REACH Toward 242 SVHC

The European Chemicals Agency (ECHA) has announced two new REACH substances of very high concern (SVHC) of 242 SVHC. Let’s discover them!

The 2 New Chemicals for a Total of 242 SVHC

On March 1st, 2024, Norway proposed Bis(α,α-dimethylbenzyl) peroxide and France TPhP to the candidate list of SVHCs. What are these two chemicals?

Substance Name	CAS #	Hazards	Applications (Where used)	References
Bis(α,α-dimethylbenzyl) peroxide	201-279-3	Reprotoxic	Production of plastic and rubber goods, as well as chemicals. Items incorporating wood (such as flooring, furniture, and toys), stone, plaster, cement, glass, or ceramics (like dishes, cookware, food containers), and plastics (including food packaging, mobile phones, and toys).	1
Triphenyl phosphate (TPhP)	204-112-2	Endocrine disruptor	TPhP is a flame retardant and a plasticizer in polymer formulations, adhesives, sealants, cosmetics, and personal care items. Its utilization extends to consumers, professional workers, formulation or repackaging processes, industrial sites, and manufacturing. Furthermore, TPhP is often present as an impurity in various organophosphate flame retardants or as part of this compound family.	2

May you find these SVHCs in your products?

The List of 242 SVHC

First, ECHA maintains the Candidate List of SVHCs under the REACH regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals). Further, the Candidate List is regularly updated (every six months) with substances meeting the criteria for identification as SVHCs, which may include substances posing risks to human health or the environment.

The current candidate list is available on our EU REACH main page.

What are the 242 SVHC?

As discussed above, SVHC stands for “Substance of Very High Concern.” SVHCs are chemical substances that experts identify as potentially posing a risk to human health or the environment within the European Union (EU). SVHCs are subject to regulatory scrutiny to be part of the Candidate List maintained by ECHA under the REACH regulation.

Scientists identify chemicals as SVHCs for various reasons, including:

Carcinogenic, mutagenic, or toxic to reproduction (CMR) properties.
Persistence, bioaccumulation, and toxicity (PBT) characteristics.
Endocrine-disrupting properties.
Concerns regarding similar severe effects on the environment or human health.

What Happens When an SVHC is on the Candidate List?

Once a substance appears in the Candidate List as an SVHC, it may eventually be subject to authorization, restriction, or other regulatory measures under REACH. Companies must communicate information about SVHCs in their products along the supply chain and may have specific obligations related to SVHCs depending on their use and concentration. For example, SVHCs above a threshold of 0.1% in every component of an article must appear on the public SCIP database. Consequently, millions of articles containing SVHCs appear on the SCIP database.

A Summary of the EU REACH Obligations

The EU REACH regulation imposes various obligations on companies involved in the production, import, or use of chemical substances in the EU. Here’s a summary of some of the obligations under REACH:

1. Registration:

Manufacturers and importers must register substances they produce or import in one tonne or more per year. Registration involves providing information about the substance’s properties, uses, and potential hazards.

2. Evaluation:

ECHA evaluates registered substances to ensure compliance with REACH requirements. This obligation includes assessing the safety of substances and verifying the completeness and accuracy of registration dossiers.

3. Authorization:

Producers of certain SVHCs, including carcinogens, mutagens, and reproductive toxins, must apply to ECHA. Then, ECHA decides if they authorize these substances, subject to specified deadlines and conditions.

4. Restriction:

REACH empowers the EU to restrict the manufacturing, placing on the market, or use of substances posing unacceptable risks to human health or the environment. Restrictions may include bans on certain substances or their use in specific applications.

5. Communication:

Companies must communicate information on hazardous substances throughout the supply chain. This requirement includes providing safety data sheets (SDS) to downstream users and consumers and notifying ECHA of substances of very high concern (SVHCs) present in articles.

6. SVHCs:

ECHA maintains a Candidate List of SVHCs based on their hazardous properties. Companies must notify ECHA when their products contain SVHCs above specified concentration thresholds and provide safe use information to recipients. See above for more details.

7. Duty to Substantiate Safe Use:

Manufacturers and importers must ensure that the substances they place on the market are safe when customers use them. As a result, they may have to conduct chemical safety assessments and implement risk management measures. An SDS plays an important role here.

To sum up, compliance with REACH is crucial for ensuring the safe production, use, and trade of chemicals in the European Union while protecting human health and the environment. Additionally, non-compliance with REACH obligations can result in penalties and legal consequences for companies.

For any questions on SVHCs and REACH compliance, contact Enviropass!