297/2008 Coll.
LAW
Dated 16 July 2008
Amending Act no. 120/2002 Coll., On conditions for placing biocidal
products and active substances on the market and amending some related laws
, as amended, and certain related acts
Parliament has passed this Act of the Czech Republic:
PART ONE
Amendment of the conditions for introducing biocides and active substances on the market
Art. I
Act no. 120/2002 Coll., On conditions of placing of biocidal products and
active substances on the market and amending some related laws,
amended by Act no. 186/2004 Coll. and Act no. 125/2005 Coll., is amended as follows:
First In § 1, paragraph 1, including footnotes Nos. 1 and 1a reads:
"(1) This Act transposes the relevant European Community
^ 1) also follows directly applicable regulations of the European Communities
^ 1) and regulates the rights and obligations of legal
persons and entrepreneurs and competence of administrative authorities
placing of biocidal products and active substances on the market in the Czech Republic
conditions for issuing permits for the placing of biocidal products on the market
way of evaluating the effectiveness of biocides and active substances and their protection
effects on human health, animals, plants, at
wholesomeness of feed, animal and plant products, and
environment and conditions for use of biocidal products.
1) Directive of the European Parliament and Council Directive 98/8 / EC of 16 February 1998
concerning the placing of biocidal products on the market.
Commission Directive 2006/140 / EC of 20 December 2006 amending
Directive of the European Parliament and Council Directive 98/8 / EC to include
active substance sulfuryl fluoride in Annex I to Directive.
Commission Directive 2006/50 / EC of 29 May 2006 amending Annex
IVA and IVB of the European Parliament and Council Directive 98/8 / EC concerning the placing of biocidal products
market.
Commission Directive 2007/20 / EC of 3 April 2007 amending
Directive of the European Parliament and Council Directive 98/8 / EC to include the active substance
dichlofluanid in Annex I to Directive.
Commission Directive 2007/69 / EC of 29 November 2007 amending
Directive of the European Parliament and Council Directive 98/8 / EC to include the active substance
difethialone in Annex I of the Directive.
Commission Directive 2007/70 / EC of 29 November 2007 amending
Directive of the European Parliament and Council Directive 98/8 / EC to include the active substance
carbon dioxide in Annex IA thereto.
Commission Directive 2008/15 / EC of 15 February 2008 amending
Directive of the European Parliament and Council Directive 98/8 / EC to include the active substance
clothianidin in Annex I to Directive.
Commission Directive 2008/16 / EC of 15 February 2008 amending
Directive of the European Parliament and Council Directive 98/8 / EC to include the active substance
etofenprox in Annex I to Directive.
1) Commission Regulation (EC) no. 1896/2000 dated September 7, 2000 on the first phase of the program
under Article. 16 paragraph. 2 Directive of the European Parliament and of the Council
98/8 / EC on biocidal preparations, as amended.
Commission Regulation (EC) 1451/2007 on the second phase
year work program referred to in Article. 16 paragraph. 2 Directive of the European Parliament and the Council
98/8 / EC concerning the placing of biocidal products on the market. ".
Existing footnote no. 1 is referred to as a footnote
no. 1b, including the reference to the footnote.
Second In § 1 para. 2 the words "narcotic and psychotropic substances" is deleted for
word "food" the words "additives added to
food flavorings food additives intended || | animal feed ", the words" objects of common use, "shall
words" materials and articles intended to come into contact with foodstuffs, cosmetics
resources "and the word" radionuclide sources and nuclear materials ^ 1b) | || and waste "are deleted.
Footnote. 1b is repealed.
Third In § 1 para. 3, "Transport of Dangerous Goods," is deleted and
end of the paragraph, the following sentence "classification, packaging and labeling
biocidal products covered by this Act shall not apply to the carriage of biocidal
preparations by rail, road, air, water
inland and maritime transport. ".
Fourth In § 2 para. 1, "which are intended for use in a biocidal product and
" are deleted.
Fifth In § 2 para. 2, the word "intended" is replaced by "in the form in which they are supplied to the user
intended" and the words "this Act" shall
words "no. 1 of this Act".
6th In § 2 para. 4, the words "issued by the Ministry of Health (
" Ministry ") under § 3 para. 5" is replaced by "modified
in Annex no. 3 to this Act" and the word " animals ", the words"
, plants, health of animal feed, animal and plant products
".
7th In § 2 para. 5, the words "and animals" is replaced by "animals, plants
, the wholesomeness of feed, animal and plant products
" and the words "arises" with the word "biocide".
8th In § 2 paragraph 6, including footnote no. 3 reads:
"(6) The substance is a substance which
Commission of the European Communities (the" Commission ") included in the list of essential substances as part
European Community regulation concerning the placing of biocidal products on the market
^ 3 ), which is not a substance, and is marketed primarily
for biocidal purpose mentioned in § 2 para. 2, but which may be used for this purpose
used either directly or in a product containing the substance and a simple
thinner.
3) Annex IB to Directive 98/8 / EC. ".
9th In § 2, paragraph 9 is deleted.
Existing paragraph 10 shall be renumbered 9th
10th In § 2, the following paragraph 10 is added:
'(10) placing the biocidal product or the active substance on the market each
their consideration or without consideration surrender or subsequent storage other than storage
followed by consignment from the customs territory of the European Community
or disposal. For placing on the market is also considered imports
biocidal product or active substance. ".
11th Title II reads: "biocidal product, BASIC AND
ACTIVE SUBSTANCES ON THE MARKET AND use of biocidal products."
12th In the heading of § 3, the words "and use".
13th In § 3, paragraphs 1 and 2 shall be added:
"(1) The active substance is intended for use in a biocidal product can be marketed
corporation or individual
only under the conditions specified in § 8, a biocidal product can bring these people to
market only with the permission of the Ministry of health (hereinafter
"Ministry"), unless stipulated otherwise.
(2) Biocidal products may contain only active substances listed in
list of active substances included in Annex no. 2 to this Act and the
list of active substances with a low risk under Annex no. 3 to || | hereto and only basic substances, while complying with all the requirements laid down
. For meeting the specific conditions laid down in Annex
Nos. 2 and 3 to this Act corresponds
legal entity or a natural person who places biocidal product on the market, with the exception
meet specific conditions imposed authorization holders
issued pursuant to § 7, under the responsibility of the holder, and
specific conditions that apply to the use of biocidal products for which
responsible person referred to in § 3a. 2. '.
14th In § 3 para. 3, the words "natural persons authorized to conduct business and
legal entities" is replaced by "corporation or
natural persons", the words "foreign product for use as a" was deleted
and the words "biocidal product" is replaced by "putting
biocidal product on the market."
15th In § 3, paragraph 5 shall be deleted.
16th Under § 3, the following § 3a and 3b, which including footnote No.
. 3b added:
"§ 3a
(1) A legal entity or a natural person shall not use
biocidal product which has not been notified in accordance with § 35, or allowed to
placing on the market, unless stated otherwise.
(2) When using the biocidal product must
legal entity or a business or a private individual to observe the information and instructions
listed on the package label or package insert or warning
symbols, standard risk phrases or
standard precautionary statements under the Act on chemical substances and chemical
preparations ^ 3b), and specific conditions for
use of biocidal products, modified in annexes Nos. 2 and 3 to this
Law. Biocidal product may only person mentioned in the first sentence
used only to the extent necessary.
§ 3b
Legal entity or a natural person may, without notice by
§ 35 or without authorization to market for biocidal use or used for these purposes
basic substance or biocidal product containing only
such basic substances.
3b) Act no. 356/2003 Coll., On chemical substances and
preparations and amending certain laws, as amended. ".
17th § 4 paragraphs 1 to 3, including footnotes Nos. 4, 4a and 5 are added:
"(1) An application for a permit for placing a biocidal product on the market served
Ministry legal entity which has its registered office, business or its organizational component
^ 4) in the Czech Republic or physical business
a person who has a place of business in the Czech Republic (hereinafter
"the applicant") prior to its initial marketing or first use
unless the biocidal product is to be marketed. The application must be submitted in 1
copy in paper form and in 4 copies to
electronic storage media formats, and using a special kit
programs under the directly applicable European Community regulation on
review program for active substances of biocidal products ^ 4a).
