Regulation (EU) 923/2023: new restrictions on lead in PVC

News for the REACH Regulation regarding lead and its compunds in polyvinyl chloride (PVC). In fact, Regulation (EU) 923/2023 was published on May 8th 2023, amending and supplementing entry 63 of Annex XVII "lead and its compunds".

The new restrictions will apply from November 29th 2024, but through some exemptions longer transition periods may be provided.

Why is lead used in the production of PVC?

Lead has historically been used in the manufacture of PVC, or polyvinyl chloride, as a stabilizer useful in imparting special properties. The addition makes it possible to prevent degradation of the material both during compounding and during the production of articles. Lead is extremely effective in improving the thermal and mechanical properties of PVC, such as heat resistance, light resistance, and durability.

The restrictions on lead in PVC

Present in the SVHC candidate list by the European Union since 2008, lead is mentioned in numerous regulatory frameworks because of its hazardous characteristics even at low concentrations.

In fact, several sources point to the incidence of lead on nerve development, as well as causing kidney disease and interfering with proper blood pressure. Lead also tends to bioaccumulate, having a half-life of about 30 days in blood and 30 years in bone.

Lead-containing PVC articles, especially building materials, have long useful lives; when they end, as they are recycled, they reintroduce the heavy metal into the environment, which can pollute groundwater and food and, more generally, represent new sources of exposure for humans.

For these reasons, the European Union has gradually sought to reduce its use in process steps, going so far as to propose limiting its presence to 0.1 percent by weight of PVC material through a dossier submitted by the European Chemicals Agency (ECHA). Given that lead compounds as stabilizers in compounding are not effective in concentrations below about 0.5 percent, the limit should have ensured an end to their use in PVC manufacturing processes.

The presence of exemptions for individual complex cases, the lack of effective tracking systems and recycling technologies, and, more generally, the need to achieve an appropriate balance between the general long-term benefits of the circular use of these materials and the general health concerns associated with such work, led to a long and intense period of discussion, culminating in this amendment to Annex XVII of Regulation (EC) 1907/2006.

The new Annex XVII limits for lead and its compunds in PVC

The new Regulation (EU) 923/2023 effectively amends Annex XVII of Regulation (EC) 1907/2006 and significantly impacts the timeframe for compliance with the limits proposed and discussed at the European level in recent years. It should be specified that Regulation (EC) 1907/2006 is being progressively amended and updated in order to maintain the appropriate alignment with the expertise progressively acquired, developed and discussed by the scientific community.

Special attention is given to exemptions as listed in the new Annex.

The following diagram applies:

What is affected	Articles manufactured from polymers or copolymers of vinyl chloride (PVC)
Lead limits	<0.1% by weight of PVC material
By way of derogation	Items impacted by existing legislation: Articles covered by paragraph 1, in accordance with paragraphs 2 to 5, and paragraph 7, in accordance with paragraphs 8 and 10 of entry 63 of Annex XVII of the REACH Regulation Food contact materials covered by Regulation (EC) 1935/2004 electrical and electronic equipment covered by the RoHS Directive EU/65/2011 packaging and packaging waste referred to in Directive 94/62/EC toys referred to in Directive 2009/48/EC PVC-silica separators in lead-acid batteries until May 28, 2033 Flexible PVC items recovered until May 28, 2025   The following items containing recovered rigid PVC that contain lead less than 1.5 percent by weight of the recovered rigid PVC until May 28, 2033: profiles and slabs for external applications in buildings and civil engineering works, excluding bridges and terraces profiles and slabs for terraces and decks, provided that the recovered PVC is used in an intermediate layer and is fully covered with a layer of PVC or other material whose lead content is less than 0.1% by weight profiles and slabs for use in hidden spaces or voids of buildings and civil engineering works (when inaccessible during normal use, excluding maintenance) profiles and sheets for interior building applications, provided that the entire surface of the profile or sheet facing the occupied areas of a building after installation is produced using PVC or other material for which the lead concentration is less than 0.1 percent by weight Multilayer pipes (excluding drinking water pipes), provided that the recovered PVC is used in an intermediate layer and is fully covered by a layer of PVC or other material whose lead concentration is less than 0.1% by weight Fittings, excluding drinking water pipe fittings as of May 28, 2026, rigid PVC recovered from the categories of articles listed in items a. through d. may only be used for the production of new articles in any of these categories Suppliers of PVC articles containing recovered rigid PVC with a lead concentration of 0.1% or more by weight of the PVC material must ensure, before placing such articles on the market, that they are visibly, legibly and indelibly marked with the words "contains >= 0.1% lead" suppliers of PVC articles containing recovered rigid PVC must submit documentary evidence to the national control authorities, upon request, to support claims about the recovered origin of the PVC contained in such articles
Effective date	November 24th 2024

Regulation (EU) 923/2023 will therefore apply from November 24, 2023.

Our experts are available to manufacturers, importers, distributors and users of consumer goods to support the correct identification of the regulatory requirements to which different manufactured goods are subjected according to their intended use and Distribution Market.

Our Laboratories have various recognitions and accreditations, with the ability to monitor compliance status and support product development according to desired performance.

Further information
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