Identification and Impact of substances of high concern

The European Chemicals Agency (ECHA) has amended the REACH Candidate List, a list of compounds of very high concern (SVHC), more than 25 times. The European Commission requests that EU member states or ECHA include substances on this list. The substance may become a very high concern substance after a detailed review and unanimous approval. The purpose of including a substance on the Candidate list is to promote, so businesses should have the tools and procedures in place to identify them quickly. It is important to choose technologies and substances that are both environmentally friendly and economically feasible. To ensure compliance and customer satisfaction, it’s crucial to control SVHC risks throughout a product’s lifecycle. It is critical for organizations to understand the fundamentals of SVHC in order to understand why monitoring them is becoming more and more important. Article 57 of the directive cites the REACH Directive as supporting the inclusion. To be included on the Candidate List, the substance must meet the following requirements: persistent, bio-accumulative, and toxic, very persistent and bio-accumulative In accordance with Annex XIII of the REACH Regulation, substances must have a half-life longer than the specified period in each matrix (ocean, freshwater or estuarine water, marine sediment, freshwater or estuarine sediment, and soil). As per the Hazardous Substances Directive, a substance must be carcinogenic, mutagenic, or toxic to reproduction, have another chronic toxicity, or be “non-observable” at concentrations under 0.01 mg/L (1 ppm). Over time, the candidate list grows, changes, and evolves. Among the biggest impacts could be the introduction of new materials and technologies that bring more sustainable solutions to the market. The first step towards effective change is to understand the REACH Candidate List and SVHC. As a result of prompt identification, less hazardous substances can be substituted for SVHCs, which facilitates compliance until alternatives are discovered. With ComplianceXL, companies maintain a solution that shows the content and hazards of their products. It identifies SVHCs quickly, alerts customers, and ensures compliance with REACH regulations. The resolute introduction of new technologies and materials demonstrating a company’s commitment to human health, the environment, and sustainability is a hallmark of corporate social responsibility and essential to the success of modern companies affected by SVHC and REACH. Get in touch with us today!!!!

ECHA adds two new substances to the REACH SVHC list.

The European Chemicals Agency (ECHA) has updated the Candidate List of substances of very high concern, which now includes 235 hazardous chemicals. The new chemicals have been added to the REACH SVHC Candidate List to ensure a high level of protection for the environment and the health of humans when it comes to hazardous chemicals, as part of an effort to ensure a high level of protection. It should be noted that one of the chemicals added is toxic for reproduction, whereas the other has persistent and bio accumulative properties. These chemicals are used in various products such as inks, toners, plastic production, and manufacturing processes. Organizations are responsible for managing the risks associated with these chemicals and providing information to customers and consumers about their safe use. Below are the chemicals that are added to the REACH SVHC list. S.No Substance name EC number CAS number Reason for inclusion Examples of use 1 Diphenyl (2,4,6-trimethyl benzoyl) phosphine oxide 278-355-8 75980-60-8 Toxic for reproduction (Article 57c) Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modeling clay. 2 Bis(4-chlorophenyl) sulphone 201-247-9 80-07-9 vPvB (Article 57e) Manufacture of chemicals, plastic products, and rubber products.   The addition of these hazardous chemicals to the Candidate List raises concerns about their potential negative impacts on human health and the environment. Lack of awareness about the presence and risks of these chemicals can lead to unsafe handling and use, posing risks to individuals and the ecosystem. Companies must fulfill their legal obligations under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulations when their substances are included in the Candidate List. Suppliers of articles containing Candidate List substances must provide information to customers and consumers to ensure safe usage. In addition to providing a safety data sheet, suppliers of these articles above a concentration of 0.1 % (weight by weight) must inform their customers and consumers of how to safely use them. Importers, producers, and suppliers of substances on the Candidate List have specific notification and reporting requirements to ECHA to track the presence and concentration of these chemicals. If an article contains a substance on the Candidate List, importers and manufacturers must notify ECHA within six months. Notification and reporting requirements facilitate better monitoring and management of these chemicals, minimizing their negative impact on human health and the environment. ECHA’s addition of two hazardous chemicals to the Candidate List highlights the ongoing effort to identify and regulate substances that can harm people and the environment. Stricter regulations and increased transparency regarding the presence of these chemicals in products contribute to safer handling and usage. ComplianceXL helps organizations with REACH regulatory compliance services in assisting them to collect REACH information for their products. As part of our compliance data management strategy, we also assist our customers in maintaining their supplier certificates and declarations on a regular basis so that they remain up to date. Also, we will provide Maintenance services to our customers to maintain and validate the regulatory documents to make sure accurate those are up-to-date and accurate. FAQ: Q1. What is the Candidate List? A. The Candidate List is a compilation of substances of very high concern identified by the European Chemicals Agency due to their potentially harmful effects on human health or the environment. Q2. What are the benefits of the Candidate List? A. The Candidate List raises awareness about hazardous chemicals, enabling better risk management, safer product usage, and informed consumer choices. It also promotes monitoring and control of these substances, reducing their negative impact.

REACH SVHC List Updated – Now 191 Substances

On the 27 June 2018, the European Chemicals Agency (ECHA) published the new updated REACH Candidate List with 10 new Substances of Very High Concern (SVHCs). Substances on REACH SVHC list are: substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 or 2; persistent, bio-accumulative and toxic (PBT) substances; or very persistent and very bio-accumulative (vPvB) substances; any substances with evidence of similar concern, such as endocrine disruptors. The European Chemicals Agency (ECHA) has added 10 new Substances of Very High Concern (SVHC) to the Candidate List, taking the total number of substances to 191. The substances included in the Candidate List for authorization are: Octamethylcyclotetrasiloxane (D4) (CAS no. 556-67-2) Decamethylcyclopentasiloxane (D5) (CAS no. 541-02-6) Dodecamethylcyclohexasiloxane (D6) (CAS no. 540-97-6) Lead (CAS no. 7439-92-1) Disodium octaborate (CAS no. 12008-41-2) Benzo[ghi]perylene (CAS no. 191-24-2) Terphenyl hydrogenated (CAS no. 61788-32-7) Ethylenediamine (EDA) (CAS no. 107-15-3) Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA) (CAS no. 552-30-7) Dicyclohexyl phthalate (DCHP) (CAS no. 84-61-7) These substances are found in a variety of products from personal care, adhesives, sealants, plastics, and PVC. This list of the new SVHC requires companies to verify and identify where the substance is used, in both semi-finished and finished products. If the amount exceeds the defined threshold limits, companies must appropriately notify ECHA, and their customers too. Companies manufacturing or selling products in the European Union (EU) will now need to identify the presence of these SVHCs in articles above the threshold of 0.1 percent w/w, and communicate their presence in articles within six months of June 27, 2018, to downstream users. It is important to keep a constant check on this SVHC list since it is a legal obligation for all the manufacturers. If manufacturer’s article contains any substance included in the SVHC list in the concentration above 0.1% (w/w), they need to fulfill the following obligations: Duty to communication information on SVHCs – REACH article 33; Notification of SVHC in articles to ECHA- REACH article 7(2); Not only articles, but companies also need to check their products contain any substances on REACH restricted substance list. Do you want to know more on best compliance practices? Connect to our compliance specialists at [email protected].

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