Achieving regulatory product compliance in the industrial manufacturing industry requires a deep understanding of the complex regulations and standards that govern the sector. Complicating matters is the sheer volume of regulations, totaling more than 800 worldwide (including REACH, RoHS, and SCIP). Staying current with regulatory obligations, conducting due diligence, and correctly applying documentation are only a few of the many common challenges. Without the proper tools, expertise, or resources, the process is daunting.
Whether a company manages its compliance program in-house or outsources it, the challenges faced across the industry are consistent. Utilizing product compliance best practices can help companies more effectively manage their programs while partnering with a supply chain solution provider streamlines the compliance process and allows companies to focus on their core competencies. Regardless of the approach, finding a solution that helps your business remain compliant and reduce risk is imperative.
This e-book will highlight the key product compliance regulations relevant to industrial manufacturing and examine the common challenges companies face in managing them. It will also explore best practices for running a successful in-house compliance program and the benefits of leveraging automated product compliance software. Finally, it will explain how Source Intelligence’s product compliance solutions simplify the entire process, ensuring your business stays ahead of evolving requirements.
Achieving regulatory product compliance in the industrial manufacturing industry requires a deep understanding of the complex regulations and standards that govern the sector. The most common regulations companies in the industrial manufacturing space must comply with are REACH, RoHS, PFAS, SCIP, and TSCA.
The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) is a regulatory framework intended to protect human health and the environment from risks posed by exposure to chemical substances. Generally, REACH regulations apply to all chemical substances, including those used in industrial processes, the workplace, and everyday household items. REACH compliance typically requires manufacturers to register and provide detailed information about the chemicals they use in their products, as well as to assess and manage any risks associated with these chemicals.
Several countries across the globe have enacted REACH regulations, including the European Union (EU), the United Kingdom, and China. The primary difference between worldwide REACH regulations is data collection and reporting requirements. By complying with REACH regulations, companies can demonstrate their commitment to product safety and environmental responsibility, while meeting their legal obligations for the markets in which they sell products.
The Restriction of Hazardous Substances (RoHS) is another regulatory framework that aims to protect human health and the environment by restricting the use of certain hazardous substances in electrical and electronic equipment. These harmful substances include lead, mercury, cadmium, and certain flame retardants and plasticizers. RoHS requirements typically apply to companies that manufacture or import electrical and electronic equipment. The compliance process involves conducting material testing, implementing control measures, and providing documentation to demonstrate compliance.
Many countries have recognized the value of minimizing hazardous materials in electrical and electronic equipment, and as a result, have implemented their own RoHS regulatory frameworks. Some notable examples include the EU, China, Japan, South Korea, the UAE, Saudia Arabia and India. By adhering to RoHS, manufacturers from these countries contribute to a global effort towards a greener future and demonstrate their commitment to responsible manufacturing practices.
PFAS, or per- and polyfluoroalkyl substances, have become a major concern on a global scale in recent years. These chemicals, commonly found in products like firefighting foam, non-stick cookware, waterproof fabrics, PCB laminates, and semiconductor device manufacturing, have been linked to a range of health issues, including cancer and immune system dysfunction. As a result, governments around the world have been working to implement PFAS compliance measures to limit their use and protect public health.
These regulations vary from country to country, with some nations taking a more proactive approach than others. In the United States (U.S.), for example, the Environmental Protection Agency has established guidelines and standards for PFAS in drinking water and reporting requirements for PFAS manufacturing, importing, and PFAS-containing products. In Europe, the European Chemicals Agency has classified certain types of PFAS as substances of very high concern and is considering restricting PFAS use under the REACH regulation. Companies that manufacture products containing PFAS must be aware of which regulations they must comply with and the associated requirements.
EU manufacturers, assemblers, distributors, and importers of products into the EU must adhere to the Substances of Concern in Products (SCIP) database reporting requirements as established by the Waste Framework Directive and the European Chemicals Agency (ECHA). The SCIP database serves as a catalog of potentially harmful substances in products manufactured, distributed, or imported within the 21 EU member states. The database is intended to help waste operators sort and recycle articles containing Substances of Very High Concern (SVHCs) and inform consumers on how to use and dispose of such articles properly.
European Union product manufacturers, assemblers, and distributors, as well as importers of products into the EU, must submit information into the SCIP database if their products contain SVHCs above a 0.1% weight over weight (w/w) threshold at the article level. The candidate list of SVHCs is based on REACH. By complying with SCIP requirements, companies can contribute to the overall reduction of hazardous substances in the environment and promote a more sustainable and responsible approach to product manufacturing.
The U.S. Toxic Substances Control Act (TSCA) is a crucial aspect of ensuring the safety and well-being of both humans and the environment. This federal law, enacted by the U.S. Environmental Protection Agency (EPA), regulates the manufacturing, importing, processing, and distribution of chemicals in the country. The main objective of TSCA compliance is to assess and manage the potential risks posed by chemicals, making sure that they do not harm public health or the environment.
Under TSCA, companies must comply with various reporting and testing requirements, as well as maintain accurate records of the chemicals they produce or import. TSCA has also added some chemical restrictions, for example, certain persistent bioaccumulative toxic substances (PBTs), for products sold in the U.S. TSCA compliance not only protects people from hazardous substances but also encourages innovation in chemical research and development, as it promotes the use of safer alternatives.
Expand your industrial manufacturing compliance knowledge
With more than 800 product compliance regulations worldwide, understanding and adhering to compliance requirements is crucial for any business. Manufacturers must stay informed about the specific regulatory requirements that apply to their products and markets to effectively fulfill their compliance obligations and reduce risk in their supply chain.
Read the complete e-book for a comprehensive guide to minimizing risk and ensuring product compliance success.