MAGAM Study [EN]
Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation) entered into force on 20 January 2009 in the European Union, putting into practice the Globally Harmonised System (GHS) for the classification and labelling of chemicals.
The new rules on classification and labelling apply at the latest from 1 December 2010 for substances and from 1 June 2015 for mixtures (at present: preparations). Products manufactured before those dates can be sold for two further years.
The above-mentioned Regulation also brings changes regarding classification criteria, hazard statements, precautionary statements and hazard symbols. As compared with the formerly applicable Dangerous Preparations Directive (1999/45/EC) the CLP Regulation relies on much lower limits in the calculation of hazardous properties, inter alia for classification as corrosive or irritant to skin or eyes. The use of the calculation method results in the classification "corrosive to eyes" for consumer products which are currently not classified as dangerous, such as e.g. manual dishwashing products.
But appropriate labelling is a prerequisite for the best possible medical advice and treatment in cases of suspected poisoning. A labelling method, which heavily overemphasizes existing hazards, cannot make the basis for medical treatment as is really necessary. This increases the indirect risk of damage to human health and causes avoidable higher costs for the health care sector.
The "expert judgement" in the CLP Regulation will be an important instrument in efforts to arrive at adequate classifications which lead to an appropriate labelling of substances and mixtures. Experts can resort inter alia to data from accident databases, epidemiological and clinical studies, and well-documented case reports and observations (see Annex I no. 188.8.131.52 to the CLP Regulation).
Against the backdrop of such far-reaching regulatory change in Europe, the Society of Clinical Toxicology (GfKT) with its 9 networked poisons information centres in Germany, the Austrian Poisons Information Centre in Vienna and the Swiss Toxicological Information Centre in Zurich started on 1 October 2008 the MAGAM Study, in order to analyse human toxicological data from the past 10 years - as regards corrosive eye exposures to selected domestic products. This is a multi-national, retrospective analysis of data from poisons information centres on corrosive eye lesions caused by solid machine dishwashing products and other detergents, cleaning and maintenance products:
Multinationale, retrospektive Analyse von Daten der Giftinformationszentren zur Frage korrosiver Augenläsionen durch feste Maschinengeschirrspülmittel und andere Wasch-, Pflege- und Reinigungsmittel (MAGAM)
Here a short overview of the study (in German language): MAGAM Studie
Funding of the study is contributed by Industrieverband Körperpflege- und Waschmittel e.V. (IKW, the German Cosmetic, Toiletry, Perfumery and Detergent Association).
Meanwhile part 1 of the study is completed. 1.8 million human exposures in the years 1998 to 2007 from all 11 poisons information centres were analysed – in respect of eye exposures to 6 product subgroups of detergents, cleaning and maintenance products. A poster with results from part 1 was presented at the XXIX International Congress of the European Association of Poisons Centres and Clinical Toxicologists, 12/15 May 2009 in Stockholm, Sweden: POSTER [Abstract in: Clin Toxicol 2009;47(5):477].
In part 2 of the study over 2,200 cases of human eye exposure were compiled and quality assessed by early July 2009 in the new harmonised case database of GfKT. These cases are currently being analysed.
First results concerning the product group SOLID AUTOMATIC DISHWASHING PRODUCTS were presented as an oral presentation at the XXX International Congress of the European Association of Poisons Centres and Clinical Toxicologists, 11-14 May 2010, Bordeaux, France: PRESENTATION [EN] [Abstract in: Clin Toxicol 2010;48(3):245].
MAGAM study group - 12 May 2010