EC 1223/2009 Regulation

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1 EC 1223/2009 Regulatin Mrs. Sandra Ferretti Obelis s.a. C.C.O. Clmbia 2013

2 Presentatin Overview Definitins Eurpean legislatin n csmetic prducts Eurpean regulatin main requirements Recap 2

3 Definitins (1) Directive Legislative dcument issued by the Eurpean Parliament It gives a directin Regulatin Legislative dcument issued by the Eurpean Parliament Law, rule 3

4 Definitins (2) Csmetic prducts (art. 1a, 1223/2009/EC) means any substance r mixture intended t be placed in cntact with the external parts f the human bdy (epidermis, hair system, nails, lips and external genital rgans) r with teeth and the mucus membranes f the ral cavity with a view exclusively r mainly t cleaning them, perfuming them, changing their appearance, prtecting them, keeping them in gd cnditin r crrecting bdy drs 4

5 Definitins (3) A csmetic prduct is defined by Prduct full cmmercial name (e.g., Nivea, L Oreal ) Qualitative and quantitative cmpsitin (i.e., frmulatin) Claim / intend f use (i.e., what des it d?) 5

6 Definitins (4) Respnsible Persn (RP) EU resident! Assigned t be the representative f a manufacturer s csmetic prducts in frnt f the EU authrities, users and any ther 3 rd parties Requirement by the law under the directive (art 7a, 76/768/EEC) & the regulatin (art. 4, 1223/2009/EC)!! Safety Assessment reprt (SA reprt / Txiclgical Assessment reprt) Safety evaluatin f a csmetic prduct, nt a test! T be cmpleted by a Safety Assessr (specific prfile f this entity!, art. 10.2, 1223/2009/EC) 6

Definitins (5) Ntificatin One way actin, frm the RP t the Authrities i.e., the authrities are nt bliged t cnfirm the ntificatin Requirement by the Eurpean legislatin n

7 Definitins (5) Ntificatin One way actin, frm the RP t the Authrities i.e., the authrities are nt bliged t cnfirm the ntificatin Requirement by the Eurpean legislatin n csmetic prducts (directive & regulatin) Prduct Infrmatin File (PIF) All safety infrmatin cncerning 1 csmetic prduct Any csmetic prduct cmmercialized in the EU must have a PIF 7

8 Definitins (6) Prducer (OEM = Original Equipment Manufacturer) The ne wh is making the prduct Manufacturer (OBL = Own Brand Labeler) The ne rebranding the prduct under his wn brand name means any natural r legal persn wh manufactures a csmetic prduct r has such a prduct designed r manufacture, and markets that csmetic prduct under his name r trademark (art. 1d, 1223/2009/EC) 8

9 Definitins (7) Imprter The ne imprting prducts frm utside EU int the EU territry means any natural r legal persn established within the Cmmunity, wh places a csmetic prduct frm a third cuntry n the Cmmunity market (art. 1i, 1223/2009/EC) placing n the market means the first making available f a csmetic prduct n the Cmmunity market (art. 1h, 1223/2009/EC) 9

10 Definitins (8) Distributr The ne cmmercializing the prduct within a EU member state means any natural r legal persn in the supply chain, ther than the manufacturer r the imprter, wh makes a csmetic prduct available n the Cmmunity market (art. 1e, 1223/2009/EC) making available n the market means any supply f a csmetic prduct fr distributin, cnsumptin r use n the Cmmunity market in the curse f a cmmercial activity, whether in return fr payment r free r charge (art. 1g, 1223/2009/EC) 10

11 Eurpean legislatin n csmetic prducts (1) Principle 11

12 Eurpean legislatin n csmetic prducts (2) Directive 76/768/EEC Csmetic prducts directive in the EU Published in 1976! Implemented by all 27 EU member states => 27 slightly different versins Fllwed, generally accepted by the 4 EFTA cuntries (Nrway, Switzerland, Liechtenstein, Iceland) Natinal ntificatin Each member state has its wn system / requirements E.g., prduct ntified in France Can it be cmmercialized elsewhere in the EU? Will be ablished n July 11 th, 2013!!! E.g., prduct ntified in Germany in 2008 Can it be cmmercialized in Germany n July 12 th, 2013? 12

13 Eurpean legislatin n csmetic prducts (3) Regulatin 1223/2009/EC Csmetic prducts regulatin in the EU Published in Nvember 2009! In implementatin prcess by all 27 EU member states => 1 single law in EU n csmetics Centralized ntificatin CPNP = Csmetic Prducts Ntificatins Prtal Open since January 12 th, ntificatin fr the whle EU Currently applicable but will cme int full frce n July 11 th, 2013!!! E.g., prduct ntified in the CPNP in March 2012 Can it be cmmercialized in Italy n July 12 th, 2013? What abut Prtugal? 13

14 Examples f relevant regulatins REACh 1907/2006/EC Regulatin Registratin, Evaluatin, Authrizatin and Restrictin f Chemicals Regulatin n chemicals and their safe use Relevant when Frmulating t ensure that the ingredients are safe (CMRs, restrictins ) Labeling requirements given the restrictins f substances CLP 1272/2008/EC Regulatin Classificatin, Labeling and Packaging Regulatin aligning the EU systems f classificatin, labeling, and packaging f chemical substances Aersl Dispensers Directive 75/324/EEC Aersl dispensers cmpliancy requirements including testing and labeling 14

15 Examples f relevant guidance dcuments SCCS pinins Scientific Cmmittee n Cnsumer Safety Adpted in the annexes f the directive/regulatin Ntes f guidance n ingredients, tests prtcls e.g., ISO standards SCCS 8 th revisin fr the testing f csmetic substances (finished prduct pathgens t be measured) SCCS 1459/11 n fragrances and allergens new restrictins Guidance dcuments n testing, prducts safety evaluatin, requirements e.g., ISO 22716:2007 (Gd Manufacturing Practices) ISO 10130:2009 (Csmetics -- Analytical methds -- Nitrsamines: Detectin and determinatin f N- nitrsdiethanlamine (NDELA) in csmetics by HPLC, pst-clumn phtlysis and derivatizatin) ISO 11930:2012 (Csmetics -- Micrbilgy -- Evaluatin f the antimicrbial prtectin f a csmetic prduct) ISO 24444:2012 (Csmetics -- Sun prtectin test methds -- In viv determinatin f the sun prtectin factr (SPF)) 15

16 Tday Transitinal perid Perid between the publicatin f the new Regulatin (Nvember 2009) and the ablitin f the Directive (July 2013) Bth laws are applicable => prducts may be cmpliant with the Directive r with the Regulatin 16

17 Eurpean legislatin n csmetic prducts Why the Regulatin? 27 laws Natinal ntificatin Directive Regulatin Prduct Infrmatin File Safety Assessment reprt Pre market ntificatin 1 law Centralized ntificatin (CPNP) Clearer defined RP cncept Clearer defined respnsibilities f the RP Mre requirements 17

18 T remember! July 11 th, 2013 Regulatin 1223/2009/EC Directive 76/768/EEC 18

19 Eurpean regulatin main requirements (1) Nte!!! Cmpliance with the EU requirements prir cmmercializatin (art. 13) E.g., if prduct X is n the market Autmatically is assumed t be cmpliant with the EU requirements! Respnsible Persn appinted Cmplete and cmpliant Prduct Infrmatin File Ntificatin in the CPNP 19

20 Eurpean regulatin main requirements (2) A. Appint Eurpean Respnsible Persn (art. 4) Only csmetic prducts fr which a legal r natural persn is designated within the Cmmunity as respnsible persn shall be placed n the market (art. 4.1.) The RP is appinted per prduct nt manufacturer 20

21 Eurpean regulatin main requirements (3) B. Prduct Infrmatin File (art. 11) 1. Descriptin f the csmetic prducts 2. Csmetic prduct safety reprt (CPSR) = Annex I Part A: Safety infrmatin Part B: Safety Assessment reprt Based n Part A Cmpleted by a Safety Assessr! 3. Descriptin f the methd f manufacture 4. Gd Manufacturing Practice (GMP) cmpliance ISO 22716: Prf f effect claimed 6. Data n animal testing Prducer!!! prducer / manufacturer!!! Prducer!!! up t the manufacturer t check!!! Prducer!!! 21

22 Eurpean regulatin main requirements (4) Main elements f the Safety Infrmatin (Annex I, Part A, 1223/2009/EC) Infrmatin Keeper (usually) 1. Frmula (exact quantitative & qualitative infrmatin!!!) Prducer 2. Raw material physic-chemical, txiclgical & micrbilgical infrmatin (why nt necessarily the MSDS???) Raw material supplier 3. Finished prduct physic-chemical & micrbilgical specificatins Prducer 4. Finished prduct tests Stability test (usually 3 mnths) Cmpatibility test (usually 3 mnths) Challenge test (usually 1 mnth) Patch test! Prducer / Manufacturer 22