(2) An application under paragraph 1 shall to the extent determined by decree of the Ministry include
A) in addition to requirements under the Administrative Procedure
i requirements under specific conditions laid down in Annex no. 2 or 3
information to identify the manufacturer of the biocidal product and the manufacturer of the active substance and
address of the place of manufacture, || |
B) detailed quantitative and qualitative composition of the biocidal product
C) MSDS biocidal product, developed by
directly applicable European Community regulation on chemicals and chemical preparations
^ 5) if its drafting this
directly applicable regulation of the European Communities stores.
(3) An application for a permit for placing a biocidal product on the market, with the exception
biocidal product or a low-risk biocidal product
frame formulation must contain the information specified in paragraph 2 and in the range
Decree of the Ministry of these basic data
active substances and biocidal product: name, identifying information,
physical, chemical, technical or biological characteristics, type
biocidal product, analytical methods for active substances, toxicology
and ecotoxicological data, efficacy against target organisms and
recommended use, categories of users, the measures necessary to protect
humans, animals, plants, the environment, health safety
feed, animal and plant products, method of waste disposal,
classification, packaging, labeling, residues of active substances, the effects on non-target organisms
, summary and evaluation of data.
4) Act no. 513/1991 Coll., The Commercial Code, as amended
regulations.
4a) Annex III to Regulation (EC) 1451/2007.
5) Annex II of the Regulation of the European Parliament and Council Regulation (EC) no. 1907/2006
of 18 December 2006 concerning the registration, evaluation, authorization and restriction of chemicals
, establishing a European Chemicals Agency | || agents, amending Directive 1999/45 / EC and repealing Council Regulation (EEC) No.
793/93 and Commission Regulation (EC) no. 1488/94, Council Directive 76/769 / EEC and
Commission Directives 91/155 / EEC, 93/67 / EEC, 93/105 / EC and 2000/21 / EC. ".
18th In § 4 para. 4 the word "contains" be replaced by "must contain"
word "these" is replaced by "and to the extent determined by decree
ministry", the words "quantitative and chemical composition," shall be deleted; for
word "classification," the words "packaging" and the words "
comprehensive evaluation of data" is deleted.
19th In § 4 para. 5, after the words "ecotoxicological information" the words
"by Decree of the Ministry" and the word "animals" the words
'plants, feed, animal and plant products. "
20th In § 4, paragraph 7 is deleted.
Existing paragraph 8 shall be renumbered seventh
21st In § 4 para. 7, the word "preparation" is replaced by "putting
biocidal product on the market", the words "permanent residence" is
replaced by the word "residence", the words "place of business" shall be inserted | || word "central administration, its principal place of business" and
Words "business representative in the territory" is replaced by "
organizational unit in the territory of another."
22nd In § 5 para. 1, "or labels" are replaced by "a label or package insert
^ 3b)".
23rd In § 5 para. 2 first and second sentences and paragraph 5, after the word
"permission" words "to launch" and the words "biocidal product"
the words "marketing" and in paragraph 2 third sentence, the words "the name and address of the applicant
" are deleted.
24th In § 5 para. 3, the words "agree to" be replaced by "adopt
request in which" and "replaced" before the word "replace".
25th In § 5 para. 4, after the words "or 5" the words "not necessary
having regard to the nature of the biocidal product or its proposed use or
" and the word "necessary" is inserted after the word "is".
26th In § 5 para. 5, "European Commission (" Commission ")"
replaced by the word "Commission".
27th § 6 headline reads: "Evaluation of documentation biocidal product."
28th § 6 para. 1, the word "carry" is replaced by "ensure"
words "based on" is deleted at the end of the paragraph text, the words
'(hereinafter' the dossier biocidal product ")".
29th In § 6, paragraph 2 reads:
"(2) Ratings biocidal product documentation includes an assessment of its
completeness and further evaluation of the data contained in it in terms of efficiency
biocidal product on target organisms, its impact on human
animals, plants and the environment environment, and of the measures
necessary to protect humans, animals, plants, health
feed, animal and plant products, and environmental protection
as a whole in normal use of the biocidal product and in terms
actually the least favorable conditions of preparation, use, storage and disposal
biocidal product and the material it
treated. ".
30th § 6 para. 4 the word "evaluation", the word "documentation".
31st The heading of § 7 reads: "Permit for placing a biocidal product on the market."
32nd In § 7 para. 1 introductory part, the words "biocidal product"
replaced by "placing a biocidal product on the market."
33rd In § 7 para. 1 point. a) the words "a list of active substances or
list of active substances with a low risk" are replaced by "Annex.
2 or 3 of this Act, and the requirements and specific conditions
therein".
34th In § 7 para. 1 point. b) after the word "documents" the words
"biocidal product", and in paragraphs 3 and 4 of the word 'harmful'
replaces the word "unacceptable".
35th In § 7 para. 1 point. c) the words "of the data submitted in the application for a permit
" are replaced by "documentation biocidal product" and
word "animals" the words "plants, wholesomeness
feed, animal and vegetable products ".
36th In § 7 para. 4, the words "action by the competent authorities of the European Union
stores" are replaced by "directly applicable regulation
European Communities or the specific conditions laid down in Annex no. 2 or 3
saved."
37th In § 7 para. 5 first sentence, the word "require" and the words "
environment and" the word "binding", the words "biocidal product" shall
words "documentation biocidal product range § 6 . 2 "for
words" Ministry of agriculture ", the words" within the scope of § 6.
2 "and the last sentence is deleted.
38th In § 7 para. 6 of the first sentence the number "180" is replaced by "360" and
second sentence is deleted.
39th In § 7 para. 7 of the first and second sentences, the words "list of active substances or
list of active substances with a low risk" are replaced by "Annex
No. 2 or 3 of this Act ".
40th In § 7 at the end of paragraph 8 of the text, the words ";
do so can, if necessary, ex officio ".
41st In § 7 para. 9, after the word "permitted" the words "and
notified" and "kept a list in the Bulletin of the Ministry of Health
" is replaced by "kept in electronic form on its website
and at least once per calendar year in the Bulletin of the Ministry of health
list containing the designation holders
permit and persons who have submitted a notification pursuant to § 35, the types and names
Biocidal products and the names of the active substances ".
42nd In § 7 para. 10 introductory part, the words "permit holder
biocidal product" is replaced by "holder of the authorization for placing
biocidal product on the market."
43rd In § 7 para. 10 point. a) § 14 para. 2 point. c) § 15 para. 2 point.
F) and § 21 para. 2, after the word "animals" the words "plants
feed, animal and plant products."
44th § 8 reads:
"§ 8
Legal entity or a natural person may market
active substances intended for use in a biocidal product that has not been
placed on the market before 14 May 2000, to consent to sending a summary
documentation for the active substance
competent authorities of other Member States and the Commission, which publishes
ministry or competent authority of another Member State. Consent under the first sentence issued by the Ministry
according to § 12 para. 2 on the basis of a proposal under § 12 para. 1 and
attached a written declaration that the active substance is intended for use in
biocidal product. Active substances for use in biocidal
product placed on the market before 14 May 2000, may
after this date may be marketed under the conditions laid down by directly applicable regulations of the European Communities
^ 1) . '.
Footnotes. 8, 9 and 9a are hereby repealed.
45th § 9 headline reads: "Temporary authorization for placing a biocidal product on the market
".
46th In § 9. 1, first sentence, the word "authorize" is replaced by "
ex officio or at the request of the applicant authorizes the placing on the market" and the last sentence
is replaced by the phrase 'within the permit from the Ministry establishes the conditions of use || | such a biocidal product. With these conditions the licensee is obliged to demonstrably acquaint
corporation or physical
persons from him biocidal product is withdrawn and such persons are
obliged to act in accordance with the facts with which they were familiar. ".
47th In § 9, paragraph 2 reads:
"(2) The Ministry of the applicant's request to temporarily allow the marketing
biocidal product containing an active substance not listed in the Annexes.
