LAW ON BIOCIDAL PRODUCTS

LAW ON BIOCIDAL PRODUCTSI. GENERAL PROVISIONSArticle 1This Law shall regulate: list of active substances, procedures for issuing of the acts onthe basis of which the biocidal products are placed on the market, bans and restrictions forplacing on the market and use of the biocidal products; research and development of thebiocidal products; classification, packaging, labelling, advertising and safety data sheet of thebiocidal product ; Registry of biocidal products; safe use of the biocidal products; supervisionand other important issues related to sound placing on the market and use of biocidal products.Article 2Certain terms used in this Law shall have the following meaning:1. Active substance means substance or micro-organism including a virus or a fungushaving general or specific action on or against harmful organisms.2. Biocidal products means active substances or mixture containing one or more activesubstances, put up in the form in which they are supplied to the user, intended todestroy, deter, render harmless, prevent the action of or otherwise exert a controllingeffect of any harmful organism by chemical or biological means.3. Low-risk biocidal product means biocidal product containing one or more activesubstances listed in the List Ia - List of active substances contained in the low-riskbiocidal product and other substances which are not substances of concern, and underthe conditions of use which shall pose only a low risk for humans, animals and theenvironment.4. Good laboratory practice means laboratory practice conducted in accordance withprinciples (directives) set out in the Law regulating medicines and medical devices.5. Scientific research and development means any scientific experiment, analysis orresearch of the active substance, i.e. biocidal product conducted under controlledconditions.6. Harmful organism means any organism which has an unwanted presence ordetrimental effect on humans, their activities or the products they use or produce, onanimals or the environment.7. Frame formulation means specification for the group of biocidal products having thesame use and user type and which contains identical active substances. Variations inthe composition of the biocidal products with the determined frame formulation, mayfor example be, reduction in the percentage of the active substance in the biocidalproduct, alternation in the percentage of the other substances in the biocidal product orreplacement of pigments, dyes, perfumes by others presenting the same or a lowerrisk, and which do not decrease its efficacy.8. Basic substance means a substance which is listed in the List Ib – List of basicsubstances whose major use is non-pesticidal but which has some minor use asbiocidal product, either directly or in a product consisting of that substance and thinner1

simple diluent which itself is not a substance that causes concern and which is notdirectly marketed as a biocidal product e.g., carbon dioxide, nitrogen, ethanol, 2-propanol, acetic acid, diatomaceous (infusorial) soil.9. Residues of biocidal product means one or more substances present in a biocidalproduct, which remains as a result of its use, including the metabolites of suchsubstances and products that are a result of their degradation or reaction.10. Program for inclusion into the List I – List of active substances, List Ia - List of activesubstances contained in the low–risk biocidal product or List Ib – List of basicsubstances means the EU programme (Review Programme) which contains list ofactive substances placed on EU market before EU legislation on biocidal productscame into force and which contains the time period for submission of the technicaldossier for inclusion of active substances in those lists.11. Professional use means any use of biocidal products for carrying out of the registeredactivities.12. Process-orientated research and development means any research aiming to the useand further development of the active substance or biocidal product when thepossibility of usage of that biocidal product is examined either on experimental or onproduction level.13. Placing on the market means supplying or making available active substances andbiocidal products to a third parties, on the territory of the Republic of Serbia, eithercharged or free of charge, wherein the import shall be deemed as placing on themarket.14. Substance of concern means any substance, other than the active substance, which hasan inherent capacity to cause adverse effects on humans, animals and the environmentand is present in a biocidal product in sufficient concentration to create such an effect.Such a substance, unless there are other grounds for concern, would benormally a substance classified as hazardous and present in the biocidal product insuch a concentration leading the product to be regarded as hazardous.Article 3Provisions of this Law shall not apply to:1. medicines and medical devices used in human and veterinary medicine;2. foodstuffs, food additives, flavourings and raw-materials used for their production,materials and product being in contact with food;3. animal feed and its additives or feedingstuff;4. detergents to which the Law on Chemicals is applied, if without biocidal effect;5. cosmetic products;6. plant protection products.2

II. LISTS OF ACTIVE SUBSTANCESArticle 4Active substances are included in List I – List of active substances, List Ia – List ofactive substance contained in low - risk biocidal product and List Ib – List of basic substances,which are published in the Official Gazette of the EU.Lists referred to in Paragraph 1 of this Article, shall in particularly determine: name ofthe active substance, the minimum purity of the active substance in the biocidal product,product type in which the substance may be used and conditions under which the act forplacing on the market and use of the biocidal product may be issued in regard to risk thatactive substance represents on humans, animals and environment.Lists referred to in Paragraph 1 of this Article shall be taken over and published in the“Official Gazette of the Republic of Serbia”.Basic substance shall be placed on the market and used for biocidal purposes ifincluded in the List Ib – List of basic substances.III. PROCEDURES FOR ISSUING OF THE ACTS ON THE BASIS OF WHICHTHE BIOCIDAL PRODUCTS ARE PLACED ON THE MARKETArticle 5Biocidal products shall be classified into product types based on their intended use,target organism they control, area where they are used and article, i.e. surface which is treated.The Chemical Agency established by separate Law (hereinafter: the Agency) shall laydown the biocidal products types.The fee shall be charged for expert evaluation on classification of certain biocidalproduct into certain product type as well as on determination if certain product is biocidalproduct, on the basis of properties and intended use of that productArticle 6Biocidal product shall be placed on the market if:1) manufacturer or importer obtained the authorisation for placing on the market;2) it is classified, packed and labelled and has safety data sheet, pursuant to this Law.1. Inclusion of the Biocidal Product into the Temporary List of the Biocidal Products forDelivery of the Technical DossierArticle 7Manufacturer or importer may place biocidal product on the market prior to obtainingthe authorisation for placing on the market, when the Decision on inclusion of that biocidalproduct into the Temporary List for delivery of Technical Dossier was issued pursuant to thisLaw.3

Temporary List for delivery of Technical Dossier (hereinafter: Temporary List)contains data on biocidal products as well as deadlines for delivery of Technical Dossier forthat biocidal product.The deadlines given in the Temporary List the Agency shall set up on the basis ofwhether the active substance contained in the biocidal product is included in the Lists referredto in Article 4 of this Law or into the Programme for inclusion into the List I – List of activesubstances, List Ia – List of active substance contained in low-risk biocidal product and List Ib– List of basic substances (hereinafter: the Programme), or on the basis of quantities of thebiocidal product placed on the market, properties of the biocidal product that affect humans,animals and environment or lack of those data, biocidal product type and availability of dataon assessment of active or any other substance contained in the biocidal product in compliancewith other regulations.Article 8Biocidal product shall be included into the Temporary List if such biocidal productwas placed on the market in the Republic of Serbia before this Law came into force or ifactive substance contained in that biocidal product is included into List I – List of activesubstances, List Ia – List of active substance contained in low-risk biocidal product or into theProgramme, unless there is a reasonable doubt that such biocidal product representsunacceptable risk on humans, animals and environment.Article 9For the purpose of obtaining the Decision on inclusion of the biocidal product into theTemporary List, manufacturer or importer of the biocidal product shall submit the applicationto the Agency (hereinafter: the applicant for inclusion into the Temporary List)Application referred to in Paragraph 1 of this Article may be submitted by moreimporters together.Confidential data needed for the purpose of inclusion of the biocidal product into theTemporary List, foreign producer of the biocidal product may submit to the Agency, directlyor through representative who is obliged to submit the authorisation for representation.Basic data on biocidal product i.e. active substance contained in that biocidal product(hereinafter: basic data) and safety data sheet, shall be presented along with the application forinclusion into the Temporary List.Upon the request of the Agency, the applicant for inclusion into the Temporary Listshall submit samples of the biocidal product and its components.Article 10Basic data referred to in Article 9 Paragraph 4 of this Law, shall in particularlycontain: data on the identity of the biocidal product, active substances and other substancescontained in the biocidal product, data on the manufacturer of the biocidal product, data onintended use, data on the efficacy, classification, labelling and packing as well as data on riskto humans, animals and the environment and risk reduction measures which are known to theapplicant for inclusion into the Temporary List.4

