inspection
and) checks that are legal and natural persons doing business with
compliance with Chapter XV and article. 17, 56, 58 and 95 regulation on biocides,
(b)) checks that are legal and natural persons doing business with
compliance with § 2 (2). 1 (b). (b)) and section 15,
c) imposes fines for infringement of the obligations under Chapter XV and article. 17, 56,
58 and 95 regulation on biocides, European Commission decision issued in accordance with
Regulation on biocides, this law and the decisions of administrative authorities
issued pursuant to this Act,
d) handles the message on the examinations for each calendar year, and
submit them to the Ministry not later than 31 December 2006. be forwarded to the
calendar year; included in the reports are to be submitted to the date information
the inspections carried out, trade name or other identification
controlled the biocidal product, trade name or other
identification of the treated article, the name of controlled controlled
person, the size and type of packaging, the name or names of the active substances
contained in the biocidal product or active substance names, which was
treated material is treated, the quantity of the active substances in
the biocidal product, the declared type of use of the biocidal product,
the lot number of the biocidal product, broken any law or
Regulation on biocides, information about the amount of the punitive provisions and
the penalties imposed, information about detected damage to human and animal health,
the environment and the number of registered poisoning caused by sealant
medicinal products or active substances.
(4) the Ministry of the Interior as the authority to protect public health by
the law on the protection of public health ^ 11) shall exercise control over the observance
obligations and fulfil the tasks provided for in this law, the regulation on biocides
and the implementing Commission Regulation (EU) No 354/2013, within
the scope of the.
(5) the Ministry of defence as authority to protect public health by
the law on the protection of public health ^ 11) shall exercise control over the observance
obligations and fulfil the tasks provided for in this law, the regulation on biocides
and the implementing Commission Regulation (EU) No 354/2013, within
the scope of the.
§ 9
Authorities of the Customs Administration
(1) the authorities of the Customs Administration
and) it releases a biocidal product which has been authorised in accordance with the regulation on
biocides or notified pursuant to section 14 of the proposed customs procedure of free
circulation, if otherwise provided in a regulation on biocides, or without the written
Declaration by the importer that the biocidal product is intended solely for the purposes of
research and development,
(b)) was the proposed customs procedure of free circulation of substance
for use in biocidal products, which is not included in the list
According to the article. 9. 2 regulation of biocides or not listed
substances included in program review ^ 12) or without a written statement
the importer, that the active substance is intended solely for the purposes of research and development,
(c)) was the proposed customs procedure of free circulation, a substance or
biocidal product containing such a substance or a biocidal product,
It is from this substance it contains or consists of a substance
arise, without any importer of a substance or an importer of a biocidal product has been
included on the list of contractors for the types of products to which the product
belongs, published the European Chemicals Agency pursuant to article. 95
paragraph. 1 Regulation on biocides, except if it is a substance
listed in categories 1 to 5 and 7 of annex I to the regulation on biocides or
biocidal product containing only the substances listed in categories 1 to 5
and 7 of annex I to the regulation on biocides,
(d)) was the proposed customs procedure of free circulation treated
course, if all the active substances contained in biocidal products,
that has been treated or that it contains are not listed
approved active substances referred to in article. 9. 2 regulation on biocides for
the product type and use, or are not listed in annex I
Regulation on biocides, or any specified conditions are not met or
limitations of use of a substance or without a written declaration by the importer, that are
those conditions are satisfied,
(e)) are entitled to claim the Ministry for technical assistance in the case of
doubt about the scope of the obligations arising for importers of the regulation on the
Furthermore, they are entitled to biocides and to inspect the evidence submitted on
authorisation of biocidal products, led by the Ministry in accordance with § 5 para. 2
(a). (l)), and to the extent the data are the name of the biocidal
of the product, the type of biocidal product, the active ingredient contained in the biocidal
product information on the applicant, the particulars of the proposed holder of the authorisation, the date of
submission of the application and the application number of the register for biocidal products,
f) shall keep a register of the imported biocidal products, active substances and
treated articles and active substances of biocidal products, and treated
non-released items in the proposed customs procedure of free circulation,
g) will allow the Ministry to the Ministry of the environment, Ministry of
Agriculture, regional hygiene station or the Czech environmental inspection
environment of access to the registers kept by the letter f), take from
It copies, extracts or copies thereof, and
(h) the number of messages processed) for biocidal products, active substances and
treated articles non-released into the proposed customs procedure of free
circulation for each calendar year and shall be submitted by the Ministry of
until 31 December 2006. March of the following calendar year.
