Act No. 324 / 2016 Coll.
Act on Biocidal Products and Active Substances and on the amendment of certain related acts (Biocidal Act)
Valid
Law
Effective from 18.10.2016
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324
THE LAW
of 6 September 2016
on biocidal products and active substances and amending certain related laws (Biocidal Act)
Parliament has decided on this law of the Czech Republic:
BIOCIDAL PREPARATIONS AND ACTIVE SUBSTANCES
SUBJECT MATTER OF THE ADJUSTMENT
This law regulates the making available on the market and use of biocidal products (1) following the directly applicable European Union provisions.
(a) certain obligations of legal and business natural persons when making biocidal products available on the market in the Czech Republic and their use;
(b) the obligation of the health service provider to report data on poisoning with biocidal products and active substances to the National Health Information System;
(c) the competence of administrative authorities in the exercise of the administration in the supply and use of biocidal products, in the field of active substances and in the supply of treated articles;
(d) penalties for infringement of the obligations laid down in the directly applicable European Union provisions governing the making available on the market and use of biocidal products (1) and this law.
CERTAIN OBLIGATIONS OF LEGAL AND UNDERTAKING PHYSICAL PERSONS IN THE SUPPORT OF BIOCIDAL PRODUCTS ON THE MARKET IN THE TERRITORY OF THE CZECH REPUBLIC
(1) Legal and business natural persons who make the biocidal product available on the market in the Czech Republic
(a) provide, at the request of the Ministry of Health (hereinafter referred to as the Ministry), a model or design of packaging, labelling or package information2;
(b) ensure that the biocidal product is labelled in the Czech language, including package leaflet (3);
(c) ensure that the biocidal product is classified, labelled and packaged in accordance with Article 69 of Regulation (EU) No 528 / 20124 of the European Parliament and of the Council ("the Biocidal Regulation"), in the absence of the biocidal product referred to in Article 13 (1).
(2) Legal and business natural persons submitting to the Ministry an application for authorisation of a biocidal product or an application for mutual recognition of a national authorisation of a biocidal product shall submit to the Ministry:
(a) an application for authorisation of a biocidal product or an application for mutual recognition of a national authorisation of a biocidal product in the Czech language (5);
(b) the documentation submitted for the application in the Czech language; documents which are part of the documentation and have been drawn up in a language other than the Czech language must be presented in the original language and in the same language as the Czech language),
(c) a summary of the biocidal product properties in the Czech language (6),
(d) a translation of the authorisation of the biocidal product granted by the reference Member State in the Czech language, if the application for subsequent mutual recognition of the national authorisation of biocidal production7).
(3) The Ministry may waive the requirement that the documents submitted pursuant to paragraph 2 be translated into the Czech language and inform the applicant that such a translation is not required. Such a measure may also be made by the Ministry by a declaration on its official record for an indefinite number of proceedings in the future.
NOTIFICATION
(1) The health service provider shall transmit to the National Health Information System, to the National Register of Insured or National Register of Occupational Diseases, data on poisoning by biocidal products and active substances. The data of the health service provider shall be transmitted in the manner laid down by the Health Services Act (8).
(2) Information on biocidal products and active substances obtained under the directly applicable European Union provisions governing the making available on the market and use of biocidal products (1), which are necessary for the provision of first aid or treatment, is provided free of charge in cases of poisoning or other accidents caused by biocidal products and active substances to doctors or other persons performing the medical profession of Toxicological Information Centre of General Faculty Hospital in Prague.
SCOPE OF THE ADMINISTRATIVE AUTHORITIES
State administration in the field of active substances, the supply and use of biocidal products and the supply of treated articles
(a) the Ministry;
(b) Ministry of the Environment,
(c) Ministry of Agriculture,
(d) regional health centres;
(e) Czech environmental inspection,
(f) the customs authorities of the Czech Republic ("customs authorities"),
(g) Ministry of Defence,
(h) Ministry of Interior.
