Tag: compliance eu

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

The Batteries Regulation covers batteries manufactured or imported for sale in the EU. In this guide, we list some of the battery types covered by the Batteries Regulation, such as portable batteries, SLI batteries, LMT batteries, and other batteries.

Product List Creation Methodology

We list batteries that are mentioned in the Batteries Regulation and referred to in standards under the regulation that we found searching on the CENELEC website.

Note that the standards presented in this guide have yet to be published, and these have not yet been harmonised under the regulation. To be confirmed as a harmonised standard, the standard should be referenced in the Official Journal of the European Union (OJEU).

However, it is stated on each of the cited standards on CENELEC that a citation in the OJEU for the regulation is expected.

Continue reading List of Products covered by the Batteries Regulation

In this guide, we list examples of products that are covered by the General Product Safety Regulation. By reading this guide, you also learn about the different product categories for which a harmonised standard exists under the regulation, the significance of a harmonised standard, and what you should do when selling products that are not covered by such standards.

Product List Creation Methodology

In this guide, we list product categories for which there exist one or more harmonised standards referenced under the General Product Safety Directive, and provide examples of covered products and relevant standards. Note that, according to the General Product Safety Regulation, such standards also provide a presumption of conformity with the safety requirements laid down by the regulation.

Harmonised standards are generally necessary to comply with the safety requirements set by the regulation. Applying a harmonised standard would mean that your product is presumed to be safe, as explained in Article 7 of the regulation:

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1. For the purpose of this Regulation, a product shall be presumed to be in conformity with the general safety requirement laid down in Article 5 of this Regulation in the following cases:

(a) it conforms to relevant European standards or parts thereof as far as the risks and risk categories covered by those standards are concerned, the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012; or

(b) in the absence of any relevant European standards as referred to in point (a) of this paragraph, the product conforms to national requirements, as regards the risks and risk categories covered by health and safety requirements laid down in the national law of the Member State in which it is made available on the market, provided that such law is in compliance with Union law.

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Continue reading List of Products covered by the General Product Safety Regulation