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.
Content Overview
We Help Brands & Importers With Product Compliance (US & EU)
- Book a free consultation call today with Ivan Malloci to learn how we can help you with:
- Product Requirements Lists
- Product Certification
- Product & Packaging Labeling
- Lab Testing
BOOK A FREE CONSULTATION
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.
SVHC Examples
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:
- Power cables
- Flooring
- Blood bags
- Footwear
- Electrical cables
- Packaging
- Stationery
- Toys
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:
- 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 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:
- Paints
- Coating products
- Adhesives
- Sealants
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:
- Detergents
- Food packaging
- Cleaning products
- Cosmetic products
Cadmium nitrate
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
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
- Shampoo
- Laundry detergent
- Soap
- Skin cleanser
- Adhesives
- Antifreeze
Nitrobenzene
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:
- Dyes
- Drugs
- Pesticides
- Synthetic rubber
O-toluidine
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:
- Rubber
- Tire
- Pesticides
- 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
- BMP
- TBNPA
- 2,3-DBPA
- Glutaral
- MCCP
- PDDP
- 1,4-dioxane
- 4,4′-(1-methylpropylidene)bisphenol
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
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.
Consultation
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.
FAQs
What are substances of very high concern SVHC? ›
Substances that may have serious effects on human health and the environment can be identified as substances of very high concern (SVHCs). These are primarily substances which are carcinogenic, mutagenic or toxic to reproduction as well as substances with persistent and bio-accumulative characteristics.
How many substances are on the REACH SVHC list? ›REACH SVHC list is not a static list and it is updated frequently. Up to 17 Jan 2023, there are 233 substances/entries on the SVHC candidate list.
What is the REACH criteria for substances of very high concern? ›SVHCs are substances that have hazards with serious consequences. For example, they cause cancer, or they have other hazardous properties and/or remain in the environment for a long time with their amounts in animals gradually building up.
What is SVHC on the candidate list? ›The identification of a substance as a Substance of Very High Concern (SVHC) and its inclusion in the Candidate List can trigger certain legal obligations for the importers, producers and suppliers of an article that contains such a substance.
Which substance is excluded from REACH? ›The registration and authorisation components of REACH do not apply to substances in the following categories: Scientific research and development. Food and feedstuffs. Medicinal products.
What are the six categories of hazardous substance? ›- Class 1: explosives.
- Class 2: flammable gases.
- Class 3: flammable liquids.
- Class 4: flammable solids.
- Class 5: oxidising substances.
- Class 6: substances toxic to people.
- Class 8: corrosive substances.
- Class 9: substances toxic to the environment.
They have different aims, and the requirements are different. Under EU REACH, substance data must be collected from suppliers and provided to customers when a Substance of Very High Concern (SVHC) is present over the allowed threshold.
What substances are included in REACH? ›- Human and veterinary medicines.
- Food and foodstuff additives.
- Plant protection products and biocides.
- Isolated intermediates.
- Substances used for research and development.
The objective of this priority list is to rank substances across all NPL hazardous waste sites to provide guidance in selecting which substances will be the subject of toxicological profiles prepared by ATSDR.
How do you determine REACH compliance? ›To determine REACH compliance, companies must identify and manage the risks linked to the substances they manufacture market to the EU. They have to demonstrate to ECHA (European Chemicals Agency) how they've made sure the substance can be safely used without harming the end customer.
What is SVHC compliance? ›
Substances of Very High Concern (SVHC) testing provides business, consumers, and end-users with the assurance that tested products and materials do not contain a detrimental amount of chemicals that are hazardous to human health and the environment.
How do you comply with REACH chemical regulations? ›To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
How often is SVHC list updated? ›The EU REACH SVHC List is typically updated twice per year, resulting in affected companies needing to re-evaluate their product compliance and possibly re-collect substance data from their suppliers.
How do you check if a substance is REACH registered? ›The REACH Registered Substances List and Pre-registered Substances List can be found on ECHA's website. Companies can check whether their substances have been pre-registered or registered by other companies.
What are materials of concern? ›Materials of Concern means any waste, substance or material that is classified, regulated, defined or designated under Environmental Law as radioactive, explosive, highly flammable, hazardous or toxic or as a contaminant or a pollutant, or for which liability or standards of conduct may be imposed, including petroleum ...
