Diapositive 1

Report
PRODUCT INFORMATION FILE
R. MONTIGNY
Regulatory Advisor
International Scientific Regulatory Affairs , L’OREAL
Cosmetic PIF, Notification, GMP Management Workshop – TAPEI 4th December 2012
PRODUCT INFORMATION FILE
1.
2.
3.
History
Regulatory provisions
Guidelines for PIF
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HISTORY
- Started with implementation of the EU cosmetic
Directive in 1976
- Based on the principles that :
 Cosmetic products must be safe and
safety is the responsibility of the Manufacturer
 Authorities should control the conformity of
marketed products
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PRODUCT INFORMATION FILE
Cosmetic products must be safe: this is the main
principle of this regulation.
“Cosmetic products shall not damage human health
under normal or reasonably foreseeable conditions
of use ”
(art.2 of the EU Cosmetic Directive)
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Authorities should survey or monitor marketed
products:
Member States shall take all measures necessary to
ensure that, in the labeling, putting up for sale and
advertising of cosmetic products, text, names, trade
marks, pictures and figurative or other signs are not
used to imply that these products have characteristics
which they do not have.
(art. 6 - § 3 of the EU Cosmetic Directive )
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PRODUCT INFORMATION FILE
Further in the text of the EU Cosmetic Directive 76/768
exists a provision that sets the basis of the “product
Information file” although this official name is not yet
adopted:
The manufacturer … responsible for placing … cosmetic
product on the Community market shall for control
purposes keep the following information readily
accessible to the competent authorities …
(Art. 7a of the EU Cosmetic Directive)
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PRODUCT INFORMATION FILE
(a) the qualitative and quantitative composition of the
product; in the case of perfume compositions and
perfumes, the name and code number of the
composition and the identity of the supplier;
(b) the physico-chemical and microbiological
specifications of the raw materials and the finished
product and the purity and microbiological control
criteria of the cosmetic product;
(Art. 7a of the EU Cosmetic Directive)
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(c) The method of manufacture complying with the good
manufacturing practice laid down by Community law
or, failing that, laid down by the law of the Member
State concerned;
(d) Assessment of the safety for human health of the
finished product. To that end the manufacturer shall
take into consideration the general toxicological
profile of the ingredients, their chemical structure and
their level of exposure.
(Art. 7a of the EU Cosmetic Directive)
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PRODUCT INFORMATION FILE
(e) The name and address of the qualified person or
persons responsible for the assessment referred to
in (d)
(f) Existing data on undesirable effects on human
health resulting from use of the cosmetic product;
All these information should be kept readily available
at the address specified on the label in accordance with
Article 6 (1)
(Art. 7a of the EU Cosmetic Directive)
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All these information were known as “The Product
Dossier” in the industry jargon.
In 2007 a revision (or “recast”) of the EU Cosmetic
Directive 76/768 EEC was undertaken by the EU
authorities and achieved in 2009. It is named the
Regulation (EC) No 1223/2009 it is going to enter
into force next year with more detailed provisions and
duties for industry and authorities. In this new
regulation, The “Product Dossier” becomes the
Product Information File.
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PRODUCT INFORMATION FILE
The spirit of the former Directive 76/768 is
maintained in the new Cosmetic Regulation EC No
1223/2009
Safety of cosmetic products remains always the most
important principle:
“A cosmetic product made available on the market
shall be safe for human health when used under
normal or reasonably foreseeable conditions of
use…”
(EU Cosmetic Regulation No 1223/2009 Art. 3)
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An important set of Definitions helps to clarify the
meaning of the terms used in the articles such as:
Cosmetic products,
Substance,
Mixture,
Manufacturer,
Distributor,
Making available on the
market,
Placing on the market,
Importer,
Harmonized Standards,
Responsible persons,
Safety Assessor,
Undesirable effect, etc…
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Examples of definitions:
Distributor:
any natural or legal person in the supply chain, other than
the manufacturer or the importer, who makes a cosmetic
product available on the Community market. (Art 2.1 (e))
Importer: any natural or legal person established within
the Community, who places a cosmetic product from a
third country on the Community market. (Art 2.1 (i))
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Examples of definitions:
Placing on the market: the first making available of a
cosmetic product on the Community market. (Art 2.1
(h))
Making available on the market: any supply of a
cosmetic product for distribution, consumption or use
on the Community market in the course of a
commercial activity, whether in return for payment or
free of charge. (Art 2.1 (g))
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Examples of definitions:
In the EU the right to market a cosmetic product in
conformity to the regulation relies on the responsibility
of the marketer. Responsibility is a very important
burden and plays a major role. Provision for defining
the layout of the responsibility frame is necessary:
“Only cosmetic products for which a legal or natural
person is designated within the Community as
‘responsible person’ shall be placed on the market”.
