EU REACH vs. RoHS Compliance: What is the Difference?
The European Union has established safety regulations to protect people and the environment from the presence of hazardous materials in products placed on the EU market, two of the most prominent being REACH and RoHS. REACH and RoHS compliance in the EU often occur unanimously, but there are key differences in what’s required for compliance and how it is enforced.
REACH stands for the Registration, Evaluation, Authorization, and Restriction of Chemicals, and RoHS stands for the Restriction of Hazardous Substances. While EU REACH and RoHS regulations overlap in some areas, companies must understand the differences between the two in order to ensure compliance and avoid the risk of unknowingly violating the law.
Continue reading for a breakdown of the differences between EU REACH and RoHS compliance.
What is the scope of EU REACH vs. RoHS?
While REACH and RoHS have a shared purpose, REACH has a larger scope. REACH applies to nearly all products, while RoHS solely covers Electronics and Electrical Equipment (EEE).
REACH is a European regulation that restricts the use of certain chemical substances in all parts and products manufactured, sold, and imported within the EU.
RoHS is a European directive restricting the use of 10 specific substances in EEE manufactured, distributed, and imported within the EU.
Which substances are restricted under EU REACH and RoHS?
REACH and RoHS have their own list of restricted substances, both of which are managed by the European Chemicals Agency (ECHA).
There are currently 224 chemical substances restricted under REACH. The substances are restricted regardless of whether they are used on their own, in a mixture, or in an article.
There are currently 10 substances restricted under RoHS above specific concentrations:
- Cadmium (Cd): < 100 ppm
- Lead (Pb): < 1000 ppm
- Mercury (Hg): < 1000 ppm
- Hexavalent Chromium: (Cr VI) < 1000 ppm
- Polybrominated Biphenyls (PBB): < 1000 ppm
- Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
- Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
- Benzyl butyl phthalate (BBP): < 1000 ppm
- Dibutyl phthalate (DBP): < 1000 ppm
- Diisobutyl phthalate (DIBP): < 1000 ppm
There are exemptions to RoHS compliance in Article 4(1) within the directive. Annexes III & IV list restricted substances that are exempt when used in specific applications. Exemption use must be disclosed in RoHS compliance declarations.
How do companies comply with EU REACH and RoHS?
REACH and RoHS each have their own requirements that companies must follow to demonstrate compliance. Compliance requires considerable effort, so ongoing compliance programs are essential.
REACH requires companies that manufacture, distribute, or import more than one ton of substances per year to apply for authorization for Substances of Very High Concern (SVHCs) on the authorization list. The regulation also restricts companies from using substances on the restricted list.
RoHS is a self-declaring directive in which companies declare compliance with the CE Marking. This CE marketing demonstrates that the company generated a technical file. A technical file contains information about the product, as well as the steps taken to ensure RoHS compliance. Companies must keep a technical file for 10 years following the placement of the product on the market.
What are the differences between REACH and RoHS enforcement in the EU?
Failing to comply with REACH or RoHS can result in steep fines and/or product recalls, possibly leading to reputational damage. A single product recall can negatively impact several suppliers, manufacturers, and brands.
Since REACH is a regulation, enforcement provisions are determined at the European Commission level in Schedule 1 of the REACH Enforcement Regulations, while Schedule 6 states that enforcement powers granted to individual EU member states fall within existing regulations.
Penalties for REACH non-compliance include fines and/or incarceration unless civil law processes present a more suitable remediation route. Cases are investigated individually to determine if prosecution is necessary. Due diligence defenses are not admissible in these cases.
RoHS is a directive, which means that although it was passed collectively by the EU, member states implemented RoHS with their own legislative framework, including application and enforcement. As such, enforcement policies vary by country, as do penalties and fines.
Source Intelligence REACH and RoHS Compliance Solutions
Collecting and analyzing REACH and RoHS supplier data is not always a simple task. Source Intelligence provides both REACH and RoHS compliance solutions that simplify the data collection and analysis process, including:
- Validating supplier information
- Gathering evidence documentation
- Compiling product level declarations
- Consolidating data
Our solution facilitates streamlined data collection from suppliers including REACH Declarations, Full Materials Declarations (FMDs), safety data sheets, lab test reports, and more. Our team is also available for technical support to ensure the provided documentation is accurately analyzed and applied.
When you partner with Source Intelligence, we work with you to assess your needs and capabilities. Whether you need a solution with a team of experts to manage your REACH and RoHS compliance, or a solution that simply provides the software to support your compliance initiatives, we’ll deliver a tailored solution that best fits your goals.
REACH and RoHS regulations across the globe are ever-evolving, necessitating timely supply chain communication and accurate data collection. That’s where Source Intelligence comes in – we help businesses achieve and maintain compliance. Request a demo of our REACH and RoHS solutions to see how effortless they can be.