General Product Safety Regulation (GPSR): An Essential Guide

Posted on by Ivan Malloci — 6 Comments

The General Product Safety Regulation (GPSR) is a new regulation that will replace the General Product Safety Directive (GPSD). Its purpose is to set safety and other requirements for all consumer products, regardless of whether product-specific regulations, directives, or standards exist.

This is already the case with the GPSD, but the GPSR goes beyond the GPSD in some aspects. The GPSR also provides more detailed requirements, for example, in terms of product and packaging labelling.

In this guide, we help you better understand the new GPSR and the steps you must take before it finally replaces the GPSD.
Continue reading General Product Safety Regulation (GPSR): An Essential Guide

United States Product Labeling Requirements: A Complete Guide

Posted on by Fredrik Gronkvist — 21 Comments

Products sold in the United States must generally be labeled or marked according to the requirements in the applicable regulations. Some labeling requirements apply to all products, while others only cover certain types of products, materials, or even age groups.

Commonly, a single product is subject to several different product labeling and marking requirements, which is why you can often see a plethora of product information and compliance marks on everything from phone chargers to baby clothing.

This guide serves as an introduction to US product labeling and marking requirements for clothing, electronics, children’s products, furniture, and many other products.

Note that this guide covers both federal and some state-level labeling requirements. That being said, this is not an exhaustive list of labeling requirements in the United States.

Continue reading United States Product Labeling Requirements: A Complete Guide

ASTM F963-23 Children’s Product Safety Standard: An Overview

Posted on by Ivan Malloci — Leave a comment

ASTM F963-23 is the latest version of ASTM F963, a safety standard that sets requirements for children’s products in the US. Compliance with ASTM F963-23 will become mandatory on April 20, 2024.

It covers requirements regarding chemical and heavy metals, mechanical, physical, and electrical safety, and more.

In this guide, we explain what you must know about ASTM F963-23, which products must comply with it, how you should ensure compliance, and where to buy the standard.

Continue reading ASTM F963-23 Children’s Product Safety Standard: An Overview

Medical Devices Labelling Requirements in the European Union

Posted on by John Vinod Khiatani — 1 Comment

Medical Devices Labelling Requirements EU
Products covered by the Medical Devices Regulation are required to be accompanied by labelling information, such as CE marking, traceability information, notified body information, and instructions.

This guide serves as an introduction to labelling requirements in the context of the Medical Devices Regulation.
Continue reading Medical Devices Labelling Requirements in the European Union

EU Notified Bodies for Medical Devices: An Overview

Posted on by John Vinod Khiatani — Leave a comment

EU Notified Bodies for Medical Devices

Certain products covered by the Medical Devices Regulation (MDR) require the involvement of a notified body before being placed in the EU market. The extent of the involvement of the notified body is determined based on the classification of the medical device.

In this guide, we explain in which case a notified body should be approached. Additionally, we provide a list of various notified bodies in the EU for medical devices and explain how you can search for a notified body in other EU member states.

Methodology

The list of EU-notified bodies that we provide is retrieved from the notified bodies (NANDO) database. Note that we only provide examples of notified bodies for some countries, not a definitive list.

Continue reading EU Notified Bodies for Medical Devices: An Overview

Cosmetic Testing Companies in the European Union

Posted on by John Vinod Khiatani — 1 Comment

Cosmetic Testing Companies in the European Union

Before a cosmetic product is placed in the EU market, a safety assessment of the cosmetic product must be conducted and a cosmetic product safety report drafted.

Some cosmetics testing companies can help in performing the necessary testing to verify that your product doesn’t contain banned substances – and compiling the documents needed to create the cosmetic product safety report.

In this article, we list companies that claim to have lab testing facilities in the EU and provide testing services for cosmetic products according to the provisions in the Cosmetic Products Regulation.

Continue reading Cosmetic Testing Companies in the European Union

Cosmetic Product Safety Reports in the European Union

Posted on by John Vinod Khiatani — 1 Comment

Cosmetic Product Safety Reports in the European Union
All cosmetic products must be subject to a safety assessment before being sold in EU markets. A key document that is produced during this stage is the Cosmetic Product Safety Report (CPSR) which is required to ultimately place the product in the market.

In this guide, we address common questions concerning the CPSR, unveil the individuals and businesses that are necessarily involved with its production, and provide a list of companies that provide related services.
Continue reading Cosmetic Product Safety Reports in the European Union

Responsible Person for Cosmetic Products in the EU

Posted on by John Vinod Khiatani — Leave a comment

Responsible Person for Cosmetic Products in the EU
The key role when placing cosmetic products in EU markets is that of the responsible person. Without the responsible person assigned to the cosmetic product, it would not be possible to legally sell it within the EU.

In this guide, we address common questions associated with this role and explain what importers and manufacturers must know about the duties of the responsible person.
Continue reading Responsible Person for Cosmetic Products in the EU

Cosmetic Notification Requirements in the European Union

Posted on by Yvette Shen — 1 Comment

Cosmetic Notification Requirements in the European Union
The Cosmetic Products Regulation states that the responsible person (e.g., the manufacturer or importer) must use the Cosmetic Products Notification Portal (CPNP) to notify the EU regarding their cosmetic products, as well as nanomaterials used in cosmetic products.

In this guide, we explain the notification requirements as described in the Cosmetic Products Regulation.
Continue reading Cosmetic Notification Requirements in the European Union

Cosmetic Products Labelling Requirements in the European Union

Posted on by Yvette Shen — Leave a comment

Cosmetic products sold in the European Union must be labelled according to the provisions of the Cosmetic Products Regulation. Cosmetic labels must, for example, contain information about the company selling the product, content, batch number, and intended use.

Thera are also restrictions concerning product claims, and requirement related to precautions and warnings.

Further, we also cover labelling requirements that are part of regulations other than the Cosmetic Products Regulation, but that are still applicable to cosmetic products.

Continue reading Cosmetic Products Labelling Requirements in the European Union