European Chemicals Agency Issues REACH Manual on Divulged Company Information

ECHA Required to Publish Certain Info, Including from REACH Registration

ECHA is required to publish certain information it holds on substances (on their own, in mixtures or in articles) over the Internet, including much of the information received from companies as part of the REACH registration process.²

Manual Tells Industry Which Registration Info is Divulged, Etc

ECHA’s manual provides information about the online access to information on registered chemical substances and is meant to help readers understand:

• the basic rules ECHA applies when it disseminates information on registered chemicals;
• which information will be made publicly available on the ECHA website; and
• the steps in the (largely) automated dissemination process.

1. Information Made Publically Available

The following information held by ECHA on substances (whether on their own, in preparations or in articles) is made publicly available, free of charge, over the Internet:

(a) name in the IUPAC³ Nomenclature, for dangerous substances within the meaning of Directive 67/548/EEC, without prejudice to paragraph 2(f) and (g) (below);

(b) if applicable, the name of the substance as given in EINECS⁴;

(c) the classification and labeling of the substance;

(d) physicochemical data concerning the substance and on pathways and environmental fate;

(e) the result of each toxicological and eco-toxicological study;

(f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;

(g) the guidance on safe use provided in accordance with sections 4 and 5 of Annex VI;

(h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.

2. Info Made Publically Available, Unless Request for Confidentiality Accepted

The following information on substances (whether on their own, in preparations or in articles) will be made publicly available, free of charge, over the Internet, except where a party submitting the information submits a justification accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned (partial list):

(a) if essential to classification and labeling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;

(b) the total tonnage band (i.e. 1-10 tons, 10-100 tons, 100-1000 tons or over 1000 tons) within which a particular substance has been registered;

(c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e) (above);

(d) the trade name(s) of the substance;

(e) the name in the IUPAC Nomenclature for non-phase-in substances which are dangerous within the meaning of Directive 67/548/EEC for a period of six years;

(f) the name in the IUPAC Nomenclature for dangerous substances within the meaning of Directive 67/548/EEC that are only used as one or more of the following: (i) as an intermediate; (ii) in scientific research and development; (ii) in product and process orientated research and development.

¹REACH entered into force on June 1, 2007, and is intended to streamline and improve the former legislative framework on chemicals of the EU. It stands for Registration, Evaluation, Authorization and Restriction of Chemicals and places greater responsibility on industry to manage the risks that chemicals may pose to health and the environment.

²Under REACH, manufacturers or importers who are established in the EU and who manufacture or import chemical substances (as such, in preparations or in articles) in quantities of one ton or more annually have to register those substances with ECHA. Non-EU manufacturers, formulators or producers can appoint “only representatives” who fulfill the obligations of the importers. [See ITT’s Online Archives or 04/09/10 news, (Ref: 10040930), for most recent BP summary on REACH registration.]

³International Union of Pure and Applied Chemistry

⁴European Inventory of Existing Commercial Substances

ECHA Manual (dated 04/29/10) available at http://echa.europa.eu/doc/reachit/dsm_15_dissemination_manual.pdf