In an increasingly global and competitive consumer landscape, new products are being manufactured and sold every day, with sometimes unexpected and potentially hazardous results. In the US, the Consumer Product Safety Commission (CPSC) issued over 300 recalls for about 350 different types of products in 2012; in all, more than 59 million items have been recalled to date due to design flaws, safety violations or unforeseen hazards that put their owners/consumers at risk. In 2008, six infants in China died and approximately 300,000 people fell sick due to consumption of infant formula, milk and other food materials and components adulterated with melamine.
Spurred by such incidents, over the past few years, there has been an exponential increase in new global product-related regulations and standards, with a multitude of new restrictions, reporting, classification and labeling and packaging requirements. The important characteristic of these regulations is that they transfer the responsibility of risk management to the producers and importers of the products.
How can companies reduce the burden of complying with different product-related regulations? I recommend they follow a few crucial steps:
- Thoroughly understand the relevant product-targeted regulations, their compliance requirementsand impact
- Identify and map the organization product lines/processes to specific regulations via acompliance matrix
- Conduct a methodical gap analysis to identify possible loopholes
- Develop an efficient data management system - since most of the product-targeted regulations aredata intensive, with burden of proof on the company, this is important
- Ensure hazard identification and risk assessment of all your products on human health and on theenvironment
- Ensure supply chain collaboration. For example, some regulations require information from bothupstream and downstream supply chain partners
- Confirm safe and compliant handling, storage and transport of regulated materials andproducts
- Implement non-biological procedures like (Quantitative) Structure Activity Relationships forToxicological Risk Assessment (TRA) of chemicals rather than biological models (rats, mice, guinea pigs, etc.). This prevents unnecessary animal testing and is also cost-effective
- Adopt 'green chemistry' and 'Design for the Environment' (DfE) methods to create new ways tomake your products sustainable
- Last but not the least, implement automated systems that can help you manage regulatorycompliance by analyzing regulatory changes, material data, suppliers, or BOM change, and quantity and movement tracking
Regulation is here to stay. Effectively gathering and owning data about the product portfolio and ensuring regulatory compliance benefits not only the consumers, but the companies as well. By looking at regulation as an opportunity instead of a challenge, companies can improve their innovation track record and gain competitive advantage.