REACH restrics chemicals, heavy metals, and other substances in consumer products. When it comes to Substance of Very High Concern (SVHC)s, additional notification requirements apply to importers and manufacturers if a product contains an SVHC above a certain percentage.
In this guide, we explain what Substance of Very High Concern (SVHC)s are and list some of the more common SVHCs – such as DIPP, DPP, formaldehyde, and cadmium nitrate.
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 that is part of the SVHC Candidate List is regulated under REACH.
If a substance fulfills one or more of the criteria of Article 57 of REACH Regulation, then member states or the ECHA can propose to add it to the SVHC Candidate List. Here are some of the most important criteria:
a. The substance is deemed to be CMR 1 or CMR 2 carcinogen, mutagen, or toxic for reproduction
b. The substance is deemed to be a PBT (persistent, bioaccumulative, and toxic) according to Annex III of REACH
c. The substance has the potential to cause endocrine issues
When a proposal is made, the ECHA initiates a 45 days public consultation period with the goal of assessing 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 the 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, importers or manufacturers of products containing SVHCs in concentration over 0.1% weight by weight (w/w) must notify the substances’ presence in their products to the ECHA.
The notification process consists in registering and entering the required data on the SCIP (Substances of Concern In articles as such or in complex objects (Products)) database, which is established under the Waste Framework Directive.
Also, importers and manufacturers must notify their customers of the presence of SVHC in their products when the SVHC content exceeds 0.1% by weight if requested to do so.
Further, companies that import or manufacture chemicals listed as SVHC in an amount greater than 1 ton per year, must register with the ECHA as well.
Are SVHCs allowed in consumer products?
Importers and manufacturers are allowed to use SVHCs in their products, 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 products that might contain SVHC:
- Footwear might contain DPP, among other SVHCs (DPP)
- Textiles might contain DIPP, among other SVHCs
- Shampoo might contain 1,4-Dioxane, among other SVHCs
- Dyes might contain nitrobenzene, among other SVHCs
- Porcelain might contain Cadmium nitrate, among other SVHCs
What is the difference between SVHCs and substances listed in Annex XVII?
The SVHC is a list of hazardous chemicals to humans. Suppliers selling products that contain more than 0.1% by weight of SVHCs must abide by the notification requirements listed above.
Annex XVII of the REACH regulation is a list of hazardous substances, mixtures, or articles that are restricted in the EU market. The restriction methods are different for different substances. The processes and requirements to introduce a new substance to Annex XVII are explained in Articles 68 and 69 of REACH.
For example, PBB is not allowed to be used in textile articles that are intended to come into contact with the skin. As another example, the concentration level of benzene in the free state shall not exceed 0.0005% by weight in toys.
Below we list examples of substances on the SVHC Candidate List.
Dipentyl phthalate (DPP)
Dipentyl phthalate (DPP) is an SVHC that is identified by the ECHA as toxic for reproduction and may impair fertility and cause harm to the unborn child. The main use of DPP is as a plasticizer in polyvinyl chloride (PVC). Examples of PVC consumer products include:
Diisopentyl phthalate (DIPP)
Diisoheptyl phthalate (DIPP) is an SVHC that is identified by the ECHA as a toxic substance that harms fertility and causes harm to the unborn child. Examples of consumer products that may contain DIPP include:
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 could disrupt the endocrine properties of human beings and pollute the air, water, and soil. Examples of products that might contain this group of chemicals are:
- Coating products
4-Nonylphenol, branched and linear, ethoxylated
4-Nonylphenol, branched and linear, ethoxylated is a group of closely related chemicals that are on the SVHC Candidate List because they are endocrine disruptors which could lead to development issues and might be related to breast cancer. Examples of products that might contain this group of chemicals are:
- Food packaging
- Cleaning products
- Cosmetic products
Cadmium nitrate is identified as an SVHC because it is a carcinogenic and mutagenic substance. It can cause adverse effects on multiple organs after repeated exposure, especially to the kidney and bone. Examples of consumer products that might contain cadmium nitrate include:
- Glass (painting)
- Porcelain (painting)
- Cadmium-nickel sinter plates of storage batteries
1,4-Dioxane is identified as an SVHC because it can be carcinogenic to humans and pollute the drinking water and air. Exposures to 1,4-Dioxane over a shorter amount of time can cause damage to the liver, kidney, and respiratory system.
