Gonzalo Manchego

Business Consultant
Center for International Regulatory Assistance
Rockwell Hall
600 Forbes Avenue
Pittsburgh, PA 15282
Email: mancheg672@duq.edu
Phone: 412.396.5840

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    REACH & ROHS

    REACH is the Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals.
    It became effective on June 1, 2007.

    REACH Flyer--REACH Database Flyer--REACH and RoHS Flyer

    REACH applies to all chemicals, not only chemicals used in industrial processes but also to chemicals used in day-to-day life products such as cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances.

    REACH covers chemical substances on their own, as a part of preparations, or in articles.

    REACH includes the following 6 main provisions, which are selectively applied to chemical substances:

    1. Registration

    There is a general obligation to register chemical substances manufactured in the EU or imported to the EU in quantities above 1 ton per year. This requirement applies irrespective of whether the substances are classified as hazardous or not. Substances that are NOT registered cannot be manufactured or imported to the EU.

    REACH requires that chemical substances on their own, in preparations and those which are intentionally released from articles have to be registered to the European Chemicals Agency (ECHA). For substances that are released incidentally during the use of an article, a simple notification to the EU authorities is required.

    Registration requires submission to ECHA (an EU organization) of a technical dossier, and a chemical safety report (when the volume of the substance is above 10 ton per year).

    Notification of Substances in articles: Suppliers of articles from outside the EU or their "only representative" must notify ECHA in case a substance present in the article meets all the following conditions:

    • The substance has been identified as of very high concern (SVHC),
    • The substance has been included in the candidate list for inclusion in Annex XIV REACH,
    • The substance is present in the articles in quantities totaling over 1 ton per year (per producer/importer), and
    • The substance present in the articles is above a concentration of 0.1% weight by weight

    2. Evaluation

    The EU authorities check that the registration dossiers comply with REACH requirements. They also coordinate substance evaluation and, if they determine it is needed, they will require more information on a substance that could be harmful to human health or the environment.

    3. Authorization

    Manufacturers or importers using or making available substances of very high concern (SVHC) have to apply for an authorization of each use. These substances are included in Annex XIV of REACH.

    Substances of very high concern are defined as: substances that are carcinogens or mutagens; toxic to the reproductive system; persistent, bio accumulative; and toxic or very persistent and very bio accumulative.

    Companies applying for authorization will have to demonstrate that the risks associated with the uses of these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks. Applicants will also have to investigate the possibility of substituting these substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.

    4. Restriction

    When unacceptable risks to humans or the environment have been identified, the EU prohibits and imposes restrictions to: manufacture of products, placing products on the market, and use of these substances.

    5. Information in the supply chain

    The primary tool for information transfer is the materials safety data sheet (MSDS). The information through the supply chain provisions ensures that all users have the information they need to use chemicals safely.

    Manufacturers or importers have to provide a safety data sheet to all their downstream users and distributors when supplying a dangerous substances or preparations to another party or parties. In addition, where exposure scenarios are developed as a result of conducting a Chemical Safety Assessment, they must be annexed to the MSDS.

    When supplying a substance on its own, the MSDS has to be prepared for the substance itself. When supplying a substance in a preparation, the Safety Data Sheet has to be prepared for the preparation.

    For substances subject to authorization, details of granted, denied authorization, imposed restrictions, and other relevant information necessary to enable appropriate risk management measures must be given to suppliers.

    Unless requested by users or distributors, there is no obligation to provide a MSDS for dangerous substances to the general public but sufficient information to enable safe use of the substance should be provided.

    6. Classification and Labeling Inventory

    Classification and labeling inventory provisions ensure that the classifications and labeling of dangerous substances manufactured in or imported into the EU are available to all.

    **Important Terms used in REACH**

    • Substance: A substance is defined as a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. The term substance includes both: substances obtained by a chemical manufacturing process (for example formaldehyde or methanol) and substances in their natural state.
    • Preparation: A mixture or solution composed of two or more substances. Preparations can contain several substances. However, preparations are not the same as multi-constituents substances. The difference between preparation and multi-constituent substance is that a preparation is gained by blending of two or more substances without any chemical reaction occurring, whereas a multi-constituent substance is the result of a chemical reaction. Typical examples of preparations include paints, varnishes, and inks.
    • Article: Any object that has been given a specific shape, surface or design which determines its function to a greater degree than does its chemical composition (e.g. manufactured goods such as textiles, electronic chips, furniture, books, toys, and kitchen equipment).
    • Importer: Any natural or legal person established within the EU Community who is responsible for import.
    • Downstream user: Any natural or legal person established within the EU Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.
    • Use: Any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilization.
    • Alloy: A metallic material, homogenous on a macroscopic scale, consisting oftwo or more elements so combined that they cannot be readily separated by mechanical means.
    • Additive: A substance that has been intentionally added to stabilize the substance.
    • Constituent: any single species present in a substance that can be characterized by its unique chemical identity.
    • Impurity: an unintended constituent present in a substance as produced. It may originate from the starting materials or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added.
    • Main constituent: A constituent, not being an additive or impurity, in a substance that makes a significant part of that substance and is therefore used in substance naming and detailed substance identification.
    • Mono-constituent substance: a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w).
    • Multi-constituent substance: a substance, defined by its composition, in which more than one main constituent is present in a concentration ≥ 10% and < 80% (w/w).