REGUL ATIONS
Overview of the
Product Information File
Regulation (EC) No 1223/2009 came into
full force on 11 July 2013. It repealed
Directive 76/768/EEC which had existed
in parallel between January 2010 and July
2013. The requirement for manufacturers
and importers to hold product information
was first introduced by the 6th Amendment
to the cosmetic directive (Directive
93/35/EEC). Further requirements were
added in the 7th Amendment (Directive
2003/15/EC). The 7th Amendment
introduced further requirements related
to: the safety assessment of cosmetic
products for children and of products
for external intimate hygiene; data on
animal testing; and information on product
composition and on undesirable effects to
be made easily accessible to the public.
Regulation (EC) No 1223/2009 goes
further by requiring a product information
file to be kept for 10 years for each
product placed on to the market.1
The product information file builds on the
product information required under the
directive but requires a cosmetic product
safety report instead of a cosmetic safety
assessment. The information that the
cosmetic safety assessor must consider
is specified in Annex I of Regulation (EC)
No 1223/2009. The product information
file has a different structure to the product
information required under the directive.
The requirement for publicly available
information is retained.
Responsible person
The responsible person is required by
Regulation (EC) No 1223/2009 to keep
and have access to a product information
file for each product placed on the market.
The product information file should be kept
for a period of 10 years following the date
on which the last batch of the cosmetic
product was placed on the market.1
The responsible person has the duty of
maintaining the product information
file as specified by Article 11 of Regulation
(EC) No 1223/2009. The information in
the product information file should include
that required by the safety assessor to
complete the cosmetic product safety
report. Regulation (EC) No 1223/2009
10 P E R S O N A L C A R E September 2014
Dr Martin Perry, Dr Roger Pengilly SGS, UK
requires that the responsible person is able
to make the product information file readily
available to the competent authority of the
member state in which the file is kept at
the address stated on the label. The
product information file can be in electronic
form or other format. The responsible
person should ensure that the product
information file is readily available in
a language easily understood by the
competent authority of the member state.
What should the
PIF contain?
Regulation (EC) No 1223/2009 states in
Article 11 that the product information file
should contain:
w A description of the cosmetic product
which enables the product information
file to be clearly attributed to the
cosmetic product.
w The cosmetic product safety report.
w A description of the method of
manufacturing and a statement on
compliance with good manufacturing
practice. Good manufacturing practice is
covered in Article 8 of the Regulation.
w Where justified by the nature or the
effect of the cosmetic product, proof of
the effect claimed for the cosmetic
product.
www.morguefile.com
ABSTRACT
Regulation (EC) No 1223/2009 requires
that a product information file is kept
for every cosmetic product placed onto
the market within the European Union.
This article looks at the requirements
that this regulation sets for the product
information file and what it needs to
include.
w Data on any animal testing performed
by the manufacturer; his agents or
suppliers, relating to the development
or safety assessment of the cosmetic
product or its ingredients, including any
animal testing performed to meet the
legislative or regulatory requirements of
third countries.
Description of the cosmetic product
Regulation (EC) No 1223/2009 requires
that the product information file contains
a description of the product which enables
the product information file to be clearly
attributed to the cosmetic product.
The Colipa2 guidelines state that the
product information file should include: the
exact product name; an internal reference
that uniquely identifies the product and
formulation; and a description of the
products function, if it is not obvious from
the product name. The product name
should be consistent with the product
name used when notifying the product on
the cosmetic product notification portal.
Colipa guidelines recommend that the
product notification reference number
is included in the product description.3
Cosmetic Product Safety Report
The product information file must contain
a cosmetic product safety report which
meets the requirements of Regulation (EC)
No 1223/2009. Annex I of Regulation (EC)
No 1223/2009 specifies what a cosmetic
product safety report should contain.
Any information required by the cosmetic
safety assessor for the cosmetic product
safety report should be included in the
product information file.

Method of manufacture and GMP
The product information file should contain
a brief description of the manufacturing
process. According to the Colipa guidelines
the method of manufacture should
contain a brief overview of the method of
manufacture including bulk storage and
filling and should be applicable to the
manufacturing sites concerned.4 As well as
a summary of the manufacturing process
the Colipa guidelines also state that the
product information file should contain
references to the manufacturing
documentation used to manufacture
the cosmetic product.
Article 8 of Regulation (EC) No
1223/2009 requires that the manufacture
of cosmetic products comply with good
manufacturing practice (GMP) to ensure
that products are safe to human health.
Compliance is presumed if the product
is manufactured in accordance with
the relevant harmonised standards.
