The EU Responsible Person has to keep updated:
The Cosmetic Product Information File (PIF)

What is?
A collection of documents that describe the Cosmetic product. It includes a Safety Assessment signed by a qualified expert.

Why?
It is requested by EU laws (both the old 76/768 and the new Reg.1223/2009).

How?

Old Directive 76/768

• List of information (composition, purity criteria, statements)
• Safety Assessment

New Regulation 1223/2009

• Product Information File (description, manufacturing methods, claims substantiation, Cosmetic Product Safety Report)
•  Cosmetic Product Safety Report:
   Part A: Cosmetic Product Safety Information (composition, purity, exposure  calculation)
   Part B: Cosmetic Product Safety Assessment (Conclusion, Warnings, Reasoning,  Approval)

Changes by 1223/2009 (improvements):

• More articulated and detailed Structure
• Less “statements” and more Scientific Reasoning and Calculations

How can we help you?
We can:
Edit it, Keep it updated, Provide the service of REMOTE DOSSIER (link alla nuova pagina)  your dossier in your hands in few minutes

For any free information CONTACT US or call us on  +39 3405180274, Dr. Matteo Zanotti Russo

Need More details? See below:

Compared  to the preceding Directive 76/768,  the new Regulation no. 1223/2009  provides an important implementation in the structure of the documentation which the Responsible Person has  to draft and retain (updated) for the immediate availability of the authorities. As one can see, the new safety documentation is very structured and better defined than in the past, and the realisation and documentation of verifications is particularly important on: 

• stability and compatibility, specific investigations on raw materials,
• calculation of the Margin of Safety (MOS),
• assessment and calculations on the level of exposure
• the obligation to undertake the challenge test
• assessment of the efficiency tests,
• statistical analysis of possible undesirable effects. 

Thanks its 10 years of experience and its constant communication with Trade Associations and Health Authorities, Angel Consulting can offer you full assistance in the management, drafting, updating and  retention of every information required by the Regulation.

For any free information CONTACT US or call on +39 3405180274, Dr. Matteo Zanotti Russo

Safety Assessment (Art. 10):In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.

Product information File (Art 11)
1. 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.

2.  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);
(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;
(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.

Safety Report (Annex 1)

PART A – Cosmetic product safety information

1. Quantitative and qualitative composition of the cosmetic product
2. Physical/chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4. Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. The targeted (or exposed) population(s).
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product

Part B -  Cosmetic product safety assessment

1. Assessment conclusion
2. Labelled warnings and instructions of use
3. Reasoning
4. Assessor’s credentials and approval of part B