REACH - InfoDyne: Logiciels - Calcul de l'étiquetage réglementaire

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REACH

What is REACH?

REACH ( Registration, Evaluation and Authorisation of CHemical Substances) is the set of European regulations that went into effect on 1st June 2007 for the purpose of improving European legislation concerning the protection of human health and the environment.

REACH was established in European Parliament and Council Regulation (CE) 1907/2006 of 18 December 2006 concerning the registration, evaluation and authorisation of chemical substances, as well as the restrictions applicable to these substances (REACH), instituting a European Chemicals Agency, modifying Directive 1999/45/CE, and repealing Council Regulation (CEE) 793/93 and Commission Regulation (CE) 1488/94, as well as Council Directive 76/769/CEE and Commission Directives 91/155/CEE, 93/67/CEE, 93/105/CE and 2000/21/CE.

Fundamental Principle

The REACH regulations are based on the principle that it is the responsibility of manufacturers, importers and upstream users to ensure that they manufacture, put on the market or use substances that have no effects that are harmful to human health or the environment. These provisions are based on a principle of precaution. (Title I – Section 1)

Objective

To increase knowledge of chemical substances in order to improve the protection of health and the environment
To increase the competitiveness of the European chemical industry
To improve the exchange of information between the various parties involved in the industry
To ensure the free circulation of substances on the internal market of the European Union
To establish a European Chemicals Agency

Function

As of 1st June 2008, for new substances in quantities greater than or equal to 1 tonne per year, a REACH registration application must be filed with the Agency before the chemical substance is produced or imported. An interim registration system will be granted for certain chemical substances.

The system is based on four main processes:

Registration: Manufacturers and importers of chemical substances must submit a registration application to the Agency for any chemical substances manufactured in or imported to the European Union in quantities greater than or equal to 1 tonne per year, per company.
No chemical substance that is subject to registration can be manufactured or imported until it is registered.
Evaluation: The evaluation process enables the Agency to verify that the industry is fulfilling its obligations and avoids unnecessary animal testing.
There are two types of evaluation: The evaluation of the application and the evaluation of the substance.

- Evaluation of registration applications conducted by the Agency

i) Evaluation of testing proposals for chemicals manufactured or imported in quantities of 100 tonnes or more per year.
ii) Evaluation of application compliance.

- Evaluation of chemical substances conducted by the relevant authorities in the Member States.

Authorisation: Certain chemical substances (CMR (Carcinogen, Mutagen, toxic to Reproduction) category 1 and 2, PBT (Persistent, Bioaccumulable and Toxic) and vPvB (very Persistent and very Bioaccumulable)) are subject to authorisation in order to limit the risks for people and the environment. No substance that is subject to the authorisation process can be used unless it has received authorisation for that use. The purpose of this system is to ensure that each use of certain substances that are the greatest cause for concern in terms of health or the environment, is subject to authorisation, so that they can be strictly controlled.
The substances that are cause for an extremely high level of concern are gradually included in Appendix XIV of the REACH regulations. Once included in this appendix, they can no longer be put on the market or used after a stop date, referred to as the “expiration date,” as long as the company has not received authorisation.
Restriction: A safety net for the system, to manage risks that are not otherwise covered. Specific uses of certain chemical substances may be limited or prohibited on the European market.

The European Chemicals Agency, based in Helsinki, oversees the implementation of the REACH regulations and coordinates the application evaluations conducted by the Member States of the European Union.

IT Tools

A manufacturer or importer must use the REACH-IT portal in order to pre-register its chemical substances between 1^st June 2008 and 1^st December 2008.

IUCLID5 (International Uniform ChemicaL Information Database) is an international database used to gather consistent information on chemicals.
IUCLID5 is the tool used to collect the data. IUCLID5 can be used to prepare the registration application, as well as other types of applications (RDAPP applications, classification and labelling notifications, notifications of chemical substances contained in other items, DU reports and Appendix XV applications).