Understanding and Complying with the REACH Regulation

The REACH regulation is designed to improve the protection of human health and the environment. REACH will replace more than 40 existing EU legislations and regulations. This change will affect manufacturers, importers, wholesalers and retailers who distribute their products in the EU market.

As a manufacturer, importer or retailer, you must know what chemical substances are in your products. Depending on the contents, you will be subject to different requirements with regard to your company’s registration, declaration, licence and information.

Definitions

To determine which requirements apply to you, you should be aware of the following three definitions:

Substances:
Substances are a chemical element and its compounds, including the additives required to maintain its stability and the impurities caused by the process used.

Mixtures (Preparations):
Mixtures were formerly known as “preparations”. As such this refers to mixtures or solutions consisting of two or more chemical substances.

Products:
Products have a specific shape, surface or design that determines their end function to a greater degree than their chemical composition.

Registration

The obligation to register applies to substances distributed in the EU market. The authority responsible for such registrations is the European Chemicals Agency (ECHA).

Substances which meet at least one of the following conditions must be registered:

• Substances that are imported into the EU or produced in the EU in quantities of more than 1 tonne per year
• All substances in mixtures that are imported into the EU or produced in the EU in quantities of over 1 tonne per year (e.g. cosmetics, candles, ink for fountain pens or cartridges)
• All substances in products and substances that will be released from a product that are imported into the EU or produced in the EU in quantities of over 1 tonne per year (such as products that release fragrances, e.g. scented rubbers)

Evaluation

The ECHA and Member States evaluate chemical substances according to the risks and quantities. These evaluations form the basis for further requirements and conditions such as applications, licences or restrictions. The evaluation procedure also includes public consultations

More information can be found on the ECHA website: http://echa.europa.eu/home_de.asp

Application

An application must be completed if a product contains substances that are classified as SVHC (Substances of Very High Concern). The ECHA must be notified of substances if the following conditions apply:

• The substance is available and is imported into the EU or produced in the EU in quantities of over 1 tonne per year per manufacturer or importer AND
• The substance constitutes more than 0.1% (mass content) of the product AND
• The substance is classified as SVH. The following schedules apply:
• For substances entered on the list of candidates before 1 December 2010, the application must be submitted by 1 June 2011 at the latest.
• For substances entered on the list of candidates after 1 December 2010, the application must be submitted to the list no later than 6 months after its inclusion.

Licence

The substances listed in annex XIV are subject to the requirement for licensing if they are used in the EU after the expiry date and restrictions or exceptions have not already been defined for them. Substances that have not been licensed may not be brought to market. In order to obtain a licence, an application must be submitted to the ECHA confirming that the dangers and risks to human health and the environment are manageable.

Restriction

In order to standardise the legal requirements for chemical substances, annex XVII of the REACH regulation contains a number of demands. These are based on the “classic” requirements, which are in the original Directive No. 76/769/EEC and its amendments.

Effective communication between downstream users and suppliers at all stages of the REACH process helps to ensure the relevant information is received within the supply chain.