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Full version of Act No. 86 / 2009 Coll., Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related acts, as resulting from subsequent amendments — Full text of Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related laws, as resulting from subsequent amendments.

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Full text of Act No. 86 / 2009 Coll. - Full text of Act No. 120 / 2002 Coll., o...

86

PRESIDENT OF THE GOVERNMENT

Announces

full text of Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related acts, as is apparent from the amendments made by Act No. 186 / 2004 Coll., Act No. 125 / 2005 Coll. and Act No. 297 / 2008 Coll.

THE LAW

on the conditions for the placing on the market of biocidal products and active substances

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

CONDITIONS OF THE MARKETING AUTHORISATION

HLAVA I

BASIC PROVISIONS

§ 1

Subject matter

(1) This Act implements the relevant provisions of the European Communities (1), building on the directly applicable regulations of the European Communities (1a) and regulates the rights and obligations of legal persons and business natural persons and the powers of administrative authorities when placing biocidal products and active substances on the market in the Czech Republic, the conditions for granting authorisations for placing biocidal products on the market, the method of evaluating the effectiveness of biocidal products and active substances and the protection against their effects on human health, animals, plants, the health of feed, animal and plant products and the environment, and the conditions of use of biocidal products.

(2) This Act shall not apply to medicinal products, veterinary products, medical devices, foodstuffs, additives added to foods, flavourings, additives intended for animal feed, feed, materials and articles intended to come into contact with food, cosmetic products and plant protection products.

(3) This Act is without prejudice to specific legislation on technical requirements for products and chemicals and chemical products. Requirements for the classification, packaging and labelling of biocidal products covered by this Act shall not apply to the transport of biocidal products in rail, road, air, inland waterway and maritime transport.

§ 2

Definition of basic terms

(1) The active substance is a chemical or micro-organism, including viruses and fungi, which have a specific or general effect on harmful organisms.

(2) A biocidal product is an active substance or a product containing one or more active substances in the form in which they are supplied to the user, intended for the purpose of killing, repelling, defusing, preventing or achieving any other regulatory effect on any harmful organism by chemical or biological means; a list of biocidal product types with a brief description of each type is given in Annex 1 to this Act.

(3) Any organism which has an adverse effect on humans or the presence of which is undesirable, affects the activity of people or objects which are using or producing, or affects other living organisms or the environment; when using biocidal products, the harmful organism is a target organism.

(4) A low-risk biocidal product is a product which does not contain any controlled substances and as active substances only contains substances listed in the low-risk active substances listed in Annex 3 to this Act; the product must, under the conditions of its use, pose only a low risk to human health, animals, plants, feed health, animal and plant products and the environment.

(5) The substance under consideration is any substance which may have an adverse effect on human health, animals, plants, feed, animal and plant products and the environment, with the exception of the active substance, and is present or produced in a biocidal product in such a concentration that the whole product is classified as dangerous (3).

(6) The basic substance is a substance which the Commission of the European Communities (hereinafter referred to as the Commission) will include in the list of essential substances as part of the European Community Regulation concerning the placing of biocidal products on the market (market), which is not a controlled substance and is not placed on the market primarily for the biocidal purposes referred to in Article 2 (2) but which may be used for that purpose either directly or in a product containing that substance and a simple diluent.

(7) The framework composition is the composition of a group of biocidal products having the same uses and user categories; biocidal products with the same framework composition shall contain the same active substances of the same characteristics and may only show such variations from the composition of the authorised biocidal product of that group which do not reduce the efficacy of the biocidal product and do not increase the risks associated with the presence of the individual ingredients; a derogation from the composition of the authorised biocidal product may include only such a reduction in the percentage content of the active substance, a change in the percentage composition of one or more non-active substances or a replacement of one or more pigments, dyes or flavouring substances by other substances which present the same or lower risk and do not reduce the efficacy of the biocidal product.

(8) Residuem is the remainder of one or more substances contained in a biocidal product, including products of metabolism and degradation products or reactions of those substances, which, after the use of the biocidal product, remains, for example, in soil, air, water, body fluids and tissues of animals or humans, food and feed where the presence of such substances is not desirable.

(9) For the purposes of this Act, import shall mean the placing of a biocidal product or active substance under the customs procedure for free circulation or inward processing in the return system.

(10) The placing on the market of a biocidal product or active substance shall be any transfer or storage other than storage, which shall be followed by dispatch from the customs territory of the European Community or disposal. Imports of a biocidal product or active substance shall also be considered as placing on the market.

HLAVA II

INTRODUCTION OF THE BIOCIDAL PRODUCT, THE BASIC AND EFFECTIVE SUBSTANCE ON THE MARKET AND THE USE OF THE BIOCIDAL PRODUCT

§ 3

Basic conditions for placing on the market and use

(1) An active substance intended for use in a biocidal product may only be placed on the market by legal persons or by acting natural persons under the conditions laid down in Article 8, and a biocidal product may only be placed on the market under the permission of the Ministry of Health (hereinafter referred to as "the Ministry"), unless otherwise provided for in this Act.

