the report from dermatological research of … · product purpose shampoo the responsible person is...

79
B (659/11/2016) THE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT WITH HALF OPEN PATCH TEST Product Komili Bebe Responsible Person Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş. Report number B-1529/16 Issue date 19.12.2016

Upload: others

Post on 31-Jan-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

B – (659/11/2016)

THE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT

WITH HALF OPEN PATCH TEST

Product

Komili Bebe

Responsible Person

Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.

Report number B-1529/16 Issue date 19.12.2016

Page 2: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

2/5

Table of contents 1. RESEARCH BASIS ........................................................................................................................................ 3

2. PRODUCT CHARACTERISTIC ..................................................................................................................... 3

3. METHODOLOGY ........................................................................................................................................... 3

4. THE AIM OF STUDY ..................................................................................................................................... 4

5. SUBJECT – VOLUNTEERS SELECTION ..................................................................................................... 4

6. RESULTS ...................................................................................................................................................... 4

7. CONCLUSION ............................................................................................................................................... 5

Page 3: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

3/5

1. RESEARCH BASIS Order date 29.11.2016

Order number 659/11/2016

Research time frame 05.12.2016 – 16.12.2016

Report issue date 19.12.2016

CUSTOMER NAME

Pim Eğitim ve Danişmanlik Hizmetleri, Göktürk Mah. Çamlık Cad. 3 Meşe Sok. No: 3 New Life Sit. B Blok D:17 Eyüp-İstanbul 34077 Turkey

RESPONSIBLE PERSON NAME

Company name Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.

Address

Product name Komili Bebe Ingredients Aqua, Cocamidopropyl Betaine, Polysorbate-20, Olive Oil PEG-7 Esters, Sodium Laureth

Sulfate, Lauryl Glucoside, PEG/PPG-120/10-Trimethylolpropane Trioleate, Laureth-2, Sodium Benzoate, Phenoxyethanol, Olea Europaea Fruit Oil (Olive Oil), Citric Acid, Parfum

2. PRODUCT CHARACTERISTIC Product Package Supplementary – clear plastic jar labeled with name of the product Product Appearance Clear liquid with pleasant scent

Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition and microbiological purity of the delivered research samples.

3. METHODOLOGY The study was conducted in accordance with Regulation of the European Parliament and Council

Regulation (EC) No 1223/2009 of 50 November 2009 on cosmetic. The study was conducted in accordance with recommendation of Cosmetics Europe – The

Personal Care Association Guidelines: product test guidelines for the Assessment of Human Skin Compatibility 1997 guidelines for the evaluation of the Efficacy of Cosmetic Products 2008.

Patch tests according to Jadassohn-Bloch with Rudzki modifications were conducted under careful supervise of medical specialists – dermatologists. The assessment of the allergenic and irritant features was made on a group of 30 healthy volunteers with a diagnosis-proven in studies or history of various types of allergies, atopic dermatitis, hypersensitivity to cosmetics and/or household chemicals /not currently taking any medication that may have any effect on the result of the test/, familiarized with contraindications and recommendations for the study. The probands’ selection, samples application and reading took place in Diagnostic Test in Bialystok. The tested preparation in a commercial formulation is applied to chamber cell-petal patches of Finn Chamber® which are put around a vane. Patches are removed after 48 hours and the first reading is conducted. Another reading takes place 72 hours after insertion of the sample. A dermatologist

Page 4: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

4/5

based on the observations of skin reactions evaluates allergenic action of the conducted substance. Positive reaction (erythema) confirms allergenic properties of the formulation, negative reaction (no erythema) confirms the absence of allergenic properties of the formulation.

4. THE AIM OF STUDY The aim is to assess irritating and allergenic properties of the product in a healthy adult volunteer

by single insert of patch test and the reading of skin reaction after 48 and 72 hours.

5. SUBJECT – VOLUNTEERS SELECTION The selection of probands – volunteers was conducted by a dermatologist according to the

Declaration of Helsinki of 1964 (with subsequent amendments), Polish laws, Cosmetics Europe directives with applying inclusion and exclusion criteria. 30 people took part in the study at the age of 20 - 59 years old: 15 women and 15 men who met the requirements for entering the study and agreed to informed consent to participate in the study. The skin at the selected area was normal, without any lesions. Subjects were informed not to use any kinds of antihistamines or pharmacological agents at the time of test, which may affect the tests’ results.

6. RESULTS Subject Age Code Sex Erythema Oedema Scaling Subject Age Code Sex Erythema Oedema Scaling

1 C 44 F (0) (0) (0) 16 26 A M (0) (0) (0) 2 B 25 M (0) (0) (0) 17 37 C F (0) (0) (0) 3 A 38 M (0) (0) (0) 18 42 C M (0) (0) (0) 4 B 41 F (0) (0) (0) 19 48 B F (0) (0) (0) 5 C 20 M (0) (0) (0) 20 31 A F (0) (0) (0) 6 A 55 F (0) (0) (0) 21 53 C M (0) (0) (0) 7 B 38 F (0) (0) (0) 22 28 B M (0) (0) (0) 8 A 46 F (0) (0) (0) 23 44 A F (0) (0) (0) 9 C 22 M (0) (0) (0) 24 59 C F (0) (0) (0)

10 B 57 F (0) (0) (0) 25 45 A M (0) (0) (0) 11 A 22 M (0) (0) (0) 26 33 C M (0) (0) (0) 12 B 47 M (0) (0) (0) 27 37 B M (0) (0) (0) 13 C 39 F (0) (0) (0) 28 42 C F (0) (0) (0) 14 A 25 F (0) (0) (0) 29 47 C M (0) (0) (0) 15 A 50 M (0) (0) (0) 30 52 B F (0) (0) (0)

Legend: E (erythema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong O (oedema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong S (scaling) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong (-) – negative result, (?) – questionable result M – man, F – woman A – positive allergenic screening, B – hypersensitive skin, C – confirmed allergy

RESULTS: In 30 subjects, the results of patch tests were negative, which means that the product does not cause irritation or allergy reaction in those subjects.

Page 5: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

5/5

7. CONCLUSION 1. Having conducted patch tests, one may state that the Komili Bebe does not have irritant or allergenic

action. 2. The issued opinion does not apply to anybody with an allergy to any of the ingredients of the tested

preparation. 3. The issued opinion does not include analysis of the composition of the product. 4. The tested preparation fulfills requirements for cosmetic products of declared specification i.e. hypo –

allergic, in regards to human health safety. Stamp and Signature of investigator

Adam A. Wroński MD. PhD. Aleksander Wroński MD. PhD 1. The report may be reproduced only in its entirety. Another form of copying requires the written consent of the Contractor. 2. Report from research carried out in two identical copies (copy 1 – Customer, copy 2 –Diagnostic-Test). 3. The results refer only to the product of the composition given by the Principal. 4. The study is an in vivo study, i.e. assessment of the impact of cosmetics on the skin under the Act on cosmetics dated March 30,

2001 and does not constitute a clinical trial within the meaning of the Act on the Law of the pharmaceutical dated 6 September 2001.

5. The presented results apply only to the sample. After completion of the study Dr. Koziej Sp. o.o. sp. k. does not store provided by the Customer testing of materials or samples of the products tested.

Page 6: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

B – (658/11/2016)

THE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT

WITH HALF OPEN PATCH TEST

Product

Komili Bebe

Responsible Person

Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.

Report number B-1553/16 Issue date 19.12.2016

Page 7: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

2/5

Table of contents 1. RESEARCH BASIS ........................................................................................................................................ 3

2. PRODUCT CHARACTERISTIC ..................................................................................................................... 3

3. METHODOLOGY ........................................................................................................................................... 3

4. THE AIM OF STUDY ..................................................................................................................................... 4

5. SUBJECT – VOLUNTEERS SELECTION ..................................................................................................... 4

6. RESULTS ...................................................................................................................................................... 4

7. CONCLUSION ............................................................................................................................................... 5

Page 8: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

3/5

1. RESEARCH BASIS Order date 29.11.2016

Order number 658/11/2016

Research time frame 05.12.2016 – 16.12.2016

Report issue date 19.12.2016

CUSTOMER NAME

Pim Eğitim ve Danişmanlik Hizmetleri, Göktürk Mah. Çamlık Cad. 3 Meşe Sok. No: 3 New Life Sit. B Blok D:17 Eyüp-İstanbul 34077 Turkey

RESPONSIBLE PERSON NAME

Company name Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.

Address

Product name Komili Bebe Ingredients Aqua, Cocamidopropyl Betaine, Polysorbate-20, Olive Oil PEG-7 Esters, Sodium Laureth

Sulfate, Lauryl Glucoside, PEG/PPG-120/10-Trimethylolpropane Trioleate, Laureth-2, Sodium Benzoate, Phenoxyethanol, Olea Europaea Fruit Oil (Olive Oil), Citric Acid, Parfum

2. PRODUCT CHARACTERISTIC Product Package Supplementary – clear plastic jar labeled with name of the product Product Appearance Clear liquid with pleasant scent

Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition and microbiological purity of the delivered research samples.

3. METHODOLOGY The study was conducted in accordance with Regulation of the European Parliament and Council

Regulation (EC) No 1223/2009 of 50 November 2009 on cosmetic. The study was conducted in accordance with recommendation of Cosmetics Europe – The

Personal Care Association Guidelines: product test guidelines for the Assessment of Human Skin Compatibility 1997 guidelines for the evaluation of the Efficacy of Cosmetic Products 2008.

Patch tests according to Jadassohn-Bloch with Rudzki modifications were conducted under careful supervise of medical specialists – dermatologists. The assessment of the allergenic and irritant features was made on a group of 30 healthy volunteers no allergological history, familiarized with contraindications and recommendations for the study /not currently taking any medication that may have any effect on the result of the test/. The probands’ selection, samples application and reading took place in Diagnostic Test in Bialystok. The tested preparation in a commercial formulation is applied to chamber cell-petal patches of Finn Chamber® which are put around a vane. Patches are removed after 48 hours and the first reading is conducted. Another reading takes place 72 hours after insertion of the sample. A dermatologist based on the observations of skin reactions evaluates allergenic action of the conducted substance. Positive

Page 9: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

4/5

reaction (erythema) confirms allergenic properties of the formulation, negative reaction (no erythema) confirms the absence of allergenic properties of the formulation.

