How can you comply with new poison centre notification requirements?
Ahead of this year’s Regulatory Summit Europe, Chemical Watch took the opportunity to speak to Caroline Raine, Associate Director – Regulatory at NCEC UK. She gave them some advice for companies that need to comply with the new poison centre notification requirements, ahead of the first notification deadline in January 2020.
Q) Annex VIII specifies the harmonised format for notifications and introduces the requirement for a Unique Formula Identifier (UFI) to be created for every mixture. Please outline these and other changes companies should expect.
Annex VIII introduces the need to create and include a Unique Formula Identifier (UFI) on the mixture label and include it with the poison centre notification. It also introduces declaration of full composition for consumer and professional goods, standardised procedure for mixtures in mixture submissions. Reduced submission for industrial mixtures is also a new option along with group submissions and generic product identifiers. The European product categorisation system has also been introduced to help member states with their reporting requirements.
Q) What is the status of the implementation of Annex VIII across member states? If EU countries are not prepared or preparing, what is causing the confusion/hesitation?
The status varies across each member state and the document on Echa’s website provides a good summary of the status of each country.
Some countries (Austria, Italy, Lithuania, Slovakia, Spain) require a change in their own national legislation before an implementation date can be determined.
Other countries are busy getting their IT systems ready to be able to accept notifications in the new harmonised format.
Q) You've said that any mixtures that have been previously notified to member states can benefit from the transitional period, which ends 1 January 2025. Can you explain the benefits of notifying now to maximise the benefit of the transitional period?
The requirement to notify hazardous mixtures within the European member states is a mandatory requirement already in place. Waiting until the format is harmonised leaves companies non-compliant and open to penalties. There are a number of reasons to notify now under the current arrangements:
- It is mandatory now and enforcement is increasing across member states;
- Many member states currently allow a reduced notification and therefore full composition does not need to be disclosed. This effectively buys up to seven years where your full composition does not need to be disclosed – until 2025 – assuming no change is made to the declared information that would require an update within that time;
- UFI numbers on labels are delayed until 2025, allowing companies time to update labels in a timely manner (buying you time to create UFIs, design and print labels);
- Many member states are increasing their cost for notification and therefore delaying notifications could ultimately have significant cost implications. There are still some member states that do not charge, but as time goes on we are seeing more impose fees. The majority of poison centres do not have the infrastructure to accept the volume of notifications that are expected in the agreed upon format. Whereas, currently two-thirds of poison centres are free to notify; and
- If you use other suppliers’ mixtures in your formulation, then from 2020 you will need to include their UFI in your submission. Therefore, if your supplier makes any change to their product that would require an update to their notification (such as change in composition, classification, etc) then they will need to generate a new UFI which could trigger an update to your own notifications.
Notification for some companies is going to be a hefty piece of work and any notifications that are completed before the Annex VIII deadlines are valid until 2025, assuming no change in classification after notification. Companies can buy themselves up to seven years to monitor these regulations and how these changes are going to affect their company.
Q) Member states intend to do things slightly differently. What are the differences between member states that companies need to be aware of?
Member states have the ability to accept notifications in their specified languages, so not all member states will accept notifications in English. The implementation date for each member state will also vary. And the decision to charge fees for making notifications also remains at the discretion of the member states, which means will be free and others will charge.
Q) Can you explain the options for submissions? What are the benefits/pitfalls of choosing one or the other of those options?
Member states have two options – they can either just use the Echa submission system, or they can continue to accept notifications via either their own system or the Echa submission system. Three countries have chosen the latter option, to use their own system or Echa’s: Austria, Germany and Portugal.
Most countries have chosen to go with only the Echa submission system, but several member states have yet to have yet to make public their intentions, for example, France. Given that France has its own well-established system it would not be surprising if they planned to continue to use it.
The Echa submission system allows notifications to be prepared in your own language and it then translates your notification into other member states’ languages. Unfortunately, this does not extend to the toxicological information which must be provided (section 11 of the SDS). This remains as free text that must be translated by the notifier. It is worth noting that translations are only built into the online submission system; if you plan to prepare your notification files using the stand-alone IUCLID software it does not have the built-in translations.
Q) Will there be cost implications for companies? What are they?
Under the current system, several member states charge fees for notifications: Belgium, Croatia, Sweden, Finland, Ireland, Hungary, Italy and Norway. Under the new Annex VIII harmonised notifications, only Croatia and Spain state they are considering fees. All the other member states have either indicated that there will be no notification fees, or that they will be levied by the member state appointed body. The remaining nine member states have not yet indicated if they will charge fees or not.
Given that the implementation of Annex VIII is likely to impact poison centres significantly, I would not be surprised if more member states start to introduce fees.
And of course there is the actual cost in time for companies to do the notifications, or the physical cost if the notifications are outsourced.
Should you require any more information on the Annex VIII to CLP harmonised notification process please do get in touch with me, I would be more than happy to help.
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Information is correct as of 16:00, 22 July 2019.