(2) Biocidal products may contain only active substances listed in the list of active substances set out in Annex 2 to this Act and in the list of low-risk active substances set out in Annex 3 to this Act and only basic substances, while respecting all the requirements laid down. The specific conditions laid down in Annexes 2 and 3 to this Act shall be met by the legal person or the natural person who places the biocidal product on the market, except for the specific conditions imposed on the holder of the authorisation under Article 7 under which the holder is responsible and the specific conditions relating to the use of the biocidal product under the responsibility of the person referred to in Article 3a (2).

(3) The legal persons or natural persons who import the biocidal product shall submit to the customs authority, together with the customs declaration and decision of the Ministry to authorise the placing on the market of the biocidal product or the importer's written declaration that the biocidal product is intended solely for scientific research and development or for trial purposes.

(4) The provisions of paragraphs 1 and 2 shall not apply to biocidal products and active substances intended solely for scientific research and development and test purposes.

§ 3a

(1) A legal person or an operating natural person may not use a biocidal product which has not been notified under Paragraph 35 or authorised for placing on the market unless otherwise specified.

(2) When using a biocidal product, a legal person or a business or non-business natural person shall comply with the information and instructions given on the packaging, label, or package leaflet or warning symbols, the standard phrases indicating the specific risk, or the standard precautionary statements according to the Chemicals and Chemical Preparation Act (3b) and the specific conditions for use of the biocidal product as set out in Annexes 2 and 3 to this Act. The biocidal product may be used only to the extent necessary by the person mentioned in the first sentence.

§ 3b

A legal person or an operating natural person may, without notification under Paragraph 35 or without authorisation, place on the market for biocidal use or use for such purposes a basic substance or biocidal product containing only such basic substances.

Application for authorisation to place the biocidal product on the market

§ 4

(1) An application for authorisation to place a biocidal product on the market shall be made to the Ministry by a legal person having its registered office, business or organisational component (4) in the territory of the Czech Republic, or by an operating natural person who has his place of business in the Czech Republic (the applicant) before its first placing on the market or first use unless the biocidal product is intended to be placed on the market. The application shall be submitted in 1 copy in paper form and in 4 copies in electronic data media in formats and using a special set of programmes in accordance with the directly applicable Regulation of the European Communities on a programme of review of the active substances of biocidal production4a).

(2) The application referred to in paragraph 1 must contain, to the extent provided for by the Ministerial Order:

(a) in addition to the administrative requirements as well as those laid down in the specific conditions laid down in Annex No 2 or 3, the particulars identifying the biocidal product manufacturer and the active substance manufacturer and the address of the manufacturing site;

(b) the detailed quantitative and qualitative composition of the biocidal product;

(c) a safety data sheet for a biocidal product drawn up in accordance with the directly applicable regulation of the European Communities on chemicals and chemical preparation (5), provided that its preparation is required by this directly applicable regulation of the European Communities.

(3) The application for authorisation to place a biocidal product on the market, with the exception of a low-risk biocidal product or a framework-based biocidal product, shall include the information referred to in paragraph 2 and, to the extent provided by the Ministerial Decree, the following essential information on the active substances and the biocidal product: name, identification data, physical, chemical and technical or biological characteristics, type of biocidal product, analytical methods for the determination of the active substance, toxicological and ecotoxicological data, efficacy on target organisms and recommended uses, user categories, measures necessary for the protection of humans, animals, plants, the environment, the health of feed, animal and plant products, the manner of disposal of waste, classification, packaging, labelling, residues of active substances, effects on non-target organisms, summary and data assessment.

(4) The application for authorisation to place a low-risk biocidal product or a framework-based biocidal product on the market shall include the particulars referred to in paragraph 2 and, to the extent provided by the Ministerial Decree, the essential information on the biocidal product: name, identification data, physical and chemical characteristics, type of biocidal product and area of use, user category, method of use, efficiency, analytical methods, method of disposal, classification, packaging and labelling.

(5) The Ministry shall invite the applicant to submit, in the case of an application referred to in paragraph 3, in addition to the essential data on the active substance and the biocidal product, the supplementary physico-chemical, toxicological and ecotoxicological data as provided for in the Ministerial Decree, if necessary for the evaluation of the biocidal product with regard to the nature of the active substances, the type of biocidal product, the method of use and the expected exposure of humans, animals, plants, feed, animal and plant products and the environment.