Data on efficacy referred to in Paragraph 1 of this Article shall be submitted to theAgency in Serbian, but it can be also submitted in English as one of the official languages inthe EU.The Agency shall lay down the content of the data from Paragraph 1 of this Article.Article 11The Agency shall, within 30 days at the latest from the day of submitting of theapplication from Article 9 of this Law and the complete basic data, issue the Decision oninclusion of the Biocidal product into the Temporary List.Where there is the doubt that biocidal product represents risk to humans, animals andthe environment or in the case of doubt that the biocidal product is not efficient enough, theAgency shall instruct the applicant to the procedure for obtaining the authorisation for placingbiocidal product on the market.Where necessary, the decision referred to in Paragraph 1 of this Article may set out theconditions for placing on the market and use of the biocidal product, for the purpose ofprotection of human and animal health and the environment.The fee shall be charged for the evaluation of the basic data.Against the Decision from Paragraph 1 of this Article, an appeal may be lodged to theMinister in charge of environmental protection (hereinafter: the Minister).Decision referred to in Paragraph 5 of this Article is final and administrative procedureagainst it may be initiated.2. Authorisation for placing of the biocidal product on the marketArticle 12For the purpose of obtaining the authorisation for placing of the biocidal product onthe market (hereinafter: the authorisation), manufacturer or importer of the biocidal productshall submit the application to the Agency (hereinafter: the applicant for authorisation).Application referred to in Paragraph 1 of this Article may be submitted by moreimporters together.Confidential data needed for the purpose of issuing of the authorisation, foreignproducer of the biocidal product may submit to the Agency, directly or through representativewho is obliged to submit the authorisation for representation.Upon the request of the Agency, the applicant for authorisation shall submit samplesof the biocidal product and its components.Article 13Technical Dossier shall be presented along with application for authorisation.Technical Dossier shall be submitted in Serbian, but it can be also submitted in English as oneof the official languages in the EU.The Technical Dossier for biocidal product contains data on active substance andbiocidal product, in particular: identity, data on physical and chemical properties, data on5

methods of detection, identification and analysis; data on toxicological and eco-toxicologicalproperties, data on effectiveness against target organisms and intended uses, data on measuresnecessary to protect humans, animals and environment, data on classification, labelling andpackaging as well as summary of the Technical Dossier.The Technical Dossier for low-risk biocidal product contains data on active substanceand biocidal product, in particular: identity, data on physical and chemical properties, data onintended use, data on effectiveness against target organisms, data on methods of detection,identification and analysis, as well as data on classification, labelling and packaging.Technical dossier from Paragraphs 2 and 3 of this Article shall contain full descriptionof the studies conducted or a bibliographical reference to those data.If some of the data referred to in Paragraphs 2 and 3 of this Article are not necessary tobe provided owing to the nature of the biocidal product or of its proposed uses or if testing forthe purpose of data delivery is not scientifically necessary or technically possible, justificationin written form must be submitted.Instead of the Technical Dossier, or certain parts of the Technical Dossier consent foruse of such data may be submitted by a person who already submitted Technical Dossier tothe Agency for similar biocidal product.Along with the consent from Paragraph 6 of this Article, evidence that variations inthe composition of the biocidal product are in accordance with acceptable variations set out inthe frame formulation shall be presented.Data from the Technical Dossier may be used for the same or similar biocidal producteven without the consent from Paragraph 6 of this Article, within the deadlines laid down bythe Agency, and in such case the evidence that the biocidal product is the same or evidencefrom Paragraph 7 of this Article shall be submitted.The Agency shall lay down the scope and the content of the Technical Dossier for thebiocidal product i.e. low-risk biocidal product.Article 14Test methods laid down in the Law on Chemicals shall be applied for obtaining of thedata on physical, chemical, toxicological and eco-toxicological properties of the activesubstance and biocidal product necessary for the Technical Dossier.Internationally accepted and harmonised test methods shall be used, where the testmethod from paragraph 1 of this Article is inappropriate, i.e. nonexistent.If methods referred to in Paragraph 1 of this Article are not used for testing, theadequacy of such methods shall be verified for every single test, taking into account theminimisation of the testing on vertebrates.New testing of the active substance and biocidal product shall be carried out in thelaboratory whose work is harmonised with the principles of Good Laboratory Practice.Testing of the efficacy of the active substance and biocidal product shall be carried outin the laboratory with quality control and quality insurance.The Agency shall lay down test methods for the efficacy of the active substance andbiocidal product.6

Article 15If the Technical Dossier is incomplete, i.e. justification from Article 13 Paragraph 5 ofthis Law is not acceptable, the Agency shall require from the applicant for authorisation tosubmit complete Technical Dossier within the prescribed time period.If the applicant for authorisation fails to amend the Technical Dossier within theprescribed time limits, the Agency shall set out new time period, but total time limits shall notexceed six months.If the applicant for authorisation fails to amend the Technical Dossier referred to inParagraph 2 of this Article, the Agency shall issue the Decision on refusal of the application.Against the Decision referred to in Paragraph 3 of this Law an appeal may be lodgedto the Minister.Decision of the Minister referred to in Paragraph 4 of this Article shall be final andadministrative procedure against it may be initiated.Article 16On the basis of the technical dossier, the Agency carries out the assessment of thebiocidal product to determine its effects on humans and animals and the environment, possibleunacceptable effects on target organisms as well as its efficacy and risk within the intendeduses.When assessing the low-risk biocidal products, the Agency carries out only efficacyassessment.Geographical and health characteristics as well as specificity of the environmentalcompartments on the territory of the Republic of Serbia shall be taken into account in theprocedure of assessment of the biocidal product.The Agency may, when carrying out assessment of the biocidal product, require fromthe applicant to submit additional data within the given time period.The time period from Article 18 Paragraph 1 of this Law for the evaluation of thedossier shall start only after the dossier is complete.The Agency shall lay down common principles for the evaluation of dossiers forbiocidal products.Article 17When carrying out assessment of a biocidal product, it is determined if the biocidalproduct meets the following conditions:1. the active substance contained in the biocidal product is included in the List I – Listof active substances, List Ia – List of active substance contained in low-risk biocidal productfor that product type and it fulfilles any requirements for active substance laid down in theselists;2. it is possible to establish the nature and quantity of active substance, othersubstances contained in the biocidal product and residues of the biocidal product which resultfrom the authorised use of the biocidal product, and which are important due to theirtoxicological and eco-toxicological properties;7

