Document Detail


Harmonisation of product notification to Poisons Centres in EU Member States.
MedLine Citation:
PMID:  23298219     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
INTRODUCTION: In the European Union (EU), notification of product information by industry to poisons centres and/or competent authorities is a legal obligation for mixtures classified as hazardous. However, EU legislation does not specify the precise information needed for this product notification. As a consequence, varying requirements have been developed in different EU Member States. The European Commission (EC) carried out an assessment of whether harmonisation of product notification can be achieved. This manuscript provides an overview of the most important (discussion) points to reach harmonisation.
COMPOSITION AND CONCENTRATION OF INGREDIENTS: Discussions have focused mainly on whether non-classified ingredients should be notified only above a concentration threshold and on the use of defined, narrow concentration ranges instead of exact concentrations for hazardous ingredients.
ELECTRONIC DATA EXCHANGE FORMAT: All stakeholders agree to the development of an electronic data exchange format for product notification and identify the eXtensible Markup Language (XML) as the most appropriate format.
EUROPEAN PRODUCT DATABASE: Instead of multiple notifications to national databases, the EC will analyse the benefits, feasibility and costs of a European product database to provide a centralised portal for companies to upload their product information. Poisons centres and competent authorities need to have access to this information.
UNIQUE PRODUCT IDENTIFIER: A Unique Product Identifier (UPI) on the product label can unambiguously identify the product and its formula and links it to the corresponding notified product information. A procedure for the creation of a UPI by companies has already been proposed.
PRODUCT CATEGORY SYSTEM: There is broad support for the development of a hierarchical product category system to facilitate statistical analyses and comparability of poisoning incidents in EU Member States.
OUTLOOK: Following a 3-year assessment period, the EC concluded that harmonisation of product notification is an achievable goal. In order to draft an Annex to the CLP Regulation concerning this topic, a new working group with representatives of EU Member States, European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) and other stakeholders will attempt to find consensus on harmonisation of product notification.
Authors:
P Brekelmans; R de Groot; H Desel; M Mostin; K Feychting; J Meulenbelt
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Publication Detail:
Type:  Journal Article     Date:  2013-01-09
Journal Detail:
Title:  Clinical toxicology (Philadelphia, Pa.)     Volume:  51     ISSN:  1556-9519     ISO Abbreviation:  Clin Toxicol (Phila)     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-07     Completed Date:  2013-04-02     Revised Date:  2013-07-15    
Medline Journal Info:
Nlm Unique ID:  101241654     Medline TA:  Clin Toxicol (Phila)     Country:  England    
Other Details:
Languages:  eng     Pagination:  65-9     Citation Subset:  AIM; IM    
Affiliation:
National Poisons Information Centre, University Medical Centre Utrecht, Utrecht, The Netherlands. p.brekelmans@umcutrecht.nl
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MeSH Terms
Descriptor/Qualifier:
Chemical Industry / legislation & jurisprudence*
Databases, Factual
Disease Notification
European Union
Humans
Poison Control Centers / legislation & jurisprudence*
Safety Management

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