(6) The information on the properties of the active substances and biocidal products submitted pursuant to paragraphs 3, 4 and 5 shall be supported by protocols with a detailed and complete description of the tests carried out and the methods used or the literary references to those methods, together with a copy of the text of those methods. Such documents may be submitted in English. Tests on active substances and biocidal products shall be carried out on the specified methods6) and under conditions of compliance with the correct laboratory praxe7). The use of methods other than those laid down must be justified in the protocol. The Ministry may require that the information contained in the application be supplemented if it is not sufficient to carry out an evaluation of the efficacy and properties of the biocidal product in accordance with Section 6.

(7) An application for authorisation to place a biocidal product on the market may also be submitted to the Ministry by a natural person authorised to do business or by a legal person residing or having a permanent residence permit, registered office, place of business, central administration, principal place of business or organisational component in the territory of another Member State of the European Union ("the Member State ').

§ 5

(1) The Ministry may require the applicant to provide him, free of charge, with a sample of the active substance or biocidal product in the amount necessary to carry out the tests as well as a sample of the packaging, label or package leaflet (3b).

(2) Before submitting an application for authorisation to place a biocidal product on the market requiring testing on vertebrate animals, the applicant shall inform the Ministry whether the biocidal product for which he intends to apply is similar to the biocidal product already authorised and what is the name and address of the holder or holders of the authorisation. At the same time, it shall submit a written declaration that it intends to apply for authorisation to place the biocidal product on the market in its own interest and that it has the other information necessary to submit the application. The Ministry shall provide the applicant with the information required and inform the holder of the authorisation and invite them to cooperate with each other to prevent repeated toxicological tests on vertebrate animals.

(3) In the case of a biocidal product which is similar to a product already authorised in accordance with § 7 and whose active substances are the same, including the degree of purity and the type of impurities, the Ministry may accept an application in which the second and the other applicants replace the data required in accordance with § 4 (3), (4) or (5) with the certified written consent of the first applicant using the data submitted by them for the purpose of granting the authorisation to the other applicant.

(4) Where certain required data pursuant to Article 4 (3), (4) or (5) are not necessary in view of the nature of the biocidal product or its proposed use, or are not technically possible or scientifically necessary to provide them, the applicant shall justify this in the application submitted.

(5) The Ministry shall keep for 15 years applications for authorisation to place the biocidal product on the market, including the data submitted and other documents. Such documents shall be made available to the Commission and the competent authorities of the other Member States on request.

§ 6

Evaluation of the biocidal product dossier

(1) The Ministry, the Ministry of the Environment and the Ministry of Agriculture shall ensure the evaluation of the data contained in the application submitted pursuant to Article 4 (hereinafter referred to as the "Biocidal Product Documentation").

(2) The evaluation of the biocidal product dossier shall include an evaluation of its completeness and further an evaluation of the data contained in it in terms of the effectiveness of the biocidal product on the target organisms, its impact on humans, animals, plants and the environment, as well as of the measures necessary for the protection of humans, animals, plants, feed health, animal and plant products and the protection of the environment as a whole, both under conditions of normal use of the biocidal product and under conditions of the least favourable conditions of preparation, use, storage and disposal of the biocidal product and material treated by it.

(3) The Ministry, the Ministry of the Environment and the Ministry of Agriculture, in carrying out the evaluation and adoption of decisions concerning the authorisation of a biocidal product, also assess the applicant's reasons for not providing certain data in accordance with Article 5 (4).

(4) The Ministry will adapt the procedure and detailed specification of the principles for the evaluation of dossiers for biocidal products and active substances by decree.

§ 7

Authorisation to place the biocidal product on the market

(1) The Ministry will allow the placing on the market of a biocidal product only if:

(a) the active substances contained therein are listed in Annex 2 or 3 to this Act and the requirements and specific conditions set out therein are met;

(b) is established on the basis of the most recent scientific and technical knowledge and it is apparent from the evaluation of the biocidal product dossier submitted pursuant to Article 4 (3), (4) or (5) that, in view of the usual conditions of use of the biocidal product, the usual conditions of use of the treated material, the consequences of use of the biocidal product and the possibility of its disposal, the biocidal product

1. is sufficiently effective;

2. where the recommended method of use does not have unacceptable effects on the target organisms, such as resistance or cross-resistance or unnecessary suffering and vertebrate pain,

3. does not have unacceptable effects on human or animal health, in the recommended manner of use, directly or indirectly, for example by means of drinking water, food or feed, indoor air or effects on the working environment, on the health of humans or animals,

4. does not, in view of its transformation and distribution in the environment, have unacceptable effects on the environment or its residues, in particular contamination of surface water, groundwater and drinking water,

(c) the nature and quantity of its active substances and, where necessary, any toxicologically or ecotoxicologically significant impurities and additives and their residues relevant for their effect on humans, animals, plants, feed health, animal and plant products and the environment resulting from the authorised use may be analysed,

(d) the results of the tests on the physical and chemical properties of the biocidal product shall be considered acceptable for the purposes of its authorised use, storage and transport.

(2) The Ministry shall specify in the authorisation referred to in paragraph 1 the conditions for placing the biocidal product on the market.

