SVHC Regulatory Mechanism Analysis and Plasticizer Compliance Guide
SVHC Regulatory Mechanism Analysis and Plasticizer Compliance Guide
Through recent in-depth communications with our European partners, we have confirmed that the European Chemicals Agency (ECHA) currently has no plans to draft restrictions on the use of DPHP for 2027, and it remains fully compliant for use in automotive applications. Should there be any future regulatory updates, we will share timely information across UPC's official platforms (such as our WeChat Official Account).
As a professional manufacturer of plasticizers, UPC possesses rich and comprehensive compliant application solutions and regulatory expertise. To help enterprises better navigate the challenges of EU green regulations, we have outlined the core concepts of SVHC, REACH, and ECHA below, clarifying their relationships and the latest regulatory trends.
SVHC (Substances of Very High Concern) is a core concept of the EU's REACH Regulation (Registration, Evaluation, Authorization and Restriction of Chemicals), which entered into force in June 2007. REACH was designed to replace the reactive "regulate only after incidents occur" approach with a proactive model that places the burden of proving chemical safety on industry. The SVHC Candidate List is one of the most powerful regulatory tools under REACH: once a substance is listed, companies must fulfil communication and notification obligations (notification to ECHA is required when the substance is present in articles above 0.1% w/w and the total annual tonnage exceeds one ton). Listed substances are also prioritized for the Authorization List (Annex XIV) — once subject to authorization, they cannot be placed on the EU market without an explicit permit.
The Relationship Between SVHC and ECHA
Understanding the SVHC list requires knowing the authority behind it: ECHA established in 2007 and headquartered in Helsinki, Finland, ECHA is the central implementing body of REACH. The relationship can be summarized as follows: REACH is the legal framework, the SVHC list is a regulatory instrument under that framework, and ECHA is the "gatekeeper" of the list.
ECHA plays three roles in the SVHC system.
1. Receipt and assessment: dossiers proposing substances as SVHCs, submitted by EU Member States, are received by ECHA and opened for public consultation.
2. Decision and publication: after the consultation and review process, ECHA formally adds substances to the Candidate List on its website, and the associated obligations for companies take effect immediately.
3. Recommending authorization: ECHA regularly selects the highest-priority substances from the Candidate List and recommends them to the European Commission for inclusion in the Authorization List (Annex XIV). In other words, a substance's entire journey from "suspected" to "restricted" proceeds under ECHA's stewardship.
For companies, the only authoritative source of the SVHC Candidate List is the ECHA website (https://echa.europa.eu/candidate-list-table). The page is updated in real time and is searchable by substance name, EC number, or CAS number, with each entry stating its date of inclusion and the reason for listing. Because the list is typically updated twice a year and third-party reproductions often lag behind or contain errors, companies are strongly advised to verify compliance obligations directly on the ECHA website rather than relying on secondary sources.
Criteria for Listing a Plasticizer
Whether a plasticizer is listed as an SVHC depends on its intrinsic hazardous properties, assessed against the criteria set out in Article 57 of REACH:
1. CMR substances: Carcinogenic, Mutagenic, or toxic for Reproduction. This is where plasticizers are most frequently caught: certain phthalate plasticizers have been shown in animal studies to cause reproductive and developmental toxicity, interfere with the endocrine system, and impair fertility or fetal development, and are therefore classified as Category 1B reproductive toxicants.
2. PBT and vPvB substances: substances that are Persistent, Bioaccumulative and Toxic, or very Persistent and very Bioaccumulative. These substances accumulate in the environment and in living organisms over long periods.
3. Substances of equivalent concern (Article 57(f)): most notably endocrine disruptors (EDCs). Even where the evidence does not fully meet the CMR criteria, a substance may be included on a case-by-case basis if scientific evidence indicates probable serious, irreversible effects on human health or the environment.
The procedure is initiated by an EU Member State or by ECHA itself. Following public consultation, a substance is added to the list directly if no Member State objects; in case of disagreement, the matter is referred to the Member State Committee (MSC) for a decision. The list is normally updated twice a year.
Listed Plasticizers and Related Substances
As of February 2026, the SVHC Candidate List contains 253 entries (verifiable on the ECHA Candidate List page). The most representative plasticizers and related additives include:
1. DEHP (bis(2-ethylhexyl) phthalate): Listed in the very first batch in 2008, it is the most widely used general-purpose plasticizer. It was listed due to its Category 1B reproductive toxicity, and in 2017 its entry was updated to add endocrine-disrupting properties (Article 57(f)) as an additional reason for inclusion, further tightening control.
2. DBP (dibutyl phthalate) and BBP (benzyl butyl phthalate): Listed in the same 2008 batch, both Category 1B reproductive toxicants, commonly used in PVC products and adhesives; their entries were likewise supplemented with endocrine-disrupting properties in 2017.
3. DIBP (diisobutyl phthalate): Listed in 2010 for reproductive toxicity; it is often used as a low-cost substitute for DBP.
4. DnHP, DIHP, DPP, DnOP and other phthalates: Listed successively between 2012 and 2013 due to reproductive toxicity.
5. Short-chain chlorinated paraffins (SCCPs): Listed in 2008 on the basis of PBT and vPvB properties — they serve both as flame retardants and plasticizers, but are extremely persistent in the environment and accumulate through the food chain.
6. Bisphenol A (BPA): Listed in 2017, combining reproductive toxicity with well-documented endocrine-disrupting properties — a textbook Article 57(f) case. Strictly speaking, BPA is mainly a monomer for polycarbonate and epoxy resins and is used as an additive in PVC; its inclusion illustrates how regulation has expanded from "traditional plasticizers" to "polymer additives."
Currently, SVHC regulations apply only to the aforementioned items; on the other hand, high-molecular-weight phthalates (such as DINP and DPHP) and non-phthalate esters (such as DOTP and DINCH) represent compliant and safe plasticizer solutions.
Author
Jirun Xia | Sales Manager | REBU
Managing Editor
August Chang | Project Manager | Office of President
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