Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
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Europe – REACH Impact on Non EU exporters
Are you ready to comply with REACH?
What is Reach
Reach is an EU regulation on Import of Chemicals in European Union.
Registration, Evaluation, Authorisation and Restrictions of CHemicals (REACH) entered into force
in June 2007.
This new legislation addresses the current EU chemicals policy and introduces new legal
obligations for the industry.
The chemical producers as well as the downstream users of chemicals and producers of finished
products are now brought under the ambit of Reach. Companies importing products to the EU
market will have to comply with the same strict requirements as the EU companies.
With implementation of REACH, Registration or authorisation is a precondition to access the EU
market. Ability to provide REACH compliant products will be decisive for choosing a supplier.
You may gain a competitive advantage if you start preparing for compliance now. REACH shifts
the burden to industry, such that all partners in the supply chain are obliged to ensure the safety of
the chemical substances they handle.
Scope for Reach
REACH will require a registration of some 30,000 chemical substances. The registration process
requires the manufacturers and importers to generate data for all chemicals substances produced
or imported into the EU above one tonne per year. This data should be filed in a registration
dossier, which should be submitted to the European Chemicals Agency (ECHA).
For substances of very high concern, authorisation will be necessary. These substances will be
prioritised and over time included in Annex XIV. Once they are included, industry will have to
submit applications to the Commission for authorisation on continued use of these substances. In
addition, EU authorities may impose restrictions on the manufacture, use or placing on the market
of substances causing an unacceptable risk to human health or the environment.
Safety Data Sheets will have to be provided to downstream users by manufacturers and importers,
to inform them about the potential risks of the concerning substance.
The European Chemicals Agency is in charge of the day-to-day management of REACH.
Substances exempt from REACH
Some substances are exempted from REACH altogether: radioactive substances, wastes,
substances under customs supervision and, substances necessary for the interests of defence.
If chemical substances used to manufacture other chemical substances are never separated from
the mixture of other chemicals inside a closed system, they are fully exempt from REACH (non-
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
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Europe – REACH Impact on Non EU exporters
isolated intermediates). Intermediates that are separated out during the production process
(isolated intermediates) will have to be registered, but with simplified information requirements
commensurate with their lower risk.
Substances exempt from Registration
Some substances are exempted from Registration: substances occurring in nature such as
minerals, ores and or concentrates, cement clinker, natural gas, liquefied petroleum gas, natural
gas condensate, process gases and components thereof, crude oil, coal and coke are also not
required to be registered as long as they are not chemically modified.
In addition, a number of basic substances for which the hazards and risks are well known are also
exempted: hydrogen, oxygen, several noble gases (argon, helium, neon, xenon), and nitrogen.
There are also exemptions from large parts of REACH for substances in food, medicinal products,
plant protection because those are regulated in specific legislation.
Polymers are for the time being also exempted from registration and evaluation. However,
monomers must be registered.
Nanomaterials are included in the scope of REACH, therefore substances should be registered,
authorised etc.
How does REACH affect your company?
Your company may be affected as producer, importer of chemicals, but also importer of finished
products to the EU market, downstream user of chemicals etc.
Each individual case should be carefully assessed, as for one substance you may be the importer,
for another a downstream user etc.
Assessing impact is a company specific issue - your situation is not the same as your competitor.
No data, no market: registration or authorisation is a precondition to sell on the EU market.
Ability to provide REACH compliant products will be decisive for choosing a supplier.
Almost all industries and sectors are affected.
REACH affects EU based producers of chemicals, preparations, but also downstream users of
chemicals and producers of finished products.
REACH affects companies producing outside the EU and exporting chemicals, preparations,
finished products to the EU market.
The same company may be importer/producer and downstream user for different substances.
Some examples:
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
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Europe – REACH Impact on Non EU exporters
If your supplier of chemicals is based outside EU, your company is considered to be the importer,
and therefore will have to comply with the same obligations as an EU based producer of
chemicals.
Even if you import components to the EU and assemble them, you have to comply with obligations
under REACH related to the substances contained in the imported components.
Even if you import very small amount of substances below 1t per year, you’ll need to comply with
REACH obligations regarding authorisation if some of these are substances of very high concern.
