LAW ON BIOCIDAL PRODUCTS I GENERAL PROVISIONS

Unofficial translation

LAW

ON BIOCIDAL PRODUCTS

(Official Gazette of the Republic of Srpska, no. 37/09)

I – GENERAL PROVISIONS

Article 1

This Law shall regulate: terms and conditions for placing biocidal products on the

market and the use thereof in the Republic of Srpska (hereinafter the Republic); conditions for

a risk assessment and assessment of biocidal efficacy for issuing an authorization to place a

biocidal product on the market; the procedure for issuing authorizations; research and

development; classification, labelling and packaging, advertising and technical safety standard;

conditions for the import of biocidal products; safe use; authorization for manufacture and trade

of biocidal products: data availability, supervision and other significant issues for safely placing

biocidal products on the market and their use.

Article 2

For the purposes of this Law, the following definitions shall apply:

a) biocidal products means any substance or mixture, in the form in which it is supplied to

the user, containing or generating one or more active substances, with the intention of

destroying, deterring, rendering harmless, preventing the action of, or otherwise

exerting a controlling effect on, any harmful organism by chemical or biological means.

b) Low-risk biocidal products means a product which contains as active substance only

one or more of those listed in Annex IA and which do not contains any substances of

concern, namely hazardous substances whose concentration shall not classify a biocidal

product as hazardous, and which under the conditions of use, a biocidal product shall

pose only a low risk to humans, animals and the environment,

c) Annex I, Annex IA and Annex IB are lists of active substances harmonized at the level

of European Union (hereinafter: the EU), whereas: Annex I is List of active substances

with requirements agreed at community level for inclusion in biocidal products; Annex

IA is the List of active substances with requirements agreed at community level for

inclusion in low-risk biocidal products; Annex IB is the List of basic substances with

requirements agreed at community level,

d) Basic substance means a substance listed in the Annex IB, whose major use is non-

pesticidal but which has some minor use as a biocidal product, either directly or in a

product consisting of that substance and simple diluent which itself is not a substance

that causes concern; The substances, which could potentially enter Annex IB are, inter

alia, the following, carbon dioxide, nitrogen, ethanol, propanol-2, acetic acid,

kieselguhr.

e) active substance means a substance or a micro-organism, including virus or fungi,

having general or specific action on or against harmful organisms;

f) substance of concern means any substance, other than the active substance, which has

an inherent capacity to cause an adverse effect on humans, animals or the environment

and is present or is produced in a biocidal product in sufficient concentration to create

such an effect,

g) harmful organism means any organism which has an unwanted presence or a detrimental

effect for humans, their activities or the products they use or produce, or for animals or

for the environment,


h) residue means one or more of the substances present in a biocidal product which remains

as a result of its use including the metabolites of such substances and products resulting

from their degradation or reaction,

i) Placing on the market means supplying or making available biocidal products to users,

on the territory of the Republic, whether in return for payment or free of charge,

j) Frame formulation means specification for a group of biocidal products having the same use

and user type, and which contains identical active substances; Variations in the composition

of the biocidal products with determined frame formulation, may, for instance, be reduction

in the percentage of the active substance in the biocidal product, alternation in percentage

composition of the other substances, replacement of pigments, dyes, perfumes and others,

whereas those deviations must not affect the risk level or the efficacy of a biocidal

product,

k) full procedure (authorization) means the procedure for issuing authorization for placing

biocidal products on the market of the Republic, by the Minister of Health and Social

Welfare (hereinafter: the Minister), upon the applicant’s request,

l) shortened procedure (registration) means the procedure in which the

Minister, following an application submitted by an applicant, after verification that the

documentation meets the relevant requirements of this Law, allows the placing on the

market of a low-risk biocidal product in the territory of the Republic,

m) special procedure means a procedure for placing biocidal products on the market and

the use thereof in the Republic, on the basis of frame formulation,

n) Letter of access means a document, signed by the owner or owners of relevant data

protected under the provisions of this Law, which states that these data may be used by

the public administration body for the purpose of granting an authorisation for placing

a biocidal product on the market or its inclusion into the Annex I, IA and IB.

o) product and process oriented research means any scientific development related to

product development or the further development of a substance, on its own, in mixtures

or in articles in the course of which pilot plant or production trials are used to develop

the production process and/or to test the fields of application of the substance,

p) Professional use means every use of a chemical for conducting registered activities.

q) scientific research and development means any scientific experimentation, analysis or

chemical research carried out under controlled conditions in a volume less than 1 tonne

per year,

r) scientific research and development of a biocidal product means scientific research,

analysis and conducting research under controlled conditions that includes determining

specific characteristics of substances, their effects, efficiency, harmful effects on

humans, animals and the environment, as well as scientific research aimed at

discovering a new biocidal product,

s) Process-orientated research and development of a biocidal product means research for

the purpose of further development of a biocidal product in the course of which trials

on the experimental and production level are used to test the other potential fields of

application of the biocidal product,

t) Applicant means a producer of biocidal products or an authorized representative of a

foreign producer of biocidal products headquartered in the Republic, asking

authorization to place biocidal products on the market of the Republic,

u) Authorization holder means a legal person who acquired the authorization to use and

place biocidal products on the market in the Republic.

v) Letter of acces means a document, signed by the owner or owners of relevant data

protected under the provisions of this Law, which states that these data may be used by


competent authorities for the purpose of granting an authorisation for placing a biocidal

product on the market or its inclusion into the Annex I, IA and IB.

w) Programme for inclusion into the Annex I, IA means the programme which contains the list

of active substances placed on EU market before EU legislation on biocidal products came

into force, and which contains the time period for the inclusion of active substances in those

lists.

x) Acceptable Daily Intake (ADI) means the amount of residues that during the long-term

consumption do not present a threat to human health,

y) AOEL means Acceptable Operator Exposure Level

z) MRLs means Maximum Residue Limits

aa) Accredited laboratory means a testing laboratory that has undergone the accreditation

procedure in accordance with the ISO/IEC 17025 international standard or BAS

ISO/IEC 17025 domestic standard.

bb) Accredited method means a testing method of a laboratory confirmed by the

accreditation procedure in accordance with the ISO/IEC 17025 international standard

or BAS ISO/IEC 17025 domestic standard.

cc) Accreditation means attestation performed by a third party, relating to the conformity

assessment body or the laboratory, and is used as official proof of its competence to

carry out specific conformity assessment tasks, or tests,

dd) Competent authority within the meaning of this Law is the Ministry of Health and Social

Welfare of the Republic (hereinafter: the Ministry).

Article 3

(1) Provisions of this Law shall not apply to:

a) medicines and medical devices used in human and veterinary medicine,

regulated by specific laws,

b) food products, food additives, flavourings and raw-materials used for their

production, materials and products being in contact with food, and which are

regulated by specific Law.

c) animal feed and its additives, including other products used in animal feed,

d) substances and products that are considered as waste according to the waste

management regulations,

e) detergents regulated by the law on chemicals, except in case a detergent has a

biocidal effect

f) cosmetic products regulated by a specific law,

g) plant protection products regulated by a specific law.

