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How To Comply With New European Union Cosmetics Regulations (Larger Slides)
1.
5/14/2013 1 Webinar Update on European
UnionUpdate on European Union Regulations for Cosmetics and Beauty Products 21.2.2013 Mr. Doram Elkayam – Obelis s.a. Chief Operations Officer © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 www.obeliscosmetics.net Regulatory Framework Cosmetics 1223/2009/EC © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 www.obeliscosmetics.net
2.
5/14/2013 2 Introduction (1) 1223/2009/EC• 1223/2009/EC o
1223 – reference number o 2009 – year of publication o EC – European Community • 30 November 2009 – 11 July 2013 o Transitional period © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 o Both the current directive 76/768/EEC & the new regulations 1223/2009/EC are applicable • 11 July 2013 o 1223/2009/EC will completely replace 76/768/EC Introduction (2) • Applicable to all 27 EU Member States ! • No Transposition ! => 1 single law o EU member states may not add or remove requirements © Obelis s.a. 2012 Version 1, Revised on 09.01.2012
3.
5/14/2013 3 Obj ti Introduction (3) •
Objectives o Better defined responsibilities ! Manufacturer, importer, responsible person, distributor o Safety assessment Regulation of ingredients o Avoid multiple notifications to authorities and anti-toxic centers © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 o Specific provisions for nanomaterials ! o Set criteria for claims o Harmonized market surveillance Introduction (4) Unchanged provisions from 76/768/EEC New Provisions o Basic principles o Ban of animal testing o Regulated ingredients o Manufacturing activities Labelling (except nano & claims) o Responsible Person o Distributors o European notification o Nanomaterials o Product information file (PIF) o Cosmetic product safety report © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 o Labelling (except nano & claims) o Definition of cosmetic product o Cosmetovigilance o Claims o CMR substances o Market surveillance
4.
5/14/2013 4 Introduction (5) Application Dates
Products already on the market New products Notification 11 January 2012 11 July 2013 Prior to placing on the market Notification of products with nano 11 January 2013 11 July 2013 6 months before placing on the market © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 Product information file & safety report 11 July 2013 When placed on the market Labelling [nano] 11 July 2013 When placed on the market Steps to Compliance, Conformity & EU Market © Obelis s.a. 2012 Version 1, Revised on 09.01.20128 www.obeliscosmetics.net
5.
5/14/2013 5 Steps to the
EU Market (1) Step 1 – Designating a Responsible Person “Only cosmetic products for which a legal or natural person is designated within the Community as “responsible person” shall be placed on the market.” (art. 4.1.) Written mandate ! © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 (Article 4.4.) 9 Step 2 – Product(s) classification Steps to the EU Market (2) o Cosmetic product definition “Cosmetic product means any substance or mixture intended to be placed in contact with external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucos 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 .“ (Article 2, paragraph 1a) o To consider Product formulation © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 Product formulation Product function Product claim ! Any change in a product’s function, formulation or claim => a new product 10
6.
5/14/2013 6 Steps to the
EU Market (3) Step 3 – Building the Product Information File, per product! 1. Description of the cosmetic product 2. Safety Report (CPSR) Cosmetic product Safety Information File Cosmetic product Safety Assessment 3. Method of manufacture 4 GMP © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 4. GMP 5. Proof of effect(s) claimed, where applicable 6. Data on animal testing 7. Labels 11 Steps to the EU Market (4) Step 4 – Notification Notification to the Competent Authorities and Anti-Toxic Centers – Directive 76/768/EEC Notification to the Cosmetic Products Notifications Portal (CPNP) – Regulation 1223/2009/EC ! ! Always completed by the Responsible Person © Obelis s.a. 2012 Version 1, Revised on 09.01.201212
7.
5/14/2013 7 Step 5 –
Entering the EU market Steps to the EU Market (5) Step 5 Entering the EU market © Obelis s.a. 2012 Version 1, Revised on 09.01.201213 Steps to the EU Market (6) Step 6 – Remain Compliant and Keep updating any individual Product Information File (!) © Obelis s.a. 2012 Version 1, Revised on 09.01.201214
8.
5/14/2013 8 Product Information File (PIF) ©
Obelis s.a. 2012 Version 1, Revised on 09.01.201215 www.obeliscosmetics.net Product Information File (1) • Definition o Mandatory technical file required for each cosmetic product to be placed on the market o Full overview of a cosmetic product (in terms of formula, safety reports, labels….) ! Each and every cosmetic product must have a Product Information File (PIF) © Obelis s.a. 2012 Version 1, Revised on 09.01.201216
9.
