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10 March

The document outlines the course structure and modules related to fine chemicals, including topics such as chemical patents, process development, and safety considerations. It also discusses the EU REACH legislation, its impact on Indian chemical exporters, and the requirements for registration and data sharing. Key concepts include the classification of substances, registration obligations, and the complexities of compliance for both EU manufacturers and non-EU exporters.

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Krishna Gautam
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3 views

10 March

The document outlines the course structure and modules related to fine chemicals, including topics such as chemical patents, process development, and safety considerations. It also discusses the EU REACH legislation, its impact on Indian chemical exporters, and the requirements for registration and data sharing. Key concepts include the classification of substances, registration obligations, and the complexities of compliance for both EU manufacturers and non-EU exporters.

Uploaded by

Krishna Gautam
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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10 March

Course structure & Modules


1. Overview of Fine Chemicals as an industry 13. Process Development & Scale-up
2. Chemical Patents 14. Batch Processes: Scheduling & Equipment
3. Fine Chemical Case-studies Selection
4. Economics & business considerations 15. Separation processes in fine chemical industry e.g.
5. The Pharma Industry SMBRs / Batch distillation / Drying / Crystallization
6. The Agrochemicals Industry (Dr Roland) 16. Safety Considerations during process development
7. Competitive Analysis, Balance Sheets and Financial & route selection
Statements 17. Micro reactors and batch-to-continuous
8. Analytical Instrumentation and methods conversion
9. Chemical Regulations / REACH / PFAS 18. Waste reduction, effluent treatment, green
10. Carbon Footprint / CO2 Regulations / ETS / chemistry and pollution control strategies
CBAM
11. P&IDs
12. Natural products and industrial fermentation
Registration, Evaluation, Authorization and Restriction of Chemicals

EU-REACH LEGISLATION FROM THE


PERSPECTIVE OF INDIAN CHEMICAL
EXPORTERS
Core points about REACH
• Why do we need Chemical product safety
regulations?
• How would you design the rules?
• What sort of distortions can rules cause?
• What is fair?
The REACH / EU-SDS / CLP Jargon
Only SIEF
Lead Registrant Tonnage
Representative Substance Info
(LR) Certificate
(OR) Exchange Forum

QSAR / Read-
End points
across

Compliance Letter of Access


SVHC List IUCLID
Check (LoA)

Not surprisingly, REACH is often described as the most complex legislation in EU history……
REACH: History and its deep effect on Indian exporters

• Law passed in EU: Dec 2006


• Not just for imports. Applies to EU manufacturers as well
• Impact on SDS preparation and labelling
• Fine & Specialty chemicals affected significantly due to larger
product portfolio but smaller revenues per product
• SMEs face worst impact
Fundamental elements of REACH
legislation
1. All substances are covered by the REACH Regulation
unless they are explicitly exempted from its scope.
2. Registration requires manufacturers and importers of
chemicals to obtain relevant information on their
substances and to use that data to manage them safely.
3. To reduce testing on vertebrate animals, data sharing is
required for studies on such animals. For other tests,
data sharing is required on request by other registrants.
4. Better information on hazards and risks and how to
manage them safely will be passed down and up the
supply chain.
‘non-EU manufacturer’ who is exporting into EU has no responsibilities under REACH
Mono-constituent substances & SIP
• Main constituent concentration >80%
• Composition is known
• Impurities
– Must be unintended
– All impurities >1% must be identified and
quantified
– >0.1% impurities if PBT etc.
Multi-constituent substances and SIP
• More than one main constituent, each main constituent ≥10%
but <80%
• Each main constituent completely identified by IUPAC name
• Typical, min and max concentrations of each constituent
reported in composition
– “Reaction mass of [main constituent 1] and [main constituent 2]
and …”
– Eg
• Reaction mass of o-xylene and m-xylene
• Racemate without optical activity
• Reaction mass of stereoisomers
• Multiple structural isomers
Examples of multi-constituent
substances
REACH legislation enacted in 2007 but gradual, staggered deadlines
Effective Geographical Scope of REACH sometimes extends beyond the EU zone

• Indirect Exports
e.g. USA
• Swiss
• UK-Brexit
Crucial concepts relating to REACH
legislation
• The registration obligations apply to the individual substances themselves,
independently of whether they are on their own, in a mixture or in an article.
• Only substances have to be registered under REACH, mixtures or articles do
not.
• Data sharing, “one substance, one registration”, joint registrations and SIEF
(Substance Information Exchange Forums)

OR Contract→SIP / Sameness Testing → Inquiry Dossier → Obtain LoA Price→


Negotiation → Dossier Submission →ECHA Fees → Completeness Check→
Registration Number (01-2119447106-44-0008)
Tonnage Bands, End points and registration fees, SME discounts, Isolated
Intermediate Registrations

Total Cost = Registration Fee + LoA cost + Testing Costs + OR Fees


Categories of Tests
• Physico Chemical
• Toxicology
• Ecotoxicology
• Environmental
Only Representative
Case Study: Indian Supplier not selling to EU but still needing
REACH registration

Indirect Exports Formulators

• Indian Ingredient Manufacturer • Indian Ingredient Manufacturer


• Sector: Emulsifier • Selling Mainly to Indian Formulators
• Post REACH (2018) company decided not • Sector: Solvents
to export to EU
• Formulator wants REACH registered
• >50% exports to US Traders
ingredients
• USA Traders wanted a EU-REACH
Registration
Indian Ingredient
India→USA→Germany Manufacturer→ Indian
Formulator → EU
Only Representative
OECD Test Guidelines for Chemicals
Test No. 203: Fish, Acute Toxicity Test
• The fish are exposed to the test substance preferably for a period of 96
hours. Mortalities are recorded at 24, 48, 72 and 96 hours and the
concentrations which kill 50 per cent of the fish (LC50) are determined
where possible.
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