The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation came into effect in 2007 to protect human health and the environment by restricting the use of certain hazardous substances in products made and sold in the EU, and to increase the competitiveness of the EU chemicals industry.
In order for potentially hazardous substances to fall in scope of REACH, they must first be identified as substances of very high concern by the European Chemicals Agency (ECHA) at the request of member states or the European Commission. Once a substance is confirmed as an SVHC, it is added to the Candidate List. The Candidate List contains substances eligible for inclusion on the Authorisation List; their priority is determine by ECHA. The Authorisation List restricts the use of certain substances in the EU without authorization from ECHA. Certain substances are restricted from being manufactured, marketed, or used across the EU by REACH Annex XVII, also known as the Restricted Substances List, whether they are authorized or not. These substances are deemed to pose a substantial risk to human health and the environment.
Learn more about EU REACH on the ECHA website.
Company Requirements Under EU REACH
Under the EU REACH Regulation, onus is placed on industry to monitor and disclose hazardous chemicals in the products they produce and sell in the EU. If a product contains substances from the Candidate List above the allotted threshold, companies are required to communicate the presence of these substances to downstream customers and ECHA, and potentially provide safe use instructions. Substances on the Authorisation List are not permitted to be used by companies in products they make or sell in the European Economic Area (EEA) unless they receive authorization from ECHA. Companies should also be aware of the increasing number of substances on the Restricted Substances List, as the restrictions in place that could restrict or prevent substance use entirely can dramatically impact product composition and products being sold in the EU.
Compliance With REACH
In order to facilitate compliance with the constantly evolving REACH Regulation, companies must remain updated on SVHCs and changing regulatory requirements to ensure the effectiveness of their product compliance programs. Efficient supply chain communication and full material disclosures help companies gain visibility into their product composition, eliminating the need to reach out to their supply chain every time SVHCs are updated. In order to maintain compliance, companies must ensure they are aware of new developments to these lists as they occur.
Use the Assent Materials Declaration Tool to edit, validate, and generate your IPC-1752A and IPC-1754 declaration files.
The REACH Regulation & PFAS
Per- and polyfluoroalkyl substances (PFAS) are a family of fluorocarbon chemicals that are persistent, bioaccumulative, and toxic. As a result, these substances are increasingly subject to a variety of global regulations, and a number of PFAS chemicals are on the Candidate List of SVHCs. Now that these chemicals are on the Candidate List, companies must notify ECHA if one or more are present in their articles above the specified threshold, or if that substance is used in quantities of more than one metric ton per year. Other impacts of PFAS under REACH include:
- Part obsolescence
- Pressure from consumers and NGOs to remove PFAS from supply chains
- Investment firms reconsidering their investments
- Insurers excluding PFAS from their policy coverage
Assent’s REACH SVHC Solution
Assent’s REACH SVHC solution helps companies stay compliant with ever-changing restricted substance lists and requirements. Some highlights include:
- Comprehensive substance tracking and reporting
- Automatic notifications for new substances added to the Candidate List
- Centralized SVHC management solution for collection, storage, and reporting
- Streamlined supply chain communications through the Campaign Manager
- Upload declarations directly into the system based on known product compositions
- Hosts roll-up features from part, to component, to product with unlimited bill of materials (BOM) relationships