(2) Provisions of this Law shall not apply to biocidal products in transit through the

territory of the Republic, and which are under customs supervision and provided that they are

not in any way changed, processed or treated.

(3) Provisions of this Law relating to classification, labelling and packaging of biocidal

products shall not apply to carriage of biocidal products by rail, road, sea, inland waterway and

air.

Article 4

Production, trade and use of hazardous chemicals, import and export of highly

hazardous chemicals, restrictions and bans of chemicals and plant protection products (the

Rotterdam Convention), safety at work, advertising that would lead to fallacy of users are

regulated by special regulations.


II – BIOCIDAL PRODUCTS AND ACTIVE SUBSTANCES IN BIOCIDAL

PRODUCTS

Article 5

(1) Biocidal products and lower-risk biocidal products shall be classified into types

depending on the manners of their use, organisms which they affect, facilities in which they are

used and items and surfaces treated by biocidal products.

(2) The Minister shall issue a decree prescribing the types of biocidal produts in

accordance with Paragraph 1 of this Article.

Article 6

(1) Biocidal products shall contain active substances harmonized at the EU level and

included on one of the following lists: List of active substances with requirements agreed at

community level for inclusion in biocidal products (Annex I); List of active substances with

requirements agreed at community level for inclusion in low-risk biocidal products (Annex IA);

List of basic substances with requirements agreed at community level (Annex IB).

(2) When placing an active substance into one of the Lists referred to in Paragraph 1 of

this Article, the following conditions for using that active substance shall be determined:

minimum purity level of the active substance, nature and the maximum of impurities in the

active substance, type of biocidal product in which the substance may be used, manner of the

use, organisms affected by it, consumer category (for instance industry, professional

consumers, utility hygiene, general use), and other conditions determined in relation to the risk

the active substance poses to human health, animals and the environment.

(3) In addition to conditions under Paragraph 2 of this Law, the following conditions,

when relevant, shall be determined for an active substance in a biocidal product: Acceptable

Operator Exposure Level (AOEL), Acceptable Daily Intake (ADI), Maximum Residue Limits

(MRLs), as well as the effect of the substance on non-targeted organisms and the behavior in

the environment.

(4) Allowed range of concentration for an active substance in a lower-risk biocidal

product in Annex I A shall also be written.

(5) The Minister shall issue a decree promulgating the procedure for inclusion into the

lists of active substances in biocidal products (Annexes I, IA, and IB), and the list of active

substance that are not allowed to be used in biocidal products.

(6) Lists referred to in Paragraph 1 of this Article shall be published in the Official

Gazette of the Republic of Srpska and shall be revised, if necessary.

III – AUTHORIZATION FOR PLACING BIOCIDAL PRODUCTS ON THE

MARKET

1. Procedure for issuing authorization for placing biocidal products on the market

Article 7

(1) A biocidal product may be placed on the market and used for intended purposes if

the Minister issues an authorization for placing that biocidal product on the market and if the

biocidal product is classified, packed and labelled in accordance with this Law.

(2) Along with each package of a biocidal product, instructions for its use shall be

written in one of the official languages of the Republic.


(3) Notwithstanding Paragraph 1 of this Article, a biocidal product may be placed on

the market and used prior to the issuing of an authorization if a biocidal product is included in

the Programme of technical dossier submission (hereinafter: the Programme).

(4) In case a biocidal product is placed on the market according to the procedures and

before this Law enters into force, and if the active substance from that biocidal product is on

the Lists I and IA, or is in the Programme for the inclusion into the Lists I, IA and IB, the

Minister shall issue a Decision on the inclusion into the Programme.

Article 8

(1) An application for placing a biocidal product on the market may be submitted by a

producer of a biocidal product or an authorized representative of a foreign producer

headquartered in the Republic (hereinafter: the Applicant) within a legal entity.

(2) Prior to placing a biocidal product on the market, the Applicant shall submit basic

data on a biocidal product to the Ministry.

Article 9

(1) The procedure for issuing authorization for placing biocidal products on the market

shall be conducted in two phases:

a) in the first phase, an applicant shall submit basic data regarding a biocidal

product,

b) in the second phase, an applicant shall submit a technical dossier for an active

substance and a biocidal product.

(2) Upon the request of the Ministry, the Applicant referred to in Article 7 of this Law

shall deliver the samples of biocidal products and their ingredients.

(3) Authorization for placing a biocidal product on the market shall not be necessary

for a biocidal product containing a basic substance as an active substance that is on the List IB

or is in the process to be included in it.

(4) A legal person placing a biocidal product on the market from Paragraph 3 of this

Article shall submit basic data on the biocidal product to the Ministry prior to placing it on the

market.

Article 10

(1) Basic data on biocidal products shall contain information on: a manufacturer of a

biocidal product, authorized representative of a foreign producer, the identity of a biocidal

product and its active substances, data on the efficacy, declaration content, intended use and

data on classification, labelling and packaging of biocidal products.

(2) Technical Dossier for biocidal product shall contain in particular data on: physical

and chemical properties of an active substance and a biocidal product, identification and

analysis; data on toxicological and eco-toxicological properties, detection methods, intended

uses and effectiveness against target organisms and, data on measures necessary to protect

humans, animals and the environment, as well as the summary of a Technical Dossier.

(3) Technical Dossier under Paragraph 2 of this Article shall also contain description

of the examinations conducted when obtaining above-mentioned data or bibliographical

reference for those data.

(4) The Minister shall prescribe a decree stipulating the content of basic data about a

biocidal product, scope and the content of a technical dossier and guidelines for the preparation

of the summary of a dossier.


Article 11

(1) Within 30 days from the submission of an application for an authorization to place

a biocidal product on the market, the Minister shall decide whether a biocidal product shall be

included in the Programme, or an authorization shall be required to place that biocidal product

on the market.

(2) Decision regarding the inclusion in the Programme under Paragraph 1 of this Article

may specify the conditions for placing a biocidal product on the market and its use, with a view

to protecting human health, animals and the environment.

(3) The Programme under Paragraph 1 of this Article shall contain basic data about a

legal person, the name of a biocidal product, the name of an active substance contained in it,

and the deadline technical dossier submission.

(4) The Minister shall determine the deadline for the inclusion in the Programme on

the basis of the quantity that is being placed on the market at the annual level, effects of biocidal

products on human health, animals and the environment, type of biocidal products, the lack of

data on the effects of biocidal products on human health, animals and the environment,

submission of data assessment pursuant to other regulations that are not aligned with this Law,

and on the basis of the fact whether an active substance in a biocidal product is included in the

Lists I or IA, or in the Programme for the inclusion into the EU List I or IA.

Article 12

(1) In the second phase of the procedure, the Ministry shall assess biocidal products on

the basis of the technical dossier submitted.

(2) The Committee on Biocidal Products shall provide its professional opinion in the

process of authorization issuing.

(3) The Committee on Biocidal Products shall be appointed by the Minister and shall

consist of seven expert members from the Ministry and recognized experts from toxicology,

veterinary medicine, pharmacy, biology, ecology, taking into consideration equal

representation of both sexes.

(4) The Minister shall issue a decree prescribing the conditions and the manner of the

work of the Committee referred to in Paragraph 3 of this Article.

