REACH Regulation (EC) No 1907/2006

REACH, Regulation (EC) No 1907/2006, is the EU law on the Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007. Its aims are a high level of protection of human health and the environment, the promotion of alternative methods for assessing the hazards of substances, and the competitiveness of the chemical industry.

For REACH and KKDIK compliance of your products, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

What REACH applies to

REACH applies to chemical substances on their own, in mixtures and in articles. A substance manufactured in or imported into the EU in quantities of 1 tonne or more per year per company has to be registered with the European Chemicals Agency (ECHA).

Outside the scope are:

• Radioactive substances
• Substances under customs supervision, in temporary storage, in a customs zone or in transit, if they are not treated or processed
• Non-isolated intermediates
• The transport of dangerous substances by rail, road, inland waterway, sea or air
• Waste
• Substances exempted in the interests of defence

Who registers

• EU manufacturers and importers of substances on their own
• EU manufacturers and importers of substances in mixtures
• EU producers and importers of articles, where a substance is intended to be released from the article
• An Only Representative established in the EU, appointed by a manufacturer, formulator or article producer outside the EU to take over the registration duties of its importers

A company outside the EU cannot register itself. For an exporter in Turkey, this means either relying on each EU importer to register or appointing an Only Representative.

What a registration contains

A technical dossier with:

• Identity of the manufacturer or importer
• Identity of the substance
• Information on manufacture and identified uses
• Classification and labelling
• Guidance on safe use
• Study summaries and robust study summaries of the information required for the tonnage band
• Testing proposals, where required
• For 1 to 10 tonnes, exposure-related information

For substances registered at 10 tonnes or more per year, a chemical safety assessment is carried out and documented in a chemical safety report.

Registration follows the principle of one substance, one registration. Companies registering the same substance submit jointly, with a lead registrant filing the shared data.

Evaluation, authorisation and restriction

• Evaluation. Testing proposals and registration dossiers are examined, and substances of concern are evaluated.
• Authorisation. Substances of very high concern placed on the authorisation list can be used or placed on the market only for uses that have been authorised. Manufacturers, importers and downstream users can apply, alone or jointly, for one or several uses. An application contains the identity of the substance and the applicant, the uses applied for, a chemical safety report, an analysis of alternatives and, where suitable alternatives exist, a substitution plan.
• Restriction. The manufacture, placing on the market or use of certain substances is limited or banned under set conditions.

Safety data sheets

The supplier of a substance or mixture that is classified as hazardous provides the recipient with a safety data sheet. It is supplied on paper or electronically, at no charge, in the official language of the country where the product is placed on the market. When the sheet is updated, the new version is sent to all recipients supplied within the preceding 12 months. After registration, the sheet includes the registration number.

REACH and other chemical rules

• RoHS. For electrical and electronic equipment, REACH applies alongside RoHS (Directive 2011/65/EU). RoHS limits ten specific substances: lead, cadmium, mercury, hexavalent chromium, PBB, PBDE and four phthalates. REACH is wider and covers all substances. See RoHS testing.

KKDIK: the Turkish counterpart

Turkey has its own regulation modelled on REACH, known by its Turkish abbreviation KKDIK. It is a separate system:

• Registrations are made to the Ministry of Environment, Urbanisation and Climate Change through its Chemicals Registration System, not to ECHA.
• The duty falls on manufacturers and importers established in Turkey for substances at 1 tonne or more per year.
• A company outside Turkey can appoint an Only Representative established in Turkey.
• An EU REACH registration does not count in Turkey, and a KKDIK registration does not count in the EU.
• Substances that are not registered cannot be manufactured, imported or placed on the Turkish market.

What a company can do first

1. List all substances in its inventory, on their own, in mixtures and in articles.
2. Determine which are in scope and at what tonnage.
3. Establish its role in the supply chain for each: manufacturer, importer, downstream user or distributor.