5/14/2013 9 Product Information File
(2) • Remarks o Differences between the PIF by the Directive 76/768/EEC & Regulation 1223/2009/EC o Kept by the RP, at the EU address specified on the label Readily accessible to the Competent Authorities of the RP Member State In the national language or a language easily understood by the Competent Authority (in electronic or other format) © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 For a period of 10 years after the last batch was placed on the market Updated, when necessary 17 Product Information File (3) El t f th PIF A t 11 1223/2009/EC• Elements of the PIF - Art. 11, 1223/2009/EC: o Product description which enables the product information to be clearly attributed to the respective cosmetic product o Cosmetic Product Safety Report (Safety Information + Safety Assessment) and data on SUE & UE o Method of manufacturing © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 o GMP o Proof of effect claimed when justified by the nature or the effect of the cosmetic product o Data on animal testing o Labeling 18
10.
5/14/2013 10 Product Information File
(4) 1. Cosmetic Product Safety Report (Annex I, 1223/2009/EC)y p ( , / / ) o Part A – Safety Information File 1. Qualitative & quantitative composition 2. Physico-chemical, microbiological & toxicological specifications of the raw materials 3. Physico-chemical, microbiological & toxicological specifications of the finished product 4. Stability Test of the finished product b l b h f l d k © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 5. Compatibility Test between the formulation and its packaging 6. Challenge Test of the finished product 7. Impurity, traces, information about the packaging material 8. Data on undesirable/ serious undesirable effects 19 Product Information File (5) 1. Safety Report o Part B – Safety Assessment report Safety Assessor – a qualified person, possessing a EU degree in a relevant discipline + 3 years of professional experience Toxicological Assessment of the finished product** Safety Assessors’ credentials © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 y Any particular label warnings and precautions for use ** The assessment as per the new regulation 1223/2009/EC is more detailed than as per the current directive 76/768/EEC 20
11.
5/14/2013 11 2 Good Manufacturing
Practices = GMP Product Information File (6) 2. Good Manufacturing Practices = GMP o Were created to ensure that the method of manufacturing is in alignment with the requirements of protection of health o Certificate / declaration o 76/768/EEC – no specific requirements according to which the standard must be like o 1223/2009/EC – specific standards required ISO 22716 © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 3. Method of manufacture complying with the GMP 21 4 D t d i bl ff t Product Information File (7) 4. Data on undesirable effects 5. Proof of effect(s) claimed, where applicable o Clinical tests, scientific research… o “Claims manual” to be issued by the European Commission in 2012 6. Data on animal testing o Performed by the manufacturer, his agents or suppliers o Including any animal testing performed in non-EU countries 7 Labels © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 7. Labels o 4 possible elements container, outer-packaging, sticker, leaflet o Specific elements must appear on each (existing) component of the label o National official language(s) ! 22
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5/14/2013 12 Safety Assessment © Obelis
s.a. 2012 Version 1, Revised on 09.01.2012 www.obeliscosmetics.net Safety Assessment (1) • Definition o Toxicological Assessment of a finished cosmetic product no test o Part of the Safety Report in the PIF o Completed by a Safety Assessor © Obelis s.a. 2012 Version 1, Revised on 09.01.2012
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5/14/2013 13 Safety Assessment (2) •
Remark o Differences between the Safety Assessment as per 76/768/EEC & 1223/2009/EC o To be updated when necessary o Special Safety Assessment for cosmetic products targeting © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 Children <3 Intimate hygiene Safety Assessment (3) 76/768/EEC 1223/2009/EC Based on the toxicological profile of the ingredients Based on all the elements of Safety Information File 1. Qualitative & quantitative specifications 2. Physico-chemical, microbiological & toxicological specifications of the raw materials 3. Physico-chemical, microbiological & toxicological specifications © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 of the finished product 4. Stability Test of the finished product 5. Compatibility Test between the formulation its packaging 6. Challenge test of the finished product
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5/14/2013 14 Safety Assessment (4) Elements
Required: 1. Assessment conclusion 2. Scientific reasoning leading to the conclusion 3. Labeling warnings & instructions for use 4. Safety Assessor signature Along with the Safety Assessment © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 1. Safety Assessor’s credentials 1. Name 2. Address 3. Proof of qualification 4. Date 5. Signature Safety Assessment (5) • Safety Assessor Qualifications o Diploma in the field of pharmacy, toxicology, dermatology, medicine or similar discipline o Diploma from a EU Member State University! o Minimum of 3 years experience in the field © Obelis s.a. 2012 Version 1, Revised on 09.01.2012
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5/14/2013 15 E R ibl
PEuropean Responsible Person © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 www.obeliscosmetics.net EU Responsible Person (1) • Definition (Article 2. – 76/768/EEC) o “[…] manufacturer or his authorized agent or any other person responsible for placing the product on the Community market.” ⇒ no formal definition © Obelis s.a. 2012 Version 1, Revised on 09.01.201230
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5/14/2013 16 R ibiliti d