(3) A biocidal product classified under specific legislation3) as a highly toxic, toxic, carcinogenic category 1 or 2, mutagen category 1 or 2 or as toxic for reproduction category 1 or 2 cannot be authorised for sale or use by the consumer.

(4) In cases where the directly applicable regulation of the European Communities or the specific conditions laid down in Annex No 2 or 3 impose conditions for the authorisation of a biocidal product and for the use of a biocidal product, in particular where such conditions protect the health of distributors, users, workers and consumers, animals or the environment, the Ministry shall authorise the placing on the market of a biocidal product subject to compliance with those requirements.

(5) Before issuing a decision authorising the placing on the market of a biocidal product, the Ministry of the Environment shall seek a binding opinion from the Ministry of the Environment on the evaluation of the biocidal product dossier in the scope of Section 6 (2) in terms of environmental protection and a binding opinion from the Ministry of Agriculture in the scope of Section 6 (2) in terms of efficacy for veterinary purposes, the protection of livestock and plants and the health of feed, animal and plant products.

(6) The Ministry will issue a decision authorising the placing on the market of a biocidal product within 360 days and, in the case of a low-risk biocidal product or a biocidal product meeting the requirements of the framework composition, within 60 days of the date of initiation of the proceeding. The Ministry of the Environment and the Ministry of Agriculture shall send the Ministry their written opinions pursuant to paragraph 5 no later than 90 days and, in the case of a low-risk biocidal product or a biocidal product complying with the requirements of the framework composition, within 30 days of receipt of the application from the Ministry.

(7) The decision to permit the placing on the market of a biocidal product shall be taken for a maximum period of time pending the expiry of the inclusion of a biocidal product active substance in Annex No 2 or 3 to this Law. However, the period of validity shall not exceed 10 years from the first or renewed inclusion of the active substance in Annex 2 or 3 to this Law for a given biocidal product type. A decision to authorise the placing on the market of a biocidal product may be renewed in accordance with the provisions of the first and second sentences of this paragraph and after verifying that the conditions referred to in paragraphs 1 and 3 are met. The renewal decision for authorisation to place the biocidal product on the market may be limited, where necessary, to the period necessary for the Ministry to carry out such verification.

(8) At the same time as the authorisation of a biocidal product, the Ministry sets out the framework composition if the applicant so requests; may do so, if necessary and ex officio.

(9) The Ministry keeps a register of authorised and notified biocidal products and publishes, on an electronic basis, on its website and at least once a calendar year in the Ministry of Health Bulletin, a list containing the names of the authorisation holders and persons who have submitted a notification pursuant to § 35, the types and names of biocidal products and the names of active substances.

(10) The holder of the authorisation to place the biocidal product on the market shall notify the Ministry of Health of new data which may affect the continued duration of the authorisation as soon as it becomes aware; are, in particular, the following information concerning the active substance or biocidal product containing that substance:

(a) new knowledge of the effects of the active substance or biocidal product on humans, animals, plants, feed, animal and plant products or on the environment;

(b) a change in the manufacturer of the active substance;

(c) a change in the composition of the active substance;

(d) a change in the composition of the biocidal product;

(e) a change in the content and type of impurities or co-formulants;

(f) modification of residue levels,

(g) the development of resistance of the target organism; or

(h) other significant changes, such as packaging.

(11) The Ministry shall immediately notify the other Member States and the Commission of the information referred to in paragraph 10.

§ 8

A legal person or an operating natural person may place on the market an active substance intended for use in a biocidal product which was not placed on the market before 14 May 2000, only after consent has been given to the competent authorities of the other Member States and the Commission to send a summary of the dossier to the active substance to the competent authorities of the other Member States and to the competent authority of another Member State. The consent referred to in the first sentence shall be issued by the Ministry pursuant to Article 12 (2) on the basis of a proposal pursuant to Article 12 (1) and an attached written declaration that the active substance is intended for use in a biocidal product. Active substances intended for use in a biocidal product which were placed on the market before 14 May 2000 may be placed on the market after that date under conditions laid down directly by the provisions of the European Communities (1a).

§ 9

Temporary authorisation for placing on the market of a biocidal product

(1) The Ministry shall, on its own initiative or at the request of the applicant, authorise the placing on the market of a biocidal product which does not meet the requirements of this Act for a period not exceeding 120 days if such a measure proves necessary as a result of an unforeseen danger which cannot be managed by other means. In the authorisation, the Ministry shall determine the conditions for the use of such a biocidal product. The holder of the authorisation shall be required to provide evidence of the legal persons or natural persons taking the biocidal product from it and shall comply with the facts with which they have been informed.

