The EU regulation imposes strict REACH requirements on manufacturers, importers, and suppliers of articles. Accordingly, these requirements protect human health and the environment by ensuring transparency and safety in using potentially hazardous substances. Manufacturers, importers, and suppliers of articles from various sectors—including electronics, electrical, and other industries—must understand and comply.
REACH is an acronym for Registration, Evaluation, Authorisation, and Restriction of Chemicals. According to REACH, an article is an object with a specific shape, surface, or design that determines its function more than its chemical composition. Substances in articles refer to chemicals incorporated in such objects that may have regulatory obligations under REACH. These obligations include registration, communication, and notification.
The table below summarizes common scenarios and associated obligations for substances in articles:
Obligation | Legal Basis | Substances Concerned | Thresholds |
|---|---|---|---|
Communication of information on substances in articles (via SCIP database) | REACH Article 33 | Substances included in the Candidate List of SVHC | Concentration > 0.1% w/w in article
No tonnage threshold |
Notification of substances in articles (to ECHA) | REACH Article 7(2) | Substances included in the Candidate List of SVHC | 1 tonne/year and concentration > 0.1% w/w in article |
Registration of substances in articles | REACH Article 7(1) | Substances intended to be released from articles under normal or reasonably anticipated usage conditions | 1 tonne/year per SVHC |
Restriction of substances | REACH Annex XVII | Various hazardous chemicals in certain materials and applications | Varies |
The REACH requirements are legal provisions under Regulation (EC) No 1907/2006. The obligations for substances in articles focus on ensuring the safety and traceability of chemicals incorporated into products. Consequently, these requirements address substances that may endanger human health or the environment. The regulation applies to all companies placing articles on the European market. Failure to comply with REACH requirements may result in penalties, restricted market access, or reputational harm.
Manufacturers and importers must address obligations depending on the presence and concentration of certain substances in their articles. The following highlights the main requirements:
Suppliers must inform customers if their articles contain Candidate List Substances of Very High Concern (SVHCs) above a concentration of 0.1% weight-by-weight (w/w), component level.
Importantly, this obligation applies regardless of the volume of goods sales or the quantity of SVHC placed on the market, even below 1 tonne.
The information must include the substance name and guidance on safe use. This communication ensures that customers and end-users are aware of potential risks. Accordingly, suppliers must submit information about these articles to the SCIP (Substances of Concern In Products) database. This database, maintained by the European Chemicals Agency (ECHA), ensures transparency for consumers and waste operators regarding the presence of hazardous substances in products throughout their lifecycle. Additionally, ECHA updates the Candidate List approximately every six months as it identifies new SVHCs.
Additionally, to the communications obligation above, producers or importers must notify the ECHA if:
Notification ensures that ECHA and Member States are aware of the presence of these substances for further regulatory actions if needed.
Further, if SVHCs are intentionally released from an article (e.g., scented candles or printer cartridges) during its normal or reasonably anticipated conditions of use, manufacturers must register these chemicals with ECHA, above 1 tonne per year. The registration process requires detailed information about the substance and its safe use.
On top of the obligations above, we should not forget the REACH restrictions of hazardous chemicals per Annex XVII. For example, Nikel is restricted when indirect prolonged contact with the skin.
Complex objects are products made up of multiple articles. According to REACH, manufacturers must evaluate every component within a complex object separately for compliance. For example, components of a smartphone include the battery, casing, flexible cables and connectors as individual articles. Therefore, the supplier must assess every component for SVHCs exceeding 0.1% w/w and any associated obligations.
Adherence to the REACH requirements offers multiple advantages:
To meet the REACH requirements for substances in articles, manufacturers and importers should:
Notably, engaging with stakeholders across the supply chain is critical. This collaboration ensures smooth communication and helps identify potential compliance gaps early in the process.
Identifying SVHCs and Annex XVII restricted chemicals requires access to detailed supply chain data and comprehensive analysis. Complex supply chains make tracking compliance across multiple suppliers difficult. Additionally, frequent updates to REACH requirements demand continuous monitoring and adaptation.
Manufacturers can address these challenges by adopting software tools to track chemical compliance. Training staff on REACH obligations ensures awareness across teams. Moreover, engaging consultants or compliance experts helps navigate regulatory complexities effectively. Leveraging partnerships with suppliers can also streamline the compliance process.
REACH compliance is not just about avoiding penalties. It fosters innovation by encouraging manufacturers to develop safer alternatives to hazardous substances. This proactive approach can lead to products that align with market demands for sustainability and safety.
Furthermore, meeting REACH requirements enhances a company’s global standing. It demonstrates responsibility and builds trust with customers, stakeholders, and regulatory bodies. In summary, manufacturers position themselves for long-term success by investing in compliance today.
Apart from the obligations for substances in articles, REACH applies to substances and mixtures in other contexts. These include requirements for registering, evaluating, and authorizing chemicals used in industrial processes or sold as standalone products. Manufacturers and importers must also ensure compliance with these broader chemical management obligations.
Enviropass can help you meet REACH requirements by assisting with compliance assessments and SCIP database submissions. Contact us!
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