Product Compliance Resources provided by ProductIP

2021-02-19

REACH Regulation (EC) 1907/2006

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

ALWAYS REACH

REACH applies to all chemical substances; those used in industrial processes and also those in consumer products like detergents or paints. Additionally REACH applies also to all substances that are inevitably present in manufactured products.

The REACH regulation consists of hundreds of pages, many annexes and extensive lists of chemical substances. The European Chemicals Agency (ECHA) has published thousands of pages of guidance to explain whatneeds to be done by the industry. Updates and changes occur regularly.

Where do you start?

Substances

If you are placing substances on the European market in more than 1000 kg per year then you are required to register that substance first. Registration of a substance involves submitting a vast and complicated technical dossier with information about the risks of the substance. The registration is evaluated by ECHA. This is the "no data, no market" principle of REACH.

This registration is also applicable to substances intended to be released from articles like ink from a pen or fragrances from scented articles.

Safety Data Sheet

If you are using chemicals in your production facility, office or warehouse then please make sure you follow the advice for safe handling, use and disposal. This information must be made available in a Safety Data Sheet.

Most products are articles within the meaning of REACH

An article is composed of one or more substances given a specific shape, surface or design of any material. Most of the commonly used products in households and industries are articles, e.g. furniture, clothes, toys, vehicles, books and electronics. 

"Packaging is always to be treated as an article separate from the contents of the package. Therefore, the obligations on substances in articles also apply to packaging materials."

REQUIREMENTS

The main requirements of REACH for (substances in) articles are:

  • Restrictions in Annex XVII;
  • Obligations for SVHC's.

Annex XVII restrictions

Annex XVII contains restrictions on the presence of certain hazardous substances in articles.

The restrictions are specific for types of use, products or materials. For example the restriction of six phthalates in plasticised materials used in toys and childcare articles. The restriction does not (yet) apply to other products.
Or the restriction for migration of nickel from metal materials but only when coming into prolonged contact with the skin, like jewellery.

In order to comply with all the restrictions in Annex XVII it is important to know and understand if your products fall in the scope of the restriction based on the intended and foreseeable use of the product.

SVHC obligations

Some substances present high risks to the human health and/or to the environment. These substances are known as "Substances of Very High Concern", in short SVHC. The substances are published in the so-called Candidate List, it is updated twice a year.

Communication

If an article contains SVHC's with a concentration above 0,1% (w/w) then you are obliged to inform your supply chain about each SVHC and how to use it safely.

Information

Consumers may request information about SVHC's too. This information must be provided within 45 days and free of charge.

Notification

If an article contains SVHC's with a concentration above 0,1% (w/w) and the total amount of the SVHC exceeds 1 tonne per year per producer (or importer) then you must notify ECHA.

Authorisation (Annex XIV)

SVHC's are candidates that may not be allowed to be imported, marketed or used later in time. These substances are then added to Annex XIV of REACH and one can only continue using these substances if authorisation has been granted.

Need more information?

Check out the ECHA website or contact the REACH Helpdesk.

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