We recently published a comprehensive overview and introduction to REACH, and in this article we’ll look in more detail at how REACH works.
In this post:
What Does REACH Stand For?
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It’s a European Union regulation dating from 2007 regarding the safe use of chemicals, written with the aim of improving the protection of human health and the environment from risks posed by chemicals.
REACH requires that the chemical industry has certain and transparent knowledge of the properties of its substances and that it manages and communicates potential risks effectively. It also actively works to reduce testing on animals by promoting alternative methods, and it increases healthy competition between European chemical companies.
Key Takeaways
REACH is an EU regulation that requires the registration of hazardous chemicals
It’s intended to minimise the health and environmental risks of substances
This regulation is applicable to chemical manufacturers, chemical importers, and chemical distributors operating in the EU
Companies must comply by submitting all necessary document to the European Chemical Agency (ECHA) for evaluation
ECHA may either authorise or restrict or even ban certain chemicals
Registration fees vary depending on the type and size of the company
What Companies Does REACH Apply To?
The REACH regulations are actually applicable to the majority of companies in the European Union, as they concern all chemical substances whether they are for use industrially, commercially, or domestically. The regulations relate to any company which intends to manufacture or import a tonne or more per year of a particular chemical or product containing chemicals. For example, that includes household cleaning products, paints, and electrical appliances.
REACH applies to:
- Chemical manufacturers: companies that sell the chemicals they make either directly or through another company
- Chemical importers: companies that buy chemicals, chemical blends or finished products containing chemicals – such as plastic products or furniture – from outside the European Union
- Chemical distributors: you store and distribute chemicals or chemical blends within the EU
- ‘Downstream’ users: companies that use chemicals or chemical blends in any industrial or professional activity
REACH obligations don’t apply to chemical companies established outside the European Union. The responsibility for meeting REACH obligations is with the importers established in the EU.
How Does REACH Work?
To comply with REACH regulations, a company must identify and manage any risk associated with the chemical substances they produce and/or sell within the EU. Responsibility for doing this is firmly placed on the company.
- Companies must register the chemicals they produce or sell, demonstrating how the substance can be used safely and working together with other companies registering the same substance
- These registration documents are sent to the European Chemical Agency (ECHA) for evaluation and the registration of compliance
- The EU Member States evaluate substances if any concerns for human health or the environment are raised.
- Regional authorities and the ECHA’s scientific committees undertake assessments to ascertain whether the risks posed by the chemical substances can be managed
- If the risks aren’t manageable, the substance can be banned, limited or restricted – normally to be replaced by a safer substance
The REACH Registration Process
Any company within the EU that manufactures, distributes, imports, or uses more than one metric tonne of chemicals per year is covered by REACH. Each company is mandated to submit all pertinent documents to ECHA.
The steps for REACH registration are as follows:
- Prepare and submit an enquiry to ECHA – You need to formally enquire if your company is covered by REACH. You can do this online. You must also create a dossier using the latest version of IUCLID.
- Prepare and submit a joint submission – This step is necessary if there are two or more registrants who place the same substance in the market. The registrants must form a Substance Information Exchange Forum (SIEF).
- Register your substance – Submit your dossier for evaluation and pay the fees.
Authorisation and Restriction
Once you have submitted your application for registration to ECHA, your documents will undergo an evaluation process.
Your substance will either be authorised to enter the EU market or certain restrictions in terms of tonnage, formulations, and distribution will be placed on it.
This is particularly true for ‘substances of very high concern’ (SVHCs). These include carcinogenic, mutagenic or toxic for reproduction (CMR) substances, as well as those which are persistent, bioaccumulative and toxic (PBT).
REACH regulations have socio-economic impacts of forcing companies to become more environmentally sustainable by moving away from using SVHCs.
How Much Does REACH Cost?
REACH charges different fees depending on the type of submission and size of company. There are also other costs related to REACH registration, such as safety assessments and research into substitutes if your product doesn’t comply with regulations.
Financial Impact and Benefits
REACH registration entails added costs for companies in terms of technical testing, documentation, and fees.
However, it has far-reaching benefits in terms of improving products, protecting human health, and preventing or mitigating negative environmental impacts.
Conclusion
The main goals of REACH regulation of protecting human health and lowering the environmental risks of chemicals are effectively being accomplished. For example, it’s ensuring that companies are becoming more sustainable in their practices. New technologies are being developed and alternative substances are being used to comply with REACH.
For useful short guides to different aspects of REACH, such as Substances of Very High Concern (SVHCs) and minimisation of animal testing, we recommend reading the excellent Health & Safety Executive resources.