Association of Users and Distributors of AgroChemicals in Europe
35, rue des Mathurins, 75008 Paris – France Web Site : http://www.audace-ass.com
Press Release following the issue of Order No. 2001-317 of 4 April 2001
Almost four years after lodging his complaint with the European Commission, which gave the French State formal notice to comply with Community law, Daniel ROQUES, the Chairman of AUDACE, cannot fail to be pleased with the very recent publication of Order No. 2001-317 of 4 April 2001 establishing a simplified procedure for the marketing authorisation of pesticides originating from the European Economic Area.
The notice to importers (Official Journal on 7 August 1999) is an authoritative decision that enabled parallel imports of agrochemicals in national law. The decree finally allows any third party to challenge the importer in court if he has not fulfilled its obligations in respect to the provisions of that law.".
The Association AUDACE wishes to make it clear, for the information of all distributors and, therefore, of its members, that, henceforth, any introduction of a product within the national jurisdiction, which has not been submitted to the competent authorities as an application for authorisation, will be deemed unlawful and that it will no longer offer legal defence to importers who refrain from meeting this requirement.
However, Daniel ROQUES also points out that this recognition of the role of importer in law, 43 years after it was recognised as one of the founding principles of the Treaty of Rome, still leaves a number of problems unresolved.
Not least of these is the question of determining the identity of products.
In anticipation of the outcome of its efforts with the competent authorities, the answer suggested by AUDACE is remarkably simple and can be summarised as follows:
As the Marketing Authorisation is national and applies to all the territories of a State, however different they may be in agronomic, plant protection or environmental, especially climatic, terms, none of these conditions associated with the use of products can justify, objectively, differences in their formulation in different countries.
Obviously the same applies to considerations relating to the protection of human and animal health and to the environment.
At present, none of the commercial specialities authorised in a Member State can, therefore, be specific to that State and any difference in composition from the reference product authorised in another State cannot, objectively, undermine an acknowledgement of their identity, as they have a common origin in that they were manufactured following the same formula, by the same company or by associated companies or by companies operating under licence.
AUDACE is fully aware that its firmly-held opinion will conflict with the reply given on 12 April by the Minister of Agriculture to a Senator stating that:
"The possible risks to those who apply the products, consumers and the environment are calculated in each Member State according to the specific conditions of use of pesticides in each country. Indeed, agricultural practices, the vulnerability of water resources and dietary habits differ from one State to another. This is the reason, in the majority of cases, why a pesticide may be authorised in one Member State and not in another."
Daniel ROQUES, with due respect, hopes that the Minister will be so good as to cite a single one of these cases which can be confirmed to exist.
For the time being, AUDACE will oppose any refusal, not based on objective grounds, to recognise the identity of a product imported into this country with the reference product.
Reply address - Boite Postale 27 F - 41 600 Nouan-Le-Fuzelier - Tel 02 54 96 88 13 - Fax 02 54 88 41 84
Décret no 2001-317 du 4 avril 2001 établissant une procédure simplifiée d'autorisation de mise sur le marché des produits phytopharmaceutiques en provenance de l'Espace économique européen
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