Poison Centre Notification (PCN)
The requirement to submit information
to poison centres is not a new one. Indeed, the requirement to provide information
on hazardous mixtures to poison centres has been around since the 1999
Dangerous Preparations Directive, and was transposed into CLP (via Article 45)
Because the original requirement was based on a Directive,
each Member State implemented the requirement in their own way, leading to different notification systems across the EU. Therefore, at the
time of introducing CLP, the European Commission agreed to undertake a review
of these requirements to see if harmonisation of notification requirements
across the EU would be beneficial. This
review was duly undertaken and led to the introduction of Regulation (EU)
2017/542, amending CLP by adding an annex on harmonised information relating to
emergency health response (Annex VIII).
The new Annex VIII requires information for poison centres
to be submitted using a new harmonised format. In addition, it requires that
suppliers create new Unique Formula Identifier (UFI) for each hazardous mixture
that they place on the market, to be included on labels and safety data sheets
as specified in the regulation.
Notifications for new hazardous mixtures being placed on the
market, and updates to existing hazardous mixture notifications, must be made
in the new format from
- 1 January 2021 for hazardous
mixtures supplied to consumers (delayed from 1 Jan 2020)
- 1 January 2021 for hazardous
mixtures supplied to professional users
- 1 January 2024 for hazardous
mixtures supplied to industrial users.
All existing notifications need to be updated to the new
format by 1 January 2025, if they have not already been done so as above.
Many suppliers who have not previously notified their hazardous
mixtures to poison centres are waiting for the new systems to be put in place
before making their notifications by the above deadlines. Whilst this may be
acceptable in some EU Member States, e.g. the UK, who have been running a
voluntary scheme of notifications, this is not the case in all Member States, many
of whom did enact the requirements of the DPD and CLP. Suppliers should check
the requirements for each Member State where they place mixtures on the market,
and make notifications as required. Information about existing national schemes
can be found on the ECHA website via the list of National Helpdesks.
This also includes information on whether an emergency telephone number needs
to be added to section 1.4 of the SDS.
The new format for making notifications requires suppliers
to provide detailed information on their product, including
identifiers, including the new UFI
- Hazard classification
and labelling of the mixture
- Either exact
percentage composition, or composition ranges. If using composition ranges,
suppliers must be within specified ranges which depend on the hazard of the
ingredient, and are much narrower than those typically used on Safety Data
- Details on physical
form, pH, packaging, etc.
- Information on
- Use information
using a new product categorisation system
These requirements apply to all mixtures placed on the
market that are classified for either physical hazards or health hazards. The
new requirements do not apply to mixtures classified only for hazards to the
Mixtures which are outside the scope of CLP, e.g. foods and
feedstuffs, medicines and cosmetics in their retail packaging are also exempt,
though it should be noted that for e.g., bulk mixtures which are not yet in their
final packaging and are still subject to CLP, notification would still be
required. In this case, the industrial mixtures deadline would apply as there
are separate notification requirements under other sectoral legislation for the
There are also exemptions for mixtures that meet the
definition of “scientific research and development” and to mixtures for “product
and process oriented research and development”. Mixtures classified only as
gases under pressure; and/or explosives (unstable explosives and Divisions 1.1
to 1.6) are also exempted.
Products supplied only for industrial use can also benefit
from reduced notification requirements (an SDS can be submitted instead of
detailed compositional information) but only where the supplier can provide the
full information required 24/7. If this is not possible, a full notification
must be submitted.
There has been a lot of discussion over what is an
industrial mixture. A mixture is only considered to be an industrial mixture if
all uses, including down the supply chain, are industrial. A fragrance blend that
goes into a household cleaning product, for example, would not be considered to
be an industrial mixture, even though the immediate customers of the supplier
may be using it at an industrial site to create the household cleaning product.
A new, central submission
portal has been created by ECHA to make it easier for companies to make
their notifications. An overview of which countries are accepting submissions through the portal, what languages
they accept, and whether a fee may be charged for submissions is also
Further information on the new requirements, including tools
and guidance can be found on the ECHA website here.
Denehurst Chemical Safety Ltd
Note that PCN does not apply in the UK and there is currently no intention of the UK introducing an EU-style system. Unless in Northern Ireland, UK legal entities cannot be responsible for Notifications and although possible to prepare submissions to help EU customers, the EU importers retain the legal obligation to ensure qualifying mixtures are correctly Notified.