Ministry
(1) Ministry
(a) decide on the authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation;
(b) pursuant to Article 27 (1) of the Biocidal Regulation, accept notifications of placing on the market in the Czech Republic of a biocidal product authorised by a simplified procedure in another Member State, receive information on the notification or application made in the reference Member State pursuant to Article 6, 7 and 8 of Commission Implementing Regulation (EU) No 354 / 2013 and adopt a revised summary of the biocidal product characteristics referred to in Article 9 of Commission Implementing Regulation (EU) No 354 / 2013; the dispute referred to in Article 27 (2) of the Biocidal Regulation shall proceed with the coordination group;
(c) decide to accept, extend or withdraw provisional restrictions or prohibit the supply or use of a biocidal product authorised by a simplified procedure in another Member State pursuant to Article 27 (2) of the Biocidal Regulation;
(d) in accordance with Article 30, 33, 34, 35, 36 and 37 of the Biocidal Regulation, decide on national authorisations for a biocidal product or its renewal pursuant to Article 31 of the Biocidal Regulation or Article 5 of Commission Delegated Regulation (EU) No 492 / 2014;
(e) decide to amend and revoke the authorisation of a biocidal product in accordance with a decision of the European Commission pursuant to Article 36 of the Biocidal Regulation;
(f) pursuant to Article 48, 49 and 50 of the Biocidal Regulation, decide to amend and revoke the authorisation of a biocidal product; pursuant to Article 52 of the Biocidal Regulation, decide to grant a grace period for the marketing and use of existing stocks of the biocidal product,
(g) in accordance with Article 44 (5) of the Biocidal Regulation, propose to the European Commission the terms of the Union authorisation valid in the Czech Republic or propose to the European Commission not to apply the Union authorisation to the Czech Republic; to this end, require binding opinions from the Ministry of the Environment and the Ministry of Agriculture, which will provide binding opinions within the deadline set by the Ministry,
(h) decide on the authorisation, amendment and revocation of the authorisation of parallel trade for a biocidal product pursuant to Article 53 of the Biocidal Regulation;
(i) decide on a provisional authorisation for the making available on the market or use of a biocidal product on the territory of the Czech Republic pursuant to Article 55 of the Biocidal Regulation and on the modification and withdrawal of such authorisations;
(j) in accordance with Article 56 (2) of the Biocidal Regulation, accept notifications of intended experiments or tests for research or development purposes which include an unauthorised biocidal product or an unapproved active substance intended solely for use in a biocidal product and are entitled to require the submission of further information to assess the impact of an unauthorised biocidal product or an unapproved active substance on human or animal health or the environment;
(k) pursuant to Article 56 (3) of the Biocidal Regulation, decide on the authorisation or prohibition of conducting experiments or tests for research or development purposes which include an unauthorised biocidal product or an unapproved active substance intended solely for use in a biocidal product;
(l) pursuant to Article 81 (2) of the Biocidal Regulation, it provides applicants and any other interested parties with information on the obligations arising from this Act and the directly applicable European Union provisions governing the making available on the market and use of biocidal products (1),
(m) representing the Czech Republic in the coordination group, the Biocidal Products Committee and the Standing Committee on Biocidal Products established by the Biocidal Regulation (9),
(n) reporting and carrying out information obligations towards the European Commission under the Biocidal Regulation (10);
(o) pursuant to Article 3 (3) of the Biocidal Regulation, submit to the European Commission an application for a decision on whether a substance is considered as nanomaterials and whether the product or group of products is considered as a biocidal product or a treated article; to that end, the Ministry shall be entitled to ask the Ministry of the Environment or the Ministry of Agriculture for professional assistance, which shall provide professional assistance within the time limit set by the Ministry,
(p) submit to the European Commission an application for review of the approval of an active substance for one or more product types under the conditions laid down in Article 15 (1) of the Biocidal Regulation,
(q) inform the public of the benefits and risks of biocidal products and of ways of minimising their use in accordance with Article 17 (5) of the Biocidal Regulation; to that end, the Ministry shall be entitled to ask the Ministry of the Environment or the Ministry of Agriculture for professional assistance, which shall provide professional assistance within the time limit set by the Ministry,
(r) perform the tasks of protecting the confidentiality of information referred to in Article 66 of the Biocidal Regulation;
(s) Article 88 of the Biocidal Regulation authorises the adoption of appropriate provisional measures concerning the authorised biocidal product in order to protect human health, in particular for vulnerable groups such as pregnant women and children, animal health or the environment, where the Ministry has reasonable grounds for doing so; It also decides to extend or repeal the provisional measure,
(t) carry out other tasks of the competent authority in accordance with the directly applicable European Union rules governing the making available on the market and use of biocidal products (1), unless otherwise provided for by this law;
(u) decide on the conditions of use of the biocidal product or the prohibition of making the biocidal product available on the market in the Czech Republic pursuant to Article 13 (2).
(2)
(a) assess the completeness of the application for authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation, the application for national authorisation referred to in Article 29 of the Biocidal Regulation, the application for national authorisation referred to in Article 34 (1) of the Biocidal Regulation, the application for mutual recognition of an authorisation referred to in Article 33 or Article 34 (2) of the Biocidal Regulation, the application for authorisation referred to in Article 43 of the Biocidal Regulation, the application for modification of the authorisation referred to in Article 50 of the Biocidal Regulation, the application for the approval of an active substance referred to in Article 7 of the Biocidal Regulation, and the application for renewal of an authorisation pursuant to Article 2 of the Commission Delegated power (EU) No 492 / 2014,
(b) carry out the evaluation of an application for authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 29 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 34 (1) of the Biocidal Regulation, an application for renewal of a national authorisation pursuant to Article 31 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 4 of the Commission Delegated Regulation (EU) No 492 / 2014, an application for a Union authorisation pursuant to Article 43 of the Biocidal Regulation, an application for renewal of a national authorisation pursuant to Article 45 of the Biocidal Regulation, an application for an authorisation pursuant to Article 50 of the Biocidal Regulation, an application for approval of an active substance in accordance with Article 7 of the Biocidal Regulation; carry out a comparative assessment within the evaluation where the Biocidal Regulation so provides;
(c) process the draft assessment report on the application for a national authorisation pursuant to Article 29 of the Biocidal Regulation, the application for a national authorisation pursuant to Article 34 (1) of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 31 of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 4 of the Commission Delegated Regulation (EU) No 492 / 2014, the application for authorisation of a Union authorisation pursuant to Article 43 of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 45 of the Biocidal Regulation, the application for modification of a national authorisation pursuant to Article 50 of the Biocidal Regulation, the application for approval of an active substance pursuant to Article 7 of the Biocidal Regulation; further develop recommendations for the renewal of the approval of an active substance in respect of an application for renewal of an active substance in accordance with Article 13 of the Biocidal Regulation and for the renewal of an authorisation in respect of an application for renewal of a Union authorisation in accordance with Article 45 of the Biocidal Regulation; carry out an assessment of the applicant's comments on the draft assessment report in accordance with the Biocidal Regulation,
(d) carry out the assessment and approve the summary of the biocidal product characteristics proposed by the reference Member State for the purpose of mutual recognition of the national authorisation referred to in Article 33 and 34 of the Biocidal Regulation;
(e) carry out an assessment as to whether the authorisations of a biocidal product issued need to be amended or revoked on the basis of information obtained from the authorisation holder and information from official activities;
(f) make an assessment as to whether the information obtained from the notification of intended trials or tests for research or development may have an unacceptable adverse impact on human or animal health or the environment;
(g) on the basis of the notification referred to in Article 27 of the Biocidal Regulation, carry out an assessment as to whether a biocidal product authorised by a simplified authorisation procedure in another Member State complies with the criteria laid down in Article 25 of the Biocidal Regulation;
(h) prepare an application to be submitted to the European Commission concerning the modification of certain conditions of Union authorisation pursuant to Article 44 (5) of the Biocidal Regulation;
(i) carry out an assessment as to whether, on the basis of new evidence, it is appropriate to adopt provisional measures under Article 88 of the Biocidal Regulation;
(j) transmit to the Toxicological Information Centre: General Faculty Hospital in Prague to provide first aid or treatment information on approved active substances and authorised or notified biocidal products,
(k) accept and keep a register of notified biocidal products and publish it on its website on an ongoing basis,
(l) manages an electronic information system for the keeping of records on biocidal products notified pursuant to Article 14, on biocidal products authorised for making available on the market in the Czech Republic and on applications for authorisation of biocidal products submitted,
(m) accept reports of checks carried out by the authorities referred to in Section 8 and the customs authorities referred to in Section 9;
(n) be entitled to require the presentation of a model or design of packaging, labelling or package leaflet of a biocidal product;
(o) collect administrative fees under the conditions laid down in the Biocidal Regulation and this Act and decide on the level of reimbursement of professional costs.
(3) The Ministry may entrust the activities referred to in paragraph 2 (a) to (i) to the State Health Institute or any other organisation for which it exercises the function of founder or founder.
(4) In the course of the activities referred to in paragraph 2 (a) to (i), the Ministry shall request a binding opinion from the Ministry of the Environment in terms of environmental protection and a binding opinion from the Ministry of Agriculture in terms of animal health. In the request for a binding opinion, the Ministry shall set a reasonable time limit for sending a written opinion in accordance with the first sentence.
