Short description of key points to manage the Product information file in the new Eu regulation 1223/09 for cosmetics

1. How to easy manage the Product
Information File for the EU cosmetic
regulation
Dr. Giulio Pirotta
Neovita consulting – neogiul@tin.it

2. PIF legal basis – regulation 1223/09
• Article 10 (safety assessment)
• Article 11 (product information file)
DIRECTIVE
REGULATION
Concept - General content- Public
availability of certain information
concept - general content
- Public availability of certain
information
Info available
Structure and level of detail
Safety Statement
Reasoning for safety assessment
Collection of data
Cosmetovigilance
G. Pirotta - neogiul@tin.it

3. Definitions
Cosmetic product
• 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 odours.
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.
Placing on the market
• the first making available of a cosmetic product on the Community market.
Importer
• any natural or legal person established within the Community, who places a
cosmetic product from a third country on the Community market
G. Pirotta - neogiul@tin.it

4. Definitions
Product Information File
• information to meet the requirements of Article 11 of the
EC Regulation.
• minimum set of information listed ANNEX I
Readily accessible
•
•
•
•
accessible to the competent authority of the Member State
electronic or other format
language easily understood by the competent authority.
available at the address of the responsible person labelled
on the product
• within 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.
G. Pirotta - neogiul@tin.it

5. Responsible person
Definitions
• 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.
Safety assessor
• a natural person who carries out the cosmetic product Safety
Assessment, and who is in possession of a diploma or other
evidence of formal qualifications awarded on completion of a
university course of theoretical and practical study in pharmacy,
toxicology, medicine or similar discipline, or a course recognised as
equivalent by a Member State.
Cosmetic Product Safety Report (CPSR)
• part of the Product Information File, documentation showing that a
safety assessment has been conducted. The CPSR shall, as a
minimum, contain the information requested in Annex I of the
Cosmetics Regulation
G. Pirotta - neogiul@tin.it

6. The Responsible Person must
• Ensure that a cosmetic product placed on the EU
market is safe for human health
• Maintain the Product Information File
• demonstrate, upon request, that the product placed on
the market meets the requirements of the Regulation;
• Ensure safety assessment performed by qualified
safety assessor
G. Pirotta - neogiul@tin.it

7. The Responsible Person must
• Keep the product’s safety assessment and the data
as part of the Cosmetic Product Safety Report in the
P.I.F. and update it according to relevant new data;
• Ensure the P.I.F. available for control authorities;
• Be the first point of contact for authorities
G. Pirotta - neogiul@tin.it

8. The safety assessor must
• Assess the safety of the cosmetic product before
it is placed on the EU market;
• may also have to gather all the necessary
information to document the safety assessment;
• May cooperate with the responsible person to
ensure the safety assessment is readily accessible
to the competent authority and up-to-date.
G. Pirotta - neogiul@tin.it

9. PIF – expiry date
Retained 10
years after
last batch of
product was
placed on the
market;
products no
longer on the
market as of
11 July 2013,
the P.I.F. must
be retained
until 11 July
2020;
G. Pirotta - neogiul@tin.it
Updating:
«as needed»
no timeframe

10. THE PIF
THIS IS THE MOST
ADVANCED VERSION !
G. Pirotta - neogiul@tin.it

11. G. Pirotta - neogiul@tin.it
Source- Cosmetics Europe (COLIPA)
guidelines

12. Cosmetic product
safety assessment
Cosmetic product
safety info
PRODUCT
INFORMATION FILE
Other
manufacturing data
R&D data
G. Pirotta - neogiul@tin.it

13. Definizione
prodotto
Identificare
fonti dati
Valutazione
sicurezza
Stesura
finale
Elaborazione
bozza
Product
Information
File
G. Pirotta - neogiul@tin.it

14. Product information file
• Description of the product
• Cosmetic safety report
– Part A
– Part B
• Manufacturing process
– GMP ISO 22716
• Proof of claims (ECO/Organic)
• Data animal testing
• (Eco/sustainability data) ?
G. Pirotta - neogiul@tin.it

15. The Cosmetic Product Safety Report
Annex I of the Regulation, Part A
•
•
•
•
•
•
•
•
•
•
Cosmetic Product Safety Information
Qualitative / quantitative composition of the product
Physical/chemical characteristics and stability
Microbiological quality
Impurities, traces, information about the packaging
material
Normal and reasonably foreseeable conditions of use
Exposure to the cosmetic product
Exposure to the substances contained in the product
Toxicological profile of substances
Undesirable effects and serious undesirable effects
Information on the cosmetic product
G. Pirotta - neogiul@tin.it

16. The Cosmetic Product Safety Report
Annex I of the Regulation, Part B
Cosmetic Product Safety Report
•
•
•
•
•
Cosmetic Product Safety Assessment:
Assessment conclusions
Labelled warnings and instructions for use
Reasoning (calculation)
Assessor’s credentials and approval
• EU Guidelines?
G. Pirotta - neogiul@tin.it

17. detailed
• general toxicological profile of the ingredients
• chemical structure and their level of exposure
• Impurities, traces, information about the
packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product
• Information on the cosmetic product.
G. Pirotta - neogiul@tin.it

18. detailed
• The Safety Assessment includes:
• Ingredient characterization
– phys-chem data
– purity and profile of impurities,
– chemical structure of ingredients (structural alerts)
• Exposure assessment and considerations
– (target users)
• Assessment of all relevant hazard information;
– Calculation of safety or exposure margins, as appropriate;
• Product stability and microbiological quality
• Cosmetovigilance to support continued product safety.
G. Pirotta - neogiul@tin.it

19. Safety Assessment: reasoning
• Exposure assessment and calculation
– (MOS-NOAEL)
• Selection of the appropriate toxicological
endpoints for the safety assessment and
justification for waiving of endpoints
• Weight of evidence approach
• WHY THE PRODUCT IS SAFE ?
G. Pirotta - neogiul@tin.it

20. Frequency critical points
Source : presentazione “Valutazione dei dossier informativi e segnalazione
Reazioni avverse – Isabella De Angelis – Dip. Ambiente e connessa prevenzione
Primaria – Istituto Superiore di Sanità – Roma – 20 giugno 2013
G. Pirotta - neogiul@tin.it

21. TIPS and TRICKS
Clear structure of documents
Simple and clear wording
data not available? >> clear statement
Point not needed? >> clear statement
Shared data – identify the source
G. Pirotta - neogiul@tin.it

22. TIPS
G. Pirotta - neogiul@tin.it