ACT
of 13 September 2002
on biocidal products 1)
(uniform text)
Chapter 1
General provisions
Article 1. 1. The Act specifies:
1) conditions of placing on the market and use on the territory of the Republic of Poland of biocidal
products and active substances used in biocidal products, taking the requirements on efficacy and
safety of their use into consideration;
2) principles of mutual recognitions of authorizations for placing on the market and entries to the
register of low risk biocidal products between the Republic of Poland and the other Member
States of the European Union.
2. The Act shall aim at preventing threats to humans’ and animals’ health as well as threats to the
environment that may result from effect of biocidal products.
Article 2. The provisions of the Act shall be not applied to:
1) medicinal products,
2) food additives authorised for use in foodstuffs,
3) materials and articles intended to come into contact with food,
4) animal feedstuffs,
5) cosmetics,
6) plant protection products,
7) medical devices
- in the scope specified by the separate provisions.
Article 3. For the purposes of this Act the following definitions shall apply:
1) biocidal product – active substances and preparations containing one or more active substances,
put up in the form in which they are supplied to the user, intended to destroy, deter, render
harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by
chemical or biological means;
2) low risk biocidal product – a biocidal product, meeting jointly the following conditions:
a) contains as active substances only one or more active substances entered into the list,
referred to in Article 6(3), Clause 2,
b) does not contain any substance(s) of concern,
c) under the conditions of use poses only a low risk to humans, animals or the environment;
3) active substance - a substance or micro-organism including a virus or a fungus, having general or
specific action on or against harmful organisms;
4) harmful organism - any organism, which has an unwanted presence or a detrimental effect for
humans, their activities or the products they use or produce, or for the animals or for the
environment;
5) residues - one or more of the substances present in a biocidal product which remains as a result
of its use including the metabolites of such substances and products resulting from their
degradation or reaction;
6) the applicant responsible for placing of a biocidal product or an active substance on the market–
the entrepreneur or its representative or a branch office of the foreign entrepreneur in the
meaning of the provisions of the Act of 2 July, 2004 on freedom of business activity (Journal of
Laws No. 173, item 1807, as amended 2)), as well as the entrepreneur or its representative having
a seat on the territory of the Member State of the European Union or the Member State of the
European Free Trade Association (EFTA) – parties to the agreement on the European Economic
Area;
7) basic substance – a substance entered into the list, referred to in Article 6(3), Clause 3, whose
major use is non-pesticidal but which has some minor use as a biocide either directly or in a
biocidal product consisting of the substance and a simple diluent which itself is not a substance of
concern and which is not directly marketed for this biocidal use;
8) letter of access - a document, signed by the owner or owners of relevant data, authorizing to their
use for the purpose of granting the authorization or a registration of a biocidal product;
9) placing on the market – supply of a biocidal product on the territory of the Republic of Poland,
both collecting a charge and free of charge, as well as storage or keeping a biocidal product after
its supply, excluding storage or keeping in customs warehouse or for the purpose of utilization of
a biocidal product;
10) scientific research and development – research covering carrying-out of analyses under
controlled conditions in terms of operation and included determination of specific physical –
chemical and biological properties of a biocidal product, its effect, ways of use and efficacy and
research related to its development;
11) frame formulation – specification defined for a group of biocidal products having the same use
and user type; this group of products must contain the same active substances of the same
specifications, and their compositions must present only variations from a previously authorized
biocidal product which do not affect the level of risk associated with them and their efficacy, In this
context, a variation is the allowance of a reduction in the percentage of the active substance
and/or an alteration in percentage composition of one or more non-active substances and/or the
replacement of one or more pigments, dyes, perfumes by others presenting the same or a lower
risk, and which do not decrease its efficacy.
12) substance of concern – any substance, other than the active substance, which has an inherent
capacity to cause an adverse effect on humans, animals or the environment and is present or is
produced in a biocidal product in sufficient concentration to create such an effect; the substance
shall be classified as dangerous in the meaning of the provisions of chemical substances and
preparations.
Chapter 2
Marketing and use of biocidal product
Article 4. 1. Only these biocidal products may be marketed and used on the territory of the
Republic of Poland, for which:
1) authorization for placing a biocidal product on the market, hereinafter referred to as the
‘authorization’, was issued,
2) provisional authorization was issued,
3) decision on entering into the register of the low risk biocidal products, hereinafter referred to as
the ‘registration’, was issued,
4) authorization, referred to in Article 54, was issued
- provided their classification, packaging and labelling pursuant to the requirements specified by the
Act.
2. Biocidal product shall be used in reasonable manner, by combination of physical, chemical,
biological and other measures allowing for reduction of use of the biocidal product to indispensable
minimum, as well as in compliance with the recommendations provided on the label and leaflet.
Article 5. 1. The minister competent for health shall issue the authorization and registration, for
the period not exceeding 10 years, starting from the day of the first or subsequent entry of active
substance onto Annex I or IA, referred to in Article 6(3), Clauses 1 and 3, and not exceeding the
validity date specified in these lists for a given active substance.
2. The minister competent for health may, after expiration of the period, referred to in Paragraph
1, may prolong the validity of the authorization and issue the registration after verifying that the
conditions, referred to in Article 9(1), are met.
3. In justified cases, the minister competent for health may, on request of the applicant
responsible for placing a biocidal product or an active substance on the market, hereinafter referred to
as the ‘applicant’, prolong the validity of the authorization by the period indispensable to complete the
activities, referred to in Paragraph 2, however not longer than for a period of one year.
Article 6. 1. The biocidal products shall be divided into groups classified by general scope of use
and into product types classified by detailed use.
2. The minister competent for health shall, in cooperation with the minister competent for the
environment, specify, by means of a regulation, groups and product types of biocidal products,
according to their use, taking the general scope of use and their detailed use in the classified groups
and product types into consideration.
3. The minister competent for health shall announce, by means of an announcement, in the
‘Polish Monitor’ Official Journal of the Republic of Poland:
1) list of active substances authorized to use in biocidal products divided into groups and product
types,
2) list of active substances authorized to use in low risk biocidal products and related requirements,
3) list of basic substances and related requirements,
4) validity dates of entries of active substances into the lists, referred to in Clauses 1 and 2
- taking the necessary requirements aiming at preventing threats to humans’ and animals’ health and
for to the environment into consideration, according to Annex I or IA kept by the European
Commission.
