EU substance approval dossier contains no information related to environmental emissions
This article is part of the December 2018 edition of our EU life sciences & regulatory newsletter, focusing on some recent key developments.
In its judgment of 21 November 2018, the EU General Court ("GC") rules that an EU substance approval dossier contains no information related to environmental emissions. As a result, the EU Commission was entitled to refuse public disclosure of confidential glyphosate substance data, where this was justified to protect the confidentiality of commercial and industrial information (T-545/11 RENV, Stichting Greenpeace Nederland and PAN Europe -v- Commission).
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Background
The judgment marks the end of a five-year legal battle between environmental NGOs and the EU Commission which started when the EU Commission refused to grant the NGOs access to confidential information submitted by glyphosate manufacturers for the initial EU approval of glyphosate. Access had been requested to certain parts of the dossier revealing the detailed chemical composition of the glyphosate substance, its manufacturing process and the impurities and composition of the finished products presented at the time to obtain substance approval at EU level.
The EU Commission explained in its refusal decision that the information requested did not relate to environmental emissions and that, moreover, disclosure should be refused out of a need to protect company knowhow and intellectual property rights of the manufacturers seeking the EU approval of glyphosate (Article 4(2) of the Transparency Regulation (1049/2001)). Disclosure of the information requested would have made it possible to reconstitute the manufacturing process of glyphosate.
The NGOs disagreed arguing that access should be granted since the information in question qualified, in their view, as information relating to environmental emissions governed by the Aarhus Emissions rule. Accordingly, they argued, disclosure could not have been refused on the grounds that it concerns confidential commercial and industrial information.
The initial judgment of the GC sided with the NGOs (T-545/11, Stichting Greenpeace Nederland and PAN Europe -v- Commission) but was successfully appealed by the EU Commission, with the support of Germany and a significant number of European and American industry associations. In 2016, the EU Court of Justice ("ECJ") set aside the initial judgment on appeal and referred the case back to the GC for a new assessment (C-673/13 P, Commission -v- Stichting Greenpeace Nederland and PAN Europe).
The Court judgment
In its 21 November 2018 judgment, the GC reverses its initial position and upholds the EU Commission's decision to refuse access to the confidential parts of the glyphosate dossier. The GC agrees with the EU Commission that the information requested does not contain information relating to environmental emissions, as defined by the ECJ on appeal.
Given the two-tier nature of the EU regime involving the approval of a substance at EU level and the subsequent authorisation at Member State level of plant protection products containing an approved substance, the GC considers that no information on environmental emissions can be found in the EU substance approval dossier. At EU level, the GC argues, there is no assessment yet of any actual or foreseeable emissions into the environment, since the substance is released only at a later stage "via a plant protection product subject to the authorisation procedure" and is moreover "not intended to be released into the environment as such, but may be released only once integrated in a plant protection product subject to authorisation".
The GC's judgment ensures the continued useful application of the sector-specific rules on confidentiality set out in Article 63 of the Plant Protection Products Regulation (1107/2009) which protects specifically listed categories of regulatory information from public disclosure, including information on the method of manufacture and information on the complete product composition. It is in this context particularly helpful to operators that the judgment accepts that the information requested by the NGOs in the present case may reveal sensitive information on the specific substance manufacturing process and that this remains valuable knowhow whose disclosure can harm commercial interests, even where the information has been submitted 15-20 years ago.
This is an important judgment, following on the landmark ruling by the ECJ on appeal, as the GC prescribes for the first time how the Aarhus Emissions rule must be applied concretely to regulatory data submitted by operators in order to obtain the approval or the renewal of a plant protection substance at EU level.
Note: Ashurst LLP acted for the European Crop Protection Association (ECPA) and the European Chemical Industry Council (CEFIC), which intervened in support of the EU Commission before the EU Court of Justice (appeal proceedings) and the EU General Court (referral proceedings).
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