Introduction to REACH and SVHC Substances Management

What is REACH? An Overview of the Regulation

The REACH Regulation (EC No 1907/2006), enforced on June 1, 2007, is the European Union's comprehensive framework for managing chemical risks. Developed since 1998, with its final implementation phase completed in 2018, REACH applies to manufacturers, importers, and downstream users of chemical substances—whether used on their own, in mixtures, or in articles. The regulation's central purpose is to ensure a high level of protection for human health and the environment while maintaining competitiveness and innovation within the EU chemicals industry and encouraging the substitution of hazardous substances with safer alternatives.

Before REACH came into force, regulators were required to prove that a substance was harmful before it could be restricted. Under REACH, this burden has reversed: the "no data, no market" principle now applies. This means that any chemical substance used in the EU in quantities of one tonne or more per year must be registered with the European Chemicals Agency (ECHA). In essence, REACH transfers the responsibility for chemical safety onto industry, requiring companies to identify and manage the risks associated with the substances they manufacture or import, and to demonstrate their safe use.

Registration Obligations Under REACH

The central obligation under REACH is substance registration. Any company manufacturing or importing a substance into the EU in quantities of one tonne or more per year must submit a registration dossier to ECHA. This dossier includes detailed information on the substance's properties, uses, classification, and safe handling measures. Registration requirements also extend to substances present in mixtures, and in some cases, to substances contained in articles—particularly when the substance is intended to be released during normal use.

For substances produced in quantities exceeding 10 tonnes per year, a Chemical Safety Report (CSR) is also required under REACH Article 14. This report documents the chemical safety assessment, demonstrating that risks to human health and the environment are adequately controlled throughout the substance's life cycle.

If a company fails to register a substance by the relevant deadline, it can no longer legally manufacture or import that substance into the European market. The consequences of this can be severe, including loss of market access, enforcement actions, and reputational damage. Companies must therefore ensure robust data collection and close supply chain coordination to meet these obligations. While REACH addresses a broad list of substances, certain exemptions apply, such as those for radioactive substances or substances under customs supervision.

Understanding Substances of Very High Concern (SVHCs)

A central feature of REACH is the identification and management of Substances of Very High Concern (SVHCs). These substances are characterized by hazardous properties, including:

• Carcinogenic, mutagenic, or toxic to reproduction (CMR), meeting the criteria for classification in category 1A or 1B according to Regulation (EC) No. 1272/2008 (CLP)
• Persistent, bioaccumulative, and toxic (PBT)
• Very persistent and very bioaccumulative (vPvB), not necessarily toxic
• Substances identified on a case-by-case basis—such as endocrine disruptors, respiratory sensitizers, or neurotoxicants—for which there is scientific evidence of probable serious effects

Once identified, SVHCs are added to the Candidate List, which is regularly updated by ECHA. Inclusion on this list does not immediately ban the substance, but it triggers immediate legal obligations for companies, particularly regarding communication and notification.

From Candidate List to Authorization or Restriction

ECHA regularly recommends substances from the Candidate List for inclusion in Annex XIV, also known as the Authorization List. Once a substance is moved to Annex XIV, it cannot be placed on the market or used after a specified "sunset date" unless an authorization has been granted for a specific use, or the use is exempted. Alternatively, if a substance is moved to Annex XVII, it becomes restricted or banned. Unlike Annex XIV, which applies to specific substances regardless of use, Annex XVII restrictions are often tailored to applications—for example, the ban on lead in jewelry or phthalates in toys.

In summary, SVHC-related risks are managed through two main mechanisms:

• Authorization (Annex XIV): Companies must demonstrate that risks are adequately controlled, or that socio-economic benefits outweigh the risks and no suitable alternatives exist.
• Restriction (Annex XVII): Imposes bans on the manufacture, use, or placing on the market of certain hazardous substances. These restrictions apply to all companies, regardless of tonnage, and can target specific uses or products.

Together, these mechanisms aim to progressively replace hazardous substances with safer alternatives.

Figure 1. Example of an entry in the REACH Authorization List (Annex XIV)

Figure 2. Example of an entry for phthalates in the REACH Restricted Substance List (Annex XVII)

SVHCs in Articles: The 0.1% Threshold Rule

REACH distinguishes between substances, mixtures, and articles, with the latter representing one of the most complex aspects of the regulation. Articles are defined as objects which, during production, are given a special shape, surface, or design that determines their function to a greater degree than their chemical composition does—examples include electronics, textiles, and furniture. Companies dealing with articles must assess whether SVHCs are present above regulatory thresholds, based on the following criteria:

• Whether an SVHC is present in an article above 0.1% weight by weight (w/w)
• Whether the total quantity of that SVHC exceeds one tonne per year, per producer or importer
• Whether the substance is intended to be released during normal use (e.g., ink cartridges, matchboxes, cleaning wipes)

These triggers can result in obligations such as notification to ECHA or communication along the supply chain.