Chapter 3
Placing a biocidal product on the market
Article 7. 1. Applications to issue the authorization, provisional authorization or registration,
modification of data constituting a basis to issue the authorization, provisional authorization or
registration, prolongation of validity date of the authorization, provisional authorization or registration
shall be submitted by the applicant to the President of the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products, hereinafter referred to as the ‘President of the
Office’.
2. Issuing or refusal to issue the authorization, provisional authorization or registration,
modification of data constituting a basis to issue the authorization, provisional authorization or
registration, prolongation of validity date of the authorization, refusal of prolongation and shortening of
the validity date of the authorization, provisional authorization or registration shall be made by means
of an administrative decision.
3. The minister competent for health shall issue the authorization or the registration on the basis
of documents provided by the President of the Office, stating that the application on issuing the
authorization or registration and the submitted dossier meet the requirements defined in Article 8 and
in Article 9(1), respectively.
4. The minister competent for health shall issue a provisional authorization on the basis of
documents provided by the President of the Office, stating that the application on issuing the
authorization and the submitted dossier meet the requirements defined in Article 8(1)(3) and in Article
9(1), Clauses 2 - 7, respectively.
Article 8. 1. The application on making the registration, issuing of the authorization or provisional
authorization shall contain in particular:
1) first name and surname or name and address or seat of the applicant;
2) first name and surname or name and seat of a manufacturer of a biocidal product and address of
a manufacturer of active substances contained in a biocidal product;
3) trade name of a biocidal product covered by the application;
4) quantitative and qualitative data referring to the composition of a biocidal product;
5) physical and chemical properties of a biocidal product;
6) product type of a biocidal product according to its use, taking the scope of use into consideration;
7) categories of users;
8) application methods.
2. The following should be enclosed to the application on making an registration:
1) dossier indispensable to assess the efficacy of a biocidal product;
2) dossier of active substances contained in a low risk biocidal product;
3) description of analytic methods concerning a biocidal product;
4) type of specific direct packaging, classification and labelling of a biocidal product as well as draft
labelling and leaflet of a biocidal product, if applicable;
5) safety data sheet of active substances contained in a biocidal product, subject to the provisions of
Article 8c;
6) letter of access, referred to in Clauses 1 - 3, provided that the applicant is not its owner.
3. The following should be enclosed to the application on issuing of authorization or provisional
authorization:
1) dossier indispensable to assess a biocidal product;
2) dossier of active substances contained in a biocidal product;
3) letter of access, referred to Clauses 1 and 2, provided that the applicant is not its owner;
4) type of specific direct packaging, classification and labelling of a biocidal product as well as draft
labelling and leaflet of a biocidal product, if applicable;
5) safety data sheet of a biocidal product and active substances contained in a biocidal product,
subject to the provisions of Article 8c.
Article 8a. 1. The minister competent for health shall, in cooperation with the minister competent
for the environment, specify, by means of a regulation:
1) templates of applications, referred to in Article 8(1),
2) way of submitting a dossier, referred to in Article 8(2) and (3),
3) requirements that should be met by dossier indispensable to assess an active substance and
biocidal product
- taking the assurance of the proceedings effectiveness into consideration.
2. The minister competent for health shall, in cooperation with the minister competent for the
environment, specify, by means of a regulation, common principles for assessment of dossier of a
biocidal product and criteria of procedure of the assessment of a biocidal product, taking the
proceedings on toxicological and ecotoxicological studies, indispensable to assess risk for humans,
animals and the environment into consideration.
Article 8b. 1. Data and documents, referred to in Article 8, shall be submitted by the applicant in
two copies and on electronic carrier.
2. Data and documents, referred to in Article 8(2), Clause 1 - 3 and in Paragraph 3(1 – 2), may be
submitted in English; data and documents, referred to in Article 8(2), Clauses 4 - 6 and Paragraph 3,
Clauses 3 - 5 shall be submitted by the applicant in Polish.
3. The President of the Office may, in justified cases, require from the applicant to provide a
sample of a biocidal product and its components.
Article 8c. Safety data sheet shall be prepared for the biocidal products and active substances
contained in a biocidal product, classified as dangerous, pursuant to the principles defined by the
provisions of the Act of 11 January 2001 on chemical substances and preparations (Journal of Laws
No. 11, item 84, as amended 3)).
Article 8d. 1. Tests of physical and chemical properties, toxicological and ecotoxicological tests
and additional tests, referred to in Article 20(1), shall be performed according to the principles of the
Good Laboratory Practice in the meaning of Article 2(1), Clause 11a of the Act of 11 January 2001 on
chemical substances and preparations and pursuant to the provisions issued under Article 24(2),
Clauses 2 – 4 and Paragraph 4 of this Act.
2. Shall the tests, referred to in Paragraph 1, be performed before 14 May, 2000 or using the
methods incompliant with these referred to in Paragraph 1, the President of the Office may recognize
the tests performed using different methods, in particular methods recognized on international level,
as equivalent. Refusal to recognize the tests shall be justified by the President in writing.
Article 9. 1. The minister competent for health shall issue the authorization or registration,
providing that the following conditions are met:
1) all active substances of a biocidal product are entered into the lists, referred to Article 6(3),
Clause 1 and 2;
2) a biocidal product is sufficiently effective in control of a harmful organism;
3) a biocidal product causes no undesirable effect on target organism, and in particular results in
unacceptable resistance, cross-resistance or contributes to unnecessary suffering of vertebrates,
referred to in the Act of 21 August 1997 on animals protection (Journal of Laws of 2003, No. 106,
item 2002, as amended 4));
4) a biocidal product or its residues have no undesirable impact on the environment, in particular in
relation to:
a) fate and behaviour in the environment, in particular to surface water pollution (including
estuaries and salt water), ground water and drinking water,
b) harmful effect to non-target organisms;
5) it is possible to determine type and amount of active substance and, if reasonable, all impurities of
toxicological and ecotoxicological significance, other components and residues of toxicological
and ecotoxicological significance, which may be produced in a result of application compliant with
the registered category;
6) physical and chemical properties of a biocidal product, enabling its safe use, storage and
transport, were determined;
7) health and safety rules for using, storing and transport of biocidal products were specified.
2. The requirements, referred to in Paragraph 1(2 – 7), to be met by a biocidal product, shall be
specified, taking the current scientific and technical knowledge for a biocidal product used in a way
and on conditions specified on the label and in the leaflet as well as the necessity of disposal of a
biocidal product and its packaging into consideration.
Article 10. 1. The authorization shall be issued within the period of 12 months from the day of
submitting of the complete application form by the applicant.
