Harmonisation of product notification to Poisons Centres in EU Member States

Abstract

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.

Keywords:

• Poisons centres practise
• Product notification
• CLP regulation

Declaration of interest

The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.

Appendix

Members of the EAPCCT Working Group on Poisons Centre Activities and European Regulatory Issues (until May 2012):

Bjornstad, Mette (Norway)

Bradberry, Sally (UK)

Brekelmans, Pieter (Netherlands)

Butera, Raffaella (Italy)

Casey, Patricia (Ireland)

Desel, Herbert (Germany, chairman EAPCCT WG)

Dupriez, Christophe (Belgium)

Ebehoj, Niels (Denmark)

Feychting, Karin (Sweden)

Ganzert, Martin (Germany)

Garnier, Robert (France)

de Groot, Ronald (Netherlands, coordinator CLP issues)

Kupferschmidt, Hugo (Switzerland, Past-President EAPCCT)

Lazaro Trueba, Iciar (Spain)

Manel, Jacques (France)

Martinez Arrieta, Rosa (Spain)

Mathieu-Nolf, Monique (France)

Mostin, Martine (Belgium)

Nitescu, Viorela (Romania)

Oder, Mare (Estonia)

Pelclova, Daniela (Czech republic)

Puskarczyk, Emmanuel (France)

Sarc, Lucija (Slovenia)

Sesano, Farbizio (Italy)

Stürer, Andreas (Germany)