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Authorisation of active substances

An active substance shall be approved in accordance with the detailed provisions in Annex II if it may be expected, in the light of current scientific and technical knowledge, that PPPs containing that substance meet a number of requirements. When applied in accordance with good plant protection practice and having regard to realistic conditions of use, the PPP shall have no immediate or delayed harmful effect on human health or animal health, directly or through drinking water, food, feed, or air; it may not have any unacceptable effects on plants or plant products or on the environment considering, inter alia, its impact on non-target species, on biodiversity and the ecosystem. It must also be sufficiently effective and not cause unnecessary suffering and pain to any vertebrates to be controlled. Furthermore, the residues, when the PPP is applied in accordance with good plant protection practice and having regard to realistic conditions of use, may not have any harmful effects on human health, including that of vulnerable groups such as pregnant women, infants and children, and workers subject to high pesticide exposure over the long term, or any unacceptable effect on the environment. Known cumulative and synergistic effects shall be taken into account where there are approved scientific methods available to assess such effects. These requirements shall be evaluated in the light of uniform principles. (Art 4.)

An active substance, safener, or synergist may not be approved if it is considered to be a persistent organic pollutant or a persistent, bioaccumulative, and toxic (PBT) substance. Approval may be subject to conditions and restrictions, including those relating to the manner and conditions of application; designation of areas where the use of PPPs containing the active substance may not be authorised; and the need to impose risk mitigation measures and monitoring after use. (Arts 4 and 6.)

It normally takes about three years from application to approval of a new active substance.

Safeners or synergists are subject to the same authorisation requirements as active substances (Art 25). Co-formulants do not require authorisation, but they can be subject to a general ban on use in PPPs and are then listed in Annex III (Art 2).

Low-risk active substances and basic substances used in PPPs are subject to less strict requirements. A basic substance is an active substance which is not predominantly used for plant protection purposes but nevertheless is useful in plant protection, but is not placed on the market as a PPP It must not be a substance of concern nor have an inherent capacity to cause endocrine-disrupting, neurotoxic, or immunotoxic effects. There are also specific rules for approving any PPPs which contain any low-risk active substances. (Arts 22, 23, and 47.)

A work programme was to be adopted in 2014 in order to review the synergists and safeners that were already on the market when the Regulation came into force so as to phase these into the new system (Arts 26 and 81). However, at the time of writing such a programme had still to be adopted.

An application for the approval of an active substance, or for an amendment to the conditions of an approval, shall be submitted by the producer to a Member State (‘the rapporteur Member State’), together with information demonstrating that the active substance fulfils the approval criteria, including summaries and results of tests and studies.

The rapporteur Member State is to make an independent, objective, and transparent assessment in the light of current scientific and technical knowledge. It shall normally within twelve months prepare and submit to the Commission and the European Food Safety Authority a report (‘draft assessment report’) assessing whether the active substance can be expected to meet the approval criteria. The draft assessment report is circulated to the other Member States for comments and made available to the public. The Authority then adopts a conclusion in the light of current scientific and technical knowledge on whether the active substance can be expected to meet the approval criteria. It is for the Commission to present a so-called review report and a draft Regulation to the Standing Committee on the Food Chain and Animal Health, taking into account the report by the rapporteur Member State and the conclusion of the Authority.

A Regulation shall be adopted in accordance with the examination procedure, approving or not approving the active substance. Approved active substances are included in a specific Regulation containing a list of active substances.[1] [2] [3]

A first approval shall be for a period not exceeding ten years and a renewal shall be for a maximum of fifteen years. The Commission may review the approval of an active substance at any time. (Arts 5, 14, 21, and 22.)

  • [1] See Commission Implementing Regulation (EU) No 540/2011 implementing Regulation (EC)No 1107/2009 of the European Parliament and of the Council as regards the list of approved activesubstances [2011] OJ L 153/1.
  • [2] Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 ofthe European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products [2011] OJ L 155/127.
  • [3] The Member States belonging to each zone are listed in Annex I.
 
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