2. Registration shall be issued within 60 days, starting from the day of submitting of the complete
application by the applicant.
3. Authorization or registration of a biocidal product, for which the authorization was issued or
registration in one of the Member States of the European Union was made, shall be issued within the
following periods:
1) 120 days – in case of the authorization,
2) 60 days – in case of registration
- from the day of submitting of the complete application by the applicant.
Article 11. 1. The authorization and registration shall be subject to withdrawal, if:
1) it was stated that data provided in the application on issuing the authorization or in the application
on registration were untrue or equivocal;
2) the applicant places a biocidal product on the market and use incompliant with the conditions
specified in the authorization or registration;
3) a biocidal product fails to meet one of the conditions, referred to in Article 9(1), Clauses 2 – 7;
4) an active substance contained in the biocidal product was removed from the lists, referred to in
Article 6(3), Clauses 1 and 2.
2. The minister competent for health shall notify the applicant on commencing the proceedings on
withdrawal of the authorization or registration due to the reasons specified in Paragraph 1, requiring
from it, if necessary, to provide additional explanations within the period of 30 days.
3. The minister competent for health shall withdraw the authorization or registration without
observing the conditions, referred to in Paragraph 2, in the event in which the biocidal product poses a
direct threat to health of humans, animals or to the environment. The decision on withdrawal of the
authorization or registration shall have the order of immediate enforceability.
4. The minister competent for health may, in its decision on withdrawal of authorization or
registration, in specific cases on request of the applicant, determine an additional deadline to remove,
store, sale or use of the existing stock of biocidal products.
Article 12. The authorization or registration may be withdrawn on justified request of the
applicant.
Article 13. 1. The applicant may submit an application form to issue a provisional authorization
in the event, in which a biocidal product contains active substances not entered into the lists, referred
to in Article 6(3), Clauses 1 and 2.
2. The minister competent for health shall issue a provisional authorization for the period not
exceeding 3 years, if any of the Member States of the European Union made no reservations to the
assessment submitted under Article 36(1).
3. If the procedure of placing an active substance on the lists, referred to in Article 6(3), Clause 1
and 3, was not terminated before the expiry of the three-year period, the minister competent for health
may prolong the validity of the provisional authorization for the period not exceeding one year. The
provisions of Paragraph 2 shall apply respectively.
4. A provisional authorization shall be subject to withdrawal at any time, if it is stated, in the result
of tests of an active substance, that such substance fails to meet the criteria enabling it to be placed
on the lists, referred to in Article 6(3), Clause 1 and 2.
5. The provisions of Article 10(1), Article 11 and Article 17(1) shall apply to the provisional
authorization, respectively.
Article 14. 1. In the event of any unexpected threat posed by harmful organisms, controlling of
which by biocidal products placed on the market is ineffective, the minister competent for health may
issue an administrative decision on temporary placing on a market of a biocidal product containing a
substance not entered into the lists, referred to in Article 6(3), Clause 1 and 2 and without observing
the conditions specified in Article 4(2) and in Article 9(1), for the period not exceeding 120 days.
2. The decision, referred to in Paragraph 1, shall specify detailed restrictions and conditions for
using of a biocidal product, taking in particular the type of threat, place of occurrence of such threat
and properties of a biocidal product into consideration.
3. The decision, referred to in Paragraph 1, shall be withdrawn after disappearance of threat, or
after stating insufficient efficacy of a biocidal product.
4. The minister competent for health shall notify each time the competent authorities of the
Member States of the European Union, the competent authorities of the Member States of the
European Free Trade Association (EFTA) – parties to the agreement on the European Economic Area
and the European Commission on issuing of the decision, referred to in Paragraph 1, and provides
access to information, referred to in Article 15(1), Clauses 1 and 3 – 10.
Article 15. 1. The authorization, provisional authorization and registration shall specify in
particular:
1) name of a biocidal product;
2) name and surname or name and address or seat of the applicant;
3) content of active substance, together with specification of their chemical names or other names,
enabling to determine the identity of the substances as well as name and address of their
manufacturer;
4) type and usable form of a biocidal product and its use;
5) scope and conditions of marketing in a biocidal product as well as scope and conditions of its use
and, depending on the case, reasons of change of these conditions;
6) type of packaging;
7) content of label and leaflet of a biocidal product in Polish language version;
8) shelf life of a biocidal product;
9) expiry date of the authorization;
10) number of authorization, provisional authorization or registration and date of issuing.
2. Data covered by the authorization, provisional authorization and registration shall be public.
Article 16. The authorization concerning a biocidal product classified under the provisions on
chemical substances and preparations as toxic, very toxic or as a category 1 or 2 carcinogen, or as a
category 1 or 2 mutagen or classified as toxic for reproduction category 1 or 2, shall define additionally
the scope of its marketing and use, excluding admissibility of retail sale or non-professional use.
Article 17. 1. The applicant, after obtaining of the authorization, shall be obliged to immediately
inform the President of the Office on any data and circumstances, which may influence the
requirements and conditions constituting a basis of issuing of the authorization, in particular:
1) new technical knowledge or information on the effect of the active substance included in a
biocidal product for the health of humans, animals and the environment;
2) changes in the source or composition of the active substance or changes of the composition of
the biocidal product;
3) resistance of target organisms to the biocidal product;
4) change to type of packaging.
2. The applicant shall be obliged to notify the President of the Office on change to actual state,
made after registration or concerning data included in the authorization. The applicant is obliged to
notify the President of the Office on any factual changes concerning the information submitted in the
register after the inclusion into the register.
3. The President of the Office shall immediately inform the Member States of the European Union
and the European Commission on each potentially harmful effect for the health of humans, animals
or the environment, any changes of the composition of a biocidal product, its active substances,
impurities, auxiliary substances or residues.
Article 18. As a result of new information relating to the safety of humans, animals or the
environment or as a result of information that conditions laid down in the authorisation, provisional
authorisation or registration are not complied with, authorisation provisional authorization registration
shall be obliged to review the dossier based on which the above documents were issued and shall
request the applicant to submit additional data.
Article 19. 1. In the events, in which it results from technological progress and technical
knowledge on the efficacy and with view to the safety of the health of humans, animals or the
environment, the authorization, provisional authorization or a decision to make a registration may be
modified ex officio or on the reasonable request of the authorization holder who was granted with the
authorization, provisional authorization or registration, in its part relating to the intended use of a
biocidal product or the scope and conditions of placing on the market and uses of the product in
question
2. The provisions of Article 13(1) and (2) shall be applied, respectively, to the evaluation of
modified scope of uses of a biocidal product.