According to established EU legal interpretation, the 0.1% threshold applies to each individual article component rather than to the entire complex product. For example, if a tiny plastic washer in a washing machine contains 0.2% of an SVHC, the threshold is triggered for that specific component—necessitating compliance actions for the entire machine.

Supply Chain Communication Obligations

When a substance is identified as an SVHC and exceeds the 0.1% threshold in an article, REACH imposes strict communication obligations to ensure transparency throughout the supply chain and to consumers. Two main duties arise:

• Supplier information duty: Suppliers must provide their customers with sufficient information to allow safe use of the article, including, at a minimum, the name of the SVHC. Upon request from a consumer, a supplier must also provide sufficient information for safe use within 45 days, free of charge.
• SCIP database reporting: Since 2021, companies must submit information to the SCIP database (Substances of Concern In articles as such or in complex objects (Products)) for any article containing an SVHC above 0.1%. This ensures that waste operators have access to information regarding hazardous chemicals within the circular economy.

It should be noted that the European Commission has proposed discontinuing the SCIP database as part of a "simplification package" for environmental law introduced in December 2025. The Commission intends to replace SCIP with the Digital Product Passport and a common chemicals data platform, although critics warn that these alternatives may not be fully operational for several years.

Consequences of Non-Compliance

Non-compliance with REACH requirements can have significant business consequences. One of the most immediate risks is loss of market access—products that fail to meet REACH obligations may be withdrawn from the EU market or denied entry altogether.

Regulatory authorities in EU Member States enforce REACH through inspections and penalties. Fines for non-compliance can be substantial and vary by country, often reaching into the millions of euros depending on the severity of the violation. Notable examples include:

• Unregistered substance imports: A German trader, Mr. Pinckernelle, imported approximately 20 tonnes of nicotine sulphate from China—a flammable product that is toxic to humans and has long-term adverse effects on the aquatic environment. The substance is used in Russia as an industrial disinfectant and in animal housing facilities; however, this use is banned in the EU under the Biocides Regulation (EU) No 528/2012. The penalty included a €340,000 fine and a prison sentence.
• Consumer goods recalls: Cases have included lead and/or cadmium found in solder used in imported electronics (speakers, cameras, solar panels), as well as "soft plastic" toys containing phthalates (DEHP, DBP) and short-chain chlorinated paraffins (SCCPs). Penalties included mandatory withdrawal from the market, public recall notices, and destruction of non-compliant inventory at the importer's expense.

Supply chain disruption represents another major risk. Companies rely on upstream suppliers for substance data and compliance assurances; if a supplier fails to meet REACH obligations, downstream users may be forced to halt production or seek alternative sources, resulting in delays and increased costs. Furthermore, the inclusion of a substance on the Candidate List can trigger immediate commercial impacts—customers may demand substitution, and companies may face reputational risks if associated with hazardous substances.

Best Practices for SVHC Management

To enable effective SVHC management, companies must implement robust processes for tracking substances, monitoring regulatory updates, and engaging with suppliers. This is a long-term, ongoing process that includes:

• Establishing and maintaining an inventory of substances and materials
• Conducting regular screening of products against the Candidate List
• Investing in research focused on substituting hazardous substances where feasible
• Adopting compliance-aware product design and development practices
• Using digital tools and databases to support compliance efforts across complex products and supply chains

Digitalization is especially important given the dynamic nature of the Candidate List, which is updated periodically as new substances are identified as SVHCs. This continuous evolution requires ongoing monitoring, since inclusion on the Candidate List can serve as an early warning signal—many substances are eventually moved to Annex XIV or become subject to restrictions. Companies should therefore treat Candidate List inclusion as a trigger for risk assessment and potential substitution planning.

Proper SVHC substances management is not merely a regulatory requirement but a strategic necessity. Companies must navigate a complex and evolving landscape of rules to maintain compliance and ensure continued market access. As regulatory scrutiny increases and sustainability expectations grow, proactive REACH compliance will remain a key factor in long-term business success.