2 or 3 of this Act, which was not on the market on May 14, 2000
for uses other than for research and development under Title IV if
A) on the basis of the evaluation of the active substance, submitted pursuant to § 12
applicant concludes that the active substance complies with the standards
classifying inventory in accordance with § 13
B) it is expected that the biocidal product complies with the conditions provided for in §
7, paragraph. 1 point. b) to d)
C) no other Member State on the basis of the summary sent by
§ 12 paragraph. 2 has no objection to the dossier to the active substance or
case pursuant to paragraph 3, the Commission issued a decision, according to which
documentation is complete.
This authorization is valid until the date of inclusion in the list
provided for in Annex no. 2 or 3 of this Act, but not longer than three years
date of its enforcement. In the event that an active substance is not
after the expiry of this period included in the list provided for in Annex no. 2 or 3
to this Act, the authorization may be at the request of its holder
renewed for another year. ".
48th In § 9, after paragraph 2 the following paragraph 3 is added:
"(3) If a Member State in proceedings pursuant to paragraph 2
objections to the completeness of the dossier for the active substance ministry suspend proceedings until
time of publication of the Commission's decision. If the Commission decides that the documentation is not
complete, the ministry will invite the applicant to supplement the documentation. ".
The former paragraphs 3 to 5 shall be renumbered 4 to 6
49th In § 9 par. 4 of the first sentence, the word "opinion" is replaced
"binding opinions" and in the second sentence, the words "only if they are
opinions of both ministries to permit positive, and" are deleted.
50th In § 9, paragraph 5 reads:
"(5) The permit for placing a biocidal product on the market in accordance with paragraph 1 or 2
inform the Ministry without undue delay
other Member States and the Commission together with justification authorization;
Department progresses similarly in case of extension of the permit. If
Commission decision, based on which the Ministry is obliged
permit issued under paragraph 1 or 2 change or cancel
Ministry ex officio issued a permit changed or canceled in accordance with
Conditions set out in the Commission's decision. ".
51st In § 9, paragraph 6 reads:
"(6) An application under paragraph 1 or 2 may also submit to the Ministry
person referred to in § 4 para. 7.".
52nd The heading of § 10 reads: "Mutual recognition of authorizations for placing biocidal
product on the market."
53rd In § 10 paragraph 1, including footnote no. 8 reads:
"(1) The placing on the market of a biocidal product which has been authorized or registered
^ 8) in another Member State has authorized the Ministry upon request
applicant or person referred to in § 4 para. 7, submitted before
its first placing on the market within 120 days, in the case of a biocidal product with low risk
within 60 days from the date the application was
ministry submitted, provided that the active substance of the biocidal product
included in the list set out in Annex no. 2 or 3 of this Act and
the requirements therein. The Ministry determines the permit
conditions for admitting the biocidal product on the market in another Member State
.
8) Article. 2. 1 point. i) k) Directive of the European Parliament and of the Council
98/8 / EC. ".
54th In § 10 paragraph. 2, "a document of the first authorization of biocidal
product summary and evaluation of the data referred to in § 4 para. 2 or 3,"
replaced by "the translation first authorization for placing the biocidal product
market issued in another Member State into the Czech language
data referred to in § 4 para. 2 and a summary of the information referred to in § 4
paragraph. 3; ".
55th In § 10 paragraph. 3, "adjusts the authorizations accordingly,"
replaced by "and seeks to regulate" and at the end of the text paragraph shall be added
words "suspend the application and notifies its intention and its
reasons other Member States, the Commission and the person referred to in paragraph 1
the ministry shall proceed in accordance with the decision of the competent authority
European Union. ".
56th In § 10 paragraph. 4 first sentence, the word "proposes"
replaced by the word "intends", the words "permission issued a" be replaced by "interrupts
application procedure" and the words "and the Commission" shall be replaced "
Commission and the person referred to in paragraph 1".
57th In § 10 paragraph. 7, first sentence, the word "opinion" is replaced
"binding opinions", the second sentence after the word "his" shall be inserted
"binding" and the last sentence is deleted.
'58. The heading of § 11 reads: "Change and cancellation of the authorization for placing the biocidal product on the market
".
59th In § 11 para. 1 point. b) the word "animals" the words "
plants, feed, animal and plant products."
60th In § 11 para. 1, letter c) reads:
"C) at the request of the licensee, if the request shall change
reasons, even after the change will be met the conditions in § 7 para. 1
third."
61st In § 11 para. 2 and 3, the words "a list of active substances or
list of active substances with a low risk" are replaced by "modified
list in Annex no. 2 or 3 of this Act".
62nd In § 11 par. 4, letter a) reads:
"A) the active substance has been removed from Annex no. 2 or 3 of this Act
or are no longer fulfilled in these annexes or modified requirements
specific conditions."
63rd In § 11 para. 5 first sentence, the word "Ministry" the words
"ex officio authorization holders" at the end of the text paragraph, the following sentence
"With the abolition of the permit or its expiry, as well as the | || deadlines for the disposal, storage, sale or use of existing stocks of biocidal product
licensee shall demonstrably acquainted
corporation or natural persons from him
biocidal product is withdrawn and such persons are obliged to proceed
in accordance with the facts with which they were familiar. ".
64th In § 11, after paragraph 5 the following paragraph 6 is added:
"(6) The Ministry may require that the holder of the authorization submitted
information necessary for the proceedings pursuant to paragraph 1 or 4. If necessary
ministry may, at the request of the licensee
extend the validity of the authorization for the period necessary for its review; but always from
ex officio extend the validity of the authorization for the period necessary to provide information
in the first sentence. ".
Former paragraphs 6 and 7 become paragraphs 7 and 8
65th In § 11 para. 7 first sentence, the word "opinion" is replaced
"binding opinions", the second sentence after the word "his" the word
"Binding" and the last sentence is replaced by "
Ministry will issue a decision within 30 days of receipt of binding opinions
concerned authorities.".
66th § 12 including the title and footnote no. 9 reads:
"§ 12
Procedure for inclusion of an active substance to the list
(1) Based on current scientific and technical knowledge
active substances to the list of active substances to the list of active substances with a low risk
a list of essential substances, which are part of the European Communities
regulations on the marketing biocidal products on the market ^ 9).
Proposal for the inclusion of an active substance in these lists are submitted to the Ministry.
Applicant who submits a proposal to the Ministry under the second sentence, shall
ministry simultaneously request for approval from the Ministry of sending a summary
data under a) and b) the competent authorities of other Member States and the Commission
. Draft first sentence is served in one copy in paper form and
in 4 copies on electronic storage media formats
and using a special set of programs under the directly applicable European Communities
a review program for active substances
biocidal products ^ 4). For the elements of a valid § 4 para. 2
similarly; must further proposal to the extent provided by ministerial decree contain
A) basic and additional data on the active substance,
B) basic and additional data at least about one biocidal product
which contains the active substance for which inclusion in the list of applicant applies
(hereinafter 'the dossier for the active substance ").
(2) Ministry, the Ministry of Environment and Ministry of Agriculture
ensure evaluation of the dossier to the active substance.
If the documentation is complete, the Ministry will issue to the applicant within 90 days of approval
sending a summary of the dossier for the active substance
competent authorities of other Member States and the Commission will invite the applicant to simultaneously
application for dossier evaluation the active substance for the purposes
of inclusion in the list of active substances to the list of active substances
low risk or a list of essential substances.
(3) If the applicant submits a proposal to the Ministry for dossier
active substance in accordance with paragraph 2, second sentence, the Ministry, the Ministry
Environment and Ministry of Agriculture will be the guest of
aspects and the principles covered in § 6 para. 2-4 that
based on the general evaluation of the documentation drawn up by the Ministry
final report within 12 months of receipt of the proposal.
(4) Ministry interrupts the evaluation referred to in paragraph 3 and ask the applicant to submit
additional information, if it finds that the evaluation of the active substance
not be complete without this information. Time from interrupt
evaluation of the receipt of the required data into the twelve month period referred to in paragraph 3
counted. The reasons for discontinuation of the trial
Ministry shall inform the other Member States and the Commission.
