Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the 2006/1907 regulation of the European Union about registration, evaluation, authorisation and restriction of chemical substances, and establishes an European Agency for chemical substances with the consequent registration of many chemical substances imported or produced inside the E.U., new or just existing in the E.U. territory. This system aims to guarantee a greater security on the field of manufacturing and use of chemical substances.

REACH obliges the industries to collect complete information on properties of produced or imported substance, for a quantity greater than one tonnage for year, and obliges to demonstrate the security about the use of that substance. With the preceeding normative, the public authorities of the Member States had to demonstrate the existence of a risk so that to deny the use of a substance. The actual inversion of this test guarantee a greater effectiveness of the procedure.

These information must be subsequently transmitted to the European Agency of chemical products, that aims to manage these procedures. The Agency is located to Helsinki, and manages the registration of substances through the creation of data bases. Without the registration, a substance can't be neither produced or imported on the market of the European Union.

The public authorities of Member States must examine the registration dossiers and worrying substances. These authorities are obliged to issue or not the authorization for substances that has a risk for the human health or the environment. The procedure has been simplified, even if there are other possible restrictions about some of this dangerous substances.

The REACH system, adopted at the end of 2006, substitutes 40 preceeding legislative laws. Based on the preceeding legislation, the chemical substances put on the market before the 1981 (that is about the 99% of the substances currently on the market) wasn't subjected to testing. Moreover, the preceeding procedure, too slow, penalized the innovation and the substitution of substances available on the market.

The first exipiration of REACH is shot, the new European Regulation for registration, evaluation, authorisation and restriction of chemical substances, and with the definitive approval on 13 December 2006, the European Parlament has re-designed the community normative context about chemical substances.

In fact, since 1 June 2008, the pre-registration phase has start for the industries, that has an expiration on 1 December 2008 to acquire the right to continue the production and/or importing of chemical substances of interest, postponing in a second time the dossier preparation and the studies needed for a future registration. Next, the E.U. Agency will publish (from 1 January 2009) the list of pre-registered substances.

REACH revisits more of 40 legislations and involves 2000 chemical companies in Italy and more of 100000 industrial transformation companies. The pre-registration is a must that anyway doesn't oblige instantly the industries to register, and doesn't require any cost. The entities that doesn't pre-register, expires immediately the possibility to produce and/or import a chemical substance on the market. In fact, the REACH regulation is a normative law funded on precaution principle that, upon establishing the provisions applicable to manufacturing, insertion on the market or use of chemical substances, obliges the industries that produces, imports and/or uses substances to evaluate the intrinsic properties and to evaluate the needed actions to manage the risks connected to them.

The pre-registration phase of REACH, that begins on 1 June 2008 and ends in 31 December 2008, must be used by chemical products industries and companies to prepare their dossiers, that must be subsequently used in the registration phase, for the effective registration of substances. The dossier compiled by the industry or company must contain all the data needed for registration, including eventually animal and environment test projects, fees shared with other companies that wants to register same substances, and so on. The main agency that coordinates the entire REACH system, that is the ECHA, will evaluate these dossiers and so it will communicate to the interested companies if the registration has been succesfully approved or not.

K4ICT is able to provide assistance and consultance on dossier compilation for agencies interested to the registration. In particular, we are able to provide the following services:

• Dossier preparation and transmission to the main Agency: assembly service of available data, selection of key studies, preparation of study summaries to the needed level of detail, preparation of any experiment proposal, and finally transmission, after completion, of the technical dossier to the Agency in electronic format.
• Chemical Safety Report: creation of the chemical safety report that contains the evaluation of all the hazards eventually present in the substance and contains, for the hazardous substances, the evaluation of the exposure and the risks for each identified use of the same substance. Development of the needed exposure scenarios that describes the use operational conditions of a substance in its life cycle, and the risk management measures to apply to achieve a secure use. The preparation of these scenarios, that will be used inside the evaluation of the chemical security, requires a combined work of specialists with different skills. If available, technicians of the company must be involved; in any case, maximum transparency and collaboration will be guaranteed with the client, so that to enhance a positive interaction and a shared result.

IUCLID, acronym of International Uniform ChemicaL Information Database is a public application software to acquire, store, maintain and exchange information on intrinsic properties and effects of chemical substances. It's primarily addressed to chemical industried and public administrations.

IUCLID is under the responsability of the European Chemicals Bureau (ECB), the Institute of Health and Consumer Protection (IHCP) section, related to the Joined Research Center (JRC) of the European Commission, and it's distributed free-of-charge. The version 5 has been developed and made public since June 2007; IUCLID 5 is the fundamental instrument for the chemical industry to meet the obligations imposed by REACH, the European Union law that handles the production, importation and use of chemical substances in the Union territories.

K4ICT is able to provide assistance and training on IUCLID, moreover we provide an optimal consultance in the installation and the help on pre-registration with IUCLID. In particular, it's possible to inquire for the following services:

• Installation of standalone and workstation versions
• Installation of pre-registration plug-in and training
• Training on the general usage of the application; in particular:
  • IUCLID structure and main information
  • creation and use of several kind of user (legal entities) inside the application
  • structure of standalone and workstation versions
  • dataset related to substances: EC, EINECS and ELINCS numbers, structured information on substance
  • importing and exporting of datasets
  • registration dossier creation
  • pre-registration use