The European Commission has accepted
EN ISO 22716:2007 as a relevant
harmonised standard.5
Companies must demonstrate
compliance by including a statement on
good manufacturing practice in the product
information file. Regulation (EC) No
1223/2009 does not require that good
manufacturing practice is proved by
certification or auditing by third parties
however auditing and certification could be
one of the ways used to demonstrate good
manufacturing practice. Regulation (EC)
No 1223/2009 requires that member
states monitor compliance with the
principles of good manufacturing practice.
Proof of effect and claims
Any claims made for a cosmetic product
must be substantiated. The technical
data collected when substantiating the
claim must be kept within the product
information file. If it is not possible to
hold the actual data within the product
information file then this technical data
must be referenced within the product
information file. This applies to claims
made for the product irrespective of
the communication medium or type of
marketing tool used and irrespective of
the target audience.4
The European Commission have
determined that claims for cosmetics
must meet the following six criteria: legal
compliance; truthfulness; evidential
support; honesty; fairness; and informed
decision-making.6,7
Responsibility for substantiating claims
rests with the responsible person. It is their
responsibility to ensure that the means of
substantiating the claim is adequate and
appropriate for the product. In cases where
the effect of the product is obvious (e.g.
shampoo to wash hair) there is no need to
include data on the performance of the
product. If claims such as sun protection
factor (SPF) are made then this claim will
need substantiating and the data kept
in the product information file.
Animal testing
The 7th Amendment8 of Directive
76/768/EEC established a regulatory
framework for the phasing out of testing
of cosmetics on animals. The regulatory
framework has also been incorporated into
Regulation (EC) No 1223/2009 which
has replaced directive 76/768/EEC as
amended. Article 18 of Regulation (EC) No
1223/2009 details what animal testing is
prohibited, and the dates by when it should
be phased out. Article 11 of Regulation
(EC) No 1223/2009 requires that the
product information file contains any data
on animal testing performed by the
manufacturer, his agents or suppliers.
This applies to both the ingredients and
the finished product and relates to both
the development and safety assessment
of these. The product information file
should also include details of any animal
testing performed to meet the legislative
and regulatory requirements of countries
outside the European Union. This
information should be open to inspection
by the competent authorities. Colipa9
guidelines interpret this to mean any
animal testing performed by the
manufacturer, his agents or supplier on
cosmetic products and ingredients after
11 September 2004. Companies should
contact their suppliers to ensure they are
kept fully informed of any animal testing.
PIF structure
Regulation (EC) No 1223/2009 does not
specify in what format the product
information file is stored. The product
information file does need to have a
structure. It should contain or reference all
REGUL ATIONS
the information that is required for the
cosmetic product safety report. The product
information could include the following
information: product description; formulation
(INCI names, CAS, EINECS/ELINCS
numbers) and percentages; method of
manufacture; product specification; stability
report, microbiological specification;
preservative efficacy (challenge) test report
where applicable; packaging specification
including materials used to make packaging;
allergen declaration for fragrances; IFRA
statement for fragrances; animal testing
statement including any testing carried out
to meet the regulatory requirements of
countries outside the European Union; good
manufacturing practice (GMP) statement or
certificate; declarations; claims
substantiation; notification on cosmetic
product notification portal documentation;
cosmetic product safety report; material
safety data sheets (MSDS) for raw
ingredients; dermatological testing if
applicable; label and pack copy; other (for
additional information).
Labelling
Article 19 of Regulation (EC) No
1223/2009 on the labelling of cosmetic
products requires that the name and
address of the responsible person is on
the container and packaging of cosmetic
products. If more than one address is
present then the one where the responsible
person makes readily available the product
information file must be highlighted. This is
often done by underlining this address.
Language
The product information file should be
available in a language easily understood by
the competent authority. This would
normally be in the national language(s) for
the country where the product information
file is held, unless it has been established
that the competent authority is willing to
accept another language. This applies to all
September 2014 P E R S O N A L C A R E 11
 REGUL ATIONS
the information covered under Article 11.2
ae. Any supporting documentation such
as laboratory reports, letters or publications
etc can be retained in the language in
which they were written providing it is
an official EU language.10 There is not a
requirement to have these documents
translated into a language easily
understood by the competent authority but
the contents of these documents may need
to be explained to the competent authority.