3. it is established, in the light of current scientific and technical knowledge thatbiocidal product, when used under normal conditions:- is sufficiently effective;- has no unacceptable effects on the target organisms, such as unacceptableresistance or cross-resistance or unnecessary suffering or pain of vertebrates;- has no unacceptable effects itself, or as a result of its residues, on human or animalhealth, directly or indirectly (e.g. through drinking water, indoor air or the work place)or on surface and ground-waters;- has no unacceptable effects itself, or as the result of its residues, on the environmenthaving particular regard to its fate and distribution in the environment, particularlycontamination of surface, ground and drinking water, as well as its impact on nontarget organisms;4. its physical and chemical properties have beed determined and deemed acceptablefor purpose of appropriate use, storage and transport.The condition referred to in Point 3, Paragraph 1 of this Article shall be taken intoconsideration for the intended use of the material treated with that biocidal product.When carrying out assessment of the biocidal product from Paragraph 1, the Agencyshall take into consideration requirements determined by other legal acts regulating health andsafety at work, consumer’s protection, animal health and environmental protection.Article 18The Agency shall, within one year from the day of submitting of the application forauthorisation and complete Technical Dossier, i.e. 60 days for low-risk biocidal product andfor biocidal product within the established frame formulation, issue the authorisation.The authorisation shall contain: data on the applicant; trade name of the biocidalproduct; name and content of the active substances and other substances contained in thebiocidal product whose concentration does not affect the efficacy and classification of thebiocidal product; biocidal product type and conditions for placing on the market and use;period of validity of the authorisation as well as other data.Conditions for placing on the market and use of the biocidal product from Paragraph 2of this Article may for example be: authorised uses, manner of storage and keeping, retailer’sfacilities depending on the properties and biocidal product type etc.The authorisation shall be issued for the period of 10 years or for the period for whichactive substance contained in that biocidal product is included into the List I – List of activesubstances, List Ia – List of active substance contained in low-risk biocidal product.Against the Decision on authorisation from Paragraph 1 of this Article, an appeal maybe lodged to the Minster.Decision from Paragraph 1 of this Article shall be final and administrative procedureagainst it may be initiated.Article 19Person with the intention to carry out experiments involving vertebrates for thepurpose of preparing of the Technical Dossier for the biocidal product shall require from the8

Agency whether the experiments on vertebrates have already been carried out for the sameactive substance, or for the same or similar biocidal product.Person from Paragraph 1 of this Article shall, along with the application, provide thestatement that he intends to place biocidal product on the market as well as the data onchemical composition of the active substance, i.e. biocidal product that he intends to test onvertebrates.The Agency shall, within 30 days from the day of acceptance of the application,provide the data on the person who carried out experiments on vertebrates.Article 20The fee shall be charged for the completeness check of the Technical Dossier and forcarrying out assessment of the biocidal product based on the Technical Dossier.The amount of fee from Paragraph 1 of this Article shall be established depending onthe volume of the data for Technical Dossier or depending on the type of active substance inthe biocidal product, i.e. biocidal product type.3. Establishment of the frame formulationArticle 21The applicant for the authorisation may submit the request to the Agency forestablishing a frame formulation for that biocidal product.Along with the application from Paragraph 1 of this Article, evidence that thevariations in the composition of the biocidal product which may be envisaged within the frameformulation do not affect the level of risk or efficacy of the biocidal product, shall bepresented.The Agency may even without the application from Paragraph 1 of this Articleestablish a frame formulation when it has complete Technical Dossier for biocidal product.The Agency shall inform the applicant for authorisation on the established frameformulation for a particular biocidal product.Article 22Conditions for placing on the market and use, given in the authorisation, shall be thesame for all biocidal products within the established frame formulation.The Agency shall issue the Decision on cancellation of the authorisation for biocidalproducts within the established frame formulation if the Decision on cancellation of theauthorisation was issued for any of the biocidal products within the established frameformulation.Against the Decision from Paragraph 2 of this Article, an appeal may be lodged to theMinister.Decision from paragraph 3 of this Article shall be final and administrative procedureagainst it may be initiated.9

4. Recognition of the authorisation for placing on the market of biocidal product Issued bythe competent authority of the EU Member StateArticle 23The Agency may issue authorisation for a biocidal product containing active substanceincluded into the List I – List of active substances or List Ia – List of active substancecontained in low-risk biocidal product, on the basis of an act by which the competent authorityof the EU Member State authorises placing on the market of the biocidal product.For the purpose of issuing of the authorisation referred to in Paragraph 1 of thisArticle, summary of the Technical Dossier and verified copy of an act by which the competentauthority of the EU Member State authorises placing on the market of the biocidal product,with certified translation into Serbian, shall be presented along with the application.The Agency shall carry out assessment of the data given in the summary of theTechnical Dossier and determine whether the target organisms is not present in harmfulquantities, if the unacceptable tolerance or resistance of the target organisms to the biocidalproduct is demonstrated or if the circumstances of use of the biocidal product (climate orbreeding period of target organisms etc.) differ significantly from those in the Member Statewhere biocidal product was authorised.The Agency shall issue the authorisation if it determines that placing on the marketand use of the biocidal product, under the same conditions as in the Member State wherebiocidal product was authorised, presents acceptable risk to humans, animals and theenvironment.The Agency may issue the authorisation with changed conditions for placing on themarket and use of the biocidal product from those given in the act issued by the competentauthority of the EU Member State, so that conditions for issue of the authorisation laid downin Article 17 of this Law are satisfied.The Agency shall issue the authorisation from Paragraph 1 of this Article within 120days for the biocidal product, i.e. 60 days for the low-risk biocidal product, from the day ofsubmitting of the complete application.Verified copy referred to in Paragraph 2 of this Article shall not be older than sixmonths.Period of validity of the authorisation shall be the same as the period of validity of theact from Paragraph 1 of this Article.The fee shall be charged for carrying out assessment of the data from Paragraph 3.Against the Decision from Paragraphs 4 and 5 of this Article, an appeal may be lodgedto the Minister.Decision from Paragraph 9 of this Article shall be final and administrative procedureagainst it may be initiated.The Agency shall lay down the content of the summary of the Technical Dossier aswell as biocidal product types for which the application for recognition of the act fromParagraph 1 of this Article may be refused.10

