An Overview of REACH SVHCs (Substances of Very High Concern): Understanding SVHCs and Compliance
The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) is a European Union (EU) regulation introduced in 2006. Its primary aim is to safeguard human health and the environment by enhancing transparency and knowledge surrounding chemical substances used within the EU while promoting the adoption of safer alternatives. For companies manufacturing products in the EU, understanding and complying with REACH, particularly regarding Substances of Very High Concern (SVHCs), is crucial. In this article, we will provide an overview of REACH SVHCs, the chemicals they encompass, and their significance in ensuring compliance with REACH.
What Are SVHCs?
Substances of Very High Concern, commonly abbreviated as SVHCs, constitute a specific category of chemical compounds that fall under the regulatory framework of the European Union's REACH regulation. SVHCs may exhibit various hazardous properties, including:
Carcinogenicity (the ability to cause cancer)
Mutagenicity (the ability to induce genetic mutations)
Toxicity to reproduction (harmful effects on fertility and unborn children)
Bioaccumulation (the tendency to accumulate in living organisms and move up the food chain).
Substances are identified and designated as SVHCs due to their potential to pose significant risks to human health and the environment.
Health Concerns: SVHCs, such as lead compounds and phthalates, can have detrimental effects on human health. These substances may lead to developmental issues, reproductive problems, or even cancer when exposed to them over time.
Environmental Impact: Some SVHCs, like certain flame retardants, have been found to persist in the environment for extended periods, accumulating in ecosystems and posing threats to wildlife. Substances that accumulate in living organisms can move up the food chain, concentrating in higher-level predators. This bioaccumulation can ultimately affect the environment and human health (for example, when consuming contaminated seafood).
Regulations Governing the Use of SVHCs in Products
Using SVHCs in your products is not banned entirely, but requires authorization to be used in any product.
The EU imposes stringent restrictions on the concentration of SVHCs in products, limiting them to 0.1% of the total product weight, across all types of products. The monitoring and reporting of SVHCs are integral components of REACH compliance, as Article 33(1) of the REACH regulation requires manufacturers and importers of products in the EU to inform customers about the presence of Substances of Very High Concern (SVHCs) in their products if these substances surpass a concentration of 0.1% weight by weight. Additionally, they must offer instructions for the safe utilization of the product.
What Chemicals Are Included as SVHCs?
The list of SVHCs is not static; it evolves as new data and research emerge. Currently, there are over 200 SVHCs, and this list continues to grow as more chemicals are scrutinized. You can find a full list of SVHCs on the European Chemicals Agency (ECHA) Candidate List.
SVHCs encompass a wide range of substances. Here are a few examples of substances on the list of SVHCs:
Phthalates: This class of chemicals is commonly found in plastics, cosmetics, and various other consumer products. Some phthalates have been linked to adverse health effects. Several phthalates are included on the list of SVHCs because they are toxic for reproduction.
Lead: Lead, found in various products like paints and batteries, is known for its toxicity, especially in children.
Bisphenol A (BPA): Often used in the production of polycarbonate (PC) and epoxy resins, BPA can interfere with hormones and reproduction, potentially affecting human health. BPA is listed on the SVHC list as 4,4'-isopropylidenediphenol.
Formaldehyde: Widely used in the production of resins, adhesives, and various household products, formaldehyde is recognized for its potential carcinogenic properties. Exposure to formaldehyde can lead to respiratory issues and skin irritation. It is included on the list of SVHCs due to its classification as a carcinogen.
Ensuring REACH Compliance with QIMA
SVHCs represent a critical aspect of the EU's commitment to safeguarding human health and the environment. Companies manufacturing products in the EU must stay vigilant about the inclusion of SVHCs in their products and take the necessary steps to ensure compliance with REACH regulations. By understanding the significance of SVHCs and partnering with experts like QIMA, businesses can not only meet their legal obligations but also contribute to a safer and more sustainable future.
Our regulatory experts at QIMA can help you understand and ensure compliance with all relevant requirements under REACH, including those surrounding SVHCs. We offer compliance solutions that help businesses identify, assess, and manage the presence of SVHCs in their products. Our expertise and experience in regulatory compliance and laboratory testing make us a valuable ally for companies striving to meet REACH requirements.
Join over 30,000 global brands and book your REACH testing today.
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