(5) The members of the Committee on Biocidal Products under Paragraph 3 of this

Article shall receive remuneration.

Article 13

(1) The Committee on Biocidal Products shall perform the following expert tasks:

a) provide proposals for authorization issuing or rejecting the application,

b) provide professional opinion when issuing the authorization, namely

professional opinion for introducing a Decision on the ban or the restriction of

the use of biocidal products, and

c) provide professional opinion on the proposal for determining frame formulation.

(2) Members of the Committee on Biocidal Products shall not be persons employed

within the legal entity that produces, and places biocidal products on the market, persons

involved in the preparation and assessment of a technical dossier of biocidal products, as well

as their spouses, blood relatives up to the fourth degree of consanguinity, and second degree of

affinity.

(3) The member of the Committee on Biocidal Product under Paragraph 2 of this

Article shall sign the conflict of interest statement.


Article 14

(1) The procedure for issuing the authorization for placing a biocidal product on the

market in the Ministry shall last 90 days from the day when the applicant submitted the full

application.

(2) If a technical dossier is not complete or the rationale for placing a biocidal product

on the market is not acceptable, an applicant shall be obliged to submit the amendments to the

technical dossier. The deadline for submitting the amendments shall not be longer than 60 days.

(3) If the applicant does not comply with the specified deadline under Paragraph 2 of

this Article, the Minister shall issue a Decision rejecting applicant’s application, and when

justified, shall decide to withdraw a biocidal product from the market.

(4) For lower-risk biocidal products, whose registration is done under shortened

procedure, and for biocidal products within frame formulation, and whose registration is done

under special procedure, the deadline for issuing authorization shall be 60 days from the day of

the full application submission.

(5) Deadline for issuing the authorization under Paragraph 1 and 4 of this Article shall

be stationary when the Ministry requires additional information, and shall cease to be stationary

when the required information is obtained.

(6) Decision under Paragraph 3 of this Article shall be final and no appeal shall be

allowed against it, but an administrative litigation may be initiated.

Article 15

During the technical dossier assessment process, the Ministry shall determine whether

a biocidal product meets the following criteria:

a) is the active substance contained in a biocidal product registered in the EU List

I or List I A for that type of biocidal products,

b) can the amount and the nature of an active substance and other substances be

determined, as well as the amount of residue significant for toxicological and

eco-toxicological properties,

c) does it or its residue has unacceptable effects on human health, animals and

underground waters, either directly or indirectly,

d) does it and its residue during the degradation and their expansion in the

environment cause the contamination of surface, underground waters and

drinking water.

e) does it have an unacceptable effect on non-targeted organisms, and

f) are physical and chemical properties of a biocidal product acceptable for the use,

disposal and transport.

Article 16

(1) Assessment of a biocidal product on the basis of the submitted technical dossier

shall be done also for the risk assessment for determining its effect on human health, animals

and the environment, possible unwanted effects on targeted organisms, as well as its efficiency

and the risk during the intended use.

(2) During the technical dossier assessment, the Ministry shall take into account the

geographical, health characteristics and other specifics of the environment important for the

results in the use of biocidal products.

(3) During the technical dossier assessment of the lower-risk biocidal product, only the

assessment of efficiency shall be performed.

(4) The Minister shall issue a decree stipulating the principles of biocidal product

assessment on the basis of a technical dossier, as well as the instructions for the practical

procedures for the biocidal products assessment on the basis of its technical dossier.


(5) The risk assessment shall be done in addition to the assessment prescribed by this

Article in accordance with the Law regulating the chemical risk assessment.

Article 17

(1) Having determined that a biocidal product meets all prescribed criteria for being

placed on the market, the Minister, considering the opinion of the Committee on Biocidal

Products, shall issue authorization for placing a biocidal product on the market and the use

thereof.

(2) For the technical dossier assessment and authorization issuance, the applicant shall

pay a fee, which shall be the revenue of the Republic.

(3) An appeal against Decision under Paragraph 1 of this Article shall not be allowed,

but an administrative litigation may be initiated.

Article 18

(1) The authorization for placing a biocidal product on the market shall contain the data

on the producer, authorized representative of a foreign producer in the Republic, the name of a

biocidal product, the name and the content of an active substances and other substances in a

biocidal product in the concentration by which it can affect the efficacy of a biocidal product

and its classification, the intended use, terms and conditions of use, authorization validity and

other important data regarding a biocidal product.

(2) Authorization validity may be up to 10 years, namely the period determined for the

active substance contained in a biocidal product, and which is on the List I or List IA.

(3) Authorization under Paragraph 1 of this Article may specify special conditions for

placing a biocidal product on the market, as well as the place of sale, depending on the

properties of a biocidal product.

(4) The Minister shall issue a decree stipulating special conditions for placing a biocidal

product on the market.

Article 19

(1) The Applicant may submit an application to the Ministry asking for establishing

frame formulation for that biocidal product.

(2) Along with the application, the Applicant under Paragraph 1 of this Article shall

submit the proof that deviations from the frame formulation, which may be predicted, do not

affect the risk level and efficacy of a biocidal product

(3) The Ministry shall inform the person under Paragraph 1 of this Article about the

frame formulation for a biocidal product for which an authorization has been issued.

(4) The Ministry may determine the frame formulation without the application under

Paragraph 1 of this Article if it possesses the technical dossier for a given biocidal product and

notifies the applicant about that within 30 days from determining the frame formulation.

Article 20

(1) Conditions for placing a biocidal product on the market, authorization validity,

manners of use and other stipulated conditions for a biocidal product shall be the same for all

biocidal products within the frame formulation.

(2) If the Minister issues a Decision revoking the authorization for a biocidal product

for which the frame formulation has been determined, the Minister shall issue a Decision

revoking authorizations for other biocidal products within the frame formulation.

(3) Decision under Paragraph 2 of this Article shall be final and no appeal shall be

allowed, but an administrative litigation may be initiated.


2. Inventory of Biocidal Products

Article 21

(1) The Minister shall determine the Inventory of Biocidal Products for which the

authorization has been issued.

(2) The Inventory of Biocidal Products under Paragraph 1 of this Article shall be the

integral part of the Integrated Inventory of Chemicals and shall be available through the

electronic data base kept by the Ministry.

(3) The Inventory of Biocidal Products referred to in Paragraph 1 of this Article shall

be submitted to the competent authority for chemicals in BiH, which shall forward it to the

European Commission and other EU Member States, if necessary.

(4) The Minister shall pass a decree stipulating the data necessary for the Inventory of

Biocidal Products and the manner of keeping thereof.

3. Testing methods

Article 22

(1) Testing methods prescribed by the Law on Chemicals shall be used when testing

biocidal products and their active substances for the purpose of obtaining data in the technical

dossier, namely data regarding physical, chemical, toxicological and eco-toxicological

properties.

(2) Internationally recognized and harmonized testing methods shall be used if the

testing method for a biocidal product is not appropriate or does not exist.

Article 23

(1) For the part of the technical dossier relating to the data on the efficacy of biocidal

products, testing may be performed in the accredited laboratories having quality system and

quality control system.

