Microplastic Regulations in the United States: An Overview

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Microplastics are tiny plastic particles that can be found in consumer products such as cosmetics, or toothpaste.

The Microbead-Free Waters Act of 2015f amended the Federal Food, Drug, and Cosmetic (FD&C) Act to prohibit microbeads, which are a type of microplastics that are intentionally added to products such as rinse-off cosmetics. The reason is that microplastics can end up in waterways and harm fish and other marine life.

In this guide, we explain what microplastics are, which products may contain them, and how the FDA and various state regulations restrict some types of microplastics from being used in products.
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Microplastic Regulations in the European Union: An Overview

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Microplastics are particles that are smaller than 5 mm and made of polymers and additives. These can be found in products such as cosmetics, personal care products, and cleaning products.

Microplastics can get released into the environment, harming it. As such, the EU now restricts microplastics and products and mixtures that contain intentionally added microplastics.

In this guide, we explain what importers and manufacturers should know about microplastics, including which products may contain them, whether these are banned, and how the REACH and EU Ecolabel Regulations restrict microplastics.
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European Union Authorised Representatives: A Complete Guide

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Request a free EU Authorised Representative Quotation Here

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

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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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Hazardous Materials Regulations: An Essential Guide

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Hazardous Materials Regulations
The Hazardous Materials Regulations sets requirements related to the transportation of dangerous materials, which include substances and products – such as batteries.

In this guide, we explain what the general requirements are and how US importers and manufacturers can use the Hazardous Materials Table to find relevant information concerning the requirements for their specific hazardous materials or product. We also provide a case study, focusing on the requirements for lithium batteries.
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Bisphenol A (BPA) Regulations in the United States: An Overview

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Bisphenol A (BPA) is an organic chemical used to improve durability and heat resistance in plastics. As such, it has long been used when manufacturing plastic products, from kitchen utensils and toys to certain medical devices.

That said, studies show that BPA may interfere with hormones, and cause other damage to the human body. It’s therefore not surprising that BPA is regulated in the United States, especially in food contact products designed for children.

In this guide, we explain what importers and manufacturers must know about BPA restrictions, including FDA 21 CFR, California Proposition 65, and other state regulations.

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Technical Documentation for CE Marked Products in the EU

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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?

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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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Bisphenol A (BPA) Regulations in the European Union: An Overview

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A broad range of products can contain Bisphenol A (BPA), which is used to enhance plastic durability. However, Bisphenol A (BPA) is restricted under various regulations in the EU due to its potential to cause harm to human health.

More specifically, Bisphenol A is restricted in consumer products, food contact materials, and toys in the European Union.

In this guide, we explain how regulations REACH, the Toy Safety Directive, and other regulations, including some national laws, either restrict or relate to Bisphenol A.

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