CHAPTER XV

INFORMATION AND COMMUNICATION
SECTION 1

Monitoring and reporting

Electronic public access
Article 67
1
From the date on which an active substance is approved, the following up-to-date information held by the Agency or the Commission on active substances shall be made publicly and easily available free of charge:
a
where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
b
if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
c
the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
d
physicochemical endpoints and data on pathways and environmental fate and behaviour;
e
the result of each toxicological and ecotoxicological study;
f
acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
g
the guidance on safe use provided in accordance with Annexes II and III;
h
analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
2
From the date on which a biocidal product is authorised, the Agency shall make publicly and easily available free of charge the following up-to-date information:
a
the terms and conditions of the authorisation;
b
the summary of the biocidal product characteristics; and
c
analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.
3
From the date on which an active substance is approved, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on active substances:
a
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
b
the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
c
information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
d
the trade name(s) of the substance;
e
the assessment report.
4
From the date on which a biocidal product is authorised, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information:
a
study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and
b
the assessment report.