(2) Testing of biocidal products for technical dossiers shall be done in laboratories

meeting the criteria of good laboratory practice.

(3) The Minister shall issue a decree stipulating the conditions to be met by

laboratories, as well as methods for examining biological efficacy of biocidal products.

Article 24

(1) A producer of a biocidal product who intends to carry out laboratory tests, with a

view to preparing a technical dossier for a biocidal product he wants to place on the market,

shall address the Ministry, prior to the testing, asking information about whether testing had

been performed for the same or similar biocidal product, in order to protect vertebrates against

retesting.

(2) Within 30 days from submitting the request for the information under Paragraph 1

of this Article, the Ministry shall inform the applicant about the person that conducted the

testing on vertebrates.

(3) The applicant may use the data for technical dossier or part of them from other

person with the submitted consent for the use of those data for the same or similar biocidal

product by an authorization holder.


Article 25

(1) The Applicant may use the data from a technical dossier for the same or similar

biocidal product without the consent of the authorization holder if:

a) more than 10 years have passed from the first issuance of the authorization in

the EU for a biocidal product containing the active substance that was not in the

Programme for the inclusion in the Lists I, IA or IB, and

b) more than 10 years have passed from the date of the inclusion of an active

substance on the List I or List IA, for that type of a biocidal product, and given

the fact that the mentioned substances had already been included in the

Programme for the inclusion into the Lists I, IA or IB in the EU.

(2) The Applicant under Paragraph 1 of this Article shall, along with the request submit

a proof that a biocidal product to which the request relates is the same as the one for which an

authorization for placing on the market and the use has already been issued.

4. Recognition of foreign authorization

Article 26

(1) The Minister may, on the basis of an application of the authorized representative of

a foreign producer possessing the authorization issued by the competent authority of the EU

Member State, issue an authorization for placing a biocidal product on the market of the

Republic of Srpska if it contains the active substance from the List I or List IA in the EU.

(2) Person referred to in Paragraph 1 of this Article shall, in addition to the application

for the recognition of a foreign authorization, submit to the Ministry the summary of a technical

dossier and a certified copy of the authorization issued by the competent EU Member State.

Article 27

(1) The Ministry shall conduct a professional assessment of the data from a technical

dossier. The assessment shall apply to the following inquiries: are target organisms present in

harmful amounts in the Republic; are climate conditions, reproduction period of target

organisms, circumstances of use, and other important conditions for the efficacy of biocidal

products the same or significantly different in the country that issued the authorization, in

relation to the conditions in the Republic.

(2) Along with the assessment under Paragraph 1 of this Article, the Ministry shall

assess whether placing on the market of a biocidal product poses unacceptable risk to human

health, animals and the environment. On the basis of the assessment result, the Ministry shall

either issue the authorization or reject the application.

(3) The Minister shall issue the authorization for placing a biocidal product on the

market or shall issue a Decision rejecting the application referred to in Paragraph 2 of this

Article within 90 days for a biocidal product or within 60 days for a lower-risk biocidal product

from the day of the receipt of the application.

(4) Authorization validity for placing a biocidal product on the market of the Republic

shall be the same as the validity of the authorization issued by the competent authority of the

EU Member State.

(5) For data assessment and authorization issuance on the basis of a foreign

authorization, a fee shall be paid that shall be the revenue of the Republic.


Article 28

(1) During the authorizationissuing procedure, the Minister may change the conditions

for placing a biocidal product on the market and its use in relation to the foreign authorization,

if deemed justified.

(2) The Minister shall pass a decree prescribing the scope and content of the request

and the summary of a technical dossier, type of biocidal products whose application for foreign

authorization recognition may be rejected, as well as terms and conditions for placing a biocidal

product on the market and its use, in the procedure of foreign authorization recognition.

5. Conditions for issuing a temporary authorization, validity period prolongation,

revocation of an authorization and issuing a new authorization

Article 29

(1) The Minister may issue a temporary authorization for placing a biocidal product on

the market within 30 days from the day of the application submission by a foreign person in

case of the occurrence of a harmful organism that cannot be suppressed by biocidal products

on the market and for which the authorization has been issued in the regular procedure.

(2) A legal person that submitted an application for a temporary authorization under

Paragraph 1 of this Article, shall submit the proof on the unpredicted occurrence of a harmful

organism, explanation of the non-existence of the efficient biocidal product on the market, data

on the efficacy of the biocidal product for which a temporary authorization is requested,

proposal of systemic monitoring, data about the necessary amount of a biocidal product and the

data about the person to to handle the use of a biocidal product.

(3) The Ministry shall carry out a professional assessment of the data referred to in

Paragraph 2 of this Article, and on the basis of positive opinion, it shall issue a Temporary

Authorization.

(4) Authorization under Paragraph 3 of this Article shall specify the following

conditions for the use of the mentioned biocidal product: necessary amount of a biocidal

product, the date of the commencement of use, scope and conditions of use, users, period of use

and the systemic monitoring manner.

(5) The validity of a temporary authorization shall not be longer than 120 days from

the day of the issuing thereof.

Article 30

(1) A temporary authorization may be issued for a new manner of the application and

other conditions of the use of a biocidal product in relation to the ones prescribed in the

authorization for a biocidal product for which the authorization for placing a biocidal product

on the market of the Republic has been already issued.

(2) A holder of a temporary authorization shall, upon the end of the authorization

validity or when a biocidal product ceases to be used for the prescribed purpose, submit to the

Ministry a report on the used amount of a biocidal product, results of systemic monitoring and

other data relevant when unpredicted situation arises.

Article 31

(1) A legal person possessing a Decision on the inclusion of a biocidal product on the

Programme shall comply with the conditions specified in the Decision, which relate to placing

a biocidal product on the market, namely the use of the programme for the intended purpose.

(2) The authorization holder or a person possessing a Decision on the inclusion of a

biocidal product into the Programme shall supervise all effects and circumstances regarding the

biocidal product that indicate the changes of the biocidal product efficiency or occurrence of


harmful effects on human health, animals and the environment, and shall notify the Ministry

about that.

(3) A person referred to in Paragraph 2 of this Article shall notify the Ministry about:

a) the change of a manufacturer,

b) the change of the biocidal product composition,

c) resistance occurrence,

d) adverse effects on human health, animals or the environment,

e) the change of data in technical dossier, namely, in the basic data of a biocidal

product, and

f) other changes of basic data or data from the dossier.

Article 32

(1) On the basis of the notification on the change under Article 31, Paragraph 3 of this

Law, the Ministry shall carry out the assessment and may require additional information from

the authorization holder or a person possessing a Decision on the inclusion of a biocidal product

into the Programme. Following the submission of the information required, the Ministry shall

issue a Decision on the revocation of an authorization or issue the authorization in accordance

with the new data.

(2) Other applicant shall not use the information referred to in Paragraph 1 of this

Article in the period of five years from the submission of the information concerned.

Article 33

(1) The Minister may issue a Decision on the revocation of the previously issued

Decision on the inclusion of a biocidal product into the Programme, if:

a) the inclusion of an active substance into List I or List IA is rejected,

b) the evaluation of the data submitted indicates that the mentioned activity is

aimed at the protection of human health, animals and the environment, and

c) a person possessing a Decision on the inclusion in the Programme does not

comply with the conditions for placing a biocidal product on the market and the

use thereof.

