The material compliance requirements, such as those of the RoHS Directive, REACH Regulation or POP Regulation, are complex and detailed. At the same time, violations can have far-reaching consequences for companies. This makes it all the more important to create transparency about the substances actually used and contained along the supply chain and to systematically include this information in the risk assessment.
With Regulation (EU) 2023/988 on general product safety (General Product Safety Regulation - GPSR), the European Union has further specified the framework for handling hazardous products. A product that is classified as dangerous in one Member State is generally also considered dangerous in all other Member States. If a product is recalled, consumers must be informed clearly and comprehensibly and be entitled to an effective, free and prompt remedy. Information on dangerous products is also published via the European rapid alert system Safety Gate.
Obligations of economic operators
The GPSR assigns extensive obligations to manufacturers. These include, among other things
Ensuring that products are designed to be safe:
- Ensuring that products are designed safely;
- Carrying out internal risk analyses and preparing the relevant technical documentation;
- Acting promptly and informing consumers and national authorities via the Safety Business Gateway if they believe a product on the market is dangerous;
- Passing on information about accidents;
- Provide essential product safety and traceability information on products or their packaging;
- Providing contact details for receiving and investigating complaints and keeping an internal register of complaints received.
Importers and distributors also bear responsibility. They must ensure that the products are safe and refuse to place products on the market that they believe do not meet these requirements. In addition, manufacturers or importers and the competent market surveillance authorities must be informed and support appropriate measures.
The link between GPSR and material compliance
At first glance, general product safety appears to be separate from material compliance requirements. However, a closer look at Delegated Regulation (EU) 2024/3173 shows that the two areas are closely linked.
The regulation supplements the GPSR and creates a harmonized framework for the operation of the Safety Gate rapid alert system. Among other things, it specifies the information to be provided in the event of reports on dangerous products and the criteria according to which risks are assessed.
The presumption of a serious risk in certain case constellations is of particular importance. Such a presumption may exist, for example, if:
The product contains a chemical substance that is prohibited by Union harmonization legislation, or the substance in question is used in a concentration that exceeds the limit value specified in the aforementioned legislation (see 4.1 d)).
The relevant legislation includes in particular
- the REACH Regulation (EC) No. 1907/2006,
- the POP Regulation (EU) 2019/1021 and
- the RoHS Directive 2011/65/EU.
This means that violations of substance restrictions can have a direct impact on the product safety assessment of a product.
Substance data is often underestimated
Many companies still have room for improvement when it comes to collecting and evaluating substance information. Information from the supply chain is often documented but not systematically analyzed or properly checked for compliance. This creates risks that often only become apparent in the context of customer inquiries, market surveillance measures, or internal audits.
It is noteworthy that Delegated Regulation (EU) 2024/3173 does not require any additional conditions—such as third-party reports, damage reports, or evidence of actual impacts—to presume a serious risk associated with prohibited or restricted substances. Rather, the decisive factor is the exceeding of an applicable limit value or the use of a prohibited substance.
For companies, this means that compliance with substance restrictions should not be viewed exclusively as a material compliance issue, but also as an integral part of product safety and risk management.
What are the possible consequences?
If the available information suggests that a product is dangerous, the GPSR obliges manufacturers to act immediately.
In the event of a serious risk, the GPSR requires rapid intervention by the market surveillance authorities, even if the risk has no immediate impact. The presumption of a serious risk according to the cases in Delegated Regulation (EU) 2024/3173 should therefore be diligently verified or, if confirmed, immediate action should be taken.
- Take the necessary corrective action to bring the product into compliance in an effective manner, which may include withdrawal from the market or recall, where appropriate;
- Informing consumers
- Notify the competent market surveillance authorities of the Member States where the product has been made available on the market via the Safety Business Gateway.
It should be noted that the required information does not necessarily have to be actively communicated to the manufacturer. Instead, the available information must be appropriately evaluated and the necessary conclusions drawn.
Conclusion
Material compliance and product safety are more closely linked than it appears at first glance. Exceeding limit values from the RoHS Directive, the REACH or POP Regulation can, according to Delegated Regulation (EU) 2024/3173, give rise to the presumption of a serious risk - even if no specific personal injury, property damage or environmental damage has occurred to date.
This is based on the risk assessment of the substances in question, which was carried out during the legislative process and which ultimately led to their restriction or ban. The presumption of a serious risk must be carefully examined and verified by the manufacturer. However, it illustrates that substance data is no longer just a question of material compliance, but is increasingly becoming an essential part of product and risk management.
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Author's note
This article has been machine translated into English.
TERMS AND ABBREVIATIONS
REACH = Registration, Evaluation, Authorization and Restriction of Chemicals
POP = Persistent Organic Pollutants
