# Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division: Circumstances in which required

Extent: E+W+S+N.I.

The study shall be carried out where the plant protection product:
(a)is a gas or liquified gas;
(b)is a smoke generating plant protection product or fumigant;
(c)is used with fogging/misting equipment;
(d)is a vapour releasing plant protection product;
(e)is supplied in an aerosol dispenser;
(f)is in a form of a powder or granules containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis);
(g)is to be applied from aircraft in cases where inhalation exposure is relevant;
(h)contains an active substance with a vapour pressure > 1 × 10–2 Pa and is to be used in enclosed spaces such as warehouses or glasshouses;
(i)is to be applied by spraying.
A study shall not be required if the applicant can justify an alternative approach under Regulation (EC) No 1272/2008, where applicable. For this purpose, acute inhalation toxicity of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the toxic potential of the total mixture.
The head/nose only exposure shall be used, unless whole body exposure can be justified.

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Source: https://www.legislation.gov.uk/eur/2013/284/annex/section/7/division/7.1/division/7.1.3/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-284/annex/section-7/division-7.1/division-7.1.3/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.