Cassandra Taylor
Regulatory Specialist,
Nexreg Compliance Inc.
Regulatory International
Influences
Harmonized notification of hazardous
mixtures to poison centers in Europe
Chemical products are available for a variety of uses to professionals
and the general public. Unintentional human
exposure to these products can pose significant health
hazards under circumstances of misuse or accidents. When an accidental
exposure takes place, emergency responders need access to
accurate and relevant information about the chemical product in
order to provide the best possible care.
According to current European Union (EU) legislation, member
states must appoint a body responsible for receiving information
relating to dangerous mixtures placed on the market. Many member
states have implemented a system to collect this information
and provide it to poison centers that will then give medical advice
in health emergencies. Under this current legislation, a lack of
member state harmonization has led to substantial variation in the
existing national notification systems, data formats and information
requirements. This is a challenge for companies selling hazardous
mixtures in different member states because they must submit
similar information multiple times in various formats in order to
meet the individual requirements of each country. Poison centers
have also reported difficulties matching products to the corresponding
notification in up to 40% of emergency exposure calls,
which can lead to devastating consequences. This system is flawed
and regulators have taken action to implement change.
The new Annex VIII to the CLP (Regulation (EC) No 1272/2008
on the classification, labeling and packaging of substances and mixtures)
was designed to harmonize the format and content of the notification
requirements and correct the inconsistencies that emerged
under the previous system. Importers of chemicals into the EU
and downstream users placing hazardous mixtures on the market
will be responsible for complying with the updated requirements
established in Annex VIII to the CLP.
Notification Deadlines & State-specific
Considerations
CLP regulated mixtures that are hazardous based on health or
physical effects must be notified before they are placed on the market.
The deadline for compliance with Annex VIII is Jan. 1, 2020
for consumer mixtures, Jan. 1, 2021 for professional mixtures and
Jan. 1, 2024 for industrial mixtures. For mixtures that have been
notified in a member state before 2020, there is a transition period
for updated notification with a deadline of Jan. 1, 2025. However,
if there is a change to the product composition or labeling, or if
the mixture is placed on the market in another member state, then
a new notification according to Annex VIII will have to be submitted
in advance of the 2025 transitional period deadline.
Mixtures will still need to be notified in each separate member
state where they are placed on the market. This is done either
directly via a member state appointed body or via the European
Chemicals Agency (ECHA) poison center notification (PCN)
portal. Each member state will determine how products will be
notified; some member states allow for either notification method
to be used. The language of submission is the official language(s)
of the member state unless the member state specifies otherwise.
In many cases, this means that English submissions are not acceptable.
Submission information includes the Globally Harmonized
System for Classifying Hazardous Chemicals (GHS) hazard classification,
toxicological information and the product composition.
New Features
Labels for hazardous mixtures placed on the market will now be
required to carry a 16-digit Unique Formula Identifier (UFI). The
UFI will enable poison centers to rapidly and unambiguously identify
submitted information when called upon to provide advice
when dealing with a poisoning incident. All products with the
same UFI must have the same composition.
When a raw material used to formulate a product is a mixture,
then it is called a Mixture in Mixture (MiM). If the supplier has
notified the raw material to the PCN portal, then this MiM may
be used in the notification for the overall product. All that is
needed is the UFI of the MiM and the percentage of the MiM in
the product. This allows the supplier to maintain confidentiality
and saves the notifier time since they do not need to add the full
composition to the notification. It is important to note that if the
36 Spray September 2019