Certain chemicals are classified as Substances of Very High Concern (SVHCs) under the REACH regulation. Products and mixtures containing SVHCs can be subject to reporting requirements.
This guide addresses some common questions concerning SVHCs and explores the REACH requirements affecting articles containing SVHCs. Additionally, we explain the differences between SVHCs and restricted substances under Annex XVII of REACH.
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What is a Substance of Very High Concern (SVHC)?
The European Chemicals Agency (ECHA) defines a Substance of Very High Concern (SVHC) as a “substance that may have serious and often irreversible effects on human health and the environment”. Any substance part of the SVHC Candidate List is regulated under REACH.
If a substance fulfils one or more of the criteria of Article 57 of the REACH Regulation, then member states or the ECHA can propose to add it to the SVHC Candidate List. Here are some examples of the criteria:
a. The substance is classified as a CMR substance of category 1A or category 1B under the CLP Regulation
b. The substance is deemed to be a PBT (persistent, bioaccumulative, and toxic) according to Annex XIII of REACH
c. The substance has the potential to cause endocrine issues
When a proposal is made, the ECHA initiates a 45-day public consultation period to assess if the substance should be included in the SVHC Candidate List. If the ECHA doesn’t receive any adverse comments, the substance is included in the list. If the ECHA receives adverse comments and its committee doesn’t reach an agreement, then a final decision is made by the European Commission.
You can browse the list on the ECHA website.
Are SVHCs banned?
A substance that is included in the SVHC Candidate List is not banned. However, there are other requirements to consider.
If an article contains SVHC content above 0.1% by weight, importers and manufacturers have a duty to:
a. Submit a notification about the article to ECHA through the SCIP database.
b. Provide recipients of the articles such as distributors with sufficient information such as the name of the SVHC and information for the safe use of the article.
c. Notify their customers of the presence of SVHC in their products if requested.
Additionally, when SVHCs are present in articles in quantities over a tonne per year and the individual product contains SVHCs in concentration over 0.1% by weight, a notification of the SVHC’s presence must be made to ECHA.
In this case, you must prepare a report using the IUCLID software and submit the notification through REACH-IT.
SVHCs can be included in the authorisation list (Annex XIV of REACH). Substances listed here are prohibited unless authorisation is granted or exemptions apply.
Are SVHCs allowed in consumer products?
Importers and manufacturers are allowed to use SVHCs in their articles, as long as they comply with the notification requirements outlined in the previous section. Therefore, it is likely that some consumer products sold in the EU market contain SVHCs. Here we list some examples of SVHCs and articles that may contain them.
| SVHC | Examples of articles |
| 1,4-Dioxane |
|
| Bumetrizole |
|
| Bis(α,α-dimethylbenzyl) peroxide |
|
| Melamine |
|
| Glutaral |
|
| Barium diboron tetraoxide |
|
| 4-tert-butylphenol |
|
| Octamethylcyclotetrasiloxane |
|
What is the difference between SVHCs and substances listed in Annex XVII?
The SVHC is a list of substances that may pose serious risks to humans and the environment. Companies selling articles that contain more than 0.1% by weight of SVHCs must abide by the notification requirements listed above and have duties owed to consumers and other recipients of their products.
Annex XVII of the REACH Regulation is a list that contains prohibitions and conditional restrictions affecting substances, mixtures, and articles. The restriction differs depending on the substance.
Here are some examples of restrictions affecting the use of substances listed in Annex XVII:
a. PBBs cannot be used in textile articles intended to come into contact with the skin.
b. The concentration level of benzene in the free state must not exceed 0.0005% by weight in toys or parts of it.
SVHC Examples
Here we list examples of substances on the SVHC Candidate List.
Phthalates
There are several phthalates that ECHA identifies as SVHCs. These are substances that may adversely affect fertility and an unborn child. Furthermore, they can be toxic to aquatic life.
Here are some examples of phthalates that are listed as SVHCs:
- BBP
- DEHP
- DBP
- DPP
Here are some examples of products that may contain such phthalates::
- Textiles
- Clothing
- Footwear
- Accessories
Formaldehyde, oligomeric reaction products with aniline
Formaldehyde, an oligomeric reaction product with aniline is a group of related chemicals that are in the SVHCs Candidate List because they contain carcinogenic and skin sensitising properties. The risks due to exposure include organ damage, cancer, and allergic skin reactions. Additionally, it is very toxic to aquatic life.
Here are some examples of products that may contain the SVHC:
- Plastic products
- Coating products
Melamine
ECHA identifies melamine as an SVHC because it has carcinogenic properties and may be endocrine disrupting. The risks that it may pose include damage to organs with repeated exposure, cancer, and damage to unborn children.