(5) The Ministry will send a final report to the applicant, the other Member States and the Commission
along with a proposal to include or not include the active substance in the lists
under paragraph 1; when a final report
Ministry proceeds according to the principles laid down in § 13.
Commission decision to include or not include the active substance in the list of active substances
, the list of active substances with a low risk or a list of essential substances familiar
Ministry of applicants.
(6) The consent referred to in paragraph 2
Ministry may ask the Commission to the evaluation of the active substance performed by another Member State of
. With the decision of the Commission which Member State the evaluation of the active substance
perform, learn about the ministry of the applicant.
(7) A proposal for inclusion of the active substance in the list of active substances
list of active substances with a low risk or a list of essential substances may
filed with the ministry and the person referred to in § 4 para. 7th
(8) The inclusion of active substances to the list of active substances
list of active substances with a low risk or a list of essential substances within
work program for the systematic examination of active substances
proceed in accordance with the directly applicable European | || Community ^ 1).
(9) adjusts Ministry decree
detailed specification information relating to the identification of the active substance, and the body of the
Indicating the generic name, chemical or taxonomic name and strain
physical, chemical, technological and biological properties
analytical methods for detection and identification, efficacy, and intended use
, toxicological and metabolic studies, ecotoxicology
data, measures necessary to protect humans, animals, plants and
environment, residues of active substances, the effects on the target organisms
, classification, labeling, summary and evaluation.
(10) Proceedings of the proposal to amend the inclusion of an active substance in the list
active substances to the list of active substances with a low risk or
list of basic substances or extension of this classification, paragraphs 1-9
analogy.
9) Annexes I, IA and IB to Directive 98/8 / EC.
Commission Directive 2006/140 / EC.
Commission Directive 2007/20 / EC.
Commission Directive 2007/69 / EC.
Commission Directive 2007/70 / EC. ".
67th In § 13 para. 1, first sentence, the words "active substance is classified as"
replaced by the word "Ministry" and the word "knowledge" the words
"the Commission will propose the inclusion of an active substance".
68th In § 13 para. 2 of the introductory part, the words "classification"
replaced by "the Ministry proposal to include" and "may also be subject
" is replaced by the word "conditional".
69th In § 13 para. 2 at the end of the text of letter h), the words "
plants, health of animal feed, animal and plant products
".
70th In § 13 paragraph 3-5 added:
"(3) The Ministry shall propose to the Commission not to include in the list of active substances
low risk of such an active ingredient which is under special
regulation on chemical substances and preparations ^ 3b)
carcinogenic, mutagenic, toxic to reproduction or sensitizing
or has the ability to accumulate in the environment and not easily degradable
.
(4) The Ministry shall propose to the Commission of inclusion in the list referred to in paragraph 1
just for biocidal product types listed in Annex no. 1 to
this Act, for which a dossier has been submitted in accordance with § 12 para. 1 | || point. b). The proposal to include the active substance in the list of active substances with
low risk may be subject to a range of concentrations in which
allowed.
(5) The Ministry may re-propose to the Commission that the inclusion of the active substance
list referred to in paragraph 1 has been 10 years after renewed
no longer than a period of 10 years. If the Ministry obtains
evidence that any of the conditions listed in paragraph 1 or 3
is not met, the Commission may propose to review the inclusion of an active substance in
list. ".
71st In § 13 para. 6 of the introductory part of the word "classification"
replaced by "The ministry may propose to the Commission that the inclusion of" and
words "may be refused or canceled inclusion in the list" is replaced
" it was refused or its listing has been canceled. "
72nd In § 13 para. 6 point. a) the words "§ 12 para. 4" is replaced by "
§ 12 paragraph. 3" and the word "animals" the words "plant health
feed, animal or plant products."
73rd In § 13 para. 6 point. b) the word "type", the word
"biocidal" after the word "of" the words "(hereinafter
" alternative material ")," and the word "animals" the words "| || plants, the wholesomeness of feed, animal or plant products
".
74th In § 13 para. 7 first sentence, the words "to initiate the procedure" is deleted and
words "consider alternative substance or substances" are replaced
"provide an assessment of alternatives".
75th In § 13 para. 8 of the introductory part, the words "paragraph 6"
replaced by "paragraphs 6 and 7".
76th In § 14 para. 1 the words "research, applied research and development"
replaced by "research or development, including applied research and development
", the words "under § 4", the words "or § 9 paragraph. 1 "
number" 13 "is replaced by" 12 "and the words" paragraph. 1 and 2 "are deleted.
77th In § 14 para. 2 of the introductory part of the provision reads:
"Legal entities or natural persons carrying out research, development or testing
necessary for filing an application pursuant to § 4 and § 9.
1, or for filing a petition under § 12 are required throughout
Experiments run for 15 years from the end of experiments
keep records of the biocidal product or active substance, which contain ".
78th In § 14 par. 2 point. b) the words "natural persons authorized to
business" is replaced by "individuals doing business."
79th In § 14 para. 4, the words "natural persons authorized to conduct business and legal
" is replaced by "legal entities or individual entrepreneurs'
word" and "before the word" or "at the end of paragraph is added | || sentence "Such persons are also obliged to notify the ministry completion
applied research or development.".
80th In § 14 para. 5, the words "person who intends to carry out experiments,"
replaced by "legal entity or a natural person prior to their commencement
" and the words "and provide information needed to assess the request
" is replaced by '; the application shall include information necessary to assess
experiments or tests. "
81st In § 14 para. 6 after the word "test" the words "ex officio"
and the word "animals" the words "plant health
feed safety, animal or plant products."
82nd In § 14 para. 7 first sentence, the word "opinion" is replaced
"binding opinions", the second sentence after the word "his" shall be inserted
"binding" and the last sentence shall be replaced by "The ministry will issue | || decision within 30 days of receipt of binding opinions
concerned authorities. ".
83rd In the heading of § 15, the words "or the petitioner" shall be deleted.
84th In § 15 Paragraph 1 reads:
"(1) An applicant under § 4, 9, 10 or 12, as well as the person marketing the active substance
procedure under § 8, the documentation submitted to the Ministry
mark data that should not be disclosed to third
persons (hereinafter referred to as "confidential data"), and apply in this case with a detailed justification
. The request of the Ministry. The Ministry always meet
request that concerns of the full composition of a biocidal product. ".
85th In § 15 par. 2 letter d) reads:
"D) physical and chemical data concerning the biocidal product or active substance
".
86th In § 15 par. 3 of the introductory part of the word "disclose"
inserted the word "confidential" and "marked in accordance with paragraph 1," are deleted.
87th In § 15 par. 3 letter a) reads:
"A) persons performing evaluation of biocidal product documentation or
documentation for the active substance".
88th In § 15 par. 3 letter c) shall be deleted.
Existing letters d) to f) are renumbered c) to e).
89th In § 15 par. 3 letter d) reads:
"D) Member States".
90th In § 15 para. 4, after the words "paragraph 3" the words "point. a) to c
) "after the word" shall "with the word" confidential "and" marked
pursuant to paragraph 1, except those listed in paragraph 2 "are deleted.
91st In § 15 paragraph 5 reads:
"(5) If a person referred to in paragraph 1 shall disclose any confidential information
can not continue as such can be considered; this fact is
person referred to in paragraph 1 shall inform the Ministry. ".
92nd In § 16 para. 1, "or the petitioner under § 4, 8 and 13"
replaced by "pursuant to § 4, 9, 10 or 12" and the words "or proposers" and
'or petitioners, "the deleted.
