Introduction.
EU市場に輸出する日本企業にとって、「REACH規則」への対応は避けて通れません。
その中でも特に注意すべきが、「SVHC：高懸念物質」制度です。
As of 2025, the SVHC list has expanded to over 240 substances, with new substances added every six months (January and July).
Companies exporting products containing target substances to the EU are required to keep up to date with the latest list and properly fulfill their notification and reporting obligations.
This article explains in detail the basic concept of SVHC under REACH, the scope of SVHC, the notification procedure to ECHA (European Chemicals Agency), penalties, and practical measures that Japanese companies should take.
What is an SVHC under the REACH Regulation?
SVHC refers to chemical substances identified as particularly hazardous to humans and the environment in the REACH regulation.
In other words, the SVHC system is a system to individually manage "particularly hazardous substances" within REACH as a whole.
The REACH regulation itself requires "businesses that manufacture or import 1 ton or more of a chemical substance per year" to register with ECHA.
On the other hand, in the case of SVHC, the obligation to manage the substance is not based on the "amount imported," but on the concentration (0.1 wt% or more) contained in the product.
This is a very important point.
In other words, even if the amount manufactured or imported is small, if a product contains 0.1 wt% or more of an SVHC, it is subject to reporting.
This makes the regulation applicable not only to manufacturers of finished products, but also to suppliers of parts, materials, and packaging materials.
Examples of products covered by SVHC
SVHC applies to "finished products" as well as chemical substances.
Therefore, a wide range of industries are covered, including
| type of industry | Typical products covered | Examples of applicable SVHCs |
|---|---|---|
| Industrial Equipment | Electronic components, cables, coated metals | Phthalate esters (plasticizers), lead compounds |
| printing business | Ink, toner, adhesives | Benzotriazole, formaldehyde |
| Cosmetics and Daily Necessities | Packaging, containers, fragrances | BPA, dibutyl phthalate (DBP) |
| Furniture & Clothing | Plastic parts, dyes | Hexavalent chromium, azo dyes |
| Processed Foods | Packaging films, labels | PFAS (organo-fluorine compounds) |
In particular, even stricter restrictions are planned for PFAS (organofluorine compounds) and phthalates, and it has been pointed out that their use may be banned after 2026.
Obligation to notify and register SVHCs
When supplying products containing SVHC to the EU market, companies are obliged to notify ECHA (European Chemicals Agency).
Conditions for which notice is required
SVHC in the product contains more than 0.1wt%.
Annual EU distribution volume of 1 ton or more
Where and how to submit
Submitted to: ECHA (European Chemicals Agency)
Submission Method:
Create a notice in IUCLID (software provided by ECHA)
Submit online via the ECHA Submission Portal
After submission, ECHA will issue an acknowledgement of receipt (UUID number)
Description (main items)
Manufacturer/Importer Information
Product name, category, application
Name, concentration, and location of SVHC (identified by component)
Safety and Usage Information
■ Points to keep in mind if you do not have an EU base
Japanese companies cannot notify ECHA directly.
Therefore, notification must be made through a legal entity in the EU or a responsible person in the EU.
This mechanism is common not only for cosmetics and chemicals, but also for industrial products in general.
SCIP reporting (mandatory reporting for recycling purposes)
Apart from REACH, SCIP reporting of products containing SVHCs has been mandatory under the Waste Framework Directive since January 2021.
Requirements for SCIP reporting
SVHC in the product contains more than 0.1wt%.
All businesses (manufacturers, importers, distributors) supplying the EU market are eligible
Report Contents
Product information (name, category, features, etc.)
Contained SVHC information (substance name, concentration range, location)
Information on safe use
Submission Method
Create an account with ECHA Cloud Services
Create a report file in IUCLID
Submit through the ECHA Submission Portal
This SCIP data will be registered in a public database that recyclers and municipalities will refer to during the reuse and disposal process.
In other words, this system is designed to protect the environment and make the supply chain transparent.
SVHC Support for Swapsss
Swapsss has a dedicated team of Europe-based professionals who can assist you with
Acting Head of EU
Submission of ECHA Notification and SCIP Report on behalf of ECHA
Supply Chain Survey and Material Analysis Support
Quarterly updated report on the latest SVHC listings
Individual notification and risk alerts when laws are revised
While it is extremely difficult for a Japanese company to comply alone, Swapsss can act as "your company's European branch" and handle practical affairs on your behalf, enabling you to achieve compliance with a minimal burden.
summary
The SVHC of the REACH regulation is one of the most practical and strict systems of chemical substance management in the EU.
Since obligations are based on "concentration" rather than "quantity," it cannot be underestimated that small and medium-sized enterprises and parts manufacturers are also subject to this regulation.
SVHC updates the list twice a year (currently over 240 types)
Obligation to notify when 0.1wt% or more is contained
ECHA notification + SCIP reporting required
Must have a responsible person in charge of EU (if you do not have a base in Europe, you cannot apply)
Swapsss provides comprehensive support for ECHA compliance, proxy applications, and monitoring reports.
Please contact us if you have any questions about REACH/SVHC compliance for your products for Europe.