Article 24In the procedure of issuing of the authorisation referred to in Article 23 of this Law forthe low-risk biocidal product, the Agency shall carry assessment whether it is low-riskbiocidal product.Against the Decision from Paragraph 1 of this Article, an appeal may be lodged to theMinister.Decision from Paragraph 2 of this Article shall be final and administrative procedureagainst it may be initiated.5. Renewal of authorisation, cancellation and issuing of new authorisation, cancellation ofand issuing of new Decision on Inclusion of the Biocidal Product into the Temporary ListArticle 25Validity of authorisation may be extended upon the request of the applicant.Application referred to in Paragraph 1 of this Article shall be submitted at the latestwithin one year before the validity of the authorisation for the biocidal product expires, i.e. atthe latest within 60 days before the validity for low-risk biocidal product expiresExtension of the authorisation shall be carried out in a manner and pursuant to theprocedure for the issuing of the authorisation.Article 26Holder of the Decision on inclusion of the biocidal product into the Temporary Listand holder of the authorisation shall comply with the conditions for placing on the market ofthe biocidal product given in those acts, label biocidal product and list in the safety data sheetthe intended use and conditions of its use set out in those acts.Holder of the Decision on inclusion of the biocidal product into the Temporary Listand holder of the authorisation shall keep the records on the quantities of the biocidal productplaced on the market, total turnover of the biocidal product in the previous year, quantities ofthe stock and quantities of the biocidal product removed from the market as well as on thepersons to whom the biocidal product was sold or provided free of charge.Person referred to in Paragraph 1 of this Article shall submit to the Agency data fromthe records the latest by 31 st of March of the current year for the previous year and shall keepthose data for at least 10 years.If the holder of the Decision on inclusion of the biocidal product into the TemporaryList and holder of the authorisation ceded his activities or part of his activities to the thirdperson, the obligation to keep the data shall be transferred to that person, and if he terminatedhis activates the responsible person of the holder of the Decision on inclusion of the biocidalproduct into the Temporary List and holder of the authorisation shall, immediately after thetermination of activities, submit those data to the Agency.The Agency shall lay down the manner of keeping of the records from Paragraph 2 ofthis Article.Person from Paragraph 1 of this Article shall monitor all the circumstances related tothe use of the biocidal product which may have harmful effect on humans, animals and the11

environment as well as impacts and circumstances related to the efficacy of the biocidalproduct.Person referred to in Paragraph 1 of this Article shall immediately inform the Agencyon:1) New knowledge on effects of the active substance or biocidal product on thehumans, animals and environment;2) Changes of the manufacturer of the active substance;3) Changes in the composition of the active substance;4) Changes in the composition of the biocidal product;5) Development of resistance;6) Other changes of the basic information or data from the Technical Dossier.Article 27The Agency may, on the basis of the new findings from Article 26 Paragraph 6 of thisLaw or developments in scientific and technical knowledge, require form the holder of theauthorisation to submit additional data.If on the basis of the new findings from Article 26 Paragraph 6 of this Law,developments in scientific and technical knowledge and additional information fromParagraph 1 of this Article, it is evaluated that the biocidal product no longer meets the criteriareferred to in Article 17 of this Law, the Agency may:1) Issue the Decision on cancellation of the authorisation;2) Issue new authorisation.The Agency shall also issue the Decision on cancellation of the authorisation in thecases when:1) The active substance contained in the biocidal product is no longer included in theList I – List of active substances, List Ia – List of active substance contained in low-riskbiocidal product for that biocidal product type;2) The authorisation was issued on the basis of false data;3) Holder of the authorisation requires so;4) Holder of the authorisation fails to comply with the conditions for placing of thebiocidal product on the market;5) Holder of the authorisation is no longer established on the territory of the Republicof Serbia;6) Holder of the authorisation fails to label the biocidal product or fails to list mannerand conditions for its use in the safety data sheet.Time period and manner of handling with biocidal product placed on the market shallalso be set out in the Decision from Paragraphs 2 and 3 of this Article.Time period from Paragraph 4 of this Law shall not exceed one year for placing on themarket, i.e. two years for use of the biocidal product.The fee shall be charged for the evaluation of the new findings as well as additionaldata.12

Against the Decision referred to in Paragraphs 2 and 3 of this Article, an appeal maybe lodged to the Minister.Decision referred to in Paragraph 7 of this Article shall be final and administrativeprocedure against it may be initiatedArticle 28The Agency shall issue the Decision on cancellation of the Decision on inclusion ofthe biocidal product into the Temporary List when:1) the holder of the Decision on inclusion of the biocidal product into the TemporaryList fails to submit the application for issuing of the authorisation prior to the expiry of thetime period set out in the Temporary List for that biocidal product;2) inclusion of the active substance contained in that biocidal product into the List I –List of active substances or List Ia – List of active substance contained in low-risk biocidalproduct for that product type is refused;3) it brings the decision to refuse the application for authorisation to the holder of theDecision on inclusion of that biocidal product into the Temporary List;4) holder of the Decision on inclusion of the biocidal product into the Temporary Listfails to comply with the conditions for placing on the market of the biocidal product;5) holder of the Decision on inclusion of the biocidal product into the Temporary Listis no longer established on the territory of the Republic of Serbia;6) holder of the Decision on inclusion of the biocidal product into the Temporary Listfails to label the biocidal product or fails to list manner and conditions for its use in the safetydata sheet.Time period and manner of handling with the biocidal product placed on the marketshall also be set out in the Decision referred to in Paragraph 1 of this Article.Time period referred to in Paragraph 2 of this Article shall not exceed one year forplacing on the market, i.e. two years for use of the biocidal product.Against the Decision from Paragraph 1 of this Article, an appeal may be lodged to theMinister.Decision from Paragraph 4 of this Article shall be final and administrative procedureagainst it may be initiated.Article 29The Agency shall issue new Decision on inclusion of the biocidal product into theTemporary List or issue the new authorisation in the cases when conditions for use of theactive substance included into the List I – List of active substances, List Ia – List of activesubstance contained in low-risk biocidal product were changed.In the act referred to in Paragraph 1 of this Article, the Agency may require thatbiocidal product is removed from the market and may set out deadline and way for itsremoval.New authorisation shall be issued with the same period of validity as the previousauthorisation.13

Against the Decision from Paragraph 1 of this Article an appeal may be lodged to theMinisterDecision from Paragraph 4 of this Article shall be final and administrative procedureagainst it may be initiated.6. Temporarily permitArticle 30In the case of unforeseen danger which cannot be suppressed by other means or bybiocidal products for which the Decision on inclusion of the biocidal product into theTemporary List or authorisation was issued, temporarily permit may be issued for placing ofthe biocidal product on the market (hereinafter: temporarily permit).Temporarily permit may also be issued for the new manner and conditions of use ofthe biocidal product for which the Decision on inclusion of the biocidal product into theTemporary List or the authorisation was issued.Manufacturer or importer of the biocidal product shall submit to the Agency theapplication for the temporarily permit (hereinafter: the applicant for the temporarily permit)Application referred to in paragraph 1 of this Article may be submitted by foreignproducer through his representative, i.e. representation office established on the territory of theRepublic of Serbia.Where the applicant is the representative i.e. representation office, the evidence shallbe submitted along with the application.Upon the request of the Agency, the applicant for the temporarily permit shall submitsamples of the biocidal product and its components.Article 31Along with the application for the temporarily permit, the applicant shall be requiredto submit evidence on: unpredicted presence of harmful organism, justification ofunavailability of biocidal product on the market which can suppress harmful organism, data onefficacy of the biocidal product, quantities needed, persons that will use the biocidal productas well as proposal for systematic monitoring of use of that biocidal product.The Agency shall, on the basis of the evaluation of the data referred to in Paragraph 1of this Article, issue the temporarily permit within 30 days from the day of submitting of thecomplete application.Conditions for limited and controlled use shall be established in the temporarily permitas follows: quantities, the date when the use starts, area of use, manner of use, method ofsystematic monitoring, users and period of use.Period of validity of the temporarily permit shall not exceed 120 days.Period of validity of temporarily permit may be extended only in the case when, evenafter the expiry of 120 days, harmful organisms were not sufficiently suppressed.The fee shall be charged for the evaluation of the data referred to in Paragraph 1 of thisArticle.14

