Environmental Assessment

REACH SVHC COMPLIANCE

EU REACH is a European Regulation for chemicals control. Importantly, REACH SVHC and Annex XVII apply to product manufacturers, importers, and distributors.

REACH SVHC and Annex XVII Current Lists

The current EU REACH SVHC list in PDF and Excel formats:

REACH SVHC

REACH 233 SVHC Table

Latest Version of the SVHC REACH Substances List

REACH 233 SVHC Table

Latest Version of the SVHC REACH Substances List

The current EU REACH Annex XVII list in PDF and Excel formats:

Annex XVII Table

Latest Version of Annex XVII - Restrictions List

Annex XVII Table

Latest Version of Annex XVII - Restrictions List

REACH Testing - The Enviropass Approach

EU REACH SVHC testing is similar to RoHS: your suppliers and subcontractors can provide all the necessary documentation to help get started. The documentary approach also allows easy monitoring of product compliance throughout the growing Candidate list.

This method offers the best value for your SVHC declaration and certificate of compliance under the EU REACH SVHC law and the REACH Annex XVII, avoiding dozens of expensive analyses for potentially dangerous substances that a sample may contain.

REACH Enviropass

CLASSIC REACH SVHC

By using Classic REACH, you allow Enviropass to undertake the documentary assessment of your products, including:

  • Up-to-date data collection with your suppliers/subcontractors;
  • Quality validation of documents and risk analysis;
  • Preparation of analysis results and certificates of compliance.

 

You can access REACH and RoHS testing services together at a bundled rate!

DELUXE REACH SVHC

In addition to the Classic REACH service, Deluxe REACH gives you the tools to take control of REACH compliance.  Deluxe REACH includes:

  • Customized training on products auditing, allowing you to conduct the analyses and to update yourself on the declarations of conformity (DoC);
  • Auditing your REACH risk assessments.

Online REACH Training

A unique online training on EU REACH, SVHC, and SCIP compliance is now available! 

What is the EU REACH Regulation?

REACH is an acronym for Registration, Evaluation, Authorization, and restriction of Chemicals.

This term is also the title of the European regulation No 1907/2006/EC of 18 December 2006.

Article 1.1 of the REACH regulation defines the purpose of REACH as ensuring a high level of protection of the environmental and human health in the European Union.

Does REACH SVHC Apply to Any Product?

Almost! Substances in pure form, preparations and mixtures are in the REACH scope. The scope also includes products, referred to as articles in the regulation.

As a result, most manufactured goods must be REACH compliant, such as electronic devices, medical equipment, furniture, batteries, instruments, hardware, solder, adhesives, ink cartridges, etc. Contrary to RoHS Europe, REACH also regulates product packaging.  

Some exclusions do apply, such as the products from the drugs, food, petroleum, and nuclear industries.

REACH SVHC Scope

What are the EU REACH SVHCs?

SVHC stands for Substances of Very High Concern. Every six months, SVHCs get added to a so-called Candidate list. Often, many products we buy will contain SVHCs. High-tech devices such as electronics are often good candidates. There are, for example:

  • Lead
  • 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME) (CAS No. 110-71-4)
  • Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins, SCCPs) (CAS No. 85535-84-8)
  • Diarsenic trioxide (CAS No. 1327-53-3)
  • 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) (CAS  No. 71888-89-6)
  • Perfluorohexane-1-sulfonic acid and its salts (PFHxS) (CAS No. 355-46-4)
  • And dozens of other substances.

Why Regulate Substances of Very High Concern?

Cancer is the second leading cause of death globally, and about 1 in 6 deaths is due to cancer, according to the World Health Organisation (WHO). Scientists have identified 3 external causes:

  • physical carcinogens, such as ultraviolet and ionizing radiation
  • biological carcinogens, such as infections from certain viruses, bacteria, or parasites; and
  • chemical carcinogens. This term includes asbestos, aflatoxin (a food contaminant), components of tobacco smoke, and arsenic (a drinking water contaminant).

We find SVHCs in this last category of chemical carcinogens. Other SVHCs are mutagen, reproductive toxicant, (very) persistent, (very) bioaccumulative (vPvB), toxic (some also see regulation in the USA, under TSCA PBT), or endocrine disruptors.