3. If modifications in the authorization call for the amendment of specific conditions relating to an
active substance included on the list, referred to in Article 6(3), Clauses 1 and 2, such modifications
may be introduced after the evaluation of the active substance with regard to the proposed changes,
under the procedure laid down in Chapter 4.
Article 19a. 1. Data modifications covered by the authorization, provisional authorization or
registration as well as change to dossier constituting a basis to issue the authorization, provisional
authorization or registration shall be made by the minister competent for health on request of the
authorisation holder ..
2. The minister competent for health shall specify, by means of a regulation:
1) template of authorization on making modification to the authorization, provisional authorization or
registration as well as change to dossier constituting a basis to issue the authorization, provisional
authorization or registration,
2) type and scope of implemented changes and the scope of the required documents and analyses
justifying introduction of a change,
3) type of modification, requiring submitting of the application, referred to in Article 8(1),
4) way and mode of implementing changes
- taking in particular the type of data covered by changes, scope of analyses confirming the relevance
of implementing a change and way of their documenting as well as proper assessment of a biocidal
product into consideration.
Article 19b. 1. In the event of change of the applicant, the minister competent for the health shall
issue a new authorization, or provisional authorization or registration on the basis of the application
on change of the applicant entering into the rights and obligations of the previous applicant .
2. The application, referred to in Paragraph 1, shall be accompanied by the applicant with the
agreement on transfer of rights and obligations and a statement that the other elements of the
authorization and dossier constituting a basis of its issuing remain unchanged.
Article 20. 1. The applicant, on request of the President of the Office, submit the results of
additional tests of a biocidal product or an active substance included in it, if dossier enclosed to the
application is not sufficient to evaluate the product as laid down in Article 9(1), Clauses 2 – 7.
2. The procedure is initiated on the day of receiving of the complete dossier with information
necessary to evaluate a biocidal product or the authorisation to use information if the applicant does
not own it.
Article 21. Tests, referred to in Article 20(1), shall be conducted at the expense of the applicant
Article 22. 1. A biocidal product, or low risk biocidal product, placed on the market on the territory
of the Republic of Poland, shall be subject to include registration of Biocidal Products.
2. The Register and register files of Biocidal Products are kept by the President of the Office.
3. The Register of Biocidal Products shall be kept in a form of electronic information carriers and
shall be secured against access of unauthorized persons.
4. The Register of Biocidal Products shall be composed of three parts:
1) part I – containing the list of biocidal products, on which the authorizations or provisional
authorizations were issued;
2) part II – containing the list of low risk biocidal products, for which registration was made;
3) part III – containing the list of biocidal products, on which the authorisation, referred to in Article
54, was issued.
5. The Register of Biocidal Products shall cover data, referred to in Article 15(1).
Article 23. 1. The information referred to Register of Biocidal Products shall be not confidential
and shall be available to third persons.
2. Documents submitted in the proceedings for the authorization shall be available to the person
having their legal interest in it, subject to the provisions on protection of classified information and
protection of industrial property.
Article 24. 1. For reasons pertaining to confidentiality of commercial or industrial nature, the
applicant may submit a reasonable request not to reveal information included in the dossier, referred
to in Article 8(2), Clause 1 – 3 or Paragraph 3, Clause 1 and 2, to any third persons.
2. The President of the Office shall render confidential information covered by confidentiality
clause by the authorising and registering body of the other Member State of the European Union.
3. The request, referred to in Paragraph 1, may not apply to:
1) first name and surname or name, address or a seat of the applicant;;
2) name, seat of the biocidal product manufacturer;
3) name, seat of the active substance manufacturer;
4) name, content of active substances present in the biocidal product and its trade name;
5) name of the other substances recognized as dangerous in the meaning of the separate
provisions;
6) physical and chemical data concerning the active substance and a biocidal product;
7) ways of rendering the active substance and a biocidal product;
8) summary of the results of the tests required to establish the use of the substance or biocidal
product, its effect on humans, animals and the environment and its ability to induce resistance;
9) recommended methods and precaution to reduce risk resulting from use, handling a biocidal
product, its storage, transport, use as well as from fire and other hazards;
10) safety data sheets;
11) analytical methods allowing to identify conditions, referred to in Article 9(1), Clauses 2 – 7;
12) methods of disposal of packaging;
13) procedures to be followed and measures to be taken in the case of spillage or leakage;
14) first aid and medical advice in the event of poisoning or allergy symptoms in humans.
4. The applicant may any time withdraw the request, referred to in Paragraph 1, or to submit an
application on repealing the confidentiality clause, referred to in Paragraph 2.
5. When the applicant discloses the previously confidential data, it is obliged to notify the
President of the Office on such fact.
Article 24a. 1. The President of the Office, within one month after termination of each quarter,
informs the competent authorities of the Member States of the European Union and the Member
States of the European Free Trade Association (EFTA) – parties to the agreement on the European
Economic Area, on any biocidal product, on which an authorization was issued or registration was
made within this quarter, on implemented changes to the authorization or registration, on withdrawal of
authorization or registration, on prolongation of validity date or registration.
2. Information, referred to in Paragraph 1, shall contain in particular the following data:
1) name and surname or name and address or a seat of the applicant;
2) name of a biocidal product;
3) name and content of an active substance present in this product, as well as name and content of
each dangerous substance in the meaning of the provisions on chemical substances and
preparations;
4) any acceptable residues;
5) type and usable form of a biocidal product and its use;
6) scope and conditions of marketing in a biocidal product as well as scope and conditions of its use
and the reasons to change such conditions;
7) other information on a biocidal product.
Article 24b. The President of the Office shall provide the competent authorities of the Member
States of the European Union and the Member States of the European Free Trade Association (EFTA)
– parties of the agreement on the European Economic Area with a list of the biocidal products, on
which the authorization was issued and of the low risk biocidal products, for which registration was
made, once a year.
Article 25. 1. The President of the Office shall, ex officio or on request of the applicant, specify
frame formulation and submit it to the applicant together with the authorization, provisional
authorization or registration concerning a given biocidal product.
2. If a subsequent application for authorization, provisional authorization or registration concerns
a new biocidal product based in the same active substance and when the applicant has the
authorisation to use the data giving him a right to this frame formulation, the authorization, provisional
authorization or registration shall be issued within the period not exceeding 60 days, starting from the
day the application was submitted by the applicant.