Against the Decision referred to in Paragraph 2 of this Article an appeal may belodged to the Minister.Decision referred to in Paragraph 7 of this Article shall be final and administrativeprocedure against it may be initiated.Holder of the temporarily permit shall instruct the user to the conditions for limitedand controlled use of the biocidal product.Article 32The Agency shall cancel temporarily permit if the biocidal product is not sufficientlyeffective to destroy harmful organisms as well as if it use causes the damage which is biggerthan the one caused by harmful organism.The Agency shall issue the new temporarily permit with changed conditions for use ifbiocidal product is not sufficiently effective and therefore it is necessary to change theconditions for its use or if changing the conditions decreases the possibility that biocidalproduct effect causes bigger damage than the one caused by the harmful organisms.Holder of the temporarily permit shall, after the completion of use of the biocidalproduct or the latest after validity of the temporarily permit expires, submit to the Agencyreport on used and unused quantities of the biocidal product and on the results of thesystematic monitoring of use of such biocidal product.Against the Decision referred to in Paragraphs 1 and 2 of this Article an appeal may belodged to the Minister.Decision from Paragraph 4 of this Article shall be final and administrative procedureagainst it may be initiated.IV. BANS AND RESTRICTIONS FOR PLACING ON THE MARKET AND USE OFTHE BIOCIDAL PRODUCTArticle 33The Agency shall, in the case of reasonable doubt that active substance or biocidalproduct represents unacceptable risk on humans, animals and environment, lay down ban onplacing on the market and use of the biocidal product or restriction on placing on the market oruse of the biocidal product or active substance, in accordance with legislation regulatingchemicals.Fee shall be charged for expert evaluation of properties and intended use of certainbiocidal products regarding bans and restrictions for placing on the market and use of certainbiocidal product and etc.V. REGISTER OF BIOCIDAL PRODUCTSArticle 34The Agency shall, on the basis of the data submitted for the purpose of issuing of theDecision on inclusion of the biocidal product into the Temporary List, issuing of the15

authorisation or temporarily permit as well as on the basis of the data referred to in Article 26Paragraph 3 and Article 32 Paragraph 3 of this Law, keep the Register of the BiocidalProducts as a an integral part of the Integrated Chemicals Registry established by the separatelaw regulating chemicals.The Register of the Biocidal Products shall in particular contain: name and address ofthe holder of the Decision on inclusion of the biocidal product into the Temporary List, holderof the authorisation or holder of the temporarily permit as well as the number, date of issuingand period of validity of such acts; name and properties of active substances and othersubstances contained in biocidal product; classification of all hazardous active substances andother hazardous substances contained in biocidal product; trade name of the biocidal product;biocidal product type and authorised uses; formulation of the biocidal product (liquid,granules, powder, solid); tariff heading; maximum residue limit if available; conditions forplacing on the market and use of the biocidal product; as well as safety data sheet.The Agency shall, annually, publish in the “Official Gazette of the Republic of Serbia”following data from the Register of Biocidal Product: name and address of the holder of theDecision on inclusion of the biocidal product into the Temporary List or holder of theauthorisation; trade name of biocidal product; number, date of issuing and period of validity ofsuch acts.VI. RESEARCH AND DEVELOPMENT OF THE BIOCIDAL PRODUCTArticle 35Biocidal product, for which the Decision on inclusion into the Temporary List or theauthorisation was not issued, may be placed on the market only for the purposes of scientificresearch and development or process-orientated research and development.The Agency shall issue the certificate for placing on the market of the biocidal productused for process-orientated research and development.Manufacturer or importer of the biocidal product shall, along with the application forissuing of the certificate referred to in Paragraph 2 of this Article, submit the data on the activesubstance or biocidal product, in particular: identity; data on labelling; data on quantities to beused; name and addresses of those persons who will use it; effects of that active substance orbiocidal product on human or animal health or impact on the environment, if available as wellas the envisaged date of starting and completing of the research.Person carrying out scientific research and development or process-oriented researchand development shall make a report on the biocidal product for which he conducted theexperiment and such report shall contain: data on identity, data on labelling, quantities in use,persons using it as well as data on the effect of the active substance or biocidal product onhuman and animals health and impact on the environment, if available.Persons carrying out scientific research and development or process-orientatedresearch and development shall submit the report referred to in Paragraph 4 of this Article tothe Agency upon request.16

Article 36If, while using the biocidal product referred to in Article 35 Paragraph 1 of this Lawfor scientific research and development, or for process-orientated research and development,the release of that biocidal product into the environment may occur, the Agency shall issue thepermit for such research.Along with the application for permit referred to in Paragraph 1 of this Article, theperson carrying out scientific research and development, or process-orientated research anddevelopment shall submit the data on active substance or biocidal product, in particular:identity; data on labelling; quantities to be used; name and addresses of those persons who willuse it; effects of the active substance or biocidal product on human and animal health and theimpact on the environment; envisaged date of starting and completing of the research; purposeof the research; plan for carrying out research; professional skills of the persons carrying outresearch; monitoring of the research process; intended use; data on waste generated as well asthe description of the facilities and testing conditions and other data on sound use of the activesubstance or biocidal product.If on the basis of the assessment of the data from Paragraph 2 of this Law, the Agencyestablishes that scientific research and development, or process-orientated research anddevelopment represents acceptable risk, it shall issue the permit for such research.The Agency may specify conditions (for example: quantity, treated area) in the permitunder which the experiments are conducted.Holder of the permit for scientific research and development, or process-orientatedresearch and development shall comply with the conditions set out in the permit.The fee shall be charged for the assessment of the data referred to in Paragraph 3 ofthis Article.Against the Decision referred to in Paragraph 3 of this Article an appeal may belodged to the Minister.The Decision referred to in Paragraph 7 of this Article is final and administrativeprocedure against it may be initiated.VII. CLASSIFICATION, PACKAGING, LABELLING, ADVERTISING ANDSAFETY DATA SHEET OF THE BIOCIDAL PRODUCTArticle 37Classification of biocidal product, content and delivery of safety data sheet for biocidalproduct shall be in compliance with legislation regulating chemicals, and packaging, labellingand advertising of biocidal product shall be in accordance with such legislation and specificrequirements for the biocidal product.Preparation and submission of the safety data sheet for biocidal product classified ashazardous and for active substance used exclusively in biocidal product shall be in accordancewith legislation regulating chemicals.The Agency shall lay down specific requirements for packaging, labelling andadvertising of the biocidal product.17

