Act No. 45 / 2019 Coll.
Law amending certain laws in connection with the adoption of a regulation of the European Parliament and of the Council on mercury
Valid
Law
Effective from 01.03.2019
45
THE LAW
of 30 January 2019
amending certain laws in the context of the adoption of a regulation of the European Parliament and of the Council on mercury
Parliament has decided on this law of the Czech Republic:
Amendment to the Public Health Insurance Act
Act No. 1 / 2006, Act No. 1 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 6 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5, Act No. 5, Act No. 2006, Act No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No the Act No. 47 / 2016 Coll., Act No. 66 / 2017 Coll., Act No. 150 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 200 / 2017 Coll., the Constitutional Court's finding, published under No. 231 / 2017 Coll., Act No. 290 / 2017 Coll. and Act No. 282 / 2018 Coll., is amended as follows:
1. In Annex 1, point 23 reads as follows:
| „23. | 014 | Výplň stálého nebo dočasného zubu (bez ohledu na počet plošek, včetně rekonstrukce růžku) | W | 1. U pojištěnců do dne dosažení 15 let nebo u ošetření dočasného zubu hrazeno při použití plastického materiálu, nejde-li o amalgám, samopolymerující kompozit nebo fotokompozit, v rozsahu celého chrupu a dále v rozsahu řezáků a špičáků hrazeno i při použití samopolymerujícího kompozitu a v rozsahu stálých řezáků a stálých špičáků hrazeno i při použití fotokompozitu. Při použití dózovaného amalgámu se hradí jen v případech, kdy není použití jiného materiálu možné z hlediska zdravotního stavu pojištěnce. 2. U pojištěnců od 15 let do dne dosažení 18 let hrazeno při použití dózovaného amalgámu v rozsahu celého chrupu v základním provedení a dále v rozsahu řezáků a špičáků hrazeno i při použití fotokompozitu nebo samopolymerujícího kompozitu. 3. U těhotných a kojících žen hrazeno při použití plastického materiálu, nejde-li o amalgám, samopolymerující kompozit nebo fotokompozit, v rozsahu celého chrupu a dále v rozsahu řezáků a špičáků hrazeno i při použití samopolymerujícího kompozitu. Při použití dózovaného amalgámu se hradí jen v případech, kdy není použití jiného materiálu možné z hlediska zdravotního stavu pojištěnce. 4. U pojištěnců neuvedených v bodech 1 až 3 hrazeno při použití dózovaného amalgámu v rozsahu celého chrupu v základním provedení a dále v rozsahu řezáků a špičáků hrazeno i při použití samopolymerujícího kompozitu.“. |
2. in Annex 1, point 24 is deleted;
Points 25 to 71 shall be renumbered 24 to 70.
Amendment of chemical law
Act No. 350 / 2011 Coll., on Chemicals and Chemical Mixtures and on the Amendment of Certain Acts (Chemical Act), as amended by Act No. 279 / 2013 Coll., Act No. 61 / 2014 Coll., Act No. 324 / 2016 Coll., Act No. 183 / 2017 Coll. and Act No. 299 / 2017 Coll., is amended as follows:
1. In footnote 2, the second sentence is replaced by "Regulation (EC) No 649 / 2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of dangerous chemicals, as amended. 'and the sixth sentence is replaced by" Regulation (EU) 2017 / 852 of the European Parliament and of the Council of 17 May 2017 on mercury and repealing Regulation (EC) No 1102 / 2008'.
2. In the introductory part of Section 23, the words "or their use 'shall be inserted after the words" articles on the market' and after the words "mixtures on the market '.
3. in Article 23, the following point (d) is inserted after point (c):
"(d) Ministry of Defence,"
Points (d) to (h) shall be renumbered as points (e) to (i).
4. In Article 24, paragraphs 5 to 7 are added:
"(5) The Ministry of the Environment shall, within its scope referred to in paragraph 1 (f), accept the notification referred to in Article 8 (3) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council, assess its completeness and evaluate the information referred to in Article 8 (4) of this Regulation; In the framework of the evaluation, it shall seek the opinion of the Ministry of Health.
