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Introduction to REACHAwareness and Compliance Assistance Workshop for the Exporters of Apparel
Date: 3rd August 2011 Venue: India Habitat Centre, New Delhi
Mikael Henzler, Managing Director, adelphi
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Introduction to REACH
• Introduction to REACH
• Registration
• How are non-EU producers affected?
• Evaluation
• Authorisation
Agenda
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Introduction to REACH
• Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is an European Union Regulation (Regulation (EC) No 1907/2006).
• The REACH-Regulation entered in force in 1 June 2007.
• REACH addresses the production, import and use of chemical substances in Europe, and their potential impacts on both human health and the environment.
Background of REACH
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Introduction to REACH
“no data - no market - no production”
Impact of REACH
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Introduction to REACH
• No differentiation: REACH creates a single system for both „existing“ and „new“ chemicals.
• Convergence of several chemical safety related legislation and guidance under one umbrella
• REACH reversed the responsibilities from the authorities to the industries. The industry now has to demonstrate the safety of chemicals on the market.
=>“extended producer responsibility”
Characteristics and aim of the Regulation
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Identifi
ed U
se
Introduction to REACH
REACH in the Supply Chain
Producer / Importer
Downstreamuser
Downstreamuser
End User
ECHARegistration
SDS
SDS
Condit
ions
of
Use
Chemical Safety Report
(No REACH Actor)
CSR
SDS EU Safety Data Sheet
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Introduction to REACH
• All EU-manufacturers and EU-based importers producing or importing chemical substances into the EU with more than 1t/a have to register these substances.
• Some substances are exempted from registration. E.g. re-imports, polymers, some substances for medicinal products.
• Registration at European Chemicals Agency (ECHA).
• No data, no market!=> Failure in registration means that the
substance is not allowed in the EU.
Registration
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Introduction to REACH
• Manufacturers and importers have to supply detailed data about each substance (properties, classification, uses and safe ways of handling) in the registration dossier.
• The larger the quantities produced, the more information regarding risk to health and the environment will be required.
Registration
>1t
>10 t
>100t
>1000t
Grade of information required
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Introduction to REACH
How are non-EU producers affected?
Non EU produce
r
Importer
Delivers substances
Asks for the identity and the concentration of the imported substances and for Certification of REACH compliance
ECHA
Registers substance
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Introduction to REACH
• If non-EU producers want to avoid disclosure of sensitive information to importers, they can appoint an “only representative” within the EU.
• “Only representative” then fulfills the registration obligations of the importer. The only representative can represent one or several “non-Community manufacturers”.
• In this case importer is not obliged to register and is regarded as downstream user.
„Only representative“
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Introduction to REACH
„Only representative“
Gives information on
the substance
Non EU producer
Importer
Delivers substances
ECHA
Registers substance„Only
representative“
Provides Safety Data Sheet
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Introduction to REACH
• The ECHA performs evaluation of registration dossier.
• Evaluation of dossier is to ensure that the data provided during Registration is complete and accurate.
• Member States will carry out substance risk checks on the chemicals used in large quantities (over 100 tones per year) and especially high-risk substances.
• If necessary, the authorities can ask the manufacturer for additional information or decide that a substance requires an authorization.
Evaluation
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Introduction to REACH
• Chemicals that are known to be of very high concern require authorizations for use on an individual basis.
• Applicants will have to demonstrate that:o they can control the dangers, or o that no alternatives exists for the toxic chemicals and
o the socio-economic arguments for authorizing such substances outweigh the risks posed by the chemical.
• Authorization will last only for a specified period.
• The European Commission can also ban substances if it finds the risks unacceptable
Authorisation
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Introduction to REACH
REACH also applies to articles containing chemicals, such as:
Apparel containing dyes, softners, etc
Leather containing chrome, dyes, polish, etc
Auto components containing paints, metal plating, etc.
Electrical and electronic equipments containing brominated flame retardants, lead, etc.
=> REACH is relevant for several exporting industries to EU-countries
Substances in articles
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Introduction to REACH
• REACH regulates the production, import and use of chemical substances in Europe.
• REACH stands for Registration, Evaluation and Authorisation and Restriction of Chemicals.
• Industry is responsible for safety and registration.
• Importers in EU require detailed substances information from non-EU producers.
• REACH also applies for chemical substances in articles => High relevance of REACH for Indian exporting industry
Key Messages
adelphiCaspar-Theyss-Strasse 14a 14193 Berlin
T +49 (0)30-89 000 68-0F +49 (0)30-89 000 68-10
•Mikael Henzler•Managing Director•[email protected]