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
INFOSHEET
Europe – REACH Impact on Non EU exporters
REACH- Current Developments
ECHAs Member State Committee agreed on the identification of 14 SVHC's
At its meeting in Helsinki of 7 and 8 October 2008 the ECHA Member State Committee
unanimously agreed on the identification of 14 Substances of Very High Concern (SVHC) that may
become subject to authorisation. One additional substance was already identified as SVHC
without Member State Committee involvement as no comments were provided during the public
consultation.
These 15 substances will be included in the ‘Candidate List’ which will be published on the ECHA
website later in October.
The following substances are concerned:
- Anthracene
- 4,4'- Diaminodiphenylmethane
- Dibutyl phthalate
- Cobalt dichloride
- Diarsenic pentaoxide
- Diarsenic trioxide
- Sodium dichromate
- 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
- Bis (2-ethyl(hexyl)phthalate) (DEHP)
- Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified
- Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
- Bis(tributyltin)oxide
- Lead hydrogen arsenate
- Benzyl butyl phthalate
- Triethyl arsenate
For more information visit the ECHA website at echa.europa.eu
Commission Regulation amending Annexes IV and V has been officially published
The Commission Regulation amending Annexes IV and V of the REACH Regulation has been
offically published. Member States on the REACH Article 133 Committee voted on the Regulation
in June, with all but three voting to accept the text, which has now also been reviewed by the
European Parliament.
Please find the official text here:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:268:0014:0019:EN:PDF
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
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Europe – REACH Impact on Non EU exporters
Q&A about REACH
All that the foreign companies should know about REACH
1) Does any company, which supplies products to EU needs to analyze, whether REACH affects
it?
Yes, any company, which supplies products to EU needs to analyze, whether REACH affects it.
REACH is a complex legislation which may impact in different way the ability of foreign companies
to export products to the EU. The scope of legal obligations differs from one company to another.
Because every company is in unique situation, professional assessment of company-specific
obligations is needed to guarantee that all aspects of REACH compliance are covered.
2) What companies does REACH affect?
REACH affects a company, when:
Company exports substances in quantity more than 1 ton a year - for each substance (there are
exceptions)
Substances in finished product are intentionally released substances and in quantity more than 1
ton a year
Exported products contain substances of very high concern in quantity above 1t/y and in
concentration above 0.1% weight by weight, and from which exposure cannot be excluded.
3) What should be done in the first instance?
Make a list of products, imported to EU
Classify products by categories:
Finished product
Substance
Preparation
Determine what substances are contained in a finished product
Determine quantity of substances per year
Determine if there’re released substances
4) What is considered to be a finished product (article)? What are intentionally released
substances?
Finished product (article) means an object which during production is given a special shape,
surface or design which determines its function to a greater degree than does its chemical
composition.
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
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Europe – REACH Impact on Non EU exporters
Release of substances from products is intended when:
the release is essential for the end use function of the product or when the product would not work
sufficiently without the release (e.g. release of ink from felt tip pens, release of detergents from
cleaning wipes); the release contributes to a quality or minor function of the product, i.e. the
release contributes to an added value of the product, which is not directly connected to the end
use function (e.g. release of perfume from a perfumed eraser or dishwasher tablet).
5)
What are substances of very high concern?
Substances of very high concern are:
Substances meeting the criteria for classification as carcinogenic category 1or 2 Substances
meeting the criteria for classification as mutagenic category 1 or 2 Substances meeting the criteria
for classification as toxic for reproduction category 1 or 2 Substances which are persistent,
bioaccumulative and toxic
Substances which are very persistent and very bioaccumulative
Substances having endocrine disrupting properties
Current existing detailed lists from Directive 67/548/EEC and other EU legislations can be used as
an interim /start base till EU commission has published candidates list and later develops final list.
6) If a company considers that it is not affected by REACH, who can confirm it?
Self-declaration. Each company is responsible for assessing and defining its legal obligations
under REACH.
7) Is there any sample self-declaration?
There is no official sample for self-declaration. CEFIC - the EU association of chemical producers
drafted one. But preparing self-declaration his is very much company-specific issue, therefore
standard self-declaration does not help. EPPA offers to prepare a company-specific self
declaration - it is a result of the assessment of legal obligations and status of preparation.
