REACH Regulation

An Overview
 Contents
•Understanding REACH

•How does REACH work

•Obligations under REACH

•What do you manufacture/import

•Registration

•Registration – Substances to be registered

•Data sharing

•Duty to communicate
 Understanding REACH

REACH is a regulation of the EU, adopted to improve the protection of human health and the
environment from the risks that can be posed by chemicals, while enhancing the competitiveness of
the EU chemicals industry. It also promotes alternative methods for the hazard assessment of
substances in order to reduce the number of tests on animals.
 Understanding REACH Cont.

In principle, REACH applies to all chemical substances; not only those used in industrial
processes but also in our day-to-day lives, for example in cleaning products, paints as
well as in articles such as clothes, furniture and electrical appliances. Therefore, the
regulation has an impact on most companies across the EU.
 Understanding REACH Cont.

REACH places the burden of proof on companies. To comply with the regulation, companies must
identify and manage the risks linked to the substances they manufacture and market in the EU. They
have to demonstrate to ECHA how the substance can be safely used, and they must communicate the
risk management measures to the users.
 Understanding REACH Cont.

•If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the
long run, the most hazardous substances should be substituted with less hazardous ones.
•REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered
into force on 1 June 2007.
 How does REACH work

•REACH establishes procedures for collecting and assessing information on the properties and
hazards of substances.

•Companies need to register their substances and to do this they need to work together with other
companies who are registering the same substance.

•ECHA receives and evaluates individual registrations for their compliance, and the EU Member
States evaluate selected substances to clarify initial concerns for human health or for the
environment. Authorities and ECHA's scientific committees assess whether the risks of substances
can be managed.

•Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to
restrict a use or make it subject to a prior authorisation.
 Obligations under REACH
•Different obligations are specified under REACH

•Depending on the role in the supply chain

•Manufacturer
•Importer
•Only representative
•Downstream user

•First step is to identify what is your role and obligations under REACH
 What do you manufacture/ import
•Different obligations depending whether:

Substance – only substances have to be registered

Preparation – when contained in a preparation each individual substance needs to

be registered. Substances that have been registered by the manufacturer/importer and that are being
mixed in to a preparation by a downstream user, do not need to be registered again by the latter.

Article – individual substances in articles are also potential for registration

 Registration
•Companies have the responsibility of collecting information on the properties and the uses of
substances that they manufacture/import at or above 1 tonne/year.

•Companies also have to make an assessment of the hazards and potential risks presented by the
substance.

•This info is communicated to ECHA through a registration dossier containing the hazard
information and, where relevant, an assessment of the risks that the use of the substance may pose
and how these risks should be controlled.

•Registration applies to substances on their own, substances in mixtures and certain cases of
substances in articles.
 Registration Cont.
•Chemical substances that are already regulated by other legislations such as medicines, or
radioactive substances are partially or completely exempted from REACH requirements.

•Registration is based on the "one substance, one registration" principle. This means that
manufacturers and importers of the same substance have the obligation to submit their registration
jointly.

•For substance registration a fee is usually charged.

 Registration –
Substances to be registered
•The legislation allowed for a transitional regime for substances which, under certain conditions,
were already manufactured or placed on the market before REACH's entry into force.

•Substances fulfilling at least one of the following criteria may be considered as phase-in substances:

Substances listed in the  European Inventory of  Existing  Commercial Chemical

Substances (EINECS) 

Substances that have been manufactured in the EU (including the countries that joined on 1
January 2007) but have not been placed on the EU market after 1 June 1992

Substances that qualify as "no-longer polymer''

Registration Timelines
 Registration –
Substances to be registered Cont.
•All substances that do not fulfil any of the criteria for phase-in substances are considered as non-
phase-in substances.

•Normally, non-phase-in substances have not been manufactured, placed on the market or used in the
EU before 1 June 2008.

•Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to

ECHA and subsequently register the substance in accordance with REACH before they can
manufacture or import the substance.
 Data sharing

•Data collected through vertebrate animal testing must be shared, against

payment.

•Substance Information Exchange Forum (SIEF) (for pre-registered

substances)
• prior to registration
• before testing is carried out

•Inquiry process – for substances which have not been pre-registered

• potential registrant inquires from the Agency
 Duty to communicate
•The registrant communicates with his Downstream Users so as to be able to prepare the registration
dossier.

• In particular the registrant will need information about DUs uses and the risk management
measures they have already put in place

•Provide a Safety Data Sheet (SDS) to customers

•The final Exposure Scenario developed for identified uses as part of the Chemical Safety
Assessment has to be communicated to the registrant’s customers as an annex to the SDS as this
provides instructions of risk management measures that should be in place in order to ensure
adequate control of risks.

•The SDS will have to be updated with the new information required by REACH for the first supply
of the substance or preparation as soon as this information is required by the different title of
REACH.
Thank you for your attention