4. THE AIM OF STUDY The aim is to assess irritating and allergenic properties of the product in a healthy adult volunteer

by single insert of patch test and the reading of skin reaction after 48 and 72 hours.

5. SUBJECT – VOLUNTEERS SELECTION The selection of probands – volunteers was conducted by a dermatologist according to the

Declaration of Helsinki of 1964 (with subsequent amendments), Polish laws, Cosmetics Europe directives with applying inclusion and exclusion criteria. 30 people took part in the study at the age of 21 - 62 years old: 16 women and 14 men who met the requirements for entering the study and agreed to informed consent to participate in the study. The skin at the selected area was normal, without any lesions. Subjects were informed not to use any kinds of antihistamines or pharmacological agents at the time of test, which may affect the tests’ results.

6. RESULTS Subject Age Sex Erythema Oedema Scaling Subject Age Sex Erythema Oedema Scaling

1 30 F (0) (0) (0) 16 30 F (0) (0) (0) 2 23 F (0) (0) (0) 17 28 F (0) (0) (0) 3 27 M (0) (0) (0) 18 41 M (0) (0) (0) 4 48 M (0) (0) (0) 19 62 F (0) (0) (0) 5 58 F (0) (0) (0) 20 43 M (0) (0) (0) 6 44 F (0) (0) (0) 21 51 M (0) (0) (0) 7 36 F (0) (0) (0) 22 44 F (0) (0) (0) 8 26 M (0) (0) (0) 23 21 M (0) (0) (0) 9 49 F (0) (0) (0) 24 32 F (0) (0) (0)

10 51 M (0) (0) (0) 25 54 F (0) (0) (0) 11 32 M (0) (0) (0) 26 33 F (0) (0) (0) 12 56 F (0) (0) (0) 27 49 M (0) (0) (0) 13 42 M (0) (0) (0) 28 50 M (0) (0) (0) 14 35 F (0) (0) (0) 29 55 F (0) (0) (0) 15 40 M (0) (0) (0) 30 29 M (0) (0) (0)

Legend: E (erythema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong O (oedema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong S (scaling) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong (-) – negative result, (?) – questionable result M – man, F – woman RESULTS: In 30 subjects, the results of patch tests were negative, which means that the product does not cause irritation or allergy reaction in those subjects.

Page 10: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

5/5

7. CONCLUSION 1. Having conducted patch tests, one may state that Komili Bebe does not have irritant or allergenic

action. 2. The issued opinion does not apply to anybody with an allergy to any of the ingredients of the tested

preparation. 3. The issued opinion does not include analysis of the composition of the product. 4. The tested preparation fulfills requirements for cosmetic products of declared specification, in regards

to human health safety. Stamp and Signature of investigator

Adam A. Wroński MD. PhD. Aleksander Wroński MD. PhD 1. The report may be reproduced only in its entirety. Another form of copying requires the written consent of the Contractor. 2. Report from research carried out in two identical copies (copy 1 – Customer, copy 2 –Diagnostic-Test). 3. The results refer only to the product of the composition given by the Principal. 4. The study is an in vivo study, i.e. assessment of the impact of cosmetics on the skin under the Act on cosmetics dated March 30,

2001 and does not constitute a clinical trial within the meaning of the Act on the Law of the pharmaceutical dated 6 September 2001.

5. The presented results apply only to the sample. After completion of the study Dr. Koziej Sp. o.o. sp. k. does not store provided by the Customer testing of materials or samples of the products tested.

Page 11: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 12: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 13: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 14: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 15: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 16: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 17: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 18: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 19: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 20: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 21: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 22: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 23: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 24: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 25: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 26: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 27: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 28: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 29: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 30: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 31: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 32: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 33: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 34: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 35: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ���������

�678'<�3(5,2' ��������������������

�/$%�,' ����������

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�352'8&7�1$0( .20,/,�6(16,7,9(�+$9/8

678'<�5(3257

���+2856�3$7&+�7(676.,1�72/(5$1&(�$66(660(17

�&(57,),&$7(�,' ����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�0(7+2'

���

�%5$1'

�352'8&7�7<3(

4$&6�/WG

���+RXUV�VHPL�RFFOXGHG�SDWFK�WHVWV

127�5,16('��:(7�:,3(6

.20,/,�6(16(7,9(

7$%/(�2)�&217(176

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

678'<�6800$5<���$%675$&7

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$

7(67�0$7(5,$/

0(7+2'�35,1&,3/(

&$/&8/$7,216

5(68/76

',6&866,21�$1'�&21&/86,21

5(68/76�$87+(17,&,7<

��

��

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/($33/,&$7,21�'85,1*����+2856�6(0,�2&&/8'('�3$7&+�21����92/817((56

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 36: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

5HJXODWRU\7KH�VWXG\�KDV�EHHQ�FRQGXFWHG�E\�VXLWDEO\�WUDLQHG��TXDOLILHG�DQG�H[SHULHQFHG�SHUVRQQHO�LQ�DFFRUGDQFH�ZLWK�WKH�'HFODUDWLRQ�RI�+HOVLQNL��������DQG�VXEVHTXHQW�UHYLVLRQV��:RUOG�0HGLFDO�$VVRFLDWLRQ��������&RXQFLO�IRU�,QWHUQDWLRQDO�2UJDQL]DWLRQV�RI�0HGLFDO�6FLHQFHV�DQG�WKH�:RUOG�+HDOWK�2UJDQL]DWLRQ��������DQG�WDNLQJ�LQWR�FRQVLGHUDWLRQ�WKH�UHTXLUHPHQWV�RI�'LUHFWLYHV���������(&�DQG�������8�(&�UHODWLQJ�WR�WKH�LPSOHPHQWDWLRQ�RI�JRRG�FOLQLFDO�SUDFWLFH�LQ�WKH�FRQGXFW�RI�FOLQLFDO�WULDOV�RQ�PHGLFLQDO�SURGXFWV�IRU�KXPDQ�XVH�DQG�WKH�&2/,3$�*XLGHOLQHV�HGLWHG�RQ������IRU�WKH�´3URGXFW�7HVW�*XLGHOLQHV�IRU�WKH�$VVHVVPHQW�RI�+XPDQ�6NLQ�&RPSDWLELOLW\µ��

3UHFDXWLRQV�KDYH�EHHQ�WDNHQ�WR�DYRLG�WKH�SRVVLELOLW\�WKDW�SDUWLFLSDQWV�LQ�WKH�VWXG\�PLJKW�H[SHULHQFH�XQGHVLUDEOH�HIIHFWV��

(WKLFDO�UHTXLUHPHQWV�ZKLFK�KDYH�EHHQ�WDNHQ�LQWR�FRQVLGHUDWLRQ�LQ�WKH�SODQQLQJ�RI�WKH�VWXG\��LQFOXGH�L��SDUWLFLSDQWV�DUH�LQIRUPHG�YROXQWHHUV�VHOHFWHG�DIWHU�DSSOLFDWLRQ�RI�LQFOXVLRQ�QRQ�LQFOXVLRQ�FULWHULD�LL��SDUWLFLSDQWV�DUH�DZDUH�RI�WKH�SXUSRVH�DQG�QDWXUH�RI�WKH�VWXG\�DQG�RI�DQ\�IRUHVHHDEOH�ULVNV�LQYROYHG�LQ�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�DQG�KDYH�JLYHQ�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�WKH�VWXG\�VWDUWV�LLL��D�VDIHW\�HYDOXDWLRQ�KDV�EHHQ�FRQGXFWHG�RQ�WKH�SURGXFW�WHVWHG��EHIRUH�WKH�VWXG\�VWDUWV��LY��WKH�WHVW�SURFHGXUHV�FRQIRUPV�WR�QDWLRQDO�UHJXODWLRQV��Y��WKH�(WKLFDO�5HYLHZ�&RPPLWWHH�LQFOXGH�PHGLFDO��QRQ�PHGLFDO��DSSURSULDWH�H[SHUWV�DQG�OD\�PHPEHUV��LW�KDV�FRQVLGHU�WKH�JHQHUDO�HWKLFV�RI�WKH�WHVW�DQG�YHULILHG�WKDW�WKH�VDIHW\�DQG�LQWHJULW\�RI�WKH�SDUWLFLSDQWV�LQ�WKH�WHVW�DUH�SURWHFWHG��WDNLQJ�LQWR�DFFRXQW�LQIRUPDWLRQ�RQ�WKH�LQJUHGLHQW�V��YL��DOO�UHDVRQDEOH�FDUH�KDV�EHHQ�WDNHQ�WR�DYRLG�FDXVLQJ�H[FHVVLYH�VNLQ�UHDFWLRQV�RU�RWKHU�DGYHUVH�KHDOWK�HIIHFWV�LQ�WKH�SDUWLFLSDQWV�GXULQJ�WKH�VWXG\�YLL��VDIHW\�SURFHGXUHV�DUH�LQ�SODFH�LQ�WKH�HYHQW�RI�DQ\�XQH[SHFWHG�DGYHUVH�UHDFWLRQV��LQFOXGLQJ�DSSURSULDWH�PHGLFDO�FRYHU�YLLL��YROXQWHHUV�DUH�UHZDUGHG�IRU�WKHLU�WLPH��LQFRQYHQLHQFH��HWF���EXW�WKH�UHZDUG�LV�QRW�VR�JUHDW�WKDW�LW�ZRXOG�SHUVXDGH�WKHP�WR�SDUWLFLSDWH�

&RQILGHQWLDOLW\5HTXLUHPHQWV�RI�/DZ�����������RQ�WKH�3URWHFWLRQ�RI�,QGLYLGXDOV�ZLWK�UHJDUG�WR�WKH�3URFHVVLQJ�RI�3HUVRQDO�Data�DUH�WDNHQ�LQWR�FRQVLGHUDWLRQ��3URFHVVLQJ�RI�YROXQWHHUV�SHUVRQDO�GDWD�LV�FDUULHG�RXW�E\�GRFWRUV�RU�RWKHU�SHUVRQV�UHQGHULQJ�PHGLFDO�VHUYLFHV��SURYLGHG�WKDW�WKH�&RQWUROOHU�LV�ERXQG�E\�PHGLFDO�FRQILGHQWLDOLW\�RU�RWKHU�REOLJDWLRQ�RI�SURIHVVLRQDO�VHFUHF\��SURYLGHG�IRU�LQ�/DZ�RU�FRGH�RI�SUDFWLFH��DQG�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��3URFHVVLQJ�LV�FDUULHG�RXW�ZLWKLQ�WKH�ODERUDWRU\�SUHPLVHV�DQG�UHODWHV�WR�SHUVRQDO�GDWD�RI�WKH�YROXQWHHUV��SURYLGHG�WKDW�WKH�ODWWHU�KDYH�JLYHQ�WKHLU�FRQVHQW�DQG�WKDW�VXFK�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��7KH�DQRQ\PLW\�RI�WKH�YROXQWHHUV�LV�UHVSHFWHG�ZLWKLQ�DOO�VWXGLHV�FDUULHG�RXW�LQ�RXU�ODERUDWRULHV��(DFK�YROXQWHHU�FDQ�EH�LGHQWLILHG�E\�WKH�,QYHVWLJDWRU��WKH�GRFWRUV�DQG�DOO�WKH�SHUVRQV�LQ�FKDUJH�RI�WKH�VWXG\��WKDQNV�WR�KLV�SHUVRQDO�YROXQWHHUV�FRGH�

$UFKLYLQJ7KH�ODERUDWRU\�ERRN�ZKLFK�FRQWDLQV�DOO�WKH�LQIRUPDWLRQ��UDZ�GDWD�DQG�UHVXOWV��UHJDUGLQJ�WKH�VWXG\�DQG�WKH�VWXG\�UHSRUWV�DUH�NHSW�LQ�WKH�ODERUDWRU\�DUFKLYHV�GXULQJ���\HDUV�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 37: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

678'<�6800$5<���$%675$&7

$33/,&$7,21�'85,1*����+2856�6(0,�2&&/8'('�3$7&+�21����92/817((56

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/(

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ���������

�678'<�3(5,2' ��������������������

�/$%�,' ����������

�352'8&7�1$0( .20,/,�6(16,7,9(�+$9/8

�&(57,),&$7(�,' ����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�7(67�0(7+2'

���

�%5$1'

�352'8&7�7<3(

4$&6�/WG

6LQJOH�DSSOLFDWLRQ������+RXUV�VHPL�RFFOXGHG�SDWFK�WHVWV

127�5,16('��:(7�:,3(6

.20,/,�6(16(7,9(

�3$1(/ ���KHDOWK\�DGXOW�YROXQWHHUV

�$33/,&$7,21�$5($ 2Q�WKH�EDFN

�48$17,7<�2)�352'8&7 �����PO

�0(7+2'2/2*<�$%675$&7 7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVWPDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFKUHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQUHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHGDVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQGXQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJVFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�DQXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ�YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LVFDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFKYROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\LUULWDQW���

5(68/7 � 7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�LV������

&21&/86,21 � $FFRUGLQJ�WR�WKH�H[SHULPHQWDO�FRQGLWLRQV�RI�WKH�VWXG\��WKH�WHVW�SURGXFW��FDQ�EH�FRQVLGHUHG�DV�Non irritant UHJDUGLQJ�,WV�SULPDU\�VNLQ�WROHUDQFH�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

����������

Page 38: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

6NLQ�FRPSDWLELOLW\�LV�GHILQHG�DV�WKH�DEVHQFH�RI�VNLQ�LUULWDWLRQ�XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH��WDNLQJ�LQWR�DFFRXQW�REMHFWLYH�UHDFWLRQV�DV�ZHOO�DV�VXEMHFWLYH�UHVSRQVHV�VXFK�DV�VWLQJLQJ��EXUQLQJ�RU�LWFKLQJ��6NLQ�LUULWDWLRQ�LV�GHILQHG�DV�QRQ�LPPXQRORJLFDO�ORFDO�VNLQ�LQIODPPDWLRQ�

7KLV�WHVW�LQYROYHV�VLQJOH�DSSOLFDWLRQ�����KRXU�VHPL�RFFOXGHG�SDWFK�WHVW�7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�D�QXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ��YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LV�FDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFK�YROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\�LUULWDQW���

7KH�REMHFWLYH�RI�WKH�WHVW�LV�WR�GHWHUPLQH�ZKHWKHU�RU�QRW�WKH�SURGXFW�LV�OLNHO\�WR�LQGXFH�VNLQ�LUULWDWLRQ��XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH�FRQGLWLRQV�

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$�

1XPEHU�RI�YROXQWHHUV$�QXPEHU�RI�20�YROXQWHHUV�KDV�EHHQ�UHFUXLWHG�WR�VDWLVI\�WKH�REMHFWLYHV�RI�WKH�WHVW��

3DQHO�FKDUDFWHULVWLFV9ROXQWHHUV�DUH�VHOHFWHG�RQ�WKH�EDVLV�RI�LQFOXVLRQ�DQG�QRQ�LQFOXVLRQ�FULWHULD��7KH�YROXQWHHUV�VDWLVI\�DOO�WKH�LQFOXVLRQ�FULWHULD�DQG�DUH�QRW�LQ�FRQIOLFW�ZLWK�DQ\�RI�WKH�QRQ�LQFOXVLRQ�FULWHULD�DQG�KDG�D�PHGLFDO�H[DPLQDWLRQ��KHDOWK�FHUWLILFDWH��DQG�D�GHUPDWRORJLFDO�H[DPLQDWLRQ��7KH�YROXQWHHUV�DUH�FOHDUO\�LQIRUPHG��YHUEDOO\�DQG�LQ�ZULWLQJ��UHJDUGLQJ�WKH�QDWXUH�RI�WKH�VWXG\��WKH�WLPHWDEOH��FRQVWUDLQWV�DQG�SRVVLEOH�ULVNV��7KH\�JLYH�WKHLU�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�

,QFOXVLRQ�FULWHULD? ,QIRUPHG�YROXQWHHUV�ZKR�DJUHH�WR�IROORZ�WKH�FRQGLWLRQV�VSHFLILHG? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�DJH����������\HDUV�ROG�? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�JHQGHU����IHPDOH�DQG�RU�PDOH? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�RULJLQ�DQG�KHDOWK�? IUHH�IURP�DQ\�GHUPDWRORJLFDO�SUREOHPV�RQ�WKH�DUHD�VWXGLHG? PHHW�WKH�VSHFLILF�VWXG\�FULWHULD�RQ�VNLQ�W\SH? SURRI�RI�KRPH�DGGUHVV��VRFLDO�VHFXULW\�QXPEHU? DEOH�WR�XQGHUVWDQG�WKH�*UHHN�ODQJXage�DQG�WKH�VWXG\�UHTXLUHPHQWV

1RQ�LQFOXVLRQ�FULWHULD? YROXQWHHUV�ZKR�GRHV�QRW�PHHW�WKH�LQFOXVLRQ�FULWHULD? SUHJQDQF\�RU�QXUVLQJ�FRQGLWLRQ�? LUULWDWHG�VNLQ�RQ�WHVW�VLWH�V�? EOHPLVKHV��PDUNV��H�J��WDWWRRV��VFDUV��VXQEXUQ��RQ�WKH�WHVW�VLWH�V�? PHGLFDWLRQ�ZKLFK�PD\�DIIHFW�VNLQ�UHVSRQVH�DQG�RU�SDVW�PHGLFDO�KLVWRU\? SUHVHQWLQJ�VNLQ�SDWKRORJ\�ZKLFK�PD\�LQWHUIHUH�ZLWK�WKH�DLP�V��RI�WKH�VWXG\�? SUHVHQWLQJ��FRQWDFW�DOOHUJ\�WR�RQH�RI�WKH�LQJUHGLHQWV�RI�WKH�WHVWHG�SURGXFW? SDUWLFLSDWLRQ�LQ�DQRWKHU�VLPXOWDQHRXV�VWXG\�? SDUWLFLSDWLRQ�LQ�D�SUHYLRXV�VWXG\�ZLWKRXW�DQ�DSSURSULDWH�UHVW�SHULRG�EHWZHHQ�VWXGLHV? PLQRUV�RU�PDMRUV�SURWHFWHG�E\�WKH�ODZ�DQG�SHRSOH�DGPLWWHG�LQ�D�VDQLWDU\�RU�VRFLDO�LQVWLWXWLRQ�IRU�RWKHU�SXUSRVH�WKDQ�

UHVHDUFK? SHUVRQV�GHSULYHG�RI�OLEHUW\�E\�OHJDO�RU�DGPLQLVWUDWLYH�GHFLVLRQ��SDWLHQWV�LQ�HPHUJHQF\�VLWXDWLRQ? YROXQWHHUV�ZKR�UHIXVHG�WR�JLYH�WKHLU�IUHH�DQG�LQIRUPHG�FRQVHQW�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 39: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

6WXG\�FRQVWUDLQWV'XULQJ�WKH�OHQJWK�RI�WKH�VWXG\��WKH�YROXQWHHUV�DUH�DVNHG�

? 1RW�WR�SXW�DQ\�SURGXFW��DOVR�ZDWHU�RQ�WKH�SDWFKHV�DUHD�? 1RW�WR�KDYH�D�EDWK��QHLWKHU�WR�H[SRVH�WKHPVHOYHV�WR�89�? 7R�DYRLG�DOO�LQWHQVH�VSRUWLYH�DFWLYLWLHV�WKDW�FRXOG�UHPRYH�WKH�SDWFK�? 1RW�WR�WDNH�DVSLULQ��DQWL�KLVWDPLQLFV��FRUWLFRLGV��DQWL�LQIODPPDWRULHV�DQG�DQ\�RWKHU�WUHDWPHQW�GHFUHDVLQJ�RU�

DYRLGLQJ�LQIODPPDWLRQV�RU�DOOHUJLHV�RU�LQWHUIHULQJ�ZLWK�WKH�VNLQ�PHWDEROLVP�

9ROXQWHHUV�ZLWKGUDZDOV3DUWLFLSDQWV�ZLOO�EH�ZLWKGUDZQ�IRU�WKH�IROORZLQJ�UHDVRQV�

? WKH\�GR�QRW�IROORZ�WKH�FRQGLWLRQV�RI�WKH�6WXG\�,QIRUPDWLRQ�6KHHW�? WKH\�VXIIHU�DQ\�LOOQHVV�RU�DFFLGHQW�RU�GHYHORS�DQ\�FRQGLWLRQ�GXULQJ�WKH�VWXG\�ZKLFK�FRXOG�DIIHFW�WKH�RXWFRPH�RI�WKH�

VWXG\�? WKH\�QR�ORQJHU�ZLVK�WR�SDUWLFLSDWH�LQ�WKH�VWXG\�

7(67�0$7(5,$/

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ���������

�678'<�3(5,2' ��������������������

�/$%�,' ����������

�352'8&7�1$0( .20,/,�6(16,7,9(�+$9/8

�&(57,),&$7(�,' ����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�6725$*(�&21',7,216

���

�%5$1'

�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

127�5,16('��:(7�:,3(6

.20,/,�6(16(7,9(

$�VDPSOH�RI�WKH�WHVWHG�SURGXFW�LV�NHSW�DW�WKH�4$&6�ODERUDWRULHV�IRU���PRQWK�DIWHU�WKH�HQG�RI�WKH�VWXG\��$IWHU�WKLV�GDWH�DQGXQOHVV�FRQWUDU\�UHTXLUHPHQW�IURP�WKH�VWXG\�VSRQVRU��WKH�SURGXFW�ZLOO�EH�GHVWUR\HG�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 40: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

0(7+2'�35,1&,3/(

7KH�SULQFLSOH�RI�WKH�VWXG\�LV�EDVHG�RQ�WKH�VLQJOH�DSSOLFDWLRQ�RI�����PO�RI�WHVWHG�SURGXFW��RQ�WKH�VNLQ�RI�WKH�EDFN�RI�DGXOW�YROXQWHHUV��7KH�SURGXFW�LV�NHSW�LQ�FRQWDFW�ZLWK�WKH�VNLQ�IRU����KRXUV�XQGHU�VHPL�RFFOXGHG�SDWFK�

(TXLSPHQW

7KH�HTXLSPHQW�XVHG�IRU�WKH�VHPL�RFFOXGHG�SDWFK�LV�FRPSRVHG�RI�D�VPDOO�SODVWLF�FDYLW\�RI������FP²�ZLWK�D�ILOWHU�WLVVXH�DW�WKH�ERWWRP�ZKLFK�LV�PDGH�WR�UHFHLYH�WKH�SURGXFW�WR�WHVW��$OO�WKLV�LV�IL[HG�WR�D�K\SRDOOHUJHQLF�QRQ�ZRYHQ�DGKHVLYH�WDSH�

'RVH�OHYHO

7KH�DPRXQW�RI�WHVW�PDWHULDO�DSSOLHG�WR�HDFK�SDWFK�����PO�LV�VXIILFLHQW�WR�ILOO�WKH�FKDPEHU�DQG�VDWXUDWH�WKH�SDG�ZLWKRXW�RYHUIORZLQJ�IURP�LW�ZKHQ�DSSOLHG�WR�WKH�VNLQ�

7HVW�PDWHULDO�DSSOLFDWLRQ

7KH�DUHD�RQ�ZKLFK�WKH�SDWFK�LV�DSSOLHG�LV�SUHYLRXVO\�FOHDQHG�XS�ZLWK�GHPLQHUDOLVHG�ZDWHU�DQG�GULHG�ZLWK�FHOOXORVH�FRWWRQ�ZRRO�WLVVXH�7KH�SDWFKHV�DUH�SXW�RQ�WKH�EDFN�RI�WKH�YROXQWHHU�7KH�SURGXFWV�DUH�WHVWHG�SXUH�RU�GLOXWHG�GHSHQGLQJ�RQ�WKHLU�W\SH�DQG�WKHLU�XVH��? 0RVWO\��WKH�SURGXFWV�DUH�WHVWHG�SXUH��? 5LQVH�RII�SURGXFWV�DUH�WHVWHG�GLOXWHG�DW�����? 'HWHUJHQWV�DUH�WHVWHG�GLOXWHG�DW�����? +\GURSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�GHPLQHUDOLVHG�ZDWHU? /LSRSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�PLQHUDO�RLO�? 3RZGHUV�DUH�SXW�SXUH�LQ�WKH�SDWFK�VPDOO�FDYLW\�DQG�WKHQ�PRLVWHQHG�VXIILFLHQWO\�ZLWK�D�GURS�RI�PLQHUDO�RLO�LQ�RUGHU�

WR�WR�HQVXUH�JRRG�FRQWDFW�ZLWK�WKH�VNLQ�DQG�DYRLG�WKH�SURGXFW�GLVSHUVLRQ�ZKLOH�DSSO\LQJ�WKH�SDWFK�7KH�SDWFKHV�WKXV�SUHSDUHG�DUH�OHIW�LQ�FRQWDFW����KRXUV�

1HJDWLYH�FRQWUROV

:KLOVW�WKLV�DFWLYLW\�LV�DOZD\V�EH�RQ�D�FDVH�E\�FDVH�EDVLV�DQG�ZLOO�GHSHQG�RQ�WKH�QDWXUH�DQG�W\SH�RI�VWXG\��WKH�PRVW�FRPPRQ�DSSURDFK�LV�WR�FRPSDUH�WKH�UHVXOWV�REWDLQHG�IRU�WKH�WHVW�PDWHULDOV�ZLWK�WKRVH�RI�VXLWDEOH�SRVLWLYH�DQG�RU�QHJDWLYH�FRQWUROV��RU�ZLWK�VLPLODU�PDWHULDOV�$��QHJDWLYH��FRQWURO�LV�D�SDWFK�ZLWKRXW�DQ\�SURGXFW��DSSOLHG�LQ�WKH�VDPH�FRQGLWLRQV�DV�WKH�SURGXFW�WR�EH�WHVWHG�? LI�WKH�SURGXFW�LV�WHVWHG�SXUH��HPSW\�SDWFK�? LI�WKH�SURGXFW�LV�WHVWHG�GLOXWHG��SDWFK�ZLWK�����PO�RI�WKH�VROYHQW�XVHG��GHPLQHUDOLVHG�ZDWHU�RU�PLQHUDO�RLO��

9LVXDO�DVVHVVPHQW

7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ��6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU�ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 41: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

(;$03/(�2)�6&25,1*�6&$/(

(5<7+(0$

�� �QR�HYLGHQFH�RI�HU\WKHPD

���� �PLQLPDO�RU�GRXEWIXO�HU\WKHPD

�� �VOLJKW�UHGQHVV��VSRWW\�DQG�GLIIXVH

�� �PRGHUDWH��XQLIRUP�UHGQHVV

�� �VWURQJ�XQLIRUP�UHGQHVV

�� �ILHU\�UHGQHVV

'5<1(66��6&$/,1*�

�� �QR�HYLGHQFH�RI�VFDOLQJ

���� �GU\�ZLWKRXW�VFDOLQJ��DSSHDUV�VPRRWK�DQG�WDXW

�� �ILQH�PLOG�VFDOLQJ

�� �PRGHUDWH�VFDOLQJ

�� �VHYHUH�VFDOLQJ�ZLWK�ODUJH�IODNHV

2('(0$

� �DEVHQFH�RI�RHGHPD

�� �SUHVHQFH�RI�RHGHPD

(;$03/(�2)�6&25,1*�6&$/(

7KH�UHVXOWV�REWDLQHG�DUH�FRPSDUHG�WR�WKRVH�REWDLQHG�RQ�WKH�FRQWURO�]RQH��7KH�$YHUDJH�,UULWDWLRQ�,QGH[��RU�3ULPDU\�6NLQ,UULWDWLRQ��LV�FDOFXODWHG�DV�WKH�DYHUDJH�RI�UHDGLQJV��REWDLQHG�RQ��WKH�YROXQWHHUV�SRSXODWLRQ�

�1XPEHU�RI�YROXQWHHUV

YRO���WR�YRO�Q�PDUNV�7���> @� QXPEHU�RI�UHDGLQJV

&ODVVLILFDWLRQ�RI�WKH�LUULWDQW�SRWHQWLDO

$YHUDJH�LUULWDWLRQ�LQGH[ &ODVVLILFDWLRQ

�������� 1RQ�LUULWDQW

����������� 9HU\�VOLJKWO\�LUULWDQW

����������� 6OLJKWO\�LUULWDQW

�������� 0RGHUDWHO\�LUULWDQW

�������� ,UULWDQW

!����� 9HU\�LUULWDQW

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 42: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76

3DQHO�GHVFULSWLRQ7KLV�VWXG\�LQFOXGHV����KHDOWK\�DGXOW�YROXQWHHUV�ZKRP�FKDUDFWHULVWLFV�DUH�GHVFULEHG�EHORZ�

9ROXQWHHUV�FKDUDFWHULVWLFV

(YHQWV�RFFXUHG�GXULQJ�WKH�VWXG\

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ) �� 1RUPDO�VNLQ

� ���� ) �� 1RUPDO�VNLQ

� ���� ) �� 1RUPDO�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� 0 �� 1RUPDO�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ) �� 1RUPDO�VNLQ

�� ���� 0 �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

92/�,'92/817((5

&2'( 6(; $*( &+$5$&7(5,67,&6

1RQH�RI�WKH�YROXQWHHUV�VHOHFWHG�WRRN�D�WUHDWPHQW�FRQWUDLQGLFDWHG�ZLWK�WKH�VWXG\�

6WXG\�ZLWKGUDZDOV1R�ZLWKGUDZDO�RI�WKH�VWXG\�KDSSHQHG�

6NLQ�UHDFWLRQV1R�VNLQ�UHDFWLRQ�ZDV�QRWLFHG�E\�WKH�GHUPDWRORJLVW�RQ�WKH�UHIHUHQFH�DUHD�IRU�DOO�WKH�YROXQWHHUV�

5HVXOWV�DQDO\VLV5HVXOWV�REWDLQHG�IRU�HDFK�YROXQWHHU�DV�ZHOO�DV�WKH�FRUUHVSRQGLQJ�LUULWDWLRQ�LQGH[�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

����������

Page 43: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76��FRQWLQXHG�

�',675,%8725�352'8&7�0$18)$&785('�%<�5(&(,37�'$7( ����������678'<�3(5,2' ���������������������/$%�,' �����������352'8&7�1$0( .20,/,�6(16,7,9(�+$9/8

