Substance of Concern
A substance of concern is a chemical substance present in a product that may have harmful effects on human health or the environment. Under ESPR, substances of concern must be disclosed in the Digital Product Passport to enable safe handling, recycling, and end-of-life management.
Full Definition
Substances of concern are defined in ESPR Article 2(28) as "substances that are hazardous, or that have properties that render them undesirable in products, including substances subject to restrictions or prohibitions under other Union law." This includes substances on the REACH Candidate List (substances of very high concern, SVHCs), substances restricted under REACH Annex XVII, substances prohibited under RoHS, and substances classified as hazardous under the CLP Regulation.
ESPR Annex III requires the DPP to contain information about substances of concern present in the product, including the substance name (IUPAC name and CAS number), the location of the substance in the product, and the concentration of the substance. This information is required to enable recyclers to safely handle the product at end of life and to enable market surveillance authorities to verify compliance with substance restrictions.
The disclosure of substances of concern in the DPP is one of the most challenging aspects of ESPR compliance for manufacturers with complex supply chains. Many manufacturers do not currently have full visibility of the substances present in components sourced from sub-suppliers. Building the supply chain transparency required for substance of concern disclosure requires engagement with all tiers of the supply chain.
Related Terms
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Register Your Digital Product Passport →Substances of Concern in ESPR: The Legal Definition
Article 2(28) of ESPR defines a substance of concern as any substance that meets one or more of the following criteria: it meets the criteria for classification as hazardous under the CLP Regulation (EC 1272/2008); it is a persistent, bioaccumulative, and toxic (PBT) substance or a very persistent and very bioaccumulative (vPvB) substance; it is an endocrine disruptor; it is a persistent, mobile, and toxic (PMT) substance or a very persistent and very mobile (vPvM) substance; or it is identified in the delegated act as a substance of concern for the specific product category. The ESPR definition of substance of concern is broader than the REACH definition of substance of very high concern (SVHC) — it includes a wider range of hazardous substances.
SCIP Database and ESPR Substance Disclosure
The SCIP database (Substances of Concern In articles as such or in complex objects/Products) is operated by ECHA (European Chemicals Agency) and contains information on substances of concern in articles. Under Article 9 of the Waste Framework Directive, suppliers of articles containing SVHCs above 0.1% by weight must submit information to the SCIP database. The ESPR DPP substance disclosure requirement is directly linked to the SCIP database — manufacturers that are already submitting SCIP notifications can use their SCIP data as the basis for the ESPR DPP substance disclosure. The ESPR delegated acts will specify the threshold concentrations for substance disclosure in the DPP for each product category.
The ESPR definition of substance of concern is broader than the REACH definition of substance of very high concern (SVHC). Under ESPR, a substance of concern is any substance that meets one or more of the following criteria: it is classified as hazardous under the CLP Regulation (EC 1272/2008); it is a persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substance; it is an endocrine disruptor; it is a substance that impedes the safe and effective recycling of the product. The practical implication is that ESPR DPPs will need to disclose a much wider range of substances than the current REACH SVHC disclosure requirements. Manufacturers should conduct a comprehensive substance mapping exercise for each of their products to identify all substances of concern that must be disclosed in the DPP.