(2) The Minister shall issue a Decision on the revocation of the previously authorization

for placing a biocidal product on the market under official duty if:

a) active substance in the biocidal product is excluded from the List I or List IA,

b) the authorization for that biocidal product has been issued on the basis of

inaccurate data,

c) conditions on the basis of which the authorization has been issued occurred,

d) authorization holder requested it, with the explanation provided,

e) on the basis of scientific and technological achievements, there occurred changes

that may affect adversely human health, animals and the environment,

f) authorization holder changed the headquarters outside the Republic.

(3) In the Decision on the revocation of the previously issued authorization referred to

in Paragraphs 1 and 2 of this Article, the Minister shall determine the manner of the withdrawal

of biocidal products and the deadline for biocidal products to be on the market.

(4) Decision under Paragraph 3 of this Article shall be final and an appeal shall not be

allowed, but an administrative litigation may be initiated.

Article 34

(1) The Minister may issue a new authorization in which the conditions for placing a

biocidal product on the market are changed only in the following cases:


a) upon the receipt of the explanation by an authorization holder regarding the

changes occurred,

b) if the conditions of the use of an active substance registered in the List I or List

IA are changed, and

c) if, on the basis of new findings obtained by scientific and technological testing

it has been determined that an active substance has adverse effects on human

health, animals and the environment.

(2) New authorization shall be issued for the same validity period as the previously

issued authorization.

(3) The Minister shall determine the manner of use and the deadline for the withdrawal

of biocidal products from the market during the process of the issuing a new authorization.

(4) An appeal against the authorization referred to Paragraph 1 of this Article shall not

be allowed, but an administrative litigation may be initiated.

Article 35

When believed that a biocidal product poses a significant threat to human health,

animals and the environment, the Ministry shall prescribe a ban on placing a biocidal product

on the market and its use, namely a ban on the use of an active substance in accordance with

the regulations on chemicals, and shall oblige a legal person to conduct additional examination.

IV – RESEARCH AND DEVELOPMENT

Article 36

(1) The authorization for placing a biocidal product on the market shall not be

necessary if a biocidal product is used for scientific research and development and for product

and process–oriented research.

(2) Person using a biocidal product for the purpose referred to in Paragraph 1 of this

Article shall notify the Ministry in writing on the following: planned import of biocidal products

with the data on the quantity to be imported, data on the biocidal product, manufacturer, manner

of classification and labelling, date of the commencement and termination of research, names

and surnames of the persons to use the biocidal product or the active substance, as well as

available data about effects of the biocidal product on human health, animals and the

environment.

(3) On the basis of data assessment under Paragraph 2 of this Article, the Minister shall

give consent for the import of biocidal products and the use thereof for the above-mentioned

purposes.

Article 37

(1) If during the use of a biocidal product for scientific research, a biocidal product or

an active substance is released in the environment, the Minister shall, notwithstanding Article

36, Paragraph 1, issue the authorization for the use of a biocidal product for the mentioned

purposes.

(2) Along with the application for the authorization, the applicant shall, in addition to

the data from Article 36, Paragraph 2 of this Law, submit the data about the aim of the research,

research plan, data on the professional competence of the personnel, description of the facility

and terms under which research shall be conducted, manner of keeping the data on research

progress, manner of the use of a biocidal product, keeping data on the generated waste and other

evidence regarding safety.


(3) The Ministry shall carry out the assessment of the data under Paragraph 2 of this

Article for issuing the authorization for scientific research and development, as well as for

product and process-oriented research.

(4) If estimated that the use of a biocidal product or a substance in scientific research

may have adverse effects on human health and the environment, the Minister may in

authorization prescribe specific conditions for the biocidal treatment (quantity, treated area) or

prohibit research.

V- CLASSIFICATION, PACKAGING, LABELLING,

ADVERTISING AND SAFETY DATA SHEET

Article 38

(1) Classification, labelling, packaging, advertising, the content of a safety data sheet

(hereinafter: SDS), and the submission of an SDS for a biocidal product shall be done in

accordance with the regulations on chemicals.

(2) The Minister shall issue a decree prescribing specific requirements regarding the

classification, packaging, labelling and advertising of a biocidal product.

Article 39

(1) Biocidal products classified as hazardous shall not be labelled as less hazardous or

safe to human health, animals or the environment or labelled in a manner misleading a user as

regards the its hazards.

(2) When labelling a biocidal product under Paragraph 1 of this Article, the following

labels shall not be used “lower-risk biocidal product”, “nontoxic”, “safe”, and the like.

Article 40

(1) A legal person possessing the authorization for placing a biocidal product on the

market shall ensure proper classification, packaging and labelling, and an SDS that is properly

revised pursuant to the regulations on chemicals.

(2) A legal person placing a biocidal product on the market shall make an SDS available

to every user of a biocidal product, user in the industry, and other users upon their request when

procuring a biocidal product, with a view to undertaking preventive measures for users’ health

and working environment when preforming registered activities.

Article 41

(1) Advertising and giving recommendations and proposals to users shall be allowed

only for the biocidal products registered in the Inventory of Biocidal Products.

(2) When providing information under Paragraph 1 of this Article, it is necessary to

write as follows: “a biocidal product is to be used carefully”, “before the use, read the

declaration and other data on the biocidal product”. The mentioned text shall be visible and

written in one of the official languages in the Republic.

(3) The name of a biocidal product and the information on the its use shall be provided

when notifying about the biocidal product.


VI – CONDITIONS FOR THE IMPORT

AND EXPORT OF BIOCIDAL PRODUCTS

Article 42

(1) Biocidal products may be imported by authorization holders, temporary

authorization holders, and persons possessing a Decision on the inclusion into the Programme,

as well as on the basis of the consent for using a biocidal product for scientific research and

development and process and product-oriented research and development, namely holders of

authorization for using a biocidal product for scientific research.

(2) Biocidal products classified as hazardous in accordance with the provisions of the

law on chemicals and regulations issued thereunder shall be imported for further sale only by

legal persons meeting the requirements for the wholesale of hazardous chemicals.

(3) Biocidal products for own purposes may be imported by legal persons meeting the

requirements for the production and use of hazardous chemicals.

(4) Lower-risk biocidal products may be imported by legal persons meeting the

requirements for the production and sale of common use items.

(5) Importers under Paragraph 1 of this Article shall, prior to customs clearance, submit

a request to a health and sanitary inspector for conducting sanitary supervision of a biocidal

product that is being imported, and shall on that occasion submit proof under Paragraph 1 of

this Article by which placing on the market and the use of biocidal product is allowed.

Article 43

(1) In case a legal person did not comply with the requirements under Article 42,

Paragraph 2 of this Law, a biocidal product shall be returned to its sender.

(2) A health and sanitary inspector who conducted sanitary supervision over a biocidal

product that is being imported shall submit a report on the supervision conducted to the

Ministry.

(3) The Minister shall issue a decree stipulating the content of the report and the

deadline for the mentioned report submission.

