The Benefits of Submitting Poison Centre Notifications Before the Implementation of Annex VIII
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.
So, what is happening to improve harmonisation? – The implementation of Annex VIII to CLP
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:
- Colour,
- pH,
- hazards,
- toxicological effects,
- and precautionary statements.
As well as:
- Full composition Information, including non-hazardous components,
- Size,
- types of packaging,
- and product categorisation code.
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.
When will the changes come into effect?
- 1st of January 2020 – Annex VIII applies to consumer mixtures
- 1st of January 2021 – Annex VIII applies to professional mixtures
- 1st of January 2024 – Annex VIII applies to industrial mixtures
- 1st of January 2025 – Submissions made prior to Annex VIII no longer valid
Who needs to notify?
Any importer or downstream user who is:
a) placing a product on the market in that member state
and
b) that product is classified for health or physical effects within the EU.
Only Representatives are also able to submit notifications.
Exemptions from notification:
- Finished cosmetics products,
- Research and development,
- Explosives,
- Non-hazardous gases,
- and products not classified for health or physical effects.
What are the benefits of notifying before 1st of January 2020
- The transition period for those currently in compliance with existing Poison Centre notifications (2025, so long as no significant change occurs)
- In most member states notifying is currently free!
- Typically, less information & fewer updates are required
- Avoid the rush to notify in Q3 of 2019 with all other companies