CE Marking is mandatory for almost all products that enter the EU marketplace. The United States regulates product safety via a variety of federal agencies. The Congress is first required to enact a product safety law, which pertains to the products being sold or distributed, and then the appropriate federal agency (such as the Consumer Product Safety Commission, the Federal Trade Commission, Occupational Safety and Health Administration, or the National Highway Traffic and Safety Administration), may create the regulations or rules to implement the law. This then creates a framework for implementing the regulatory law.
Depending on the nature of the product itself, this determines which Federal Agency is involved. For example, the U.S. Consumer Product Safety Commission (CPSC) is a common agency. The CPSC aims to protect consumers from unreasonable risks of serious injury or death from products under its jurisdiction. The CPSC was formed by Congress in congruency with the Consumer Product Safety Act (CPSA), which was created to protect the public against injury or death from consumer products.
In addition to the CPSA, the Consumer Product Safety Improvement Act (CPSIA) of 2008 is a United States law that imposes testing and documentation requirements. This act sets new acceptable levels of various substances and sets new requirements on manufacturers of products covered by the act.
Regulated products in the US are divided into the following subsets:
- Vehicles/vehicle-related products
These products are covered by Federal Agencies in most cases. On the other hand, non-regulated products do not have standards or bans. Most products that do not fall into the above categories are non-regulated products.
Every state in the U.S.A. has its own liability law according to its own standards, as sanctioned by Congress. The drafting of product safety requirements and compliance inspection is carried out by the same federal agency.
You are required to file a report for dangerous and defective products, but that doesn’t mean they won’t get placed on the market as they are not banned.
Before a product can be placed on the market in Europe, CE marking on a product is mandatory to prove that it meets the fundamental legal requirements of the relevant Directive(s). If the product does not fall under the scope of the CE marking, the General Product Safety Directive 2001/95/EC (GPSD) may apply. The GPSD exists to ensure the safety of non-regulated consumer products before they become available to the masses. Every new Directive is designed from scratch and is applicable throughout the EU, irrespective of the country. The European Commission drafts the Directives and national authorities to complete the inspection process.
To summarise the key differences between EU and US product compliance:
- The US system does not use CE marking or any other (general) conformity marking.
- In the EU there is just one procedure to comply with your regulated product with applicable legislation, namely by following the steps towards CE marking. In the US the kind of product and thus the applicable Federal Agency determines which steps to follow to comply with your product.
- In the US, both the design of the product safety requirements and the inspection on compliance are carried out by assigned parties, such as National Recognized Testing Laboratories (NRTL). An NRTL is accredited and their assessment is accepted by the Authorities having Jurisdiction in the US. In the EU the European Commission does the designing, but national authorities do the inspection.
- In the EU new directives are designed from scratch. In the US product requirements are based on national laws as enacted by Congress.
- Standards are on a voluntary base in the EU as a rule but can be mandatory in the US.
- In the US, some state laws and regulations are enacted which are more stringent than federal laws. In the EU, European laws are harmonized at the same level for all member states.
- Case law in the US emphasizes a ‘general duty to warn’ against product risks.
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