(5) The Ministry may, upon request, issue to the applicant a certificate of approval of the Ministry to be the evaluating competent authority for the application under Article 7, 13, 26, 43, 45 or 50 of the Biocidal Regulation. The Ministry shall not issue the certificate referred to in the first sentence, in particular where it is clear that the active substance or biocidal product referred to in the application referred to in Article 7, 13, 26, 43, 45 or 50 of the Biocidal Regulation has a negative effect on human or animal health or the environment, or where, for capacity reasons, the application under Article 7, 13, 26, 43, 45 or 50 of the Biocidal Regulation could not be evaluated within 365 days of the date of approval of the application pursuant to Article 7, 13, 26, 43, 45 or 50 of the Biocidal Regulation. The Ministry shall, upon request, issue to the applicant a certificate of consent to be the evaluating competent authority if the application for amendment is made in accordance with Article 50 of the Biocidal Regulation and if the competent authority which evaluated the initial application for authorisation of the European Union for the biocidal product concerned is the competent authority. There is no legal entitlement to issue the certificate referred to in the first sentence. The Ministry shall notify the applicant that it has not issued the certificate referred to in the first sentence.
Ministry of Environment
(1) Ministry of the Environment
(a) issue a binding opinion on environmental protection at the request of the Ministry in accordance with Article 5 (4); the opinion shall also indicate the number of hours spent on the activities referred to in paragraph 2 for the purpose of determining the level of reimbursement of the costs of professional activities carried out pursuant to Article 16;
(b) provide the Ministry with initiatives to amend or revoke the authorisation of a biocidal product, to mutual recognition of a national authorisation or to review the approval of an active substance in terms of environmental protection;
(c) cooperate with the Ministry under Article 5 (1) (o) and (q) in terms of environmental protection;
d) cooperate with the Ministry in representing the Czech Republic in the bodies referred to in § 5 (1) (m) on the section of environmental protection.
(2) Ministry of Environment in the framework of a binding opinion on environmental protection
(a) assess the completeness of the application for authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation, the application for national authorisation referred to in Article 29 of the Biocidal Regulation, the application for national authorisation referred to in Article 34 (1) of the Biocidal Regulation, the application for mutual recognition of an authorisation referred to in Article 33 or Article 34 (2) of the Biocidal Regulation, the application for authorisation referred to in Article 43 of the Biocidal Regulation, the application for modification of the authorisation referred to in Article 50 of the Biocidal Regulation, the application for the approval of an active substance referred to in Article 7 of the Biocidal Regulation, and the application for renewal of an authorisation pursuant to Article 2 of the Commission Delegated power (EU) No 492 / 2014,
(b) carry out the evaluation of an application for authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 29 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 34 (1) of the Biocidal Regulation, an application for renewal of a national authorisation pursuant to Article 31 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 4 of the Commission Delegated Regulation (EU) No 492 / 2014, an application for a Union authorisation pursuant to Article 43 of the Biocidal Regulation, an application for renewal of a national authorisation pursuant to Article 45 of the Biocidal Regulation, an application for an authorisation pursuant to Article 50 of the Biocidal Regulation, an application for approval of an active substance in accordance with Article 7 of the Biocidal Regulation; carry out a comparative assessment within the evaluation where the Biocidal Regulation so provides;
(c) process the draft assessment report on the application for a national authorisation pursuant to Article 29 of the Biocidal Regulation, the application for a national authorisation pursuant to Article 34 (1) of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 31 of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 4 of the Commission Delegated Regulation (EU) No 492 / 2014, the application for authorisation of a Union authorisation pursuant to Article 43 of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 45 of the Biocidal Regulation, the application for modification of a national authorisation pursuant to Article 50 of the Biocidal Regulation, the application for approval of an active substance pursuant to Article 7 of the Biocidal Regulation; further develop recommendations for the renewal of the approval of an active substance in respect of an application for renewal of an active substance in accordance with Article 13 of the Biocidal Regulation and for the renewal of an authorisation in respect of an application for renewal of a Union authorisation in accordance with Article 45 of the Biocidal Regulation; carry out an assessment of the applicant's comments on the draft assessment report in accordance with the Biocidal Regulation,
(d) carry out an assessment of the summary of the biocidal product characteristics proposed by the reference Member State for the purpose of mutual recognition of a national authorisation pursuant to Article 33 and 34 of the Biocidal Regulation;
(e) carry out an assessment as to whether the authorisations of a biocidal product issued need to be amended or revoked on the basis of information obtained from the authorisation holder and information from official activities;
(f) carry out an assessment as to whether the information obtained from the notification of intended experiments or tests for research or development may have an unacceptable adverse impact on the environment;
(g) on the basis of the notification referred to in Article 27 of the Biocidal Regulation, carry out an assessment as to whether a biocidal product authorised by a simplified authorisation procedure in another Member State complies with the criteria laid down in Article 25 of the Biocidal Regulation;
(h) prepare an application to be submitted to the European Commission concerning the modification of certain conditions of Union authorisation pursuant to Article 44 (5) of the Biocidal Regulation;
(i) carry out an assessment as to whether, on the basis of new evidence, it is appropriate to adopt provisional measures pursuant to Article 88 of the Biocidal Regulation.
(3) If the Ministry of the Environment finds that it is necessary to request additional information from the applicant in order to carry out the activities referred to in paragraph 2, it shall request additional information from the Ministry requesting it from the applicant. The deadline for issuing the binding opinion provided for in Article 5 (4) shall be suspended until the Ministry has forwarded the additional information provided by the applicant to the Ministry of the Environment.
Ministry of Agriculture
(1) Ministry of Agriculture
(a) at the request of the Ministry pursuant to Article 5 (4), issue a binding opinion on the protection of animal health; the opinion shall also indicate the number of hours spent on the activities referred to in paragraph 2 for the purpose of determining the level of reimbursement of the costs of professional activities carried out pursuant to Article 16;
(b) provide the Ministry with initiatives to amend or withdraw the authorisation of a biocidal product, to mutual recognition of a national authorisation or to review the approval of an active substance for the protection of animal health;
(c) cooperate with the Ministry pursuant to § 5 (1) (o) and (q) with regard to animal health,
d) cooperate with the Ministry in representing the Czech Republic in the bodies referred to in § 5 (1) (m) on the section on animal health protection.
(2) Ministry of Agriculture in the framework of a binding opinion on animal health protection
(a) assess the completeness of the application for authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation, the application for national authorisation referred to in Article 29 of the Biocidal Regulation, the application for national authorisation referred to in Article 34 (1) of the Biocidal Regulation, the application for mutual recognition of an authorisation referred to in Article 33 or Article 34 (2) of the Biocidal Regulation, the application for authorisation referred to in Article 43 of the Biocidal Regulation, the application for modification of the authorisation referred to in Article 50 of the Biocidal Regulation, the application for the approval of an active substance referred to in Article 7 of the Biocidal Regulation, and the application for renewal of an authorisation pursuant to Article 2 of the Commission Delegated power (EU) No 492 / 2014,
(b) carry out the evaluation of an application for authorisation of a biocidal product in accordance with the simplified procedure referred to in Article 26 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 29 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 34 (1) of the Biocidal Regulation, an application for renewal of a national authorisation pursuant to Article 31 of the Biocidal Regulation, an application for a national authorisation pursuant to Article 4 of the Commission Delegated Regulation (EU) No 492 / 2014, an application for a Union authorisation pursuant to Article 43 of the Biocidal Regulation, an application for renewal of a national authorisation pursuant to Article 45 of the Biocidal Regulation, an application for an authorisation pursuant to Article 50 of the Biocidal Regulation, an application for approval of an active substance in accordance with Article 7 of the Biocidal Regulation; carry out a comparative assessment within the evaluation where the Biocidal Regulation so provides;
(c) process the draft assessment report on the application for a national authorisation pursuant to Article 29 of the Biocidal Regulation, the application for a national authorisation pursuant to Article 34 (1) of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 31 of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 4 of the Commission Delegated Regulation (EU) No 492 / 2014, the application for authorisation of a Union authorisation pursuant to Article 43 of the Biocidal Regulation, the application for renewal of a national authorisation pursuant to Article 45 of the Biocidal Regulation, the application for modification of a national authorisation pursuant to Article 50 of the Biocidal Regulation, the application for approval of an active substance pursuant to Article 7 of the Biocidal Regulation; further develop recommendations for the renewal of the approval of an active substance in respect of an application for renewal of an active substance in accordance with Article 13 of the Biocidal Regulation and for the renewal of an authorisation in respect of an application for renewal of a Union authorisation in accordance with Article 45 of the Biocidal Regulation; carry out an assessment of the applicant's comments on the draft assessment report in accordance with the Biocidal Regulation,
(d) carry out an assessment of the summary of the biocidal product characteristics proposed by the reference Member State for the purpose of mutual recognition of a national authorisation pursuant to Article 33 and 34 of the Biocidal Regulation;
(e) carry out an assessment as to whether the authorisations of a biocidal product issued need to be amended or revoked on the basis of information obtained from the authorisation holder and information from official activities;
(f) carry out an assessment as to whether the information obtained from the notification of intended experiments or tests for research or development may have an unacceptable adverse impact on animal health;
(g) on the basis of the notification referred to in Article 27 of the Biocidal Regulation, carry out an assessment as to whether a biocidal product authorised by a simplified authorisation procedure in another Member State complies with the criteria laid down in Article 25 of the Biocidal Regulation;
(h) prepare an application to be submitted to the European Commission concerning the modification of certain conditions of Union authorisation pursuant to Article 44 (5) of the Biocidal Regulation;
(i) carry out an assessment as to whether, on the basis of new evidence, it is appropriate to adopt provisional measures pursuant to Article 88 of the Biocidal Regulation.