(2) the Directorate-General of customs duties provides on-demand of the authorities referred to in
paragraph 1 (b). (g)) the following information:
and) identification of the importer, and the name or names and surnames
or the name or business name and address of the place of residence or the place of
business,
(b)) the identification of the recipient, and the name or names and surnames
and the address of the place of stay
c) description, including the business name and type of product by its inclusion
in the combined nomenclature set out in annex I to Council Regulation (EEC) No.
2658/87 ^ 13),
(d)) the country of departure and the country of origin of the biocidal product or active substance
or treated the subject,
(e)) the quantity of the biocidal product or active substance or treated
the subject expressed in volume, weight or number of units.
(3) the provision of the information referred to in paragraph 2 is not a violation of confidentiality pursuant to
the tax code ^ 14).
TITLE V OF THE
ADMINISTRATIVE OFFENCES
§ 10
Misdemeanors
(1) a natural person has committed the offence by
and) uses a biocidal product in contradiction with information and instructions
listed on the label or package insert or fails to respect warning
symbols, standard phrases indicating the special risks, or
standard instructions for safe handling according to chemical law ^ 15)
or hazard pictograms, signal words, hazard statements about
hazard or precautionary statements by directly
of the applicable legislation of the European Union relating to the classification,
labelling and packaging of substances and mixtures ^ 16) and specific conditions for the
the use of the biocidal product,
(b)) it's a biocidal product which has been authorised in accordance with the regulation on
biocides or has not been notified in accordance with section 14 or does not meet the requirements for
the authorisation provided for by the regulation on biocides, without being granted
the temporary permit, or
(c)) it's a biocidal product in contravention of article 17 paragraph 2. 5 sentence
the second regulation on biocides.
(2) for the offence referred to in paragraph 1 can be used to impose a fine of up to $50,000.
§ 11
Administrative offences of legal entities and natural persons-entrepreneurs
(1) a legal entity or individual entrepreneur is committed by the administrative
tort by
and delivers on the market) in the territory of the Czech Republic
1. a biocidal product which has been authorised in accordance with regulation on biocides
or has not been notified under section 14,
2. the biocidal product in accordance with the conditions laid down in the decision
issued under this Act or by a regulation on biocides,
3. a biocidal product authorised in another Member State by a simplified
the procedure contrary to the terms of use set out in the notice provided by the
According to the article. 27 para. 1 Regulation on biocides,
4. a biocidal product which does not meet the requirements for the authorization provided for
According to the regulation on biocides, without being granted temporary permission
According to the regulation on biocides, or it shall appear on the market in violation of
the terms of the temporary permit,
5. a biocidal product which is not classified, labelled and packaged in a
According to § 2 (2). 1 (b). (c)),
6. a biocidal product that is not marked in any language, or
the package leaflet are not listed in any language,
7. a biocidal product before the date notified under section 14 (a). l),
8. the biocidal product as referred to in § 13 para. 1, which is not marked in accordance with
§ 15 para. 2,
(b)) gives on the market in the territory of the United States or it's the biocidal product
authorised in another Member State by a simplified procedure, which has not been
before placing on the market in the territory of the Czech Republic pursuant to article. 27
Regulation on biocides,
(c) the holder of the authorization shall supply) as being on the market in the territory of the United States of a biocidal
the product, which is not classified, labelled and packaged in accordance with the
requirements referred to in article 14(2). 69 regulation on biocides,
(d)) shall appear on the market in the territory of the Czech Republic a biocidal product that is
composed of substances appearing on the list published by the European Agency for
chemical substances referred to in article. 95 para. 1 Regulation on biocides (hereinafter referred to as
"list of suppliers"), such a substance contains or from which such
substance arise, without the supplier of a substance or product supplier was
included on the list of contractors for the types of products to which the product
belongs, except in the case of the substances referred to in the categories
1 to 5 and 7 of annex I to the regulation on biocides or biocidal product
containing only the substances listed in categories 1 to 5 and 7 of annex I
Regulation on biocides,
e) launches on the territory of the United States treated the subject in violation of
article. 58 para. 2 regulation on biocides,
(f) does not provide the appropriate designation) treated the subject in accordance with art.