(2) At the request of the applicant, the Ministry will temporarily authorise the placing on the market of a biocidal product containing an active substance not listed in Annexes 2 or 3 to this Act which was not on the market on 14 May 2000 for any other use than for science and research under Title IV, provided that:

(a) on the basis of the evaluation of the dossier for the active substance submitted pursuant to Article 12, the applicant concludes that the active substance complies with the principles of inclusion of the substance in the list referred to in Article 13;

(b) the biocidal product may be expected to satisfy the conditions laid down in Article 7 (1) (b) to (d);

(c) no other Member State shall object to the completeness of the dossier for the active substance or, in the case referred to in paragraph 3, on the basis of a summary sent pursuant to Article 12 (2) The Commission has taken a decision according to which the dossier is complete.

This authorisation shall be valid until the date of inclusion of the active substance in the list set out in Annexes 2 or 3 to this Law but shall not exceed 3 years from the date of enforcement. Where an active substance is not included in the list provided for in Annexes 2 or 3 to this Act after that period, the authorisation may be extended for a further year at the request of its holder.

(3) Where another Member State applies objections to the completeness of the dossier for the active substance in the procedure referred to in paragraph 2, the Ministry shall suspend the procedure until a Commission decision has been taken. If the Commission decides that the dossier is incomplete, the Ministry shall invite the applicant to complete the dossier.

(4) Prior to the decision to authorise the placing on the market of a biocidal product referred to in paragraph 1 or 2, the Ministry shall seek binding opinions pursuant to Article 7 (5). The Ministry shall authorise the biocidal product referred to in paragraph 2 within the time limits referred to in Section 7 (6).

(5) The Ministry shall inform the other Member States and the Commission without undue delay of the authorisation for placing the biocidal product on the market referred to in paragraph 1 or 2, together with the justification for the authorisation; Similarly, the Ministry shall proceed in the event of an extension of the authorisation. Where a decision of the Commission on the basis of which the Ministry is required to amend or revoke an authorisation issued pursuant to paragraph 1 or 2 is issued, the Ministry shall, on its own initiative, amend or revoke the authorisation issued in accordance with the conditions laid down in the Commission Decision.

(6) The application referred to in paragraph 1 or 2 may also be made to the Ministry by the person referred to in Article 4 (7).

§ 10

Mutual recognition of authorisations for placing on the market of a biocidal product

(1) The placing on the market of a biocidal product which has been authorised or registered (8) in another Member State shall be authorised by the Ministry, at the request of the applicant or of the person referred to in Article 4 (7), submitted before its first placing on the market, within 120 days, in the case of a low-risk biocidal product within 60 days of the date on which the application was submitted to the Ministry, provided that the active substances of the biocidal product are included in the list set out in Annex 2 or 3 to this Act and the requirements therein are met. The Ministry shall specify in the authorisation the conditions for placing the biocidal product on the market in another Member State.

(2) The application referred to in paragraph 1 shall contain a certified translation of the first authorisation for placing the biocidal product on the market issued in another Member State in the Czech language, the particulars referred to in § 4 (2) and the summary and evaluation of the data referred to in § 4 (3); in the case of a low-risk biocidal product, the data referred to in Section 4 (4), with the exception of those on the efficacy of the biocidal product where the summary is sufficient.

(3) If the Ministry finds that conditions of use such as climate or conditions of reproduction of the target organism differ substantially from those in the Czech Republic in the Member State where the biocidal product was first authorised, or there is evidence of resistance of the target organism to the biocidal product, and intends to modify the conditions referred to in § 20 (1) (e), (f), (g), (i), (k) and (l) (2), it shall suspend the application procedure and inform the other Member States, the Commission and the person referred to in paragraph 1 of this intention and its reasons. Furthermore, the Ministry shall act in accordance with the decision of the competent authority of the European Union.

(4) Where, on the basis of an examination of an application submitted pursuant to paragraph 1, the Ministry concludes that the biocidal product does not comply with the requirements of Section 7 (1) and as a result intends to restrict or refuse the marketing authorisation, it shall suspend the application procedure and inform the other Member States, the Commission and the person referred to in paragraph 1 accordingly. At the same time, it shall send them the reasons for its opinion, the name of the biocidal product and its specification. Furthermore, the Ministry shall act in accordance with the decision of the competent authority of the European Union.

(5) Where, on the basis of an assessment of an application submitted pursuant to paragraph 1, the Ministry concludes that a low-risk biocidal product does not comply with the provisions of Section 2 (4), it shall not authorise the biocidal product and shall discuss this with the competent authority of the Member State which authorised the biocidal product first. If no agreement is reached within 90 days, the Ministry shall forward the discrepancy raised to the Commission. Where a competent authority of the European Union decides that a biocidal product complies with the provisions of Paragraph 2 (4), the Ministry shall authorise the biocidal product.

(6) The Ministry may not comply with the application referred to in paragraph 1 in the case of biocidal products of product-types 15, 17 and 23 listed in the Annex to this Act. They shall communicate their opinion together with the justification to the other Member States and to the Commission.