Are medicines exempt from REACH? ›Chemicals used in finished pharmaceutical products (drug active, excipients) as well as certain intermediates are exempt from the REACH Registration, Evaluation and Authorisation processes.
Does REACH apply to food? ›(Article 2(6)(d) of the REACH Regulation). The reason for these exemptions is that Regulation (EC) No 178/2002 on food safety already requires that food for humans and feed for animals cannot be placed on the market unless they are safe. REACH does not affect the application of the EU legislation on foodstuffs.
Does REACH apply to metals? ›EC Regulation 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The regulations require all 'substances', which includes all metals, to be registered under REACH.
What are the 7 main groups of hazardous substances? ›- Class 1: Explosives.
- Class 2: Gases.
- Class 3: Flammable liquids.
- Class 4: Flammable solids.
- Class 5: Oxidising substances.
- Class 6: Toxic substances.
- Class 7: Radioactive material.
- Class 8: Corrosive substances.
- Explosive (Symbol: exploding bomb)
- Flammable (Symbol: flame)
- Oxidising (Symbol: flame over circle)
- Corrosive (Symbol: corrosion)
- Acute toxicity (Symbol: skull and crossbones)
- Hazardous to the environment (Symbol: environment)
What are 5 harmful substances? ›
- Asbestos.
- Formaldehyde.
- Hazardous/Toxic Air Pollutants.
- Lead.
- Mercury.
- Per- and Polyfluoroalkyl Substances (PFAS)
- Pesticide Chemicals. Glyphosate.
- Polychlorinated Biphenyls (PCBs)
REACH is a European Regulation and is an acronym for the Registration, Evaluation, Authorisation and Restriction of Chemicals. The overall aims of REACH are to: Provide a high level of protection of human health and the environment from the use of chemicals. Allow free movement of substances on the EU market.
What are the REACH limits? ›Restrictions are regulatory measures to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market or use of a substance.
Who needs to be REACH compliant? ›You must comply with REACH if you manufacture or supply articles, or are importing articles from outside the EU. REACH may also apply to a chemical substance you recover from waste in quantities of one tonne or more per calendar year. Some chemical substances are partially or completely exempt from REACH.
How many chemicals are in REACH? ›The REACH Regulation went into effect on June 1, 2007 and has been described as the most complex created by the EU. It will affect industries worldwide and applies to all chemicals manufactured, used, or present in products in the EU. This may apply to as many as 143,000 substances.
What are the restricted substances list Annex XVII of REACH? ›Some substances are literally banned by REACH annex XVII. These substances include Polychlorinated terphenyls (PCTs),asbestos fibres, pentachlorophenol and and its salts and esters, and monomethyl-tetrachlorodiphenyl methane. Many of them are persistent organic pollutants (POPs).
What is restricted substance? ›Special restricted substances are S4D substances that are also listed in Appendix B and are commonly referred to as S4B medicines. They include some barbiturates and anabolic and androgenic steroidal agents. S4B medicines have more stringent dispensing requirements than other S4D medicines.
What is meant by a substance 2 list the points of? ›A substance can not be separated by any physical method. The properties/composition of a pure substance is fixed. Examples of substances are sugar as well as iron.
What is the deadliest material? ›Botulinum toxin, is basically the most lethal poison known to man. An average 70 kg human being only would have to take around 100 nanograms of this protein to die (it has an LD50 of 1.5–2.0 ng/kg).
Why restricted substances list is important? ›Why restricted substances list is important? or Why RSL is important? Implementing RSL and conducting RSL testing allows companies to build brand identity, win consumer confidence and at the same time protect consumer health and the environment by identifying and eliminating harmful substances from their supply chains.
How do you calculate REACH example? ›
The basic formula for calculating reach is impressions divided by frequency (reach = impressions/frequency).
What is the difference between RoHS and REACH compliance? ›The main difference between RoHS and REACH is that RoHS bans substances that are present in electronics and is specific to the aforementioned 6 hazardous materials. REACH, however, pertains to all chemicals including those used to make a product. This can include materials, solvents, paints, chemicals, and more.
