2._sandra_ferretti_-_regulacion_ue.pdf

Obelis s.a. 2013 Version 2, Revised on 04.12.2012

EC 1223/2009 Regulation

Mrs. Sandra Ferretti Obelis s.a. C.C.O.

Colombia 2013


Presentation Overview

Definitions

European legislation on cosmetic products

European regulation main requirements

Recap

2


Definitions (1)

Directive

o Legislative document issued by the European Parliament

o It gives a direction

Regulation

o Legislative document issued by the European Parliament

o Law, rule

3


Definitions (2)

Cosmetic products (art. 1a, 1223/2009/EC)

means any substance or mixture intended to be placed in contact with the external parts of

the human body (epidermis, hair system, nails, lips and external genital organs) or with

teeth and the mucous 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 odors

4


Definitions (3)

A cosmetic product is defined by

o Product full commercial name (e.g., Nivea, LOreal)

o Qualitative and quantitative composition (i.e., formulation)

o Claim / intend of use (i.e., what does it do?)

5


Responsible Person (RP)

o EU resident !

o Assigned to be the representative of a manufacturers cosmetic products in front of the EU authorities, users and any other 3rd parties

Requirement by the law under the directive (art 7a, 76/768/EEC) & the regulation (art. 4, 1223/2009/EC) ! !

Safety Assessment report (SA report / Toxicological Assessment report)

o Safety evaluation of a cosmetic product, not a test !

o To be completed by a Safety Assessor (specific profile of this entity !, art. 10.2, 1223/2009/EC)

6

Definitions (4)


Notification

o One way action, from the RP to the Authorities

i.e., the authorities are not obliged to confirm the notification

o Requirement by the European legislation on cosmetic products (directive & regulation)

Product Information File (PIF)

o All safety information concerning 1 cosmetic product

o Any cosmetic product commercialized in the EU must have a PIF

7

Definitions (5)


Producer (OEM = Original Equipment Manufacturer)

o The one who is making the product

Manufacturer (OBL = Own Brand Labeler)

o The one rebranding the product under his own brand name

o means any natural or legal person who manufactures a cosmetic product or has such a

product designed or manufacture, and markets that cosmetic product under his name or

trademark (art. 1d, 1223/2009/EC)

8

Definitions (6)


Importer

o The one importing products from outside EU into the EU territory

o means any natural or legal person established within the Community, who places a

cosmetic product from a third country on the Community market (art. 1i, 1223/2009/EC)

placing on the market means the first making available of a cosmetic product on the Community

market (art. 1h, 1223/2009/EC)

9

Definitions (7)


Distributor

o The one commercializing the product within a EU member state

o means any natural or legal person in the supply chain, other than the manufacturer or

the importer, who makes a cosmetic product available on the Community market (art. 1e,

1223/2009/EC)

making available on the market means any supply of a cosmetic product for distribution,

consumption or use on the Community market in the course of a commercial activity, whether in

return for payment or free or charge (art. 1g, 1223/2009/EC)

10

Definitions (8)


European legislation on cosmetic products (1)

Principle

11



Directive 76/768/EEC

o Cosmetic products directive in the EU

o Published in 1976 !

o Implemented by all 27 EU member states => 27 slightly different versions

Followed, generally accepted by the 4 EFTA countries (Norway, Switzerland, Liechtenstein, Iceland)

o National notification

Each member state has its own system / requirements

E.g., product notified in France

Can it be commercialized elsewhere in the EU?

o Will be abolished on July 11th, 2013 ! ! !

E.g., product notified in Germany in 2008

Can it be commercialized in Germany on July 12th, 2013?

12



Regulation 1223/2009/EC

o Cosmetic products regulation in the EU

o Published in November 2009 !

o In implementation process by all 27 EU member states => 1 single law in EU on cosmetics

o Centralized notification

CPNP = Cosmetic Products Notifications Portal

Open since January 12th, 2012

1 notification for the whole EU

o Currently applicable but will come into full force on July 11th, 2013 ! ! !

E.g., product notified in the CPNP in March 2012

Can it be commercialized in Italy on July 12th, 2013?

What about Portugal?

13


REACh 1907/2006/EC Regulation Registration, Evaluation, Authorization and Restriction of Chemicals

o Regulation on chemicals and their safe use

o Relevant when

Formulating to ensure that the ingredients are safe (CMRs, restrictions)

Labeling requirements given the restrictions of substances

CLP 1272/2008/EC Regulation Classification, Labeling and Packaging

o Regulation aligning the EU systems of classification, labeling, and packaging of chemical substances

Aerosol Dispensers Directive 75/324/EEC

o Aerosol dispensers compliancy requirements including testing and labeling

14

Examples of relevant regulations


SCCS opinions Scientific Committee on Consumer Safety

o Adopted in the annexes of the directive/regulation

o Notes of guidance on ingredients, tests protocols e.g.,

SCCS 8th revision for the testing of cosmetic substances (finished product pathogens to be measured)

SCCS 1459/11 on fragrances and allergens new restrictions

ISO standards

o Guidance documents on testing, products safety evaluation, requirements e.g.,

ISO 22716:2007 (Good Manufacturing Practices)

ISO 10130:2009 (Cosmetics -- Analytical methods -- Nitrosamines: Detection and determination of N-nitrosodiethanolamine (NDELA) in cosmetics by HPLC, post-column photolysis and derivatization)

ISO 11930:2012 (Cosmetics -- Microbiology -- Evaluation of the antimicrobial protection of a cosmetic product)

ISO 24444:2012 (Cosmetics -- Sun protection test methods -- In vivo determination of the sun protection factor (SPF))

15

Examples of relevant guidance documents


Today

Transitional period

o Period between the publication of the new Regulation (November 2009) and the abolition

of the Directive (July 2013)

o Both laws are applicable => products may be compliant with the Directive or with the

Regulation

16


Why the Regulation?

17

European legislation on cosmetic products

Directive Regulation

Product Information File

Safety Assessment report

Pre market notification

27 laws National notification

1 law

Centralized notification (CPNP)

Clearer defined RP concept

Clearer defined responsibilities of the RP

More requirements


To remember !

July 11th, 2013

18

Regulation 1223/2009/EC Directive 76/768/EEC


European regulation main requirements (1)

Note !!!

o Compliance with the EU requirements prior commercialization (art. 13)

o E.g., if product X is on the market

Automatically is assumed to be compliant with the EU requirements ! Responsible Person appointed

Complete and compliant Product Information File

Notification in the CPNP

19



A. Appoint European Responsible Person (art. 4)

o 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.)

The RP is appointed per product not manufacturer

20



B. Product Information File (art. 11)

1. Description of the cosmetic products

2. Cosmetic product safety report (CPSR) = Annex I

Part A: Safety information

Part B: Safety Assessment report

Based on Part A

Completed by a Safety Assessor !

3. Description of the method of manufacture

4. Good Manufacturing Practice (GMP) compliance

ISO 22716:2007

5. Proof of effect claimed

6. Data on animal testing

21

Producer !!!

Producer !!!

Producer !!!

producer / manufacturer !!!

up to the manufacturer to check !!!



Main elements of the Safety Information (Annex I, Part A, 1223/2009/EC)

22

Information Keeper (usually)

1. Formula (exact quantitative & qualitative information !!!) Producer

2. Raw material physico-chemical, toxicological & microbiological

information (why not necessarily the MSDS ???) Raw material supplier

3. Finished product physico-chemical & microbiological specifications Producer

4. Finished product tests

Stability test (usually 3 months) Compatibility test (usually 3 months) Challenge test (usually 1 month) Patch test !

Producer / Manufacturer



Main elements of the Safety Information

23

Information Keeper (usually)

5. Packaging specifications Packaging supplier

6. Instructions for use and warnings Producer / SA

7. Exposure to the cosmetic product Producer / SA

8. Undesirable effects and serious undesirable effects Producer / manufacturer



Claims

o A cosmetic product

means any substance or mixture intended to be placed in contact with the external parts of the

human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the

mucous 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 odors (art. 1a, 1223/2009/EC)

o Claims must be supported by proof

shall not be used to imply that these products [which were established to be cosmetics] have

characteristics or functions which they do not have (art. 20.1)

24


Free of preservatives perfume Whitening tooth paste

Killing bacteria soap Helping circulation foot care cream

Anti-wrinkle cream

Prevents formation of cellulite

24 hours sun protection lotion Use with injuries

Anti-dandruff shampoo Combats excessive body odor

Cream helping problematic skin

!

!

!


25


Claims

o Natural / Bio / Organic = implies that the raw materials were produced following specific

rules & regulations

o When to claim natural / bio / organic

Different organizations across Europe Different interpretations

26



Claims

27


ECOCERT Natural & Organic Natural

minimum of 95% of all

plant-based ingredients in

the formula &


ingredients by weight must

come from organic farming.


plant-based ingredients in the

formula &


ingredients by weight must

come from organic farming.


Claims

28


NaTrue Natural Natural with organic portion

Organic

ingredients must be natural but they do not have to be organic

at least 70% of natural ingredients must stem from controlled organic production and/or controlled wild collection.

at least 95 % of natural ingredients must come from controlled organic cultivation and/or controlled wild collection



C. Notification (art. 13)

o To be completed

To the CPNP

By the RP

When the product is compliant

o 1 notification for the whole EU

29



C. Notification (art. 13)

o Who has access to the CPNP

Responsible Person to notify

Only to the files he notified

Distributor to notify labels if brought changes (after July 11th 2013)

Only to the names of the products based on search

Competent Authorities & Anti-toxic centers

All information except drafts!

30


exclusively & mainly

Any substance

or mixture

Placed in contact with the

external parts of the human

body + teeth + mucous

membranes of the oral

cavity

Cosmetic product

1. Cleaning,

2. Perfuming,

3. Changing appearance,

4. Protecting,

5. Keeping in good condition,

6. Correcting body odors

1 2

3

31

Recap (1)


Recap (2)

European laws on cosmetics

o Directive 76/768/EEC = will be abolished on July 11th, 2013

o Regulation 1223/2009/EC = will fully replace the directive on July 11th, 2013

Principle Safety

Compliance with the European requirements prior commercialization

32


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

3

Recap (3)


Note

Speed of the notification process depends on:

o RP knowledge, professionalism, capabilities

o the speed of collecting the correct information

o raw material suppliers / packaging suppliers / producers choice

Producer GMP compliancy (ISO 22716:2007) is a EU requirement

34


Thank you for your attention !

35

Date post:	16-Dec-2015
Category:	Documents
Upload:	eskasc
View:	6 times
Download:	2 times

2._sandra_ferretti_-_regulacion_ue.pdf

Documents