93rd In § 16, Subsection 2, including footnote no. 10 reads:
"(2) The Ministry may not be used without the written consent of the first applicant
benefit of other applicants following information:
A) of the active substance that was not on the market before 14 May 2000 and is
listed in Annex no. 2 or 3 of this Act, for a period of 15 years from the date
its first inclusion in the lists provided for in these Annexes
B) of the active substance which was on the market before 14 May 2000,
First 14 May 2010, with the exception of information protected by special legislation
inventions, rationalization proposals and industrial designs
and their protection ^ 10), for which it will continue to protect the information
time specified by these specific legal regulations
but not later than 14 May 2010
Second for a period of 10 years from the date of first inclusion of the active substance in the list
provided for in Annex no. 2 or 3 of this Act, if it is a
data, which were presented for the first time as the basis for the first effective inclusion of either
substance or biocidal product type, additional to those
Lists
C) a biocidal product containing an active substance that was not on
market before 14 May 2000, from which an enforceable permits
placing on the market in any Member State are less than 10 years
D) a biocidal product containing an active substance which was on the market
before 14 May 2000
First 14 May 2010, with the exception of information protected by special legislation
inventions, rationalization proposals and industrial designs
and their protection ^ 10), for which it will continue to protect the information
time specified by these specific legal regulations
but not later than 14 May 2010
Second for a period of 10 years from the date of first inclusion of the active substance in the list of active substances or
list of active substances with a low risk adjusted
in Annex no. 2 or 3 of this Act, if it is the data that were
presented for the first time as the basis for the first inclusion of either the active ingredient or an additional
biocidal product type on those lists
E) have been submitted for changes to the permit conditions pursuant to § 11
or for changes of inclusion in the list of active substances
list of active substances with a low risk or a list of essential substances
or extension of this classification under § 12 para. 10 of the first submission
are less than 5 years; This does not affect the obligation
meet the deadlines set out in subparagraphs a) to d).
10) Act no. 527/1990 Coll., On inventions, industrial designs and
rationalization proposals, as amended.
Act no. 207/2000 Coll., On Protection of Industrial Designs and the Amendment to Act no.
527/1990 Coll., On inventions, industrial designs and rationalization proposals
, as amended. ".
94th In § 17 para. 1 introductory part of the word "canceled"
words "disappeared, was" in a letter e) the words "formulation type,"
replaced by "form a biocidal product."
95th In § 17 para. 3, after the word "receive" the words "
from another Member State" and the words "under § 9. 5 and § 12 para. 3" is
replaced by "the biocidal product or active substance ".
96th In § 19, the introductory part of the second sentence, the word "these"
replaced by "specific conditions provided for in Annex no. 2 or 3
to the Act and these other".
97th In § 20 at the end of paragraph 1 is replaced by a comma and
letter m) is added:
"M) the information set out in the specific conditions laid down in Annex.
2 or 3 of this Act.".
98th In § 20 para. 2 the words "k) and points. l) Section 2 "are replaced by" k)
m) and in paragraph 1. l), point 2 '.
99th Under § 21, the following new § 21a and 21b are inserted:
"§ 21a
The obligations set out in § 19 to 21 corresponds
legal entity or a natural person who places biocidal product on the market.
§ 21b
The active substance placed on the market for use in biocidal product is
classified, packaged and labeled in accordance with a special regulation on
chemical substances and preparations ^ 3b). ".
100th In the heading of Title VII, the words "and the results of inspections" are deleted.
One hundred and first § 22 including footnotes Nos. 15 and 16 reads:
"§ 22
(1) Medical device transmits manner stipulated by a special legal
regulation on data transfers to the National Health Information System
^ 15) information about the poisonings with biocidal products or active substances
National Health Information System and the National
hospitalized registry or the National registry of occupational diseases; when the
according to a special legal regulation 16).
(2) Information on active substances and biocidal products
obtained under this Act that are necessary for first aid or treatment
provides in cases of poisoning or other accidents caused
active substances or biocidal products doctors or other persons exercising the medical profession
Toxicological information Centre
General Teaching Hospital in Prague.
15) Decree no. 552/2004 Coll., On the transmission of personal and other data to
National Health Information System for management
national health registers.
16) Act no. 20/1966 Coll., On Public Health Care, as amended
regulations. ".
102nd In § 23 of the introductory part of the word "market" the words "and
their use."
103rd In § 24 para. 1 a) and b) are deleted.
Existing letters c) to j) are marked as letters a) to h).
104th In § 24 para. 1 a) and b) are added:
"A) receives notification of biocidal products, suggestions for inclusion of active
substances to the list of active substances to the list of active substances with a low risk
a list of essential substances according to § 12 para. 1, proposals to amend
and the extension of this classification and the proposals for the evaluation of the
active substance for the purposes of inclusion in these lists,
B) decisions on matters pursuant to § 7, 9, 10, 11, § 12 para. 2, § 14 para. 5 and 6
, § 15 para. 1 and § 35 para. 4 and 5, gives proposals on matters
inclusion of active substances to the list of active substances to the list of active substances with a low risk
a list of essential substances in accordance with § 13 and kept for a period of 15 years
all documentation related ".
105th In § 24 para. 1 point. c) after the word "documents" the words
"biocidal product", the word "release" the words "
change or cancel", the words "and documents" the words "to effectively || | substance ", the word" registration "is replaced by" inclusion "
words" public health "is replaced by the word" man "and at the end of the text
subparagraph the words" as well as amendment and extension of the || | inclusion ".
106th In § 24 para. 1, letter d) reads:
"D) keep records of authorized and notified biocides and
publish it in accordance with § 7 para. 9".
107th In § 24 para. 1 point. f) the words "and makes decisions according to § 14 paragraph
. 5 and 6 "are deleted.
108th In § 24 at the end of paragraph 1 is replaced by a comma and
letters i) to l) are added:
"I) fulfills tasks according to § 4 para. 5 and 6, § 5, § 7 para. 11, § 14 para. 3,
§ 15 paragraph. 3 and 5 and § 16
J) keep records of checks carried out by regional health departments,
Czech Environmental Inspectorate or customs
containing identifying information of the inspected person, the amount of fines merits
under which fines were imposed and enforceable
kinds of enforceable remedies imposed
K) by the directly applicable European Community ^ 1)
receives and evaluates the documentation for active substances on the list
active substances, active substances with low risk and a list of basic
substances, prepares a final report accepts
related notice in cases where the Czech Republic intended as a reporter to ensure
program implementation review of existing active substances
L) passes toxicological information center for first aid or treatment
information on active substances and biocidal products
. ".
109s. In § 24 para. 2 the words "point. e) "is replaced by" point. c) ae)
evaluation and documentation pursuant to paragraph 1. k) "and the words"
which has established "is replaced by" to which it performs the function of a founder or founder
".
110th In § 24 at the beginning of paragraph 3, the following sentence "In performing the tasks
under this Act is the Ministry in its scope
authorized to take action on the basis and within the limits of the directly applicable European Communities
Biocides and effective
substances ^ 1a). ".
111th In § 24, the following paragraphs 4 and 5 are added:
"(4) The Ministry shall cooperate with the Commission and the competent authorities of the Member States
within its jurisdiction under paragraph 1 and provide them with information and opinions
in scope, form and time intervals in accordance with this Act
and applicable regulations of the European Communities on
biocides and active substances ^ 1).
(5) The Ministry sends every third year to 30 November the Commission
summary report on inspections carried out, enforceable
corrective actions imposed and fines and cases of poisoning
biocidal products or active substances in the Czech Republic
over this period. ".
112th In § 25 point. a) the words "issued by the Ministry
opinion on a decision on the authorization of biocidal products on the proposal to register
active substances to the list of active substances to the list of active substances
Low risk and a list of essential substances "are replaced by" a concerned
authority in extradition proceedings, amend or revoke authorization for placing
biocidal product on the market; issue a binding opinion. "
113th In § 25 point. b) the words "cooperates with the Ministry on
evaluation of dossiers submitted for the issuance, amendment or repeal
decision on the authorization of biocidal products and documentation" are replaced
words "evaluates documentation", the word "registration" is replaced by | || "inclusion", the words "in terms of" the words "its completeness and
terms" and at the end of the text of letter b) the words "and
amendment and extension of the inclusion".
114 respectively. In § 25, at the end of subparagraph b) is replaced by a comma and
letters c) to e), added:
"C) submitted to the Ministry suggestions to amend or repeal
authorization for placing a biocidal product on the market
D) the authority concerned in a trial experiments or tests
according to § 14 paragraph. 5 and prohibition proceedings experiments or tests or determination
conditions pursuant to § 14 para. 6; binding opinion issued in terms of protection
environmental
E) decide on appeals against decisions issued by the Czech Environmental Inspection
. ".
