The chemicals that fall outside the scope of the REACH regulation are (see exemptions in Article 2):
- Radioactive substances
- Substances subject to customs supervisión, in a temporary warehouse or free zone, provided they are not subject to any type of treatment or transformation.
- Intermediates no isolated.
- The transport of dangerous substances.
- Residues (unless they have been imported or marketed).
In addition, Member States may provide for exceptions for defense reasons.
There are certain uses that are exempt from part of the REACH obligations:
- Substances used in human or veterinary medicines, as well as in food or feed (including food additives and flavorings), are exempt from the following Titles of the Regulation (provided they are regulated by their sectoral legislation):
- Title II: Registration
- Title V: Intermediate Users
- Title VI: Evaluation
- Title VII: Authorization
- Cosmetics and health products that are applied in direct contact with the human body, as well as human or veterinary medicines and food or feed (Article 2.6) are exempt from Title IV (Information in the supply chain). Of course, only when it is the finished product, intended for the end user.
- Biocides and phytosanitary products that are regulated by specific regulations are considered registered (Article 15). As regards substances notified in accordance with Directive 67/548 / EEC, notification will be considered an application for registration (Article 24).
- Substances covered by Annexes IV and V of the Regulation are exempt from Titles II, V and VI (Article 2.7)
- Isolated intermediates will have less strict registration rules, and should only present specific information about their risks (see articles 17 and 18). For more information, consult the Guidance for Intermediate Substances.
- Polymers are exempt from registration and evaluation (Article 2.9), but not their constituent monomers. For more information, consult the Guidance on Monomers and Polymers.
- Substances used for research and development purposes are governed by special rules (Article 9)
WHAT IS AN INTERMEDIATE USER IN THE REACH REGULATIONS?
An intermediate 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 intermediate users. The reimporter covered by the exemption contemplated in article 2, section 7, letter c) will be considered an intermediate user.
WHAT IS THE CATALOG OF CLASSIFICATION AND LABELING?
ECHA creates and maintains as a database a classification and labeling catalog that includes substances whose registration is mandatory and substances that meet the criteria because they are considered dangerous and that are marketed as such or in the form of Prepared in concentrations above the specified limits. For each of these substances, the following information is included:
- Identity of the manufacturer or importer responsible for the marketing of the substance.
- Identity of the substance or substances.
- Classification of the danger of the substance.
- Substance hazard label.
- When appropriate, the specific limits of concentration.
WHAT DOES THE REGISTRATION CONSIST OF? WHAT SHOULD BE RECORDED?
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 tonne / 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.
Some of the information presented in the registration dossier may be presented jointly with the members of a consortium of the Forum for the Exchange of Information.
The request 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 an amount equal to or greater than 10 tons / year.
The ISQ should include the identified uses of the substance, demonstrating that the risks that may be involved for human health and the environment are adequately controlled.
The Agency assigns a number to each application for registration. Registrants are required to share certain information, that which occurs from the results obtained from tests with vertebrate animals, with other applicants in order to follow the principle of REACH “a substance, a record” (OSOR, in English).
WHAT DOES A SUBSTANCE BE CONSIDERED TO BE SVHC?
The substances considered SVHC (substances of very high concentration) are those that meet one of the criteria of Article 57 of the REACH Regulation. This type of substance will be included in Annex XIV (List of substances subject to authorization) and its use is subject to authorization by ECHA.
WHAT DOES REACH AFFECT TO 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 as of June 1, 2007. This format was subsequently modified by regulation (EU) No. 453 / 2010.
WHAT IS THE ECHA AND WHAT PAPER DOES IT HAVE?
The REACH Regulation establishes the creation of the European Agency for Chemical Substances and Mixtures (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 interlocutor between all interested parties.
Gestionará el proceso de registro y se encargará de la evaluación de los expedientes (comprobación y evaluación de las propuestas de ensayo). It will manage the registration process and will be responsible for the evaluation of the files (verification and evaluation of the test proposals). It will also play a key role in supporting the Commission, the Member States and other agents, coordinating actions in the evaluation of substances and establishing and directing computer infrastructures.
The Agency has an important power of decision, as well as a Room of Resources, where it will be decided on the resources interposed against its decisions.
WHAT IS REGULATION 453/2010?
Regulation (EU) No. 453/2010 modifies Annex II of REACH where the guide for the preparation of safety data sheets is established and has been applied since December 1, 2010.