TITLE XII / INFORMATION
Article 117
Reporting
The first report shall be submitted by 1 June 2010.
The first report shall be submitted by 1 June 2011.
The first report shall be submitted by 1 June 2011.
Every five years, the Commission shall publish a general report on:
the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and;
the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods.
The first report shall be published by 1 June 2012.
Article 118
Access to information
Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person:
details of the full composition of a ►M3 mixture ◄ ;
without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or ►M3 mixture ◄ , including information about its precise use as an intermediate;
the precise tonnage of the substance or ►M3 mixture ◄ manufactured or placed on the market;
links between a manufacturer or importer and his distributors or downstream users.
Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.
Article 119
Electronic public access
The following information held by the Agency on substances whether on their own, in ►M3 mixtures ◄ or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):
without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
if applicable, the name of the substance as given in EINECS;
the classification and labelling of the substance;
physicochemical data concerning the substance and on pathways and environmental fate;
the result of each toxicological and ecotoxicological study;
any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;
the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI;
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.
The following information on substances whether on their own, in ►M3 mixtures ◄ 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:
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;
the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered;
the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
information, other than that listed in paragraph 1, contained in the safety data sheet;
the trade name(s) of the substance;
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:
as an intermediate;
in scientific research and development;
in product and process orientated research and development.
Article 120
Cooperation with third countries and international organisations
Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals ( 31 ) or under Article 181a(3) of the Treaty, provided that both the following conditions are met:
the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;
the third party protects the confidential information as mutually agreed.