58 para. 3, 4 and 6 of the regulation on biocides,
g) does not provide the consumer with information about biocidal treatment treated
According to the article subject. 58 para. 5 of the regulation on biocides,
h) has failed, or not does not update the safety data sheet to
the biocidal product in accordance with art. 70 regulation on biocides,
(I) fails to comply with the requirements of the ad) of the biocidal product according to the article. 72
Regulation on biocides,
j) as the permit holder does not keep records of biocidal products in
accordance with article 6(1). 68 the regulation on biocides, which he places on the market or is
make available to the authorities referred to in § 8 para. 1,
to) while performing experiments or tests has failed or does not keep a written
the records referred to in article. 56 para. 1 Regulation on biocides, or performing
experiments or tests which can occur to leak into the
the environment, fail to comply with the obligation of notification according to art. 56 para. 2 of the regulation on
biocides,
l) performs an experiment or test in violation of a decision issued pursuant to section 5 of the
paragraph. 1 (b). k),
to notify the Department of m) all of the information referred to in section 14 (a). a) to m)
or provides false information,
n) uses a biocidal product which has been authorised in accordance with the regulation on
biocides or has not been notified in accordance with section 14 or does not meet the requirements for
the authorisation provided for by the regulation on biocides, without being granted
temporary permits,
about) it's the biocidal product in contradiction with information and instructions
listed on the label or package insert or fails to respect warning
symbols, standard phrases indicating the special risks, or
standard instructions for safe handling according to chemical law ^ 15)
or hazard pictograms, signal words, hazard statements about
hazard or precautionary statements by directly
of the applicable legislation of the European Union relating to the classification,
labelling and packaging of substances and mixtures ^ 16) and specific conditions for the
the use of the biocidal product,
p) it's the biocidal product in conflict with rational application of
the combination of physical, biological, chemical or other measures
as appropriate, through the use of biocidal products
limited to the minimum necessary and does not take appropriate preventive measures,
q) makes a change to the biocidal product in contravention of the implementing regulation
The Commission Regulation (EU) No 354/2013
r) ceases to use or apply the proposed change of the biocidal
of conflict with the implementing Commission Regulation (EU) No 354/2013
fails to comply with the notification requirement in the) contrary to the implementing regulation of the Commission
Regulation (EU) No 354/2013
t) do not submit a revised summary of the biocidal product characteristics in
contrary to the Commission's implementing Regulation (EU) No 354/2013, or
u) fails to comply with another obligation under the biocides regulation or of the implementing
Commission Regulation (EU) No 354/2013, than that is listed in subparagraph (a))
paragraphs 1 to 4, 6 and 7 and in (b)) to t).
(2) an administrative offense shall be fined in the
1 000 000 Czk), in the case of an administrative offence referred to in paragraph 1 (b). and)
7, referred to in paragraph 1 (b). (e)) l) to (n)) or p)),
(b)) 3 000 000 CZK in the case of an administrative offence referred to in paragraph 1 (b). (f)) to
I) or (j)),
(c)) $5 000 000 in the case of an administrative offence referred to in paragraph 1 (b). and)
1 to 6 or 8, referred to in paragraph 1 (b). b) to (d)), k) or o).
§ 12
Provisions common to administrative offences
(1) a legal and individual entrepreneur for the administrative offence does not match,
If it proves that made every effort that could be
require that the breach of a legal obligation.
(2) in determining the amount of the sanction legal or entrepreneurial natural
the person shall take account of the seriousness of the administrative offense, in particular to the method of
criminal offence and its consequences, and the circumstances under which it was committed.
(3) the legal entity responsible for the administrative offence or entrepreneurial natural
the person shall cease, if the administrative authority has commenced proceedings about him up to 1 year
from the date on which it learned, but not later than within 3 years from the date on which the
has been committed.
(4) The liability for the acts, which took place in the business
person or in direct connection with him, subject to the provisions of
liability and sanctions legal persons.
