Product Risk and Safety Assessment in the European Union: An Overview

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EU Risk Assessment

A Risk and Safety Assessment can be described as a document that lists potential safety hazards, and how you as an importer or manufacturer will act in case any of these risks become reality. Creating a risk and safety assessment document is mandatory when importing and manufacturing a range of products in the European Union, and that is what we cover in this guide.

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REACH Annex XVII Substances List: An Overview

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REACH restrics chemicals, heavy metals, and other substances in consumer products sold in the European Union. That being said, different rules apply to substances that are considered as more harmful.

Substances listed in Annex XVII of the REACH regulation are considered to be more harmful and therefore restricted. The restrictions can differ – in terms of limits or an outright ban – depending on the product type and age group.

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REACH SVHC Substance List: An Overview

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REACH restrics chemicals, heavy metals, and other substances in consumer products. When it comes to Substance of Very High Concern (SVHC)s, additional notification requirements apply to importers and manufacturers if a product contains an SVHC above a certain percentage.

In this guide, we explain what Substance of Very High Concern (SVHC)s are and list some of the more common SVHCs – such as DIPP, DPP, formaldehyde, and cadmium nitrate. Continue reading REACH SVHC Substance List: An Overview

List of Products Covered by the EU Construction Products Regulation 

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Construction Products

Importing or manufacturing construction products requires compliance with the EU Construction Products Regulation. The regulation sets out requirements such as safety and performance standards, documentation, and labeling.

In this guide, we provide a list of products that are referenced in Annex IV of the Construction Products Regulation. We also list applicable harmonised standards for each product category.
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List of Products Covered by the WEEE Directive

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WEEE Products List

The Waste Electrical and Electronic Equipment Directive (WEEE) Directive applies to electrical and electronic equipment waste and waste collection. It also covers labeling requirements used to indicate separate waste collection.

In this guide, we list examples of products covered by the WEEE Directive. We made the selection based on the product categories listed in the relevant annexes of the directive itself. We also include examples of relevant EN standards.

That said, keep in mind that WEEE covers essentially all electrical and electronic products – not only those listed in this guide.

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List of Product Liability Insurance Companies in the European Union

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Manufacturers, importers, and online vendors selling products in the European Union are ultimately responsible for product safety and compliance. However, product safety issues can be caused by unforeseen manufacturing defects or supply chain-related issues.

In short, importers and manufacturers cannot entirely eliminate the risk of safety and compliance issues – resulting in personal injury or property damage.

Should the worst happen, product liability insurance can cover some of the costs involved. In this guide, we list some of Europe’s leading product liability insurance providers, located in Germany, the Netherlands, Italy, France, and Scandinavia. Continue reading List of Product Liability Insurance Companies in the European Union

Plastic Product Regulations and Safety Standards in the European Union

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Plastic Products

Plastics and consumer products made of plastics are subject to chemical restrictions, bans, labeling, and lab testing requirements. In this guide, we explain how REACH, RoHS Directive, and many other regulations apply to plastic materials and consumer products.

Further, we also look into plastic food contact materials regulations, and regulations concerning single-use plastics in the European Union.

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Declaration of Conformity (DoC) Requirements For Importers & Amazon Sellers

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A Declaration of Conformity (DoC) is mandatory for all products covered by one or more ‘CE marking’ directives. In this guide for importers and Amazon sellers, we explain how to create a DoC, associated costs, relevant products, and much more.

DoC Sample Texts

Further, this guide also includes Declaration of Conformity sample texts for the following:

  • Low Voltage Directive 2014/35/EU
  • EMC Directive 2014/30/EU
  • Radio Equipment Directive 2014/53/EU
  • RoHS Directive 2011/65/EU
  • Toy Safety Directive 2009/48/EC
  • Personal Protective Regulation (EU) 2016/425
  • Ecodesign Directive 2009/125/EC

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List of Products Covered by the General Product Safety Directive (GPSD)

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The General Product Safety Directive (GPSD) requires that all products sold in the EU are generally safe to use. Hence, the GPSD can be said to apply to all product categories. However, the GPSD does reference product-specific standards – known as harmonised standards.

In this guide, we list several product categories covered by GPSD harmonised standards, and explain how the GPSD can apply even if no such standards exist for your product. Continue reading List of Products Covered by the General Product Safety Directive (GPSD)

Harmonised Product Standards in the European Union: A Complete Guide

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Harmonised standards in the European Union refer to standards referenced under certain directives and regulations, such as the Toy Safety Directive or the Personal Protective Equipment Regulation. Whereas the directives and regulations provide more general compliance requirements on safety, labeling, and documentation – harmonised standards serve as practical ‘blueprints’ that can be followed to implement said compliance requirements for specific products.

In this guide, we explain how to identify relevant harmonised standards and how the implementation can work. We also list some examples of such standards for toys, electronics, PPE, and many other product categories. Continue reading Harmonised Product Standards in the European Union: A Complete Guide