EU REACH Registration | European Union Chemical Regulation

EU Chemical Regulation

EU REACH

What is REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) ?

REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances in diﬀerent ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.

How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.

ECHA receives and evaluates each registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientiﬁc committees assess whether the risks of substances can be managed.

Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.

REACH Timeline

Post 31st May’2018, Deadline all chemicals are treated equally and chemicals which were not registered within REACH with European Chemical Agency will not be allowed to be marketed or manufactured within EU.

REACH Registration Process

To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. The main principle of REACH is “one substance, one registration”.

During joint submission process, one of the member among the manufacture of same chemicals nominate himself as lead registrant and the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co- registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in IUCLID6.

REACH Registration Dossier

A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report.

1) Technical Dossier

Identity of manufacturer/importer;
Identity, volume and identiﬁed uses of substance;
Classiﬁcation and labelling;
Study report and robust study summaries according to Annex VII to X (physiochemical, toxicological, eco-toxicological properties, );
Testing proposal;
Statement whether tests have been carried out on vertebrate animals;

2) Chemical Safety Report (> 10 ton per year)

Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment;
Exposure Scenario is required if classiﬁed as dangerous or PBT/vPvB; operational conditions and risk management measures for each use; exposure estimation