WHAT IS AN INTERMEDIATE USER IN THE REACH REGULATION?
A downstream user is any natural or legal person established in the Community, other than the manufacturer or the importer, who uses a substance, as such or in the form of a preparation, during the course of his industrial or professional activities. Distributors or consumers are not downstream users. The re-importer covered by the exemption referred to in article 2, paragraph 7, letter c) shall be considered a downstream user.
WHAT IS THE CLASSIFICATION AND LABELING CATALOG?
ECHA creates and updates a classification and labeling catalog in the form of a database, which includes the substances for which registration is mandatory and the substances that meet the criteria for being considered dangerous and that are marketed as such or in the form of prepared in concentrations above specified limits. For each of these substances the following information is included:
Identity of the manufacturer or importer responsible for marketing the substance.
Identity of the substance or substances.
Hazard classification of the substance.
Hazard label for the substance.
Where applicable, specific concentration limits.
WHAT DOES THE REGISTRY CONSIST OF? WHAT MUST BE REGISTERED?
The REACH regulation provides for the obligation on the part of manufacturers and importers to submit an application for registration to the Agency for all substances imported or manufactured as such or in the form of preparations in quantities equal to or greater than 1 ton / year and contained in articles that are released under normal or reasonably foreseeable conditions of use and are present in the article in quantities greater than 1 ton / year.
Part of the information presented in the registry dossier may be presented jointly with the members of a consortium of the Information Exchange Forum.
The application must include a technical file (with different information requirements depending on the volume and potential danger of the substance) and a chemical safety report (CSR) for substances manufactured or imported in quantities equal to or greater than 10 tons / year. .
The ISQ must include the identified uses of the substance, demonstrating that the risks that they may pose to human health and the environment are adequately controlled.
The Agency assigns a number to each application for registration. Registrants are obliged to share certain information, which comes from the results obtained from tests with vertebrate animals, with other registrants in order to follow the principle of REACH «one substance, one registration» (OSOR).
WHAT DOES IT MEAN THAT A SUBSTANCE IS CONSIDERED SVHC?
Substances considered SVHC (substances of very high concern) are those that meet one of the criteria of article 57 of the REACH Regulation. These types of substances will be included in Annex XIV (List of substances subject to authorization) and their use is subject to authorization by ECHA.
HOW DOES REACH AFFECT SAFETY DATA SHEETS (SDS)?
The REACH Regulation establishes in its annex II a new model of safety data sheets (SDS) that is mandatory for all substances and mixtures since June 1, 2007. This format was later modified by Regulation (EU) No. 453 / 2010.
WHAT IS ECHA AND WHAT ROLE DOES IT HAVE?
The REACH Regulation establishes the creation of the European Chemicals Agency (ECHA), located in Helsinki. The Agency will be the core of the REACH system, managing the technical, scientific and administrative aspects of the Regulation, ensuring its proper functioning and acting as an interlocutor between all interested parties.
He will manage the registration process and will be in charge of the evaluation of the files (verification and evaluation of the test proposals). It will also play a key role in supporting the Commission, Member States and other actors, coordinating actions in the evaluation of substances, and establishing and managing information technology infrastructures.
The Agency has significant decision-making power, as well as a Board of Appeals, where it will decide on the appeals filed against its decisions.
WHAT IS REGULATION 453/2010?
Regulation (EU) No. 453/2010 modifies Annex II of REACH which establishes the guide for the preparation of safety data sheets and is applicable from December 1, 2010.