The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.
REACH also addresses the continued use of chemical substances of very high concern (SVHC) because of their potential negative impacts on human health or the environment.
From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one tonne per year and the SVHC is present at more than 0.1% of the mass of the object.
The European Commission supports businesses affected by REACH by handing out – free of charge – a software application (IUCLID) that simplifies capturing, managing, and submitting data on chemical properties and effects.
The aim of REACH is to improve the protection of human health and the environment by identification of the intrinsic properties of chemical substances.
[9] The European Commission's (EC) White Paper of 2001 on a 'future chemical strategy' proposed a system that requires chemicals manufactured in quantities of greater than 1 tonne to be 'registered', those manufactured in quantities greater than 100 tonnes to be 'evaluated', and certain substances of high concern (for example carcinogenic, mutagenic and toxic to reproduction – CMRs) to be 'authorised'.
The EC adopted its proposal for a new scheme to manage the manufacture, importation and supply of chemicals in Europe on in October 2003.
This ensures that manufacturers, importers, and also their customers are aware of information relating to health and safety of the products supplied.
For many retailers the obligation to provide information about substances in their products within 45 days of receipt of a request from a consumer is particularly challenging.
The list of harmful substances is continuously growing and requires organizations to constantly monitor any announcements and additions to the REACH scope.
A requirement is to collect, collate and submit data to the European Chemicals Agency (ECHA) on the hazardous properties of all substances (except Polymers and non-isolated intermediates) manufactured or imported into the EU in quantities above 1 tonne per year.
In addition, industry should prepare risk assessments and provide controls measures for using the substance safely to downstream users.
In addition, national officials concluded that 64% of the substances under evaluation (126 out of 196) lacked the information needed to demonstrate the safety of the chemicals marketed in Europe due to inadequate industry data.
It passed the first reading in the European Parliament on 17 November 2005, and the Council of Ministers reached a political agreement for a common position on 13 December 2005.
A separate regulation – the CLP Regulation (for "Classification, Labelling, Packaging") – implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive.
[14] In the European Green Deal of 2020, a commitment was made to update the REACH regulation to ban between 7,000 and 12,000 toxic substances in all consumer products, except where truly essential.
Even where they might not do direct harm to humans, they can contaminate the air or water, and can enter the food chain through plants, fish or other animals.
According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981.
Of the 100,000 chemicals used in Europe today, “only a small fraction has been thoroughly evaluated by authorities regarding their health and environmental properties and impacts, and even fewer are actually regulated,” according to a report for the European Commission.
[24] Only representatives are EU-based entities that must comply with REACH (Article 8) and should operate standard, transparent working practices.
The Only Representative assumes responsibility and liability for fulfilling obligations of importers in accordance with REACH for substances being brought into the EU by a non-EU manufacturer.
An article in the business news service Chemical Watch described how some "pre-registrants" may simply be consultants hoping for work ("gold diggers") while others may be aiming to charge exorbitant rates for the data they have to offer ("jackals").
[25] Source:[26] The European Chemical Agency (ECHA) has published the REACH Authorisation List,[28] in an effort to tighten the use of Substances of Very High Concern (SVHCs).
To sell or use these substances, manufacturers, importers, and retailers in the European Union (EU) must apply for authorization from the ECHA.