(5) administrative offences under this Act under discussion
and the regional hygiene station), in the case of administrative offences pursuant to section 10 and
11,
(b)) the Czech environmental inspection, in the case of administrative offences pursuant to section
10, paragraph 1. 1 (b). and) and § 11 (1) 1 (b). and) points 5 and 7, § 11 (1) 1
(a). c), (d)) to (l)), o) and (p)).
(6) the authority which levied the fine it imposed.
(7) income from the fines imposed on the regional hygiene stations is
State budget revenue. Income from fines imposed by the Czech inspections
the environment is the income the State Environmental Fund of the Czech
of the Republic.
TITLE VI OF THE
TRANSITIONAL PERIOD
section 13 of the
The conditions under which it is possible to deliver on biocidal products on the market
the territory of the Czech Republic
(1) a biocidal product which does not meet the conditions of article 81(3). Article 17(1). 1, art. 19
paragraph. 1 and article. 20 (2). 1 Regulation on biocides, can be supplied on the market
on the territory of the Czech Republic or in use, if it has been notified in accordance with section 14 and
If
and) all the active substances contained in the biocidal product are existing
active substances, which have been evaluated according to the directly applicable
Regulation of the European Union relating to the review of the work programme
existing active substances ^ 12), but not yet for this type of
of approved or are being evaluated under the directly applicable
Regulation of the European Union relating to the review of the work programme
existing active substances, but not yet for this type of
approved or
(b)) of the active substance are a combination of existing active substances listed in
(a)) and the active substances approved in accordance with regulation on biocides.
(2) the Ministry of supply and the use of the biocidal product according to the
paragraph 1 prohibit, if it is proved that the biocidal product is not
sufficiently effective or represents a serious immediate or long-term
the risk to human health, in particular of vulnerable groups, such as
pregnant women and children, or animal health or for the environment.
(3) a legal and individual entrepreneur may not available on the market in the territory of
The United States notified the biocidal product pursuant to section 14, for which
No request for authorisation of a biocidal product or a request for
simultaneous mutual recognition of the biocidal product by the date
approval of an active substance in the biocidal product for the given type
the product, or by the date of the last approval of the active substance
contained in the biocidal product for that product type, if the biocidal
the product contains more than one active substance, and that the date on which the
expires 180 days from the date of approval of the last active substance contained in
the biocidal product; existing stocks of such biocidal product can be
use the to the day on which expires 365 days from the date of the last approval
the active substances contained in the biocidal product.
(4) the Legal and entrepreneurial natural person exits the making available on the market on
the territory of the Czech Republic of a biocidal product notified in accordance with section 14, if the
contains a substance that has not been approved in accordance with article 3(1). 9. 1 (b). (b))
Regulation on biocides, no later than 12 months from the date of the decision on the
disapproval of the active substance; existing stocks of such of the biocidal
the product can be used until the date on which it shall expire 18 months from the
decision.
(5) the Legal and entrepreneurial natural person may continue to
the market in the territory of the Czech Republic notified under section of the biocidal product
14, if it was for such a biocidal product authorisation
biocidal product or application for simultaneous mutual recognition of the biocidal
of not later than the date of the approval of the active substances contained in biocidal
product characteristics for the product type or by the date of approval of the
the last active substance contained in the biocidal product for the given type
If the biocidal product contains more than one active
substance, but no longer than for a period of 3 years from the date of approval of the last effective
substances that are contained in the biocidal product; the time limit referred to in the first sentence,
stops for the article 88(2) procedure. 37 regulation on biocides.
(6) the Legal and entrepreneurial natural person may not available on the market in the territory of
The United States a biocidal product referred to in paragraph 5, if the
the Ministry rejects an application for authorisation of a biocidal product as referred to in
paragraph 5, or if on the basis of the decision of the competent authority of another
Member State Ministry denies the request for simultaneous mutual recognition
a national authorisation of the biocidal product referred to in paragraph 5, or
If the European Commission decides to reject the application for authorisation of the Union
the biocidal product referred to in paragraph 5, as from the date on which it shall expire
180 days from the date of the decision rejecting the application for authorisation of the biocidal
product or application for simultaneous mutual recognition of national
the authorisation; existing stocks of such biocidal product may be used
the day on which expires 365 days from the date of the decision to refuse authorization,
of the biocidal product.
§ 14
The obligation of notification
Legal and entrepreneurial natural person who intends to place on the market on
biocidal product within the Czech Republic referred to in § 13 para. 1, the
the Ministry through the information system referred to in § 5 para. 2
(a). l) no later than 15 days before the date of the biocidal
product on the market in the territory of the United States the following information:
and) first and last name, or the name or business name and address of the registered office
the notifier,
(b)) first and last name, or the name or business name and address of the registered office
the biocidal product manufacturer and the manufacturer of the active substance,
(c)) the trade name of the biocidal product,
(d)) and the international chemical names for the identification of active substances, where
available, and their concentration in metric units,
(e) the names of the other) the chemical substances contained in the biocidal product
including the international identification, if available, and their concentration in the
metric units,
(f)) the type or types of the biocidal product according to annex V
Regulation on biocides,
(g)) the category of users to which the biocidal product
limited,
h) the Protocol on determination of proving the effectiveness of the biocidal
of the target organisms; the Protocol for the determination of effectiveness of the
submitted in any language, if the Protocol for the determination of the effectiveness in another
than English, it must be present in the original texts and at the same time in
an officially certified translation into the Czech language,
I) text labelling in Czech language
j) instructions for use in the English language, if it is not part of the text marking
packaging,
k) the approximate amount of the biocidal product on the market in territory of the supplied
The United States for the calendar year,
l) the date of first supply prediction on the market of a biocidal product on the
the territory of the Czech Republic,
m) safety data sheet prepared in English by directly
of the applicable legislation of the European Union governing the registration, evaluation,
authorisation and restriction of chemical substances ^ 17).
§ 15
Specific requirements for the labelling of biocidal products
(1) a legal and entrepreneurial natural person who supplies the biocidal
product as referred to in § 13 para. 1 on the market in the territory of the Czech Republic,
ensure that was marked by chemical law ^ 15) or by directly
of the applicable legislation of the European Union relating to the classification,
labelling and packaging of substances and mixtures ^ 16).
(2) a person referred to in paragraph 1 shall further ensure that the packaging
It contained the following legible and indelible details in Czech
language:
and the identity of the individual) active ingredients and their concentrations in
metric units,
(b) information about any nanomaterials) contained in the product and
information about the specific risks related to it; behind every expression
indicating that nanomaterials shall bear the word "nano" in parentheses,
(c)) first and last name, or the name or business name and address of the person
responsible for the delivery of the biocidal product on the market in the territory of the United
Republic,
(d) the type, composition)
(e)) the use of the biocidal product,
f) instructions for use, the frequency of application and dosage in metric
units expressed in a way that is understandable to the user for each
the use of the biocidal product,
g) particulars of likely direct or indirect adverse
side effects and first aid instructions,
h) sentence "before use, please read the attached instructions." if it is to
accompanied by a leaflet, and, where appropriate, a warning about the risks to
vulnerable groups, such as pregnant women and children,
I) guidance on safe disposal of the biocidal product and its packaging,
possibly including the prohibition on reuse of packaging,
j) batch number or designation and the expiry date of the biocidal product
under normal conditions of storage,
k) comes into account the period of time necessary for it to it's
the biocidal effect, the interval to be observed between applications
of the biocidal product or between application and the next use of the treated
the subject, or for the subsequent entry of humans or animals to the area where he was
biocidal product used, including particulars concerning decontamination means
and measures and duration of necessary ventilation of treated area, information about
adequate cleaning of the equipment intended for the application of the biocidal product and
information on precautionary measures during use and transport,
l) comes into account categories of users to which the use of the
the biocidal product is restricted,
m) comes into account information on any specific danger to
the environment, particularly as regards the protection of non-target organisms and the
Prevention of pollution of water.
(3) the information referred to in paragraph 2 (a). (d)), f), (g)), i), (j)), k) and (m)) can
to be place on the packaging listed in the package insert, which is part of the
the package, if it is necessary due to the size and function of the biocidal
of the product.
