by Source Intelligence
on April 5, 2021
The European Union has compliance programs pertaining to the use and presence of hazardous materials in products placed on the EU market, two of which include:
The scopes of the two programs overlap in some areas, however, they present differences that companies must understand and be familiar with to ensure they comply with the requirements.
In some cases, differences may be subtle or ambiguous due to language. As a consequence, many businesses believe they are not in scope and may unknowingly take on the risk of pursuing illegal operations.
Let’s have a rundown of the two programs and outline how to achieve compliance in a way that does not cripple internal resources.
REACH is a law addressing the risks associated with exposure to certain chemicals throughout the lifecycle of the product, any product, including waste and disposal.
RoHS applies to products only and aims to protect human health and the environment by restricting the use of hazardous substances in products above specific thresholds.
While REACH covers mixtures and articles in any product placed on the European market, RoHS specifically focuses on EEE (Electronic and Electrical Equipment) and related accessories.
As of 2021, REACH restricts the use of 211 chemicals or SVHCs listed here: Substances of Very High Concern.
Under RoHS, 10 substances are restricted above specific concentrations (RoHS 3):
Both lists are managed by ECHA authorities and scientific committees, which are responsible for assessing how risks associated with these substances can be managed.
REACH legislation requires companies that manufacture or import above one ton of substances per year to register said substances and apply for permission to use those on the authorization list. Additionally, they cannot use substances on the restricted list.
RoHS directive requires a two-step certification: companies must test the EEE (including cables, spare parts, and accessories) against the ten listed substances and confirm the levels are below specified thresholds. They also must audit manufacturing processes and demonstrate on-site RoHS compliance, before submitting the technical file and ultimately receiving a certification statement.
Note that products in scope of REACH compliance may also fall under RoHS. This is also true for a number of other EU chemical regulations such as the SCIP Database.
To achieve compliance, organizations must deploy considerable efforts to prove they meet the substance-related requirements and to implement ongoing compliance programs.
Both legislations are evidence-based, meaning collecting supplier data and documentation is the key to success.
Non-compliance with either REACH or RoHS can lead to steep fines and/or product recalls, with all the reputational damage it entails. According to an AGCS report, a single product recall can have a ripple effect, impacting many suppliers, manufacturers, brands, and even countries.
As a regulation, REACH enforcement provisions are determined at the European Commission level in Schedule 1 of the REACH Enforcement Regulations and Schedule 6 lists powers granted to national enforcing authorities.
Non-compliance constitutes a criminal offense unless civil law processes present a more suitable remediation route. Each case is studied as it arises and may or may not lead to the decision to prosecute.
Companies must be aware that a “due diligence” defense will not be admissible.
RoHS is a European directive, which means all member states passed it into law in their own legislative framework. As such, enforcement policies vary by country, as do penalties and fines.
At Source Intelligence, we are very familiar with complex regulations. We are also aware of the acute difficulty of managing globally dispersed multi-tier supply chains. One of the core functionalities of our AI-powered compliance technology is specifically designed to simplify data management.
More and more materials are under scrutiny and subject to testing to determine their level of toxicity to human health and the environment. REACH and RoHS are constantly evolving, necessitating flexible and responsive solutions to help you achieve compliance and maintain it. That’s where Source Intelligence comes in.
Request a demo of our solution to see how effortless REACH and RoHS compliance can be.