(7) Prior to the decision to authorise the placing on the market of a biocidal product referred to in paragraph 1 or the initiation of the procedure referred to in paragraphs 3 to 6, the Ministry shall seek binding opinions pursuant to Article 7 (5). The Ministry of Environment and the Ministry of Agriculture shall communicate in writing their binding opinions to the Ministry within 60 days and, in the case of a low-risk biocidal product, within 30 days of receipt of the application.

§ 11

Amendment and withdrawal of authorisation for placing on the market of a biocidal product

(1) The Ministry may amend the authorisation for placing the biocidal product on the market

(a) on the basis of data notified pursuant to Article 7 (10),

(b) taking into account new knowledge of science and technology or new requirements for the protection of human and animal health, plants, feed, animal and plant products and environmental protection; or

(c) at the request of the holder of the authorisation, if the application states the reasons for the change and even after the amendment the conditions laid down in Article 7 (1) and (3) are fulfilled.

(2) Where a modification of the authorisation to place the biocidal product on the market is subject to the scope of use of the biocidal product, that amendment shall comply with the specific conditions laid down for the active substance in the lists set out in Annex No 2 or 3 to this Law.

(3) Where the modification of the authorisation to place a biocidal product on the market involves the modification of the specific conditions set out for an active substance in the list of active substances or lists set out in Annex No 2 or 3 to this Act, such modification of the authorisation may only be made after a re-evaluation of the active substance pursuant to Section 12.

(4) The Ministry shall revoke the authorisation for placing the biocidal product on the market if:

(a) the active substance has been excluded from Annex 2 or 3 to this Act or is no longer satisfied in those Annexes with the modified requirements or specific conditions;

(b) one of the conditions referred to in Article 7 (1) (b) to (d) is not fulfilled;

(c) it is found that false or misleading information has been submitted concerning the facts on the basis of which the authorisation of the biocidal product was granted; or

(d) the holder of the authorisation so requests.

(5) When the authorisation for placing a biocidal product on the market is revoked, the Ministry shall, on its own initiative, fix a period for the official holder of the authorisation for the disposal, storage, sale or use of existing stocks of the biocidal product. Similarly, authorisations for placing on the market of a biocidal product shall be terminated if the holder of the authorisation so requests. The authorisation holder shall be obliged to provide evidence of the withdrawal or termination of the authorisation as well as of the time limits for the disposal, storage, sale or use of existing stocks of the biocidal product, to the legal persons or the natural persons taking the biocidal product from it and to act in accordance with the facts with which they were informed.

(6) The Ministry may require the holder of the authorisation to provide him with the information necessary for the proceedings referred to in paragraph 1 or 4. Where necessary, the Ministry may, at the request of the holder of the authorisation, extend the authorisation for the period necessary for its examination; However, it shall, on its own initiative, extend the validity of the authorisation to the period necessary for the provision of the information referred to in the first sentence.

(7) Prior to the decision to amend or revoke the authorisation to place the biocidal product on the market referred to in paragraph 1 or 4, the Ministry shall request binding opinions pursuant to Article 7 (5). The Ministry of the Environment and the Ministry of Agriculture shall communicate in writing their binding opinions to the Ministry within 30 days of receipt of the request. The Ministry shall take a decision within 30 days of the date of receipt of the binding opinions of the authorities concerned.

(8) The Ministry shall inform the Commission and the other Member States of the amendment or withdrawal of the authorisation to place the biocidal product on the market, giving reasons.

HLAVA III

ESTABLISHMENT OF THE ACTIVE SUBSTANCE IN THE LIST

§ 12

Procedure for listing an active substance

(1) On the basis of current scientific and technical knowledge, active substances are included in the list of active substances, the list of low-risk active substances and the list of essential substances which are part of the European Communities' rules on the placing of biocidal products on the market (9). The proposal to include the active substance in these lists shall be made to the Ministry. The applicant who submits a proposal to the Ministry in accordance with the second sentence shall simultaneously submit a request to the Ministry for the approval of the Ministry for sending the summary of the data referred to in points (a) and (b) to the competent authorities of the other Member States and the Commission. The proposal referred to in the first sentence shall be made in 1 copy in paper form and in 4 copies in electronic data media in formats and using a special set of programmes in accordance with the directly applicable Regulation of the European Communities on a programme of review of the active substances of biocidal production4a). Paragraph 4 (2) shall apply mutatis mutandis to the elements of the proposal; Furthermore, the proposal to the extent covered by the Ministerial Decree must include:

(a) basic and supplementary data on the active substance,

(b) basic and supplementary data on at least one biocidal product containing the active substance which the applicant requests (hereinafter referred to as the active substance dossier).

