GPSR Harmonised Standards
The General Product Safety Regulation (GPSR) establishes a framework for ensuring product safety within the EU. A critical aspect of compliance involves adhering to harmonised standards, which define safety requirements for specific product categories. Products that meet these standards are presumed to be safe, simplifying compliance for manufacturers and sellers.
Examples of Harmonised Standards
Harmonised standards are European standards developed by recognised standardisation bodies (CEN, CENELEC, ETSI) and referenced in the Official Journal of the European Union (OJEU). These standards provide a presumption of conformity with relevant EU legislation, such as the General Product Safety Regulation (GPSR) and CE Marking directives.
1. Electrical & Electronic Products (Low Voltage Directive - LVD, EMC Directive)
- EN 60335-1:2020 – Safety of household and similar electrical appliances
- EN 60065:2014 – Audio, video, and similar electronic apparatus
- EN 60950-1:2006+A2:2013 – Information technology equipment safety
- EN 55032:2015 – Electromagnetic compatibility (EMC) requirements for multimedia
2. Toys & Children's Products (Toy Safety Directive 2009/48/EC)
- EN 71-1:2014+A1:2018 – Mechanical and physical properties of toys
- EN 71-2:2020 – Flammability of toys
- EN 71-3:2019 – Migration of certain hazardous elements in toys
- EN 62115:2020 – Electrical toys safety
3. Personal Protective Equipment (PPE Regulation 2016/425)
- EN 166:2001 – Personal eye protection
- EN 420:2003+A1:2009 – General requirements for protective gloves
- EN 149:2001+A1:2009 – Filtering half masks for protection against particles
4. Machinery & Industrial Equipment (Machinery Directive 2006/42/EC)
- EN ISO 12100:2010 – General principles for machine safety design
- EN 60204-1:2018 – Safety of machinery – Electrical equipment of machines
What if There Are No Harmonised Standards for My Product?
If your product lacks a harmonised standard under the GPSR, you are still responsible for ensuring compliance. In such cases, you should consider:
- Non-harmonised European standards.
- National standards from EU member states.
- International standards from other markets.
- Industry best practices and risk assessments.
Documentation Requirements
Under Article 9 of the GPSR, manufacturers must maintain comprehensive technical documentation demonstrating product safety before placing items on the market.
Technical Documentation Must Include:
- General product description.
- Essential safety characteristics.
- Risk assessment and mitigation measures.
- Relevant standards and compliance strategies.
- Test reports and results.
Instructions & Warnings
Manufacturers must provide clear safety instructions and warnings in the official language(s) of the country where the product is sold.
Labelling Requirements
Manufacturers must ensure products include:
- Identification details (batch, serial number, type).
- Contact information (manufacturer, Responsible Person, importer, if applicable).
- Safety and usage warnings.
If direct labelling is impractical, this information must be included on the packaging or accompanying documentation.
E-Commerce & Distance Sales Requirements
Retailers and marketplaces such as Amazon, Temu, and Shein must ensure that online product listings include:
- Manufacturer and Responsible Person details.
- Product images and identifying information.
- Safety and warning labels.
Dangerous Products & Recalls
If a product is found to be unsafe, manufacturers must:
- Take corrective actions, including recalls if necessary.
- Inform consumers via safety notices.
- Notify EU market surveillance authorities through the Safety Business Gateway.
Amazon & Marketplace Compliance
The GPSR strengthens the role of online marketplaces in ensuring product safety. Platforms like Amazon require sellers to provide:
- Test reports
- Technical documentation
- Label verification
Amazon has already started requesting these documents, and GPSR enforcement will likely make such requirements more stringent.
Stay Compliant with EaseCert
EaseCert provides expert support to help businesses navigate GPSR compliance, including documentation, labelling, and Responsible Person services. Contact us to ensure your products meet the latest EU safety standards.
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