What is REACH?

What is REACH?

The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) (EC 1907/2006) is a safety regulation that was implemented by the European Union (EU) to prevent the use of certain toxic chemical substances in products manufactured, sold, and imported within the European Union (EU). 

Why Was REACH Created?

REACH was enacted in order to protect human health and the environment through better and earlier detection of harmful chemical substances. The substances restricted under REACH’s regulations have proven links to a myriad of health effects, including:

• High blood pressure
• Kidney damage
• Cardiovascular disease
• Reproductive issues
• Cancer

They also can have lasting effects on the environment including toxicity to aquatic life, loss in biodiversity, decreased growth in plants and animals, and negative health effects in vertebrates. 

Which Substances Are Covered in REACH?

There are currently 240 substances listed on REACH’s Substances of Very High Concern List as of January 2024. The list includes substances such as lead carbonates and sulfates, chloroethene, benzene, asbestos fibers, mercury compounds, arsenic compounds, cadmium, and more. 

The full list of restricted substances can be found on the European Chemicals Agency (ECHA) website.

How Often Does REACH Add New Substances To Its List?

REACH updates its list twice a year in January and June. To remain compliant, it is important that manufacturers regularly check and update their compliance status as REACH’s regulations change to reflect new and emerging substance threats. 

Who Does REACH Apply To?

REACH applies to manufacturers and importers who either produce goods in or import goods to the European Union. While some other entities may also have compliance obligations under REACH, manufacturers and importers are the primary bearers of responsibility for compliance. 

The Four Fundamentals of REACH:  

Registration

REACH requires the registration of chemical substances manufactured or imported into the EU in quantities exceeding 1 metric ton per year. REACH assigns the registration obligation on manufacturer and importer. Registrations are submitted to the European Chemicals Agency (ECHA) through their website.  

The registration dossier must contain information including: 

• Hazard information
• Assessment of the risks the substances may pose
• How to control these risks
• Properties and uses

These evaluations must be done prior to manufacturing or importing goods in the EU. 

Substances over 10 tons per year must also have a chemical safety assessment and be recorded in the chemical safety report as part of the dossier. The assessment will look at hazard assessment (classification, PBT conclusions and dose characterization) as well as exposure assessment (scenarios and exposure limits).

It is important to note that there is a duty to ensure registration information stays up to date with any new or relevant information. This record keeping is a critical part of remaining in compliance with REACH.

Evaluation

Dossiers are considered “living documents.” As such, they must be regularly kept up to date with the ever-changing requirements of REACH. 

To ensure that registrations are being kept up to date the ECHA will examine the quality of the registration. REACH evaluation is done through Dossier and Substance Evaluations.  

• Dossier Evaluation requires ECHA to perform a compliance check on minimum 5% of the dossiers submitted for registration. At which ECHA then notifies the registrant of any deficiencies.
• Substance Evaluation requires ECHA and the EU Member States to select 30 highly used chemical substances annually to be placed on the “Community Rolling Action Plan”, commonly referred to as “CoRAP”, for further evaluation. Each Member State has a designated agency that performs the evaluation, and it is not performed by ECHA. Chemical substances placed on the CoRAP may eventually be added to the restriction lists.  

Authorization

All companies that wish to use chemical substances identified as a “substance of very high concern” (SVHC) within the EU must obtain use-authorization. The authorization process aims to ensure that SVHCs are progressively replaced by less dangerous substances or alternative technologies.  

Per REACH Article 33, companies must declare the presence of SVHCs at a concentration above 0.1% weight by weight (w/w) at the article level. Companies are required to provide the names of any SVHCs present in their products, along with any safe use information for those substances (must be provided within 45 days of request). After companies complete this process, they are permitted to use the declared SVHCs.

Restriction of CHemicals

Restrictions are usually limits or bans for SVHC substances. They can apply to substances, mixtures or articles. Restrictions are applied to substances that pose an unacceptable risk to human or environmental health. The restrictions are specific and not blanket bans.

A “public intention to prepare” must be made in the registry of intentions and within 12 months, a proposal for restriction must be made public and contain the identity and justifications, such as identified risks and information on alternatives to be accepted and includes a consultation period.

Substances of Concern in Products (SCIP)

Any article containing SVHCs must be declared to the ECHA so that this information can be made available to waste operators and consumers. In order to make data sharing under REACH more accessible, ECHA has added a database called Substances of Concern in Products (SCIP). Any newly sold product (post 2021) containing at least one SVHC above the declaration threshold will need to be registered. This falls under the Waste framework Directive (WFD), that works on management of SVHC containing articles at end of life.

Who Is Responsible For What Under REACH?

According to the ECHA website:

Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.

Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.

In conclusion, REACH places the responsibility of compliance on companies that manufacture and market in the EU. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. Manufacturers and importers are required to know if they are using any SVHCs, if so, demonstrate their safe handling procedures to ECHA, and communicate the risk management measures to their users. Companies must register this information in a central database in the European Chemicals Agency (ECHA) in Helsinki.