Access to information
for the public
The product information file is the
intellectual property of the responsible
person. However Regulation (EC) No
www.morguefile.com
1223/2009 requires that some of the
information in the product information file
is made accessible to the public. Article 21
of Regulation (EC) No 1223/2009 requires
that the following are made accessible
to the public by any appropriate means:
qualitative and quantitative composition of
the cosmetic product; the name, code
number and identity of the supplier of any
perfume or aromatic composition; and any
data on undesirable effects and serious
undesirable effects from using the cosmetic
product. Consumers should be able to
contact the responsible person to request
access to this information using the
contact details printed on the products
label or packaging.
Qualitative and quantitative composition
of the product includes the list of
ingredients as labelled on the cosmetic
product and percentage concentrations of
those ingredients in the product which are
listed in Annex VI of Regulation 1272/2008
(the regulation on Classification and
labelling of substances and mixtures, also
known as CLP)11 and in the classification
and labelling inventory published by ECHA.
According to the Colipa guidelines the
percentage concentrations can be rounded
up and indicated as <x % or alternatively
as a range xy% in order to protect
commercial secrecy and intellectual
property rights.12
Regulation (EC) No 1223/2009 defines
an undesirable effect as an adverse
reaction for human health attributable to
the normal or reasonably foreseeable use
of a cosmetic product.13 The undesirable
effect suffered by the person needs to be
directly linked to the use of the cosmetic
product. The Colipa guidelines state that
anecdotal or ambiguously reported effects
or those related to the abuse or misuse
of the product are not classified as
undesirable effects.
Serious undesirable effects are
undesirable effects which result in
temporary or permanent functional
incapacity, disability, hospitalisation,
12 P E R S O N A L C A R E September 2014
congenital anomalies or an immediate
vital risk or death.13 Colipa advises that
companies should calculate the number of
undesirable effects or serious undesirable
effects per million units placed on the
market in countries of the European Union.
Where the number of units placed on the
market is small the actual number of
undesirable effects reported should be
provided.14
Details of the undesirable effects
reported by consumers to the responsible
person should also be shared with the
cosmetic safety assessor so that the
cosmetic product safety report can be
updated.
Location and access to
product information file
The public have no rights in law to have
access to the product information file.
The competent authority of the member
state in which the product information file
is kept have a right to see the product
information file. The responsible person is 6 Commission Regulation (EU) No 655/2013.
required to make the product information
file readily available at the address stated
on the product label. The product
information file can be in electronic or
other format. Where there is more than
one address on the label the address
where the responsible person makes
readily available the product information
file shall be highlighted (e.g. underlined).
If the product is manufacture outside
the European Union the product
information file must be accessible at
the address on the label. Any supporting
information for the product information
file if not held at the address where the
product information file is kept must be
readily accessible.
The interpretation of readily available
differs amongst member states. In some
countries the competent authority expects
the product information file to be
immediately available, in other countries
the responsible person is expected to make
available the product information file within
72 hours of receiving the request from the
competent authority. In France the product
information file must be immediately
available, it is not acceptable that the
product information file is held at a sub-
contractors address. In Italy there is some
uncertainty as to what readily available
means. The time period under Directive
76/768/EEC was up to 72 hours and this
is being used at present. In Spain readily
accessible is interpreted to be 2-3 days.
Competent authorities from other
member states do not have a right to
access the product information file. Instead
they have to request the competent
authority of the member state where the
product information file is held to check
the product file for compliance with Article
11(2) of Regulation (EC) No 1223/2009
and for evidence that the product is safe.
Conclusion
This article has been written as a guide
as to what should be in the product
information file. We have made some
suggestions as to what may be contained
within the product information file.
Product information files must comply
with the requirements of Regulation (EC)
No 1223/2009. PC
References
1 Regulation (EC) No 1223/2009, Article 11.
2 Colipa guidelines on the product information file
requirement, page 9.
3 Colipa guidelines on the product information file
requirement, page 17.
4 Colipa guidelines on the product information file
requirement, page 20.
5 Official Journal of the European Union, 21 April
2011; Vol. 54: C 123/3.
7 Guidelines to Commission Regulation (EU)
No 655/2013.
8 Directive 2003/15/EC.
9 Colipa guidelines on the product information file
requirement, page 22.
10 Colipa guidelines on the product information file
requirement, page 12.
11 Regulation (EC) No 1272/2008 of the European
Parliament and of the council of 16 December
2008 on classification, labelling and packaging of
substances and mixtures (CLP), amending and
repealing Directives 67/548/EEC, and amending
Regulation (EC) No 1907/2006.
12 Colipa guidelines on the product information file
requirement, page 23.
13 Regulation (EC) No 1223/2009, Article 2.
14 Colipa guidelines on the product information file
requirement, page 24.