TITLE VII
REIMBURSEMENT OF THE COSTS FOR THE IMPLEMENTATION OF TECHNICAL OPERATIONS
section 16 of the
(1) a legal and entrepreneurial natural person is liable to the Ministry of
pay the costs of an expert in the management of operations and other
at the request of the activities launched under this Act, the regulation on
biocides, of Commission implementing Regulation (EU) No 354/2013 and regulation
The Commission delegated Regulation (EU) No 492/2014. For technical operations
the process evaluation and assessment for the purposes of the release
binding opinions or other processing, evaluation and assessment for the
performance of the tasks of the Ministry needs according to § 5 para. 1 and § 5 para. 2 (a).
a) to i).
(2) the Legal and entrepreneurial natural person is required to pass the
Ministry of an advance on the reimbursement of costs for carrying out professional tasks.
(3) the manner of determining the amount of the reimbursement costs for carrying out professional tasks in
the framework of the various activities, the maximum amount of reimbursement of the costs of implementation
Professional acts within the framework of the various activities and the amount of the advances to cover
the cost of the implementation of the professional acts within the framework of the various activities
down detailed legislation. The amount of the reimbursement of the costs of implementation
Professional operations within individual activities shall be established so as to
cover the costs for the implementation of these actions in the necessary amount.
(4) the Ministry of returns and entrepreneurial natural person, legal entity, within 30 days
of the effective date of the decision on the application
and an advance on the reimbursement of costs) in full if the
1. paid an advance on the reimbursement of costs, without obligation to, or
2. the Professional operation has not started, or
(b)) a proportion of the paid deposit to cover the costs corresponding to the
Professional acts have been performed.
(5) a legal and individual entrepreneur within 30 days from the date of acquisition
the decision on the request, will pay the difference between the advance to cover
the costs referred to in paragraph 2 and the actual amount of the costs in the event that
the actual amount of reimbursement of the costs exceeds the deposit.
(6) where the obligation to pay the costs of making the same
vocational act within the framework of the joint submission of more persons referred to in paragraph 1,
pay it jointly and severally.
TITLE VIII
COMMON AND FINAL PROVISIONS
§ 17
Service by register for biocidal products
The decision in relation to the application filed by directly
applicable European Union legislation governing the delivery of biocidal
products on the market and use of the ^ 1) shall be delivered only
through the registry of biocidal products according to art. 71 the regulation on
biocides. The decision will be deemed received on the fifteenth day following its
Insert in the register of biocidal products.
section 18
The Member State of
Member State for the purposes of this Act, a Member State of the European
the European Union or a State party to the agreement on the European economic area, or
The Swiss Confederation.
§ 19
Powers of execution
The Ministry will issue a decree to implement section 16(1). 3.
section 20
Transitional provisions
(1) biocidal products authorised for placing on the market pursuant to law No.
120/2002 Coll., on conditions for placing biocidal products and active
substances on the market and amending certain related laws, in the version in force
before the date of entry into force of this law, shall be construed as allowed
According to the regulation on biocides and can be available on the market in the territory of the United
Republic under the conditions and for the period of validity referred to in those
authorizations.
(2) biocidal products placed on the market pursuant to section 35 of the Act No 120/2002 Sb.
before the date of entry into force of this Act shall be construed as notified in accordance with
§ 14.
(3) the designation of biocidal products specified in § 13 para. 1 that are
After the entry into force of this Act, placed on the market in the territory of the United
the Republic, must be brought into line with the requirements for designation under section
15 no later than 6 months from the date of entry into force of this Act.
(4) a proceeding under the Act No 120/2002 Coll., which began before the date of the acquisition of
the effectiveness of this law, and to this day, completes and hedge contingent exposures rights
and duties related thereto shall be assessed in accordance with Act No 120/2002
Coll., in the version in force before the date of entry into force of this Act.
section 21
Technical regulation
This Act has been notified in accordance with the directive of the European Parliament and of the
Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision
information in the field of standards and technical regulations and rules on services,
the information society, as amended.
section 22
Regulation (EEC)
Shall be repealed:
1. the first and fourth Parts 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, and the annex to the Act No 120/2002 Sb.
2. Section 15 of Act No. 186/2004 Coll., amending certain laws
in connection with the adoption of the law on the customs administration of the Czech Republic.
3. the first Part of Act No. 127/2005 Coll., amending Act No 120/2002
Coll., on conditions for placing biocidal products and active substances on the market
and amending certain related laws, as amended by Act No. 186/2004
Coll., and some other laws.
