How Substances Are Placed On the Authorisation List

How Substances Are Placed On the Authorisation List

In an effort to remove harmful substances from the European market, the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation restricts the use of substances that pose a threat to the public and environment. There are four REACH substance lists that support the processes and requirements for regulating harmful substances, including: 

  • The Registry of Intentions. 
  • The Candidate List of Substances of Very High Concern (SVHCs). 
  • The Authorisation List (Annex XIV). 
  • The Restricted Substances List (Annex XVII).  

Each subsequent list increases restrictions until the substance is completely removed from the manufacturing process. In order to maintain compliance with the REACH Regulation, companies should become familiar with how substances move between the REACH chemical lists. This blog concerns the Authorisation List. 

For a substance to move from one list to another, Member State Committees (MSCs) across the EU can petition the European Chemicals Agency (ECHA) to determine whether additional restrictions are required. To petition the ECHA for tighter restrictions on EU REACH list substances, an MSC must draft a recommendation that includes: 

  • Hazards posed by the substance and reasons it should be included under authorization.
  • A sunset date, stating the final date the substance can be used without authorization or exemption.
  • Last application date, stating the deadline for submitting an application to gain an exemption for substance use or inclusion in the market.
  • Review periods for certain uses, if any.
  • Uses exempted from the authorization requirement, if any. 

Following the publication of the draft, members of the public are invited to submit authorization applications and ask questions about the restriction. Applications must include information such as plans for replacement of the harmful substance and reasons other substances cannot immediately replace it. This is the ideal time for companies and other interested parties to gain insight into how the transition of a substance from the Candidate List of SVHCs to the Authorisations List will affect them, and provides the opportunity to weigh in on the change.

Learn more about how substances move between REACH lists in our whitepaper, Understanding the REACH Authorisation & Restricted Substances Lists.

After the public information session has been held, the ECHA prepares an invoice for any applicant(s) requesting authorization to use the proposed Authorisation List substance. Once this fee is paid, the ECHA begins reviewing the request. During this stage, the ECHA also collects feedback from the public on the proposed addition and conducts independent research. The Committee for Socio-Economic Analysis (SEAC) and the Committee for Risk Assessment (RAC) also draft opinions on the substance.

Upon completion of the ECHA’s draft, the MSC provides comments, answers questions and offers its final argument for the inclusion of the harmful substance. After taking all research and comments into account, the ECHA publishes a final ruling on the addition of the substance to the Authorisation List. If enough evidence was discovered to justify the addition, the European Commission publishes the ruling in the Official Journal, and enforcement of the new addition to the Authorisation List begins.

Companies that monitor changes made to REACH chemical lists are well positioned to maintain a Certificate of Compliance. As substances are added to the Authorisation List, companies are able to apply for authorization in a timely manner. However, proactively removing substances on the SVHC list is another, more long-term solution to maintaining compliance. This also mitigates the risk of authorization being denied or contested by a member state, resulting in a last-minute scramble for suppliers that do not use the specified substance.

There are a lot of moving parts in establishing an effective REACH certification program, but if due diligence is performed, the parts will more easily work together. Automation can help companies be proactive in maintaining compliance.

To learn more about how Assent can help you manage your REACH program more effectively, contact us at