EU REACH Regulation Explained

What is the REACH Regulation and its objectives?

REACH is an acronym for the Registration, Evaluation, Authorisation and Restriction of Chemicals. Officially named Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, and serves as the primary EU legislation designed to safeguard human health and the environment from potential chemical risks. It has been in effect since 2007.

The European Chemicals Agency (ECHA) oversees the administration of the REACH Regulation in the EU, managing industry data submissions in the form of dossiers and offering guidance and support to industries via its website, documentation, and national helpdesk within the European Union (EU), the European Economic Area (EEA) and other countries such as Switzerland, Türkiye, Serbia and Montenegro.

The objectives of the REACH Regulation are to:

• Ensure a high level of protection of human health and the environment against harmful substances
• Assess the safety of chemical substances in use in the EU
• Promote innovation and competitiveness
• Promote alternative (non-animal) methods for the assessment of the hazards of substances

How does the REACH Regulation work?

The REACH Regulation implements a systematic procedure for collecting and evaluating information on the properties and risks of substances through the following four steps:

1. Registration

Companies must register substances exceeding 1 tonne per year with ECHA, providing a technical dossier. For substances produced or imported in quantities of 10 metric tonnes or more per year, a Chemical Safety Report (CSR) is required. The technical dossier and CSR are to identify and manage the risks associated with their use.

2. Evaluation

ECHA and Member States assess submitted industry information to establish if a substance could harm human health or the environment. This is achieved through compliance checking, dossier evaluation and substance evaluation processes.

Some substances, such as those that are carcinogenic, endocrine disruptors, or possess long-lasting harmful properties that bioaccumulate, are considered substances of very high concern (SVHCs).

3. Authorisation

The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.

Companies desiring to use or market SVHCs must apply to ECHA for authorisation.

4. Restriction of Chemicals

If certain substance on its own, in a mixture or in an article pose an unacceptable health or environmental risk, the REACH Regulation may introduce restrictions or bans. Restrictions can be applied to any substance, including those that do not require registration.

What products are regulated under the REACH Regulation? What does it mean to the softlines, leather, toys and hardlines industry?

The REACH Regulation has a very wide scope, applying to all chemical substances manufactured, imported, marketed, or used within the EU, whether alone, in mixtures, or in articles.

The REACH Regulation impacts businesses of various sizes across different sectors, even those who may not think of themselves as being involved with chemicals.

For consumer products, chemicals are integral to the production process, from dyes in textiles and footwear or coatings in cookware and painted toys.

It is important to consider that REACH defines an article as an object which during production is given a special shape, surface or design that determines its function to a greater degree than its chemical composition such as textiles, apparel, footwear, fashion accessories, furniture, childcare items and toys.

The articles which contain substance as a Substance of Very High Concern (SVHC) can trigger certain legal obligations for the importers, producers and suppliers of these articles which must comply to sell these articles in Europe.

As a brand or manufacturer in the softlines, leather, toys and hardlines industry, how can I comply with the REACH Regulation?

To comply with the REACH Regulation, brands or manufacturers should:

• Identify and manage risks associated with substances used in manufacturing, ensuring that concentrations of restricted substances and SVHCs remain within legal limits.
• Understand that any substance, not just those needing registration, may be subject to restrictions. Where applicable, use less dangerous substances or technologies as alternatives.
• Carry out chemical testing via a third-party laboratory as mandated by the REACH Regulation.
• Stay informed about updates to the REACH Regulation and SVHCs list by regularly visiting the ECHA website or subscribing to Eurofins newsletters.

How can the Eurofins Softlines & Leather network of laboratories help?

Our laboratories worldwide offer a comprehensive range of testing and consulting services for REACH and REACH-similar regulations, providing reliable and affordable chemical testing for your products/articles to comply with the Annex XVII restrictions, Substances of Very High Concern (SVHCs) and the SCIP database regulated by the EU REACH Regulation.

Find out more about Eurofins Chemical Testing Services for REACH.