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This method offers the best value for your SVHC declaration and certificate of compliance under the REACH SVHC law and the 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.
By using Classic REACH, you allow Enviropass to undertake the documentary assessment of your products, including:
Note that you can apply for both REACH and RoHS testing services at a lower cost.
In addition to the Classic REACH service, Deluxe REACH gives you the tools to take control of REACH compliance. Deluxe REACH includes:
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.
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.
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:
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:
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:
Certain SVHCs only have probable effects on human health and the environment, but the precautionary principle applies.
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.
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 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.
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.
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.
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.
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).
Countries such as Korea and Turkey have enacted REACH-like regulations. In the USA and Canada, toxic substances are also regulated in specific acts.
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.
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.