Technical Report 130

Regulation (EC) No 1107/2009 concerning the placing on the market of PPP

Annex II of Regulation (EC) No 1107/2009 concerning the placing on the market of PPP (EP and Council of the EU, 2009), describes procedures and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II:

  • Section 3: Criteria for the approval of an active substance
    • Section 3.6: Impact on human health; specifically for ED: 3.6.5
    • Section 3.8: Ecotoxicology; specifically for ED: 3.8.2

Section 3.6.5. of Annex II of the PPP Regulation states:

An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a PPP, 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.

By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).

Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered to have endocrine disrupting properties.

In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties.