How new legislation for plastic materials in contact with drinking water will look in the future?

Directive 98/83/EC has been amended several times and considering the transition period, since January 12, 2021, it is Directive (EU) 2020/2184 that regulates the quality of water intended for human consumption.

Water intended for human consumption

For the purpose of the directive, it will be understood as “water intended for human consumption”:

1. all water, either in its original state or after treatment, intended for drinking, cooking, food preparation or other domestic purposes in both public and private premises, regardless of its origin and whether it is supplied from a distribution network, supplied from a tanker or put into bottles or containers, including spring waters.
2. all water used in any food business for the manufacture, processing, preservation or marketing of products or substances intended for human consumption.

Hygiene requirements of materials that come into contact with drinking water

In article 11 of the presented directive, they specify the minimum hygiene requirements for materials that come in contact with water intended for human consumption. To this end the member states should guarantee that materials destined for its use in new installations, or in the case of repair or reconstruction work on existing installations for the abstraction, treatment, storage or distribution of water intended for human consumption and coming into contact with such waters:

1. directly or indirectly compromise the protection of human health as provided for by this Directive;
2. adversely affect the colour, odour or taste of the water;
3. enhance microbial growth;
4. leach contaminants into the water at levels that are higher than necessary in view of the intended purpose of the material.

European positive lists of starting substances

By the start of 2025, the commission should have adopted the European positive lists of starting substances (EPL), compositions or constituents for each group of materials, which are authorised for use in the manufacture of materials or products in contact with water intended for human consumption, including, where appropriate, conditions for their use and migration limits, which are to be determined on the basis of the methodologies adopted.

It is important to highlight that the baseline list of substances for organic materials will take into account the list established by Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food. However, this Regulation only includes substances for the manufacturing of plastics and not for rubber or organic coatings.

In Annex V of the Directive presented it indicates that the organic materials only should be compounds for:

1. the starting substances listed in the European positive list of starting substances to be established by the Commission, and
2. substances in relation to which there is no possibility that the substance and its reaction products are present at levels exceeding 0,1 μg/l in water intended for human consumption, unless for specific substances a more stringent value is needed taking into account their toxicity.

The organic materials (plastic, rubber, coatings) will be analysed in accordance with what is indicated in Table 1 of Annex V and must be verified:

• European positive list of starting substances for organic materials. EPL
• Odour and flavour
• Colour and turbidity
• Leaching of total organic carbon
• Migration testing of the relevant parameters Annex I of this Directive
• MTCtap of substances on the positive list; test results in terms of migration of substances will be transformed into estimated levels at the tap
• Unexpected substances (GC-MS)
• Enhancement of microbial growth

In addition to the positive list, it is also implementing on a European level with a watch list of substances or compounds that arouse public concern or among the scientific community for health reasons, such as pharmaceuticals, endocrine-disrupting compounds and microplastics. The watch list shall indicate a guidance value for each substance or compound and where necessary a possible method of analysis that does not entail excessive costs.

Method of testing organic materials

The methods for testing should be in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein.

In article 11, it also specifies that, no later than the 12^th January 2024 should exist procedures and methods for testing and accepting final materials as used in a product made from materials or combinations of starting substances, compositions or constituents on the European positive lists, including methods for testing the effects on water quality, having regard to any relevant European standards. In addition, the Commission shall request one or several European standardisation organisations to draft a European standard for uniform testing and assessment of products in contact with water intended for human consumption, in order to facilitate compliance with this Article.

To this end, in 2021 the JRC (Joint research Centre) published a technical study where it presents an inventory of the European and international standards related to the requirements of hygiene of materials that come into contact with drinking water. This document should serve as a starting point for the subsequent gap analysis and the subsequent preparation of standardization mandates from the European Commission to CEN (European Committee for Standardisation).

How to apply this legislation in Spain?

The Directive had been transposed on a national level in RD 3/2023 of the 10^th January, for which they establish the techno-sanitary criteria of the quality of water intended for human consumption, its control and supply. From the 12/01/2023 it is in force and in relation to materials and products indicates that until the European positive lists of substances are available, manufacturers must ensure that they comply with the provisions of Article 44.1, justifying the compliance based on the current state of the art, and issuing the corresponding responsible statement. Therefore, the controls to be carried out to ensure compliance will be:

• Colour, odour and flavour of the water
• Microbial growth
• Migration of water contaminants at levels higher than necessary for the intended purpose of such material or that worsen water quality and in no case shall exceed the parametric values in Annex I.

Once the EPL is published, the controls to be carried out will be those indicated in the Directive and mentioned before.

In relation to the watch list, it is in force of the RD 3/2023 the national watch list includes the substances: β-Estradiol, Nonylphenol, Azithromycin and Diclofenac. In addition, it indicates that the microplastics will be included in the list when the European commission adopts a standardised methodology to measure the microplastics in water intended for human consumption. The analysis of these substances will be carried out in the catchment areas and in the in surface and groundwater monitoring programs carried out by the water administration.

From this analysis, it can be concluded that until 2025 there will not be available a positive list nor methodology testing for each of the substances, of which a practical approach for plastics intended for contact with water for human consumption would be to apply the legislation on plastics in contact with food in combination with the rest of the tests established by this directive and/or its transposition in Spain.

At AIMPLAS, we provide personalized advice to manufacturers of materials and articles intended for contact with drinking water in order to design the best strategy and adapt to legislative changes, including the performance of the necessary tests.