3. Fees shall be collected for the activities related to authorization of a biocidal product, including
deciding on an application on issuing or prolongation of the authorization or provisional authorization
or decision to include registration, change to this documents and submitting for placing of an active
substance in Annex I or IA.
4. Fees referred to in Paragraph 3, shall be the revenue of the State Budget.
5. The minister competent for health shall specify,, by means of a regulation, amount of fees,
referred to in Paragraph 3, and way of their payment, taking the amounts of such payments in the
other Member States of the European Union and the workload relating to the operation in question.
Article 26. The provisions of the Code of Administrative Proceedings shall apply to the issues
relating to the procedures concerning authorizations, provisional authorizations or decision to include
into the register in the scope not regulated by the Act.
Chapter 4
Active substances
Article 27. 1. An active substance intended to use in biocidal product may be placed on the
market on the territory of the Republic of Poland, provided that the following conditions are met:
1) it is included in the list of active substance, referred to in Article 6(3), Clauses 1 and 2;
2) it has been classified, packed and labelled pursuant to the provisions on chemical substances
and preparations;
3) dossier meeting the conditions laid down in Article 8(2), Clauses 1 – 3 or Paragraph 3, Clauses 1
-2, shall be submitted and accompanied by a statement that the active substance is intended to
be a component of a biocidal product – with reference to an active substance, which was not
placed on the market before 14 May, 2000.
2. The provisions of Paragraph 1 shall not apply to active substances used for purposes specified
in Article 48.
Article 28. 1. The minister competent for health shall submit an application to the European
Commission to include an active substance of a biocidal product to list of active substances for the
preliminary period of 10 years, if:
1) in the light of the current scientific and technical knowledge the following may be stated:
a) biocidal product containing this active substance,
b) low risk biocidal products,
c) basic substances
- meet the conditions, referred to in Article 9(1), Clauses 2 – 7, taking the accumulation effect
resulting from use of biocidal product containing the same active substance into consideration, if
applicable;
2) the requirements are met in relation to:
a) minimum degree of purity of the active substance,
b) and maximum acceptable concentrations level of specific impurities,
c) biocidal product types, in which the active substance may be used,
d) manner and area of use,
e) categories of users, specifying if a biocidal product is intended for industrial, professional or
general use,
f) other particular conditions resulting from the evaluation of available data;
3) the following data are specified:
a) Acceptable Operator Exposure Level (AOEL) – in relevant cases,
b) Acceptable Daily Intake (ADI) and Maximum Residua Limit (MRL) – in relevant cases,
c) fate and behaviours in the environment and impact on non-target organisms.
2. Application for the inclusion of an active substance of a biocidal product into the list of active
substance must contain identification of the group of the biocidal product and, if possible, information
on range of concentrations, in which the active substance may be used.
Article 29. The minister competent for health shall refuse to submit the application, referred to in
Article 28, if based on the provisions on chemical substances and preparations the active substance
has been classified as, toxic for reproduction, , subject to bioaccumulation or long-term degradation in
the environment.
Article 30. The minister competent for health shall provide access, on request of the European
Commission, to dossier on an active substance meeting the requirements, referred to in Article 28.
Article 31. The minister competent for health may refuse to submit the application, referred to in
Article 28, or may submit the application to remove an active substance from list Annex I or IA, if:
1) the evaluation of an active substance that under normal conditions of its use in a biocidal product
any concerns related to risk to the health of humans, animals or to the environment arise or
2) other active substance for the same group of a biocidal product is entered into the register, which
in the light of scientific and technical knowledge poses significantly lower risk to health of humans,
animals or to the environment.
Article 32. Making a decision on refusal to submit the application, referred to in Article 28, or
submitting the application on removal of an active substance from Annex I or IA shall be preceded by
an assessment performed by the President of the Office of at least one alternative active substances
to state, if it may be used with similar effect on target organisms and without significant economic
losses and practical inconveniences and not increasing risk to health of humans, animals or to the
environment.
Article 33. The minister competent for health shall submit for making an entry or changes in the
existing entry of an active substance of a biocidal product in Annex I or IA of the European
Commission following verification of dossier and stating that it meets the requirements, referred to in
Article 9(1), Clauses 2 – 7, in cases, in which the applicant submitted the following documents:
1) dossier of an active substance;
2) dossier of at least one biocidal product containing this active substance;
3) statement of the applicant, that summary dossier, referred to in Clauses 1 and 2, shall be
provided to the remaining competent authorities of the European Union, to the competent
authorities of the Member States of the European Free Trade Organization (EFTA) – parties of
the agreement on the European Economic Area and to the European Commission.
Article 34. 1. The minister competent for health may submit an application to the competent
authority of the European Commission to prolong the expiry of entry on Annex I or IA (to the register of
active substances of an active substance of a biocidal product) by the subsequent period not
exceeding 10 years.
2. The minister competent for health may submit the application to the competent authority of the
European Commission to review the entry to Annex I or IA of an active substance of a biocidal product
due to new information on failing to meet the conditions specified in Articles 28 and 29.
3. In the case, referred to in Paragraph 2, the minister in charge of health may submit an
application to the competent authority of the European Commission to prolong the validity of an entry
to the register by the period indispensable to determine, if an active substance meets the
requirements specified by the Act.
Article 35. Shall an active substance be removed from the list of active substances, the minister
competent for health issues, within the period not exceeding 4 years from the date of removal of this
substance from Annex I or IA, a ban to place on the market on the territory of the Republic of Poland
of the biocidal product containing the active substance removed from the register.
Article 36. 1. The minister competent for health shall, within the period not exceeding 12 months
from the day of submitting dossier of an active substance, make an assessment and submit to the
European Commission, the Member States of the European Union and the Member States of the
European Free Trade Organization (EFTA) – parties to the agreement on the European Economic
Area and to the applicant a copy of this assessment, together with application on making an entry of
an active substance of a biocidal products into Annex I or IA, or refusal to submit an application on
making such registration.
2. In the event, in which in the course of assessment of dossier, a need for its supplementing by
additional data indispensable to perform complete assessment occurs, the minister competent for
health shall request from the applicant to provide access to such data. In such case, course of the
term, referred to in Paragraph 1, shall be suspended to the moment of receiving such additional data.
3. In the event, referred to in Paragraph 2, the minister competent for health shall inform the
Member States of the European Union and the Member States of the European Free Trade
Organization (EFTA) – parties of the agreement on the European Economic Area and the European
Commission at the same date, in which it requested from the applicant on providing additional data.
