The European Union’s REACH regulation is a piece of legislation meant to protect human health, ensure worker safety and safeguard the environment through the preemptive identification and, when necessary, restriction of chemical substances used in products manufactured in, and imported into, all EU Member States.
One Substance, One Registration: REACH Streamlines Data Collection
Principally, the use of any chemical substance over a certain volume threshold per year must be registered by the manufacturing or importing company to the European Chemical Agency (ECHA), along with detailed information about its properties, its specified use, its potential risks to the consumer and instructions for proper use and risk mitigation.
Think of REACH as a way for the ECHA to compile a comprehensive database of substances meant for use in both personal and industrial products. Plus, REACH registration procedures--including prior inquiry, data sharing and joint registration--allow to reduce testing redundancies and registration costs to the individual company.
What is the Substance Volume Threshold Requiring Registration?
Since 2010, three deadlines have been established for 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, 2013: Between 100 and 1000 metric tons.
(Production is measured against this threshold on a three-year rolling average.)
What is Required Before Registration?
Inquiry
Before a company can begin the registration process, they must conduct an inquiry with the ECHA to determine if that substance has been previously registered. This is done through an electronic inquiry dossier filled out with as much clarifying details as possible regarding the substance in question.
Once submitted, the ECHA will:
- Find out if the substance has been registered or inquired about previously, and by whom
- Bring companies together so they can share data and submit a joint registration
- Provide inquiring companies with summarized information concerning the substance in question
(While an inquiry is pending, companies are not to begin the registration process or conduct any tests on vertebrate animals.)
Substance Information Exchange Forum (SIEF)
Once the ECHA has addressed your inquiry, they will direct you towards other companies who’ve previously registered or inquired about the same substance so that details about your usage and testing results can be exchanged.
If the substance in question has been previously registered, you will join an existing SIEF and share your information as well as the costs of your testing and analysis. Otherwise, a new SIEF will be developed.
Data Sharing
Data sharing amongst manufacturing and importing companies seeking to register the same substance is key to REACH’s streamlined approach to organizing substances. Companies are required to work together to register as a group so registration costs can be shared and redundant testing -- particularly on vertebrate animals -- can be avoided. The ECHA stipulates: “New studies on vertebrate animals cannot be repeated.”
Ready to Register?
Once the data has been agreed upon by all participating registrants, the registration process can commence. Companies collaborating over the same substance are expected to submit a Joint registration.
The registering company or companies must compile a technical dossier and, when necessary, a chemical safety dossier, all to the purpose of explaining in detail:
- The properties of the substance
- Its intended use
- Potential health and safety risks to consumer, worker and the environment -- including all relevant physicochemical, toxicological and ecotoxicological information
- Consumer usage instructions and emergency safety procedures
Once registered, the ECHA makes the compiled substance information available on its website so that the public can stay informed about a substance’s properties and hazardous potential.
From this infographic you can see registration statistics from each EU Member State.
Obtaining and maintaining REACH compliance requires consistent attention to production methods and your supply chain. If you are a larger company, or are principally contracting a factory overseas, it can be challenging to stay on top of REACH requirements--particularly as the latest threshold limit deadline nears.
QIMA can provide quality third-party lab testing and on-site inspections--from the factory floor, not what the factory wants you to test--to ensure your product meets all REACH requirements and is ready to reach the EU market.
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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