Article 44

For the export of a biocidal product that is registered in the Inventory of Biocidal

Products and for which an authorization has been issued is no additional authorizations shall be

required.

VII – SAFE USE OF BIOCIDAL PRODUCTS

Article 45

(1) A person handling a biocidal product shall ensure that there are no adverse effects

on human health, animals, and the environment, taking care of the rational application of the

combination of physical, biological, chemical and other appropriate measures against target

organisms, and shall ensure that a biocidal product is used only as necessary.

(2) A person handling a biocidal product shall comply with all prescribed measures in

accordance with the instructions, including the stipulated concentration of a biocidal product in

order to protect human health, animals and the environment.

(3) Prescribed maximum amounts of residue in biocidal products or on treated

facilities, items, organisms, rooms or other places shall not be exceeded.


Article 46

(1) Biocidal products for general use classified as hazardous, extremely toxic,

carcinogenic category 1 or 2, mutagenic category 1 or 2 or biocidal products that have adverse

effects on reproduction categories 1 or 2 shall not be placed on the market.

(2) Biocidal products under Paragraph 1 of this Article may be used only by

professional users meeting the criteria in terms of human resources, space and equipment.

(3) The Minister shall issue a decree stipulating more specific criteria referred to in

Paragraph 2 of this Article.

(4) Systemic monitoring of placing biocidal products on the market and its metabolites

shall be done in accordance with the Law on chemicals.

VIII – CONSENT FOR PERFORMING THE ACTIVITY

Article 47

(1) Activities of manufacture, trade, use and storage of biocidal products shall be

performed only by legal persons meeting the criteria in terms of human resources, space and

equipment.

(2) The Minister shall appoint the Committee for determining whether conditions in

Paragraph 1 of this Article are fulfilled. The Committee shall consist of two expert members

from pharmacy, technology, veterinary, phytopharmacy and medicine, depending on the field

of the interest of a legal person.

(3) Upon the receipt of the proposal from the Committee, the Minister shall issue a

Decision on the fulfilment of conditions under Paragraph 1 of this Article.

(4) An appeal against a Decision under Paragraph 3 of this Article shall not be allowed,

but an administrative litigation may be initiated.

(5) The Minister shall issue a decree promulgating the conditions in terms of human

resources, space and equipment under Paragraph 1 of this Article, as well as the criteria and the

procedure of the work of the Committee referred to in Paragraph 2 of this Article.

Article 48

(1) A natural person engaged in the retail sale of biocidal products shall obtain the

consent for the mentioned activity from the competent organ of the unit of the local self-

government on whose territory the person is registered in accordance with the Law.

(2) The competent organ of the unit of the local self-government under Paragraph 1 of

this Article shall submit one copy of the Decision to the Ministry.

(3) An appeal may be lodged against the Decision under Paragraph 1. The appeal shall

be submitted to the Ministry.

Article 49

(1) A request for obtaining the Decision on the criteria fulfilment under Article 47,

Paragraph 3 of this Law shall be submitted to the Ministry by a legal person engaged in the

activities of manufacture, trade, use and storage of a biocidal product. The request shall contain

the following data: address of a legal person, and the name of a natural person within a legal

entity, the name of a biocidal product to be produced, used or stored, the manner of use and the

data on preventive measures for safe keeping and use of a biocidal product.

(2) For determining the fulfilment of conditions under Article 47, Paragraph 1, and for

issuing a Decision on the fulfilment of conditions under Article 47, Paragraph 3 of this Law,

the applicant shall pay a fee that is the revenue of the Republic.


(3) The Ministry shall keep the Registry of legal and natural persons that received the

Decision on the fulfilment of criteria for performing the activities of manufacture, trade, use

and storage of biocidal products. The Registry shall be available to the public.

IX – KEEPING RECORDS ON BIOCIDAL PRODUCT

Article 50

(1) Authorization holders and natural persons professionally using biocidal products

shall keep records on biocidal products in accordance with the regulations on chemicals.

(2) Person placing a biocidal product on the market by 31 March of the current year

shall submit the Ministry a report for the previous year. The report shall contain the data on

produced, used and imported amount of biocidal products, amount of supplies by 31 December

of the previous year and the amount of biocidal products withdrawn from the market, on the

basis of the data from the records.

(3) A professional user of biocidal products shall keep records on the amount of

procured biocidal products, supplies, and the amount of the used biocidal products and the

purpose for which they were used.

(4) A person shall keep the data from the Records at least five years from the day of

their entry.

Article 51

(1) Health care institutions shall collect and submit data on acute poisoning and other

effects of biocidal products on human health to the Ministry and competent health institute. The

mentioned data shall be used for medical purposes aimed at prevention and treatment, especially

in emergencies, and shall not be used for other purposes.

(2) Authorization holders shall make available all information from the SDS and other

information for the needs of health care institutions referred to in Paragraph 1 of this Article.

Article 5

Legal persons who manufacture, place on the market or use biocidal products shall

collect, store and safely dispose empty packaging and residues after the use of biocidal products

in accordance with the waste regulations.

Article 53

Authorization holders for manufacture, placing on the market and use of biocidal

products shall be responsible for the damage occurred due to the violation of the provisions of

this Law or due to declared properties of biocidal products on which the authorization holder

has impact.

X – BANS AND RESTRICTIONS FOR PLACING ON THE MARKET

AND USE OF THE BIOCIDAL PRODUCT

Article 54

(1) Bans and restrictions from manufacture and placing on the market of a biocidal

product shall be determined in accordance with the regulations on chemicals.

(2) In case there is justified doubt that a biocidal product, namely the substance in its

composition, presents a threat to human health, animals and the environment, the Ministry may

prescribe a ban on the use or the restriction for placing on the market and use of a biocidal


product for certain purposes in accordance with the procedure prescribed by the Law on

chemicals.

Article 55

(1) Biocidal products classified as toxic, extremely toxic, cancerous categories 1 or 2,

mutagenic categories 1 or 2 or whose properties have adverse effects on endocrine system shall

not be placed on the market for general use.

(2) Biocidal products under Paragraph 1 of this Article shall be used only by

professional users meeting the criteria in terms of human resources, space and equipment.

(3) The Minister shall issue a Decree promulgating the conditions under Paragraph 2

of this Article.

Article 56

(1) Persons engaged in the trade of biocidal products under Article 55, Paragraph 1 of

this Law, shall sell them only to professional users meeting the criteria under Article 55,

Paragraph 2 of this Law.

(2) Persons engaged in the trade of biocidal products under Article 55, Paragraph 1 of

this Law shall, in addition to prescribed records, keep the records on the expiry date of a biocidal

product, date of sale, amount of the biocidal product sold, the name and address of the person

who procured the biocidal product. The mentioned person shall be provided with a signature of

the person buying the biocidal product, when taking a biocidal product.

(3) The Minister shall issue a decree promulgating the manner of keeping the records

and the submission of the data from the records under Paragraph 2 of this Article, as well as the

period for keeping the data.

XI – DATA AVAILABILITY

Article 57

(1) Data submitted to the Ministry for the issuing of authorization shall be available to

the public.

(2) A legal person that submitted an application for obtaining authorization may ask to

classify some data as confidential in accordance with this Law and the regulations on data

protection.

