The findings refer to EFSA’s opinion regarding the potential exposure to 4-chloroaniline (PCA), a metabolite of diflubenzuron, as a significant toxic residue.
The food safety authority had said that potential exposure to PCA as a residue - either for consumers or for workers and bystanders or residents - should be considered a concern since a threshold for a genotoxic carcinogen cannot be assumed.
In 2005, the EFSA scientific committee recommended that genotoxic and carcinogenic substances should not be deliberately added to foods or for use earlier in the food chain, if they leave residues which are both genotoxic and carcinogenic in food.
In a more recent statement from 2012, a scientific committee expressed that wider application of the margin of exposure (MoE) beyond the contaminants and impurities it considered would raise some scientific and risk management issues.
PCA is considered both an impurity and a metabolite and the applicability of the MoE approach required risk managers considerations.
Diflubenzuron deliberations
Chemtura sold its AgroSolutions business to platform specialty chemicals firm, Arysta in November 2014. Among the assets purchased were the shares of the legal entity Chemtura Netherlands BV, which filed the application with the Court. The name of that legal entity was recently changed to Arysta LifeScience Netherlands BV.
The case against EFSA was filed in December 2015. Here, the ECJ issued a temporary order that required EFSA to delete its conclusions on diflubenzuron from its website.
In the latest hearing, dated 29th February 2016, Chemtura had put forward two main arguments in support of its claim.
Chemtura argued that EFSA based the conclusion at issue on questionable science without having all the relevant evidence at its disposal, in particular reliable evidence showing a risk to human or animal health. Chemtura claimed it had not been asked to provide input.
Chemtura also argued that publication of the disputed conclusion would adversely affect its reputation, market share and turnover, since it would cause irreparable damage to the reputation of its product containing diflubenzuron.
It believed that publication of the conclusion would have a ‘devastating and permanent effect on its reputation and business interests, which could not be subsequently remedied, even if a later scientific report were to refine the earlier findings.’
No competitive advantage
EFSA added that it would only sustain claims for commercial confidentiality regarding pesticide applications when there was a legitimate argument to be made that information could be used for competitive purposes. This, they said, was not the case in this application.
“The Court has found in favour of EFSA's arguments that reject confidentiality claims made by Chemtura,” said EFSA in a written statement. “This conclusion has now been reinstated on our website.”
“However, this order concerns only the interim measures. EFSA now awaits the main case brought by the applicant, which remains open and will be resolved in a year’s time.”
A spokesperson for Arysta LifeScience said: "A final decision has not yet been made by the General Court of the European Union regarding the main application concerning EFSA’s publication of confidential information about the active ingredient diflubenzuron. We are not in a position to comment on pending judicial or administrative matters."
Diflubenzuron is a pesticide that is approved for use in the EU. According to the World Health Organisation (WHO) it is specifically an insect growth regulator, used in agriculture, horticulture and forestry against butterflies and moths, beetles, flies, wasps and in public health against mosquitoes and other harmful insects.