The European Court of Justice (ECJ) has recently handed down a landmark judgment which clarifies when the notification obligations under REACH relating to substances of very high concern (SVHCs) apply.
REACH requires that where a finished product (known as an article) contains an SVHC in a concentration of more than 0.1 percent by weight in volumes of one ton per year across the product range the presence of that SVHC should be notified to the European Chemicals Agency.
Categories of SVHCs include substances that are carcinogenic, mutagenic, toxic for reproduction and substances in regard of which there is scientific evidence of probable serious effects to human health or the environment.
In addition, suppliers of products must also provide consumers with sufficient information to allow the safe use of a product where it contains an SVHC in a concentration above 0.1 percent
These obligations have meant that manufacturers have had to assess their products for the presence of listed hazardous substances and calculate the volume of those substances as a percentage of the weight of the finished product.
There has been some debate across Europe about whether the 0.1 percent threshold applies to the finished product itself or each of its component parts. Many manufacturers and Member States have taken the, not unreasonable, stance of assessing the presence of any SVHC in all of a product's component parts and then working out the concentration of any affected substance based upon the weight of the finished product.
The ECJ has now clarified this position by ruling that "each of the articles, incorporated as a component of a complex product, is covered by the relevant duties to notify and provide information, when they contain an SVHC in a concentration above 0.1 percent of their mass".
This means that the 0.1 percent threshold for notifying SVHCs applies to each of the individual components of a product, rather than the finished product itself.
This will have a significant impact for manufacturers of complex multi constituent products who have previously been able to rely upon the fact that the use of a component with a high concentration of an SVCH would likely not trigger a notification requirement when combined with other components.
We can help you to assess how the notification obligations under REACH impact on your products and how this decision may affect you.