Here are some examples of products that may contain melamine:
- Construction materials
- Foot-wear
- Leather products
- Paper and cardboard products
Bis(4-chlorophenyl) sulphone
This substance is an SVHC as it may have persistent, bioaccumulative and toxic properties. Exposure to the substance causes serious eye irritation. Additionally, it can cause harm to aquatic life.
Here we provide some examples of products that may contain this SVHC:
- Textile products
- Flooring
- Construction materials
- Electronic equipment
1,4-dioxane
1,4-Dioxane is identified as an SVHC because it is found to have carcinogenic properties. Exposure to it may cause cancer, serious eye irritation, and respiratory irritation. Additionally, it is highly flammable in liquid and vapour form.
Here are some examples of products that may contain the SVHC:
- Flooring
- Furniture
- Toys
- Construction materials
4,4′-sulphonyldiphenol
This substance is an SVHC because it is toxic to reproduction and endocrine disrupting. The risks it poses include damage to fertility and an unborn child.
Here are some examples of products that may contain the SVHC:
- Furniture
- Toys
- Leather gloves
- Newspapers
- Toilet paper
Is the SVHC list updated?
The SVHC list is updated frequently. At the time we wrote this guide, the latest update of the SVHC list took place in June 2024, with the addition of Bis(α,α-dimethylbenzyl) peroxide.
Currently, there are more than 200 substances on the SVHC Candidate List.
What is the process for listing new SVHCs?
The process to add a substance to the SVHC Candidate List is as follows.
Registry of SVHC intentions until outcome
1. Member states or ECHA (following the European Commission’s request) create a dossier to propose substances to be identified as SVHCs.
2. The proposal is prepared according to the requirements of Annex XV to REACH, which include two main parts:
a. Data and scientific evidence for identifying the substance as an SVHC
b. Further information relevant to the follow-up process (the uses, volumes, and possible alternatives to the substance).
3. The proposal is then published in the registry of intentions on ECHA’s website to notify the public of the proposed SVHC and to give interested members of the public a chance to comment.
Consultation
After the publication of the proposal, ECHA invites all interested parties to submit comments or provide further information in a 45-day consultation period. Consultations occur twice a year. Member states or the ECHA may respond to the comments.
Adding substances to the SVHC Candidate List
If ECHA does not receive any comments challenging the identification of the substance, then the proposed substances are directly added to the SVHC Candidate List.
If a unanimous agreement is not reached, the issue is referred to the European Commission for final determination.
Can SVHCs be listed in Annex XVII?
A substance that is an SVHC can also be listed in Annex XVII. However, it can also be the case that a substance is only listed in either the Candidate List or Annex XVII.
It is important to identify where substances are mentioned, as SVHCs and substances restricted by Annex XVII carry their own requirements. For example, a substance can be restricted under Annex XVII for certain products, while it is considered an SVHC for products not listed.
Here we provide some examples of substances that are mentioned in either lists or both.
| Substance name | Candidate List of SVHC | Annex XVII (examples of restrictions) |
| Lead and its compounds | Listed | Jewelry < 0.05% by weight
Articles that may be placed in the mouth by children under reasonable conditions < 0.05% by weight Articles made in PVC < 0.1% of the PVC material |
| Octamethylcyclotetrasiloxane | Listed | After 6 June 2026, prohibited from being used as a solvent for dry cleaning of textiles, leather and fur |
| Bisphenol A (4,4′-isopropylidenediphenol) | Listed | Thermal paper < 0.02 % by weight |
| Melamine | Listed | Not listed |
| Glutaral | Listed | Not listed |
| Asbestos fibers | Not listed | Prohibited, including in mixtures and articles |
| Toluene | Not listed | Adhesives or spray paints for consumer use < 0.1% by weight |
| Formaldehyde and formaldehyde-releasing substances | Not listed | After 6 August 2026, furniture and wood-based articles < 0.062 mg/m3 release rate
After 6 August 2026, articles other than furniture and wood-based articles < 0,080 mg/m3 release rate |
How do I know if a certain product or material contains an SVHC?
Ideally, your supplier would be aware and notify you whether an article or material supplied by him contains SVHCs. However, it is not always guaranteed that suppliers, especially those from non-EU countries, would have access to such information.
In practice, to identify whether a product or material contains SVHCs, it should be sent to a lab testing company for testing.
How do I know which SVHCs to test for?
Our recommendation is that you ask a lab to assess all applicable substance tests that may apply to a certain product and material. Keep in mind that some labs may only test according to the Annex XVII list by default.
If you want to get your product tested to the SVHC list as well it’s therefore important to mention this to your lab before booking REACH testing.
Where can I find a complete list of SVHCs?
You can visit the official website of ECHA to consult the SVHC Candidate List. Keep in mind that the list is updated periodically. Therefore, if you are an importer or manufacturer of consumer products, you should keep track of the updates.
