To harmonise information relating to emergency health response across Europe, the European Commission is implementing Annex VIII to Classification Labelling and Packaging (CLP) regulation. What effect will this have on manufacturers and downstream users, and how will Poison Centre notifications change?
Should an industrial worker or consumer come into contact with a hazardous/toxic chemical, Poison Centres are on hand to provide rapid curative advice. Poison Centres are designated in each country to provide advice to physicians and in some cases, consumers. These poison centres, in the EU, answer approximately 1,700 calls per day from physicians or consumers, 50% of which are related to the accidental exposure of hazardous chemicals to children. (European Commission, Poison Centres)
According to Classification Labelling and Packaging (CLP) regulation (Article 45), each member state of the EU is required to have a national appointed body which provides information on hazardous mixtures to Poison Centres. These national bodies receive all information on preparations or mixtures which are considered dangerous/hazardous based on health or physical effects. (Poison Centres, ECHA).
The ultimate goal for Poison Centres is to harmonise implementation, increase efficiency and be more cost effective, but there are issues with harmonisation across Europe.
EU member states’ national appointed bodies have different levels of data requirements, including the format that data is submitted in and the level of detail required. For example, Belgium submits their data in an “.XLS index” format, Germany as an “.XML index” format with 3 data tabs, and Austria as an SDS “Key” file. This creates problems in the number of different submissions required, in identifying the correct harmful substance and curative action when exposure occurs.
Annex VIII to CLP consists of several changes to processes and procedures of information submission to achieve harmonisation. The implementation of Annex VIII will require a base level of information, most of which is typically present on a Safety Data Sheet (SDS), such as:
As well as:
Annex VIII also requires the inclusion of a Unique Formula Identifier (UFI) on product labels, which will be generated by an ECHA tool. The UFI will allow any Poison Centre to quickly determine the composition and provide advice on the method of treatment.
Any importer or downstream user who is:
a) placing a product on the market in that member state
b) that product is classified for health or physical effects within the EU.
Only Representatives are also able to submit notifications.