REACH svhc COMPLIANCE

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REACH SVHC and Annex XVII Current Lists

Download
REACH 209 SVHC Table
The Latest Version of the SVHC REACH Substances List
REACH 209.pdf
Adobe Acrobat Document 558.9 KB
Download
Annex XVII Table
The Latest Version of the Annex XVII - Restrictions List
REACH Restriction List Annex XVII August
Adobe Acrobat Document 684.1 KB

REACH Testing - The Enviropass Approach

REACH Enviropass

Just like Europe RoHSREACH SVHC testing can be performed using documentation provided by your suppliers and subcontractors. Get a free demo from Enviropass!

 

This method offers the best value for your SVHC declaration and certificate of compliance under the REACH SVHC law and the REACH Annex XVII, avoiding you dozens of expensive analysis for potentially dangerous substances present in a tested product.


The documentary approach also allows easy monitoring of product compliance throughout the growing Candidate list.

CLASSIC REACH

 

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.

Note that you can apply for both REACH and RoHS testing services at a lower cost.

 

 

DELUXE REACH

 

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

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

What is the REACH Regulation?

REACH SVHC

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


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


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 Apply to any Product?

REACH SVHC Scope

Almost! Substances in pure form, preparations & mixtures, as well as products (so-called articles in the regulation) are in the REACH scope.  

 

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, the packaging is also regulated under REACH.  

 

However, some exclusions apply, such as the drugs, food, petroleum, and nuclear industries.

What are the REACH SVHCs?

SVHC stands for Substances of Very High Concern. Every six months, SVHCs are added to a so-called Candidate list.


Several SVHCs are commonly used in the products we buy, such as electronics. 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 Regulating Substances of Very High Concern?

REACH SVHC Cancer

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, such as asbestos, components of tobacco smoke, aflatoxin (a food contaminant), 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 (PBT), and/or endocrine disruptors.

 

The following additional criteria of new SVHCs are being considered:

  • 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.

The SVHC Obligations

Obligation

Communication of information on substances in articles

(REACH chapter 3)

Legal basis in REACH Regulation

REACH, article 33

Actors concerned

Article suppliers

Substances concerned

Substances included in the Candidate List of Substances of Very High Concern for authorization

Tonnage threshold

-

Concentration in article threshold

0.1% (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 the professional customer. Additionally, if any SVHC present in your products exceeds a total of one ton per producer/importer and per year, then ECHA must be notified.

 

As a result, if you don't disclose any SVHC, you are stating that none of them are contained in the product you introduced into the EU market. Since the SVHC list is updated every 6 months, it is critical to maintaining your technical file up-to-date.

The SCIP Notification of SVHC

 

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

 

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

 

 

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

 


What is Considered as an Article under REACH?

This is a key definition when it comes to declaring SVHCs. An article is defined 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'' article 3(3)

 

Since September 10th, 2015, the Court of Justice of the European Union (CJEU) has decided that producers must disclose any SVHC that is above 0.1 % weight by weight in every article that constitutes a product. This the 'Once an article, always an article' rule.

The REACH Annex XVII

Another list, different from the SVHC list, restricts the use of certain hazardous chemicals, in certain applications, substances, mixtures, and articles. This is the annex XVII.

 

 

For example, according to the annex XVII, nickel and nickel compounds, can not be present in parts that can come into direct and prolonged contact with a user's skin, such as buttons, casing or viewfinders, with a nickel finish.

REACH Record Keeping

Per article 36 of the REACH regulation, it is mandatory to keep the REACH information, like the reported SVHCs for at least ten years after the last article with placed into the EU market.

What if I don't Comply with REACH?

Rapex REACH SVHC

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

 


Products that don't have proper SVHC declarations or don't comply with the REACH Annex XVII can be withdrawn from the whole European Union market. Surveillance authorities may also order product recalls.

The History of REACH

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


On December 30th, 2006 the completed text of the REACH law was published.


The REACH chemical regulation came into effect on June 1st, 2007.  Since then, it has gradually entered into force.  Article 33 on SVHC has also been deploying itself over the years.


Other countries developed Europe REACH like regulations, such as Korea (K-REACH).

REACH-like Regulations Worldwide

Countries such as Korea and Turkey have enacted REACH-like regulations. In the USA and Canada, toxic substances are also regulated in specific acts.

The US TSCA

This US federal Toxic Substances Control Act (TSCA) was enacted in 1976 to manage hazardous chemicals in commerce. The TSCA is currently being modernized to strengthen the role of the Environmental Protection Agency (EPA) in evaluating and regulating potentially hazardous chemicals.

The Canadian CMP

Like the US TSCA,  the Canadian Chemicals Management Plan (CMP) is managed at the federal level, by both the Minister of Environment and Climate Change and the Minister of Health Canada. Candidate substances are assessed through a Priority Substances List (PSL). Then, depending on the outcome of the assessment, they are recommended for addition to the List of Toxic Substances. When a substance is on the toxic substances list, then a preventive and control actions are implemented.

Please contact Enviropass to assess the REACH compliance of your products.

Enviropass Expertise Inc.

Suite 211 - 1750 St-Louis

Montreal, H4L 5N4, Quebec, Canada

Tel: +1 (514) 887-7871