23 Eurpean regulatin main requirements (5) Main elements f the Safety Infrmatin Infrmatin Keeper (usually) 5. Packaging specificatins Packaging supplier 6. Instructins fr use and warnings Prducer / SA 7. Expsure t the csmetic prduct Prducer / SA 8. Undesirable effects and serius undesirable effects Prducer / manufacturer 23

24 Eurpean regulatin main requirements (6) Claims A csmetic prduct means any substance r mixture intended t be placed in cntact with the external parts f the human bdy (epidermis, hair system, nails, lips and external genital rgans) r with teeth and the mucus membranes f the ral cavity with a view exclusively r mainly t cleaning them, perfuming them, changing their appearance, prtecting them, keeping them in gd cnditin r crrecting bdy drs (art. 1a, 1223/2009/EC) Claims must be supprted by prf shall nt be used t imply that these prducts [which were established t be csmetics] have characteristics r functins which they d nt have (art. 20.1) 24

25 Eurpean regulatin main requirements (7) Free f preservatives perfume Whitening tth paste! Killing bacteria sap Anti-wrinkle cream Helping circulatin ft care cream Prevents frmatin f cellulite! 24 hurs sun prtectin ltin Use with injuries Anti-dandruff shamp Cmbats excessive bdy dr Cream helping prblematic skin! 25

26 Eurpean regulatin main requirements (8) Claims Natural / Bi / Organic = implies that the raw materials were prduced fllwing specific rules & regulatins When t claim natural / bi / rganic Different rganizatins acrss Eurpe Different interpretatins 26

27 Eurpean regulatin main requirements (9) Claims ECOCERT Natural & Organic Natural minimum f 95% f all plant-based ingredients in the frmula & minimum f 10% f all ingredients by weight must cme frm rganic farming. minimum f 50% f all plant-based ingredients in the frmula & minimum f 5% f all ingredients by weight must cme frm rganic farming. 27

Eurpean regulatin main requirements (10) Claims NaTrue Natural Natural with rganic prtin ingredients must be natural but they d nt have t be rganic at least 70% f natural ingredients

28 Eurpean regulatin main requirements (10) Claims NaTrue Natural Natural with rganic prtin ingredients must be natural but they d nt have t be rganic at least 70% f natural ingredients must stem frm cntrlled rganic prductin and/r cntrlled wild cllectin. Organic at least 95 % f natural ingredients must cme frm cntrlled rganic cultivatin and/r cntrlled wild cllectin 28

29 Eurpean regulatin main requirements (11) C. Ntificatin (art. 13) T be cmpleted T the CPNP By the RP When the prduct is cmpliant 1 ntificatin fr the whle EU 29

30 Eurpean regulatin main requirements (12) C. Ntificatin (art. 13) Wh has access t the CPNP Respnsible Persn t ntify Only t the files he ntified Distributr t ntify labels if brught changes (after July 11 th 2013) Only t the names f the prducts based n search Cmpetent Authrities & Anti-txic centers All infrmatin except drafts! 30

31 Recap (1) Any substance r mixture 1 2 Csmetic prduct 3 1. Cleaning, exclusively & mainly 2. Perfuming, 3. Changing appearance, 4. Prtecting, 5. Keeping in gd cnditin, 6. Crrecting bdy drs Placed in cntact with the external parts f the human bdy + teeth + mucus membranes f the ral cavity 31

32 Recap (2) Eurpean laws n csmetics Directive 76/768/EEC = will be ablished n July 11 th, 2013 Regulatin 1223/2009/EC = will fully replace the directive n July 11 th, 2013 Principle Safety Cmpliance with the Eurpean requirements prir cmmercializatin 32

within the Cmmunity as respnsible persn shall be placed n the market

Fr each csmetic prduct placed n the market, the respnsible persn shall

33 Recap (3) I. Only csmetic prducts fr which a legal r natural persn is designated within the Cmmunity as respnsible persn shall be placed n the market (Article 4.1.). II. Fr each csmetic prduct placed n the market, the respnsible persn shall ensure cmpliance with the relevant bligatins set ut in this Regulatin (Article 4.2.). Hand Cream EU RP appintment 1 Regulatry bligatins (PIF, ntificatin) 2 Hand Cream EU RP: Name & Address 3

34 Nte Speed f the ntificatin prcess depends n: RP knwledge, prfessinalism, capabilities the speed f cllecting the crrect infrmatin raw material suppliers / packaging suppliers / prducers chice Prducer GMP cmpliancy (ISO 22716:2007) is a EU requirement 34

35 Thank yu fr yur attentin! 35

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