What is REACH formula? ›How to calculate reach in advertising is simple: Reach = Impressions/Frequency. It is an average of the gross reach over the course of the life of an ad campaign.
What is the difference between REACH Annex XVII and REACH SVHC? ›The main difference between Annex XVII and the SVHC Candidate List is the level of substance control and the specific requirements.
What does it mean to be REACH compliant? ›REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) compliance deals with the regulations that were created to improve the environment and protect human health. REACH addresses the risks associated with chemicals and promotes alternative methods for the hazard assessment of substances.
When was SVHC last updated? ›On 10 June 2022, the European Chemicals Agency (ECHA) published the 27th update of the REACH candidate list1. One (1) new Substance of Very High Concern (SVHC) was added.
What are the five rules of chemical safety? ›- 1 Learn the hazard communication standard. ...
- 2 Train employees about chemical hazards. ...
- 3 Provide safety data sheets (SDSs) ...
- 4 Label all containers of hazardous chemicals. ...
- 5 Create a written hazard communication program.
Don't mix chemicals.
What are the four hazardous substances? ›- biological agents - such as fungi, bacteria, viruses.
- natural substances - such as grain, flour or enzyme dusts.
- substances generated by work - such as soldering or welding fumes, or wood dust.
- chemical products used or produced at work - such as adhesives or cleaning agents.
There are generally five types of toxicities; chemical, biological, physical, radioactive and behavioural. Disease-causing microorganisms and parasites are toxic in a broad sense but are generally called pathogens rather than toxicants.
What are the five classifications of substances hazardous to health? ›
- chemicals.
- products containing chemicals.
- fumes.
- dusts.
- vapours.
- mists.
- nanotechnology.
- gases and asphyxiating gases and.
Therefore, Substances of Concern (SoC) are co-formulants in biocidal products, in addition to the active substance, which can pose a potential risk for humans and the environment. The Biocidal Products Regulation states explicitly that SoCs must be included in the risk assessment.
What are the 9 main groups of hazardous substances? ›There are 9 hazardous substances symbols you need to know: flammable, oxidising, explosives, gas under pressure, toxic, serious health hazard, health hazard, corrosive and environmental hazard. Read more about them and examples of each here.
What are the 3 harmful substances? ›- Asbestos. Asbestos is a material used in a wide variety of applications, including pipe insulation, drywall, flooring, ceiling insulation, and roofing. ...
- Pesticides. ...
- Paint Fumes.
GHS uses three hazard classes: Health Hazards, Physical Hazards and Environmental Hazards. These aren't required by OSHA. Health hazards present dangers to human health (i.e. breathing or vision) while physical hazards cause damage to the body (like skin corrosion).
What are the 5 factors of toxicity? ›- Form and Innate Chemical Activity.
- Dosage.
- Exposure Route.
- Absorption.
- Alcohol. ...
- Antianxiety and sedative drugs. ...
- Caffeine.
- Cannabis (including marijuana. ...
- Hallucinogens. ...
- Inhalants. ...
- Opioids. ...
- Stimulants (including amphetamines.
- Asbestos.
- Formaldehyde.
- Hazardous/Toxic Air Pollutants.
- Lead.
- Mercury.
- Per- and Polyfluoroalkyl Substances (PFAS)
- Pesticide Chemicals. Glyphosate.
- Polychlorinated Biphenyls (PCBs)
If you are unsure, always check with the product's supplier. The labels of hazardous chemicals usually contain the words 'danger' or 'warning', along with relevant pictograms and details of hazards.
What is an example of substance of concern? ›Substances of Concern means chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, radioactive materials, petroleum and petroleum products.
What is an example of a harmful substance? ›
Radon in basements, lead in drinking water, exhausts from cars and chemicals released from landfills are just a few examples of toxic substances that can hurt you. By understanding how, you can reduce your exposure to chemicals and reduce your risk of harmful health effects.
How do you categorize a substance? ›If it is pure, the substance is either an element or a compound. If a substance can be separated into its elements, it is a compound. If a substance is not chemically pure, it is either a heterogeneous mixture or a homogeneous mixture. If its composition is uniform throughout, it is a homogeneous mixture.