Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 121
Section Section Change made
(Version 2) (Version 1.6)
2.1.2.5 1.5.3.4 - The need for a non-EU manufacturer to provide the only
representative with up-to-date information on the list of EU
importers has been reworded as a recommendation. Other
options are considered to keep the only representative
informed.
- The scope of the previous subsection on the tasks of the
only representative has been changed to cover exclusively the
registration obligations.
- The information regarding pre-registration by an only
representative has been moved to section 4.2.
- The requirement to submit a new registration dossier in case
of change of only representative without agreement of the
earlier one has been eliminated.
- The requirement to submit separate registrations by an only
representative is further clarified.
2.2.1 1.6.1 - The content has been restructured.
- The requirement to provide information of the substances in
the bulk and nanoform where applicable has been included.
2.2.2.1 1.6.3.1 - The content has been streamlined.
- A reference to the specific legislation applicable to
radioactive substances is included in a footnote.
2.2.2.4 1.6.3.4 - The content has been streamlined.
2.2.2.5 1.6.3.5 - The definition of intermediates has been included.
2.2.3 1.6.4 - The content has been restructured.
- Reference to the authorisation and restriction obligations is
included.
2.2.3.1 1.6.4.1 - The scope of the exemption in substances used for food or
feedingstuffs is further clarified.
- The application of the exemption to exports and imports is
clarified.
2.2.3.2 1.6.4.2 - The application of the exemption in medicinal products to
exports and imports is clarified.
- References to the authorisation requirement under REACH
are deleted to avoid misunderstandings.
2.2.3.4 1.6.4.4 - The example regarding Annex V exemption has been
deleted. A reference to the <strong>Guidance</strong> on Annex V is introduced
instead.
2.2.3.5 1.6.4.5 - Reference to the criteria to determine the sameness of
substances has been introduced.
- The requirements to benefit from the exemption in the case
of recovered substances are further clarified.
- Additional information on the <strong>Guidance</strong> on waste and
recovered substances is added.
2.2.3.6 1.6.4.6 - Reference to the criteria to determine the sameness of
substances has been introduced.
- The conditions to benefit from the exception regarding the
supply chain of the re-imported substance have been clarified.
- Reference to the requirements regarding information in the
supply chain has been introduced.
2.2.3.7 1.6.4.7 - A definition of polymer is provided.
- The conditions for the registration of monomers are
explained.
2.2.3.8 1.6.4.8 - The title has changed.
- The threshold of one tonne per year for PPORD notification is
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