115th In § 26 point. a) the words "issued by the Ministry
opinion on a decision on the authorization of biocidal products on the proposal to register
active substances to the list of active substances to the list of active substances with a low risk
a list of essential substances" are replaced by "
is concerned body in proceedings on the issue, amend or revoke authorization for placing
biocidal product on the market; issue a binding opinion. "
116th In § 26 point. b) the words "cooperates with the Ministry on
evaluation of dossiers submitted for the issuance, amendment or repeal
decision on the authorization of biocidal products and documentation" are replaced
words "evaluates documentation", the word "registration" is replaced by | || "inclusion", the words "in terms of" the words "its completeness and
terms" and at the end of the text of letter b) the words "and
amendment and extension of the inclusion".
117th In § 26 at the end of subparagraph b) is replaced by a comma and
letters c) and d) are added:
"C) submitted to the Ministry suggestions to amend or repeal
authorization for placing a biocidal product on the market
D) the authority concerned in a trial experiments or tests
according to § 14 paragraph. 5 and prohibition proceedings experiments or tests or determination
conditions pursuant to § 14 para. 6; binding opinion issued in terms of protection
animal and plant health and animal feed
animal and plant products. ".
118th § 27 including the title reads:
"§ 27
Regional Hygiene Station
Regional Health Authority
A) oversee the legal entities or entrepreneurs
natural persons comply with the provisions of this Act,
directly applicable European Communities regulations on biocidal products and active substances
^ 1), the Ministry's decision issued on the basis thereof
and decisions issued pursuant to subparagraph c)
B) imposes legal entities or natural persons entrepreneurs
fines for breaches of the law, directly applicable regulations
European Communities on biocidal products and active substances-1a)
a ministerial decision issued on their basis ,
C) is entitled to legal persons or entrepreneurs individuals
using biocidal product or placing the biocidal product or
active substance on the market in contravention of this Act,
directly applicable EC legislation on biocides and active substances
^ 1) or the decision of the Ministry, to impose a ban on
biocidal product or active substance on the market, prohibition of the use
biocidal product or carry out remedial measure consisting in the withdrawal
biocidal product or active substance from the market or distribution
or their disposal,
D) hears offenses under § 32a
E) send to the Ministry annually at 30 September a comprehensive report on the state
conducted inspections and corrective measures by letters
c) and fines pursuant to subparagraph b) imposed an enforceable judgment, for the past 12
months of the date of August 31 of each calendar year. ".
119th In § 29 point. a) the words "natural persons authorized to
business and legal entities" is replaced by "
legal entities or natural persons carrying on business" and end the text of the letter is
words "and decisions issued pursuant to subparagraph b)" .
120th In § 29 point. b) the words "the conditions and deadlines for assuring remedy
" replaced "is entitled to impose a ban on the placing of biocidal
product on the market or carry out remedial measure consisting in the withdrawal
biocidal product from the market, distribution or
its disposal ".
121st In § 29 point. c) and § 30 point. e) the words "natural persons
authorized to do business and legal entities" is replaced by "
legal entities or individuals doing business."
122nd At the end of § 29 is replaced by a comma and letter d)
added:
"D) send to the Ministry annually at 30 September a comprehensive report on the state
conducted inspections and corrective measures by letters
b) and fines pursuant to subparagraph c) imposed an enforceable judgment, for the past
12 months to 31st August each year. ".
123rd In § 30 point. b) the words "Regional Public Health" is replaced
"regional hygiene station."
124th In § 30 point. d) the words "the conditions and deadlines for assuring remedy
" replaced by "the release into free circulation
biocidal product."
125th At the end of § 30 is replaced by a comma and letter f)
added:
"F) forwarded to the Ministry annually at 30 September a comprehensive report on the state
conducted inspections and measures under letters d) and
fines according to letters e) stored enforceable decision, for the previous 12
months of the date of August 31 of each calendar year. ".
126th In § 31, the word "supervision" is replaced by "Control" and the words
"armed security" is replaced with the word "security".
127th Under § 31 the following § 31a, including the heading and footnotes
line no. 17a and 17b reads:
"§ 31a
Exercise of state control
(1) The regional health authority shall proceed in the exercise of state control
under the law on the protection of public health ^ 17); Czech Environmental Inspectorate
environment and customs authorities act in the exercise of state control
by the State Control Act-17b). When exercising state control are
county health departments, the Czech Environmental Inspectorate and the customs authorities
further authorized
A) take samples of active substances and biocidal products and make
visual documentation,
B) verify the identity of persons inspected and also identify individuals
persons representing during the examination of the inspected person and authority
for such representation.
(2) Audited persons and other persons involved in the exercise of state control
are obliged to create conditions for the implementation of state control.
Who is considered a controlled person lays down the law on state control
^ 17b).
(3) The rights and obligations of regional health authorities and the Czech Environmental Inspectorate
under this Act or
directly applicable European Communities on biocidal products and active substances
^ 1) shall also apply to dwellings, which is used for
business.
17a) Act no. 258/2000 Coll., On protection of public health and amending
some related laws, as amended.
17b) Act no. 552/1991 Coll., On state control, as amended
regulations. ".
128th A Title IX reads: "administrative infractions."
129th § 32 including the title reads:
"§ 32
Administrative offenses of legal entities and individuals
(1) A legal or natural person commits an administrative offense
that
A) in contravention of § 3 para. 1 will launch the active substance intended for use in
biocidal product in conflict with the conditions pursuant to § 8 or
places on the market biocidal product without a license pursuant to § 7, § 9 paragraph.
1 or 2 or § 10 paragraph. 1 or no notification pursuant to § 35 or in conflict with such
permission or notification
B) contrary to § 3a par. 1 applies a biocidal product that has not been
allowed to be placed on the market or placing on the market was not announced
according to § 35, or uses biocidal product in conflict with § 3a Sec. 2,
C) requests for authorization for placing the biocidal product on the market, despite a
this plan has made a written declaration in accordance with § 5 para. 2, or puts on the market
active substance in contravention of a written statement pursuant to § 8,
D) fails to comply with a condition of use of biocidal products with which it was under § 9
paragraph. 1 Introduction,
E) fails to comply with the time limit for disposal, storage, sale or use
existing stocks of biocidal product, determined in accordance with § 11 para. 5
or § 35 para. 5
F) a person referred to in § 15 para. 1 of the publication informs
confidential information pursuant to § 15 para. 5
G) fail to pack a biocidal product in accordance with § 19 of his
labeling according to § 20, or a promotion or advertisement according to § 21, or
H) comply with the obligation directly applicable European Community
on active substances and biocidal products ^ 1).
(2) A legal or natural person who uses biocidal product or
states biocidal product or active substance on the market, with
commits an administrative offense, contrary to the decision in accordance with § 27 point
. c) or § 29 point. b) uses biocidal product or fails to comply
ban the biocidal product or active substance on the market, or
biocidal product or active substance does not withdraw from the market, distribution or
nezneškodní.
(3) A legal or natural person who places
biocidal product on the market or using it, or the holder of the authorization for placing
biocidal product on the market according to § 7 commits an administrative offense by the
contrary to § 3 para. 2 fails to comply with specific conditions laid down in Annex
no. 2 or 3 of this Act.
(4) The holder of an authorization for placing a biocidal product on the market pursuant to § 7, 9
or 10 commits an administrative offense if it conflicts with § 11 para. 5
buyer familiar with the deadline for disposal, storage sale or
use of existing stocks of the biocidal product or that
permit for placing a biocidal product on the market was canceled or ended his
force.
(5) The holder of an authorization for placing a biocidal product on the market pursuant to § 7
commits an administrative offense by failing to report new data according to § 7 para.
10th
(6) The holder of a temporary permit for placing a biocidal product on the market
under § 9. 1 commits an administrative offense by the customer
familiar with the conditions of use of biocidal products.
(7) A legal or natural person performing research, development
or tests required for filing an application pursuant to § 4 and § 9. 1
or for filing a petition under § 12 commits an administrative offense by
A) contrary to § 14 para. 3 fails to record
biocidal product or active substance which is required to keep and maintain in accordance with § 14 para. 2
or
B) perform experiments or tests in conflict with § 14 para. 5 or 6.