Chapter 5
Use of data by other applicant
Article 37. 1. Data on an active substance may not be used for the benefit of the other applicant:
1) if the other applicant fails to provide the letter of access from the owner, or
2) for the period of 15 years from the date of making the first registration of active substances in the
case of an active substance, which was not marketed before 14 May, 2000.
2. In the event of active substances marketed as of 14 May, 2000, data, referred to in Paragraph
1, may not be used:
1) for the period of 10 years from the day of 14 May, 2000 in relation to any information provided
within submitting of the application on authorization or entering into the register;
2) for the period of 10 years from the date of making the entry of an active substance into Annex I or
IA in relation to information provided for the first time in order to make the first entry of an active
substance into Annex I or IA or extend the scope of its use by additional group of biocidal
products.
3. Data, referred to in Paragraph 1, which were provided in order to submit the application on:
1) change of the conditions of the authorization or registration,
2) prolongation of the expiry date of registration of active substances
- may not be used for the benefit of the other applicant for the period of 5 years from the date of
receiving of this data for the first time, however not earlier than after expiry of the terms specified in
Paragraph 1(2) and Paragraph 2.
Article 38. 1. Data on a biocidal product, contained in dossier, referred to in Article 8(2), Clauses
1 – 3 and Paragraph 3, Clauses 1 and 2, may not be used for the benefit of the other applicant:
1) if the other applicant fails to provide letter of access from the first applicant, or;
2) for the period of 10 years from the date of issuing of the first authorization or making an
registration in any Member State of the European Union – in the case of a biocidal product
containing the active substance, which was not marketed before 14 May, 2000.
2. In the event of biocidal products containing the active substance marketed as of 14 May, 2000,
data, referred to in Paragraph 1, may not be used for the benefit of the other applicant:
1) up to 14 May, 2010 for any information provided within submitting an application on authorization
or registration;
2) for the period of 10 years from the date of making the entry of an active substance onto Annex I
or IA in relation to information provided for the first time in order to make the first entry of an active
substance onto Annex I or IA or extend the scope of its use by additional group of biocidal
products.
3. Data, referred to in Paragraph 1, which were provided in order to submit the application on:
1) change of the conditions of the authorization or registration,
2) maintenance of validity of the registration of active substances
- may not be used for the benefit of the other applicant for the period of 5 years from the date of
receiving of this data for the first time, however not earlier than after expiry of the terms specified in
Paragraph 1(2) and Paragraph 2.
Article 39. In the case of a biocidal product, for which the authorization was issued or registration
was made, the minister competent for health, without prejudice to the provisions of Article 37 and 38,
may express its consent on referring by the other applicant submitting an application on authorization
or registration to data delivered by the applicant, if this applicant proves that a biocidal product is
similar and contains the same active substances, including level of purity and type of impurities.
Article 40. 1. The applicant, priori to submitting the application for the authorization of a biocidal
product, assessment of which requires performance of tests on vertebrates, shall make an inquiry to
the President of the Office on:
1) already issued authorizations or entries into the register concerning biocidal product or products
similar to this one, for which the applicant intends to submit the application on issuing of the
authorization or registration, and
2) name and surname and name and address or seat of the applicant, for which the authorization
was issued or registration was made, referred to in Paragraph 1.
2. The inquiry should contain a statement that the subsequent applicant intends to apply for
authorisation or registration on its own behalf and that it has data, referred to in Article 8(2) and (3) at
its disposal.
3. The President of the Office shall provide the applicant with information, referred to in
Paragraph 1, notifying the holders of authorisations or authorisation, referred to in Paragraph 1(2), at
the same time, on intention to submit the application on issuing of the authorization or making an
registration by this applicant.
Article 41. The subsequent applicant and the applicant, which has already obtained the
authorization or registration, having its seat on the territory of the Republic of Poland, shall take all
reasonable steps to reach an agreement on the sharing of information so as to avoid the duplication of
testing on vertebrate animals for the same biocidal product.
Chapter 6
Packaging, classification and labelling of biocidal products
Article 42. Only the biocidal products in original, tight unitary packaging, excluding a possibility of
their mistaken use for other purposes, in particular for human consumption, shall be marketed.
Article 43. 1. The biocidal products, which may be mistaken for food, drink or feedingstuff, should
be packaged to minimize the likelihood of such a mistake being made.
2. The biocidal products available to general public which may be mistaken for food drink or
feedingstuff, shall contain components to discourage their consumption.
Article 44. 1. The biocidal products should be classified and labelled, with the provisions relating
to Paragraphs 2 – 4, pursuant to the provisions relating to chemical substances and preparations.
2. Label of biocidal product shall not be misleading or give an exaggerated impression of efficacy
of the product, not mention the indications ‘low risk biocidal product’, ‘non-toxic’, ‘harmless’ or of
similar indications.
3. Label shall contain the following information in Polish language:
1) identity of every active substance and its concentration in metric units;
2) authorization number, provisional authorization number or registration number;
3) type of preparation;
4) scope of use;
5) directions for use and dose rate expressed in metric units for each use;
6) detailed information on direct and indirect adverse side effects and any directions for first aidin the
case of poisoning or allergy;
7) the sentence ‘Read attached instructions before use” in case if size of packaging makes placing
of all required data impossible;
8) directions for safe disposal of the biocidal product and its packaging of the product, pursuant to
the provisions on packaging and reuse of packaging;
9) the formulation batch number and expiry date relevant to normal conditions of storage;
10) the period of time needed for biocidal effect, the interval to be observed between applications of
the biocidal product or between application and the next use of the product treated, or the next
access by humans and animals to the area where the biocidal product has been used, particular
directions for decontamination means and measures, if applicable;
11) duration of necessary ventilation of treated areas, particulars for adequate cleaning of equipment,
particulars concerning precautionary measures during use, storage and transport, if applicable.
4. In cases justified by safe use of product, label shall additionally contain the following
information:
1) the categories of users to which the product is restricted;
2) information on any specific danger to the environment, particularly concerning protection of nontarget organisms and avoidance of contamination of water and soil;
3) for microbiological and chemical biocidal products, requirements for protection of workers from
risks related to provisions of safe and occupational hygiene.
5. Information, referred to in Paragraph 3, Clause 1, 2, 4, 7, 9 and 11, should be placed on the
label of the product. Information, referred to in Paragraph 3, Clause 3, 5, 6, 8 and 10 and Paragraph 4,
may be placed on the accompanying leaflet integral to the packaging
6. Where biocidal product identified as insecticide, acaricide, rodenticide, avicide or molluscicide,
is authorized provisional authorized, or registration was made, in accordance with provisions of the
Act and is also subject to classification, packaging and labeling according to separate provisions if a
consequence of those provisions in so far as they do not conflict with the conditions of an
authorization issued under the provisions of the Act
Article 45. The provisions of Article 42 - 44 of the Act shall be not applied to transport of biocidal
product by rail, road, inland waters, by sea and air.
