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How to reach compliance on REACH and RoHs

The European Union REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHs (Restriction of Hazardous Substances) directives are established to restrict the use of potentially harmful substances in all products sold in the EU.

Both directives are required for market access, and are commonly managed by product and materials compliance departments. But the similarities stop there. There are actually many differences between these directives. And they often create confusion.

Many of my US-based customers often ask me questions about the EU directives, REACH and RoHs.

  • How do we reach compliance?
  • And how do we comply in the best way? 

In the following, I will do my best to answer these questions. 

First of all, let me explain what RoHs and REACH is.

 

What is RoHs compliance?

The EU RoHS Directive seeks to limit the impact and exposure of specific hazardous substances to consumers and the environment and reduce occupational exposure when products or equipment are manufactured, recycled, or sent for final disposal. To be EU RoHS compliant, companies must put measures in place to control the use of hazardous substances in electrical and electronic equipment (EEE) and provide documentation demonstrating compliance with all aspects of this European Single Market directive.

Accordingly, electrical, and electronic products and all accessories sold with them cannot be placed on the market if they contain RoHS-restricted substances above maximum concentration limits at the homogeneous level. However, RoHS does include exemptions that allow some restricted substances to be used in certain very technical and specific applications if a suitable substitute is not available on the market or that substitute has a greater environmental impact. The use of any exemption must still be disclosed when making declarations of RoHS compliance.

 

What is REACH?

To achieve EU REACH compliance, companies must demonstrate evidence of a robust, ongoing compliance program with incremental improvement, which includes the collection of supplier data and documentation.

Data required to comply with the REACH Regulation, which came into effect in mid-2007, centers around Candidate List substances of very high concern (SVHCs), certain authorized substances used in EU manufacturing (Annex XIV), and restricted chemicals (Annex XVII), which are listed by the European Chemicals Agency (ECHA) at the request of member states or the European Commission.

Companies must audit their products and parts against the substances that are restricted from being manufactured, marketed, or used across the EU, and meet restriction conditions for entry. If substances are on the Authorization List, companies must gain appropriate authorization in order to use these substances in the EU.

 

What is the difference?

Both the EU REACH Regulation and EU RoHS Directive aim to reduce and restrict substances that can be deemed harmful to humans and the environment, but there are some key differences.

 

 

REACH

RoHS

Scope

A horizontal framework, applicable to all parts and products sold in the EU, with some exemptions, such as radioactive materials.

A vertical sector-specific law that focuses on all electronic and electrical equipment, with a small list of specific exclusions, such as the means of transport and equipment used solely for national security purposes.

Substances

Requires written disclosure of all SVHCs (currently a list numbering 209) in products and packaging.

Restricts the concentration of 10 specific substances in EEE products.

Evaluation

Evaluated at the article level.

Evaluated at the homogenous material level.

Legal

Is a regulation, which is legally-binding across all EU member states.

Is a directive, which means each member state must put it into national law, but it must have the same impact and effect across all territories.

 

There is some overlap between the two pieces of legislation. When a substance that is already covered under the RoHS Directive is added to the REACH SVHC Candidate List, enforcement authorities make an effort to ensure there is no conflict between requirements and that controls are consistent. There is a common understanding that RoHS should be given priority to regulate all issues pertaining to the use of substances in EEE.

Unfortunately, one more thing both REACH and RoHS have in common is the risk associated with non-compliance. Non-compliance with either law can result in reputational damage, loss of market access, recall of goods, loss of revenues, and/or fines.

 

How to reach compliance with Minerva PLM

The best way to make sure your products reach compliance is:

  • 1. To control the evolution of the supporting documents via a controlled process, e.g., a configuration management and/or change management process
  • 2. Have your regulatory information stored alongside your product master data.

Minerva PLM streamlines your regulatory information with your relevant component databases, so you are able to tie your REACH and RoHs documents to your product record. Simply go to the component inside Minerva PLM, and the platform will automatically retrieve the RoHS and REACH data upon request.

This will also give you full traceability across products and product structures and allow for roll-up of substances across the product structure (like a digital thread). It also gives you the information to understand what is inside of a product that is being sold with digital twin technology.

Additionally, Minerva PLM enables you to facilitate the gathering of REACH and RoHs information from suppliers which you are able to provide to your customers as well.

 

Remember, if the purchased part is not electronic or component, you have to audit your supplier and ask for this information. After retrieving this information from your supply chain, Minerva PLM enables you to streamline the information with your component databases.

 

As always, if you have any questions, do not hesitate to reach out to me.

About the author

Slavko Jovanovic

Slavko has high energy with the atitude to solve complex business problems using an innovative approach. Practitioner of latest software and product management processes that drives continual adaptation product to market fit. He has mastery knowledge of manufacturing process planning, execution and quality process. Solid understanding of modern and legacy software architectures and technologies including J2EE, JavaScript, RDBMS, Non-relational DB, HTML5, JQuery Cordova (PhoneGap), C, C++ along with many others.

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