(3) The Minister, on the basis of the justification assessment of the application, shall

issue a Decision on the data confidentiality.

(4) If a person that submitted an application for the authorization marked the data on

the full composition as confidential, the Ministry shall classify the data concerned as

condifendtial.

Article 58

1. Data relevant for the safety of humans, animals and, assets and the environment

shall not be classified as confidential. Those data include:

a) name and address of an applicant who places a biocidal product on the market,

namely the name and address of a manufacturer of a biocidal product,

b) name and address of an applicant who places an active substance on the market,

namely the name and address of a manufacturer of an active substance

c) name of a biocidal product, the name and quantity of an active substance in a

biocidal product


d) names of other substances according to which a biocidal product is classified as

hazardous,

e) data on physical and chemical properties of an active substance in biocidal

product,

f) methods for turning an active substance into less hazardous, or turning a biocidal

product into less less hazardous,

g) findings of efficacy testing of an active substance and a biocidal product, its

effects on humans, animals and the environment

h) recommended methods and preventive measures for hazard reduction when

storing, transporting and using a biocidal product, as well as in case of fire and

other circumstances,

i) safety data sheet,

j) methods for the analysis of the amount and nature of an active substance, other

substances in biocidal product, and residues that are significant for their

toxicological and eco-toxicological properties,

k) manner of the disposal of a biocidal product packaging and its residues,

l) first aid and health recommendations in case of an accident

2. If a person under Paragraph 1 of this Article classifies data, previously marked as

confidential, as public, the data concerned shall be published.

XII – SUPERVISION

Article 59

(1) Supervision over the application of this Law and the regulations issued thereunder

shall be performed by the Inspectorate of the Republic of Srpska via health and sanitary

inspectors authorized for performing supervision over hazardous chemicals, detergents and

biocidal products.

(2) Notwithstanding Paragraph 1 of this Article, the supervision over the application of

this Law and regulations issued thereunder, and which relate to the retail or personal use of a

biocidal product, shall be done by a health and sanitary inspection institution within the unit of

the local self-government.

(3) Health and sanitary inspectors authorized for the supervision over biocidal products

under Paragraph 1 or 2, in addition to the conditions prescribed by the Law on Inspections of

the Republic of Srpska (Official Gazette of the Republic of Srpska, no.113/05 and 1/08), shall

continually educate themselves about hazardous chemicals and biocidal products in accordance

with the training programme laid down by this law and the Law on chemicals.

Article 60

(1) During the supervision over the application of this Law, an inspector may take

samples of a biocidal product in order to determine whether it is well classified, labelled and

packed, and whether the content corresponds to a biocidal product for which the authorization

has been issued.

(2) Costs incurred by sampling shall be covered by a manufacturer, namely an importer,

or a distributor, in case it is proved that the new biocidal product is placed on the market

contrary to the provisions of this Law.

Article 61

While performing supervision activities, authorized inspector shall have the right and

responsibility to:


a) determine whether a biocidal product is placed on the market without

authorization, or Decision on the inclusion into Programme, namely whether it

is classified, packed and labelled in accordance with this Law.

b) determine whether a biocidal product is placed on the market by a legal person

headquartered in the Republic.

c) determine whether basic data have beem submitted prior to placing on the market

of a biocidal product that as an active substance contains the basic substance

written on the List of IB or is in the process to be included on the List,

d) determine whether an application for obtaining an authorization for a biocidal

product that is already on the market has been submitted before this Law entered

into force.

e) determine whether a biocidal product has been withdrawn from the market in

accordance with the Decision of the Ministry,

f) determine whether an obtained temporary authorization is used in accordance

with criteria thereof,

g) determine whether proper records are kept and submitted, namely whether the

data are accurate and submitted within the prescribed reporting period to the

Ministry,

h) determine whether the Ministry’s consent was obtained before using a biocidal

product for scientific research and development and product-process-oriented

research and development, as well as whether the research is conducted in

accordance with the prescribed conditions,

i) determine whether biocidal products is classified as toxic, extremely toxic,

carcinogenic category 1 or 2, mutagenic category 1 or 2 or a biocidal product

having adverse effects on reproduction categories 1 or 2 are placed on the market

and used for general use contrary to the provisions of this Law.

j) determine whether a biocidal product is stored and treated pursuant to this Law,

namely whether the packaging of a biocidal product and its residue are disposed

in accordance with regulations on waste disposal and management,

k) determine whether maximum residue amounts are exceeded,

l) determine whether, prior to testing on vertebrates, data were requested regarding

the testing on vertebrates for the same active substance or similar biocidal

product.

m) determine whether a legal person possesses approval of a health and sanitary

inspector issued during the supervision over the import of a biocidal product

prior to customs clearance.

Article 62

While performing assignments under Article 61, an inspector is authorized to:

a) temporarily prohibit placing a biocidal product on the market, until the

authorization is obtained or a Decision on the inclusion into the Programme, and

until a biocidal product is classified, labelled and packed in accordance with the

prescribed manner.

b) prohibit a legal person who is seated outside the Republic to place a biocidal

product on the market,

c) prohibit temporarily placing a biocidal product on the market whose active

substance as basic substance is not written or is not in the process to be included

on the List IB, and for which basic data have not been submitted,

d) order removal of biocidal product from the market for which an application for

placing on the market was not submitted,


e) order the cessation of research and seeking data on testing on vertebrates for the

same substance or similar biocidal product, for a biocidal product for which

research has been initiated or for which data already exist,

f) order the performance of instructions from the Ministry’s Decision on the

withdrawal of a biocidal product from the market,

g) order placing a biocidal product on the market and its use in accordance with

conditions for placing a biocidal product on the market, namely the Decision on

the inclusion into the Programme,

h) order withdrawal of a biocidal product from the market, as it has not been placed

on the market and used in accordance with the conditions from a temporary

authorization,

i) order submission of a report on the used amounts and systemic monitoring of a

biocidal product for which a temporary authorization has been issued,

j) order keeping prescribed records, keeping data on a biocidal product and

submitting reports,

k) order submission of notifications for the use of a biocidal products used for

product and process-oriented research,

l) temporarily prohibit the use of a biocidal product for scientific research and

development, as well as for the process and product-oriented research and

development, until obtaining an authorization,

m) prohibit the use of a biocidal product for scientific research and development,

as well as for the process and product-oriented research and development which

is not in accordance with prescribed conditions,

n) order the withdrawal of a biocidal product from the market used for general use

despite the ban,

o) prohibit the storage of biocidal products in inappropriate room, and the

management of empty packages and residues contrary to waste regulations,

p) give instructions about what to do with treated objects, rooms, items, organisms

and other places if the residue amounts have been exceeded.

q) prohibit the work of a legal person who does not possess the Decision by the

Minister on the fulfilment of conditions for manufacture, wholesale, storage and

use of biocidal products,

r) prohibit the trade of biocidal products for which no approval was obtained from

a health and sanitary inspector, issued during the supervision procedure prior to

customs clearance,

s) order the performance of assignments in accordance with competences.