Chapter 7
Advertising of biocidal products
Article 46. 1.Every advertisement for a biocidal product must be accompanied by the following
sentence: ‘Biocidal product must be used safely. Read the label and product information before use’.
The sentence shall be clearly distinguishable in relation to the whole advertisement.
2. In the text, referred to in Paragraph 1, the expression ‘biocidal’ may be replaced by an accurate
description of the product type being advertised.
Article 47. Advertising of a biocidal product shall not mislead in respect of the risk from the
product to man and the environment. Under no circumstances may the advertising of a biocidal
product mention ‘low risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indications.
Chapter 8
Scientific research and development
Article 48. 1. It shall be prohibited to perform scientific and developmental research, supporting
placing on the market of a biocidal product or an active substance intended to use exclusively in a
biocidal product and for which the applicant obtained no authorization, if the following conditions are
not met:
1) persons responsible for these research shall prepare and keep dossier covering the identity of a
biocidal product or an active substance, labelling data,, supplied amounts, names and addresses
of the persons, to whom the biocidal product or active substance are supplied, as well as
prepared dossier containing all available data on possible effects on humans and animals health
and impact on the environment;
2) shall notify the President of the Office on performed research.
2. Dossier, referred to Paragraph 1(1), should be accessible on each request of the President of
the Office.
3. If in result of the research, referred to Paragraph 1, can release of a biocidal product or an
active substance into the environment is possible, data, referred to Paragraph 1(1) should be
delivered to the President of the Office prior to launching of research in order to obtain a test
authorisation ..
4. Authorisation, referred to Paragraph 3, shall be issued by the President of the Office as a result
of assessment of available data, specifying in it the amount of active substance and territory, to which
using of a biocidal product shall be limited.
5. Research, referred to in Paragraph 3, may be performed only after obtaining of a authorisation
of the President of the Office, regardless of the fact, whether the biocidal product or active substance
are to be marketed on the territory of the Republic of Poland, or not.
6. If research, referred to in Paragraph 3, result in harmful effects to health of humans and
animals or results in undesirable effects on the environment, the President of the Office may refuse to
issue of authorisation on these research or specify the conditions to limit use of the biocidal product,
indispensable to prevent occurrence of these effects.
Chapter 9
Surveillance
Article 49. Surveillance of the provisions of the Act on biocidal products and placing of biocidal
products and active substances on the market and their use in professional activity shall be carried out
by the State Sanitary Inspection and:
1) State Labour Inspection – Surveillance and control of the provisions of the Act by the employers;
2) State Fire Brigade – labelling of storage facilities of biocidal products;
3) Border Guard and customs authorities – import of biocidal products and active substances used
in biocidal products;
4) Trade Inspection – labelling and packaging of biocidal product in wholesale and retail sale;
5) Inspection of Environmental Protection – disposal of waste packaging of biocidal products.
Chapter 9a
Poisonings control
Article 49a. 1. The consultation centres as well as toxicological information centres, hereinafter
referred to as the ‘toxicological centres” shall be responsible for control of poisonings with biocidal
products
2. Toxicological centres shall operate permanently in 24h mode for the whole year, ensuring
medical consultation in the case of poisonings with biocidal products.
3. The minister competent for health shall specify, by means of a regulation, a list of toxicological
centres responsible for control of poisonings with biocidal products and the entities obliged to report
on poisonings, taking their professional knowledge and location of the territory of the Republic of
Poland into consideration.
Article 49b. 1. Toxicological centres shall collect, register and store in archives the reports on
poisonings with biocidal products on poisoning form, developing database on poisonings with biocidal
products.
2. Information contained in the form, referred to in Paragraph 1, shall cover basic data on a
biocidal product, sex and age of a person subject to poisoning, circumstances, in which the poisoning
took place and description of effects on health occurred in a result of exposure to biocidal product.
Article 49c. 1. Toxicological centres shall provide the President of the Office with a report on the
reported poisonings with biocidal products every 6 months and provide it with data on poisonings with
biocidal products on each request.
2. Information covered by the report, referred to in Paragraph 1, shall include summary data on
biocidal products, persons subject to poisoning, circumstances, in which the poisoning took place and
description of effects on health occurred in a result of exposure to biocidal product.
3. Operational costs of the toxicological centre related to preparation of the report, referred to in
Paragraph 1, may be financed from the State Budget, from the funds, dispenser of which is the
minister competent for health.
4. The minister competent for health shall specify, by means of a regulation, template of
poisoning form, report on reported cases of poisonings with biocidal products, detailed scope of
information on the reported poisoning with biocidal products, way of collecting and storing data on
poisonings with biocidal products as well as way and mode of financing costs, referred to in Paragraph
3, taking the necessity of harmonization and ensuring completeness of reported data into
consideration.
Article 49d. 1. The President of the Office shall provide the toxicological centres with data on
biocidal product placed on the market and to be used in a form of safety-data sheet, and if it is not
required, data on qualitative and quantitative composition of a biocidal product as well as name and
surname or name and address or seat of the applicant. This data may be used by toxicological centres
for therapeutic and preventive purposes exclusively, in cases of stating or suspecting of a poisoning
with a biocidal product.
2. The President of the Office shall provide the toxicological centres with data and information,
referred to in Paragraph 1, every 3 months and in the event of occurrence of poisoning with biocidal
product, data of which were not delivered to the toxicological centres, on their each request.
Article 49e. The President of the Office shall provide the European Commission with the report
on the reported poisonings once in 3 years.
Chapter 10
Principles of mutual recognition of authorizations and entries into the register between the
Republic of Poland and the other Member States of the European Union
Article 50. 1. If the applicant submits the application on issuing of the authorization or making an
entry to the register of a biocidal product, for which it obtained the authorization or registration in the
other Member State of the European Union or the Member State of the European Free Trade
Association (EFTA) – a party of the agreement on the European Economic Area, the minister
competent for health shall be obliged to issue the authorization or registration, provided that the active
substance used in biocidal product fulfil the requirements laid down in Article 9(1).
2. Application, referred to in Paragraph 1, shall include a summary of the dossier, as required in
Article 8, and certified copy of the first authorization granted for this biocidal product in the Member
State.....
