Category: European Union

List of EN 71 Lab Testing Companies: An Overview

Posted on by Ivan Malloci — Leave a comment

EN 71 Lab Testing Companies

Importers and manufacturers must ensure that products covered by the Toy Safety Directive comply with EN 71 standards, which are harmonised under the Directive. EN 71 standards cover requirements related to substances, mechanical properties, flammability, and more.

Compliance usually necessitates testing. If the product passes testing, your chosen testing company issues a test report specifying your product’s compliance with the relevant requirements. In this guide, we list several testing companies that offer services related to EN 71.

Methodology

For this guide, we have selected several companies that claim to offer EN 71 testing and related services. We have also prioritised companies that have testing facilities in both the EU and Asia.

Related articles

a. EN 71 Toy Safety Lab Testing: A Complete Guide

b. List of Products Covered by the Toy Safety Directive and EN 71

c. Toy Safety Directive: An Essential Guide for Importers and Manufacturers

Continue reading List of EN 71 Lab Testing Companies: An Overview

Products covered by the Medical Devices Regulation: An Overview

Posted on by John Vinod Khiatani — Leave a comment

Products covered by the Medical Devices Regulation: An Overview

The Medical Devices Regulation covers both products that have a medical purpose, and products without an intended medical purpose – for example coloured non-corrective contact lenses. Additionally, medical devices are divided into different classes, according the risk level. Hence, the requirements vary depending on the class of the device.

It is therefore important to understand if your product is covered by the Medical Devices Regulation and, if so, under which class it belongs.

In this guide, we list examples of products covered by regulation, ordering them by type (e.g. invasive devices), and class (e.g. Class I).

Product List Creation Methodology

1. The product examples listed in this guide are taken from section “4.2 General explanation of rules/practical issues/examples” of the “Guidance on classification of medical devices” that is available on this Guidance page.

a. The product categories listed in this guide (e.g. Non-invasive devices) are taken from the headlines and sub-headlines available in section 4.2.

b. The product examples (e.g. wheelchair) are taken from the tables available in section 4.2.

c. We have sorted the products by class of medical devices (I, IIa, IIb, III), according to the information that is provided in the tables available in section 4.2.

2. The last section of this guide (Groups of products without an intended medical purpose) is an exception.

In this case, we have taken the product examples (e.g. Short-term use coloured non-corrective contact lenses) from section “4 Classification” of the “Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies” that is available on the Guidance page linked above.In

this case, the products are sorted by class, according to the information available in section 4 of the document.

3. Note that the list below is not exhaustive and only provides examples. You can consult the guidance documents for more information.
Continue reading Products covered by the Medical Devices Regulation: An Overview

List of REACH Lab Testing Companies: An Overview

Posted on by Ivan Malloci — 2 Comments

REACH Lab Testing Companies

The REACH regulation sets restrictions on heavy metals and chemicals in consumer products and mixtures. Third-party lab testing is often the only way to verify if a certain product or material is compliant.

In this guide, we list leading companies with testing facilities in the EU and elsewhere that provide testing services corresponding to substances restricted under the REACH regulation.

Methodology

We have selected testing companies that claim on their websites to offer REACH testing and related services. Additionally, we listed companies that have testing facilities in the European Union and Asia.

Related articles

a. An Essential Guide to the REACH Regulation in the EU

b. REACH Product Lab Testing: A Complete Guide

c. List of REACH Consulting Companies: Our 9 Top Picks
Continue reading List of REACH Lab Testing Companies: An Overview

Skincare Regulations in the European Union: A Summary

Posted on by Ivan Malloci — Leave a comment

Skincare Regulations in the European Union

This guide covers requirements for skincare products, such as body lotion and soap. While we mainly focus on the Cosmetic Products Regulation and how the regulation relates to skin care products, we also cover the REACH Regulation, POPs Regulation, and Commission Decision (EU) 2021/1870.

Methodology: We list examples of skincare products provided in Annexes II to V of the Cosmetic Products Regulation. Also, we list examples of restricted substances from the following sources:

a. Annex II of the Cosmetic Products Regulation

b. Annex III to V of the Cosmetic Products Regulation (only substances for which skincare products are specifically mentioned)

c. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products (only substances for skincare care products are specifically mentioned)

d. REACH Regulation

Continue reading Skincare Regulations in the European Union: A Summary

Hair Care Regulations in the European Union: A Summary

Posted on by Ivan Malloci — Leave a comment

Hair Care Regulations in the European Union
This guide covers requirements for hair care products, such as hair sprays and hair lotions. We primarily explain the Cosmetic Products Regulation regulates substances in hair care products. We also explain the relevance of other regulations such as REACH, and the POPs Regulation in the context of hair care products.

Methodology: We provide examples of hair care products mentioned in Annexes II to V of the Cosmetic Products Regulation. Additionally, we list examples of banned and restricted substances from the following sources:

a. Annex II to V of the Cosmetic Products Regulation (only substances for which hair care products are mentioned)

b. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products (only substances for which hair care products are mentioned)

c. REACH Regulation

Continue reading Hair Care Regulations in the European Union: A Summary

Cosmetic Substance Restrictions in the European Union

Posted on by Ivan Malloci — Leave a comment

Cosmetic Substance Restrictions in the European Union

Cosmetics made for the EU market must comply with certain substance restrictions. Some substances are prohibited, while limits apply to others. In some cases, there are also positive substance restrictions, in the sense that only certain substances can be used.

In short, understanding the status of the substances used in your cosmetic products is essential when selling in the EU. This guide takes a closer look at these restrictions in the Cosmetic Products Regulation, REACH, and the POPs regulation.

Methodology: In this guide we provide examples of restricted substances that are relevant to cosmetics, taken from the following sources:

a. Annex II to VI and Articles 15 to 17 of the Cosmetic Products Regulation

b. REACH Regulation

c. POPs Regulation

d. Toy Safety Directive

e. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products

Continue reading Cosmetic Substance Restrictions in the European Union

EU Cosmetic Products Regulation: An Essential Guide

Posted on by Ivan Malloci — 8 Comments

The Cosmetic Products Regulation establishes requirements for cosmetic products in the European Union, such as makeup, hair care products, skin care products, and more. In this guide we break down the requirements of the Cosmetic Products Regulation, including substance restrictions, safety assessment, labelling, and documentation.

In addition, we also list other regulations that are relevant to cosmetics, such as the REACH regulation and CLP regulation.

Continue reading EU Cosmetic Products Regulation: An Essential Guide

Baby Pacifier Regulations & Standards in the European Union: An Overview

Posted on by Ivan Malloci — Leave a comment

Baby pacifier

Baby pacifiers, teats, and similar products are subject to strict safety standards and substance restrictions. In this guide, we explain the main requirements of relevant regulations such as the Teats and Soothers Directive, the General Product Safety Regulation, REACH, and more.

We also explain why you should not assume that pacifiers manufactured outside the EU are designed to comply with European Union safety requirements.
Continue reading Baby Pacifier Regulations & Standards in the European Union: An Overview

AC Adapter Regulations in the European Union: An Overview

Posted on by Ivan Malloci — 4 Comments

AC Adapter Safety Standards in the EU

AC adapters are a type of power supply used to charge phones, laptops, and other electronic devices. These products are subject to several regulations in the European Union, including the Low Voltage Directive, the EMC Directive, and Regulation (EU) 2019/1782, which is an implementing measure under the Ecodesign Directive.

In this guide, we cover requirements of various regulations and directives applicable to AC adapters. We also explain lab testing requirements and risk factors.
Continue reading AC Adapter Regulations in the European Union: An Overview

Clothing and Textiles Regulations in the European Union: A Complete Guide

Posted on by Ivan Malloci — 20 Comments
Clothing and textile products imported and manufactured for sale in the European Union are subject to various regulations and standards. This includes labelling requirements, chemical restrictions, flammability requirements, and safety standards specific to children’s apparel.

Continue reading Clothing and Textiles Regulations in the European Union: A Complete Guide