4. the first and second section of the Act No. 297/2008 Coll., amending Act No.
120/2002 Coll., on conditions for placing biocidal products and active
substances on the market and amending certain related laws, as amended by
amended, and some of the related laws.
5. Act No. 136/2010 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.
6. Act No. 342/2011 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.
7. Part of the sixties, the fifth law No 375/2007 Coll., amending certain
laws in connection with the adoption of the law on health services, the Act on
specific health services act and the medical rescue
the service.
8. Part of the twenty-ninth of Act No. 18/2012 Coll., amending certain
laws in connection with the adoption of the law on the customs administration of the Czech Republic.
9. Decree No. 304/2002 Coll., laying down detailed specifications
policy and procedure for evaluation of biocidal products and active substances.
10. Decree No. 305/2002 Coll., laying down the content of the request and
detailed specification of data submitted prior to the placing of the biocidal
product or an active substance on the market.
11. Decree No 382/2007 Coll., amending Decree No 307/2002 Coll.
laying down the content of the request and the detailed specifications of the data
submitted prior to the placing of the biocidal product or active substance on
the market.
12. Decree No. 343/2011 Coll., on the list of active substances.
13. Decree No. 313/2012 Coll., amending Decree No 343/2006,
a list of active substances.
14. Decree No. 91/2013 Coll., amending Decree No 343/2007 Coll.
list of active substances, as amended by Decree No. 313/2012 Sb.
PART TWO
Amendment of the Act on administrative fees
Article 23 of the
Item 95 of the annex to the Act No 634/2004 Coll., on administrative fees, in
amended by Act No. 297/2008 Coll., including footnote No 56 is added:
"Item 95
1. Submission of the application or proposal on ^ 56)
and the approval of the active substance) for the first type of
of Eur 150 000
(b) the approval of the active substance) for the first type of
If the active substance is
micro-organism £ 75 000
(c)) the approval of an active substance for another type
of Eur 75 000
(d) the renewal of the approval of the active substance) for the first
product type £ 75 000
e) restoration of approval of active substances for further
product type £ 75 000
(f) the biocidal product) $30,000
g) authorisation of biocidal products category £ 60 000
h) authorisation of the biocidal product
simplified authorisation procedure CZK 3 000
I) permit categories of biocidal products
simplified procedure-$ 6,000
j) a significant change in the authorisation of Eur 12 000
to a minor change in the authorisation) Czk 1 800
l) change of an administrative nature Czk 300
m) renewal of the authorisation of a biocidal product Eur 22 500
n) the authorisation of a biocidal product for an identical CZK 5 000
2. The submission of the notice ^ 56)
and the product) falls into the already authorised
categories of biocidal products CZK 5 000
(b)) to the product which has already been authorised
a simplified procedure in another Member
State of the European Union or in a Contracting State
The agreement on the European economic area
or in the Swiss Confederation 2 000 Czk
3. Submission of application assessment ^ 56) documentation for authorisation
of the biocidal product, when the Czech Republic fulfils the role of the
the evaluating competent authority, if it is a
and the issue of temporary permits) $3,000
(b)) to perform a comparative assessment of Czk 15 000
(c) the establishment of a maximum residue limit) $7 500
4. Receipt of the application of ^ 56)
and a parallel trade permit) $5,000
(b) the mutual recognition of national authorisations)
issued in another Member State of the European
the European Union or in a Contracting State of the agreement
on the European economic area, or
in the Swiss Confederation Czk 40 000
5. acceptance of notification of ^ 56)
the delivery of the biocidal product on the market in the territory of
The United States in the mode of the transitional period, £ 1 500
Note
The fee referred to in section 3 chooses the Administrative Office at the same time with the fee referred to in
1 (b). (f)) of this item in the cases, when the Czech Republic fulfils the
the role of the evaluation of the competent authority.
56) Law No 324/2016 Coll., on biocidal products and active substances
and amending certain related laws (law on biocides). ".