(2) The Ministry, the Ministry of the Environment and the Ministry of Agriculture will ensure an evaluation of the completeness of the dossier for the active substance. If the dossier is complete, the Ministry shall consent to the applicant within 90 days to send the summary of the dossier for the active substance to the competent authorities of the other Member States and to the Commission and shall at the same time invite the applicant to submit a proposal for the evaluation of the dossier for the active substance for the purposes of the inclusion of the active substance in the list of active substances, the list of low risk active substances or the list of essential substances.

(3) Where the applicant submits a proposal to the Ministry for the evaluation of the dossier on the active substance referred to in the second sentence of paragraph 2, the Ministry, the Ministry of the Environment and the Ministry of Agriculture shall ensure that this evaluation is carried out in the light of the principles set out in paragraphs 6 (2) to (4), on the basis of a summary assessment of the dossier, within 12 months of the date of receipt of the proposal.

(4) The Ministry shall interrupt the evaluation referred to in paragraph 3 and invite the applicant to submit further data if it finds that the evaluation of the dossier for the active substance cannot be completed without such data. The period from the interruption of the evaluation to the receipt of the required data shall not be counted within the 12-month period referred to in paragraph 3. The Ministry shall inform the other Member States and the Commission of the reasons for the interruption.

(5) The Ministry shall send the final report to the applicant, the other Member States and the Commission, together with a proposal for the inclusion or non-inclusion of the active substance in the lists referred to in paragraph 1; in drawing up the final report, the Ministry shall follow the principles set out in Section 13. The Commission decision to include or exclude an active substance in the list of active substances, the list of low-risk active substances or the list of essential substances shall be communicated by the Ministry of the applicant.

(6) Following the consent referred to in paragraph 2, the Ministry may request the Commission to carry out an evaluation of the dossier on the active substance by another Member State. The Commission decision which Member State shall carry out the evaluation of the dossier on the active substance shall be notified by the Ministry of the applicant.

(7) The proposal to include an active substance in the list of active substances, the list of low-risk active substances or the list of basic substances may be submitted to the Ministry by the person referred to in Section 4 (7).

(8) The inclusion of active substances in the list of active substances, the list of low-risk active substances or the list of basic substances within the framework of the work programme of systematic review of active substances shall be carried out in accordance with the directly applicable provisions of the European Communities (1a).

(9) The Ministry shall adapt by decree a detailed specification of the data concerning the identification of the active substance, organism and preparation, indicating the general name, chemical or taxonomic name and strain, physical, chemical, technical and biological characteristics, analytical methods for detection and identification, efficacy and intended uses, toxicological and metabolic studies, ecotoxicological data, measures necessary for the protection of humans, animals, plants and the environment, residues of active substances, effects on target organisms, classification, labelling, summary and evaluation.

(10) Paragraphs 1 to 9 shall apply mutatis mutandis to the procedure for the proposal to amend the inclusion of an active substance in the list of active substances, the list of low-risk active substances or the list of basic substances or the extension of that inclusion.

§ 13

Principles for listing an active substance

(1) On the basis of current scientific and technical knowledge, the Ministry will propose to the Commission the inclusion of an active substance in the list of active substances, the list of low-risk active substances or the list of basic substances for a period not exceeding 10 years, if the biocidal products in which the active substance is contained can be expected to meet the requirements of Article 7 (1) (b) to (d). In doing so, account shall be taken of any cumulative effects when biocidal products containing the same active substance are used.

(2) The Ministry may make the proposal to include an active substance in the list referred to in paragraph 1 subject to:

(a) a requirement for a minimum degree of purity of the active substance;

(b) by defining the maximum content of certain impurities,

(c) by identifying the biocidal product type in which the active substance may be used,

(d) by identifying the method and area of use;

(e) defining categories of users, such as industrial, professional, unprofessional;

(f) by establishing an acceptable level of exposure in the working environment;

(g) by establishing an acceptable daily intake and a maximum residue limit,

(h) setting out data on the transformation and behaviour of the active substance in the environment and the impact on animals, plants, feed health, animal and plant products;

(i) by laying down other specific conditions resulting from the evaluation of the documentation submitted.

(3) The Ministry will propose to the Commission not to include in the list of low-risk active substances an active substance which is carcinogenic, mutagenic, toxic for reproduction or sensitising under the specific legislation on chemicals and chemical production3b or is not easily degradable.

(4) The Ministry will propose to the Commission the inclusion of the active substance in the list referred to in paragraph 1 only for biocidal product types listed in Annex 1 to this Act for which a dossier has been submitted pursuant to Article 12 (1) (b). The proposal to include an active substance in the low-risk list may be subject to the range of concentrations in which it may be used.

(5) The Ministry may repeatedly propose to the Commission that the inclusion of an active substance in the list referred to in paragraph 1 be renewed after a period of 10 years, but for a maximum period of 10 years. If the Ministry becomes aware that one of the conditions referred to in paragraph 1 or 3 is not fulfilled, it may propose to the Commission a review of the inclusion of the active substance in the list.