(3) If the Ministry of Agriculture finds that it is necessary to request additional information from the applicant in order to carry out the activities referred to in paragraph 2, it shall request additional information from the Ministry which shall request it from the applicant. The deadline for the delivery of the binding opinion provided for in Article 5 (4) shall be suspended until the Ministry of Agriculture has forwarded the additional information provided by the applicant.
Control
(1) Control of compliance with the obligations arising from directly applicable European Union provisions governing the making available on the market and use of biocidal products (1), from this Act and from decisions given thereunder
(a) regional health centres;
(b) Czech environmental inspection,
(c) Ministry of Defence,
(d) Ministry of the Interior.
(2) Regional Sanitation Station
(a) checks that legal and business natural persons making biocidal products, active substances and treated articles available on the market in the Czech Republic are in compliance with the Biocidal Regulations, Commission Implementing Regulation (EU) No 354 / 2013, decisions of the European Commission issued under the Biocidal Regulation, this Act and decisions of administrative bodies issued under this Act;
(b) impose fines for infringements of obligations under the Biocidal Regulation, Commission Implementing Regulation (EU) No 354 / 2013, decisions of the European Commission issued under the Biocidal Regulation, this Act and decisions of administrative authorities issued under this Act;
(c) draw up reports on checks carried out for each calendar year and submit them to the Ministry no later than 31 March of the following calendar year; The report submitted shall include information on the date of inspection, trade name or other identification of the controlled biocidal product, trade name or other identification of the controlled subject, the name of the controlled person, the size and type of the packaging, the name or names of the active substances contained in the biocidal product or the names of the active substances by which the treated material has been treated, the quantities of active substances contained in the biocidal product, the declared type of use of the biocidal product, the batch number of the biocidal product, the infringed provisions of the law or the Biocidal Regulation, the information on the penalties applied and the level of the penalties applied, the information on the damage to human and animal health identified, the environment and the number of poisoning caused by the biocidal products or active substances.
(3) Czech environmental inspection
(a) checks that Chapter XV and Article 17, 56, 58 and 95 of the Biocidal Regulation are complied with by legal and business natural persons;
(b) checks that the legal and business natural persons comply with Sections 2 (1) (b) and 15;
(c) impose fines for infringements under Chapter XV and Articles 17, 56, 58 and 95 of the Biocidal Regulation, decisions of the European Commission issued under the Biocidal Regulations, this Act and decisions of administrative bodies issued under this Act;
(d) prepare reports of checks carried out for each calendar year and submit them to the Ministry no later than 31 March of the following calendar year; The report submitted shall include information on the date of inspection, trade name or other identification of the controlled biocidal product, trade name or other identification of the controlled subject, the name of the controlled person, the size and type of the packaging, the name or names of the active substances contained in the biocidal product or the names of the active substances by which the treated material has been treated, the quantities of active substances contained in the biocidal product, the declared type of use of the biocidal product, the batch number of the biocidal product, the infringed provisions of the law or the Biocidal Regulation, the information on the penalties applied and the level of the penalties applied, the information on the damage to human and animal health identified, the environment and the number of poisoning caused by the biocidal products or active substances.
(4) The Ministry of the Interior, as a public health authority under the Act on the Protection of Public Health (11), carries out the monitoring of compliance with the obligations and performs the tasks set out in this Act, the Biocides Regulation and Commission Implementing Regulation (EU) No 354 / 2013 within its scope.
(5) The Ministry of Defence, as a public health body under the Act on the Protection of Public Health (11), carries out the monitoring of compliance with the obligations and performs the tasks set out in this Act, the Biocidal Regulation and Commission Implementing Regulation (EU) No 354 / 2013 within its scope.
Customs authorities
(1) Customs authorities
(a) not release a biocidal product which has not been authorised under the Biocidal Regulation or notified under Article 14 into the proposed customs procedure, unless otherwise provided for in the Biocidal Regulation or without a written declaration from the importer that the biocidal product is intended exclusively for research and development purposes;
(b) does not release a substance for use in biocidal products which is not listed in Article 9 (2) of the Biocidal Regulation or is not listed in the review programme (12) or without a written declaration from the importer that the active substance is intended exclusively for research and development purposes;
(c) does not release into the proposed customs free circulation procedure a substance or a biocidal product containing or consisting of a biocidal product or from which such a substance may arise without being included in the list of suppliers for the product-types to which the product belongs, published by the European Chemicals Agency pursuant to Article 95 (1) of the Biocidal Regulation, except in the case of a substance listed in categories 1 to 5 and 7 of the Annex I of the Biocidal Regulation or a biocidal product containing only substances listed in categories 1 to 5 and 7 of Annex I to the Biocidal Regulation,
(d) does not release a treated article under the proposed customs procedure if all active substances contained in biocidal products which it has been treated or containing are not included in the list of approved active substances referred to in Article 9 (2) of the Biocidal Regulation for the product-type and use concerned, or are not listed in Annex I to the Biocidal Regulation, or any specified conditions or restrictions on the use of the substance are not fulfilled, or without a written declaration from the importer that those conditions are met;
(e) are authorised to request the Ministry's professional assistance in case of doubt as to the extent of the obligations arising for importers under the Biocidal Regulation and are further authorised to consult the register of submitted applications for authorisation of biocidal products held by the Ministry pursuant to Article 5 (2) (l), to the extent that the information is the name of the biocidal product, the type of biocidal product, the active substance contained in the biocidal product, the applicant's data, the authorisation holder's proposed date, the application date and the application number of the biocidal product register,
(f) keep a register of imported biocidal products, active substances and treated articles and biocidal products, active substances and treated articles not admitted to the proposed customs procedure,
(g) allow the Ministry, the Ministry of the Environment, the Ministry of Agriculture, the Regional Health Station or the Czech Environmental Inspection Office to inspect the records kept in accordance with point (f), to obtain copies, extracts and, where appropriate, copies,
(h) process reports on the number of biocidal products, active substances and treated articles not entered into the proposed free circulation procedure for each calendar year and submit them to the Ministry by 31 March of the following calendar year at the latest.
(2) The Directorate-General for Customs shall provide, at the request of the authorities referred to in paragraph 1 (g), the following information:
(a) identification details of the importer, the name and, where applicable, the name and surname or name or business name and address of the place of stay or place of business;
(b) identification details of the consignee, the name and, where applicable, the names and surnames and address of the place of stay;
(c) a description, including the trade name and type of product, according to its classification in the Combined Nomenclature listed in Annex I to Council Regulation (EEC) No 2658 / 8713),
(d) the country of dispatch and the country of origin of the biocidal product or active substance or the treated article;
(e) the quantity of biocidal product or active substance or treated article expressed in volume, weight or number of units.
(3) The provision of the information referred to in paragraph 2 does not constitute a breach of confidentiality under the tax rules (14).
TRANSFERS
Transfers of natural persons
(1) A natural person commits an offence by:
(a) use the biocidal product in contravention of the information and instructions given on the label or package leaflet or does not respect the warning symbols, the risk-specific standard phrases, or the standard precautionary statements according to the chemical legislation15) or hazard pictograms, signal words, hazard statements, or the precautionary statements pursuant to the directly applicable European Union Regulation on classification, labelling and packaging of substances and mixtures (16) and the specific conditions for use of the biocidal product;
(b) use a biocidal product which has not been authorised under the Biocidal Regulation or has not been notified under Article 14 or does not comply with the authorisation requirements laid down in the Biocidal Regulation without being granted a temporary authorisation; or
(c) use a biocidal product contrary to Article 17 (5), second sentence, of the Biocidal Regulation.
(2) A fine of up to 50 000 CZK may be imposed for the offence referred to in paragraph 1.