(8) A legal or natural person performing applied research or development
commits an administrative offense that contrary to § 14 paragraph
. 4 notifies the information about the biocidal product or active substance or termination
applied research or development.
(9) An administrative offense shall be fined up
A) 5,000,000 CZK, for an administrative offense under paragraph 1. a), b)
d), e), g) and h) of paragraph 2, 3, 4, 6 or paragraph 7, letter. b)
B) 2,000,000 CZK, for an administrative offense under paragraph 1. c)
or paragraph 5 or 8
C) 1,000,000 CZK, for an administrative offense under paragraph 7 letter. a)
D) CZK 500,000 in the case of an administrative offense under paragraph 1. F).".
130th Under § 32 the following § 32a, including the heading reads:
"§ 32a
Offences
(1) A person who commits an offense that uses
biocidal product in conflict with § 3a. 2nd
(2) An offense under paragraph 1 may be fined up to 50 000 CZK. ".
131st § 33 including footnotes Nos. 18 and 19 reads:
"§ 33
(1) A legal person for an administrative delict if it proves that
made every effort that could be required to breach
legal obligations prevented.
(2) In assessing the fine legal person takes into account the seriousness
administrative offense, especially the manner of its commission and its consequences, and
the circumstances under which it was committed.
(3) The liability of a legal person for an administrative tort shall expire if
Administrative authority did not commence proceedings within 1 year of the date when it became
but no later than 3 years from the date on which it was committed.
(4) Administrative offenses under this Act as the first instance
Czech Environmental Inspection, customs authorities and the regional health
station. Czech Environment Inspection discuss administrative offense
according to § 32 par. 2, if it was committed by breaking decision that
issued and an administrative tort pursuant to § 32 par. 1 point. g) If not detected
infringement for controlling import customs authority. The customs authority
heard by an administrative tort pursuant to § 32 par. 1 point. g) if it finds violations
responsibilities in controlling imports. The regional health authority shall discuss
administrative tort pursuant to § 32 par. 2, if it was committed by breaking
decisions issued, and other administrative offenses under this Act
which does not discuss the Czech Environmental Inspectorate or
customs authorities.
(5) The liability for conduct that occurred in the business of a natural person
^ 18) or in direct connection therewith, shall be subject to the provisions of the Act
on liability and sanctions to legal persons.
(6) Penalties are levied by the authority which imposed them.
(7) Income from fines imposed by the regional health authorities or customs authorities
state budget revenue, income from fines imposed
Czech Environmental Inspection income of the State Environmental Fund of the Czech Republic
^ 19).
18) § 2 para. 2 of the Commercial Code.
19) Act no. 388/1991 Coll., On the State Environmental Fund of the Czech Republic
, as amended. ".
132nd § 34 including the title and footnote no. 20 reads as follows:
"§ 34
Delivery communications challenges and applications
When delivering communications pursuant to § 5 para. 2, § 12 para. 5 and 6
notice under § 12 para. 2 and 4, or a request under § 14 para. 3 legal entities or natural persons entrepreneurs
Ministry proceeds according to the provisions of the administrative Procedure
service of documents into their own hands ^ 20).
20) Act no. 500/2004 Coll., Administrative Code, as amended by Act no. 413/2005 Coll
. ".
133rd Under § 34 the following new § 34a and 34b, which, including the title added:
"§ 34a
Proceedings on the request of the person from another Member State
The procedure for application of a natural person authorized to conduct business or legal
person residing or having a permanent residence permit, residence, place of business
central administration, its principal place of business
activity or organizational unit on the territory of another Member State to apply
§ 4 para. 1-6, § 5, 6, § 7 para. 1-8, § 9. 1 sentence
first and second, § 9. 2 to 4 and § 9. 5, first sentence, § 15 and 16
accordingly; the management of their application for inclusion of an active substance in the list
active substances to the list of active substances with a low risk or
list of basic substances and to amend or extend this classification shall be applied mutatis mutandis
§ 12 para. 1-6 and 10, § 13, 15 and 16.
§ 34b
Reimbursement of costs
Costs of fulfilling obligations in the area
placing of biocidal products and active substances on the market and use of biocidal products carries
legal entity or natural person to whom the duty is imposed. Carrying
and expenses incurred in the exercise of state control, the Law on State Control
^ 17b). ".
134th In § 35 para. 1 to 3 the introductory part, the words "Natural
person authorized to do business and legal persons"
"corporation or an individual."
135th In § 35 par. 3 letter a), including footnotes Nos. 21 and 22
reads:
") In the case of a biocidal product of a certain type that contains
only existing active substances included for this type of program review in
^ 21), which was not decided by
directly applicable European Community ^ 22) or this Act
otherwise, no later than 14 May 2010
21) Annex II to Regulation (EC) no. 1451/2007.
22) Art. 4 of Regulation (EC) no. 1451/2007. ".
136th § 36 is deleted.
137th In § 40 point. a) the words "§ 3 para. 2 and 5" are replaced by "§ 3
paragraph. 2, "and the number" 2010 "is replaced by" 2009 ".
138th In the Annex to product type with the number 6 in the column labeled
"This type of product", the word "metal".
139th The Annex shall become Annex no. 1 to the Act no. 120/2002 Coll
. and Annexes Nos. 2 and 3 are added:
"Annex no. 2 to the Act no. 120/2002 Coll.
LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS AND SPECIFIC TERMS
approved at Community level for inclusion in biocidal products
------------------------ --------------------------------------- -----------------------------------------------------------------------------------------------------
No Common Name by Minimum Date of inclusion Deadline for Expiry date Product type Specific conditions
IUPAC purity fulfillment of inclusion
Identification of active substance of requests
Numbers in biocidal (with the exception of products
when putting on the market containing more than one
active substance, for which the
deadline set || | in the last
decision on inclusion,
when it comes to their
active ingredient)
--------------- ------------------------------------------------ -----------------------------------------------------------------------------------------------------
1 sulfuryl fluoride sulfuryl fluoride> 994 g / kg 1 January 2009 31 December 2010 31 December 2018 8 1) A biocidal product
no. ES: 220-281- may only be sold
5 CAS number only professional
2699-79-8 users to this
purpose and trained
they used
2) If you use must be
introduced to
risk mitigation for
Operating and surrounding
persons.
3) A licensee
must monitor
concentration
sulfuryl fluoride in
remote troposphere and
every fifth year
from 1 January
January 2009 will report
by monitoring directly to the Commission -------------------------------------------
-------------------- -----------------------------------------------------------------------------------------------------
2 dichlofluanid N-> 96% by weight of 1 March 2009 28 February 2011 28 February 2019 8 1. Biocidal products authorized
[(Dichlorofluoroacetate for industrial or professional use
methyl) sulfonylimino must be used with appropriate
sulfanyl] -N-phenyl-N ', N'personal protective
dimethylsulfamide means.
no. EC: 214-118-7 2. Given the risks for soil
no. CAS: 1085-98-9 environment must be when using
appropriate measures are taken to mitigate
risks for the protection of the environment.
3. Containers or safety
biocidal product authorized for
industrial use indicate that
freshly treated timber must be after
Treatment stored on an impermeable
solid ground to prevent direct
losses to soil and that leakage biocidal
the product must be collected for
reuse nebozneškodnění.
----------------------------------------------- ---------------- -----------------------------------------------------------------------------------------------------
3 clothianidin (E) -l- (2-chloro-ro l, 3> 950 g / kg 1 February 2010 31 January 2012 31 January 2020 8 Ministry of Health in the assessment
thiazol-5- requests
ylmethyl) -3-methyl-2- permit biocidal
nitroguanidine no. EC: 433-460-1 product on the market in accordance
no. CAS 210880-92-5 with § 7 evaluates použitínebo
exposure scenario, if
not presentable
represented in the evaluation
risks at European
Communities (*) and if there
the risk of exposure to a biocidal
preparation. Ministry
Health in proceedings
authorization for putting
biocidal product on the market
assess the risks and
the authorization provides
conditions so that
Appropriate measures
or specific
Conditions to mitigate
identified risks. Enabling
The Ministry may
Health issued only when
where the application demonstrates that risks
It can be reduced to acceptable levels.