1,4-Dioxane is used as stabilizers for chlorinated solvents such as trichloroethane and trichloroethylene. It usually gets into the environment from accidental spills of solvents that contain it as a stabilizer. Examples of products that might contain 1,4-Dioxane include:
- Bubble bath
- Laundry detergent
- Skin cleanser
Nitrobenzene is identified as an SVHC because it can cause reproductive damage to humans. Repeated exposures to high levels can result in blood disorders in people and cause bluish skin, nausea, vomiting, and shortness of breath.
Nitrobenzene is used mainly as an intermediate to produce aniline. Nitrobenzene is also used to produce lubricating oils such as those used in motors and machinery. Products that might contain nitrobenzene include:
- Synthetic rubber
O-toluidine is an SVHC because it is a carcinogen and it is highly toxic to humans when absorbed through the skin, inhaled as a vapor, or swallowed.
Short-term exposure of humans to o-toluidine can cause blood disorder and central nervous system depression. O-toluidine is mainly used to produce dyes. It is also used in the manufacture of products such as:
- Hypnotic and anesthetic pharmaceuticals
You can find more information on the ECHA’s website.
Is the SVHC list updated?
The SVHC list is updated frequently. The latest update of the SVHC list took place in July 2021, with an addition of 8 substances:
- 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers
- Orthoboric acid, sodium salt
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.
Step 1: Member states or ECHA should inform all interested parties of their intention to propose one or more substances to be identified as the SVHCs. These parties include manufacturers, importers, distributors, wholesalers, distributors, or others in the supply chain of the products.
Step 2: The proposal to add a substance to the SVHC list is published in the registry of intentions on ECHA’s website.
SVHC proposal preparation
Step 3: The proposal of the Member States or ECHA 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 for the follow-up process (the uses, volumes, and possible alternatives to the substance).
Step 4: The proposal is examined according to the requirements of Annex XV of REACH and published on ECHA’s website once it passes the check.
Step 5: After the publication of the proposal, ECHA invites all interested parties to submit comments or provide further information in a 45 day the consultation period
Adding substances to the SVHC Candidate List
Step 6: If ECHA does not receive any comments challenging the identification of the substance, then the proposed substances are included directly in the SVHC Candidate List.
If the committee does not reach an agreement, the issue is referred to the European Commission for final determination.
Can SVHCs be listed on Annex XVII?
Yes. a substance listed on the SVHCs List can also be listed on REACH Annex XVII. However, if a substance is listed as an SVHC, it does not mean that it is also automatically listed on Annex XVII or vice versa.
As an example, lead was added to the SVHCs List in June 2018, as it was deemed toxic for reproduction. However, it was already restricted by REACH Annex XVII to be used in:
a. Jewelry < 0.05% by weight
b. Articles that might be placed in the mouth by children under reasonable conditions < 0.05% by weight
As another example, asbestos fibers are not on the SVHC Candidate List anymore because they have been prohibited to be used in every context by REACH Annex XVII.
How do I know if a certain product or material contains an SVHC?
As mentioned, notification requirements apply if your product contains a certain amount of a REACH SVHC listed substance. But, how do you know if a certain product or material contains an SVHC in the first place?
In theory, you’d just ask the supplier and receive a complete bill of substances. However, it is extremely rare that suppliers outside the EU can provide such documentation, especially when working with manufacturers in lower-cost countries.
The only option, if you really need to be sure, is to book third-party lab testing which also covers relevant SVHC tests.
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 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.
It’s also worth mentioning that REACH SVHC testing is often more expensive than REACH Annex XVII 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.