The PPP Regulation (1107/2009) governing the placing on the market of plant protection products is not vitiated by a manifest error of assessment on the part of the European Union legislator, confirmed the Court of Justice of the EU in a judgment delivered on Tuesday 1st October (Case C-616/17).
In France, supporters of the group 'Volunteer Reapers of GMOs' are being prosecuted for damaging Roundup weedkiller cans containing glyphosate on commercial premises.
The French courts are asking the Court about the compatibility of the PPP Regulation with the precautionary principle (Article 191 TFEU). According to the Court, the regulation: - could confer on the manufacturer too much discretion as regards the identification of the ‘active substance’ of its plant protection product; - provides that the analyses and assessments contained in the dossier are to be submitted by that manufacturer, with no independent counter-analysis or adequate publicity; - does not take sufficient account of the presence of several active substances in the same product and the possible 'cocktail effect' which may thereby arise; - does not ensure that sufficient tests are carried out to assess the potential long-term toxicity of marketed products.
In its judgment, the Court first states that the legislator must comply with the precautionary principle when adopting rules governing the placing on the market of plant protection products in order to ensure a high level of protection of human health.
Relying on the conclusions of Advocate-General Sharpston (see EUROPE 12212/35), the European judge nevertheless considers that the legislator did not commit a manifest error of assessment in establishing the PPP Regulation.
First, the criteria set out in the EU legislation are sufficient to prevent a manufacturer who requests the placing on the market of their plant protection product from choosing at their discretion which component is considered as the active substance. In addition, the PPP Regulation requires the cumulative and synergistic effects of the constituents of a product to be taken into account.
As regards the possibility of carrying out counter-analyses, the Court observes that the legislation requires a Member State to carry out an "independent, objective and transparent" assessment of the application in the light of the most reliable and most recent scientific data available. This assessment shall be forwarded to the other Member States and to the European Food Safety Authority (EFSA), which has the right to consult experts and to invite the European Commission to consult a Community reference laboratory. At any time, the Commission may review the approval of an active substance in the light of new scientific knowledge.
There is therefore no manifest error of assessment where the contested regulation provides that the tests, studies and analyses necessary for the authorisation procedures for a plant protection product must be submitted by the manufacturer, the Court rules.
As for public access to relevant information, the judge points out that the PPP Regulation is covered by the Directive (2003/4) on access to environmental information, which prohibits Member States from refusing access to such information on grounds relating to the protection of commercial or industrial information.
Finally, the Court recalls that a plant protection product is authorised only where the applicant proves that the product has no immediate or delayed harmful effect on human health. However, a plant protection product does not meet this condition when it exhibits long-term carcinogenicity or toxicity, it points out. In conclusion, it is the responsibility of the competent authorities, when examining an application for authorisation of a product, to verify that the tests, analyses and studies submitted by the applicant are sufficient to exclude, in the light of available scientific and technical knowledge, the risk of toxicity of a pharmaceutical product.
See the Court's judgment: http://bit.ly/2o6iSDp (Original version in French by Mathieu Bion)