Message 001
Communication from the Commission - TRIS/(2026) 1980
Directive (EU) 2015/1535
Notification: 2026/0388/CZ
Notification of a draft text from a Member State
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Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20261980.EN
1. MSG 001 IND 2026 0388 CZ EN 21-07-2026 CZ NOTIF
2. Czechia
3A. Úřad pro technickou normalizaci, metrologii a státní zkušebnictví
Biskupský dvůr 1148/5
110 00 Praha 1
tel: 221 802 216
e-mail: eu9834@unmz.cz
3B. Ministerstvo zdravotnictví
Palackého náměstí 375/4
128 00 Praha 2 – Nové Město
tel.: 224 971 111
podatelna@mzd.gov.cz
4. 2026/0388/CZ - S30E - Pollution
5. Draft Act amending Act No 258/2000 on the protection of public health and on amendments to certain related acts, as amended, and Act No 323/2025 on the single monthly employer report
6. The objective is to implement the secondary legislation adopted under Article 11 of Directive (EU) 2020/2184 on the quality of water intended for human consumption in order to harmonise the minimum hygiene requirements for materials that come into contact with water.
7.
8. The draft provides for the implementation of the directly applicable secondary legislation adopted under Directive (EU) 2020/2184 of the European Parliament and of the Council on the quality of water intended for human consumption pursuant to Article 11 thereof, in order to harmonise the specific minimum hygiene requirements for materials that come into contact with water intended for human consumption.
The Ministry of Health will become the notifying authority for conformity assessment bodies (‘notified bodies’) and will also monitor their compliance with the obligations arising from the relevant EU regulations. The regional public health authorities will continue to act as the supervisory authorities for products and materials that come into contact with drinking water.
In addition to implementing the EU legislation, the draft also introduces changes concerning work with asbestos, certificates of free sale for the export of cosmetic products and vaccination against yellow fever. Further amendments have been made to the rules governing medical personnel at organised recreational stays for children and residential outdoor education programmes; hygiene and anti-epidemic measures to be taken by care providers to prevent the occurrence and spread of healthcare-associated infections; protection against noise and vibration; and the obligation to keep records of high-risk work in connection with the single monthly employer report introduced by Act No 323/2025 on the single monthly employer report. Consequential amendments relating to that obligation have also been made to the latter Act, which is therefore also amended by this draft.
Keywords: drinking water, materials that come into contact with drinking water, asbestos, vaccination
Reference to a technical standard: ČSN EN ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services
EU legislation referred to:
• Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption;
• Commission Implementing Decision (EU) 2024/368 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards the procedures and methods for testing and accepting final materials as used in products that come into contact with water intended for human consumption;
• Commission Delegated Regulation (EU) 2024/369 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down the procedure regarding inclusion in or removal from the European positive lists of starting substances, compositions and constituents;
• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures;
• Commission Delegated Regulation (EU) 2024/371 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing harmonised specifications for the marking of products that come into contact with water intended for human consumption;
• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast), as amended.
Footnote 1 (point 3 of the transitional provisions) refers to a further thirteen Commission Regulations and one Regulation of the European Parliament and of the Council.
The following supporting documents have been submitted with the draft and uploaded to TRIS-TBT: a file containing Act No 258/2000 in the version effective until 31 December 2026 and a file containing that Act in the version effective from 1 January 2027; a reference was made to Act No 258/2000 in notification 2024/0265/CZ.
The second part of the draft, which concerns Act No 323/2025 on the single monthly employer report, is not the subject of this notification.
9. Implementation: the proposed provisions going beyond what is required for implementation do not constitute a separate additional layer of regulation, but are a necessary systemic supplement to the framework being implemented.
9a. The measure seeks to protect public health from the risks associated with adverse effects on the quality of water intended for human consumption. The risks consist primarily in the migration of substances into water from products or materials that come into direct contact with water (hereinafter ‘products or materials’), the promotion of microbial growth, changes in the physico-chemical properties of water, or the use of treatment chemicals and filter media that come into direct contact with water (hereinafter ‘water-treatment media’), water treatment technologies and equipment for the treatment of drinking or hot water in domestic distribution systems or at the point of use (hereinafter ‘equipment’), whose safety, effectiveness or hygienic suitability has not been adequately verified.
In the case of products or materials, the measure implements a harmonised European system based on uniform requirements for composition, testing, conformity assessment and marking. For chemical substances, chemical mixtures and filter media, the measure builds on the minimum requirements laid down by EU law; for other water-treatment media, water treatment technologies and equipment, it establishes a comparable level of requirements so as to ensure a uniform level of health protection and water safety.
The draft establishes a comprehensive system of requirements for all categories of products or materials, water-treatment media, water treatment technologies and equipment that are intended to come into direct contact with water or affect its quality, by laying down requirements concerning hygienic suitability, effectiveness, conformity assessment, inspection and supervision.
9b. The draft does not create a new barrier to the internal market, but contributes to the harmonisation of requirements within the European Union. With regard to products or materials in particular, it promotes the free movement of goods through a uniform conformity assessment system and the mutual recognition of conformity assessment results. In the other areas concerned, the draft primarily clarifies the existing legislation, makes it more consistent and responds to experience gained in its application. At the same time, it provides sufficient time to adapt to the new requirements. The transitional provisions in Article 11 of Regulation (EU) 2024/370 and those in the draft Act allow water-treatment media, water treatment technologies and equipment that meet the requirements of the existing legislation, as well as products or materials with a valid certificate of conformity issued under the existing legislation, to continue to be placed on the market and used until the end of 2032. The extent to which the draft restricts the internal market is therefore minimal; the draft is primarily harmonising and standardising in nature.
The existing legislation is not aligned with the new harmonised European system of requirements for products or materials. At the same time, it does not provide sufficiently systematic links between the various categories of water-treatment media, water treatment technologies and equipment affecting water quality.
One alternative was to retain the existing legislation without incorporating the new European framework or standardising the requirements for the other regulated categories. However, such an approach would lead to varying levels of public health protection and legal uncertainty regarding the placing on the market of items belonging to categories subject to differing degrees of regulation.
These alternatives would not make it possible to achieve the required level of harmonisation or to standardise the requirements concerning the safety and hygienic suitability of all regulated categories. At the same time, they would not ensure that the new European system is fully operational.
The draft reflects the scope of harmonisation laid down by European Union law and introduces only those requirements that are necessary to protect public health and ensure water safety. In non-harmonised areas, it builds on the existing legislation and standardises only the basic principles of health protection and hygienic suitability.
9c. The requirements for verifying hygienic suitability, safety and effectiveness, and for conformity assessment are proportionate to the importance of the protected interest, namely the protection of human health and the preservation of the quality of water intended for human consumption.
On the one hand, the draft lays down the requirements necessary to protect public health; on the other hand, it promotes harmonisation and legal certainty in the internal market, in particular through uniform rules for conformity assessment and for placing products in the regulated categories on the market.
Failure to achieve the objective pursued could lead to the use of products or materials, water-treatment media, water treatment technologies or equipment that adversely affect water quality or pose a health risk to consumers. From a public health perspective, such an impact would be more serious than the administrative and economic costs associated with complying with the proposed requirements.
10. Reference(s) to basic text(s): 2024/0265/CZ
The basic texts were forwarded with an earlier notification:
2024/0265/CZ
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
