Is a Risk Assessment mandatory?

Yes, a product risk assessment is mandatory in the European Union, but it is not universally required for all general consumer products in the United States and Canada.

However, even where it is not legally written into the text of the law, performing one is highly recommended to protect your business from liability.

Regional Requirements:

• European Union (EU): Mandatory. Under the General Product Safety Regulation (GPSR) and CE marking directives, a documented risk analysis is a strict legal requirement. It must be included inside your Technical File before placing the product on the market.
• United States (US): Optional but expected. The CPSC does not mandate a formal risk assessment document for general consumer goods. However, you must comply with specific safety standards (like ASTM rules). For high-risk categories like children’s toys, a hazard assessment is practically essential to ensure you pass mandatory third-party laboratory testing.
• Canada: Recommended. Health Canada does not explicitly force you to include a risk assessment document in your records for every general product. However, under the Canada Consumer Product Safety Act (CCPSA), it is illegal to sell a product that poses a danger to human health. A risk assessment is the best way to prove you did your due diligence.