Understanding EU REACH Compliance Requirements

What Is the EU REACH Regulation?

REACH stands for: Registration, Evaluation, Authorization and Restriction of Chemicals.

This EU regulation aims to protect consumers from manufactured chemicals known to be hazardous to human health while promoting competitiveness for companies that take consumer safety seriously.

REACH covers virtually every kind of products, from industrial products to those intended for personal use. It states 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). This resource provides an overview of EU REACH compliance requirements to help you ensure your products can be sold on the EU market.

Who Is Required to Register with ECHA?

Under the EU REACH regulation, manufacturers and importers of chemical substances are generally required to register their substances with (ECHA) if they meet certain criteria. You are obligated to register if the substances you produce or import into the European Economic Area (EEA) exceed quantities of one ton or more per year (this is on a per manufacturer/importer per substance basis).

The following entities are typically obligated to register under REACH:

Manufacturers: Any company that produces chemical substances within the EEA is required to register those substances. This includes manufacturers of individual substances, as well as producers of mixtures or finished products that release substances under normal or reasonably foreseeable conditions of use.

Importers: Companies that import chemical substances into the EEA in quantities of one ton or more per year are also required to register those substances. This applies regardless of whether the substances are imported as individual chemicals, mixtures, or contained in finished products.

Only Representatives: Non-EEA manufacturers that do not have a physical presence within the EEA can appoint an Only Representative (OR) to fulfill their registration obligations on their behalf. The OR, which must be based in the EEA, assumes the responsibility for registration, ensuring compliance with REACH requirements.

One of the goals of REACH is to limit redundancies for compliant companies. As such, after registering through an OR, non-EEA companies are able to conduct business with other domestic importing companies without having to register again. If you register your substance through an OR, the importer is considered a “downstream user” and is not required to make an additional registration of the substance in question.

The EU REACH Framework Explained

The regulation is designed to protect human health by promoting alternative substances to more hazardous substances. This is achieved through organizing chemicals into three lists: The Candidate List of substances of very high concern (SVHC), the Authorisation List (Annex XIV), and the Restricted List (Annex XVII).

Under REACH, there are several lists that classify and regulate different types of chemicals. These lists include:

Candidate List of Substances of Very High Concern (SVHC): The Candidate List is a compilation of substances that are identified as being hazardous to human health or the environment. These substances are deemed to have properties such as carcinogenicity, mutagenicity, toxicity to reproduction, or persistence and bioaccumulation. Being listed in the Candidate List is the first step towards potential authorization and subsequent restriction or ban of these substances.

Authorization List (Annex XIV): The Authorization List includes substances from the Candidate List that require explicit authorization for their use. Companies must apply for authorization if they wish to continue using these substances in their products or processes. Authorization is granted if it is demonstrated that the risks associated with the substance can be adequately controlled or if the socioeconomic benefits outweigh the risks.

Restriction List (Annex XVII): The Restriction List outlines substances, mixtures, or articles that are subject to specific restrictions or bans within the EU. These restrictions pertain to the manufacturing, selling, or use of the substances due to their hazardous properties.

It is important to note that these lists are dynamic and subject to regular updates as new scientific information becomes available or as the need for additional regulation arises. The purpose of these lists is to provide transparency, encourage the substitution of hazardous substances with safer alternatives, and ultimately ensure the protection of human health and the environment within the EU.

How to Comply with EU REACH

It is the responsibility of the manufacturers and importers to gather and provide adequate safety and use information on the substances being registered. The registration process involves submitting a registration dossier to the ECHA, which includes information on the substance identity, classification and labeling, physicochemical properties, toxicological data, and guidance on safe use.

In order to bring products to the EU market, a company or their OR, must:

• Identify the properties, uses, and potential risks associated with the substances they produce

• Demonstrate an ability to manage those risks to ECHA

• Establish safe use guidelines for their product that guarantees the product does not pose a health threat

It is important to note that there are certain exemptions and reduced registration requirements for certain types of substances, such as substances used in research and development, substances used for product and process-oriented research, and substances of low concern (e.g., naturally occurring substances).

