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TITLE-XII: INFORMATION
ARTICLE 119: Electronic public access
| ARTICLE 119: | Electronic public access |
1. The following information held by the Agency on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):
(a) the name in the IUPAC Nomenclature, for dangerous substances within the meaning of Directive 67/548/EEC, without prejudice to paragraph 2(f) and (g);
(b) if applicable, the name of the substance as given in EINECS;
(c) the classification and labelling of the substance;
(d) physicochemical data concerning the substance and on pathways and environmental fate;
(e) the result of each toxicological and ecotoxicological 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. The following information on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), 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:
(a) if essential to classification and labelling, 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 to 10 tonnes, 10 to 100 tonnes, 100 to 1000 tonnes or over 1000 tonnes) 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);
(d) information, other than that listed in paragraph 1, contained in the safety data sheet;
(e) the trade name(s) of the substance;
(f) 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;
(g) 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;
(iii) in product and process orientated research and development.
- Referred by:
- ARTICLE 10: Information to be submitted for general registration purposes
- ARTICLE 58: Inclusion of substances in Annex XIV
- ARTICLE 64: Procedure for authorisation decisions
- ARTICLE 69: Preparation of a proposal
- ARTICLE 72: Submission of an opinion to the Commission
- ARTICLE 77: Tasks
- ARTICLE 114: Classification and labelling inventory
- ARTICLE 120: Cooperation with third countries and international organisations