Can you say that you’re certain you know what goes into your product? If you, like most modern companies, deal with an extended supply chain, can you prove definitively that the factory you’ve hired is following all chemical regulations to the letter? What about their subcontractors, processing facilities and raw material suppliers?
Understanding the EU’s REACH Requirements
Over the past fifteen years, the manufacturing world has experienced a sea change when it comes to quality and compliance standards for materials and production. The public also has a better understanding of how hazardous certain industrial chemicals can be, and a greater appreciation for socially responsible production methods.
Products are falling under increased scrutiny, and the companies who source, manufacture and supply these products are seeing the discerning spotlight shine brighter. REACH is both the EU’s response to this scrutiny, and the means to enact it.
What is REACH?
REACH stands for: Registration, Evaluation, Authorization and Restriction of Chemicals.
This European (EU) regulation aims to protect consumers from manufacturing chemicals known to be hazardous to human health while promoting business opportunities for ethical entrepreneurs.
REACH covers virtually every kind of product, from industrial products to those intended for daily personal use. It rules that any substance that either manufactured in or imported into the EU market at a specified volume per year must be registered with the European Chemicals Agency (ECHA).
What Annual Volume of a Substance Requires Registration?
Since 2010, three deadlines have been established for different, progressively lower, thresholds of substance volumes:
- November 30, 2010: Above 1000 metric tons per year required registration.
- May 31, 2013: Between 100 and 1000 metric tons.
- May 31, 2018: Between 1 and 100 metric tons.
(Production is measured against this threshold on a three-year rolling average.)
Who is Responsible for Registering Substances with the ECHA?
EU manufacturers and importers have the ability and responsibility to register substances based on the REACH guidelines. If you are a non-EU company importing into the EU, you must go through an EU-based Only Representative (OR), a company that would act as a legal representative within the EU and register the substances on your behalf. In order to bring products to the EU market, a company, or their OR, must:
- Identify the risks associated with the substances they produce.
- Demonstrate to the ECHA the ability to manage those risks.
- Establish safe use guidelines for their product so that the use of the substance does not pose a health threat.
What Do REACH Regulations Mean for Your Business?
Supply chain visibility is more vital than ever to your company’s success, yet an alarming amount of production still goes on in dark.
In a 2017 survey of QIMA clients, only 11% say they have “full visibility over their suppliers,” and no more than half of clients would say that their products’ safety and regulatory compliance has improved over the past 12 months.
That said, as REACH implementation has taken root in the EU market, product safety and compliance there shows consistent improvement, as failure rates for products tested for REACH compliance have dropped by roughly a third compared to 2016.
REACH for Manufacturers and Importers
As stated, as of May 31, 2018, both EU manufacturers and importers must register substances exceeding the 1 ton/year threshold before their product can reach the market. About 70,000 registrations are expected to be filed before the new deadline.
This new limit has created a glut of registrations, and a potential blindspot for companies, because it is very easy for a company to exceed the a 1 ton per year limit of any substance, particularly for:
- Global companies that ship thousands of products across the globe.
- “Non chemical” industries, like Automotive and Electronic, that might still use large volumes of oil, sealants and similar products.
- Companies who’d previously conducted REACH threshold assessments and, believing that a certain substance’s volume is safely below the 1 ton/year limit, did not anticipate a sudden production spike caused by company mergers or other changes in operations.
Additionally, importing parts, components, or finished products from countries like China can be risky without oversight, because not all Chinese factories produce at, or are even aware of, REACH standards.
QIMA can ensure no unregistered chemicals fall through the cracks.
REACH for Non-EU Companies
Only entities within the EU can register a substance destined for the EU market. To register chemical data, you must do so through a REACH Only Representative (OR), an EU-based entity authorized to register a substance on your behalf.
If you register your substance through an Only Representative, the importing company is considered a Downstream User and is not required to make an additional registration of the substance in question.
One of the goals of REACH is to create incentives for responsible and progressive companies: for example, after registering through an OR, non-EU companies can enjoy greater market flexibility because they can now conduct business with various importing companies.
Importers often wish to avoid registering chemicals, opting to purchase exclusively from already registered companies, so these proactive companies increase their market value once they have successfully registered a substance and stay ahead of all competition who have failed to do the same.
Is Third Party Testing Required for REACH Compliance?
NO, and that can be potentially risky for importing companies who take for granted that their Chinese supply chain is either a) aware of REACH, or b) providing accurate information about their chemicals.
QIMA can relieve you of this unnecessary risk, potentially save you money and protect your brand fidelity. Remember, delivering the data means delivering your product to the market.
The European Market is a conduit to the World Market. Falling behind newer, tougher EU standards will not only lead to serious fines and damaged brand reputation: it will terminate your opportunity to connect with the changing world of higher production standards.
Easily Schedule Your REACH Compliance Tests Online.
Our online platform and mobile application make it easy for you to schedule REACH Compliance tests and receive your results at any time. Book new tests, view pending orders, and access results from your mobile device. Our online platform provides valuable supply chain insights, including a summary of your QC activity, all of your supplier’s quality stats, industry benchmarking data, and more.
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