VIII. IMPORT OF BIOCIDAL PRODUCTArticle 38The customs authority shall allow the import of biocidal product for which theDecision on inclusion into the Temporary List, authorisation or temporarily permit, orcertificate was issued.The customs authority shall submit to the Agency by 31 March of the current year thereport on import of biocidal products made in the previous year.IX. SAFE USE OF THE BIOCIDAL PRODUCTSArticle 39Biocidal product shall be used in such way that while handling it, it does not causeharmful effects on human and animals health and environment, taking care of the rationalapplication of combination of physical, biological, chemical and other appropriate measuresagainst target organisms as well as limiting its use to the minimum necessary.The user of the biocidal product shall comply with all precautions for safety ofhumans and animals and environment, in accordance with the instruction for use andinformation from the safety data sheet.Article 40Certain hazardous biocidal products shall not be placed on the market for general use.The Agency shall lay down biocidal products referred to in Paragraph 1 of this Article.Article 41Professional user shall keep the records on the quantity of the purchased biocidalproducts, quantity of the stocks, quantity of the used biocidal products and intended uses.Professional user shall keep the data from the records for at least 10 years and tosubmit them to the Agency upon request.The Agency shall lay down the manner of keeping of the records referred to inParagraph 1 of this Article.Article 42Certain types of hazardous biocidal products or certain biocidal product types may beused by professional user who fulfils conditions regarding staff, equipment and premises andemploys Chemical Adviser in accordance with the legislation regulation chemicals.The Agency shall, within 60 days from the day of submitting of the completeapplication, issue the Decision on fulfilment of the conditions referred to in Paragraph 1 of thisArticle.The fee shall be charged for the evaluation of fulfilment of the conditions referred to inParagraph 1 of this Article.18

The Agency shall lay down certain hazardous biocidal products or certain biocidalproducts types as well as closer conditions which professional user referred to in Paragraph 1of this Article must fulfil.Article 43Systematic monitoring of the placing on the market and use of the biocidal product,maximum residue limit of the biocidal product as well as their metabolites shall be carried outpursuant to the legislation regulating chemicals and other specific legislation.Maximum residues limit of the biocidal product in/on treated objects, premises,articles, organisms or other places, laid down by this law and other specific laws, shall not beexceeded.The Agency shall lay down the maximum residues limit of the biocidal product andthe manner of determining whether the quantities have been exceeded.The fee shall be charged for the purpose of systematic monitoring of harmful effectsof the biocidal product on human and animals health and the environment, replacement of thebiocidal product with the less hazardous one, control of the established conditions for placingon the market and use of the biocidal product.Holder of the authorisation who places biocidal product on the market shall pay thefee from paragraph 4 of this Article, the latest by 31 March of the current year for the previousone, in the certain percentage of total turnover of the biocidal product from the previous year.X. COMMISSION FOR BIOCIDAL PRODUCTSArticle 44For the purpose of providing of the expert assistance in the most complicated tasks,the Agency shall establish the Commission for Biocidal products (hereinafter: theCommission).The Commission shall:- give the opinion regarding issuing of the acts for placing on the market of biocidalproducts;- make the proposal regarding bans and restrictions for placing on the market of biocidalproduct;- give the opinion on the application for establishing of the frame formulationThe members of the Commission shall be the experts in toxicology, eco-toxicology,pharmacy, veterinary medicine, chemistry, medicine and other relevant natural sciences aswell as representatives from the other authorities responsible for certain issues related to theplacing of the biocidal product on the market.The Agency shall finance the work of the Commission, from its funds.The Commission members cannot be persons producing or placing the biocidalproduct on the market, persons taking part in development and assessment of the TechnicalDossier for the biocidal product as well as spouses, relatives up to the forth degree and in-lawsrelatives up to the second degree.19

The member of the Commission shall sign the statement that there is no conflict ofinterest.XI. EXPERT ASSISTANCE TO THE AGENCYArticle 45The Agency may, for the purpose of carrying out evaluation of the basic data,evaluation of the Technical Dossier, evaluation of the data for the temporarily permit andevaluation of the data for the permit for scientific research and development or processorientatedresearch and development, engage legal or natural person who meets the criteria onqualification and specific knowledge necessary for performing of such tasks.XII. DATA AVAILABILITYArticle 46The applicant for inclusion into the Temporary List, applicant for authorisation ortemporarily permit may indicate certain data as confidential, with the written justification thatdisclosure of such data might harm his business activity.The Agency shall consider as confidential and shall not make available to public dataon the full composition of the biocidal product.The data held by the Agency shall be available to anyone upon request.The Agency shall not allow the access to the data which are indicated as confidentialto the person referred to in Paragraph 3 of this Article if it assesses that access to such dataneeds to be restricted pursuant to this Law and Law on Free Access to Information of PublicImportance, and shall issues a Decision on that.Against the Decision referred to in paragraph 4 of this Article, an appeal may belodged to the Minister.The Decision made by the Minister from Paragraph 5 of this Article shall be final andadministrative procedure against it may be initiated.Article 47Information regarded as relevant to safety and human and animal health, safety of theproperty and environmental protection cannot be indicated as confidential:1) the name and address of the holder of the Decision on inclusion of the biocidalproduct into the Temporary List, holder of the authorisation or holder of the temporarilypermit;2) the name and address of the manufacturer of the biocidal product;3) the name and address of the importer and manufacturer of the active substance;4) the name and quantity of the active substance or other substances contained in thebiocidal product and the name of the biocidal product;20

5) name of hazardous substances which contribute to the classification of the biocidalproduct;6) data on physical and chemical properties of the active substances and biocidalproducts;7) methods of rendering the active substance or the biocidal product harmless;8) a summary of the test results of the efficacy of the active substance and the biocidalproduct and effects on humans, animals and the environment and, where applicable, its abilityto develop resistance;9) recommended methods and precautions to reduce dangers from handling, storage,transport and use and as well as from fire or other hazards;10) safety data sheet;11) methods of analysis of the quantity and nature of active substance, othersubstances contained in the biocidal product and residues of the biocidal product which resultfrom the authorised use of the biocidal product, and which are important due to theirtoxicological and eco-toxicological properties;12) methods of disposal of the biocidal product and of its packaging;13) procedures to be followed and measures to be taken in the case of the spillage orleakage;14) first aid and medical advices to be given in the case of injury.If the person referred to in Article 46 Paragraph 1 of this Law later disclosespreviously confidential information, such information shall no longer be classified asconfidential and the Agency shall be informed accordingly.The Agency may deliver confidential information to other competent authorities orauthorised persons required to comply with regulations on data confidentiality.Employees of the Agency as well as other persons having access to confidentialinformation shall keep the confidentiality of the information received even after thecompletion of the tasks for which they are responsible.XIII. LIABILITY FOR THE DAMAGEArticle 48Holder of the Decision on inclusion of the biocidal product into the Temporary List,holder of the authorisation and holder of the temporarily permit shall be liable for the damageoccurred on the territory of the Republic of Serbia in relation to the biocidal product due tofailure to comply with the provisions of this Law and due to the certain properties of thebiocidal product on which such person might have the influence.XIV. FEESArticle 49The Agency shall, with the Government consent, lay down the amount of fees referredto in Article 5 Paragraph 3, Article 11 Paragraph 4, Article 20 Paragraph 1, Article 2321

