31 October 2013
Practice Group:
European Regulatory
/ UK Regulatory
EU Court orders disclosure of proprietary
information on chemical substance
By Vanessa Edwards, Scott Megregian & Raminta Dereskeviciute
The General Court of the EU recently delivered a judgment of interest to companies
which have provided proprietary information on chemicals to EU regulators. 1
EU Regulation 1049/2001 requires EU institutions and agencies to disclose documents
held by them to any EU citizen, resident or company on request. There are certain
circumstances where request must be refused, including where disclosure would
undermine the protection of the commercial interests of a person or company, including
intellectual property. However, that exception will not apply where there is an overriding
public interest in disclosure of the information. EU Regulation 1367/2006 provides that an
overriding public interest is deemed to exist where the information requested relates to
emissions into the environment.
Greenpeace and the Pesticide Action Network had requested information from the
Commission relating to the identity and quantity of impurities present in glyphosate (an
active substance in pesticides), the analytical profile of the batches, in particular their
composition, the ‘identity’ and quantity of chemical substances added during the tests,
the duration of those tests and the actual effects on the active substance. The
information had been provided to the Commission in the context of authorization of
glyphosate as an active substance for pesticides under Directive 91/414 on plant
protection products.
The judgment focuses on the single issue whether the information requested related in a
sufficiently direct manner to emissions into the environment, in which case disclosure
was mandatory.
In its judgment annulling the Commission’s decision refusing to disclose the information,
the General Court ruled that, since the active substance must be included in a pesticide
which will be released into the air, principally by spraying, the following information
related, in a sufficiently direct manner, to emissions into the environment:
• the ‘identity’ and the quantity of each impurity contained in the active substance;
• the quantity of all the impurities present in the various lots and the minimum, median
and maximum quantity of each of those impurities;
• the exact quantities, per kilogramme or per litre, of the active substance and of
adjuvants used in their manufacture.
In contrast, the Court found that the methods of analysis and validation of the data
provided to establish the analytical profile of batches did not constitute information
relating to emissions into the environment, since it did not appear to allow the
determination, in a sufficiently direct manner, of the level of emission into the
environment of the various components of the active substance.
This judgment has significance for companies which have submitted data to EU
regulatory agencies (such as ECHA) with the expectation that the information would be
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Case T-545/11 Stichting Greenpeace Nederland and Pesticide Action Network Europe v Commission.
EU Court orders disclosure of proprietary information on
chemical substance
protected against public disclosure to maintain the submitter’s commercial interests.
Where such data relate in a sufficiently direct manner to emissions into the environment,
the agency will have to disclose it on request. The concept of information relating to
emissions into the environment is to be interpreted broadly.
To read further details on this alert which includes a discussion of potential impact in the
U.S. please click here.
Authors:
Vanessa C. Edwards
vanessa.edwards@klgates.com
+44.(0)20.7360.8293
Scott S. Megregian
scott.megregian@klgates.com
+44.(0)20.7360.8110
Raminta Dereskeviciute
raminta.dereskeviciute@klgates.com
+44.(0)20.7360.8264
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