Request permission
the placing on the market of a biocidal
preparation for the treatment of wood
outdoors
have regard to the risk
found in soil
environments and
surface and underground
Water contain information
proving that biocidal
product satisfies
requirements of § 7, including
appropriate measures
risk mitigation.
Labels or safety
Sheets biocidal product
permitted for
industrial use shall indicate
that freshly treated timber must be
after treatment
stored on an impermeable hard
ground to prevent direct losses
into the soil, and that leakage biocidal
the product must be collected
for reuse or disposal.
----------------------------------------------- ---------------- -----------------------------------------------------------------------------------------------------
4 difethialone 3- [3- (4'-bromo [1,1'-976 g / kg 1 November 2009 31 October 2011 31 October 2014 14 In view of the active substance
biphenyl] -4- yl) -1-phenyl-3- characterized as
hydroxypropyl] -4-hyper- potentially persistent,
droxybenzopyran-2- liable to bioaccumulate and
he / bromadiolone toxic or very
no. ES: Not specified persistent and very liable to
no. CAS 104653-34-1 bioaccumulation on nipřed
restoring its inclusion in
Annex applies comparative
impact assessment in accordance with §
13 par. 6 and 7
Holder fulfills these
Conditions:
1) Nominal
concentration of active
substances in preparations
will not exceed 0.0025%
weight.
Jsoupouze allowed
finished bait.
2) Biocidal products
They will include
aversive agent or
dye.
3) Biocidal products
shall not be used as a tracking
powder. 4) Primary as well
secondary exposure of humans,
target animals and the environment
environment is minimized
or considering the adoption of
appropriate and dostupnýchopatření
risk mitigation, especially
a) limiting the use
biocidal product
only professionals
b) determining the upper
size limit
packaging
c) determining
obligation to use
bait
Security boxes
tamper resistant
opening ---------------------------------------------- ----------------- -----------------------------------------------------------------------------------------------------
5 etofenprox 3 -fenoxylbenzyl-2- 970 g / kg 1 February 2010 31 January 2012 31 January 2020 8 Ministry of Health in
(4-ethoxyphenyl) -2- evaluation of permit applications
metylpropyleter biocidal product on the market
no. EC: 407-980-2 accordance with § 7 hodnotípoužití
no. CAS: 80844-07-1 or exposure scenario, if
not presentable
represented in risk assessment
at the level of the European
Communities (*) and if there
the risk of exposure to a biocidal
preparation. Ministry
Health in proceedings
authorization for putting
biocidal product on the market
assess the risks and the permit
the conditions so that
appropriate measures are taken or
specific conditions
mitigate the risks identified.
The Ministry may permit
Health issued only when
where the application demonstrates that risks
can be reduced to acceptable
level.
Due to the risk identified
for people who work with
biocidal product application
to authorize the placing on the market
biocidal product that
is used throughout the year, must
contain data on the absorption
skin. If this is not
established that there
unacceptable risk of chronic
Exposure can not biocidal
product use throughout the year,
but only intermittently or
seasonally in the range of up to 3 months
per year.
Biocidal products designed
for industrial use must
be used with appropriate
personal protective
means.
----------------------------------------------- ---------------- -----------------------------------------------------------------------------------------------------
(*) The contents and conclusions of assessment reports on the implementation of the common principles of Annex VI are available on the Commission's website:
http: //ec.europa.eu/comm/environment/biocides/index.htm
Annex No. 3 to Act. No. 120/2002 Coll.
LIST OF ACTIVE SUBSTANCES WITH LOW RISK TO COMPLY WITH A SPECIFIC
conditions agreed at Community level for inclusion in biocidal
PRODUCTS WITH LOW RISK
--------------- --------------------------------------------- ----- --------------------------------------------------
------------- number Common name in the minimum Date of inclusion Deadline for compliance-type specific date
IUPAC name Purity completion of all requirements Conditions
Identification of the active (with the exception of validity
numbers substance in inclusion
biocidal product containing more
than one active substance in respect of which
will launch
market deadline set
in the last
Decision on
inclusion
goes
their effective
substances)
--------------------------------------------- --------------- ----------------------------------- ---------------------------------
1 Carbon dioxide Carbon 990 ml / l November 1 October 31, 2011 October 31 14 Only for use
No dioxide. ES: 204-696- 2009 2019 finished
9 no. CAS: 124- gas
38-9 canisters with
catching
device. "
-------------------------------------------- ---------------- ---------------------------------- ----------------------------------
Art. II
| || Transitional provisions
management finally unfinished until the effective date of this Act shall
completed under the current legislation.
Art. III
Repealing provisions
| || Decree no. 5/2008 Coll., on the list of active substances, shall be deleted.
Art. IV
authorization to publication of the full text of the Act
Prime Minister is authorized that in the Collection of laws the full wording
Act no. 120/2002 Coll., on conditions of placing of biocidal products and
active substances on the market as derived from the laws amending it.
PART TWO | ||
amendment to the Act on administrative fees Article
.
in part V of the Annex to Act no. 634/2004 Coll., on administrative fees, as amended by Act No.
. 553/2005 Coll., Act no. 48/2006 Coll., Act no. 130/2006
Coll., and Act no. 215/2006 Coll., item 95 including footnotes.
56 reads :
"Item 95
Acceptance of an application or proposal ^ 56)
A) a permit or temporary authorization for placing
biocidal product on the market for one type
biocidal product CZK 200,000
B) a permit or temporary authorization for placing
biocidal product or a low-risk
frame formulation on the market for one type
biocidal product CZK 75,000
C) a permit or temporary authorization for placing
biocidal product biocidal product
low risk or frame formulation
market for each additional type of biocidal product
CZK 15,000
D) an amendment authorizing the biocidal
product biocidal product with low
risk or frame formulation on the market, extension of
permit or its renewal CZK 55,000
E) we are authorizing the placing on the market of biocidal
product biocidal product with low
risk or frame formulation that
already been authorized in another Member State of the European Communities
(based
mutual recognition) CZK 40,000
F) the inclusion of the active substance, the active substance
low risk and basic substances
biocidal products on the list of active substances
, the list of active substances with low
risk or a list of essential substances
for one type of biocidal product CZK 600,000
G) the inclusion of the active substance, the active substance
low risk and basic substances
biocidal products on the list of active substances
, the list of active substances with low
risk or a list of essential substances
for each additional type of biocidal product CZK 60,000
H) the evaluation of dossiers submitted for
to the inclusion of effective
substances with a low risk or basic
substances to the list of active substances to the list of active substances
low risk or
list of essential substances for one type
biocidal product CZK 3,900,000
I) the evaluation of dossiers submitted for
to the inclusion of effective
substances with a low risk or basic
substances to the list of active substances to the list of active substances
low risk or
list of essential substances for each
another type of biocidal product CZK 390 000
56) Act no. 120/2002 Coll., On conditions of placing of biocidal products and
active substances on the market and amending some related laws,
amended by Act no. 297/2008 Coll. ".
Art. VI
Transitional provisions
If the proceedings or other act in the matter of the fee started before
commencement of this Act, charge shall be levied according to the existing
Legislation, even in cases when the fee becomes payable
after the effective date of this Act.
PART THREE
Changing the law on the establishment of ministries and other central organs of state administration of the Czech Republic
Art. VII
In § 10 of Act no. 2/1969 Coll., On establishment of ministries and other central government authorities
Czech Republic, as amended Act no. 60/1988 Coll.
Law no. 37/1989 Coll., Act no. 93/1990 Coll., Act no. 203/1990 Coll.
Act no. 575/1990 Coll., Act no. 474/1992 Coll., Act no. 272/1996 Coll. ,
Act no. 258/2000 Coll. and Act no. 362/2004 Coll., at the end of the text
paragraph 1, the words "for use of biocidal products and
placing of biocidal products and active substances on the market."
PART FOUR
EFFICIENCY
Art. VIII
This Act comes into force on 1 January 2009.
Vlcek vr
Klaus vr
Pp. Čunek vr
