Poison Centres: Harmonised notifications

While harmonised poison centre notifications are mandated under Article 45 and Annex VIII of CLP, SDS requirements, and thus the obligation to provide an emergency telephone number, are regulated by Article 31 REACH. For full compliance, both of these regulations must be met. As a result of harmonised notification, a centralised system has been created, by means of which information is supplied in a standardised format to participating countries about the mixtures placed on their markets. More specifically, the amount of detail provided about the composition of the mixtures has risen in many cases, compared with the requirements of legacy national notifications. Unfortunately, the provision of an emergency telephone number in an SDS has not been harmonised and the requirements surrounding this still vary from one EU country to the next.

 In many cases, the emergency telephone service is provided by an official advisory body of the Member State concerned and is identical with the appointed body responsible for receiving the poison centre notification. Thus, it has access to the information contained in the notification and is in a position to provide high-quality emergency response. In some cases, the national appointed body for receiving the notifications and the emergency advisory body are not identical.

Nevertheless, it has access to the database operated by the appointed body. Then there is a third category of country in which access to the national databases is denied to third-party providers of emergency telephone numbers for SDSs. Two obligations concerning data transmission have to be met in such cases. The first is the submission of a harmonised poison centre notification. The second is a separate transfer of information, possibly in a different format, to the emergency telephone number provider. As a result, differences arise in respect of the fees payable. In some countries, both harmonised poison centre notification and use of the emergency telephone number in an SDS are free of charge. In others, the notification is free of charge, but a fee is levied for use of the emergency telephone number, possibly also due to the involvement of third-party emergency telephone services.

Furthermore, the requirements imposed on substances and mixtures differ under poison centre notification and Article 31 REACH namely, in that substances as well as non-hazardous or only environmentally hazardous mixtures are not harmonised notifiable. Yet many of them still have to meet the SDS requirement. Added to which, it frequently happens that REACH-compliant SDSs are submitted voluntarily and that these also contain emergency telephone numbers. Thus, an information gap exists that poison centre notification can fill only partially and on a country-specific basis. Some of these country-specific requirements are discussed below.

Additional national requirements imposed on harmonised product notifications

Section 1.6.3 of the current Guidance on Harmonised Information Relating to Emergency Health Response (version 4.0) prevents Member States on one hand from requiring information additional to that specified in Annex VIII CLP. On the other hand, it allows certain aspects to be decided at national level. Examples given there are the establishment of acceptance criteria for submissions, the application of fees, permissible submission systems, as well as the scope of application. Detailed information can be found on the websites of the national appointed bodies, albeit only in the case of some countries. In others, it may be necessary to establish contact with the responsible authority. The additional information requirements imposed by some EU countries and the related fees are explained in more detail below.

In Belgium, notifications may be submitted via either the ECHA Submission Portal or the national system. The Belgian authority charges a fee of EUR 200 for each initial notification and EUR 35 for each notification update involving a significant change (of name, classification, composition). All other notification updates are free of charge. Furthermore, Belgium explicitly encourages voluntary notifications for “non-classified” mixtures (on the basis of their health and physical effects). No fees are charged for this. The neighbouring country Luxembourg receives notification data via Belgium’s national appointed body. The advantage of this is that mixtures already notified in Belgium do not have to be notified again in Luxembourg.

 Differences across Europe

Certain countries focus particularly on detergents. For example, Germany, Greece, Italy and Portugal stipulate that all detergents and cleaning products must be notified, regardless of their classification. If these products fall outside the scope of Annex VIII CLP, but a harmonised notification is submitted for them via ECHA, they are to be deemed voluntary notifications.

In Croatia, submission of a poison centre notification, which is free of charge, via the ECHA Submission Portal is not sufficient. All product SDSs must additionally be sent in Croatian to the national appointed body via email. These are then additionally registered in a national database. A registration fee equivalent to approx. EUR 32 is levied for this, with updates costing  EUR 16 per SDS.

Since 1 January 2021, Sweden accepts notifications of mixtures intended for consumer and professional use via the ECHA Submission Portal only. Information on products intended for industrial use can still be notified via the national system. One feature here is the treatment of mixtures that are not classified as hazardous. The Swedish appointed body, which is the Poisons Centre as well, says that it also needs to know the full composition of such mixtures because they may be involved in incidents. Thus, in order to provide adequate emergency advice, products that are either not classified or classified only as environmentally hazardous are also notifiable.

The Hungarian authorities require substance information in addition to notifiable mixtures. This entails registering the SDSs of hazardous substances in the national product registry (OSIR-KBIR) if they are not already registered there. A fee equivalent to EUR 26 per substance is charged for this. There is also a fee for the harmonised poison centre notification. Each initial notification costs the equivalent of approx. EUR 45, and each update arising from a significant change of composition (change of UFI) costs EUR 34. All other changes are free of charge.

Emergency telephone numbers in SDS

In Germany, the national appointed body is the Federal Institute for Risk Assessment (BfR) and it downloads and manages the product information submitted to the ECHA. The regional poison centres (“GIZ”) provide emergency advice and companies can meet their obligations under Annex II REACH, for example, by using the corresponding emergency telephone number in the SDS for a fee. In addition, all SDSs containing this emergency telephone number must be submitted to the GIZ. This is the only way to ensure that, when emergency medical advice is needed, the product in question can be identified and appropriate treatment initiated. The consequence of this is that products falling outside the scope of Annex VIII CLP, must be also notified to the GIZ if the emergency telephone number is stated for them. In the case of hazardous mixtures, once a connection has been established with the BfR database, the GIZ have access to compositional information, additional to that given in section 3 of the SDS and are thus able to deliver a better emergency response.

The Austrian Poisons Centre (VIZ), which provides the emergency telephone service in that country, also requires that all SDSs be submitted to it. It explicitly points out that the safety data sheets of non-hazardous products should be transmitted as well, because, otherwise, a prompt emergency all-clear cannot be given in the event of a medical emergency. The VIZ operates a tiered system of prices based on the number of documents.

Sweden has made it clear that its poisons centre needs product information on mixtures that are not classified as hazardous in order to be able to provide adequate medical advice in an emergency situation. The harmonised poison centre notification meets all the requirements of Annex VIII CLP and Annex II REACH, because its national appointed body is also the poisons centre. In addition, no national fees are levied. However, products that are not classified as hazardous must still be additionally notified in the same way as classified products to ensure that the information is available. Sweden’s requirements thus go further than those of Annex VIII CLP.

In Poland, there are several providers for emergency telephone numbers. These do not have access to poison centre notification data. Accordingly, each service imposes different requirements and charges fees before the emergency telephone number can be used in the SDS.

Conclusion

On account of the ongoing high level of complexity and the frequent lack of a link between poison centre notification and emergency telephone number, it is essential to study each sales market in depth to ensure that adequate emergency response is provided.