1. In-market control in the European Union as regards cosmetic products - an industry perspective
Brian Lightfoot
Cosmetics Europe
Member Company Governmental Affairs Expert

2. Member States – In Market Control at the local level
Member States are legally obliged to monitor compliance via in-market controls
checks of cosmetic products
checks on the economic operators
checks of Safety Assessment and Product Information
physical and laboratory checks of samples from the market
check compliance with GMP.
Must hold the RP liable in case of non-compliance and ensure corrective action

3. EU Model – Placing on the Market
Responsible Person
(Manufactuer, Importer,
Brand Owner, ..)
Expert Safety Evaluation
+ other regulatory
requirements
Notification
Product Information
Specific information
examined in response
to query
In-market Control
Control Authorities
Distribution
Documentation
Labelling
Laboratory Analysis

4. MAIN ELEMENTS FOR THE IN MARKET CONTROL
Cosmetics Product Notification Portal – CPNP
Product Information File – PIF, including safety assessment
Good manufacturing practices– GMP - Key for the quality of products
Post marketing surveillance - Cosmetovigilance

5. MAIN ELEMENTS FOR THE IN MARKET CONTROL
Cosmetics Product Notification Portal – CPNP
Product Information File – PIF, including safety assessment
Good manufacturing practices– GMP - Key for the quality of products
Post marketing surveillance - Cosmetovigilance

6. CPNP - What needs to be notified?
Product category
Product name(s)
Responsible person - name and address
Country of origin (import only)
Member State where product is placed on the market
Details of physical contact person in case necessity
Nanomaterials – identification, exposure conditions
CMRs (1A & 1B) – identification
Frame formulation
Original labelling (only once)
Photograph of original packaging - if reasonably legible (only once)

7. MAIN ELEMENTS FOR THE IN MARKET CONTROL
Cosmetics Product Notification Portal – CPNP
Product Information File – PIF, including safety assessment
Good manufacturing practices– GMP - Key for the quality of products
Post marketing surveillance - Cosmetovigilance

8. Product Information File
A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product
Part A – Cosmetic Product Safety Information
Quantitative and Qualitative composition of the product
Physical / chemical characteristics and stability of the cosmetic product
Microbiological quality
Impurities, traces, information about the packaging material
Normal and reasonably foreseeable use
Exposure to the cosmetic product
Exposure to the substance
Toxicological profile of the substance
Undesirable effects and serious undesirable effects
Information on the cosmetic product
Cosmetic Product Safety Report
A description of the method of manufacturing and a statement on compliance with good manufacturing practice
Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product
Part B – Cosmetic Product Safety Assessment
Assessment conclusion
Labelled warnings and instructions of use
Reasoning
Assessor’s credential and approval of part B
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

9. P.I.F.-related responsibilities
The Responsible Person must:
Ensure that a cosmetic product placed on the EU market is safe for human health, under normal or reasonably foreseeable conditions of use;
Maintain the Product Information File;
Be in a position to demonstrate, upon request, that the product he/she has placed on the market meets the requirements of the Cosmetics Regulation;
Ensure that a safety assessment has been performed for each product by a qualified safety assessor;

10. P.I.F.-related responsibilities
The Responsible Person must (cont.):
Keep the product’s safety assessment and the data upon which it is based as part of the Cosmetic Product Safety Report in the P.I.F. and update it according to relevant new data;
Ensure that he/she has a P.I.F. available for answering enquiries by control authorities;
Be the first point of contact for enforcement authorities, should there be any enquiry on the product he/she has placed on the market.
Retain the PIF 10 years after last batch of product was placed on the market and update as necessary

11. P.I.F. Contents
Information to be kept by the company and to be made readily accessible to control authorities at the address on the product’s label:
Product description
Cosmetic Product Safety Report (CPSR)
Method of manufacture and statement of compliance with GMP
Proof of the effect claimed
Data on animal testing

12. Claims and Efficacy Two main objectives:
- consumer protection (against misleading practices);
- fair competition.
Claims are governed by legally binding, ‘common criteria’, not by regulating specific wording
Within these criteria, companies can chose the claim language, as long as the claims are supported by evidence
Claims and evidence data are responsibility of the Responsible Person, and are subject to’ in-market control

13. MAIN ELEMENTS FOR THE IN MARKET CONTROL
Cosmetics Product Notification Portal – CPNP
Product Information File – PIF, including safety assessment
Good manufacturing practices– GMP - Key for the quality of products
Post marketing surveillance - Cosmetovigilance

14. Good manufacturing practice
Compliance with GMP is mandatory and needs to be stated by the responsible person; but external certification is not required;
Choice of GMP is voluntary :
Appropriate choice is presumed if (ISO) CEN 22716:2007 is applied
Compliance can also be demonstrated in other ways, e.g. via industry-recognised standards and codes, etc.
Authorities may ask for full GMP documentation, in addition to the statement of compliance and may carry out on-site inspections

15. MAIN ELEMENTS FOR THE IN MARKET CONTROL
Cosmetics Product Notification Portal – CPNP
Product Information File – PIF, including safety assessment
Good manufacturing practices– GMP - Key for the quality of products
Post marketing surveillance - Cosmetovigilance

16. Post market surveillance of undesirable effects
RP must assess reports of undesirable events according to standard methodology (Guidelines by EU Commission and by Cosmetics Europe):
sufficiently documented ?
serious vs. non-serious effect ?
causality link between product use and undesirable effect ?
Regulatory priority is given to serious undesirable effects
Summary of non-serious cases must be recorded in the product information file
Serious cases must also be reported to the authorities

17. PRACTICAL ASPECTS OF IN MARKET CONTROL
Authorities have access to the CPNP and identify products / responsible persons to be included in random inspections
In parallel, samples from the shelves are checked for compliance with labeling and may be sent to analytical laboratories
Any health risk detected from product analysis will trigger a risk assessment and deeper PIF inspection (and vice versa)
Authorities inspect PIF at the address of the responsible person labelled on the product

18. Where are PIF inspections carried out ?
The PIF must be made accessible at the address labelled on the cosmetics product
Inspectors visit the company. No obligation to submit information to the authorities (in a routine inspection scenario)
Information remains the intellectual property of the company (except for non-compliance and sampling of evidence of criminal behaviour)
In case of cross-border inspections, authorities have a protocol for collaboration.

19. Trigger for inspections
Random inspections, not regularly spaced
The competent authorities (central and regional) establish yearly plans for inspection (PIF, facilities, retailers….)
Inspection frequency often related to performance
poor compliance leads to more frequent inspections
good compliance means less frequent inspections
Random inspections may be spontaneous, but not completely unannounced
May follow a complaint
May be invited by company (quite common)

20. Why are routine inspections usually announced ?
Typically, information is stored electronically in databases.
Announced inspections allow companies to prepare for routine inspections by extracting/arranging the information in a ‘inspection friendly’ manner
Companies will try to have experts available on the site to answer to any questions arising.
Time period is sufficient to show your PIF in the best light, but too short to ‘create’ a product information file if nonce existed.

21. Typical Inspection Items
What is the company process for releasing a product to the market (“go/no go” points to ensure compliance) ?
Presence and completeness of PIF, including claim substantiation
Safety assessment complete, signed by a qualified safety assessor (in case of doubts : deeper assessment by experts), including information on undesirable effects
In case of subcontractors : how is compliance ensured/controlled by the RP
Product label checked against requirements of the Regulation (completeness, correctness)

22. Typical Inspection items (contd.)
Traceability of products released to the market
Good Manufacturing Practices (GMP) :
Which GMP standard has been followed (according to self statement by RP)
How is this method (self) audited ?
Random check of key documents that result from this GMP standard
On-site inspection (usually only done if there are doubts over product quality and/or the truthfulness of the self declaration)

23. If non-compliance is detected
The main goal is to achieve compliance, not to punish
Options vary:
Serious and immediate risk to human health merits immediate action, possibly product witdrawal/recall and will trigger alert network across EU
Technical / formal non compliance without health consequences will be dealt with through other means
In most cases, pay a penalty fine that is ‘dissuasive, effective and proportionate’
Corrective measures must be proportionate to the risk

24. If non-compliance is detected
Member States must require corrective measures  agreed plan of action and defined timeframe
Member States must allow the responsible person to offer his viewpoint
Objective is to achieve compliance rather than to punish
Usually, non compliance triggers immediate follow-up inspection and higher frequency of inspections in the future

25. Reports on In-Market Control
Findings that indicate a serious safety risk need to be communicated to other Member States
Furthermore, Member States must assess the functioning of their surveillance activities, at least every 4 years
Summary reports are made available to the public, but need to respect justified interests of business confidentiality