(EU Cosmetic Regulation No 1223/2009 Art. 4-1)
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Examples of definitions:
Responsible person: is a legal or natural person
based within the Community who is responsible for
the placing on the EU market of a cosmetic product
and who has been designated as such. The
responsible person shall ensure compliance with
the relevant obligations set out in the Regulation.
(Art.4 1 and 4.2). The responsible person can be
one of the following:
• Manufacturer within the EU
• Person designated by a manufacturer from outside
the EU
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PRODUCT INFORMATION FILE
Responsible person can be:
• A Distributor if he modifies a product already on the
market in such a way that compliance with the
Regulation may be affected (according to Article. 4.6)
or if he places a cosmetic product on the Community
market under his name or trademark
• An Importer(s) (according to Article 4.5)
• A Third party with a written mandate from
manufacturer or importer. Additional information on
the identification of the Responsible Person can be
found in Cosmetics Europe’s Guidance Document on
Roles & Responsibilities along the supply chain.
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Responsible persons shall cooperate with authorities …
Is the first point of contact for the enforcement authorities
should there be any enquiry on the product he has placed
on the market. In particular, responsible persons shall,
further to a reasoned request from a competent national
authority, provide it with all the information and
documentation necessary to demonstrate the conformity
of specific aspects of the product, in a language which
can be easily understood by that authority.
(EU Cosmetic Regulation No 1223/2009 Art. 5-3)
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PRODUCT INFORMATION FILE
The new EU Cosmetic Regulation (EC) No 1223/2009 has
dedicated a specific chapter for Product Information file,
under the article 11:
“When a cosmetic product is placed on the market, the
responsible person shall keep a product information
file for it. The product information file shall be kept for
a period of ten years following the date on which the
last batch of the cosmetic product was placed on the
market.”
(EU Cosmetic Regulation No 1223/2009 Art. 11-1)
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PRODUCT INFORMATION FILE
The product information file shall contain the
following information and data which shall be
updated as necessary:
(a) a description of the cosmetic product which
enables the product information file to be
clearly attributed to the cosmetic product;
(b) the cosmetic product safety report referred to in
Article 10(1);…
(EU Cosmetic Regulation No 1223/2009 Art. 11-2)
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(c) a description of the method of manufacturing and a
statement on compliance with good manufacturing
practice referred to in Article 8;
(d) where justified by the nature or the effect of the
cosmetic product, proof of the effect claimed for the
cosmetic product;
(EU Cosmetic Regulation No 1223/2009 Art. 11-2)
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(e) 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.
(EU Cosmetic Regulation No 1223/2009 Art. 11-2)
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PRODUCT INFORMATION FILE
The responsible person shall make the product
information file readily accessible in electronic or other
format at his address indicated on the label to the
competent authority of the Member State in which the
file is kept.
The information contained in the product information file
shall be available in a language which can be easily
understood by the competent authorities of the Member
State.
(EU Cosmetic Regulation No 1223/2009 Art. 11-3)
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Readily accessible:
The P.I.F. should be available to control officers at the
address of the responsible person labeled (or, in case of
several addresses, highlighted) on the product, within a
reasonable time period (e.g. 72 hours). Whilst many
items may be rapidly accessible through electronic
media, there may be a short delay when information is
accessed by other means.
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PRODUCT INFORMATION FILE
Format and language of the P.I.F.
The Regulation requires the P.I.F. to be kept in
electronic format or any other format (e.g. paper),
as long as it is readily accessible to the competent
authority in the Member State where the P.I.F is kept.
The text concerning the language used for the P.I.F.
states that the information should be easily
understood by the controlling officer when he/she
comes to verify the P.I.F. in the country where it is
kept.
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PRODUCT INFORMATION FILE
Format and language of the P.I.F.
Therefore, it is obviously in the interest of the company
concerned to make the P.I.F. available in the national
language(s) for the country where the P.I.F is held,
unless it has been previously established that the
competent authority is equally willing to accept another
language. In many Member States, English will be “a
language easily understood by the competent
authorities”.
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PRODUCT INFORMATION FILE
Location of and access to the P.I.F.
Thus, the point of access to the P.I.F. for the competent
authorities is the address of the responsible person
specified on the packaging of the marketed product.
This address must be indicated on the product, as
required under Article 19.1a of the Regulation:
Each company may choose a single place within the
EU where the complete P.I.F. is accessible. This place
need not be a manufacturing site.
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PRODUCT INFORMATION FILE
Location of and access to the P.I.F.
Where there is more than one address on the
packaging of a marketed product, the single point of
access to the P.I.F. must be highlighted (e.g.
underlined). In the case of a product manufactured
outside the EU, the P.I.F. must be accessible within the
EU at the address on the label. If an abbreviated
address is used on the label, it must be sufficient to
allow the identification of and the access to the
undertaking. The address may be abbreviated to a wellknown city or town such that the normal postal service
will deliver a letter to that address.
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Location of and access to the P.I.F.
Example of address:
This address
(underlined)
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Location of and access to the P.I.F.
As the P.I.F. must be “readily accessible”, authorities
will expect that it is made available within a
reasonable period of time even if it does not have to be
physically kept at the point of access
Should the authorities request additional information,
such as further supporting documentation, this may
take a few days to be made available.
The support documentation for the P.I.F. may also not
necessarily be on company premises, e.g. it could be
at the office of a contract laboratory or consultant. It
can also be kept outside the EU.
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PRODUCT INFORMATION FILE
Location of and access to the P.I.F.
The accessibility of the documentation has to be
assured. The P.I.F. is accessible in one of the Member
States, at the discretion of the responsible person.
Should a justified request for information be made by
another Member State, such a request is transmitted
through the competent authorities of the country
where the P.I.F. is accessible. These competent
authorities will report the results of their consultation
to the competent authority of the EU Member State
which made the request.
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Location of and access to the P.I.F.
Any authority that is given access to such information
must keep it confidential. Making the P.I.F. readily
accessible does not imply providing copies of any part of
the information to control officers. Under Article 5.3, in
the exceptional case of a reasoned (i.e. motivated)
request from a national competent authority, the
responsible person shall provide it with particular pieces
of information and documentation necessary to
demonstrate that specific aspects of the product are in
compliance with the Regulation.
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Location of and access to the P.I.F.
Ownership of all data comprising the PIF, either as
hard copy or electronically, remains the property of the
responsible person. It should not be expected that an
enforcement officer removes from the premises of the
responsible person any documents of the P.I.F..
However, if there are reasonable grounds to suspect
an offence has been committed the officer may have
the power to require the responsible person to produce
any records relating to his business and seize and
detain goods or records.
(EU Cosmetic Regulation No 1223/2009 Art. 11-4)
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PRODUCT INFORMATION FILE
In short, the PIF is the mandatory compilation of
technical documentation required for each cosmetic
product to be placed on the market. According to the
EU Cosmetic Regulation 1223/2009/EC.
The elements of the PIF include but are not limited to:
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o
o
o
o
o
o
o
Product description and category
Safety report
Method of Manufacturing
Evidence of Compliance with GMP
Data on animal testing
Labeling
Data on serious undesirable health effects
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Product description and category :
- It should match the definition of the cosmetic product
laid in the regulation art.2 – (a). Actually this definition
did not change from that in the previous EU Cosmetic
Directive 76/768:
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Product description and category :
‘cosmetic product’ means any substance or mixture
intended to be placed in contact with the external parts
of the human body (epidermis, hair system, nails, lips
and external genital organs) or with the teeth and the
mucous membranes of the oral cavity with a view
exclusively or mainly to cleaning them, perfuming them,
changing their appearance, protecting them, keeping
them in good condition or correcting body odors’
(EU Cosmetic Regulation No 1223/2009 Art. 2-1 )
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Product description and category :
The assessment of whether a product is a cosmetic
product has to be made on the basis of a case-bycase assessment, taking into account all
characteristics of the product.
The cosmetic products may include the following :
(EU Cosmetic Regulation No 1223/2009 Preamble 7)
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PRODUCT INFORMATION FILE
Product description and category :
Creams1, Emulsions2, Lotions3, Gels and Oils for the
skin4, Face masks5, Tinted bases (liquids, pastes,
powders)6, Make-up powders7, After-bath powders8,
Hygienic powders9, Toilet soaps10, Deodorant soaps11,
Perfumes12, Toilet waters and Eau de Cologne13, Bath
and Shower preparations (salts, foams, oils, gels)14,
Depilatories15, Deodorants and Antiperspirants16, Hair
colorants17…
(EU Cosmetic Regulation No 1223/2009 Preamble 7)
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Product description and category :
…products for Waving18, Straightening and Fixing hair19,
Hair-setting products20, Hair-cleansing products (lotions,
powders, shampoos)21, Hair-conditioning products
(lotions, creams, oils)22, Hairdressing products (lotions,
lacquers, brilliantines)23, Shaving products (creams,
foams, lotions)24, Make-up and products removing
Make-up25, products intended for application to the
Lips26, …
(EU Cosmetic Regulation No 1223/2009 Preamble 7)
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Product description and category :
products for Care of the Teeth and the Mouth27 ,
products for Nail care and Make-up 28, products for
External Intimate hygiene29 , Sunbathing products 30,
products for Tanning without sun31 , Skin-whitening
products32 and Anti-wrinkle products33.
(EU Cosmetic Regulation No 1223/2009 Preamble 7)
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Product description and category :
The text of Article 11.2 of the Regulation differs from
the text in the Cosmetics Directive. The emphasis of
Article 11.2 is on clearly relating the finished product
with the P.I.F. The P.I.F. should include the product
name, code name, identifying code or any other product
identifier that would enable the responsible person or
competent authority to attribute the P.I.F. to the
cosmetic product placed in market. For example,
formula numbers or code numbers used during the
development of the product should be cross-referenced
with the product name or other identifier.
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PRODUCT INFORMATION FILE
Product description and category :
in the case where a product notification has been
made, it is recommended to include this product
notification reference number in the product
description.
Companies may wish to include any local language
names for the product if marketed in other countries,
and a description of the product function if it is not
obvious from the product name. The product name
should be consistent with the name used for
notification according to Article 13.
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Access to information for the public
Some of information contained in PIF are linked to
another provision existing in the regulation: which
stipulate that it should be made accessible for the
public, one of it is
• Product identification- product name & company
name,
This obligation is with the responsible person. Its
presentation may be specifically adapted for the public,
and thus differ from that of the product information.
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Safety report:
The second set of information to consider for the
product information file is the Safety report.
Annex I of the Regulation 1223/2009 provides the list
of documents necessary to assemble the Safety report.
It is composed of two parts:
Part A - The safety information
Part B - The safety assessment
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
1. Quantitative and qualitative composition of the cosmetic
product.
The qualitative and quantitative composition of the
cosmetic product, including chemical identity of the
substances (incl. chemical name, INCI, CAS,
EINECS/ELINCS, where possible) and their intended
function.
This provision already existed in the Directive EU 76/768
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
2. Physical/chemical characteristics and stability of the
cosmetic product
The physical and chemical characteristics of the
substances or mixtures, as well as the cosmetic
product.
The stability of the cosmetics product under reasonably
foreseeable storage conditions.
This provision already existed in the Directive EU 76/768
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
3. Microbiological quality
The microbiological specifications of the substance or
mixture and the cosmetic product. Particular attention
shall be paid to cosmetics used around the eyes, on
mucous membranes in general, on damaged skin, on
children under three years of age, on elderly people and
persons showing compromised immune responses.
Results of preservation challenge test.
This provision already existed in the Directive EU 76/768
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
4. Impurities, traces, information about the packaging
material
The purity of the substances and mixtures.
In the case of traces of prohibited substances,
evidence for their technical unavoidability.
The relevant characteristics of packaging material, in
particular purity and stability.
(This provision did not exist in the Directive EU 76/768)
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Safety report
PART A – Cosmetic product safety information
5. Normal and reasonably foreseeable use
The normal and reasonably foreseeable use of the
product. The reasoning shall be justified in
particular in the light of warnings and other
explanations in the product labeling.
(This provision did not exist in the Directive EU 76/768)
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
6. Exposure to the cosmetic product
Data on the exposure to cosmetic product taking into
consideration the findings under Section 5 in
relation to:
1) The site(s) of application;
2) The surface area(s) of application;
3) The amount of product applied;
This provision already existed in the Directive EU 76/768: Art 7a-(d)
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
4) The duration and frequency of use;
5) The normal and reasonably foreseeable
exposure route(s);
6) The targeted (or exposed) population(s).
Potential exposure of a specific population
shall also be taken into account.
Similar provision already existed in the Directive EU 76/768: Art 7a-(d)
…/…
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Safety report
PART A – Cosmetic product safety information
The calculation of the exposure shall also take into
consideration the toxicological effects to be considered
(e.g. exposure might need to be calculated per unit area
of skin or per unit of body weight). The possibility of
secondary exposure by routes other than those resulting
from direct application should also be considered (e.g.
non-intended inhalation of sprays, non-intended ingestion
of lip products, etc.).
Particular consideration shall be given to any possible
impacts on exposure due to particle size
…/…
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
7. Exposure to the substances
Data on the exposure to the substances contained
in the cosmetic product for the relevant toxicological
endpoints taking into account the information under
Section 6.
Similar provision already existed in the Directive EU 76/768: Art 7a-(d)
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
8. Toxicological profile of the substances
Without prejudice to Article 18, the toxicological
profile of substance contained in the cosmetic
product for all relevant toxicological endpoints. A
particular focus on local toxicity evaluation (skin and
eye irritation), skin sensitisation, and in the case of
UV absorption photo-induced toxicity shall be made
Similar provision already existed in the Directive EU 76/768: Art 7a-(d)
.…/…
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
All significant toxicological routes of absorption shall
be considered as well as the systemic effects and
margin of safety (MoS) based on a no observed
adverse effects level (NOAEL) shall be calculated. The
absence of these considerations shall be duly
justified.
Similar provision already existed in the Directive EU 76/768: Art 7a-(d)
…/…
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
Particular consideration shall be given to any possible
impacts on the toxicological profile due to
— particle sizes, including nanomaterials,
— impurities of the substances and raw material used,
and
— interaction of substances.
Any read-across shall be duly substantiated and justified.
The source of information shall be clearly identified.
Similar provision less detailed already existed in the Directive EU 76/768: Art 7a-(d)
…/…
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
9. Undesirable effects and serious undesirable
effects
All available data on the undesirable effects and
serious undesirable effects to the cosmetic
product or, where relevant, other cosmetic
products. This includes statistical data.
“Undesirable effects” already existed in the Directive EU 76/768: Art 7a-(d)
Serious undesirable effect is a new requirement
This information has to be also accessible to
public
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PRODUCT INFORMATION FILE
Safety report
PART A – Cosmetic product safety information
10. Information on the cosmetic product
Other relevant information, e.g. existing studies from
human volunteers or the duly confirmed and
substantiated findings of risk assessments carried
out in other relevant areas.
(new requirement)
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PRODUCT INFORMATION FILE
Safety report
PART B – Cosmetic product safety assessment
1. Assessment conclusion
Statement on the safety of the cosmetic product in
relation to Article 3.
2. Labeled warnings and instructions of use
Statement on the need to label any particular
warnings and instructions of use in accordance with
Article 19(1)(d).
(new requirement)
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PRODUCT INFORMATION FILE
Safety report
PART B – Cosmetic product safety assessment
3. Reasoning
Explanation of the scientific reasoning leading to the
assessment conclusion set out under Section 1 and
the statement set out under Section 2. This
explanation shall be based on the descriptions set out
under Part A. Where relevant, margins of safety shall
be assessed and discussed.
(new requirement)
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PRODUCT INFORMATION FILE
Safety report
PART B – Cosmetic product safety assessment
There shall be inter alia a specific assessment for
cosmetic products intended for use on children under
the age of three and for cosmetic products intended
exclusively for use in external intimate hygiene.
Possible interactions of the substances contained in the
cosmetic product shall be assessed.
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PRODUCT INFORMATION FILE
Safety report
PART B – Cosmetic product safety assessment
The consideration and non-consideration of the
different toxicological profiles shall be duly justified.
Impacts of the stability on the safety of the cosmetic
product shall be duly considered.
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PRODUCT INFORMATION FILE
Safety report
PART B – Cosmetic product safety assessment
4. Assessor’s credentials and approval of part B
Name and address of the safety assessor.
Proof of qualification of safety assessor.
Date and signature of safety assessor.
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PRODUCT INFORMATION FILE
Guidelines on CPSR (Cosmetic product Safety Report)
CPSR represents the main element of PIF.
It is an expert report made of several components or
modules which may be stored in different databases.
The report should contain as a minimum all
information indicated in the headings mentioned here
above. Retrievable under the same headings or similar
for ease of the competent authorities.
It is, however, also understood that it may be sufficient
that under each heading a clear reference is made to
the document, in electronic or other format, which
contains the information and which is directly available.
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PRODUCT INFORMATION FILE
Guideline on Cosmetic product Safety Report (following):
The CPSR must be drawn up in a transparent way; it
must be well-argued and easily understandable. The
structure and the content of the CPSR should reflect
the requirements of Annex I. However, if the
information is not directly presented in the document, a
reference to another readily available source should be
provided. The safety assessor can, of course, use any
additional data, when relevant. If any of the information
required by Annex I is not provided, this should be duly
justified in the CPSR (e.g. preservation challenge test)
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PRODUCT INFORMATION FILE
Guideline on Cosmetic product Safety Report (following):
Part A of the CPSR aims at gathering the data
necessary to clearly identify and quantify, from the
identified hazards, the risks that a cosmetic product
may present to human health. The hazard may arise,
for example, from the raw materials, the manufacturing
process, the packaging, the conditions of use of the
product, microbiology, quantities used, the toxicological
profile of the substances, etc. If data are inadequate to
make a proper assessment, the safety assessor may
require additional tests to be carried out.
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PRODUCT INFORMATION FILE
Guideline on Cosmetic product Safety Report (following):
The official text requires that non-clinical studies used
for the assessment of safety should be carried out in
accordance with the principles of Good Laboratory
Practices (GLP). However, an existing safety study
should not be rejected purely on the grounds that it has
not been carried out to GLP standards. It is not
necessary to repeat such studies merely to meet P.I.F.
requirements.
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PRODUCT INFORMATION FILE
Guidelines on Cosmetic product Safety Report
(following):
Part B of the CPSR is a safety assessment leading to a
conclusion about the safety of the product. The
assessment conclusion should be a statement on the
safety of the cosmetic product in relation to the safety
requirement of Article 3 of the Regulation. In his or her
reasoning, the safety assessor must take into account
all hazards identified and the intended exposure
conditions of the product.
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PRODUCT INFORMATION FILE
Guidelines on Cosmetic product Safety Report (following):
This reasoning is based on the data compiled in part A
and takes into account the safety evaluation of
substances and/or mixtures (done by the Scientific
Committee for Consumer Safety, in case the
substances appear in the annexes to the Cosmetics
Regulation, by other competent scientific committees
or panels or by the safety assessor himself), and the
safety evaluation of the cosmetic product.
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PRODUCT INFORMATION FILE
Guidelines on Cosmetic product Safety Report (following):
Products intended for children under three years of age
and products intended exclusively for external intimate
hygiene do require special attention, particularly in light
of their specific exposure characteristics.
The safety assessor may be a company employee or a
consultant. The safety assessor need not necessarily
be based within the EU. Responsible person and
safety assessor should work closely together to ensure
that the safety of the product is properly assessed,
documented and kept up-to-date.
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PRODUCT INFORMATION FILE
Guidelines on Cosmetic product Safety Report (following):
The responsible person should gather all the necessary
information, as required by either Annex I – Part A or
the information should be gathered by the safety
assessor himself, at the request of the responsible
person. Safety assessors would generally be expected
to report to the senior management of a company to
preserve the essential independence and objectivity of
the safety function. The responsible person must
establish structures and processes in order to ensure
that the safety assessor is aware of possible changes
and information on undesirable effects, as listed above.
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Duties of the responsible person with regard to the P.I.F.:
To stress the importance of the “responsible persons”
his duties can be summarized as follows:
• ensure that a cosmetic product placed on the EU
market is safe for human health under normal or
reasonably foreseeable conditions of use;
• maintain specific information on the product that he
places on the market, as specified under Article 11
of EU Cosmetic legislation P.I.F.;
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PRODUCT INFORMATION FILE
Duties of the responsible person with regard to the P.I.F.:
• be in a position to demonstrate upon request that the
product he has placed on the market meets the
requirements laid down by the EU cosmetics legislation
(Article 5.3);
• ensure that the Cosmetic Product Safety Assessment
has been performed by a safety assessor, i.e. a person
with appropriate qualifications and expertise
considering the specific requirements described in
Annex I of the Regulation;
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PRODUCT INFORMATION FILE
Duties of the responsible person with regard to the P.I.F.:
• keep the product’s safety assessment as well as the
data upon which it is based as part of a “Cosmetic
Product Safety Report” in the P.I.F. and update it in view
of additional relevant information generated subsequent
to placing the product on the market (Article 10.1(c) of
the Regulation);
• ensure that he has a P.I.F. available in order to answer
the enquiries made by the competent authority where
the P.I.F. is kept and to bring evidence that the product is
in compliance with the Regulation;
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PRODUCT INFORMATION FILE
Duties of the distributor with regard to the P.I.F:
collaborate with the responsible person and the
national competent authorities whenever necessary
to ensure compliance with the Regulation (Articles
6(3), 23 and 26); for further details, please refer to
the Colipa guidelines on Roles & Responsibilities
along the supply chain.
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PRODUCT INFORMATION FILE
Guidelines on Cosmetic product Safety Report (following):
In order to enable undertakings, in (SMEs), to comply
with the requirements laid down in Annex I, the
Commission, will publish appropriate guidelines, as
stipulated by Article 10 (1) in its last subparagraph.
Further guidance on the safety assessment of cosmetic
ingredients and finished products is provided by the
SCCS Notes of Guidance for the Testing of Cosmetic
Ingredients and Their Safety Evaluation (7th revision,
SCCS/1416/11) and the forthcoming Commission
guidance on the Cosmetic Product Safety Report.
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PRODUCT INFORMATION FILE
Qualifications of the Safety Assessor
He or she should be a qualified person with a diploma in
a “similar discipline” could be, for example, a
veterinarian, a biochemist or a chemist with appropriate
background and experience. Further guidance on this is
expected from the European Commission. It is most
obviously in a company’s interest that the safety
assessment should be sound and supportable.
Safety assessor needs not to be in Europe.
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PRODUCT INFORMATION FILE
Safety Assessor (following):
It is recommended that substantial experience – in
addition to formal qualifications – may be appropriate
for this function to be adequately fulfilled. Training
programs on risk assessment exist at European as
well as at Member States‟ national level, some of
them particularly focusing on cosmetic products.
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PRODUCT INFORMATION FILE
Duties of the safety assessor with regard to the P.I.F.:
Assess the safety of the cosmetic product before it is
placed on the market; depending on his contractual
agreement with the responsible person, the safety
assessor may also have to:
• gather all the necessary information to document the
safety assessment as laid down in the Cosmetics
Regulation (Annex I)
• collaborate with the responsible person to ensure
that the safety assessment is readily accessible to
the competent authority and kept up to date.
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PRODUCT INFORMATION FILE
Other elements of the PIF :
Method of manufacture,
This would be expected to be a brief overview of the
method of manufacture including bulk storage and
filling and should be generally applicable to the
manufacturing site(s) concerned. There should be a
summary of the process and a cross-reference to the
detailed manufacturing documentation within any
specific manufacturing site.
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PRODUCT INFORMATION FILE
Other elements of the PIF :
Statement of compliance with GMP:
Regulation requires that the manufacture of cosmetic
products shall comply with cosmetic Good
Manufacturing Practices (GMP). The cosmetic GMP and
aspects of manufacture should be addressed and cross
reference should be made to the full cosmetic GMP
documentation at the manufacturing site concerned.
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PRODUCT INFORMATION FILE
Other elements of the PIF :
Statement of compliance with GMP:
Compliance will be presumed if GMP is in accordance
with an established harmonized standard published in
the Official Journal of the European Union. A
harmonized standard is defined in Article 2.1.j of the
Regulation as a standard adopted by one of the
European standardization bodies listed in Annex I to
Directive 98/34/EC.
One such example is the CEN ISO 22716
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PRODUCT INFORMATION FILE
Other elements of PIF:
Statement of compliance with GMP:
Compliance may also be demonstrated in other ways,
for example via a reference to industry-recognized
standards and codes. However, in such cases, there is
no automatic presumed compliance.
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Other elements of PIF:
Statement of compliance with GMP:
The Cosmetics Regulation does not require a
certification to be obtained; only compliance is
expected.
Companies must confirm compliance by including a
statement in the P.I.F. Furthermore, in Article 22 of
the Cosmetic Regulation, Member States are explicitly
required to monitor compliance with the principles of
GMP.
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PRODUCT INFORMATION FILE
Other elements of the PIF:
Proof of effect claimed
The P.I.F. should contain the technical data (or crossreferences, if the data are not part of the P.I.F.)
necessary for substantiating the claimed effect(s).
This concerns any claim made for a cosmetic
product, irrespective of the communication medium
or type of marketing tool used and irrespective of the
target audience (consumers, professionals, etc.).
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PRODUCT INFORMATION FILE
Other elements of the PIF:
Proof of effect claimed
The choice of the adequate and appropriate way to
substantiate a claim remains with the responsible
person and depends on the type of product, the
packaging, the claims and their context, etc. In cases
where the effect is obvious (e.g. lipsticks to colour the
lips or shampoos to wash the hair), there is no need to
include data on performance in the P.I.F..
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PRODUCT INFORMATION FILE
Other elements of the PIF:
Proof of effect claimed
In order to assist the cosmetics industry in its
compliance with the requirements of the Cosmetics
Regulation regarding the efficacy evaluation of
cosmetic products, Cosmetics Europe has issued
Guidelines for the Evaluation of the Efficacy of
Cosmetic Products (2nd rev., 2008). Because the
methodologically sound research is essential for the
efficacy evaluation, these Efficacy guidelines provide
an overview of established testing methodologies.
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PRODUCT INFORMATION FILE
Proof of effect claimed
Specific requirements existing for sunscreen products:
• Commission recommendation on the efficacy of
sunscreen products and the claims made relating
thereto. 22 September 2006 (2006/647/EC)
• In vivo determination of Sun Protection Factor (SPF) :
ISO Standard – (ISO 24444-2010). This International
Standard is applicable to products that contain any
component able to absorb, reflect or scatter
ultraviolet (UV) rays and which are intended to be
placed in contact with human skin.
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PRODUCT INFORMATION FILE
Proof of effect claimed
• Cosmetics Europe In vitro Method for Determination
of UVA protection, March 2011
Other elements of the PIF:
Data on animal testing:
The 7th Amendment of the Cosmetic Directive
established a regulatory framework with the aim of
phasing out animal testing (see now Article 18 of the
Regulation). “Data on animal testing” should be
interpreted as a list of tests carried out, including
information on the type of test.
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PRODUCT INFORMATION FILE
Data on animal testing:
The provision applies to any animal tests performed on
cosmetic products and ingredients after 11 September
2004, relating to the development or safety evaluation
of the product or its ingredients regardless of whether
the testing was carried out within the European Union.
The information is to be included in the Product
Information and is therefore open to inspection by the
competent authorities. The scope of this requirement is
not restricted to testing carried out in order to meet the
requirements of the Cosmetics Directive.
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PRODUCT INFORMATION FILE
Access to information for the public
Data on undesirable effect and serious undesirable
effect related to the product.
These are on a European basis information on the
frequency and nature of undesirable effects linked to
the product.
• Undesirable effect is an adverse reaction for human
health attributable to the normal or foreseeable use
of a cosmetic product.(Article 2 -1 (o))
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PRODUCT INFORMATION FILE
Access to information for the public
Data on undesirable effect and serious undesirable
effect related to the product.
There should be a demonstrable link between the
affected person and the product; undesirable effects
do not include anecdotal or ambiguously reported
effects or those resulting from abuse or misuse of the
product, and do not include those related to associated
items, such as the packaging.
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Access to information for the public
Data on undesirable effect and serious undesirable
effect related to the product.
• A ”serious undesirable effect” means an undesirable
effect which results in temporary or permanent
functional incapacity, disability, hospitalisation,
congenital anomalies or an immediate vital risk or
death (Article 2.1(p) of the Regulation).
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PRODUCT INFORMATION FILE
Access to information for the public
Data on undesirable effect and serious undesirable
effect related to the product.
In order to ensure consistent information to the public,
companies should generally compute a value for the
number of (serious) undesirable effects per million
units placed on the market (including all member
states but excluding non-EU markets). However, in
situations where the actual number of items placed on
the market is small (such as a recent launch or sale
through selective distribution), the actual number of
undesirable effects may be provided.
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Conclusion
As one can understand, PIF in the EU is a comprehensive
set of information which can hardly take the shape of a
common “file”. Information are disseminated in various
places and accessible by electronic means. PIF is a
concept which is intimately linked to the spirit of the
legislation where the responsibility of compliance to the
regulation lays entirely in the hands of the responsible
person. It is fit to work in a regulatory system based on
the principle of post marketing surveillance.
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