Regulation 1107/2009 concerning the placing of plant protection products on the market, requires that a substance shall only be approved if it meets certain approval criteria (Article 4) and apply the precautionary principle to ensure that the active substance shall not have any harmful impact on human and animal health, and no unacceptable effect on the environment.
The Pesticide Regulation 1107/2009 was a mutual trialogue agreement among European Parliament, European Council and European Commission, and is called hazard-based. This means that pesticides that are considered hazards for humans and the environment, shall not be authorised for use in the production of our food and the management of green areas.
The assessment of the active substance shall first establish that the criteria are satisfied set out in points 3.6.2 to 3.6.5 and 3.7 of Annex II. The first (3.6.2 to 3.6.5) refer to the impact on human health:
The pesticide active substance shall only be approved if it is not a mutagen (Category 1A & 1B), carcinogen (Category 1A & 1B), toxic to reproduction (Category 1A & 1B) or considered as having endocrine disrupting properties that may cause adverse effect in humans.
However, for substances that are carcinogens, toxic to reproduction and endocrine disruptors the legal text has a derogation, the negligible exposure:
“…unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005[1]”.
The derogation of negligible exposure also appears in the assessment of the ecotoxicity of active substances (Annex II, 3.8.2), in which case an active substance shall only be approved if:
“it is not considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non-target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible”.