INFORMATION
Reporting
1.
Every five years, Member States shall submit to the Commission a report
on the operation of this Regulation in their respective territories, including
sections on evaluation and enforcement as described in Article 127.
The first report shall be submitted
by
2.
Every five years, the Agency shall submit to the Commission a report on
the operation of this Regulation. The Agency shall include in its report
information on the joint submission of information in accordance with Article
11 and an overview of the explanations given for submitting information
separately.
The first report shall be submitted
by
3.
Every three years the Agency, in accordance with the objective of
promoting non-animal testing methods, shall submit to the Commission a report
on the status of implementation and use of non-animal test methods and testing
strategies used to generate information on intrinsic properties and for risk
assessment to meet the requirements of this Regulation.
The first report shall be submitted
by
4.
Every five years, the Commission
shall publish a general report on
(a)
the experience acquired with the
operation of this Regulation, including the information referred to in
paragraphs 1, 2 and 3 and
(b)
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
Article 118
Access to information
1.
Regulation (EC) No 1049/2001 shall apply to documents held by the
Agency.
2.
Disclosure of the following information shall normally be deemed to
undermine the protection of the commercial interests of the concerned person:
(a)
details of the full composition of
a preparation;
(b)
without prejudice to Article 7(6)
and Article 64(2), the precise use, function or application of a substance or
preparation, including information about its precise use as an intermediate;
(c) the precise tonnage of the substance or preparation manufactured or placed on the market;
(d)
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.
3.
The Management Board shall adopt the practical arrangements for
implementing Regulation (EC) No 1049/2001, including appeals or remedies
necessary for reviewing a partial or full rejection of a confidentiality
request, by
4.
Decisions taken by the Agency pursuant to Article 8 of Regulation (EC)
No 1049/2001 may form the subject of a complaint to the Ombudsman or of an
action before the Court of Justice, under the conditions laid down in Articles
195 and 230 of the Treaty respectively.
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. 1to10 tonnes, 10 to100 tonnes, 100 to1 000
tonnes or over 1 000 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.
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 or under Article 181a (3) of the Treaty, provided that both
the following conditions are met:
(a)
the purpose of the agreement is
cooperation on the implementation or management of legislation concerning
chemicals covered by this Regulation;
(b)
the third party protects the
confidential information as mutually agreed.