REACH

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), establishing a European Chemicals Agency, abbreviated to REACH, contains a set of provisions directly binding in all EU member states. REACH is a regulation adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. 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. Regulations implemented by the provisions of this Regulation have an impact on most companies across the European Union.

Chemical Management System implemented through REACH is based on four pillars:

- Registration of a substance,

- Evaluation of the information concerning the substance and/or of registration dossier

- Granting of authorisation to place on the market and use substances of very high concern to human life and the environment

- Introduction of restrictions on the manufacturing, placing on the market and use of certain chemical substances.

The key stakeholders of the REACH system include:

- Operators (manufacturers, importers, industrial and professional users of substances, downstream users and distributors). REACH precisely defines obligations of companies, taking into account their role in the system;

- European Chemicals Agency with its headquarters in Helsinki (ECHA);

- European Commission;

- Member states, with their designated competent authorities for REACH and enforcement bodies responsible for enforcement of the laws under the national system of penalties.

The key obligation of companies is to identify risk and define methods to manage the risk of substances placed on the EU market. Companies have to provide documentation to the European Chemicals Agency (ECHA) to demonstrate how a specific substance can be safely used, and they must communicate the risk management measures to the users at every stage of the substance life cycle. To this end companies need to register (submit registration dossier) substances they manufacture or import, and to do this they need to work together for the purpose of the registration process with other companies which are registering the same substance as well as share the related cost. REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. The scope of the submitted information depends on the annual average tonnage of the substance declared by each participant of the registration process.

The European Chemicals Agency (ECHA) receives and evaluates specific registrations for their compliance, and the EU Member States evaluate selected substances based on the available scientific literature to clarify any concerns for human health or for the environment.

The European Commission and the European Chemicals Agency, through ECHA’s scientific committees (the Committee for Risk Assessment, the Member State Committee and the Committee for Socio-economic Analysis) assess whether the risks of substances can be managed. These activities are conducted in cooperation with relevant authorities of the Member States and their representatives.

If the risks are unmanageable, they can also decide to introduce various options to restrict a use of the substance, including a ban, or make it subject to a prior authorisation before the substance is placed on the market. In the long run, the most hazardous substances should be substituted with less dangerous ones.

If a company does not register a substance, it shall not be able to market this substance in the EU territory.

Companies established outside the EU are not bound by the obligations of REACH, even if they export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.

The current and regularly updated text of REACH is available at the European Chemicals Agency website (ECHA) HERE

Detailed information on the involvement of the Bureau for Chemical Substances in various activities relating to REACH requirements is available HERE