Last reviewed 9 March 2021

In this feature, Caroline Raine gives an update on Annex VIII harmonised poison centre notifications following the first implementation from date of January 2021 for consumer and professional uses.

Background

Importers and downstream users placing hazardous mixtures on the market, and distributors who modify the label or packaging for hazardous mixtures, need to notify the ingredients in those mixtures classified as hazardous for physical effects and/or health effects.

The requirement to notify information on hazardous mixtures has existed for many years now, but up until Annex VIII was introduced each country had implemented its own requirements. The type of information and the format of the information varied from Member State to Member State. Annex VIII introduced a new harmonised format for notifications.

Dates

There are no deadlines as such, the European Chemicals Agency describe them as implementation from dates;

Consumer and Professional use — 1 January 2021.

Industrial use — 1 January 2024.

For those who have already made notifications in accordance with Article 45(1) before the dates listed above (ie have done notifications via the national systems), there is an extended deadline of the 1 January 2025 by which all existing notifications must be updated to the new requirements.

Member State Implementation

Each Member State is implementing the regulations slightly differently and with different timescales. ECHA have pulled together a neat little summary document that shows the status of each Member State — Overview of Member States decisions in relation to implementation of Annex VIII to CLP Regulation (Poison Centre Notification). The document shows five keys aspects in relation to the implementation of Annex VIII of CLP;

  • Readiness of Member State to accept via ECHA submission portal

  • Submission system options

  • Notification language

  • Fees for notifications

  • Placing on the market mixtures notified via ECHA submission portal.

Let’s look at each of these in more detail.

Readiness of Member State to accept via ECHA submission portal

To date out of the thirty countries in the document, ten have not yet moved from their national systems to the Annex VIII portal. These are shown below.

Countries accepting Annex VIII notifications via the portal

Countries still accepting via their national systems

Austria Croatia Cyprus Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia

Lithuania Netherlands Norway Poland Portugal Slovenia Sweden

Belgium Bulgaria Czech Republic Iceland Liechtenstein Luxembourg Malta Romania Slovakia Spain

Submission system options

Countries will either accept via the ECHA portal ONLY, or will allow notifications to be submitted via their own national system, or the ECHA portal. Some countries have yet to inform ECHA of their decision.

Countries accepting Annex VIII portal ONLY

Countries accepting via their national systems or ECHA portal

Countries not yet informed ECHA of decision

Austria Croatia Cyprus Denmark Estonia Finland Greece Hungary Iceland Ireland Italy Lithuania Malta Netherlands Norway Poland Romania Slovakia Slovenia Sweden

Belgium France Germany Latvia Portugal

Bulgaria Czech Republic Liechtenstein Luxembourg Romania

Notification language

Many countries have indicated that they will accept English or their local language, although there are 13 countries who are insisting on their local languages ONLY. This means that all section 11 toxicological information will need to be translated.

Countries accepting English or local language

Countries accepting local language

Belgium Croatia Denmark Estonia Germany Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Portugal Spain Sweden

Austria Bulgaria Cyprus Czech Republic Finland France Greece Hungary Liechtenstein Poland Romania Slovakia Slovenia

Fees for notifications

To date only Hungary and Italy are charging fees, Croatia and Spain are considering fees. All the rest are free to notify too (at the moment!).

Placing on the market mixtures notified via ECHA submission portal

France, Germany, Italy and Spain must have received the notification before the mixture can be placed on the market. No other countries have specified this as a requirement.

Update on Tools

The ECHA submission portal was last updated in October 2020 and will receive another update in 2021.

The guidance document has just recently been updated to version 4. It now includes practical solutions introduced in the second amendment of Annex VIII to CLP. It also covers both sector-specific and cross-sector solutions.

UK based companies

UK based companies will not be able to make notifications via the ECHA harmonised submission portal, and notifications previously made by UK based companies will not be deleted but legally will be ‘void’.

The obligation to make the notification will lie with the importer, which in many cases will be your European customer. Of course, a UK company may make a voluntary notification using an EU legal entity if they wish to reduce the burden on their customers.

England, Scotland and Wales

Poison centres will remain voluntary and if you wish to make a voluntary notification you only need to send a copy of your Safety Data Sheets to the National Poison Information Service (NPIS).

You should send this information by email to sds.npis@nhs.net. The submission of a SDS to the NPIS does not in itself mean that a given product is approved for sale.

There is no obligation to generate or submit a unique formula identifier (UFI) code in Great Britain but the NPIS will register your product with its associated UFI if one has already been generated. To support the NPIS, please ensure the UFI is clearly identifiable on the front page of the SDS.

Northern Ireland

Northern Ireland will follow the Annex VIII requirements, but not through the ECHA portal. Instead, once the Annex VIII dossier has been created it should be sent to the NPIS.

Because NPIS does not have access to the European Chemicals Agency (ECHA) poison centre notification (PCN), submissions for NI must be provided in the form of a PCN and sent directly to NPIS Birmingham as the appointed body.

In order for submissions to be valid, they must be either:

  • produced directly in the ECHA-approved IUCLID desktop/cloud platform and exported as an .i6z dossier

  • if produced using a third-party tool, the submission must then be imported into the ECHA PCN, and exported as an .i6z dossier. This exported dossier will be accepted by NPIS as a submission

These submissions should be made via email to sds.npis@nhs.net.

Conclusions

Making notifications to the poison centres is a legal requirement for hazardous mixtures with health or physical classifications. If you place hazardous mixtures for health or physical effects onto the market then make sure you notify them to the relevant poison centres. Take care to ensure that you have translations available for the Section 11 toxicology information if the country requires it. And for France, Germany, Italy and Spain make sure the notification is done in advance of placing the hazardous mixture on the market.