Failure to comply with the registration requirements of REACH can result in legal consequences, including restrictions on the manufacture or importation of the substances and potential financial penalties.

Steps to Ensure EU REACH Compliance

According to ECHA and the European Commission, the burden of compliance is on domestic manufacturers and importers to ensure all hazardous substances they use are properly documented.

To determine whether or not you are in compliance, follow the steps below:

Step 1: Determine whether or not you are exempt

ECHA exempts some substances from REACH registration under the following scenarios:

• Chemical substances manufactured or imported into the EU in quantities below 1 metric ton

• Chemical substances are used for research and development

• Chemical substances are considered waste

• Chemical substances whose uses are covered by other EU legislation such as medicine and food products

• Pesticides and biocides

• Chemicals in polymers

• Companies that had notified chemical substances under previous EU legislation (Directive 67/548/EEC)

Step 2: Chemical substance inventory

If you aren’t exempt from REACH, the next step is taking an inventory of chemicals used in your products. The Restricted List (Annex XVII) is the first database to cross reference to see if the chemicals in your product are restricted under the regulation. If so, and you manufacture or import over one metric ton per year, you must proceed with registration. Next, check the Authorisation List (Annex XIV) to see if your chemicals require authorisation for use. If you manufacture or import over the one metric ton volume threshold, you must apply for authorisation with ECHA. Lastly, check the Candidate List (SVHC) for chemicals that may become restricted to prepare your supply chain for any future compliance requirements.

Step 3: Submit an inquiry dossier for your chemical substance(s).

If any chemicals over one metric ton are listed in Annex XVII, you must file an inquiry with ECHA. By filing an inquiry, you are letting ECHA know you intend to register your chemicals and they will help guide you through the registration process. ECHA will connect you with other registrants who have already submitted a dossier for any chemicals you are registering. This helps save time by encouraging information sharing between registrants and allowing you to focus on other aspects of your application.

Step 4: Submit a joint or individual registration

Once you have shared information with other registrants filing for the same chemical, a lead registrant is chosen who will submit their application first. If no other registrant uses the same chemical that is in your product, you must develop a dossier and register individually. ECHA will evaluate the dossier and verify payment to fully process your registration. Once completed, ECHA will issue a registration number to lead registrants, and all other members of the join-registration are then allowed to apply to receive their individual registration numbers.

For new registrants, REACH compliance requires third-party testing as part of the technical evaluation of a product. For companies that aren’t sure what chemicals are in their products, and therefore whether or not REACH applies, it is recommended third-party testing is conducted on their products.

Is Your Company at Risk of Non-Compliance?

The low threshold requirement for registration of one metric ton creates challenges and opportunities for growing companies. If you are a manufacturer or importer and haven’t taken the necessary steps to prepare for your registration, you could be non-compliant. This can yield significant penalties and fines amounting to hundreds of thousands of Euros.

At-risk scenarios might exist for companies with:

• Sudden production spikes due to acute increased demand

• Sales that are subject to political and socioeconomic influence, particularly within the EU (e.g. environmental policy shifts)

• Components from China that do not have supply chain visibility

QIMA can ensure no unregistered chemicals fall through the cracks.

The Benefits of EU REACH Compliance

While EU REACH compliance can appear daunting, there are benefits to ensuring your product meets the requirements. REACH is one of the strictest chemical regulations in the world, and if you are in compliance in the EU, your product will pass chemical requirements for any other market.

Other benefits include:

• Increasing your quality control measures with your suppliers

• Eliminating harmful chemicals from your supply chain

• Reducing your company’s risk of regulatory violations

• Gaining access to the entire European market

• Promoting safe environmental and human health practices to your customers

EU REACH compliance requirements are important to be aware of for any company looking to sell products in the EU. QIMA offers REACH compliance testing to help support your ECHA registration requirements. If you are still uncertain if your products are subject to REACH, QIMA can help you determine the conditions that would require you to file a registration.

More Resources

• RoHS vs. REACH Explained - Learn the difference between two strict EU regulations and how they reduce the use of harmful chemicals in products.