Period After Opening

Period after opening
PAO
Wolfgang Siegert
Special Additives International
Norderstedt, Germany
Wolfgang.Siegert@schuelke.com
www.schuelke.com
07.10.2011 | Period after opening.ppt | Copyright Schlke & Mayr GmbH | Page 2
Life cycle of a cosmetic
production
6 hours
bulk storage
2 weeks
filling
2 hours
storage
30 month
= high risk of contamination = no risk of contamination
6 month
PAO
PERIOD AFTER OPENING
PAO
THE LEGAL REQUIREMENT
PRODUCTS WITH MIN. DURABILITY PRODUCTS WITH MIN. DURABILITY 30 M: 30 M:
- - date of minimum durability: date of minimum durability: best before best before
or best by or best by . .
APPLICABLE TO PRODUCTS PLACED ON APPLICABLE TO PRODUCTS PLACED ON
THE EU MARKET AFTER 11 MARCH 2005 THE EU MARKET AFTER 11 MARCH 2005
PRODUCTS WITH MIN. DURABILITY > 30 M: PRODUCTS WITH MIN. DURABILITY > 30 M:
- - period after opening period after opening
for which the product can be used without any harm to the for which the product can be used without any harm to the
consumer consumer
PAO
MUST BE PRINTED ON BOTH THE CONTAINER AND THE MUST BE PRINTED ON BOTH THE CONTAINER AND THE
OUTER PACK OUTER PACK
MUST BE INDELIBLE, LEGIBLE AND VISIBLE BUT NO MUST BE INDELIBLE, LEGIBLE AND VISIBLE BUT NO
SPECIFICATIONS RE. SIZE AND/OR COLOUR SPECIFICATIONS RE. SIZE AND/OR COLOUR
NO OFF NO OFF- -PACK LABELLING POSSIBLE PACK LABELLING POSSIBLE
INTERPRETATION OF SCOPE
PAO
SYMBOL
Published in September 2003 Published in September 2003
30M 30M
30M 30M
30M
PAO
What means:
can be used without harm to the consumer
Mainly the microbiologically stability
Be careful with sun care products!
PAO
Can a challenge test guarantee a PAO?
It can guarantee a microbiologically
stability in a closed package
Label an expiring date
Avoid a PAO
PAO
What will influence the PAO?
Stability of preservative
Type of packaging
Consumer habits
Storage conditions after opening
PAO
How to guarantee (test) a PAO?
Produce a cosmetic product
Store it for at least 30 month
Perform an in-use test for the intended PAO
Check the microbiological quality
at the end of the test
PAO
Discussed short cuts
Test retain sample with a similar
preservative system in an in-use test
Extrapolate the results to a new formulation
PAO
Test retain sample with a similar
preservative system after storage
in a challenge test
PAO
Analyse in a retain sample with a similar
preservative system after storage
the amount of retained preservative
PAO
Fixing of the PAO based on:
Microbiological challenge tests
Analytical data (e.g. analyses of preservatives)
Type of packaging
Experience with similar recipes and product
Complaint statistics
Consumer habits and practices
PAO
PAO
Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC)1:
LABELLING OF PRODUCT DURABILITY: PERIOD OF TIME AFTER OPENING
http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/wd-04-entr-cos_28_rev_version_adoptee20040419_en.pdf
A variety of relevant methods may be used to support the period indicated on a
product, including those used during product development, since there is no
officially sanctioned methodology that could be used.
Examples of sources of information for assessing a products PaO may include:
- microbiological challenge tests
- stability data
- analytical data (e.g. preservative analysis)
- type of packaging
- experience with similar formulations and products
- consumer habits and practices.
PAO
QUESTIONS/ANSWERS ON THE PERIOD OF TIME AFTER OPENING
Based on the document adopted on 19 April 2004 by the Cosmetic Products Working Party
04/ENTR/COS/28
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/periodafteropeninglabel_qa_2005_2_en.pdf
Is the period of time after opening indicated on all cosmetic products?
The period of time after opening must be indicated on products with a shelf life
of 30 months or more. For products with a shelf life of 30 months or less the
minimum shelf life must be stated; i.e. the date up until which the product, kept
under the right conditions, can continue to fulfil its initial function without any
harm to human health.
The new labelling will not cover:
- products not at risk of deterioration;
- products which do not open (such as products in sealed packaging, or sprays)
- or products which are intended to be used only once.

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