8) Who is going to test products and check self-declaration?
National authorities in each Member State are responsible for checking compliance. Many
Member States have adopted their national legislation regarding penalties for non-compliance with
REACH. The penalties vary from 1000 to 1 000 000 Eur and 6 months to 10 years prison.
9) What happens if a company, which supplies products to EU won’t pass pre-registration?
If company misses the pre-registration period June - November 2008, it has to submit a full
registration dossier to the European Chemicals Agency prior to importing into the EU. Products
cannot be sold to the EU market without passing registration.
10) Can a Foreign company pre-register on her own?
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
INFOSHEET
Europe – REACH Impact on Non EU exporters
Foreign companies cannot pre-register. This can be done by importers or Only representative
appointed by the Foreign company.
11) Can a Foreign company register on her own?
Foreign companies cannot register. This can be done by importers or Only representative
appointed by the Foreign company.
12) How to find a special representative?
EPPA offers the services of Only representative and can pre-register and register substances
exported by foreign companies.
13) What is the Time line for REACH?
June 2007- Entry into force- Art 30 (4) info.
June 2008- Registration of Non phase in substances starts.
December 2008- Pre Registration Ends.
June 2009- Candidate list of substances of very high concern.
December 2010- Registration of phase in substances > 1000 t or
Classified as R50-R53 > 100 t , CMRs 1 & 2 > 1 t
Notification of phase in substances in products starts (Candidate List)
June 2013- Registration of Phase in substances > 100 t.
June 2018- Registration of Phase in substances > 1 t.
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
INFOSHEET
Europe – REACH Impact on Non EU exporters
SIN list published by leading NGO's
17 September 2008 - Brussels. 10 leading NGO’s representing European civil society have come
together to press The European Commission, Member States and ECHA to come up with a more
comprehensive REACH candidate list.
They would like to see at least 300 substances on the candidate list instead of the current 16.
Therefore they have launched their so-called SIN (Substitute It Now!) list. Greenpeace is, amongst
other members collaborating on the SIN list, committed to push the list in the various committees
of ECHA where it is a stakeholder member.
For more information please visit: http://www.sinlist.org
Important Guidance for non EU Producers
The 27th May of 2008 the guidance on registration has been updated in line with the new
Commission interpretation on aggregation of tonnages. Only Representatives (OR) that represent
multiple non-EU producers must submit a separate registration for each of these substance
producers.
The Commission announced further changes to the Only Representative rules, which will be
included in the guidance on registration in due time (exp. fall 2008).
If you are a non-EU producer make sure to comply with these changes in the guidance on
registration.
More...
Guidance Update
Draft REACH regulation as regards Annexes IV and V
REACH-IT bulk pre-registration functionality available!
ECHA Launch 1st Consultation on Substances of Very High Concern
Guidance available at
http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm?time=1217403231
Quick Silver Freight Systems Pvt. Ltd.
118 –B, Shahpur Jat, 1st & 2nd Floor, TSG House,
Asian Games Village, New Delhi- 110 049
Ph: 91-11-26498985, 6, 7 Fax: 91-11-26498988
Email: qusil@vsnl.com Web: www.quicksilverservices.com
INFOSHEET
Europe – REACH Impact on Non EU exporters
Which are the countries covered in European Union
Member states of the EU
Austria , Belgium , Bulgaria , Cyprus, Czech Republic , Denmark , Estonia , Finland , France
Germany , Greece , Hungary , Ireland , Italy , Latvia , Lithuania , Luxembourg , Malta ,
Netherlands , Poland , Portugal , Romania , Slovakia , Slovenia , Spain , Sweden , United
Kingdom
Candidate countries
Croatia , Former Yugoslav Republic of Macedonia , Turkey
Other European countries
Albania , Andorra , Armenia , Azerbaijan , Belarus , Bosnia and Herzegovina , Georgia
Iceland , Liechtenstein , Moldova , Monaco , Montenegro , Norway , Russia , San Marino
Serbia , Switzerland , Ukraine , Vatican City State