Poison Centre Annex VIII Member State Implementation plans

Introduction 

On the 24th April 2019 the European Chemicals Agency (ECHA) released its submission system for Poison Centre notifications to Member States under the Annex VIII to CLP Harmonised format.

Annex VIII was published in March 2017 and requires all hazardous mixtures for health or physical effects to be notified to Member State Poison Centres. The Annex VIII deadlines are phased; with the first being for consumer mixtures in January 2020, followed by January 2021 for professional use mixtures, and January 2024 for industrial use. Any mixtures that have been previously notified to Member States can benefit from the transitional period, which ends on the 1st of January 2025.

Annex VIII specifies the harmonised format for notifications and introduces the requirement for a Unique Formula Identifier (UFI) to be created for every mixture. This is then included on the label and the safety data sheet. Also introduced is the European Product Categorisation System, which is used to describe ‘the intended use of a mixture’ and will be used by Member States to facilitate reporting and monitoring of poisoning incidents at European Union (EU) level. Both the Product Categorisation System and the UFI are required as part of the notification.

In this article, we explore the current status of the implementation of Annex VIII across the EU Member States and discusses the benefits of notifying now to maximise the benefit of the transitional period.

Member State implementation

Prior to Annex VIII each Member State had implemented their own systems for receiving notifications of hazardous mixtures. Some are free, some charge fees, some require the use of an electronic security certificate, many are happy to receive information via email, whilst others have their own web portals.

So it is no surprise that although Annex VIII harmonises the information that must be provided, each Member State still intends to do things slightly differently!

When the harmonised submission system was released, a document was also made available on the “Overview of Member States decisions in relation to implementation of Annex VIII to the CLP Regulation”. This document is available on ECHA’s Poison Centre website ( view it here).

Let us have a look at the Member State implementation intentions in a little more detail.

Submission system

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 let us know their intentions, for example, France. Given that France have their own well-established system it would not be surprising if they planned to continue to use it.

Countries intending to use own notification system AND the ECHA submission system

Austria, Germany, Portugal

ECHA submission system ONLY

Croatia, Cyprus, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden

No information provided

Belgium, Bulgaria, Czech Republic, France, Iceland, Liechtenstein, Luxembourg, Romania, UK

Notification language

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 Safety Data Sheet) 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.

Member States have also indicated whether they will accept notifications in their own Member State language, or in English, or both; which is shown in the table below.

Official Member State Language only

Austria,Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Iceland, Liechtenstein, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia 

Official Member State Language or English

Belgium, Croatia, Cyprus, Estonia, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Spain, Sweden, UK

Other

Finland (Finnish and Swedish)

Fees for notification

Under the current system, several Member States currently charge fees for notifications: Belgium, Croatia, Sweden, Finland, Ireland, Hungary, Italy and Norway. Under the Annex VIII harmonised notifications only Croatia and Spain state they are currently 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 the Poison Centres significantly, I would not be surprised if more Member States start to introduce fees.

Placing on the market mixtures: notified via ECHA submission system

France, Italy and Spain have indicated that before a duty holder can place a mixture on the market, the Member State appointed body must be downloaded the notification from the ECHA system. The duty holder would be made aware when this has happened via a submission report in the ECHA system. Therefore, for France, Italy and Spain in particular, it is important to ensure you notify with sufficient time before the product is put on the market.

Countries that must have downloaded the notification before duty holder can place on the market

France, Italy, Spain

Duty holder can start placing mixture on the market immediately after confirmation of successful submission

Austria, Croatia, Cyprus, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden

No information provided

Belgium, Bulgaria, Czech Republic, France, Iceland, Lichtenstein, Luxembourg, Romania, UK

Timeline for acceptance of notifications via ECHA submission system

This still remains rather vague; Member States have either indicated that they will accept notifications between 24th April 2019 and 31st December 2019, or they have indicated that they will accept them from the 1st January 2020. To date no Member States can accept notifications in the new format – so who knows what is meant by April to December! In addition, a number of countries require a change in their own national legislation before a date can be determined and several Member States have not provided any information.

Countries that require a legislation change

Austria, Italy, Lithunia, Slovakia, Spain

Will accept notifications between 24th April 2019 and 31st December 2019

Estonia, Germany, Greece, Malta, Norway

Will accept notifications from the 1st January 2020

Croatia, Cyprus, Denmark, Finland, Hungary, Ireland, Latvia, Netherlands, Poland, Portugal, Slovenia, Sweden

No information provided

Belgium, Bulgaria, Czech Republic, France,
Iceland, Lichtenstein, Luxembourg, Romania, UK

Readiness of Member State to accept notifications via ECHA submission system

In short, there are no Member States that are ready to accept the notifications in the new harmonised format and January 2020 is not that far away!

Notify now

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 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 your notifications could ultimately have significant cost implications. There are still some Member States which 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.

  • 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 seven years to monitor these regulations and how these changes are going to affect their company.

Our advice to our clients is to notify now and benefit from the extended deadline of 2025.

“Why wouldn’t you notify now?”

Further information

The Member State intentions document will be updated by ECHA as new information is provided by each Member State.

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.

Tel: +44 (0) 1235 753 479 | Mobile: 07968 707 879 | E-mail: caroline.raine@ricardo.com 


Copyright Chemical Watch. Re-printed with the permission of Chemical Watch www.chemicalwatch.com

Information is correct as of 16:00, 22 July 2019.

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Caroline Raine

Associate Director – Regulatory

+44 (0) 1235 753654

ncec@ricardo.com Find Out More