2021 marks a year of renewed emphasis on stronger regulations and increased global product compliance enforcement. Already on January 19, 2021, the European Chemicals Agency (ECHA) added two new entries to its substances of very high concern (SVHC) Candidate List:
- Bis(2-(2-methoxyethoxy)ethyl)ether (CAS number 143-24-8).
- Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivatives, and any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety.
These additions, bringing the Candidate List to 211 unique substances, are common chemicals in inks and toners, as well as plastic and rubber tire manufacturing. The update will affect European Union reporting requirements such as REACH as well as the EU Waste Framework Directive (WFD) and SCIP.
If you are a manufacturer, importer or SVHC chemical user in the European Economic Area (EEA), you must communicate with all your downstream users of any products that contain these two substances, at greater than 0.1% weight by weight.
Additionally, if your products contain more than 0.1% weight by weight of either of these two substances, you must now submit a detailed dossier to the SCIP database to remain compliant with the EU Waste Framework Directive.
Historically ECHA has added new SVHCs twice a year. However, manufacturers, suppliers and importers should prepare for more substantial increases in the future because of the increased interest in meeting robust policy goals in the European Union.
Regulatory Trends in 2021 and Beyond
This year we can expect a number of notable regulatory compliance updates that will have implications for product compliance reporting for decades to come — from the release of IMDS 13.0 to the new SCIP database to the EU Green Deal. These changes mark a trend that will only continue — and may potentially increase reporting pressure and burdens.
The majority of regulatory bodies around the world are making an increased effort to identify and limit or ban harmful chemicals in consumer products. As our understanding of chemical adverse effects increases, calls for reducing health and environmental risks and hazards follow suit.
Companies that have a proactive hold on the chemical makeup of their products today will have an advantage over those that are reacting to regulation change-by-change and need-by-need.
Remain Compliant With a Long-Term Reporting Strategy
Companies need to adopt a long-term compliance outlook to meet the increased regulatory pressures and changes to come. The question is not if you can meet regulations here and now — but if you are set up to meet regulations 10+ years from now.
Our regulatory compliance experts recommend these steps to prepare:
- Assess your current and future reporting requirements.
- Evaluate your data quality up your supply chain.
- Develop a full materials declaration to prepare for any current and future reporting obligations.
Tetra Tech regulatory compliance experts are here to support you at any step of the process. Reach out to get started.