【EXPERT Q&A】Does European GPSR compliance require CE certification?

January 29, 2025  Source: drugdu 39

Drugdu.com expert's response:

 

Happy Chinese New Year!

Detailed Analysis on the Relationship Between GPSR Compliance and CE Certification in Europe

I. Concepts and Relationship Between GPSR and CE Certification

GPSR (General Product Safety Regulation):

It is a regulation of the European Union concerning the general safety of products, aiming to ensure that products placed on the EU market are safe under normal or reasonably foreseeable conditions of use.

It covers a wide range of product categories, including toys, electrical appliances, and various consumer goods, requiring products to meet corresponding safety, health, and environmental standards.

CE Certification:

It constitutes the "essential requirements" of European directives and is considered as the "passport" for manufacturers to enter the European market.

It indicates that the product complies with the basic requirements of the EU's "New Approach to Technical Harmonization and Standardization" directives, involving mechanical safety, electromagnetic compatibility, low-voltage safety, and other aspects.

Relationship:

Partial Overlap: Some directives and standards upon which CE certification is based overlap with the safety requirements of GPSR. For instance, the Low Voltage Directive (LVD) and the Electromagnetic Compatibility Directive (EMC) of CE certification ensure the electrical safety and electromagnetic environment safety of electrical products, which echoes the product safety requirements of GPSR.

Not Completely Identical: GPSR has a broader scope, considering the safety of products in a wider range of use scenarios, including chemical risks, physical risks, and health impacts on consumers. Therefore, even products with CE certification may need to additionally consider GPSR compliance requirements.

II. Specific Requirements for GPSR Compliance and CE Certification

GPSR Compliance Requirements:

Manufacturers need to ensure that products meet the safety requirements stipulated by GPSR, including risk assessment, labeling requirements, and traceability of responsibility.

For different product categories, GPSR may put forward specific safety requirements, and manufacturers need to conduct detailed compliance assessments for these requirements.

CE Certification Requirements:

Manufacturers need to conduct tests and assessments according to relevant directives and standards to ensure that products meet the basic requirements for CE certification.

Submit necessary technical documents and declarations of conformity to obtain the CE certification mark.

III. Compliance Suggestions

For Products with CE Certification:

Manufacturers need to additionally consider GPSR compliance requirements to ensure that products are safe in a wider range of use scenarios.

Additional testing and assessments may be required to meet the specific requirements of GPSR.

For Products Not Requiring CE Certification:

Even if products do not fall within the scope of CE certification, manufacturers still need to ensure that they comply with the requirements of GPSR.

This may involve conducting a comprehensive assessment of product safety to ensure that it poses no safety hazards to consumers during normal use.

In summary, GPSR compliance in Europe needs to consider CE certification, but they are not completely identical. Manufacturers need to conduct comprehensive compliance assessments and necessary testing work based on the nature of specific products and the involved safety risks.

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