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EU REACH Regulation (EC) No 1907/2006

By Little Pro on 2015-12-30 Views:  Update:2017-03-09

REACH standards for the 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 (REACH). It entered into force on 1 June 2007.

REACH regulation applies to all chemical substances on their own or in preparations as well as in articles(see below definition). It almost impacts every company doing business in or exporting to Europe.

Term Definition & Examples
Preparation
  • A mixture or solution composed of two or more substances;
  • Example: paints, detergents;
Article
  • An object which during production is given a special shape, surface or design, which determines its function to a greater degree than its chemical composition
  • Examples: clothes, electrical appliances, etc.

 

Reminder: Since Switzerland is not a member of the EU or the European Economic Area (EEA), EU REACH regulation does not apply. Switzerland has its own chemical regulations adopting REACH-like registration requirements. Please refer to Swiss Chemicals Ordinance (ChemO).

Key elements of the EU REACH regulation include registration, evaluation, authorization, restriction and supply chain communication. Chemical suppliers and article suppliers have different obligations under REACH.

Registration

REACH requires that manufacturers and importers register substances manufactured or imported in quantities of one tonne or more per year. This includes substances on their own, in mixtures or substances in articles when they are intended to be released under normal or reasonably foreseeable conditions of use.

For all registrations, a registration dossier has to be prepared and submitted electronically via REACH-IT to the European Chemicals Agency (ECHA). Normally, the registration must be successfully completed and a REACH registration number assigned to the registrant before a substance can be manufactured, imported or placed on the market.

Read more about EU REACH registration.

Evaluation

ECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.

Authorization

A Substance of Very High concern (SVHC) on REACH Annex XIV ("authorization list") cannot be placed on the market or used after a given date, unless an authorisation is granted for their specific use.

Read more about REACH authorization list - Annex XIV.

Restriction

REACH Annex XVII of REACH contains the list of restrictions of certain dangerous substances, mixtures and articles for their marketing and use on the European market. A restriction can apply to any substance on its own, in a mixture or in an article, including those that do not require registration.

Read more REACH restriction list - Annex XVII.

REACH Safety Data Sheets

The Annex II of REACH has set out detailed requirements on the format and content of SDSs.

REACH SDS follows a 16 section format which is internationally agreed.CLP classification and labelling info must be included in SDSs. The SDS must be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market.

  • Section 1: Registration number for substances subject to REACH registration must be provided; Email address mandatory;
  • Section 8: List applicable DNELs, OELs, and PNEC;
  • Section 15: Info on substances subject to authorization and restrictions; Indication of whether a chemical safety assessment has been conducted;
  • eSDSs: Registrants and downstream users that are required to prepare a CSR, must place the relevant exposure scenario(s) into an annex to the Safety Data Sheet.

Read ECHA Guidance on SDSs

Quick Info for Producer, Importer or Supplier of Chemicals

Registration is your main obligation. You may also be affected by authorization and restriction. You also need to comply with CLP regulation.

Quick Info for Producer, Importer or Supplier of Articles

If your article contains substance intended to be released (for example, ink in a pen), you shall read your registration obligations. Otherwise you can skip registration and evaluation part.

 

 Tags: Topics - EUREACH-like Regulation and Registration

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