(6) The Ministry may propose to the Commission that the inclusion of an active substance in the list of active substances, the list of low-risk active substances or the list of basic substances or the extension of the inclusion period be refused or the inclusion in the list is cancelled if:

(a) the evaluation carried out in accordance with Article 12 (3) shows that, under normal conditions of use of a biocidal product containing the active substance, human, animal, plant, feed health, animal or plant products or the environment could be endangered; or

(b) there is another active substance in the list of active substances or the list of low-risk active substances for the same type of biocidal product (hereinafter referred to as "alternative substance") which presents a significantly lower risk to humans, animals, plants, feed health, animal or plant products or the environment.

(7) Prior to the submission of the proposal referred to in paragraph 6, the Ministry shall ensure the assessment of alternative substances whether they can be used with similar effect on the target organism without significant economic and application disadvantages for users and without increasing the risk to health or the environment. The Ministry shall send this assessment to the other Member States and to the Commission.

(8) When applying the procedure laid down in paragraphs 6 and 7, the following conditions shall be complied with:

(a) the variety of active substances shall be maintained so that the presence of resistance to the target organism is minimal;

(b) this procedure shall apply only to active substances contained in biocidal products of the same type;

(c) the level of threat to humans, animals or the environment for the discarded or rejected active substance will be significantly higher under normal conditions of use;

(d) it shall be possible to obtain knowledge of practical application if such knowledge is not available.

HLAVA IV

SCIENTIFIC RESEARCH AND DEVELOPMENT

§ 14

(1) For the purposes of research or development, including applied research or development, and for carrying out the tests necessary for the submission of an application under § 4 or § 9 (1) or a proposal under § 12, a biocidal product may be placed on the market without the authorisation of the Ministry and the active substance without meeting the requirements set out in § 8.

(2) Legal persons or natural persons undertaking research, development or testing necessary for the submission of an application pursuant to § 4 or § 9 (1), or for the submission of a proposal pursuant to § 12, shall be required to keep records of the biocidal product or active substance containing:

(a) the identification of the biocidal product and active substance;

(b) particulars of the labelling, the quantities supplied, the names, the surnames, the permanent residence and the place of business of the commercial natural persons or of the names or business offices of the legal persons receiving the biocidal product or active substance;

(c) all available data on possible effects on human health, animals, plants, feed, animal and plant products and the environment.

(3) The records referred to in paragraph 2 shall be submitted to the Ministry if it so requests.

(4) Legal persons or legal entities carrying out applied research or development shall notify the Ministry of the data referred to in points (a) to (c) of paragraph 2 before the active substance or biocidal product is placed on the market. These persons are also obliged to notify the Ministry of the cessation of applied research or development.

(5) In the event that a biocidal product or active substance could leak into the environment in the conduct of experiments or tests, the legal person or the undertaking natural person shall be required to request the Ministry to authorise such experiments or tests before they begin; the application shall specify the data necessary for the assessment of experiments or tests and the conditions to limit the adverse environmental effects of the experiments to an acceptable level.

(6) The Ministry may prohibit, or impose restrictions on, experiments and tests carried out ex officio if it finds that their implementation endangers human health, animals, plants, feed health, animal or plant products or the environment.

(7) Prior to the decision on the authorisation of experiments and tests referred to in paragraph 5 and the decision referred to in paragraph 6, the Ministry shall seek binding opinions pursuant to Article 7 (5). The Ministry of the Environment and the Ministry of Agriculture shall communicate in writing their binding opinions to the Ministry within 30 days of receipt of the request. The Ministry shall take a decision within 30 days of the date of receipt of the binding opinions of the authorities concerned.

HLAVA V

DATA PROTECTION

§ 15

Data protection of the applicant

(1) The applicant referred to in Articles 4, 9, 10 or 12, as well as the person placing the active substance on the market in accordance with the procedure laid down in Article 8, may indicate in the documentation submitted to the Ministry the information not to be communicated to third parties (hereinafter referred to as "confidential information") and submit an application for this subject with detailed justification. The Ministry shall decide on the application. The Ministry shall always comply with the application concerning the full composition of the biocidal product.

(2) Under paragraph 1, no marking may be made:

(a) the information referred to in Article 4 (2) (a) and (b);

(b) the names and concentrations of active substances in the biocidal product and the name of the biocidal product,

(c) the names of the substances contained in the biocidal product which are dangerous (2) and contribute to the classification of the biocidal product;

Citation	Full version of Act No. 86 / 2009 Coll., Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related acts, as resulting from subsequent amendments
Regulation Type	Declared full text
Author	-
Collection	Code of Laws

Date of Promulgation	01.04.2009
Effective from	-
Effective until	-
Status	Valid

Full text of Act No. 86 / 2009 Coll.

Full text of Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related laws, as resulting from subsequent amendments

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