Tag: compliance eu

Importing or manufacturing power tools for the EU market requires compliance with various regulations, directives, and safety standards.  Non-compliant power tools may pose mechanical, electrical, or other hazards to the operator – which could potentially result in severe injury or hearing damage.

In this guide, we take a closer look at the Machinery Regulation, Noise Emission in the Environment Directive, Batteries Regulation, and other compliance requirements for power tools in the European Union.

Continue reading Power Tool Regulations in the European Union: An Overview

Request a free EU Authorised Representative Quotation Here

The General Product Safety Regulation requires that products that fall under its scope should have a responsible person who is based in the European Union.

This essentially means that an entity must be present within the EU that can be contacted by market surveillance authorities in case of compliance checks. This also impacts companies based outside the EU, that are selling to consumers located in the EU.

In this guide, we address common questions associated with the requirements for responsible persons under the General Product Safety Regulation.
Continue reading Responsible Persons under the General Product Safety Regulation

The Machinery Regulation covers many different categories of machinery. Additionally, it covers a number of products that are related to machinery, such as components and chains.

In this guide, we provide examples of products for different categories of machinery. Additionally, we provide examples of harmonised standards associated with each listed product category.

Product List Creation Methodology

In this guide, we list examples of machinery products that are referred to in harmonised standards under:

a. The Machinery Directive

b. The Machinery Regulation

The Machinery Directive is effective until 20 January 2027 after which the Machinery Regulation applies.

Most of the standards that will be harmonised under the regulation are still under draft. Many of them are updated versions of standards that are harmonised under the Machinery Directive. However, some standards under the Machinery Regulation are new – for example, EN 17128 for Personal light electric vehicles (PLEV).

Continue reading List of Products covered by the Machinery Regulation

Certain chemicals are classified as Substances of Very High Concern (SVHCs) under the REACH regulation. Products and mixtures containing SVHCs can be subject to reporting requirements.

This guide addresses some common questions concerning SVHCs and explores the REACH requirements affecting articles containing SVHCs. Additionally, we explain the differences between SVHCs and restricted substances under Annex XVII of REACH.
Continue reading REACH SVHC Substance List: An Overview

Annex XVII of the REACH regulation sets restrictions for a wide range of substances, including phthalates, lead, cadmium, and nickel. Further, some substance restrictions are specific to certain product categories, such as textiles or childcare articles.

Keeping track of Annex XVII substances is important as you generally cannot sell products or mixtures that contain such substances above the set limits.

In this guide, we address common questions related to Annex XVII and present examples of substances that are restricted for use in consumer products. Additionally, we explain how new restrictions are added to the Annex.
Continue reading REACH Annex XVII Substances List: An Overview

Good Manufacturing Practice (GMP) generally refers to a set of procedures to ensure that the products you manufacture are consistently meeting the requirements of applicable regulations. In practice, this can mean different things, depending on the product and the applicable regulations.

In this guide, we cover GMP requirements found in regulations affecting different product categories from food contact materials to cosmetic products. Additionally, we cover similar requirements (like good engineering practice) found in other regulations and explain how they differ from GMP requirements.

Note that there may be other regulations that cover GMP requirements (e.g. for for medicinal products).
Continue reading Good Manufacturing Practice in the European Union

Importers and manufacturers of baby strollers are required to comply with requirements such as testing, documentation, and labelling. Non-compliant baby strollers may, for instance, pose mechanical, physical, and chemical hazards to children. For example, stroller parts may entrap the baby and cause an injury, and substances used in coating products and dyes may affect the child’s development.

In this guide, we explain how regulations such as the General Product Safety Regulation and REACH are relevant for baby strollers.
Continue reading Baby Stroller Regulations in the European Union: A Complete Guide

Companies importing certain materials and products into the EU must comply with the Carbon Border Adjustment Mechanism (CBAM) Regulation. This includes, for example, certain materials like aluminium, iron and steel. Additionally, the regulation covers certain finished or semi-finished products made with these materials, like screws and bolts.

In this guide, we explain the regulation as it relates to the application procedures for CBAM declarants, the submission of CBAM declarations, reporting obligations, and the purchasing of CBAM certificates. Additionally, we provide a FAQ section that addresses common questions concerning the regulation.
Continue reading Carbon Border Adjustment Mechanism Regulation: An Overview