European Regulatory Update Cassandra Taylor
Nexreg Compliance Inc.
Regulatory Specialist,
Regulatory International
Influences
EU Poison Center Update:
Consumer Mixture deadline extended to 2021
The September 2019 issue of SPRAY discussed the new harmonized
reporting obligations for hazardous mixtures under Annex VIII
of CLP (Regulation (EC) No 1272/2008 on the classification, labeling
and packaging of substances and mixtures) for products sold in Europe.
As a recap, Annex VIII implements new requirements for
information that must be submitted to the appointed body or
poison center in each Member State where a hazardous mixture
is sold. Duty holders will have to submit information, including
clear identification of the mixture and the operator responsible for
placing the product on the market, the intended use, composition
and hazard information.
In addition to specific information requirements, a harmonized
electronic submission format will allow for the straightforward
retrieval of relevant information by appointed bodies. A unique
formula identifier (UFI) will need to be added to the label of each
hazardous mixture to enable clear identification of the product by
emergency responders.1
Previously, we stated that the first compliance date for harmonized
reporting of hazardous mixtures intended for consumer use
was Jan. 1, 2020. However, the latest amendment to Annex VIII of
CLP delayed this deadline to Jan. 1, 2021. The extended deadline
is intended to solve various workability concerns brought up by
industry and Member States. Some issues identified by industry
include the effects of high variability in mixture composition due
to the natural origin of ingredients; difficulty knowing exact composition
of products with complex supply chains and the impact of
multiple suppliers with the same technical properties and hazards.
Additional amendments to Annex VIII include clarification of the
text to streamline interpretation and improve coherence.
This amendment is not expected to be the last change to Annex
VIII. The European Commission has an additional amendment
underway that aims to solve some of the concerns raised by
stakeholders on the workability of the notification requirements.
Discussions are ongoing and we can expect to see more updates
throughout 2020.
If you have obligations under Annex VIII of CLP that have not
already been initiated, then you are advised to begin preparing
notifications right away. Notifications submitted according to the
existing national requirements before the 2021 deadline are not
subject to a full submission in accordance with Annex VIII until
Jan. 1, 2025.
Annex VIII notifications should only be submitted to Member
States once indicated that they are ready2 to accept submissions
via the European Chemicals Agency (ECHA) Submission Portal3.
Companies with larger product portfolios may choose to use their
own IT systems to create notifications using the system-to-system
service.
Supply chain communication4 is a key aspect in meeting the
new requirements of Annex VIII to CLP. Downstream users need
information from their upstream suppliers in order to complete
their own notifications in a timely manner. This is especially important
for supply chains that include formulators of mixtures for
consumer and professional use because the end use of the product
determines the compliance date.
ECHA’s Poison Centers website (poisoncentres.echa.europa.eu/)
has great resources and guidance on poison centre registration and
requirements. We suggest checking it out!
New REACH requirements for nanomaterials
Updated Registration, Evaluation, Authorization & Restriction
of Chemicals (REACH) Annexes (Regulation (EC) No 1907/2006
of the European Parliament and of the Council on REACH) for the
nanoforms of substances came into force on Jan. 1, 2020. The new
information requirements concern companies that manufacture or
import nanomaterials that are subject to REACH Registration in
the EU. The aim of these changes is to ensure companies are providing
adequate information to demonstrate safe use of nanoform
substances for human health and the environment.
The revised Annex VI of REACH regulation introduces the concept
of “nanoform.” It establishes the principle that all the nanoforms
of substances covered by a registration must be reported
38 Spray March 2020