Yesterday, the European Chemical Agency (ECHA) released new REACH guidance for companies that import goods containing hazardous substances above 0.1 percent by weight. While aimed at importer notifications, the guidance also addresses registration, notification and communication obligations under the REACH law related to substances in articles.
These REACH requirements apply to 173 “substances of very high concern” contained in goods imported into the EU. The new guidance replaces interim guidance on rules on hazardous substances in products issued by ECHA in December 2015. The guidance also takes into account a European Court of Justice ruling from September 2015 that the 0.1 percent notification threshold for hazardous substances in products should apply to individual components within products, and not only to the whole product.
The new guidance has applicability to an article producer, article importer and article supplier as those terms are defined under REACH. The guidance offers two user friendly tables to assist in interpreting the REACH requirements. These include:
- Table 1: A summary that details the regulatory obligations applicable to producers, importers and suppliers, the legal basis under REACH and possible exemptions that may apply; and
- Figure 1: A flowchart that provides an overview of the process regarding whether and how substances in articles may be regulated under REACH and if so, what obligations are applicable.
For U.S. companies, compliance with REACH presents ongoing challenges and this guidance makes clear that there will be renewed focus on regulatory obligations applicable to importers. According to ECHA, only 365 product notifications covering 39 of the 173 substances of very high concern have been submitted. There is a general belief that many companies are not fully complying with these requirements and that the obligations are not fully understood. The new guidance hopes to provide better direction and a clearer understanding of REACH registration, notification and communication obligations.
The EU REACH import obligations are very similar in nature to existing U.S. TSCA import/export obligations. These, too, have been the subject of confusion and misunderstanding over the years, particularly since these requirements often are managed by shipping and procurement personnel unfamiliar with environmental regulations. EPA’s new TSCA Import Certification Rule also is creating some challenges for U.S. companies particularly in connection with the electronic submissions and certifications now required.