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