What the new EU product regulations on communication of hazardous substances mean to your company?
ECHA released Version 4.0 of the guidance for companies putting products on the market in Europe that may contain substances of very high concern. Per REACH Article 33, if your company produces or imports a product into Europe, you (and your supply chain) are required to communicate safe use information for any Candidate List substances found above 0.1% by weight. The European Court of Justice decision in 2015 stating that this communication requirement is for ANY and ALL components found within a product (the ‘O5A’ principle) has led to lengthy discussions between ECHA and their Partner Expert Group stakeholders. The revised guidance is to align with the Court judgment and introduce new examples consistent with the ruling to help companies navigate these requirements.
The new guidance is more focused on Article 33, moving references to other REACH tasks to Appendices, and includes the new concept of a “complex object.” Revised Chapter 3 defines the requirements for calculations and communications for these complex and very complex objects. The upshot is that if safe use information is needed for the smallest, individual component of your product, you must provide that information all along the supply chain. But there is leeway on how to obtain and transfer the necessary background information.
It is strongly suggested that companies document the results of their compliance assessments, including:
Information requests made to your suppliers of parts and materials
Information received from those suppliers, including material certificates and test results
Company decisions regarding whether certain objects are articles, and whether specific requirements apply to the objects, based on the info received from the suppliers
The guidance states that a distributor supplying products to consumers does not comply with his communication obligation just by referring the consumer to his supplier, or the producer/importer. They publically recognize for very complex objects that there are much greater data-management and communications challenges. ECHA notes that the appropriate format for information may vary, depending on the content and the receiver (i.e. business to business versus selling to consumers). Regardless, identifying substances in articles and quantifying the amounts is usually ONLY possible if the respective information is made available by all actors in the supply chain. Chemical analysis, while possible, is time consuming, costly, as well as difficult to organize. This “top-down” approach is seen as the most efficient, but the new guidance recognizes the difficulty and suggests that identification of the materials found in the products may be done at different levels of granularity depending on the information gathered. An approach using knowledge of which materials are used in a particular article category can be combined with knowledge of which Candidate List substances are often used in those materials. Note there are risks arising from this approach with regard to impurities or residues leftover from production processes or non-EU continued use of substances that aren’t documented properly.
One example discussed in particular is a printed circuit board (PCB). Circuit board assemblies are found within many types of products, and for very complex objects, many PCBs are found. The guidance suggests that the EU producer of a PCB should obtain relevant supplier information on the components down to each individual capacitor. The importer of a capacitor may need info on the chemical make-up of the capacitor, and potentially how it was produced from his non-EU supplier. This means that very extensive data on ALL parts is still being required, even if there is some leeway on how it is communicated up the supply chain and to consumers.
The example of a very complex object is a bicycle. While cars and airplanes were included in this category, for guidance purposes a bicycle illustrated the process. It was suggested that the importer could identify all articles and materials for some of the various sub-assemblies and parts, but may not have for all parts. For the gaps, the importer may need to request further information from his non-EU supplier and group articles according to the different materials, based on information made available. In the bicycle example, materials found in the handlebar grips and tire inner tubes had SVHCs above the 0.1% weight threshold and safe use information needs to be communication on the individual parts.
It is suggested that industry groups may also aid producers by developing communication formats addressing their sector. An example of this is the automotive industry, which has been collecting substance and material information for over 15 years in a comprehensive IT system. This group has the data for both evaluating likely locations for uses of substances of concern, and also has insight into which materials and parts have already been manufactured with alternatives. While the collection of data to the lowest levels of the supply chain is still evolving, the communication of SVHCs and safe use information will be aggregated, creating an efficient process. One example is for the extensive use of printed circuit board assemblies within a vehicle. Electronics assembly suppliers will be required to obtain detailed data for materials on each component; however, safe use information added to the car’s manual may only be required if a consumer can potentially come into contact with those SVHCs. A different level of safe use communication may be needed for car repair and aftermarket part operations, especially if there is consumer contact.
This new paradigm is going to drive many industries to try to gather this information from their supply chains. Hopefully, the requirements will be common enough so that the suppliers can be open, timely, and accurate. Please feel free to contact me about your thoughts and needs on this topic. I can help you get the right people from your company at the table to talk about which products are affected (Sales?), from where (Operations?), for what materials (Engineering?) for what legislated requirement (HSE?, Legal?) Brenda at firstname.lastname@example.org