What Are REACH Substances of Very High Concern? - Assent (2024)

What Are REACH Substances of Very High Concern? - Assent (1)Substances of very high concern (SVHCs) are chemicals that have serious effects on human health or the environment. These chemicals may be individual substances or present in articles contained within a complex product. Some examples of the criteria for these substances, as stated in Article 57 of the EU REACH Regulation, include substances that are carcinogenic, mutagenic, bio-accumulative, or toxic for reproduction. Individual substances and articles within products may not contain an SVHC over the allotted 0.1 percent weight by weight threshold.

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How Are Substances Identified as SVHCs?

What Are REACH Substances of Very High Concern? - Assent (2)

Member states or ECHA identify substances as SVHCs. In the first step of this process, a dossier is prepared to explain why the substance meets the criteria established in Article 57 of REACH. A list of proposed substances is then published to the ECHA website. This publication gives interested parties — including companies importing, manufacturing, or using the substance in the EU — the opportunity to comment on the addition of the substance. Following this comment period, the substance is either automatically added to the Candidate List, or it is referred to the Member State Committee for further deliberation if comments have been made.

Company Obligations Once an SVHC Is Added to the Candidate List

Once a substance has been added to the Candidate List, companies manufacturing, importing, or using the substance in the EU have immediate legal obligations to fulfill. Companies must notify ECHA if a substance listed on the Candidate List is present in their articles above the specified threshold, or in quantities totaling more than one metric ton per year. Notification must be made no later than six months after inclusion of the substance on the Candidate List. Suppliers of articles that contain an SVHC above the threshold have a legal obligation to provide information on safe use of the article to their customers under Article 33 of REACH. Companies should also be aware of other requirements they may be in scope of, such as Authorisation and Restriction requirements, to ensure they are conducting comprehensive due diligence.

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What Are REACH Substances of Very High Concern? - Assent (2024)

FAQs

What Are REACH Substances of Very High Concern? - Assent? ›

Substances of very high concern (SVHCs) are chemicals that have serious effects on human health or the environment. These chemicals may be individual substances or present in articles contained within a complex product.

What products are articles under REACH? ›

According to REACH, an article refers to an object which, during production, is given a special shape, surface or design that determines its function to a greater degree than its chemical composition does. Examples include toys, textiles, packaging, furniture, etc.

Are SVHC and REACH the same? ›

The most hazardous substances in REACH can be designated as Substances of Very High Concern (SVHCs) and after a sunset date their use will only be allowed if authorised.

What is the REACH limit for SVHC reporting? ›

Article 33(1) of the REACH Regulation states that manufacturers and importers of articles (products) are required to notify their customers of the presence of any Substances of Very High Concern (SVHC) in their products exceeding 0.1% by weight and provide instructions on safe use of the product.

What is REACH material? ›

REACH is the EU regulation governing the manufacture and import of chemical substances. REACH is an acronym for the “registration, evaluation and authorization of chemicals” and has been in force in all EU Member States since June 1, 2007.

What substances are covered by REACH? ›

Some substances, covered by more specific legislation, have tailored provisions under UK REACH, including:
  • Human and veterinary medicines.
  • Food and foodstuff additives.
  • Plant protection products and biocides.
  • Isolated intermediates.
  • Substances used for research and development.
Sep 20, 2022

How do I know if my product is REACH compliant? ›

To determine REACH compliance, companies must identify and manage the risks linked to the substances they manufacture and 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 REACH Regulation 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 substances are restricted under the REACH list? ›

Typical hazardous substances that are restricted in products include lead, AZO dyes, DMF, PAHs, Phthalates, PFOS, the nickel release and so on.

How many substances are there in SVHC list? ›

On 23rd January 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs. With the addition of five new substances, the current list of SVHCs now contains 240 substances. Manufacture of another substance; formulation of mixtures and in fuel products.

What are the elements of REACH? ›

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.

Do US companies have to comply with REACH? ›

American and other non-EU companies selling products into the European Union must comply with an EU regulatory program known as Registration, Evaluation, Authorisation & Restriction of Chemicals, more commonly known by its acronym "REACH." EU REACH is a complex system of regulations that can severely impede the ability ...

What is required for REACH compliance? ›

The key elements of REACH compliance are for companies to register details of all chemical substances they manufacture or import into Europe in quantities above 1 tonne per year; assess any potential risks to human health or the environment associated with these substances; and provide safety information about them so ...

What are articles as defined in REACH? ›

An article is defined in REACH as 'an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition'. In a general sense, an article can usually be considered to be a finished product.

Does REACH apply to articles? ›

REACH Registration

Companies producing or importing articles must register in REACH any substance contained in an article, on the condition that the following two conditions are complied with: The substance is intended to be released by the article within its normal conditions of use.

What products need to REACH compliance? ›

REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH applies to all chemical substances, both those needed for industrial processes and those we use in our everyday lives, in paints, cleaning products, clothes, furniture and electrical appliances, for example.

What are the categories of REACH? ›

REACH uses 5 descriptors such as sector of use (SU), process category (PROC), product category (PC), article category (AC) and environmental release category (ERC) to describe identified uses (see table below).

References

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