Page 176 - CW E-Magazine (6-5-2025)

Special Report

New EU chemical rules bring major changes –

Indian exporters need to get ready

n April 10, 2025, the European in the EU unless a legal representative SHEEBA KAPOOR
Union (EU) brought into force based in the EU is responsible for the Senior Regulatory Specialist
Oa new regulation – Regula- product’s compliance. E-mail: sheebakapoor44@gmail.com
tion (EU) 2024/2865 – which amends
the existing CLP Regulation (EC Therefore, if you’re a company in These classifi cations will impact how
No. 1272/2008) governing the classi- India selling directly through Amazon your product is perceived, handled, and
fi cation, labelling, and packaging of EU or even via your own website to accepted in the EU market. If you work
chemicals. While the title might sound EU customers, you must have a formal with downstream users, they may start
like a minor administrative update, the relationship with someone in the EU asking questions soon – if they haven’t
changes it introduces are substantial – who can assume legal responsibility. already.
particularly for those in India who are This could be a distributor, a subsidi-
exporting chemicals or formulations to ary, or even a third-party “responsible Expect more scrutiny on animal
the EU market. person” – but they must be physically testing
located within the EU. The regulation places greater
I’ve been working in the regulatory emphasis on reducing animal testing.
space for over a decade, and I can confi - This change will impact many Before submitting any new classifi -
dently say that this is one of the most Indian SMEs and manufacturers that cation or toxicological data, compa-
impactful updates we’ve seen in recent have been selling small-batch specialty nies must demonstrate that they have
years. It’s not just about hazard classes products directly to the EU. considered all available non-animal
or labeling – it’s about how products methods – such as in vitro studies, read-
are sold, who is responsible, and what Four new hazard categories – check across techniques, or computational
kind of testing data is acceptable. If your classifi cations models.
you’re exporting to Europe, this is not The regulation introduces four new
something to push down your to-do list. hazard classes: If you’re commissioning studies
 Endocrine Disruptors (ED) for both through laboratories, ensure they offer
Why this matters for Indian human health and the environment; non-animal testing options and provide
exporters  PBT (Persistent, Bioaccumulative justifi cation when an in vivo test is
The EU is one of India’s largest and Toxic); deemed necessary. In some cases, EU
markets for chemicals. Whether it’s  vPvB (Very Persistent and Very authorities have rejected established

raw materials for pharma, industrial Bioaccumulative); and studies if alternative methods were not
solvents, or specialty additives, Indian  PMT and vPvM (Persistent, Mobile properly considered.

companies export a signifi cant volume and Toxic, or very Persistent and
of chemical-based products to Europe very Mobile). Mixtures and standard formula
every year. If you’re even partially products under the microscope
involved in that value chain – whether If you’ve been relying on the same Another update that might fl y
as a manufacturer, formulator, or data hazard classifi cation for your products under the radar is the new treatment of
provider – you need to understand what for years, it’s time to take a fresh look. “standard formula” mixtures – such as
this new regulation requires. For example, many polymer additives fuels or common technical blends. If
and industrial solvents could now fall your product fi ts a defi ned composition
Online sales now require EU under one of the new categories based template (as many do), you’ll need to
presence on mobility or bioaccumulation – ensure that any batch-to-batch variation
In my opinion, the most signifi cant which would require updates to your is properly documented and remains
change is the new requirement related Safety Data Sheets (SDS), labels, and within the permitted range. This could
to online and distance selling. Under possibly REACH notifi cations. increase documentation requirements,
the new rule, hazardous chemical pro- especially for toll manufacturers and
ducts cannot be sold online to customers This isn’t just about ticking a box. traders sourcing from multiple suppliers.

176 Chemical Weekly May 6, 2025

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