SVHC (Substances of Very High Concern) are substances that pose serious concern for human health or the environment; They have properties such as carcinogenic, mutagenic, toxic to the reproductive system and PBT/vPvB.
What is SVHC?
SVHC is the abbreviation of the expression “Sustances of Very High Concern” and is referred to as substances of high concern in Turkish. They are defined with the same logic in the EU REACH Regulation and its Turkish counterpart KKDIK: substances that may have serious, often irreversible, effects on human health or the environment.
A substance is defined as SVHC in one of three ways:
- CMR: carcinogenic, mutagenic or toxic to reproduction, category 1A or 1B.
- PBT / vPvB: persistent, bioaccumulative and toxic; or very persistent and very bioaccumulative.
- Equivalent concern: substances that cause the same level of concern as those above, such as endocrine disruptors.
Substances with these properties are first placed on the Candidate List. This is not a list of banned substances. It triggers information obligations and is the first step towards possible inclusion in the authorisation list. For classification information, see hazard classes and H statements.
These substances are candidate listed and may be subject to authorization over time. If SVHC is present in the goods above a certain concentration and tonnage, notification and information obligation arises.
ONAY Mühendislik assesses the SVHC status in your products and manages reporting obligations.
Consequences of Being on the SVHC List
Designating a substance as a substance of very high concern does not directly prohibit that substance; but it initiates chain obligations. If the substance is present in the goods in excess of one thousandth by weight, the party supplying the goods is obliged to provide safe usage information to the buyer. Additionally, the substance may be included in the list of substances subject to authorization in the future; This means that use without permission stops after a certain date.
Substance in Goods Declaration
The liability covers not only companies that produce chemicals, but also companies that produce and import goods. It is possible for SVHC to be present in article parts such as cable insulation, gaskets, coatings, paint layers or electronic components. Importers of articles should therefore request a composition declaration from their suppliers and consider the notification obligation for substances exceeding the threshold.
Collecting Information from the Supply Chain
In practice, the most challenging step is obtaining reliable composition information from the multi-echelon supply chain. General declarations of conformity are not sufficient; It should be clearly stated which update of which list the declaration is based on and for which part it is given. Adding a notification obligation to contracts in case the list is updated greatly reduces the burden of subsequent collective inquiries.
Alternative Substance Evaluation
The search for a substitute for an SVHC-listed substance is much more cost-effective when conducted before the authorization process begins. In the evaluation of substitutes, not only technical performance, but also the alternative substance's own hazard profile and regulatory future should be taken into account. Switching to an alternative with a similar structure may mean experiencing the same problem again in a few years.
Certification and Audit Preparation
The basic document requested in audits is the record showing which product or article was compared with which version of the SVHC list on which date. Keeping this record date stamped proves that the company has fulfilled its obligation on that date if the list is updated later. When no records are kept, compliance cannot be demonstrated even if the substance is not found.
Frequently asked questions about SVHC
What does SVHC mean?
SVHC is an abbreviation for Substances of Very High Concern; These are articles whose Turkish language is of high importance. It identifies substances that can have serious and often irreversible effects on human health or the environment.
By what characteristics does a substance qualify as SVHC?
Carcinogenic, mutagenic or toxic to reproduction (CMR) category 1A or 1B; be persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB); or endocrine disruptors, the substance may be designated as SVHC if it causes equivalent concern.
Does being on the SVHC list mean that the substance is prohibited?
No. Being on the candidate list does not directly ban the substance; It initiates the obligation to inform in the supply chain and paves the way for the substance to be included in the list of substances subject to authorization in the future.
What is the threshold for SVHC in articles?
If the SVHC in the goods is above one thousandth (0.1%) by weight, the party supplying the goods is obliged to provide the buyer with sufficient information for safe use.
Related pages
Contact ONAY Mühendislik for your process.
Official full text of the regulation: KKDIK Regulation - Official Gazette.