XIII – PENALTY PROVISIONS

Article 63

A person who is not authorized to manufacture, sell or use bicodial product shall be

penalized pursuant to the Criminal Law of the Republic of Srpska (Official Gazette of the

Republic of Srpska, no.49/03, 108/04, 37/06 and 70/06).

Article 64

(1) A fine of 5,000.00 BAM - 50,000.00 BAM shall be imposed on a legal person if:

a) prior to placing a biocidal product on the market, he does not obtain an

authorization or a decision on the entry of a biocidal product in the Programme


of technical dossier submission, or does not classify, label and pack a biocidal

product in accordance with this Law (Article 7, Paragraph 1),

b) prior to placing a biocidal product on the market, which as an active substance

contains the basic substance written or to be written on the List IB, he does not

submit the main data on the biocidal product (Article 7, Paragraph 3),

c) he places a biocidal product on the market and but is not seated in the Republic

(Article 8),

d) he does not abide by the conditions for placing biocidal products on the market

and their use, specified in the Decision on the inclusion into the Programme,

namely he allows placing a biocidal product on the market and its use (Article

18),

e) he does not submit the data for the Inventory of Biocidal Products (Article 21),

f) prior to research, he seeks the data on the research on vertebrates for the same

active substance or the similar biocidal product, or the biocidal products for

which research already commenced or has been done (Article 24),

g) he places on the market and uses a biocidal product, for which a temporary

authorization has been issued, contrary to the conditions for restricted and

controlled use determined in the authorization (Article 29)

h) upon the cessation of the use of a biocidal product for which a temporary

authorization has been obtained, he does not submit a report on the amounts used

and the result of systemic monitoring by the expiry of the temporary

authorization validity (Article 30),

i) he does not monitor the adverse effects of a biocidal product on humans, animals

and the environment (Article 31),

j) he does not withdraw a biocidal product from the market within the prescribed

period (Article 34),

k) he does not submit the data requested prior to import, namely the use of a

biocidal product or an active substance for the purpose of product-and-process-

oriented research and development (Article 36),

l) he does not ensure the authorization to use a biocidal product for scientific

development and research and product-and-process-oriented research and

development, if during the research a biocidal product is released in the

environment (Article 37, Paragraph 1),

m) he does not submit a request to a health and sanitary inspector prior to customs

clearance and does not possess an authorization by a health and sanitary

inspector for placing a biocidal product on the market issued during the

supervision when importing a biocidal product, prior to customs clearance

(Article 42, Paragraph 5),

n) maximum residue amounts are exceeded in biocidal products or on treated

facilities, rooms, items, organisms and the like (Article 45),

o) he places a biocidal product on the market that is prohibited for general use

(Article 46),

p) he does not keep records, namely the records do not contain the prescribed data

on the amount of the procured biocidal product, supplies amount, the amount

and the intended use of the biocidal product (Article 50, Paragraph 1),

q) by 31 March of the current year, he does not submit the data on the amount of

the produced, imported and used biocidal product in the previous year (Article

50, Paragraph 2)


r) he does not keep records on the banned biocidal product that has been allowed

for the use to professional user, and the records do not contain the prescribed

data (Article 50, Paragraph 3),

s) he does not keep data at least for five years (Article 50, Paragraph 4),

t) does not collect, store, and safely dispose the empty package and residue in

accordance with the regulations on waste disposal (Article 52),

u) banned biocidal product for common use is used by a professional user that does

not meet the prescribed criteria (Article 55, Paragraph 2),

v) he does not make data on biocidal products available to the public (Article 57,

Paragraph 1), and

w) he makes available to the public data marked as confidential (Article 58).

(2) For the offence under Paragraph 1 of this Article, a protective measure may be

imposed on a legal person, prohibiting him to carry out certain activities over the period of six

months.

(3) For the offense referred to in Paragraph 1 of this Article, a responsible person within

the legal entity shall be fined from 1,000 to 10,000 BAM.

(4) For the offence under Paragraph 1 of this Article, in addition to the fine, a protective

measure may be imposed on a responsible person within a legal entity, prohibiting him to carry

out certain activities up to six months.

Article 65

(1) A fine of 1,000.00 BAM -10,000.00 BAM shall be imposed on a natural person if:

a) he does not abide by protection measures when using a biocidal product (Article

45) and,

b) does not obtain the authorization by a competent authority for the retail trade of

a biocidal product (Article 48),

(2) For the offence under Paragraph 1 of this Article, in addition to the fine, a protective

measure may be imposed, prohibiting the performance of certain activities up to six months.

XIV – TRANSITIONAL AND FINAL PROVISIONS

Article 66

A holder of a Decision for placing a poison on the market, issued in accordance with

Article 49 of the Law on Poisons (Official Gazette of the Republic of Srpska, no.70/06 and

73/08), whereas the poison is on the market on the day when this Law enters into force, shall

submit an SDS and the data for the inclusion into the Programme to the Ministry, in accordance

with Article 7 of this Law, within 6 months from the date when this Law enters into force.

Article 67

Within one year of the entry into force of this Law, the Minister shall adopt the following

general acts:

a) Rulebook on the types of biocidal products according to the manner of the use

thereof (Article 5),

b) Rulebook on the list of active substances in biocidal products (Article 6),

c) Rulebook on the list of active substances not to be used n biocidal products

(Article 6)

d) Rulebook on the content of documentation for an active substance and biocidal

product assessment, scope and content of a technical dossier and the summary

of a dossier (Article 10),


e) Rulebook on the appointment of members and the work of the Committee on

Biocidal Products (Article 12),

f) Rulebook on the biocidal assessment on the basis of a technical dossier and risk

assessment procedures (Article 16),

g) Rulebook on specific conditions for placing a biocidal product on the market

(Article 18),

h) Rulebook on keeping the Inventory of Biocidal Products (Article 21),

i) Rulebook on the criteria to be met by laboratories and testing methods of

biological efficacy of biocidal products (Article 23),

j) Rulebook on conditions and the procedure for recognizing foreign authorization

for placing biocidal products on the market (Article 28),

k) Rulebook on specific requirements concerning classification, packaging,

labelling and advertising of biocidal products (Article 38),

l) Rulebook on the report content and the deadline for report submission in the

supervision process over a biocidal product that is imported (Article 38),

m) Rulebook on requirements for legal persons using biocidal products in

professional purposes (Article 46 and Article 55),

n) Rulebook on the conditions for performing the activities of manufacture, trade,

use and storage of biocidal products (Article 47), and

o) Rulebook on the manner of keeping records on biocidal products (Article 56).

Article 68

Until the introduction of general acts prescribed by this Law, general acts issued in

accordance passed pursuant to the Law on Poisons (Official Gazette of the Republic of Srpska,

no. 70/06 and 73/08), shall be applied in the part regarding products for maintenance of utility

hygiene, disinfection, disinsection, deratization, removal of bad smell and decontamination

under Article 49 of the Law mentioned.

Article 69

This Law shall enter into force on the eighth day of the publication thereof in the Official

Gazette of the Republic of Srpska.

No: 01-642/09 The Chairperson of the National Assembly

Date: 8 April 2009 Mr Igor Radojičić, m.p.

Banja Luka

LAW ON BIOCIDAL PRODUCTS I GENERAL PROVISIONS

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