CDX Regulatory News

PPWR Substances of Concern: EU Compliance Update

October 12, 2026

The European Commission has clarified how the obligation to minimise Substances of Concern (SoC) in packaging should be applied under the Packaging and Packaging Waste Regulation (PPWR).

Article 5 of the PPWR requires packaging to be manufactured so that the presence and concentration of substances of concern are minimised. The objective is to avoid unacceptable adverse effects on human health and the environment throughout the life cycle of packaging.

The obligation applies to all packaging placed on the EU market from 12 August 2026. It applies to packaging manufacturers and, where relevant, to suppliers acting for microenterprises.

How compliance can be assessed

The Commission’s FAQ explains that the general obligation under Article 5(1) may currently be assessed using Annex C of EN 13428:2004, covering the minimisation of dangerous substances and preparations and the demonstration of conformity.

EN 13428:2004 can be used as an assessment method until an updated harmonised standard becomes available. However, the standard does not create a full presumption of conformity with the PPWR rules on substances of concern.

The Commission is expected to request the development of an updated standard by 12 February 2027. This should provide a more specific approach to demonstrating compliance with the PPWR requirements.

Existing heavy-metal limits

The existing combined concentration limit of 100 mg/kg for lead, cadmium, mercury and hexavalent chromium continues to apply. For this requirement, the Commission refers to CEN Report CR 13695-1/2000 as a relevant assessment method.

The PPWR does not introduce one general concentration limit for all substances of concern. Instead, the obligation requires companies to minimise relevant substances, while specific limits apply to certain substances or groups of substances.

ECHA work on substances of concern

The European Chemicals Agency is supporting the Commission by identifying substances of concern that may affect chemical safety or negatively affect the reuse or recycling of packaging materials.

In 2026, ECHA circulated a draft working list of approximately 700 candidate substances of concern in packaging and packaging waste. The list was prepared to support data validation and the Commission’s report; inclusion on the list does not itself create a new restriction or direct compliance obligation.

The Commission, assisted by ECHA, is required to publish a report on substances of concern in packaging and packaging components by 31 December 2026.

What this means for companies

Companies placing packaging on the EU market should review the substances used in packaging materials, inks, adhesives, coatings and other packaging components. They should retain evidence supporting decisions on substance minimisation and monitor the development of the updated standard and the Commission’s forthcoming report.

Businesses should also distinguish between the general PPWR minimisation obligation and any substance-specific limits or restrictions that may apply under the PPWR, REACH or other EU chemicals legislation.

Source:  FAQ on the Packaging and Packaging Waste Regulation ; and Regulation (EU) 2025/40 on packaging and packaging waste.

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