Children’s School Supplies & Stationery Regulations in the European Union

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Children’s school supplies and stationary are subject to various safety standards, testing, and labeling requirements in the European Union. In this guide, we explain what importers and manufacturers must know about the Toy Safety Directive, CE marking, REACH, GPSD, EN standards – and other compliance requirements applicable to children’s school supplies and stationary. Continue reading Children’s School Supplies & Stationery Regulations in the European Union

Buying EN Standards Online: A Complete Guide

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EN standards cover everything from electrical safety and substances, to mechanical toy safety. It’s often necessary that importers and manufacturers carefully study the technical aspects of all relevant EN standards even at the early stages of product development. That said, EN standards are generally not available for free – but must be purchased online.

Further, EN standards can often be purchased both digitally (PDF file) or as a physical hardcopy.

In this guide, we list several online stores where you can buy EN standards covering electronics, toys, textiles, medical devices, machinery, and many other product categories. Continue reading Buying EN Standards Online: A Complete Guide

Battery Directive Guide for EU Importers: An Overview

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Batteries

Planning to import batteries to the EU? In this guide, we introduce what importers and manufacturers should know about the Battery Directive, including restricted substances, labeling requirements, registration process, collection and recycling scheme, and testing companies providing product compliance services. Continue reading Battery Directive Guide for EU Importers: An Overview

Supplement Regulations in the European Union: An Overview

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Supplements

Planning or import or manufacture supplements in the European Union? In this guide, we cover the basics of substance restrictions, labeling, notification, documentation, and lab testing requirements for a range of supplements products in the EU.

Supplements are considered as food products in the EU and are mainly regulated by Directive 2002/46/EC – which we cover in more detail in this guide. That said, other regulations may apply if the supplements contain colorants or sweeteners. Continue reading Supplement Regulations in the European Union: An Overview

Notified Bodies in the European Union: A Complete Guide

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The role of a Notified Body is to assess if a product is technically safe and compliant, correctly documented, and (in some cases) manufactured under the right conditions. In a way, the Notified Body act as a gatekeeper to the EU market – for more ‘high-risk’ and ‘sensitive’ products that cannot be ‘self-certified’.

That said, Notified Bodies are not government organizations. Instead, companies like Intertek and TUV are appointed to act as Notified Bodies for certain product categories.

In this guide, we explain what importers, exporters, and manufacturers must know about Notified Bodies and how they operate. Continue reading Notified Bodies in the European Union: A Complete Guide

Product Traceability Requirements in the European Union: An Overview

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Traceability information

Product traceability requirements exist to ensure that products can be traced to a certain importer or manufacturer, production facility, SKU, and even production run. The latter is particularly important as it enables market surveillance authorities (and sellers) to identify and trace unsafe and non-compliant products – and thereby limiting product recalls to faulty batches.

Product traceability labeling is mandatory for a wide range of products, such as electronics, kitchen products, toys, and much more. Still, product traceability is often overlooked by importers and manufacturers.

Keep reading, and learn what importers and manufacturers must learn about different types of product traceability requirements in the European Union. Continue reading Product Traceability Requirements in the European Union: An Overview

Fumigation Regulations in the European Union: An Overview

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Fumigation Regulations European Union

EU Importers are responsible to ensure that their wood packaging materials like pallets, skids, containers, cases, and dunnages, and other plant products, are not infested with pests or parasites that could cause ecological damage to the local environment

In this article, we introduce EU regulations and international pest control standards, such as ISPM 15, for wooden products, such as wood packaging materials. Continue reading Fumigation Regulations in the European Union: An Overview

Machinery Directive: An Essential Guide for EU Importers

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Treadmills

The Machinery Directive applies to machines manufactured or imported to the European Union. More specifically, it defines machinery as assemblies of movable parts. As such, it applies to everything from treadmills to dishwashers.

Keep reading, and learn what European importers must know about safety standards, CE marking, documentation, and lab testing requirements related to the Machinery Directive. Continue reading Machinery Directive: An Essential Guide for EU Importers

Face Mask Regulations and Standards in the EU: An Overview

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Face Mask Regulations in the EU
Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU.

Mentioned Products

  • 3-ply surgical face masks
  • 4-ply- surgical face masks
  • 5-ply surgical face masks
  • FFP1 mask or respirators
  • FFP2 masks or respirators
  • N95 masks or respirators
  • FFP3 masks or respirators
  • N99 masks or respirators

Continue reading Face Mask Regulations and Standards in the EU: An Overview

EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä

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Medical Devices Directive

Face masks, medical gloves, and other medical devices are regulated by the Medical Devices Directive in the European Union. The scope of the Medical Devices Directive covers safety standards, labeling, quality management systems, product registration, and documentation. Further, some medical devices are more strictly regulated than others.

In this guide, written by Anssi Ilmari Tynjälä from Innovapro, you will learn what it takes for importers and manufacturers to ensure compliance with the Medical Devices Directive. Continue reading EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä