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On the New European Regulation on Plant Protection Products
Published online by Cambridge University Press: 20 January 2017
Regulation n. 1107/2009 of the European Parliament and Council of 21 October 2009 concerning the placing of plant protection products on the market entered into force on 14 December 2009 and applies as of 14 June 2011, subject to some transitional measures set out in Article 80. It shall replace gradually the current legislation on plant protection products which is laid down in Council Directive 91/414/EEC and related implementing Regulations.
Broadly speaking, the harmonized authorization system for active substances used in plant protection products, as originally set out in Directive 91/414/ EEC, is maintained. Indeed, the placing on the market of plant protection products is still subject to a two-steps process whereby active substances are approved at the EU-level (with the inclusion into a “positive list” – Annex I to the new Regulation) while formulated products are authorised at the national level based on “Uniform Principles” laid down in a new implementing Regulation 546/2011. However, the criteria underlying each of these two steps have changed remarkably.
1 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products.
2 See Article 50(1) (a)–(d). When making their comparative assessment, Member States have to take into account the risks and benefits defined in Annex IV to the Proposed New Regulation. Note that Article 50(2) provides that a Member State may in exceptional cases also make a comparative assessment of a plant protection product that does not contain a “candidate for substitution” or that contains a “low-risk” active substance if a “non-chemical control or prevention method exists for the same use and it is in general use in the Member State”.
3 Point 2 of Annex IV states for the environment that “if relevant, a factor of at least 10 for the toxicity/exposure ratio (TER) of different plant protection products is considered a significant difference in risk”.
4 Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances.
5 Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products.
6 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products.
7 Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products.
8 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances.
