If you sell or import goods to the European Union (EU), or supply articles to a client operating in the EU, you’ll need to demonstrate REACH compliance (Registration, Evaluation, Authorisation and Restriction of Chemicals REAC Regulation). The REACH Regulation is a cornerstone product compliance regulation for the EU, setting the tone for other legislation, including the Restriction of Hazardous Substances (RoHS) Directive and the EU Waste Framework Directive.

What is REACH compliance, and what does it mean for your company? The regulation is complex, so it’s not always easy to understand REACH compliance requirements. This article provides an overview of REACH, some best practices to proactively meet your requirements, and important resources for manufacturers.

REACH Regulation Framework

The European Chemicals Agency (ECHA) enforces the regulation and is responsible for authorizing the use of certain substances and maintaining the following regulated substance lists:

Candidate List Authorisation List Restricted List
Substances with health or environmental effects that ECHA is currently evaluating for potential replacements. Substances that have been evaluated as having serious effects. Substances on this list have a sunset date after which they require authorization to use. Substances that ECHA has banned or restricted use of in certain situations.

 

The goal of the REACH Regulation is to protect human health and the environment from the effects of these potentially harmful substances of very high concern (SVHCs) by communicating or limiting their use in durable goods within the EU. To comply with this goal, durable goods manufacturers are responsible for tracking and communicating SVHCs in their products.

Protect Your EU Market Access: The REACH Handbook

Ensure your products can enter the EU market with a compliance program that meets all the requirements of the REACH Regulation. The REACH Handbook gives you expert insights to improve your compliance program, including:

  • Tracking and reporting substances of very high concern (SVHC) in articles
  • Staying ahead of PFAS risks in your supply chain
  • Managing authorization expiration dates to avoid early obsolescence

Get Your Copy Today

In the past five years, a number of per- and polyfluoroalkyl substances (PFAS) were added to the Candidate List, and there have been proposals from EU member states to further restrict PFAS use, covering thousands of existing and theoretical PFAS chemicals.

The listed PFAS are:

  • 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts, and its acyl halides (HFPO-DA), a short-chain PFAS substitute for PFOA in fluoropolymer production
  • Perfluorobutane sulfonic acid (PFBS) and its salts, a replacement of PFOS
  • Perfluoroheptanoic acid (PFHpA) and its salts

Meeting REACH Compliance Requirements

Compliance with the REACH Regulation requires that you meet the following criteria:

  1. If your products contain any substances from the ECHA Candidate List in concentrations greater than 0.1 percent weight by weight (w/w), you must provide the recipient of the article or consumer with information about safe use.
  2. You must obtain authorization from ECHA if your total manufacturing or importing of substances to use in the EU contains any SVHCs on ECHA’s Authorisation List.
  3. Your products must not exceed any limits or meet restriction conditions from ECHA’s Restricted List, and must not exceed any limits for Restricted substances.

To meet this criteria, you’ll need insight into your supply chain and detailed composition data on all the articles in your product. This can be considerably time-consuming and costly if you’re manually reaching out to suppliers and parsing through spreadsheets to find that information.

Some activities and substances — such as those in transit — are exempt from the REACH Regulation because they are covered by other legislation, or because ECHA has deemed additional REACH enforcement unnecessary. For a comprehensive list of these exemptions, check out Assent’s Knowledge Center.

REACH’s Impact on Complex Manufacturers

The REACH Regulation has broad implications for companies that sell or import to the EU and their suppliers. Manufacturers doing business in the EU need to know which, if any, REACH-regulated substances are in their products, and, in turn, their suppliers need to be able to provide this information.

This generates an enormous demand for information, as some companies may need to chase after data from hundreds of suppliers to know which REACH compliance requirements apply to their products. Suppliers will have to compile article declarations demonstrating their product is REACH compliant and submit them to their clients.

Once companies collect this product information from their supply chain, they must then complete the appropriate documentation to comply with the REACH Regulation’s disclosure requirements.

It’s important to note that the REACH Candidate List, Authorisation List, and Restricted List change periodically, so you must regularly monitor your REACH compliance requirements. Everytime a new substance is added to the Candidate List, it introduces significant risk to your existing product line. That’s why the best practice is to have a system in place to monitor all REACH list changes and audit your supply chain for the presence of any SVHCs.

Your disclosure and authorization obligations should also be reviewed every time you change product formulations or introduce new products to the market.

How to Apply for REACH Authorization

If you are required to apply to ECHA for authorization, your declaration must include, at minimum:

  • A chemical safety report.
  • An evaluation of any available alternatives to that substance.
  • A plan detailing how you propose to replace the substance in time if suitable alternatives become available.

Some manufacturers choose to provide full material disclosures (FMDs) of their products to confirm REACH compliance. It is up to each manufacturer to decide how this information is communicated, as REACH does not dictate a uniform declaration standard. It is a REACH best practice to follow a declaration standard such as IPC-1752A, IPC-1754, or IEC 62474. Whichever standard you choose, you must demonstrate that you have adequately mitigated the hazards associated with the SVHC and have the ability to phase it out in favor of a less harmful substance before ECHA’s sunset date.

How Assent Helps With REACH Compliance

Compliance with REACH starts with your supply chain and knowing what substances are in it. By knowing which SVHCs are in your articles, and which suppliers they come from, you’ll have the information needed to correctly evaluate your REACH compliance requirements and create the necessary documentation.

Assent’s supply chain data management solution gives you deep insight into your supply chain data and keeps you up to date with any changes to the REACH substances lists. To learn more about Assent’s supply chain data management solution, contact our REACH experts.

For more expert insights and tips about proactive REACH compliance from our team of regulatory specialists, download The REACH Handbook: Your Guide to SVHC Compliance.

Valerie Kuntz
Senior Regulatory Expert

Valerie specializes in Restriction of Hazardous Substances (RoHS) and Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) implementation processes at large companies, and in  Read More

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