Companies that place physical products on the market can no longer avoid material compliance. It is a legally binding component of product compliance and not a voluntary "nice to have".
Companies that do not strategically integrate material compliance into their processes at an early stage are exposing themselves to considerable business risk.
In 2025 alone, around 60% of the cases reported in the Safety Gate (2,834 of 4,772 reports) related to violations of material and environmental compliance.
Ten years earlier, this proportion was just around 30% (588 of 1,889 reports). The majority of these cases still relate to cosmetics and toys. However, electrical and electronic appliances and other products are also increasingly attracting attention.
Sanctions in material compliance
Material compliance violations are increasingly the focus of the authorities - with sometimes far-reaching consequences for the companies concerned. The primary objective in this compliance area is to protect human health and the environment. Due to these objectives, it is sufficient to simply exceed a limit value without actually causing any damage. In contrast to purely technical product compliance, the sanctions extend to criminal prosecution.
Possible consequences at a glance:
- Administrative offenses: Fines
- Criminal offenses: Prison sentences, fines
- Further measures:
- Daily penalty payment for continued violation
- In case of serious risk: Listing in "Safety Gate"
- Withdrawal of the product from the market
- Ban on marketing the product and any accompanying measures
- Request for removal of the product by national authorities
- Deletion of the online offer
- Company closure, in particular in the event of violations of occupational health and safety regulations
- Contractual penalty
Current regulatory initiatives and transparency drivers
The requirements for transparency, documentation and data availability are constantly increasing. Relevant developments include
- Environmental Crime Directive (EU) 2024/1203
- RoHS 2011/65/EU
- Very short deadlines for lead exemptions
See:EU: Official Journal listing RoHS exemptions - Revision of EN IEC 63000 including mandatory chemical analyses
See:EU: Revision of EN IEC 63000 (RoHS)
- Very short deadlines for lead exemptions
- Omnibus IV: Digitization of various legal acts including RoHS
- Environmental Omnibus: Abolition of SCIP, likely to be replaced by digital product passport requirements
- Ecodesign Regulation: Introduction of a digital product passport including "substances of concern"
- Battery Regulation: Material composition of the battery in the battery passport
- REACH Regulation: PFAS restriction proposal
- EU-wide market surveillance projects Material Compliance
- See for example: EU: Current REACH monitoring projects - findings and consequences
- Customs reform: introduction of a "single window" platform, desired improvement in cooperation between customs and market surveillance authorities and efficiency of controls (overarching in terms of overall compliance)
Opportunities and strategic advantages through proactive compliance
Material & Environmental Compliance is not only a duty, but also offers numerous strategic opportunities that can give companies a competitive advantage:
- Resilience through transparent supply chains
- Early availability of data increases supply security
- Risks from suppliers can be identified and minimized more quickly
- Preparation for the digital product passport
- Companies that systematically structure their master data are better prepared for the implementation of regulatory digitalization requirements that have already been decided and are to be implemented within the next few years
- Information can be used multiple times - efficiency gains in internal documentation and external communication
- Protection against loss of reputation and sanctions
- Companies protect themselves from expensive recalls, fines and damage to their image
- Compliance with regulatory requirements is increasingly becoming a decision-making factor for business partners
- Access to markets and customers
- Compliance is a prerequisite for market access
- Gaining the trust of customers and partners
- Increasing efficiency by integrating material compliance into processes
- Utilization of existing information through systematic documentation
- Lean communication channels to be able to respond efficiently to inquiries
- Approval for new products or changes
- Positive contribution to sustainability
- Compliance with regulatory environmental targets supports the ESG strategy
Conclusion
Those who collect information today will be able to respond to requirements and requests tomorrow. The demand for transparency will grow in the foreseeable future. Act in good time and start generating, filtering and structuring the information you need.
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Author's note
This article has been machine translated into English.
TERMS AND ABBREVIATIONS
Material compliance (substance law) focuses closely on compliance with substance restrictions (e.g. REACH, RoHS) in products, i.e. which substances may be contained. Environmental compliance , on the other hand, is broader and encompasses compliance with all environmental regulations, including waste management, emissions, recycling and resource utilization.
