Category: European Union

European Union Authorised Representatives: A Complete Guide

Posted on by Fredrik Gronkvist — 24 Comments

 
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Article 4 and 5 of the Market Surveillance Regulation (EU) 2019/1020 requires that companies established outside the EU, but selling certain products to consumers in the single market, must have an authorised representative – in particular products that require CE marking.

In practice, this means that non-EU companies pay EU entities to act as their authorised representative. Further, the packaging must also include the name and address of the authorised representative.

In this guide, we explain how this works in practice, and what the consequences can be if you don’t have an authorised representative.

Related Articles

1. This guide only covers EU AR requirements within the scope of the Market Surveillance Regulation (EU) 2019/1020. If you are looking for authorised representative requirements concerning medical devices, then you can find the relevant article here.

2. This guide covers authorised representative requirements in the UK.

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Ecodesign Directive: An Essential Guide

Posted on by Yvette Shen — 3 Comments

Ecodesign Directive

The EcodesThe Ecodesign Directive establishes a framework for general requirements and specific implementing measures for various energy-related products, such as vacuum cleaners, computers, and refrigerators.

In this guide, we explain the directive’s product scope and provide information concerning conformity assessment, documentation, labelling, and other requirements.
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Technical Documentation for CE Marked Products in the EU

Posted on by Fredrik Gronkvist — 5 Comments

Technical documentation, also referred to as a technical file, is mandatory for most products that require CE marking in the European Union. As such, technical documentation is mandatory for electronics, toys, protective equipment, medical devices, machinery, and more.

However, understanding what to include in your technical documentation, and how to actually go about creating it, can be challenging.
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Extended Producer Responsibility in France – Q&A with Léko

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Extended Producer Responsibility in France

Extended Producer Responsibility (PRO) is covered by provisions of the European Packaging and Packaging Waste Directive 94/62/EC. In practice, EPR requires producers (which includes brands, importers, or manufacturers) to finance packaging waste collection.

This is managed on a national level, by approved organisations. In France, Léko is one such Producer Responsibility Organisation (PRO).

In this guide, they share what businesses selling products in France must know about the EPR registration process, fees, Triman, and other packaging waste instructions.
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Which Countries Accept CE Marked Products?

Posted on by Yvette Shen — Leave a comment

CE mark Accepted

The European Union mandates the use of the CE marking for many product categories such as electronics, toys, medical devices, and personal protective equipment. That being said, some countries outside the EU, including Turkey and the United Kingdom, can accept the CE marking for certain products.

Other countries recognise certain aspects of the CE marking process – such as EN standards.

In this guide, we explain what you need to know about the acceptance concerning CE-marked products and EN standards in the United Kingdom, Turkey, Israel, Switzerland, Singapore, and other countries.
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List of CE Marking Service Companies: Our Top 16 Picks

Posted on by Yvette Shen — 9 Comments

Looking for a consultant or other service provider to help you understand CE marking? In this article, we list software tools, consulting companies, and testing and certification companies offering a wide range of CE mark-related compliance services.

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Essential Oil Regulations in the European Union: An Overview

Posted on by Yvette Shen — Leave a comment

Essential Oils Regulations in the EU

Essential oils can contain substances that are subject to various restrictions. These restrictions concern substances that are flammable, harmful to humans, labelling requirements, and documentation.

In this guide, we explain how regulations such as the CLP Regulation, Cosmetics Regulation, and REACH relate to essential oils. We also list a few standards and test methods relevant to essential oils.
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Classification, Labelling and Packaging (CLP) Regulation: An Overview

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CLP Regulation
The Classification, Labelling and Packaging (CLP) Regulation classifies and regulates substances, mixtures and some articles in order to protect people and the environment.

The scope of the regulation also includes consumer products mainly composed of substances, such as candles, or finger paints.

In this guide, we explain how the CLP Regulation applies to those substances and products, including requirements regarding labelling, packaging, and lab testing.
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PFAS Regulations in the European Union: An Essential Guide

Posted on by Yvette Shen — Leave a comment

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are a group of chemicals that have been used in certain consumer products for their ability to resist water and stains.

Such products include cookware, clothing, furniture, and building materials. In recent years, PFAS has been restricted by various regulations in the European Union because of their toxicity to humans and the environment.

In this article, we list examples of products that might contain PFAS, as well as regulations that restrict them, including REACH, the POPs Regulation, and the Cosmetic Products Regulation.
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CE Certificate of Conformity: A Complete Guide

Posted on by Fredrik Gronkvist — 32 Comments

A CE Certificate of Conformity (CoC) essentially states that a certain product is compliant with one or more regulations, directives or standards. It also includes information about the conformity assessment performed, the issuing company, product information, and suppliers.

In theory, this certificate is issued based on the issuing company reviewing or creating certain documents. This includes test reports and technical files.

However, as I will explain in this guide, far from all documents titled ‘Certificate of Conformity’ are valid and based on an actual conformity assessment. In short, many of these documents are invalid and can result in your products being subject to a recall, fines, or other penalties.

Alternative terms

Certificate of Conformity documents can have the following titles:

  • CE Certificate
  • Attestation of Conformity
  • Verification of Conformity
  • Certificate of Compliance

Some service providers also refer to these as voluntary certificates.

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