What is the difference between USA compliance and CE?

Understanding the Contrasts Between CE and USA Compliance

A manufacturer can ensure compliance with European product legislation and, if necessary, affix the CE marking by utilizing relevant European directives and/or regulations and selecting a harmonized standard, enabling them to access the European market with their products.

However, when it comes to entering the United States market with their products, CE marking does not apply.  Instead, the requirements for a product can be evaluated against federal regulations and/or national codes. To comply with regulations and/or national codes in the United states one can use both mandatory standards and voluntary standards.

Just like the EU, products in the US are also categorized under regulated and non-regulated products. However,  procedures and evaluation  varies greatly. It is therefore crucial to be aware of the differences between USA compliance and EU compliance.

Compliance in the United States of America (USA)

Compliance in the United States is related to adhering to various federal and state regulations, national codes and standards when selling products within the United States. Unlike the CE marking system, for the USA an approval marking is required, which may vary. An approval marking commonly know is the UL approval mark, which is given by UL after a successful evaluation by UL acting as an NRTL (Nationally Recognized Testing Laboratory). Please note, that there are also other parties which are accredited and are assigned by Authorities Having Jurisdiction to evaluate and approve product.

Every state in the USA has its own liability law according to its own standards, as sanctioned by Congress. Therefore, an Authority Having Jurisdiction (AHJ), accepts only approvals and testing carried out by assigned and accredited parties. The drafting of product safety requirements and compliance inspection are carried out by the same federal agency. In the USA product compliance often involves adherence to regulations from agencies like the Food and Drug Administration (FDA), Federal Communications Commission (FCC), Occupational Safety and Health Association (OSHA), National Fire Protection Association (NFPA), Environmental Protection Agency (EPA), Consumer Product Safety Commission (CPSC), and testing parties which carry out evaluations and approvals such as Nationally Recognized Testing Laboratories (NRTL), and others.

You are required to file a report for dangerous and defective products. Especially when providing consumer products onto the USA market, one needs to ensure that compliance is determined, because there is a high risk of lawsuits. It is highly recommended to ensure that when providing a product onto the USA market, that it complies with the regulation(s) and/or National Codes. Also, when providing an industrial product onto the market, it is recommended. However, for industrial products it becomes part of the assessment whether or not a working environment can be considered safe. Therefore, with industrial products it is a discussion as to who is legally responsible to ensure that products/equipment used in a working environment is compliant and approved. To learn more about compliance requirements in the United States, please refer to the following link.

Compliance in the European Union

Whereas, for the USA market, one must (in almost every case) apply to an accredited body, for the European market it is the other way around. It is less frequently necessary to apply to an accredited assigned body to ensure and determine product compliance. Still, it is mandatory to oblige by the European product safety legislation and one must proof compliance with these legislative requirements. Before products can be placed onto the European market, CE marking on a product is for most products mandatory to prove that it meets the fundamental legal requirements of the relevant Directive(s) and/or Regulation(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. Please note, the General Product Safety Regulation (GPSR) will replace  the current General Product Safety Directive and the Food Imitating Product Directive as from 13 December 2024.

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 complete the inspection process.

In summary

CE marking is primarily associated with product conformity in the European Economic Area, while compliance in the United States involves adhering to a range of federal and state regulations and standards. Each system has its own set of rules and requirements, and manufacturers must ensure their products meet the specific criteria for the markets in which they intend to sell them.

Still unsure about the differences between USA compliance and EU compliance, CE marking? Our experts are happy to help. Whether you’re a manufacturer in the USA, EU or somewhere else in the world, we can help you perform the entire compliance process to ensure that your products meet the specified safety requirements. Get in touch here.

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