CTPA Annual Report 2012 - page 17

CTPA Annual Report
CTPA Seminar on the EU Cosmetics Regulation
1-2 March 2012 - Royal College of Physicians, London
Dr Emma Meredith followed with the communication of
Serious Undesirable Effects (SUEs). The RP and distributor
must report SUEs to the competent authority of the
Member State where the SUE occurred within 20 calendar
days. When a SUE is reported to the Competent Authority,
that authority has to alert the authorities in all other
Member States.
Emma introduced the Commission draft guidance which has
been developed by PEMSAC (Platform European Market
Surveillance and Administrative Co-operation). Key to the
guidance is harmonised reporting of SUEs based on a
recognised causality assessment, to ensure any reported
undesirable event is linked with a cosmetic product.
The information on undesirable effects kept only applies to
those which have been classed as likely or highly likely to
be attributable to a product. All SUEs, other than those that
have been excluded from being related to a product, need to
be reported and kept in the PIF. Information on undesirable
effects, and especially SUEs, could affect the safety
assessment. Therefore, all should be considered by the
safety assessor as part of the Cosmetic Product Safety Report.
Amanda Isom presented the new Cosmetics Europe guidelines
on Product Information Files (PIFs) which have been revised
to provide practical advice on complying with the changes
under the Regulation. CTPA receives many queries relating to
the compilation of PIFs and Amanda highlighted some of the
frequently answered questions within her presentation.
To close the seminar, Dr John Hopkins, Director, Innovant
Research, and Stephen Kirk, Senior Manager – Toxicology,
Boots UK, reviewed the new requirements for the cosmetics
safety assessment and the Cosmetic Product Safety Report.
The new requirements are much more prescriptive in what
information needs to be gathered, what needs to be assessed
and how the assessment must be recorded in the report.
One major difference is that the reasoning of the safety
assessor in making his or her safety assessment must be
detailed in the report. This is not a check-box approach and
it must be based on a thorough evaluation of all data and
especially taking into account the weight of evidence.
John and Stephen covered every aspect of a safety
assessment according to the new requirements using
examples to illustrate their points where necessary.
Cosmetics Basics workshops 2012
“ Excellent update on cosmetic legislation,
very professional slides and presentations.
A very worthwhile course ”
CTPA member
Regulatory Director
“ Fantastic references for future
use. Really clear explanations
on all subjects ”
CTPA member
Own Brand Product Technologist
Another year of success for the CTPA Cosmetics Basics Workshops with more than
55 delegates attending the 4 sessions during 2012.
The CTPA Cosmetics Basics Workshops benefit a wide range of members including
manufacturers, brand owners, sub-contractors and retailers.
The format of each workshop provides an overview of the pertinent EU legislative requirements
for cosmetic products as well as giving members the opportunity to discuss specific issues
they are facing in their everyday job. It is an excellent way for members to learn more about
membership benefits and how to make the best use of CTPA services, including accessing the
right member of staff for confidential one-to-one advice.
The Cosmetics Basics Workshops have been updated for 2013 to incorporate the latest
changes to the legislative framework in Europe with the new EU Cosmetics Regulation
coming fully into force from 11 July 2013.
l to r -
Stephen Kirk
Dr John Hopkins
180 delegates from 89 companies
attended the CTPA seminar in March 2012
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