Paragraph 9, Article 27 Paragraph 6, Article 31 Paragraph 6, Article 33 Paragraph 2, Article36 Paragraph 6, Article 42 Paragraph 3 and Article 43 Paragraph 5 of this Law.XV. SUPERVISIONArticle 50Supervision over the implementation of provisions of this Law and relevant secondarylegislation shall be conducted by the Ministry in charge of environmental protection(hereinafter: the Ministry).The Ministry through environmental inspectors shall conduct inspection supervision.Supervision on classification, labelling, packing of the biocidal products, bans andrestrictions for placing on the market and use of the biocidal products as well as supervisionon the conditions of sale of the biocidal products for general use and their storage, in the retailshall be conducted by the ministry in charge of trade and trade inspectors.For the purpose of monitoring and undertaking of certain measures, environmentalinspectors and trade inspectors (hereinafter: the inspectors) shall, in cooperation with theAgency, prepare annual plans for the inspections supervision and shall submit to the Agency,twice a year, information on the results and findings of the inspections.Article 51Inspector may carry out the sampling of the biocidal product to determine if theconditions for placing on the market or use of the biocidal product are fulfilled.Costs of testing from paragraph 1 of this Article shall be paid by the producer orimporter of that biocidal product.Article 52In performing inspection activities, the inspector has the right and the duty todetermine:1) if the biocidal product is placed on market without authorisation or withoutDecision on inclusion into the Temporary List or if the biocidal product is classified, packedand labelled and has safety data sheet in accordance with this Law;2) if for the biocidal product placed on the market before this Law came into force theapplication for inclusion into the Temporary List was submitted within the prescribed timeperiod;3) if complied with the Agency’s injunction on the manner of handling with thebiocidal product placed on the market or with the injunction on the manner of withdrawal ofthe biocidal product from the market;4) if the biocidal product is placed on the market in accordance with the conditions forplacing on the market and conditions for use set out in the Decision on inclusion of thebiocidal product into the Temporary List or in authorisation or if such biocidal product islabelled and if intended use and conditions of its use are listed in the safety data sheet;22

5) if temporarily permit was obtained for the biocidal product before it is placed onthe market;6) if the holder of the temporarily permit instructed the users to the conditions forlimited and controlled use of the biocidal product;7) if the biocidal product for which the temporarily permit was issued is usedaccording to prescribed conditions;8) if the report on used and unused quantities and on results on systematic monitoringof use is submitted for the biocidal product for which the temporarily permit was issued;9) if complied with bans and restrictions for placing on the market and use of thebiocidal product;10) if the consent from the Agency was obtained prior to placing on the market of thebiocidal product for the process-orientated research and development;11) if prior to placing on the market of the biocidal product used for scientificresearch and development or for process-oriented research and development permit wasobtained for such research;12) if biocidal product is used in accordance with this Law as well as if complied withall precautions in accordance with the instructions for use and information from the safety datasheet;13) if certain hazardous biocidal product or certain biocidal product type is placed onthe market opposite to the provisions of this Law;14) if professional user, who uses certain hazardous biocidal product or certainbiocidal product type, fulfils prescribed conditions;15) if the records are kept, if the required data on biocidal product are submitted orkept as well as the accuracy of such data.Article 53While conducting the activities referred to in the Article 52 of this Law, the inspectorshall be authorised and obliged to:1) ban placing on the market of the biocidal product if authorization or Decision oninclusion into the Temporary List was not obtained or if the biocidal product was notclassified, labelled and packed in accordance with this Law;2) order that the biocidal product is classified, labelled and packed in accordance withthis Law;3) order that for the biocidal product placed on the market before this Law came intoforce application for inclusion into the Temporary List is submitted;4) order that the biocidal product, for which the application for inclusion into theTemporary List was not submitted within the prescribed time period, is removed from themarket;5) order to comply with the Agency’s injunction on the manner of handling with thebiocidal product placed on the market or with the injunction on the manner of withdrawal ofthe biocidal product from the market;23

6) order that the biocidal product is placed on the market in accordance with theconditions for placing on the market and conditions for use set out in the Decision on inclusionof the biocidal product into the Temporary List or in authorisation or that such biocidalproduct is labelled and that intended use and conditions of its use are listed in the safety datasheet;7) order that the biocidal product, which may suppress harmful organisms, isremoved from the market until the temporarily permit is obtained;8) order that the holder of the temporarily permit instructs the users to the conditionsfor limited and controlled use of the biocidal product;9) order that the biocidal product, for which the temporarily permit is issued, is usedunder prescribed conditions;10) order to submit the report on used and unused quantities and on results onsystematic monitoring of use of the biocidal product for which the temporarily permit wasissued;11) order to comply with bans and restrictions for placing on the market and use ofthe biocidal product;12) ban placing on the market and use of the biocidal product if not complied withbans and restrictions;13) temporary ban placing on the market of the biocidal product for processorientatedresearch and development until the certificate is issued;14) temporary ban placing on the market of the biocidal product for scientific researchand development or process-orientated research and development until the permit for thatresearch is obtained;15) order that the biocidal product is used in accordance with this Law as well as tocomply with precautions in accordance with the instructions for use and information from thesafety data sheet;16) order that certain hazardous biocidal product or certain biocidal product type isplaced on the market pursuant to provisions of this Law;17) order that certain dangerous biocidal product or certain biocidal product isremoved from the market if placed on the market opposite to the provisions of this Law;18) order that professional user, who uses certain dangerous biocidal product orcertain biocidal product type must fulfil prescribed conditions;19) ban use of certain hazardous biocidal product or certain biocidal product type ifprofessional user fails to fulfil the conditions;20) order that the records are kept and prescribed data on biocidal product aresubmitted or kept.Article 54Measures ordered by the inspector during supervision shall be in the form of theDecision.In the case where extremely urgent measures should be taken in order to eliminatedirect danger on humans and animals and environment, the inspector may the Decisionreferred to in Article 53 hereof make orally and order its immediate enforcement.24

The inspector shall the oral Decision referred to in Paragraph 1 of this Article make inwritten form, the latest within the 8 days from the day of making the oral Decision.Article 55Against the Decision of the environmental inspector, an appeal may be lodged to theMinister.Against the Decision of the trade inspector, an appeal may be lodged to the Minister incharge of trade.The appeal against the Decision shall not postpone its enforcement.The decision from Paragraphs 2 and 3 of this Article is final and administrativeprocedure against it may be initiated.Article 56Any legal entity, entrepreneur or natural person shall allow the inspector to conductthe supervision, shall place at his disposal the necessary documentation and other evidenceswithout delay and shall declare the facts relevant for the supervision.Article 57If the inspector, while carrying out the supervision, finds out that other laws andregulations are violated, which may have impacts on human and animal health, environmentand safety at work, he shall immediately inform the competent authority and jointly conductsupervision and take appropriate measures.Article 58The inspector shall have an official identity card, distinguishing mark and appropriateequipment.XIV. PENAL PROVISIONS1. Commercial OffencesArticle 59A fine in the amount from 1.500.000 to 3.000.000 dinars shall be charged to the legalentity for the commercial offence if such entity:1) before placing on the market of the biocidal product fails to obtain the authorisationor the Decision on inclusion of the biocidal product in the Temporary List or fails to classify,label and pack the biocidal product or does not have safety data sheet in accordance with thisLaw (Article 6 and Article 7 Paragraph 1 and Article 9 Paragraph 4);2) fails to comply with the conditions for placing on the market of the biocidal productset out in the Decision on inclusion of the biocidal product into the Temporary List or in the25