The following additional criteria for new SVHCs are under consideration:

  • Persistent, mobile, and toxic substances (PMTs), and
  • Very Persistent, Very Mobile substances (vPvMs).

Certain SVHCs only have probable effects on human health and the environment, but the precautionary principle applies.

EU REACH SVHC Obligations

Obligation

Communication of information on substances in articles

(REACH chapter 3)

Legal basis in REACH RegulationREACH, article 33
Actors concernedArticle suppliers
Substances concernedSubstances included in the Candidate List of Substances of Very High Concern for authorization
Tonnage threshold
Concentration in article threshold0.1% (w/w)

When an SVHC is present in 0.1% by weight equal to or greater than 0.1% of a given article that constitutes a more complex article, it is mandatory to inform the consumer and, subject to certain conditions, to notify the European Chemicals Agency (ECHA).

Sufficient information on any SVHC present in your products, at the article level, above the 0.1% threshold, must be made available to the consumer or client. Additionally, if any SVHC present in your products exceeds one ton per producer/importer and per year, then you must notify ECHA.

As a result, disclosing no SVHCs is equivalent to stating that the product contains none. Since the SVHC list is updated every six months, it is critical to maintain an up-to-date technical file.

The SCIP Notification of REACH SVHC

The European Chemicals Agency (ECHA) has been developing the SCIP database for greater transparency, and to enhance data sharing.

SCIP stands for Substances of Concern In articles, as such, or in complex objects (Products).

REACH SCIP SVHC

As of January 5th, 2021, any newly sold product containing at least one SVHC above the declaration threshold will have to figure on the SCIP web-based database.

Here is a tutorial and tips on SCIP notifications.

What is Considered an Article under EU REACH?

Article definition under REACH

REACH regulations contain a technical definition for article:

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. – Article 3(3).

Since 10-Sep-2015, the Court of Justice of the European Union (CJEU) has decided that producers must disclose any SVHC above 0.1% w/w in every article that constitutes a product.

This rule is also called once an article, always an article.

The REACH Annex XVII

Annex XVII restricts specific hazardous chemicals in certain applications, substances, mixtures, and articles. This list is distinct from the one that contains the SVHCs.

For example, according to Annex XVII, nickel and its compounds can not be present in parts that can come into direct and prolonged contact with human skin. This restriction includes buttons, casings, or viewfinders with a nickel finish.

REACH Record Keeping

Per Article 36 of the REACH regulation, it is mandatory to retain all REACH information (like reported SVHCs) for at least ten years after the last article gets placed into the EU market.

What if I am EU REACH non-Compliant?

The European Commission publishes non-compliant articles on the Safety Gate RAPEX website (Rapid Alert System for Non-Food Products).

Rapex REACH SVHC

Products that don’t have proper SVHC declarations or don’t comply with the REACH Annex XVII are subject to withdrawal from the European Union market.

Surveillance authorities may also order product recalls.

Other obligations may also apply to your products, like RoHSPOP halogen-freeBPR if biocides are present. In such cases, you may need to produce Safety Data Sheets (SDS).

The History of REACH

In 2001, the European Commission agreed on a Strategy for a future Community Policy for Chemicals.

The completed text of the REACH law released on 30-Dec-2006, and the REACH chemical regulation came into effect six months later on 1-Jun-2007. Since then, these laws have gradually entered into force and recognition. Article 33 on SVHC has joined suit, deploying various guidelines over the years.

REACH-like Regulations Worldwide

Other countries outside the European Union have developed Europe REACH-like regulations, such as Korea (K-REACH) and Turkey. In the USA and Canada, regulations for toxic substances also fall under specific acts.

The US TSCA

This US federal Toxic Substances Control Act (TSCA) was enacted in 1976 to manage hazardous chemicals in commerce. The Environmental Protection Agency (EPA) uses modern TSCA to strengthen its role in evaluating and regulating chemicals, notably subtances that are persistent, bio-accumulative, and toxic (PBTs).

The Canadian CMP

Like the US TSCA, the Canadian Chemicals Management Plan (CMP) is managed federally – in this case, by the Minister of Environment and Climate Change and the Minister of Health Canada. These bodies place candidate substances on a Priority Substances List (PSL): depending on the outcome of the assessment, targeted candidates join the List of Toxic Substances. Candidates placed on the toxic substances list are subject to preventive and control actions.

Contact Enviropass to assess the REACH compliance of your products.