Regulatory update
Cassandra Taylor
Regulatory Specialist,
for Europe & the UK
Nexreg Compliance Inc.
Regulatory International
Influences
If you sell hazardous products in Europe or the United Kingdom
(UK), you are probably already aware that the chemical
regulations are changing. On Jan. 1, 2021, the UK became a
“third country” to the European Union (EU). This article will
review some recent updates to the EU and UK hazardous materials
regulations, and how they relate to each other in the aftermath of
Brexit.
EU SDS updates (REACH Annex II)
In July 2020, Annex II of the Registration, Evaluation & Authorization
of Chemicals (REACH) Regulation (EC) No 1907/2006
was amended. The new amendment, Commission Regulation
(EU) 2020/878, came into force on Jan. 1, 2021. REACH Annex
II describes the requirements for the compilation of Safety Data
Sheets (SDS), including layout and content.
Amendments to Annex II were necessary to incorporate specific
EU requirements for nanoform substances, endocrine disruptors
and unique formula identifiers (UFI) into the appropriate subsections
of the SDS.
The updated REACH Annex II addresses the following:
• UFI (section 1.1, when it is indicated on the SDS)
• Nanoform properties (sections 1, 3 and 9)
• Endocrine disruptors (sections 2, 11 and 12)
• Additional information for substances included in Part 3 of
Annex VI to Regulation (EC) No 1272/2008 (section 3, when
available):
• Specific concentration limits (SCLs),
• M-factors,
• Acute toxicity estimate (ATE)
• Section 3 disclosure limits
• Closer alignment with the Globally Harmonized System of
Classification & Labeling of Chemicals (GHS) 6th and 7th
edition
Among the disclosure changes,
skin and respiratory sensitizer
1A chemicals will now have to
be disclosed when present at
0.01% or 1/10th of the assigned
SCL. Substances that are classified
for aspiration toxicity must
be disclosed when in the mixture
at 1% or more, rather than 10%
as previously indicated.
Great Britain (GB) has not
officially adopted the Annex II
update. This means that there are now
differences in the format and content provisions laid out
for GB versus EU SDS. As a result of the Annex II amendments,
EU SDS are expected to be more comprehensive compared to the
current GB and previous European SDS requirements, with additional
substance and product data points needed for compliance.
A grace period of until Dec. 31, 2022 has been provided to
update all current EU SDS to conform with the new requirements.
EU CLP updates: ATP 14
The 14th Adaptation to Technical Progress (ATP) of the EU
Regulation (EC) No 1272/2008 on the classification, labeling and
packaging of substances and mixtures (CLP) becomes mandatory
on the date of application: Sept. 9, 2021.
ATP 14 includes new classification and labeling requirements
for products containing titanium dioxide:
• Liquid products containing 1% or more of Titanium dioxide
particles with aerodynamic diameter equal to or below 10μm
will need to be classified as Carcinogen 2 and labeled with
the EUH211 statement: Warning! Hazardous respirable drop
lets may be formed when sprayed. Do not breathe spray or mist.
• Solid mixtures containing 1% or more of Titanium dioxide
will need to be will need to be classified as Carcinogen 2
and labeled with the EUH212 statement: Warning! Hazardous
respirable dust may be formed when used. Do not breathe dust.
Table 3 of Annex VI to CLP has been amended to include three
new notes that relate to the changes for Titanium dioxide. Note V
addresses Titanium dioxide fibers and sanctions the assignment of
a more severe category (Carc. 1B or 1A) and/or additional routes
of exposure when appropriate. Note W describes the particular
toxicity of Titanium dioxide as it relates to respirable dust. Note
10 specifies that the carcinogen by inhalation classification applies
only to mixtures containing 1% or more of Titanium dioxide in
the form of particles with an aerodynamic diameter ≤ 10μm.
June 2021 SPRAY 11
United Kingdom (UK) = England, Scotland, Wales & Northern Ireland
Great Britain (GB) = England, Scotland & Wales
Continued on page 18