authorisation or fails to label the biocidal product or fails to list intended use and conditions ofuse of the biocidal product in the safety data sheet (Article 26 Paragraph 1);3) fails to monitor all the circumstances related to use of the biocidal product whichmay have the harmful effect on humans, animals and environment as well as impacts andcircumstances related to the efficacy of the biocidal product (Article 26 paragraph 5);4) fails to immediately inform the Agency on the data referred to in Article 26Paragraph 7 of this Law;5) fails to handle with the biocidal product within the time period and in the mannerset out in the Decision on cancellation of the authorisation or in the new authorisation (Article27 Paragraph 4);6) fails to handle with the biocidal product within the time period and in the mannerset out in the Decision on cancellation of the Decision on inclusion of the biocidal product intothe Temporary List (Article 28 Paragraph 2);7) fails to remove biocidal product from the market within prescribed time period orin the certain manner pursuant to the Agency’s injunction ( Article 29 Paragraph 2);8) places on the market biocidal product which may suppress harmful organismsbefore obtaining the temporarily permit (Article 30 Paragraph 1);9) fails to instruct the user of the biocidal product to the conditions for limited andcontrolled use of the biocidal product (Article 31 Paragraph 9);10) if after the completion of use of the biocidal product for which the temporarilypermit was issued or the latest after the validity of the temporarily permit expires fails tosubmit to the Agency report on used and unused quantities of the biocidal product and onresults of the system monitoring of use of such biocidal product (Article 32 Paragraph 3);11) places biocidal product on the market for process-orientated research anddevelopment without the certificate (Article 35 Paragraph 2);12) places biocidal product on the market for scientific research and development, orfor process-orientated research and development without the permit for such research (Article36 Paragraph 1);13) fails to comply with the conditions set out in the permit (Article 36 paragraph 5);14) fails to use biocidal product in a prescribed manner or if fails to comply withprecautions for safety of humans and animals and environment in accordance with theinstruction for use and information from the safety data sheet (Article 39);15) places on the market certain hazardous biocidal product for general use (Article40 Paragraph 1);16) uses certain hazardous biocidal product or certain biocidal product type, but doesnot fulfil conditions set out in Article 42 Paragraph 1 of this Law.For the commercial offence referred to in Paragraph 1 of this Article, the penaltycorresponding to the damage caused, unfulfilled obligation or value of the goods or otherobjects subject to commercial offence, may be prescribed, up to the twenty times thereof.A fine in the amount from 100.000 to 200.000 dinars shall be charged for commercialoffence referred to in Paragraph 1 of this Article to the responsible person in the legal entity.26

For the commercial offence from Paragraph 1 of this Article, along with the prescribedfine, protective measure of prohibition of performing certain business activity up to 10 yearsmay be laid down to the legal entity.For the commercial offence from Paragraph 1 of this Article, along with the prescribedfine, protective measure of prohibition of performing certain activities up to 10 years may belaid down to the responsible person in the legal entity.2. OffencesArticle 60A fine in the amount from 500.000 to 1.000.000 dinars shall be charged to the legalentity if such legal entity:1) fails to keep the records on the quantities of the biocidal product placed on themarket, quantities of the stock, quantities of the biocidal product removed from the market,total turnover of the biocidal product placed on the market in the previous year as well as onpersons to whom the biocidal product was sold or provided free of charge or such records doesnot contain prescribed data (Article 26 Paragraph 2);2) fails to submit the data from the records the latest by 31 st March of the current yearfor the previous one or does not keep those data for at least 10 years (Article 26 Paragraph 3);3) fails to make the report on the biocidal product or such report does not containprescribed data or fails to submit it to the Agency upon request (Article 35 Paragraphs 4 and5);4) fails to keep the records on quanty of the purchased biocidal products, quantity ofthe stocks, quantity of the used biocidal products and intended uses or such records does notcontain prescribed data or fails to keep such data for at least 10 years or fails to submit them tothe Agency upon request (Article 41 Paragraphs 1 and 2);5) makes available to the public data on the biocidal product which are indicated asconfidential (Article 46, Paragraphs 1 and 2);6) fails to make data on biocidal products available to the public (Article 47,Paragraph 1).For the offences referred to in Paragraph 1 of this Article, the penalty correspondingto the damage caused or unfulfilled obligation, value of the goods or other objects subject tothe offence, may be prescribed, up to the twenty times of the amount of the such values.For the offence referred to in Paragraph 1 of this Article, along with the prescribedfine, protective measure of prohibition of performing certain activity up to three years may belaid down to the legal entity.A responsible person in the legal entity committing offence referred to in Paragraph 1of this Article shall be fined in the amount from 25.000 to 50.000 dinars.For the offence from Paragraph 1 of this Article, along with the prescribed fine,protective measure of prohibition of performing certain activities up to 1 year may be laiddown to the responsible person in the legal entity.For the offence referred to in Paragraph 1 of this Article entrepreneur shall be fined inthe amount from 50.000 to 500.000 dinars.27

For the offence referred to in Paragraph 1 of this Article natural person shall be finedin the amount from 10.000 to 50.000 dinars.For the offence from Paragraph 1 of this Article, along with the prescribed fine,protective measure of prohibition of performing certain activities up to 3 years may be laiddown to the entrepreneur.Article 61Responsible person in the Agency shall be fined for the offence in the amount from10.000 to 50.000 where such person:1) makes available to the public data on the biocidal products which are indicated asconfidential (Article 46 Paragraphs 1 and 2);2) fails to make data on biocidal products available to the public (Article 47,Paragraph 1).For the offence from Paragraph 1 of this Article, along with the prescribed fine,protective measure of prohibition of performing certain tasks up to 1 year may be laid down tothe responsible person in the Agency.Article 62For the offence referred to in Article 59 Paragraph 1of this law, entrepreneur shall befined in the amount from 50.000 to 500.000 dinars.For the offence from Paragraph 1 of this Article, along with the prescribed fine,protective measure of prohibition of performing certain activity up to three years may be laiddown to entrepreneur.Article 63Natural person shall be fined in the amount from 10.000 to 50.000 dinars if he fails tokeep confidential information after the completion of the tasks (Article 47 Paragraph 4).For offences referred to in Paragraph 1 of this Article, the penalty corresponding tothe amount of damage or unfulfilled obligation, value of the goods or other objects subject tothe offence, may be prescribed, up to the twenty times of the amount of the such value.XVII. TRANSITIONAL AND FINAL PROVISIONSArticle 64Manufacturer or importer who placed on the market biocidal product for thecommercial purposes until this Law comes into force shall submit application for inclusioninto the Temporary List or application for authorisation within 180 days from the day whenthe regulation from Article 10 Paragraph 2 and Article 13 Paragraph 9 of this Law comes intoforce.The Agency shall, within 180 days from the day of submitting of the application oninclusion into the Temporary List referred to in Paragraph 1 of this Article, decide upon theapplication.28

Professional user from Article 42 Paragraph 1 of this Law shall, within 180 day fromthe day when the regulation from Article 42 Paragraph 4 of this Law comes into force, submitthe application for Decision on fulfilment of the conditions.The Agency shall, within 180 days from the day of submitting of the applicationreferred to in Paragraph 3 of this Article, decide upon the application.Article 65Implementing regulations to this Law shall be enacted within two years from the daywhen this Law comes into force.Article 66This Law shall enter into force on the eight day following its publication in the“Official Gazette of the Republic of Serbia”.29