REACH

(Registration Evaluation and

Authorization of Chemicals)
DR Suresh Nadgouda
 Introduction

The new European regulation on chemicals

(REACH) has passed the European
Parliament and was adopted by the
Council on December 18th 2006:

REACH will enter into force on June 1st 2007.

The wording of the

“REGULATION (EC) No 1907/2006 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL”
is published in the official EU-Journal :

http://europa.eu.int/eur-lex/lex/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

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 Substance Inventory REACH
EINECS is a list of substances (ingredients) marketed before 1980 in the EU and does not
contain any data relating to the hazardous nature of risks.

By implementing REACH the EU will build up a novel substance

inventory which will substitute EINECS and ELINCS.
In this novel inventory each substance is characterized by
 each manufacturer/importer including his annual substance volume
 toxic and environmental hazardous properties “substances of high concern”
 measures for save handling and use -> authorisation:
permission for use has to be applied

Substances on its own or in a preparation (ingredients of a chemical product) have

to be registered by each manufacturer in the EU or importer into the EU.
Otherwise the permission of manufacturing or marketing gets lost.
Each means e.g. for a corporate group, each legal entity has to register.
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 What does “substance”
mean?
Example: Polymer dispersion Besides the Polymer all processing aids und additives
have to be considered as substances.
Composition
(regulatory: impurities are allocated
to the substance respectively)
 Polymer In case of a polymer dispersion only the
 Emulsifier A polymeric substance is manufactured.
 Emulsifier B
Lobbying was successful:
 Plasticizer
Polymeric substances are exempted from
 Defoamer
registration (for the time being).
 Biocide A
 Biocide B The manufacturer of a polymer dispersion has no duty
 (Water) to register
... but the manufacturer/importer of raw materials and
additives has.
Unfortunately …
the importer of a polymer dispersion has duties to register.
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 Importer’s duty to register
Example: Polymer dispersion

All individual substances > 1 t/yr of an imported chemical have to be

registered by the importer.

Building blocks, e.g.

 Monomer A
Composition  Monomer B
 Polymer  Monomer C
 Emulsifier A  Starter
 Emulsifier B  Chain-transfer agent
 Plasticizer  End group
 Defoamer
 Biocide A
 Biocide B Even though polymers are exempted
from registration, in case of import
all polymer building blocks > 2 %,
> 1 t/yr have to be registered.

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 What does “registration”
To get a substance listed inmean?
the inventory the substance has to be registered.
(1)

 Pre-registration (of “phase-in” substances)

Each manufacturer/importer in the EU notifies
the substance at the European Chemicals
Agency (ECHA) in Finland via internet:

substance identifier (name, CAS number), company (contact person), tonnage band

By this pre-registration the company secures the permission to

manufacture/import products containing/based on the substance until the real
registration has to be conducted.

Time window for pre-registration: 01.06.2008 – 01.12.2008

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 What does “registration”
 Registration mean? Scope / Exemptions (2) Comparison of Substances Inventories
Each manufacturer/importer in the EU (or a consortia) provides a registration dossier of
the substance at the ECHA in Finland via internet. The extend of the dossier is
dependent on the tonnage band:

Technical dossier
Registration dossier
(up (up
to 300 pages)
to 300 pages) Content of the dossier
substance identifier, company, physical-chemical data set,
toxicological data set, eco-toxicological data set, uses, chemical safety report

Tonnage band Duty to register Costs

expected until (VCI estimation, depending on data existing)
 1000 t/yr or CMR* etc. ► 01.12.2010 up to ~ 1.000.000 €
 100 ...  1000 t/yr ► 01.06.2013 up to ~ 400.000 €
 10 ...  100 t/yr ► 01.06.2018 up to ~ 250.000 €
 1 ...  10 t/yr ► 01.06.2018 ~ 20.000 €
7*CMR etc. = substances of high concern: cancinogenic, mutagenic, reprotoxic (each Cat. 1,2) or persistent hazardous to the environment
 Timelines of
REACH enters into force June 1 2007
REACH st

Article 5 No data, no market

1000 t/a, Subject to Articles 6, 7, 21 and 23, substances on their own, in preparations
Registr. or in articles shall not be manufactured in the Community or placed on the
CMR 1+2
market unless they have been registered in accordance with the relevant
( 1 t/a), R50-53 Pre-registration Evaluation provisions of thisTitle where this is required.
( 100 t/a)
Evaluation
= Tier 1 Registration End of
100 t/a Registration „Phase-in“
Evaluation
= Tier 2
Evaluation
Registration
 1 t/a Registration
= Tier 3 Evaluation

Authorisation / Restriction
Entry into
force “New Substances”

Information along the Supply Chain

Notification C&L Inventory (no tonnage threshold!)

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
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Thanks