Transfers of legal and business natural persons
(1) A legal or commercial natural person commits an offence by:
a) make available on the market in the Czech Republic
1. a biocidal product not authorised under the Biocidal Regulation or notified under Paragraph 14;
2. a biocidal product contrary to the conditions laid down in a decision under this Act or the Biocidal Regulation;
3. a biocidal product authorised in another Member State by a simplified procedure contrary to the conditions of use specified in the notification submitted pursuant to Article 27 (1) of the Biocidal Regulation,
4. a biocidal product which does not comply with the authorisation requirements laid down under the Biocidal Regulation without being granted a provisional authorisation under the Biocidal Regulation or which is placed on the market in breach of the conditions of the temporary authorisation,
5. a biocidal product not classified, labelled and packaged in accordance with § 2 (1) (c);
6. a biocidal product not labelled in the Czech language or package leaflet is not mentioned in the Czech language,
7. the biocidal product before the date notified under Paragraph 14 (l),
8. a biocidal product referred to in Article 13 (1), which is not labelled in accordance with Article 15 (2),
(b) make available on the market on the territory of the Czech Republic or use a biocidal product authorised in another Member State by a simplified procedure which has not been notified before being placed on the market in the Czech Republic pursuant to Article 27 of the Biocidal Regulation;
(c) as holder of an authorisation, make available on the market on the territory of the Czech Republic a biocidal product which is not classified, labelled and packaged in accordance with the requirements of Article 69 of the Biocidal Regulation;
(d) it shall place on the market on the territory of the Czech Republic a biocidal product consisting of a substance on the list published by the European Chemicals Agency pursuant to Article 95 (1) of the Biocidal Regulation (hereinafter referred to as "the list of suppliers") containing or from such a substance without being included in the list of suppliers for the product types to which the product belongs, except in the case of a substance listed in categories 1 to 5 and 7 of the Annex I of the Biocidal Regulation or a biocidal product containing only substances listed in categories 1 to 5 and 7 of Annex I to the Biocidal Regulation,
(e) it shall place on the market in the Czech Republic a treated article contrary to Article 58 (2) of the Biocidal Regulation;
(f) it does not ensure appropriate labelling of the treated article in accordance with Article 58 (3), (4) and (6) of the Biocidal Regulation;
(g) does not provide the consumer with information on the biocidal treatment of the treated article pursuant to Article 58 (5) of the Biocidal Regulation;
(h) does not develop, update or make available a safety data sheet for a biocidal product in accordance with Article 70 of the Biocidal Regulation;
(i) fails to comply with the advertising requirements of the biocidal product referred to in Article 72 of the Biocidal Regulation;
(j) as holder of an authorisation, does not keep records of biocidal products in accordance with Article 68 of the Biocidal Regulation which he places on the market or does not make them available to the authorities referred to in Article 8 (1);
(k) in carrying out experiments or tests, fails to produce or maintain written records as referred to in Article 56 (1) of the Biocidal Regulation or in conducting experiments or tests which may result in leakage into the environment, to comply with the notification requirement of Article 56 (2) of the Biocidal Regulation;
(l) carry out an experiment or test in contravention of a decision given pursuant to Article 5 (1) (k);
(m) not notify the Ministry of all information under § 14 (a) to (m) or provide false information;
(n) use a biocidal product which has not been authorised under the Biocidal Regulation or has not been notified under Paragraph 14 or does not comply with the authorisation requirements laid down in the Biocidal Regulation without being granted a temporary authorisation;
(o) use the biocidal product in contravention of the information and instructions given on the label or package leaflet or does not respect the warning symbols, the risk-specific standard phrases, or the standard precautionary statements under the Chemical Law 15) or hazard pictograms, signal words, hazard statements, or the precautionary statements under the directly applicable European Union Regulation on classification, labelling and packaging of substances and mixtures (16) and the specific conditions for use of the biocidal product;
(p) use the biocidal product in contravention of the rational application of a combination of physical, biological, chemical or other measures, as appropriate, through which the use of biocidal products is limited to the minimum necessary and does not take appropriate precautionary measures;
(q) make an amendment to the biocidal product contrary to Commission Implementing Regulation (EU) No 354 / 2013;
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Regulation Information
| Citation | Act No. 324 / 2016 Coll., on Biocidal Products and Active Substances and on the amendment of certain related acts (Biocidal Act) |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 03.10.2016 |
|---|---|
| Effective from | 18.10.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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