The benefits of strict cut-off criteria on human health in relation to the proposal for a Regulation concerning plant protection products

15-09-2008

Executive Summary This study assesses the health benefits of strict ‘cut-off criteria’ on human health in relation to the proposal for a Regulation concerning the placing of plant protection products on the market (COM(2006) 388). The Common Position text provides that active substances classified as carcinogen, mutagen or toxic for reproduction category 1 or 2 (CMR 1 & 2), or substances considered to have endocrine disrupting properties (ED) on the basis of internationally agreed test guidelines, shall not be approved unless exposure to humans under realistic proposed conditions of use would be negligible. The European Parliament in its first reading amendments proposed the additional criteria that substances “considered to cause a risk of developmental neurotoxic or immunotoxic properties in humans, taking into account exposure during embryonic/foetal life and/or during childhood as well as likely combination effects” should only be approved if human exposure would be negligible. In view of the continuing debate about the criteria for approval of active substances, this study provides a scientific review of evidence concerning human health effects of plant protection products, including health benefits that could accrue from the stricter cut-off criteria. The study supports the proposal of the European Parliament that in order to ensure added protection of human health, substances considered to cause a risk of developmental neurotoxic or immunotoxic effects in humans should be added to the list of classifications that would result in non-approval of active substances, unless negligible exposure can be demonstrated. The emerging epidemiological evidence for these effects will need to be translated into classification criteria before harmonised classification for these effects can be achieved. Given that many CMR3 substances may be reclassified at a future point as CMR2, the additional proposal of the European Parliament to include CMR3 as criteria for

Executive Summary This study assesses the health benefits of strict ‘cut-off criteria’ on human health in relation to the proposal for a Regulation concerning the placing of plant protection products on the market (COM(2006) 388). The Common Position text provides that active substances classified as carcinogen, mutagen or toxic for reproduction category 1 or 2 (CMR 1 & 2), or substances considered to have endocrine disrupting properties (ED) on the basis of internationally agreed test guidelines, shall not be approved unless exposure to humans under realistic proposed conditions of use would be negligible. The European Parliament in its first reading amendments proposed the additional criteria that substances “considered to cause a risk of developmental neurotoxic or immunotoxic properties in humans, taking into account exposure during embryonic/foetal life and/or during childhood as well as likely combination effects” should only be approved if human exposure would be negligible. In view of the continuing debate about the criteria for approval of active substances, this study provides a scientific review of evidence concerning human health effects of plant protection products, including health benefits that could accrue from the stricter cut-off criteria. The study supports the proposal of the European Parliament that in order to ensure added protection of human health, substances considered to cause a risk of developmental neurotoxic or immunotoxic effects in humans should be added to the list of classifications that would result in non-approval of active substances, unless negligible exposure can be demonstrated. The emerging epidemiological evidence for these effects will need to be translated into classification criteria before harmonised classification for these effects can be achieved. Given that many CMR3 substances may be reclassified at a future point as CMR2, the additional proposal of the European Parliament to include CMR3 as criteria for

Autorzy zewnętrzni

Mark Blainey, Catherine Ganzleben, Gretta Goldenman and Iona Pratt (MILIEU Ltd. - Brussels)