(6) If the Ministry of the Environment finds that the notification does not contain all the information referred to in Article 8 (3) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council, or if additional information is requested by the Ministry of Health pursuant to Article 25 (5), it shall invite the notifier to complete the notification and shall set a reasonable time limit for it. Where the notifier fails to complete the notification within the time limit set, the information referred to in Article 8 (3) (a), (b) and (d) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council shall be considered not to have been submitted.
(7) The Ministry of the Environment shall, within 30 days of the date of receipt of the opinion of the Ministry of Health, forward the notification to the European Commission if, on the basis of the evaluation carried out, it finds that the criteria referred to in the first subparagraph of Article 8 (6) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council have been met. Otherwise, the Ministry of the Environment shall inform the notifier within the same time limit, stating the reasons for the non-compliance. '
5. In Paragraph 25, paragraphs 4 to 6 are added:
"(4) The Ministry of Health, at the request of the Ministry of the Environment pursuant to Article 24 (5), gives an opinion on the notification under Article 8 (3) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council. This opinion shall include an assessment as to whether the criteria set out in the first subparagraph of Article 8 (6) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council are met in terms of the benefits of a new product with added mercury or a new manufacturing process for human health, the risks to human health and the existence of feasible technical alternatives that would provide a comparable benefit to human health. The deadline for issuing this opinion shall be 4 months and, in particularly difficult cases, 7 months from the date of receipt of the request from the Ministry of the Environment.
(5) If the Ministry of Health finds that it is necessary to request additional information from the notifier to carry out the assessment referred to in paragraph 4, it shall request the Ministry of the Environment to request it from the notifier. Pending the submission by the Ministry of Environment of supplementary information to the Ministry of Health, the deadline for the opinion referred to in paragraph 4 shall not run.
(6) The Ministry of Health issues a national plan pursuant to Article 10 (3) of Regulation (EU) 2017 / 852 of the European Parliament and of the Council. ';
6. The following Section 26a is inserted after Section 26:
Ministry of Defence
Ministry of Defence
(a) represents the Czech Republic in the institution of the European Defence Agency for the Coordination of the Implementation of the Code of Conduct for the Authorisation of Exemptions from the Regulation of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals for the Protection of the State;
(b) cooperate with the Ministry of the Environment in providing advice to manufacturers and importers concerning their obligations and responsibilities under the directly applicable European Union legislation on classification, labelling and packaging of substances and mixtures (21); and
(c) issue, at the request of the Ministry of the Environment, a binding opinion for the granting of a decision authorising an exemption pursuant to Article 2 (3) of Regulation (EC) No 1907 / 200620 of the European Parliament and of the Council, within 20 days of the date of receipt of the application; This binding opinion shall include an assessment as to whether the requested exemption is necessary for the purpose of ensuring State defence. ';
7. in Articles 27 (a), 28 (a) and 29 (a), the words "suppliers of substances, mixtures or" shall be replaced by "manufacturers, importers, downstream users, distributors and suppliers."
8. In Section 33 (1) of the Introductory Part of the Provisions and in Section 35 (1), "(d) to (h) 'is replaced by" (e) to (i)'.
9. in Article 33 (1), points (h) and (i) are renumbered as points (g) and (h).
10. in Paragraph 33 (1), the word "or" shall be deleted at the end of point (g).
11. In Article 33, at the end of paragraph 1, the dot is replaced by "or 'and the following point (i) is added:
"(i) to a person who, contrary to Regulation (EU) 2017 / 852 of the European Parliament and of the Council, has placed on the market a new mercury-added product, its withdrawal from the market."
12. Paragraph 34 (5) to (21) reads as follows:
"(5) The manufacturer, importer, downstream user or distributor commits an infringement by:
(a) in contravention of the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (20), does not provide information in the supply chain;
(b) in contravention of Title VIII, the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (20) shall be manufactured, placed on the market or used in a mixture or article;
(c) placing on the market a substance or mixture classified as dangerous without ensuring its labelling and packaging in accordance with the directly applicable European Union Regulation on classification, labelling and packaging of substances and mixtures (21);
(d) in contravention of the directly applicable European Union Regulation on classification, labelling and packaging of substances and mixtures (21), does not retain evidence of compliance with the classification and labelling requirements of the substance or mixture for the period during which the substance or mixture is placed on the market and for a period of 10 years after the last placing on the market or does not provide it to the competent administrative authorities on request;
(e) in contravention of the directly applicable European Union regulation on classification, labelling and packaging of substances and mixtures (21), it shall not indicate the hazard information in the supply of a dangerous substance or mixture which allows the conclusion of a sales contract without knowledge of the information on the label or packaging of the substance or mixture;
(f) in contravention of the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (20), it shall not retain all the information required for the performance of its duties for as long as the substance or mixture is placed on the market and for a period of 10 years from the last placing on the market.
(6) The exporter or importer shall commit an offence by:
(a) in contravention of the directly applicable European Union Regulation on the export and import of dangerous chemical substances (26), imports or exports of a substance; or
(b) in contravention of the directly applicable European Union provisions on the export and import of hazardous chemical substances (26), the Ministry of the Environment shall not provide information on imports and exports.
(7) The exporter shall commit an offence by exporting mercury, its compounds or mixtures or by exporting mercury-added products in breach of Regulation (EU) 2017 / 852 of the European Parliament and of the Council.
(8) The importer shall commit an offence by importing mercury, its compounds or mixtures or by importing mercury-added products in breach of Regulation (EU) 2017 / 852 of the European Parliament and of the Council.
(9) A person commits an offence by violating Regulation (EU) 2017 / 852 of the European Parliament and of the Council
(a) produce a mercury-added product;
(b) use mercury or its compounds in the manufacturing process or the new manufacturing process;
(c) produce or market a new mercury-added product; or
(d) use free-packed mercury.
(10) A downstream user commits an infringement by violating the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (20)
(a) not produce a chemical safety report or provide the European Chemicals Agency with the information specified; or
(b) does not identify or apply appropriate measures to adequately limit the risks identified:
1. in the safety data sheets provided to him,
2. in its own chemical safety assessment, or
3. in any information on the risk management measures provided to it.
(11) The registrant commits an infringement by contravening the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals 20)
(a) does not provide the European Chemicals Agency with the specified information;
(b) does not establish or apply appropriate measures to adequately control the risks identified in the chemical safety assessment or recommend them in safety data sheets;
(c) does not maintain or update a chemical safety report; or
(d) does not update its registration data by supplementing or submitting to the European Chemicals Agency the information it has newly identified.
(12) The importer, downstream user or supplier who is the first to place on the market in the territory of the Czech Republic a mixture which has dangerous physical and chemical properties or dangerous properties affecting health shall commit an offence by failing to provide the Ministry of Health with the information referred to in Article 22 (1) or (2).
(13) A manufacturer or distributor who places a detergent on the market in the Czech Republic shall commit an infringement by:
(a) it shall place on the market a detergent without ensuring that it is labelled in accordance with the directly applicable European Union law on detergenitech28),
(b) placing on the market a detergent which does not comply with the restrictions on the content of phosphates and other phosphorus compounds in accordance with the directly applicable European Union regulation on detergents (28); or
(c) does not provide the Ministry of Health with information pursuant to § 22 (3) or (4).
(14) The importer, downstream user, supplier, manufacturer or distributor commits an infringement by not notifying a change in the information provided to the Ministry of Health pursuant to Article 22 (5).
(15) A person who has placed on the market a substance or mixture which does not meet the requirements for classification, packaging or labelling laid down by the directly applicable European Union Regulation on classification, labelling and packaging of substances and mixtures (21) shall commit an offence by not suspending the further placing on the market of that substance or mixture in accordance with Article 33 (1) (a).
(16) A person who has placed a substance or a substance in a mixture or article on the market without complying with the obligation to register under the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (20) shall commit an offence by not withdrawing such a substance, mixture or article from the market in breach of the decision of the competent administrative authority pursuant to Article 33 (1) (b).
(17) A person who has infringed the prohibition or restriction on the placing on the market of a substance on its own or contained in a mixture or article referred to in Titles VII and VIII of the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (20) shall commit an offence by not withdrawing such a substance, mixture or article from the market in breach of the decision of the competent administrative authority pursuant to Article 33 (1) (c).
(18) A person who has placed on the market a surfactant or detergent containing a surfactant that does not comply with the biodegradability criteria laid down by the directly applicable European Union detergenitech28) shall commit an offence by not withdrawing such a surfactant or detergent containing a surfactant from the market pursuant to Article 33 (1) (g).
(19) A person who has placed on the market a detergent that does not comply with the restrictions on the content of phosphates and other phosphorus compounds laid down by the directly applicable European Union detergenation28) shall commit an offence by not withdrawing such detergent from the market pursuant to Article 33 (1) (h).
(20) A person who, contrary to Regulation (EU) 2017 / 852 of the European Parliament and of the Council, has placed on the market a new mercury-added product shall commit an offence by not withdrawing such product from the market in breach of the decision of the competent administrative authority pursuant to Article 33 (1) (i).
(21) Penalty may be imposed for offences
(a) up to 5 000 000 CZK if the offence referred to in paragraph 2 (a), paragraph 4 (a) or (c), paragraph 5 (b) or (c) or paragraphs 15 to 17,
(b) up to CZK 3 000 000, if the offence referred to in paragraph 4 (b), paragraph 5 (a), (d) to (f), paragraph 6 (a), paragraphs 7 to 9, paragraphs 10 (b), paragraph 11 (b), paragraph 13 (a) or (b) or paragraphs 18 to 20,
(c) up to CZK 2,500,000 if the offence referred to in paragraph 11 (a) or (d) is committed,
(d) up to 1 000 000 CZK if the offence referred to in paragraph 1 (a), paragraph 2 (b), paragraph 3, paragraph 6 (b), paragraph 10 (a), paragraph 11 (c), paragraph 12 or paragraph 13 (c) is committed; or
(e) up to 500 000 CZK if the offence referred to in paragraph 1 (b) or paragraph 14 is committed. "
footnote 27 is deleted.
13. Paragraph 34 (22) is deleted.
Amendment to the Health Services Act
Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Health Services Act), as amended by Act No. 167 / 2012 Coll., Act No. 437 / 2012 Coll., Act No. 66 / 2013 Coll., Act No. 303 / 2013 Coll., Act No. 60 / 2014 Coll., Act No. 205 / 2015 Coll., Act No. 47 / 2016 Coll., Act No. 126 / 2016 Coll., Act No. 147 / 2016 Coll., Act No. 189 / 2016 Coll., Act No. 193 / 2017 Coll., Act No. 206 / 2017 Coll., Act No. 251 / 2017 Coll., Act No. 298 / 2016 Coll., Act No. 65 / 2017 Coll., Act No. 183 / 2017 Coll.
1. In Paragraph 117 (2), the word "or 'shall be deleted at the end of point (n).
2. In Paragraph 117, at the end of paragraph 2, the dot is replaced by "or 'and the following point (p) is added:
"(p) use dental amalgam in the provision of health services in contravention of the directly applicable European Union regulation on mercury 56).
56) Article 10 of Regulation (EU) 2017 / 852 of the European Parliament and of the Council of 17 May 2017 on mercury and repealing Regulation (EC) No 1102 / 2008. ';
3. in Article 117 (4) (d), the words "or (p)" shall be inserted after the words "(h)."
EFFECTIVE
That law shall take effect on the first day of the calendar month following its publication, with the exception of Article II (3), which shall take effect on 1 January 2020.
Vondracek v. r.
Zeman v. r.
v z. Brabec v. r.
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Regulation Information
| Citation | Act No. 45 / 2019 Coll., amending certain laws in connection with the adoption of a regulation of the European Parliament and of the Council on mercury |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.02.2019 |
|---|---|
| Effective from | 01.03.2019 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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