Materials and products that come into contact with water intended for human consumption
National implementing legislations
The Act on Water for Human consumption (Official Gazette, No. 30/2023)Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023)
NOTE: With the date of entry into force of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) the provisions of Articles 20, 26, 36, 37, 41, 49 to 53 and 70 of theOrdinances on Health Safety of Materials and Products that come immediate into contact with food (“Official Gazette”, No. 125/2009, 31/2011, 39/2013 and 62/2013) in the part relating to products and materials that come into contact with drinking water.
The competent authority
MINISTRY OF HEALTHEmail: voda@miz.hr
Tel: 01 46 07 555
Web: zdravlje.gov.hr
Scope of application
Materials and products that come into contact with water intended for human consumption. The main requirements that business operators need to be aware of are laid down in Articles 37 and 38 of the Act on Water for Human Consumption (Official Gazette, No. 30/2023) and Articles 5-7 and 50 of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023):Article 37 of the Act on Water for Human Consumption (Official Gazette, No. 30/2023)
Legal and natural persons engaged in the import, production and distribution of construction products, materials and other products that come into contact with water intended for human consumption are obliged, while respecting the special regulations governing construction products or consumer goods, to comply with the provisions of the Act on Water for Human consumption (Official Gazette, No. 30/2023) (hereinafter: The Act) and implementing decisions of the European Commission approving materials and products that come into contact with water intended for human consumption, and implement the following:
- Ensure that materials and products, including construction products, that come into contact with water intended for human consumption do not endanger the health safety of water as defined by the Act,
- Ensure that materials and products, including construction products, that come into contact with water intended for human consumption do not adversely affect the colour, taste and smell of water and do not enhance microbial growth
- Ensure that materials and products, including construction products, which come into contact with water intended for human consumption do not leach contaminants into water in quantities that are higher than necessary in view of the material's intended purpose,
- Ensure that materials and products, including construction products, that come into contact with water intended for human consumption meet the minimum hygiene requirements and general and special conditions relating to their health safety as laid down in the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023).
- Article 38 paragraph 3 of the Act on Water for Human Consumption (Official Gazette, No. 30/2023) Materials and aproducts that come into contact with water intended for human consumption are healthy correct if they meet the following minimum hygienic requirements:
b) They do not adversely affect the colour, smell or taste of water,
c) They do not enhance microbial growth,
d) They do not leach contaminants into the water in quantities that are higher than necessary in view of the material's intended purpose,
e) They do not exceed the values of health safety parameters prescribed by the Regulation on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) and/or Implementing decisions of the European Commission approving products, materials and products coming into contact with water intended for human consumption,
f) They comply with the provisions laid down in the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) and/or Implementing decisions of the European Commission approving materials and products that come into contact with water intended for human consumption.
Article 5 of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023)
Products in contact with water intended for human consumption subject to the conditions laid down in Article 38 of the Act on Water for Human Consumption (Official Gazette, No. 30/2023) must also meet the provisions of the Regulation on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) provided that they are not made of materials that are permeable and porous and do not adversely affect water intended for human consumption.
Products that come into contact with water intended for human consumption must also comply with the restrictions laid down in Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the establishment of the European Chemicals Agency and amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directive 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, and specific rules governing construction products if they are prescribed for them.
The materials and products that come into contact with water intended for human consumption need to be accompanied by a declaration of conformity of the device indicating that they comply with the provisions of this Directive.
The declaration of conformity of the device needs to be drawn up in accordance with the requirements set out in Annex I to the given Ordinances and shall be submitted to all operators and competent authorities. The test report must always be attached to the declaration of conformity of the device. The validity of the declaration of conformity of a device is valid for as long as the same manufacturing conditions of the material or article and the legal requirements are identical.
Construction products that come into contact with water intended for human consumption, in addition to meeting the requirements of this Regulation, must meet the requirements in accordance with special regulations governing construction products.
Article 6 of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023)
Materials and products that come into contact with water intended for human consumption must be labelieither on product packaging or on an accompanying document in accordance with the provisions of the Act governing products of general use or in accordance with the Ordinances governing construction products and must have a clear purpose of materials and products and instructions for use if necessary for proper application.
Article 7 of the Ordinces on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023)
Legal and natural persons engaged in the activity of import, production and distribution of materials and products that come into contact with water intended for human consumption, public water suppliers, legal and natural persons which incorporate materials or products in new or future installations; or in the case of repair or reconstruction in existing installations for abstraction, processing, storage or distribution of water intended for human consumption and which come into contact with water intended for human consumption, and any other operator who is required to ensure compliance of materials and products coming into contact with water intended for human consumption are obliged at all stages of placing on the market or use of materials and products that come into contact with water intended for human consumption (priority facilities, water suppliers and plumbers) to establish a traceability system for materials and products that come into contact with water intended for human consumption in such a way that they know from which entities they have received the materials or products from and which entities have supplied them.
Article 50 of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023)
Pending the entry into force of the implementing and delegated decisions of the European Commission, legal and natural persons are obliged to apply the provisions of this Regulation.
Furthermore, on the date of entry into force of the implementing decisions of the European Commission for each material group (organic, metal, cement, enamels and ceramic materials, and exceptions in small or assembled components) and delegated decisions of the Commission governing the labelling of products that come into contact with water intended for human consumption and the EU declaration of conformity ofproducts , the provisions of this Ordinances which are laid down in the provisions of the Implementing decisions of the European Commission or delegated decisions of the European Commission shall cease to apply.
Legal and natural persons engaged in the activity of import, production and distribution of construction products, materials and products that come into contact with water intended for human consumption are obliged to comply with the provisions of Article 5 of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) within one year from the date of entry into force of this Regulation.
Analyses of materials and products that come into contact with water intended for human consumption made according to the provisions of the Ordinances on Health Safety of materials anad Productsthat come into contact to food (“Official Gazette”, No. 125/2009, 31/2011 and 39/2013) may be used to produce the declaration of conformity of an products in accordance with the provisions of this Ordinances , if the entity possesses for the material or products analyses identical to the analyses prescribed in this Ordinances.
Lead parameter values of 10 µg/l prescribed by the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) apply until 12 January 2036 year, after which the value of 5µg/l shall apply.
Table 4 Annex II of the Ordinances on compliance parameters, methods of analysis and monitoring of water intended for human consumption (Official Gazette, No. 64/2023) prescribes the criteria for testing the product depending on type of material.
Competent Authority for perform official controls in/on the market
State InspectorateEmail: pisarnica.dirh@dirh.hr