Skincare Regulations in the European Union

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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 it relates to skin care products, we also cover other relevant regulations, that is the REACH Regulation, the 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)
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Hair Care Regulations in the European Union

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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)
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Cosmetic Substance Restrictions in the European Union

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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.

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EU Cosmetic Products Regulation: An Essential Guide

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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

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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

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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

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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

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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

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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

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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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