PART THREE
Change of the chemical law
section 24
In section 2 of the Act No. 350/2007 Coll., on chemical substances and chemical mixtures
and on amendments to certain laws (legislation), paragraph 2, including notes
footnote # 5 and 6:
"(2) on plant protection products, auxiliary means to protect
^ 5) plant and notified to the biocidal products under the law governing
biocidal products on the market) ^ 6 from the obligations laid down in
This Act applies only to the obligations of the classification, packaging and
labelling. The authorised biocidal products under the law governing
biocidal products on the market) ^ 6 from the obligations laid down in
This Act subject to the obligations to the classification, packaging, labelling and
the obligation of notification.
5) Act No 326/2004 Coll., on phytosanitary care and amendments to certain
related laws, as amended.
European Parliament and Council Regulation (EC) No 1107/2009 of 21 October 2003.
October 2009 concerning the placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC, as amended.
6) Law No 324/2016 Coll., on biocidal products and active substances and
amending certain related laws (law on biocides). ".
§ 25
Transitional provision
The obligation of notification under section 22 of Act No. 350/2011 Coll. for mixtures or
detergents that are biocidal products and were allowed to bring
on the market according to the law No 120/2002 Coll., as amended, shall
be fulfilled no later than 6 months from the date of entry into force of this
the law.
PART FOUR
The EFFECTIVENESS of the
section 26
This Act shall take effect on the 15th day following its publication.
Hamáček in r.
Zeman in r.
Sobotka in r.
1) European Parliament and Council Regulation (EU) No 528/2012 of 22 March.
may 2012 of biocidal products on the market and use of
, as amended.
The Commission implementing Regulation (EU) No 354/2013 of the 18. April 2013
changes of biocidal products authorised under the regulation of the European
Parliament and of the Council (EU) No 528/2012.
The Commission implementing Regulation (EU) no 414/2013 of the 6. may 2013,
laying down the procedure for the authorisation of biocidal products in the same
accordance with European Parliament and Council Regulation (EU) No 528/2012.
The Commission delegated Regulation (EU) No 492/2014 of 7. March
2014, supplementing the European Parliament and of the Council Regulation (EU) No.
528/2012, as regards the rules for the renewal of authorisations of biocidal
products, which are subject to mutual recognition.
The Commission delegated Regulation (EU) no 1062/2014 of 4. August
2014, on the programme of work for the systematic examination of all
existing active substances contained in biocidal products, which
are listed in the regulation of the European Parliament and of the Council (EU) No 528/2012.
2) Article. paragraph 69. 3 (b). and) Regulation of the European Parliament and the Council (EU)
No 528/2012, as amended.
3) Article. paragraph 69. 3 (b). (b)) the European Parliament and of the Council (EU)
No 528/2012, as amended.
4) European Parliament and Council Regulation (EU) No 528/2012 of 22 March.
may 2012 of biocidal products on the market and use of
, as amended.
5) Article. 20 (2). 2 regulation of the European Parliament and of the Council (EU) No.
528/2012, as amended.
6) Article. 20 (2). 3 European Parliament and Council Regulation (EU) No.
528/2012, as amended.
7) Article. 33 para. 1 European Parliament and Council Regulation (EU) No.
528/2012, as amended.
8) Law No. 372/2007 Coll., on health services and conditions of their
provision (law on health services), as amended
regulations.
9) Article. 35 para. 1, art. paragraph 75. 2, article. 82 regulation of the European
Parliament and of the Council (EU) No 528/2012, as amended.
10) Article. 65 paragraph 1. 3, art. paragraph 81. 3 and article. 88 of the European
Parliament and of the Council (EU) No 528/2012, as amended.
11) Act No. 258/2000 Coll., on the protection of public health and amending
some related laws, as amended.
12) Commission delegated Regulation (EU) no 1062/2014.
13) of Council Regulation (EEC) No 2658/87 of 23 July. July 1987 on the tariff and
statistical nomenclature and on the common customs tariff, as amended
the text of the.
14) section 52 of the Act No. 280/2009 Coll., the tax code.
15) Law No 350/2007 Coll., on chemical substances and chemical mixtures and
amending some laws (legislation), as amended
regulations.
16) European Parliament and Council Regulation (EC) no 1272/2008 of 16 June.
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.
17) European Parliament and Council Regulation (EC) No 1907/2006 of the
the registration, evaluation, authorisation and restriction of chemicals (REACH),
, as amended.