th 76/768/EEC EU Responsible Person (2) Responsibilities under the 76/768/EEC: 1. Name & address of the “manufacturer or the person responsible for marketing the cosmetic product who is established within the Community” (Article 6.1.a.) 2. Keep the Product Information File (PIF) readily accessible to the CA (Article 7a.1. a, b, c, d, e, f, g, h.) © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 3. Notification to CA & Anti-Toxic Centers – “the manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authorities of the Member State […].” (Article 7a.4.) 31 EU Responsible Person (3) Definition(Article 4.1. – EC 1223/2009) • “Only cosmetic products for which legal or natural person is designated within the Community as responsible person shall be placed on the market” (Article 4.1.) • “For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.” (Article 4.2.) o Meaning ⇒ Obligation to have an EU RP linked to the product © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 g p ⇒ RP established within the European community ⇒ RP to fulfill the obligations under the regulation 32
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5/14/2013 17 EU Responsible Person
(4) • Responsibilities (Article 4.2.) o “For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.” © Obelis s.a. 2012 Version 1, Revised on 09.01.201233 EU Responsible Person (5) • “ensure compliance” refers to (Article 5.1.): o Article 3: Safety o Article 8: GMP o Article 10: Safety Assessment o Article 11: Product Information File (PIF) o Article 16: Nanomaterials o Article 17: Traces o Article 18: Animal Testing o Article 19(1),(2) and (5): Labelling © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 o Article 12: Sampling and Analysis o Article 13: Notification o Article 14: Restrictions for Substances Listed in Annexes o Article 15: CMR o Article 20: Claims o Article 21: Information to the Public o Article 23: Communication of SUE o Article 24: Information on substances 34
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5/14/2013 18 EU Responsible Person
(7) “Only cosmetic products for which legal or natural person is designated within the Community as responsible person shall be placed on the market” (Article 4.3.) EU Manufacturer Non-EU Manufacturer EU Importer EU Distributor Cosmetic product manufactured in the EU & commercialized in the EU (Article 4.1.) (Article 4.4.) * (Article 4.6.) * * © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 (Article 4.5.) Cosmetic product manufactured outside the EU & imported in the EU (Article 4.5.) (Article 4.6.) * EU Responsible Person (6) Tasks on a Practical View: 1. Provides name & address in the EU – mandatory on the label 2. Compiles & ensures PIF compliance prior to notification (including Safety Assessment report, product tests, labeling, GMP…) (Article 11) 3. Notifies to the European Cosmetic Products Notification Portal – CPNP (Article 13) 4. Keeps the PIF for authorities’ inspections, for a period of 10 years after the last batch was manufactured (Article 11.1.) 5. Manages cosmeto-vigilance (Article 5) 6. Represents the manufacturer towards the Competent Authorities, Anti-Toxic Centers, © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 p p , , European Commission, end users… 7. Updates & consults on EU Regulation! 36
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5/14/2013 19 EU Notification of
Cosmetics © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 www.obeliscosmetics.net EU Notification of Cosmetics (1) Notification Registration One way action Responsible Person Competent Authorities Anti-toxic Centers Two ways action Responsible Person Competent Authorities Anti-toxic Centers © Obelis s.a. 2012 Version 1, Revised on 09.01.2012
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5/14/2013 20 EU Notification of
Cosmetics (2) I d t th EC 1223/2009 R l tiIn accordance to the EC 1223/2009 Regulation: • To be completed only after the PIF was completed ! • Cosmetic products must be in compliance prior to Notification ! • Commercialization on EU market only AFTER notification ! • Towards the Cosmetic Products Notification Portal (C.P.N.P.) ! • A single notification covering the entire European Union! © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 • Products notified under 76/768/EEC will need to be re-notified under 1223/2009/EC no later than July 11th 2013! • Distributors‘ notification – additional to the RP notification EU Notification of Cosmetics (5) Distributors notification additional to the RP notification o Trabslated Label • Nanomaterials! = insoluble or biopersistent, intentionally manufactured, 1 or > dimention, 1 100nm • Additional notification N t f t i l i A III IV VI © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 o Not for nanomaterials in Annexes III, IV, VI o By the responsible person (or mandate) ! o 6 months before the placing on the market ! o Electronic notification to European Commission ! o Labeling: titanium dioxide [nano]
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5/14/2013 21 TAKE HOME MESSAGES ©
Obelis s.a. 2012 Version 1, Revised on 09.01.2012 www.obeliscosmetics.net I Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ Take Home Message (1) I. Only cosmetic products for which a legal or natural person is designated within the Community as responsible person shall be placed on the market (Article 4.1.). II. For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation (Article 4.2.). Hand Cream EU RP: Name & Address Hand Cream EU RP appointment 1 Regulatory obligations (PIF, notification) 2 © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 Address1 2 3 42
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5/14/2013 22 Take Home Message
(2) When to appoint the EU Responsible Person? PIF 1. 2. EU RP appointment PIF Notification / Market Identification Verification Confirmation 3. 4.1. 2. 3. © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 Time line to market 0 X2 X3 X4 X5 X6 X7 X8 X9 X10X1 43 Take Home Message (3) Hand Cream Manufactured in or outside EU RP & EU market © Obelis s.a. 2012 Version 1, Revised on 09.01.201244 Notification
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5/14/2013 23 Thank You for
Your Attention! Questions? © Obelis s.a. 2012 Version 1, Revised on 09.01.2012 Q
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