3. Application on making an entry into the register may, instead of summary, referred to in
Paragraph 2, shall be accompanied by dossier required for low risk biocidal products.
Article 51. 1. The President of the Office shall request changes in labels of a authorized biocidal
product, referred to in Article 50(1), if, pursuant to Article 9, it shall state that:
1) a target organism is not present in harmful quantities, on the territory of the Republic of Poland
2) unacceptable tolerance or resistance of the target organism to the biocidal product is
demonstrated
3) the relevant circumstances of use, such as climate or breeding period of the target species,
differing significantly from those in the Member State where the biocidal product was first
authorized, and an unchanged authorization may therefore present unacceptable risks to humans
or the environment.
2. Changes, referred to in Paragraph 1, may concern information, referred to in Article 44(3),
Clauses 5, 6 and 8 and in Paragraph 4(2).
Article 52. 1. Shall President of the Office state that the low risk biocidal product, which has
been registered by another Member State of the European Union incompliant, with definition, referred
to in Article 3(2), the minister competent for health may provisionally refuse registration of this product
and shall immediately communicate its concerns to the competent authority responsible for verification
of the dossier of this product.
2. In the event, in which within the period of 90 days from the day of sending the notification,
referred to in Paragraph 1, the President of the Office and the competent authority other Member
State of the European Union responsible for assessment of dossier of this product in the other
Member State of the European Union fail to reach the agreement the minister competent for health
shall notify the European Commission on this fact.
Article 53. 1. The minister competent for health, if the biocidal product, authorized by another
Member State, do not meet the conditions, pursuant to Article 9(1), Clause 1, may refuse the
authorization or registration or restrict the authorization under certain conditions and it shall notify the
European Commission, other Member States and the applicant on this fact.
2. The notification, referred to in Paragraph 1, must contain name of the product and its
specification and justification to refuse or to restrict the authorization or registration.
Article 54. 1. Within the transitional period to the day of 14 May, 2010, the placing of biocidal
products on the market in the territory of the Republic of Poland containing active substance of which
was marketed before 14 May, 2000 as the active substances of a biocidal product intended for the
other purposes than research and development and production. process – oriented research.
2. Authorization for the biocidal product, referred to in Paragraph 1, hereinafter referred to as the
‘authorization’, shall be issued by the minister competent for health.
3. Application form shall be submitted by the applicant to the President of the Office.
4. The application, referred to in Paragraph 3, shall contain:
1) name and surname or name, address or seat of the applicant;
2) trade name of a biocidal product;
3) chemical name of an active substance or other name enabling to establish the identity of the
active substance and, if available, its EC and CAS number (number given by the Chemical
Abstracts Service), its content in biocidal product as well as name and address of manufacturer;
4) intended use of a biocidal product, considering the groups and product types and usable form of a
biocidal product;
5) information if a biocidal product is intended for general use;
6) type of unitary packaging;
7) proposed label claims of the biocidal product, pursuant to Article 44;
8) content of leaflet in the event, in which size of packaging makes placing of all required data on
packaging impossible;
9) report from research confirming efficacy of the biocidal product performed using methods, which
are recognized on international level or described in the Polish Standards or using the other
methods accepted by the President of the Office, in particular the methods recognized as
applicable in the course of authorization of the biocidal products on the territory of the Republic of
Poland before 14 May, 2000;
10) expiry date of the biocidal product;
11) safety data sheet, referred to in Article 8c;
12) Applicant statement that the active substance used in the biocidal product was marketed before
14 May, 2000.
5. Authorization shall be issued, changed and withdrawn by means of an administrative decision.
6. Data covered by the authorization are public.
Chapter 11
Penal provisions
Article 55. 1. Whoever places on the market biocidal product without the authorization,
provisional authorization, authorization or registration, shall be subject to the penalty of arrest, fine or
both these penalties.
2. The same penalty should be applied to any person placing on the market non-packaged or
non-labelled biocidal product in a way specified in Articles 42 - 44.
Chapter 12
Final provisions
Article 56. The provisions of Article 10(2), Article 13(2), Article 17(3), Article 24(2), Articles 28 36, Article 37(1), Clause 2 and Paragraph 2(2), Article 38(1), Clause 2, Paragraph 2(2) and
Paragraph 3(2) and Articles 50 - 53 shall apply as of the day of the accession of Poland to the
European Union.
Article 57. The Act shall enter into force on 1 December, 2002.
_________
1)
2)
3)
4)
This act shall transpose the following Directives of the European Communities within its
regulations:
1) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998
concerning the placing of biocidal products on the market (OJ EC L 123 of 24.04.1998, page
1; OJ EU Polish special edition, chapter 3, vol. 23, page 3);
2) Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999
concerning the approximation of the laws, regulations and administrative provisions of the
Member States relating to the classification, packaging and labelling of dangerous
preparations (OJ EC L 200 of 30.07.1999, page 1, as amended; OJ EU Polish special
edition, chapter 13, vol. 24, page 109, as amended);
3) Commission Directive 2001/60/EC of 7 August 2001 adapting to technical progress Directive
1999/45/EC of the European Parliament and of the Council concerning the approximation of
the laws, regulations and administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations (OJ EC L 226 of
22.08.2001, page 5; OJ EU Polish special edition, chapter 13, vol. 26, page 419).
Amendments to the abovementioned Act were announced in Journal of Laws z 2004 No. 281,
item 2777, z 2005 No. 33, item 289, No. 94, item 788, No. 143, item 1199, No. 175, item 1460,
No. 177, item 1468, No. 178, item 1480, No. 179, item 1485, No. 180, item 1494 and No. 183,
item 1538 and z 2006 No. 17, item 127, No. 144, item 1043 and 1045, No. 158, item 1121, No.
171, item 1225 and No. 235, item 1699.
Amendments to the abovementioned Act were announced in Journal of Laws z 2001 No. 100,
item 1085, No. 123, item 1350 and No. 125, item 1367, z 2002 No. 135, item 1145 and No. 142,
item 1187, z 2003 No. 189, item 1852, z 2004 No. 96, item 959 and No. 121, item 1263, z 2005
No. 179, item 1485 and z 2006 No. 171, item 1225.
Amendments to the uniform text of the abovementioned Act were announced in Journal of Laws z
2004 No. 69, item 625, No. 92, item 880 and No. 96, item 959, z 2005 No. 33, item 289 and No.
175, item 1462 and z 2006 No. 249, item 1830.