how to comply with new european union cosmetics regulations (larger slides)

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WebinarUpdate on European UnionUpdate on European Union

Regulations for Cosmetics and Beauty Products

21.2.2013Mr. 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



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Introduction (1)

1223/2009/EC• 1223/2009/ECo 1223 – reference number

o 2009 – year of publication

o EC – European Community

• 30 November 2009 – 11 July 2013 o Transitional period

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o Both the current directive 76/768/EEC & the new regulations 1223/2009/EC are applicable

• 11 July 2013o 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

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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

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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

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o Labelling (except nano & claims)

o Definition of cosmetic product

o Cosmetovigilance

o Claims

o CMR substances

o Market surveillance

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Introduction (5)

Application Dates Products already

on the marketNew products

Notification11 January 2012

11 July 2013

Prior to placing on the market

Notification of products with nano11 January 2013

11 July 2013

6 months before placing on the

market

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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

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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 !

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(Article 4.4.)

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Step 2 – Product(s) classification


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

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Product formulation

Product function

Product claim

! Any change in a product’s function, formulation or claim => a new product

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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

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4. GMP

5. Proof of effect(s) claimed, where applicable

6. Data on animal testing

7. Labels

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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

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Step 5 – Entering the EU market


Step 5 Entering the EU market

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Step 6 – Remain Compliant and Keep updating any individual Product Information File (!)

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Product Information File

(PIF)

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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)

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• 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)

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For a period of 10 years after the last batch was placed on the market

Updated, when necessary

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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

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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

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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

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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

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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

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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

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2 Good Manufacturing Practices = GMP


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

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3. Method of manufacture complying with the GMP

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4 D t d i bl ff t


4. Data on undesirable effects5. 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 testingo Performed by the manufacturer, his agents or suppliers

o Including any animal testing performed in non-EU countries

7 Labels

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7. Labelso 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) !

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Safety Assessment

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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

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• 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

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Children <3

Intimate hygiene


76/768/EEC 1223/2009/EC

Based on the toxicological profile of the

ingredients

Based on all the elements of Safety Information

File1. Qualitative & quantitative specifications

2. Physico-chemical, microbiological & toxicological specifications

of the raw materials

3. Physico-chemical, microbiological & toxicological specifications

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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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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

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1. Safety Assessor’s credentials

1. Name

2. Address

3. Proof of qualification

4. Date

5. Signature


• 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

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E R ibl PEuropean Responsible Person

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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

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R ibiliti d th 76/768/EEC


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.)

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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.)

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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

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g p

⇒ RP established within the European community

⇒ RP to fulfill the obligations under the regulation

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• 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



• “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

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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

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“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.)

*

*

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(Article 4.5.)

Cosmetic product manufactured outside the EU & imported in the EU

(Article 4.5.) (Article 4.6.)

*


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,

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p p , ,European Commission, end users…

7. Updates & consults on EU Regulation!

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EU Notification of Cosmetics

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EU Notification of Cosmetics (1)

Notification RegistrationOne way action

Responsible Person Competent AuthoritiesAnti-toxic Centers

Two ways action

Responsible Person Competent AuthoritiesAnti-toxic Centers

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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!

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• 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


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

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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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TAKE HOME MESSAGES

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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

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Address1 2

3

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When to appoint the EU Responsible Person?

PIF

1. 2.EU RP appointment

PIF Notification / Market

IdentificationVerificationConfirmation

3. 4.1. 2. 3.

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Time line to market

0X2 X3 X4 X5 X6 X7 X8 X9 X10X1

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Hand Cream

Manufactured in or outside EU RP

&

EU market

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