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    Article 17 of the Preparations Directive 1999/45/EC is differently implemented in EU Member States. A survey on how Poisons Information Centres become informed on dangerous preparations

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    Authors
    Groot R de
    Brekelmans PJAM
    Meulenbelt J
    Series/Report no.
    RIVM rapport 233900001
    RIVM rapport 233900001
    Type
    Report
    Language
    en
    
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    Title
    Article 17 of the Preparations Directive 1999/45/EC is differently implemented in EU Member States. A survey on how Poisons Information Centres become informed on dangerous preparations
    Translated Title
    Artikel 17 van de Preparatenrichtlijn 1999/45/EG is verschillend geimplementeerd in EU lidstaten. Een onderzoek naar hoe Vergiftigingen Informatie Centra worden geinformeerd over gevaarlijke preparaten.
    Publiekssamenvatting
    A survey on the notification of information on dangerous preparations by companies to Poisons Information Centres shows that each EU Member State has made different arrangements. This is the result of missing guidelines in the Preparations Directive 1999/45/EC. The implementation of the 'Globally Harmonised System of classification and labelling of chemicals' (GHS) in the EU will replace the Preparations Directive. This is a good opportunity to harmonize product notification at an EU level and have it legally enforced. The notified product information is used for medical purposes, particularly to provide information on poisonings with these preparations. This report shows that in six countries the Poisons Information Centre (PIC) directly receives the information on the dangerous preparations. In most other countries, a governmental authority is appointed that makes the information available to the PICs. Between EU Member States different requirements are set concerning the notification of the composition of the product and the concentrations of the ingredients. There are also different procedures for notification and a considerable variety in used forms and/or applications for electronic notification. Harmonisation of product notification can be achieved if the receiving authorities first reach consensus on the required product information. Next, an agreement on an acceptable format for notification must be reached.
    Onderzoek naar de aanlevering van informatie over gevaarlijke preparaten door bedrijven aan Vergiftigingen Informatie Centra laat zien dat dit in elke EU lidstaat anders geregeld is. Dit komt doordat in de Europese Preparatenrichtlijn 1999/45/EG hierover geen duidelijke regels zijn vastgelegd. De invoering van het 'Globally Harmonised System of classification and labelling of chemicals' (GHS) in de EU gaat de Preparatenrichtlijn vervangen. Dit is een goed moment om op Europees niveau de aanlevering van productinformatie te harmoniseren en de vereisten wettelijk vast te leggen. De aangeleverde productinformatie wordt gebruikt voor medische doeleinden, met name het verstrekken van informatie in geval van vergiftigingen. Dit rapport laat zien dat in zes landen een Vergiftigingen Informatie Centrum hiervoor direct is aangewezen als ontvangende instantie. In de meeste andere landen wordt de productinformatie aan hen ter beschikking gesteld door een (ander) ontvangend overheidsorgaan. In EU lidstaten gelden verschillende vereisten voor de op te geven productsamenstelling en de concentraties van de ingredienten. Eveneens verschillen de procedures voor aanlevering en is er een aanzienlijke variatie in de gebruikte formulieren en/of applicaties voor elektronische aanlevering. Voor het bereiken van harmonisatie is het noodzakelijk dat de ontvangende instanties eerst consensus bereiken over de vereiste productinformatie. Daarna moet overeenstemming worden bereikt over een gemeenschappelijk formaat voor aanlevering.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
    URI
    http://hdl.handle.net/10029/16492
    Collections
    RIVM official reports

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