Tag: compliance eu

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.

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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.
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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.
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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.
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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.

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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.
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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.
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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.
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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.

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European Union Product Labelling Requirements: A Complete Guide

Posted on by Fredrik Gronkvist — 98 Comments

Various types of labelling requirements apply to essentially all products manufactured or imported for sales in the European Union. These are normally part of regulations and directives, such as the Low Voltage Directive or General Product Safety Regulation.

EU labelling requirements cover compliance symbols, such as the CE mark and WEEE mark, traceability, and more.

Failing to correctly label the product and packaging can result in fines or a recall – which is why it’s so important to understand the requirements that cover your products.

Note that this guide doesn’t cover packaging recycling symbols, which can be found here.

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