�&(57,),&$7(�,' ����������������������

6&$�<,/',=�6&$�<,/',=

�678'<�6321625�/27

�6725$*(�&21',7,216

���

�%5$1'�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

127�5,16('��:(7�:,3(6.20,/,�6(16(7,9(

(5<7+(0$ '5<1(66 2('(0$7RWDO�UHDGLQJV

��KUV

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� 0 ��

� ���� ) ��

� ���� ) ��

�� ���� 0 ��

�� ���� ŋ ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ŋ ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ) ��

92/�,'92/817((5

&2'(6(; $*(

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

7RWDO�UHDGLQJ���KUV��DOO�YROXQWHHUV �

1XPEHU�RI�UHDGLQJV �

7RWDO�LUULWDWLRQ���QXPEHU�RI�UHDGLQJV �

,UULWDWLRQ�LQGH[ ����

5HVXOW 1RQ�LUULWDQW

$IWHU����KRXUV�RI�DSSOLFDWLRQ��QR�VNLQ�UHDFWLRQ�ZDV�REVHUYHG��E\�WKH�GHUPDWRORJLVW�RQ�WKH�DUHD�WUHDWHG�7KH�DYHUDJH�LUULWDWLRQ�LQGH[�REWDLQHG�LV�HTXDO�WR������

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

����������

Page 44: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7KLV�GRFXPHQW�KDV�EHHQ�HOHFWURQLFDOO\�VLJQHG�E\�WKRVH�QDPHV�WKDW�DSSHDU�RQ�WKLV�UHSRUW�DQG�DUH�WKH�DXWKRUL]HG�VLJQDWRULHV�

',6&866,21�$1'�&21&/86,21

,Q�WKH�H[SHULPHQWDO�FRQGLWLRQV��DIWHU�D�VLQJOH�DSSOLFDWLRQ�RI������PO�RI�WKH�SURGXFW�XQGHU�VHPL�RFFOXGHG�SDWFK�DQG�GXULQJ���KRXUV��RQ����KHDOWK\�DGXOW�YROXQWHHUV�DQG�DFFRUGLQJ�WR�WKH�VFDOH�XVHG�IRU�WKH�LQWHUSUHWDWLRQ�RI�WKH�UHVXOWV��WKH�.20,/,6(16,7,9(�+$9/8�FDQ�EH�FRQVLGHUHG�DV�1RQ�LUULWDQW�UHJDUGLQJ�LWV�SULPDU\�VNLQ�WROHUDQFH�

5(68/76�$87+(17,&,7<

7KH�VWXG\�FRQFHUQHG�E\�WKLV�UHSRUW�ZDV�FDUULHG�RXW�XQGHU�P\�UHVSRQVLELOLW\��DFFRUGLQJ�WR�WKH�H[SHULPHQWDO�SURWRFRO�DQG�WKHTXDOLW\�SODQ�RI�WKH�4$&6�/WG�ODERUDWRU\��DQG�IROORZV�WKH�JRRG�FOLQLFDO�SUDFWLFHV�$OO�WKH�REVHUYDWLRQV�DQG�GDWD�UHFRUGHG�GXULQJ�WKLV�WULDO�DUH�UHSRUWHG�LQ�WKLV�VWXG\�UHSRUW�

,�FHUWLI\�WKH�UHUHDGLQJ�RI�WKLV�UHSRUW�DQG�GR�DJUHH�ZLWK�LWV�FRQWHQW

'DWH�������������

6WXG\�0DQDJHU��

3ULQWHG�QDPH����7VLWRXULV�&KDULODRV

'DWH�������������

,QYHVWLJDWLQJ�GRFWRU��

3ULQWHG�QDPH����&KULVWRV�3UHYH]DV

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KH�GLOXWLRQ�RI�WKH�VDPSOH�WHVWHG��GHSHQGV�RQ�WKH�W\SH�RI�SURGXFW�VHH�SDJH�����7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\�ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

����������

Page 45: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7�(�6�7���5�(�3�2�5�7�����������

3�$�7�&�+����7�(�6�7����5�(�3�2�5�7

.20,/,�6,9,�6$%81�=(<7,1�&,&(*,���/,48,'�62$3�2/,9(�%/266021

6&$�<,/',=�.$*,7�9(�.,6,6(/�%$.,0�85(7,0�$�6�

3DJH���RI��������������

6(37(0%(5�����

Page 46: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�352'8&7�1$0( .20,/,�6,9,�6$%81�=(<7,1�&,&(*,���/,48,'�62$3�2/,9(�%/266021

678'<�5(3257

���+2856�3$7&+�7(676.,1�72/(5$1&(�$66(660(17

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�0(7+2'

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

���+RXUV�RFFOXVLYH�SDWFK�WHVWV

5,16('��/,48,'�62$3

.20,/,

7$%/(�2)�&217(176

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

678'<�6800$5<���$%675$&7

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$

7(67�0$7(5,$/

0(7+2'�35,1&,3/(

&$/&8/$7,216

5(68/76

',6&866,21�$1'�&21&/86,21

5(68/76�$87+(17,&,7<

��

��

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/($33/,&$7,21�'85,1*����+2856�2&&/86,9(�3$7&+�21����92/817((56

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 47: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

5HJXODWRU\7KH�VWXG\�KDV�EHHQ�FRQGXFWHG�E\�VXLWDEO\�WUDLQHG��TXDOLILHG�DQG�H[SHULHQFHG�SHUVRQQHO�LQ�DFFRUGDQFH�ZLWK�WKH�'HFODUDWLRQ�RI�+HOVLQNL��������DQG�VXEVHTXHQW�UHYLVLRQV��:RUOG�0HGLFDO�$VVRFLDWLRQ��������&RXQFLO�IRU�,QWHUQDWLRQDO�2UJDQL]DWLRQV�RI�0HGLFDO�6FLHQFHV�DQG�WKH�:RUOG�+HDOWK�2UJDQL]DWLRQ��������DQG�WDNLQJ�LQWR�FRQVLGHUDWLRQ�WKH�UHTXLUHPHQWV�RI�'LUHFWLYHV���������(&�DQG�������8�(&�UHODWLQJ�WR�WKH�LPSOHPHQWDWLRQ�RI�JRRG�FOLQLFDO�SUDFWLFH�LQ�WKH�FRQGXFW�RI�FOLQLFDO�WULDOV�RQ�PHGLFLQDO�SURGXFWV�IRU�KXPDQ�XVH�DQG�WKH�&2/,3$�*XLGHOLQHV�HGLWHG�RQ������IRU�WKH�´3URGXFW�7HVW�*XLGHOLQHV�IRU�WKH�$VVHVVPHQW�RI�+XPDQ�6NLQ�&RPSDWLELOLW\µ��

3UHFDXWLRQV�KDYH�EHHQ�WDNHQ�WR�DYRLG�WKH�SRVVLELOLW\�WKDW�SDUWLFLSDQWV�LQ�WKH�VWXG\�PLJKW�H[SHULHQFH�XQGHVLUDEOH�HIIHFWV��

(WKLFDO�UHTXLUHPHQWV�ZKLFK�KDYH�EHHQ�WDNHQ�LQWR�FRQVLGHUDWLRQ�LQ�WKH�SODQQLQJ�RI�WKH�VWXG\��LQFOXGH�L��SDUWLFLSDQWV�DUH�LQIRUPHG�YROXQWHHUV�VHOHFWHG�DIWHU�DSSOLFDWLRQ�RI�LQFOXVLRQ�QRQ�LQFOXVLRQ�FULWHULD�LL��SDUWLFLSDQWV�DUH�DZDUH�RI�WKH�SXUSRVH�DQG�QDWXUH�RI�WKH�VWXG\�DQG�RI�DQ\�IRUHVHHDEOH�ULVNV�LQYROYHG�LQ�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�DQG�KDYH�JLYHQ�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�WKH�VWXG\�VWDUWV�LLL��D�VDIHW\�HYDOXDWLRQ�KDV�EHHQ�FRQGXFWHG�RQ�WKH�SURGXFW�WHVWHG��EHIRUH�WKH�VWXG\�VWDUWV��LY��WKH�WHVW�SURFHGXUHV�FRQIRUPV�WR�QDWLRQDO�UHJXODWLRQV��Y��WKH�(WKLFDO�5HYLHZ�&RPPLWWHH�LQFOXGH�PHGLFDO��QRQ�PHGLFDO��DSSURSULDWH�H[SHUWV�DQG�OD\�PHPEHUV��LW�KDV�FRQVLGHU�WKH�JHQHUDO�HWKLFV�RI�WKH�WHVW�DQG�YHULILHG�WKDW�WKH�VDIHW\�DQG�LQWHJULW\�RI�WKH�SDUWLFLSDQWV�LQ�WKH�WHVW�DUH�SURWHFWHG��WDNLQJ�LQWR�DFFRXQW�LQIRUPDWLRQ�RQ�WKH�LQJUHGLHQW�V��YL��DOO�UHDVRQDEOH�FDUH�KDV�EHHQ�WDNHQ�WR�DYRLG�FDXVLQJ�H[FHVVLYH�VNLQ�UHDFWLRQV�RU�RWKHU�DGYHUVH�KHDOWK�HIIHFWV�LQ�WKH�SDUWLFLSDQWV�GXULQJ�WKH�VWXG\�YLL��VDIHW\�SURFHGXUHV�DUH�LQ�SODFH�LQ�WKH�HYHQW�RI�DQ\�XQH[SHFWHG�DGYHUVH�UHDFWLRQV��LQFOXGLQJ�DSSURSULDWH�PHGLFDO�FRYHU�YLLL��YROXQWHHUV�DUH�UHZDUGHG�IRU�WKHLU�WLPH��LQFRQYHQLHQFH��HWF���EXW�WKH�UHZDUG�LV�QRW�VR�JUHDW�WKDW�LW�ZRXOG�SHUVXDGH�WKHP�WR�SDUWLFLSDWH�

&RQILGHQWLDOLW\5HTXLUHPHQWV�RI�/DZ�����������RQ�WKH�3URWHFWLRQ�RI�,QGLYLGXDOV�ZLWK�UHJDUG�WR�WKH�3URFHVVLQJ�RI�3HUVRQDO�Data�DUH�WDNHQ�LQWR�FRQVLGHUDWLRQ��3URFHVVLQJ�RI�YROXQWHHUV�SHUVRQDO�GDWD�LV�FDUULHG�RXW�E\�GRFWRUV�RU�RWKHU�SHUVRQV�UHQGHULQJ�PHGLFDO�VHUYLFHV��SURYLGHG�WKDW�WKH�&RQWUROOHU�LV�ERXQG�E\�PHGLFDO�FRQILGHQWLDOLW\�RU�RWKHU�REOLJDWLRQ�RI�SURIHVVLRQDO�VHFUHF\��SURYLGHG�IRU�LQ�/DZ�RU�FRGH�RI�SUDFWLFH��DQG�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��3URFHVVLQJ�LV�FDUULHG�RXW�ZLWKLQ�WKH�ODERUDWRU\�SUHPLVHV�DQG�UHODWHV�WR�SHUVRQDO�GDWD�RI�WKH�YROXQWHHUV��SURYLGHG�WKDW�WKH�ODWWHU�KDYH�JLYHQ�WKHLU�FRQVHQW�DQG�WKDW�VXFK�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��7KH�DQRQ\PLW\�RI�WKH�YROXQWHHUV�LV�UHVSHFWHG�ZLWKLQ�DOO�VWXGLHV�FDUULHG�RXW�LQ�RXU�ODERUDWRULHV��(DFK�YROXQWHHU�FDQ�EH�LGHQWLILHG�E\�WKH�,QYHVWLJDWRU��WKH�GRFWRUV�DQG�DOO�WKH�SHUVRQV�LQ�FKDUJH�RI�WKH�VWXG\��WKDQNV�WR�KLV�SHUVRQDO�YROXQWHHUV�FRGH�

$UFKLYLQJ7KH�ODERUDWRU\�ERRN�ZKLFK�FRQWDLQV�DOO�WKH�LQIRUPDWLRQ��UDZ�GDWD�DQG�UHVXOWV��UHJDUGLQJ�WKH�VWXG\�DQG�WKH�VWXG\�UHSRUWV�DUH�NHSW�LQ�WKH�ODERUDWRU\�DUFKLYHV�GXULQJ���\HDUV�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 48: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

678'<�6800$5<���$%675$&7

$33/,&$7,21�'85,1*����+2856�2&&/86,9(�3$7&+�21����92/817((56

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/(

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

�352'8&7�1$0( .20,/,�6,9,�6$%81�=(<7,1�&,&(*,���/,48,'�62$3�2/,9(�%/266021

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�7(67�0(7+2'

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

6LQJOH�DSSOLFDWLRQ������+RXUV�RFFOXVLYH�SDWFK�WHVWV

5,16('��/,48,'�62$3

.20,/,

�3$1(/ ���KHDOWK\�DGXOW�YROXQWHHUV

�$33/,&$7,21�$5($ 2Q�WKH�EDFN

�48$17,7<�2)�352'8&7 �����PO

�0(7+2'2/2*<�$%675$&7 7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVWPDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFKUHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQUHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHGDVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQGXQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJVFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�DQXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ�YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LVFDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFKYROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\LUULWDQW���

5(68/7 � 7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�LV������

&21&/86,21 � $FFRUGLQJ�WR�WKH�H[SHULPHQWDO�FRQGLWLRQV�RI�WKH�VWXG\��WKH�WHVW�SURGXFW��FDQ�EH�FRQVLGHUHG�DV�Non irritant UHJDUGLQJ�,WV�SULPDU\�VNLQ�WROHUDQFH�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 49: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

6NLQ�FRPSDWLELOLW\�LV�GHILQHG�DV�WKH�DEVHQFH�RI�VNLQ�LUULWDWLRQ�XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH��WDNLQJ�LQWR�DFFRXQW�REMHFWLYH�UHDFWLRQV�DV�ZHOO�DV�VXEMHFWLYH�UHVSRQVHV�VXFK�DV�VWLQJLQJ��EXUQLQJ�RU�LWFKLQJ��6NLQ�LUULWDWLRQ�LV�GHILQHG�DV�QRQ�LPPXQRORJLFDO�ORFDO�VNLQ�LQIODPPDWLRQ�

7KLV�WHVW�LQYROYHV�VLQJOH�DSSOLFDWLRQ�����KRXU�occlusive SDWFK�WHVW�7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�D�QXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ��YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LV�FDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFK�YROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\�LUULWDQW���

7KH�REMHFWLYH�RI�WKH�WHVW�LV�WR�GHWHUPLQH�ZKHWKHU�RU�QRW�WKH�SURGXFW�LV�OLNHO\�WR�LQGXFH�VNLQ�LUULWDWLRQ��XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH�FRQGLWLRQV�

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$�

1XPEHU�RI�YROXQWHHUV$�QXPEHU�RI�20�YROXQWHHUV�KDV�EHHQ�UHFUXLWHG�WR�VDWLVI\�WKH�REMHFWLYHV�RI�WKH�WHVW��

3DQHO�FKDUDFWHULVWLFV9ROXQWHHUV�DUH�VHOHFWHG�RQ�WKH�EDVLV�RI�LQFOXVLRQ�DQG�QRQ�LQFOXVLRQ�FULWHULD��7KH�YROXQWHHUV�VDWLVI\�DOO�WKH�LQFOXVLRQ�FULWHULD�DQG�DUH�QRW�LQ�FRQIOLFW�ZLWK�DQ\�RI�WKH�QRQ�LQFOXVLRQ�FULWHULD�DQG�KDG�D�PHGLFDO�H[DPLQDWLRQ��KHDOWK�FHUWLILFDWH��DQG�D�GHUPDWRORJLFDO�H[DPLQDWLRQ��7KH�YROXQWHHUV�DUH�FOHDUO\�LQIRUPHG��YHUEDOO\�DQG�LQ�ZULWLQJ��UHJDUGLQJ�WKH�QDWXUH�RI�WKH�VWXG\��WKH�WLPHWDEOH��FRQVWUDLQWV�DQG�SRVVLEOH�ULVNV��7KH\�JLYH�WKHLU�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�

,QFOXVLRQ�FULWHULD? ,QIRUPHG�YROXQWHHUV�ZKR�DJUHH�WR�IROORZ�WKH�FRQGLWLRQV�VSHFLILHG? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�DJH����������\HDUV�ROG�? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�JHQGHU����IHPDOH�DQG�RU�PDOH? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�RULJLQ�DQG�KHDOWK�? IUHH�IURP�DQ\�GHUPDWRORJLFDO�SUREOHPV�RQ�WKH�DUHD�VWXGLHG? PHHW�WKH�VSHFLILF�VWXG\�FULWHULD�RQ�VNLQ�W\SH? SURRI�RI�KRPH�DGGUHVV��VRFLDO�VHFXULW\�QXPEHU? DEOH�WR�XQGHUVWDQG�WKH�*UHHN�ODQJXage�DQG�WKH�VWXG\�UHTXLUHPHQWV

1RQ�LQFOXVLRQ�FULWHULD? YROXQWHHUV�ZKR�GRHV�QRW�PHHW�WKH�LQFOXVLRQ�FULWHULD? SUHJQDQF\�RU�QXUVLQJ�FRQGLWLRQ�? LUULWDWHG�VNLQ�RQ�WHVW�VLWH�V�? EOHPLVKHV��PDUNV��H�J��WDWWRRV��VFDUV��VXQEXUQ��RQ�WKH�WHVW�VLWH�V�? PHGLFDWLRQ�ZKLFK�PD\�DIIHFW�VNLQ�UHVSRQVH�DQG�RU�SDVW�PHGLFDO�KLVWRU\? SUHVHQWLQJ�VNLQ�SDWKRORJ\�ZKLFK�PD\�LQWHUIHUH�ZLWK�WKH�DLP�V��RI�WKH�VWXG\�? SUHVHQWLQJ��FRQWDFW�DOOHUJ\�WR�RQH�RI�WKH�LQJUHGLHQWV�RI�WKH�WHVWHG�SURGXFW? SDUWLFLSDWLRQ�LQ�DQRWKHU�VLPXOWDQHRXV�VWXG\�? SDUWLFLSDWLRQ�LQ�D�SUHYLRXV�VWXG\�ZLWKRXW�DQ�DSSURSULDWH�UHVW�SHULRG�EHWZHHQ�VWXGLHV? PLQRUV�RU�PDMRUV�SURWHFWHG�E\�WKH�ODZ�DQG�SHRSOH�DGPLWWHG�LQ�D�VDQLWDU\�RU�VRFLDO�LQVWLWXWLRQ�IRU�RWKHU�SXUSRVH�WKDQ�

UHVHDUFK? SHUVRQV�GHSULYHG�RI�OLEHUW\�E\�OHJDO�RU�DGPLQLVWUDWLYH�GHFLVLRQ��SDWLHQWV�LQ�HPHUJHQF\�VLWXDWLRQ? YROXQWHHUV�ZKR�UHIXVHG�WR�JLYH�WKHLU�IUHH�DQG�LQIRUPHG�FRQVHQW�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 50: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

6WXG\�FRQVWUDLQWV'XULQJ�WKH�OHQJWK�RI�WKH�VWXG\��WKH�YROXQWHHUV�DUH�DVNHG�

? 1RW�WR�SXW�DQ\�SURGXFW��DOVR�ZDWHU�RQ�WKH�SDWFKHV�DUHD�? 1RW�WR�KDYH�D�EDWK��QHLWKHU�WR�H[SRVH�WKHPVHOYHV�WR�89�? 7R�DYRLG�DOO�LQWHQVH�VSRUWLYH�DFWLYLWLHV�WKDW�FRXOG�UHPRYH�WKH�SDWFK�? 1RW�WR�WDNH�DVSLULQ��DQWL�KLVWDPLQLFV��FRUWLFRLGV��DQWL�LQIODPPDWRULHV�DQG�DQ\�RWKHU�WUHDWPHQW�GHFUHDVLQJ�RU�

DYRLGLQJ�LQIODPPDWLRQV�RU�DOOHUJLHV�RU�LQWHUIHULQJ�ZLWK�WKH�VNLQ�PHWDEROLVP�

9ROXQWHHUV�ZLWKGUDZDOV3DUWLFLSDQWV�ZLOO�EH�ZLWKGUDZQ�IRU�WKH�IROORZLQJ�UHDVRQV�

? WKH\�GR�QRW�IROORZ�WKH�FRQGLWLRQV�RI�WKH�6WXG\�,QIRUPDWLRQ�6KHHW�? WKH\�VXIIHU�DQ\�LOOQHVV�RU�DFFLGHQW�RU�GHYHORS�DQ\�FRQGLWLRQ�GXULQJ�WKH�VWXG\�ZKLFK�FRXOG�DIIHFW�WKH�RXWFRPH�RI�WKH�

VWXG\�? WKH\�QR�ORQJHU�ZLVK�WR�SDUWLFLSDWH�LQ�WKH�VWXG\�

7(67�0$7(5,$/

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

�352'8&7�1$0( .20,/,�6,9,�6$%81�=(<7,1�&,&(*,���/,48,'�62$3�2/,9(�%/266021

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�6725$*(�&21',7,216

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

5,16('��/,48,'�62$3

.20,/,

$�VDPSOH�RI�WKH�WHVWHG�SURGXFW�LV�NHSW�DW�WKH�4$&6�ODERUDWRULHV�IRU���PRQWK�DIWHU�WKH�HQG�RI�WKH�VWXG\��$IWHU�WKLV�GDWH�DQGXQOHVV�FRQWUDU\�UHTXLUHPHQW�IURP�WKH�VWXG\�VSRQVRU��WKH�SURGXFW�ZLOO�EH�GHVWUR\HG�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 51: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

0(7+2'�35,1&,3/(

7KH�SULQFLSOH�RI�WKH�VWXG\�LV�EDVHG�RQ�WKH�VLQJOH�DSSOLFDWLRQ�RI�����PO�RI�WHVWHG�SURGXFW��RQ�WKH�VNLQ�RI�WKH�EDFN�RI�DGXOW�YROXQWHHUV��7KH�SURGXFW�LV�NHSW�LQ�FRQWDFW�ZLWK�WKH�VNLQ�IRU����KRXUV�XQGHU�occlusive SDWFK�

(TXLSPHQW

7KH�HTXLSPHQW�XVHG�IRU�WKH�occlusive SDWFK�LV�FRPSRVHG�RI�D�VPDOO�SODVWLF�FDYLW\�RI������FP²�ZLWK�D�ILOWHU�WLVVXH�DW�WKH�ERWWRP�ZKLFK�LV�PDGH�WR�UHFHLYH�WKH�SURGXFW�WR�WHVW��$OO�WKLV�LV�IL[HG�WR�D�K\SRDOOHUJHQLF�QRQ�ZRYHQ�DGKHVLYH�WDSH�

'RVH�OHYHO

7KH�DPRXQW�RI�WHVW�PDWHULDO�DSSOLHG�WR�HDFK�SDWFK�����PO�LV�VXIILFLHQW�WR�ILOO�WKH�FKDPEHU�DQG�VDWXUDWH�WKH�SDG�ZLWKRXW�RYHUIORZLQJ�IURP�LW�ZKHQ�DSSOLHG�WR�WKH�VNLQ�

7HVW�PDWHULDO�DSSOLFDWLRQ

7KH�DUHD�RQ�ZKLFK�WKH�SDWFK�LV�DSSOLHG�LV�SUHYLRXVO\�FOHDQHG�XS�ZLWK�GHPLQHUDOLVHG�ZDWHU�DQG�GULHG�ZLWK�FHOOXORVH�FRWWRQ�ZRRO�WLVVXH�7KH�SDWFKHV�DUH�SXW�RQ�WKH�EDFN�RI�WKH�YROXQWHHU�7KH�SURGXFWV�DUH�WHVWHG�SXUH�RU�GLOXWHG�GHSHQGLQJ�RQ�WKHLU�W\SH�DQG�WKHLU�XVH��? 0RVWO\��WKH�SURGXFWV�DUH�WHVWHG�SXUH��? 5LQVH�RII�SURGXFWV�DUH�WHVWHG�GLOXWHG�DW�����? 'HWHUJHQWV�DUH�WHVWHG�GLOXWHG�DW�����? +\GURSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�GHPLQHUDOLVHG�ZDWHU? /LSRSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�PLQHUDO�RLO�? 3RZGHUV�DUH�SXW�SXUH�LQ�WKH�SDWFK�VPDOO�FDYLW\�DQG�WKHQ�PRLVWHQHG�VXIILFLHQWO\�ZLWK�D�GURS�RI�PLQHUDO�RLO�LQ�RUGHU�

WR�WR�HQVXUH�JRRG�FRQWDFW�ZLWK�WKH�VNLQ�DQG�DYRLG�WKH�SURGXFW�GLVSHUVLRQ�ZKLOH�DSSO\LQJ�WKH�SDWFK�7KH�SDWFKHV�WKXV�SUHSDUHG�DUH�OHIW�LQ�FRQWDFW����KRXUV�

1HJDWLYH�FRQWUROV

:KLOVW�WKLV�DFWLYLW\�LV�DOZD\V�EH�RQ�D�FDVH�E\�FDVH�EDVLV�DQG�ZLOO�GHSHQG�RQ�WKH�QDWXUH�DQG�W\SH�RI�VWXG\��WKH�PRVW�FRPPRQ�DSSURDFK�LV�WR�FRPSDUH�WKH�UHVXOWV�REWDLQHG�IRU�WKH�WHVW�PDWHULDOV�ZLWK�WKRVH�RI�VXLWDEOH�SRVLWLYH�DQG�RU�QHJDWLYH�FRQWUROV��RU�ZLWK�VLPLODU�PDWHULDOV�$��QHJDWLYH��FRQWURO�LV�D�SDWFK�ZLWKRXW�DQ\�SURGXFW��DSSOLHG�LQ�WKH�VDPH�FRQGLWLRQV�DV�WKH�SURGXFW�WR�EH�WHVWHG�? LI�WKH�SURGXFW�LV�WHVWHG�SXUH��HPSW\�SDWFK�? LI�WKH�SURGXFW�LV�WHVWHG�GLOXWHG��SDWFK�ZLWK�����PO�RI�WKH�VROYHQW�XVHG��GHPLQHUDOLVHG�ZDWHU�RU�PLQHUDO�RLO��

9LVXDO�DVVHVVPHQW

7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ��6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU�ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 52: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

(;$03/(�2)�6&25,1*�6&$/(

(5<7+(0$

�� �QR�HYLGHQFH�RI�HU\WKHPD

���� �PLQLPDO�RU�GRXEWIXO�HU\WKHPD

�� �VOLJKW�UHGQHVV��VSRWW\�DQG�GLIIXVH

�� �PRGHUDWH��XQLIRUP�UHGQHVV

�� �VWURQJ�XQLIRUP�UHGQHVV

�� �ILHU\�UHGQHVV

'5<1(66��6&$/,1*�

�� �QR�HYLGHQFH�RI�VFDOLQJ

���� �GU\�ZLWKRXW�VFDOLQJ��DSSHDUV�VPRRWK�DQG�WDXW

�� �ILQH�PLOG�VFDOLQJ

�� �PRGHUDWH�VFDOLQJ

�� �VHYHUH�VFDOLQJ�ZLWK�ODUJH�IODNHV

2('(0$

� �DEVHQFH�RI�RHGHPD

�� �SUHVHQFH�RI�RHGHPD

(;$03/(�2)�6&25,1*�6&$/(

7KH�UHVXOWV�REWDLQHG�DUH�FRPSDUHG�WR�WKRVH�REWDLQHG�RQ�WKH�FRQWURO�]RQH��7KH�$YHUDJH�,UULWDWLRQ�,QGH[��RU�3ULPDU\�6NLQ,UULWDWLRQ��LV�FDOFXODWHG�DV�WKH�DYHUDJH�RI�UHDGLQJV��REWDLQHG�RQ��WKH�YROXQWHHUV�SRSXODWLRQ�

�1XPEHU�RI�YROXQWHHUV

YRO���WR�YRO�Q�PDUNV�7���> @� QXPEHU�RI�UHDGLQJV

&ODVVLILFDWLRQ�RI�WKH�LUULWDQW�SRWHQWLDO

$YHUDJH�LUULWDWLRQ�LQGH[ &ODVVLILFDWLRQ

�������� 1RQ�LUULWDQW

����������� 9HU\�VOLJKWO\�LUULWDQW

����������� 6OLJKWO\�LUULWDQW

�������� 0RGHUDWHO\�LUULWDQW

�������� ,UULWDQW

!����� 9HU\�LUULWDQW

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 53: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76

3DQHO�GHVFULSWLRQ7KLV�VWXG\�LQFOXGHV����KHDOWK\�DGXOW�YROXQWHHUV�ZKRP�FKDUDFWHULVWLFV�DUH�GHVFULEHG�EHORZ�

9ROXQWHHUV�FKDUDFWHULVWLFV

(YHQWV�RFFXUHG�GXULQJ�WKH�VWXG\

� ���� ) �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ) �� 1RUPDO�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 6HQVLWLYH�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 6HQVLWLYH�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ) �� 6HQVLWLYH�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� 0 �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

92/�,'92/817((5

&2'( 6(; $*( &+$5$&7(5,67,&6

1RQH�RI�WKH�YROXQWHHUV�VHOHFWHG�WRRN�D�WUHDWPHQW�FRQWUDLQGLFDWHG�ZLWK�WKH�VWXG\�

6WXG\�ZLWKGUDZDOV1R�ZLWKGUDZDO�RI�WKH�VWXG\�KDSSHQHG�

6NLQ�UHDFWLRQV1R�VNLQ�UHDFWLRQ�ZDV�QRWLFHG�E\�WKH�GHUPDWRORJLVW�RQ�WKH�UHIHUHQFH�DUHD�IRU�DOO�WKH�YROXQWHHUV�

5HVXOWV�DQDO\VLV5HVXOWV�REWDLQHG�IRU�HDFK�YROXQWHHU�DV�ZHOO�DV�WKH�FRUUHVSRQGLQJ�LUULWDWLRQ�LQGH[�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 54: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�',675,%8725�352'8&7�0$18)$&785('�%<�5(&(,37�'$7( ���������678'<�3(5,2' ����������������������/$%�,' ������������352'8&7�1$0( .20,/,�6,9,�6$%81�=(<7,1�&,&(*,���/,48,'�62$3�2/,9(�%/266021

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�6&$�<,/',=

�678'<�6321625�/27

�6725$*(�&21',7,216

127�/,67('

�%5$1'�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

5,16('��/,48,'�62$3.20,/,

(5<7+(0$ '5<1(66 2('(0$7RWDO�UHDGLQJV

��KUV

� ���� ) ��

� ���� ŋ ��

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� ŋ ��

� ���� ŋ ��

� ���� ŋ ��

� ���� ŋ ��

�� ���� ŋ ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� ) ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� 0 ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ŋ ��

92/�,'92/817((5

&2'(6(; $*(

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

7RWDO�UHDGLQJ���KUV��DOO�YROXQWHHUV �

1XPEHU�RI�UHDGLQJV �

7RWDO�LUULWDWLRQ���QXPEHU�RI�UHDGLQJV �

,UULWDWLRQ�LQGH[ ����

5HVXOW 1RQ�LUULWDQW

$IWHU����KRXUV�RI�DSSOLFDWLRQ��QR�VNLQ�UHDFWLRQ�ZDV�REVHUYHG��E\�WKH�GHUPDWRORJLVW�RQ�WKH�DUHD�WUHDWHG�7KH�DYHUDJH�LUULWDWLRQ�LQGH[�REWDLQHG�LV�HTXDO�WR������

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 55: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76��FRQWLQXHG�

7KLV�GRFXPHQW�KDV�EHHQ�HOHFWURQLFDOO\�VLJQHG�E\�WKRVH�QDPHV�WKDW�DSSHDU�RQ�WKLV�UHSRUW�DQG�DUH�WKH�DXWKRUL]HG�VLJQDWRULHV�

',6&866,21�$1'�&21&/86,21

,Q�WKH�H[SHULPHQWDO�FRQGLWLRQV��DIWHU�D�VLQJOH�DSSOLFDWLRQ�RI������PO�RI�WKH�SURGXFW�XQGHU�RFFOXVLYH�SDWFK�DQG�GXULQJ���KRXUV��RQ����KHDOWK\�DGXOW�YROXQWHHUV�DQG�DFFRUGLQJ�WR�WKH�VFDOH�XVHG�IRU�WKH�LQWHUSUHWDWLRQ�RI�WKH�UHVXOWV��WKH�.20,/,�6,9,6$%81�=(<7,1�&,&(*,���/,48,'�62$3�2/,9(�%/266021�FDQ�EH�FRQVLGHUHG�DV�1RQ�LUULWDQW�UHJDUGLQJ�LWV�SULPDU\�VNLQ�WROHUDQFH�

5(68/76�$87+(17,&,7<

7KH�VWXG\�FRQFHUQHG�E\�WKLV�UHSRUW�ZDV�FDUULHG�RXW�XQGHU�P\�UHVSRQVLELOLW\��DFFRUGLQJ�WR�WKH�H[SHULPHQWDO�SURWRFRO�DQG�WKHTXDOLW\�SODQ�RI�WKH�4$&6�/WG�ODERUDWRU\��DQG�IROORZV�WKH�JRRG�FOLQLFDO�SUDFWLFHV�$OO�WKH�REVHUYDWLRQV�DQG�GDWD�UHFRUGHG�GXULQJ�WKLV�WULDO�DUH�UHSRUWHG�LQ�WKLV�VWXG\�UHSRUW�

,�FHUWLI\�WKH�UHUHDGLQJ�RI�WKLV�UHSRUW�DQG�GR�DJUHH�ZLWK�LWV�FRQWHQW

'DWH�������������

6WXG\�0DQDJHU��

3ULQWHG�QDPH����'LPLWULRV�7]RXYDOLV

'DWH�������������

,QYHVWLJDWLQJ�GRFWRU��

3ULQWHG�QDPH����&KULVWRV�3UHYH]DV

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KH�GLOXWLRQ�RI�WKH�VDPSOH�WHVWHG��GHSHQGV�RQ�WKH�W\SH�RI�SURGXFW�VHH�SDJH�����7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\�ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 56: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 57: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition
Page 58: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7�(�6�7���5�(�3�2�5�7�����������

3�$�7�&�+����7�(�6�7����5�(�3�2�5�7

.20,/,�1250$/�&,/7/(5�,&,1�.5(0���&5($0�'5<�6.,1

6&$�<,/',=�.$*,7�9(�.,6,6(/�%$.,0�85(7,0�$�6�

3DJH���RI��������������

6(37(0%(5�����

Page 59: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�352'8&7�1$0( .20,/,�1250$/�&,/7/(5�,&,1�.5(0���&5($0�'5<�6.,1

678'<�5(3257

���+2856�3$7&+�7(676.,1�72/(5$1&(�$66(660(17

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�0(7+2'

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

���+RXUV�RFFOXVLYH�SDWFK�WHVWV

/($9(�21��&5($0

.20,/,

7$%/(�2)�&217(176

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

678'<�6800$5<���$%675$&7

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$

7(67�0$7(5,$/

0(7+2'�35,1&,3/(

&$/&8/$7,216

5(68/76

',6&866,21�$1'�&21&/86,21

5(68/76�$87+(17,&,7<

��

��

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/($33/,&$7,21�'85,1*����+2856�2&&/86,9(�3$7&+�21����92/817((56

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 60: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

5HJXODWRU\7KH�VWXG\�KDV�EHHQ�FRQGXFWHG�E\�VXLWDEO\�WUDLQHG��TXDOLILHG�DQG�H[SHULHQFHG�SHUVRQQHO�LQ�DFFRUGDQFH�ZLWK�WKH�'HFODUDWLRQ�RI�+HOVLQNL��������DQG�VXEVHTXHQW�UHYLVLRQV��:RUOG�0HGLFDO�$VVRFLDWLRQ��������&RXQFLO�IRU�,QWHUQDWLRQDO�2UJDQL]DWLRQV�RI�0HGLFDO�6FLHQFHV�DQG�WKH�:RUOG�+HDOWK�2UJDQL]DWLRQ��������DQG�WDNLQJ�LQWR�FRQVLGHUDWLRQ�WKH�UHTXLUHPHQWV�RI�'LUHFWLYHV���������(&�DQG�������8�(&�UHODWLQJ�WR�WKH�LPSOHPHQWDWLRQ�RI�JRRG�FOLQLFDO�SUDFWLFH�LQ�WKH�FRQGXFW�RI�FOLQLFDO�WULDOV�RQ�PHGLFLQDO�SURGXFWV�IRU�KXPDQ�XVH�DQG�WKH�&2/,3$�*XLGHOLQHV�HGLWHG�RQ������IRU�WKH�´3URGXFW�7HVW�*XLGHOLQHV�IRU�WKH�$VVHVVPHQW�RI�+XPDQ�6NLQ�&RPSDWLELOLW\µ��

3UHFDXWLRQV�KDYH�EHHQ�WDNHQ�WR�DYRLG�WKH�SRVVLELOLW\�WKDW�SDUWLFLSDQWV�LQ�WKH�VWXG\�PLJKW�H[SHULHQFH�XQGHVLUDEOH�HIIHFWV��

(WKLFDO�UHTXLUHPHQWV�ZKLFK�KDYH�EHHQ�WDNHQ�LQWR�FRQVLGHUDWLRQ�LQ�WKH�SODQQLQJ�RI�WKH�VWXG\��LQFOXGH�L��SDUWLFLSDQWV�DUH�LQIRUPHG�YROXQWHHUV�VHOHFWHG�DIWHU�DSSOLFDWLRQ�RI�LQFOXVLRQ�QRQ�LQFOXVLRQ�FULWHULD�LL��SDUWLFLSDQWV�DUH�DZDUH�RI�WKH�SXUSRVH�DQG�QDWXUH�RI�WKH�VWXG\�DQG�RI�DQ\�IRUHVHHDEOH�ULVNV�LQYROYHG�LQ�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�DQG�KDYH�JLYHQ�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�WKH�VWXG\�VWDUWV�LLL��D�VDIHW\�HYDOXDWLRQ�KDV�EHHQ�FRQGXFWHG�RQ�WKH�SURGXFW�WHVWHG��EHIRUH�WKH�VWXG\�VWDUWV��LY��WKH�WHVW�SURFHGXUHV�FRQIRUPV�WR�QDWLRQDO�UHJXODWLRQV��Y��WKH�(WKLFDO�5HYLHZ�&RPPLWWHH�LQFOXGH�PHGLFDO��QRQ�PHGLFDO��DSSURSULDWH�H[SHUWV�DQG�OD\�PHPEHUV��LW�KDV�FRQVLGHU�WKH�JHQHUDO�HWKLFV�RI�WKH�WHVW�DQG�YHULILHG�WKDW�WKH�VDIHW\�DQG�LQWHJULW\�RI�WKH�SDUWLFLSDQWV�LQ�WKH�WHVW�DUH�SURWHFWHG��WDNLQJ�LQWR�DFFRXQW�LQIRUPDWLRQ�RQ�WKH�LQJUHGLHQW�V��YL��DOO�UHDVRQDEOH�FDUH�KDV�EHHQ�WDNHQ�WR�DYRLG�FDXVLQJ�H[FHVVLYH�VNLQ�UHDFWLRQV�RU�RWKHU�DGYHUVH�KHDOWK�HIIHFWV�LQ�WKH�SDUWLFLSDQWV�GXULQJ�WKH�VWXG\�YLL��VDIHW\�SURFHGXUHV�DUH�LQ�SODFH�LQ�WKH�HYHQW�RI�DQ\�XQH[SHFWHG�DGYHUVH�UHDFWLRQV��LQFOXGLQJ�DSSURSULDWH�PHGLFDO�FRYHU�YLLL��YROXQWHHUV�DUH�UHZDUGHG�IRU�WKHLU�WLPH��LQFRQYHQLHQFH��HWF���EXW�WKH�UHZDUG�LV�QRW�VR�JUHDW�WKDW�LW�ZRXOG�SHUVXDGH�WKHP�WR�SDUWLFLSDWH�

&RQILGHQWLDOLW\5HTXLUHPHQWV�RI�/DZ�����������RQ�WKH�3URWHFWLRQ�RI�,QGLYLGXDOV�ZLWK�UHJDUG�WR�WKH�3URFHVVLQJ�RI�3HUVRQDO�Data�DUH�WDNHQ�LQWR�FRQVLGHUDWLRQ��3URFHVVLQJ�RI�YROXQWHHUV�SHUVRQDO�GDWD�LV�FDUULHG�RXW�E\�GRFWRUV�RU�RWKHU�SHUVRQV�UHQGHULQJ�PHGLFDO�VHUYLFHV��SURYLGHG�WKDW�WKH�&RQWUROOHU�LV�ERXQG�E\�PHGLFDO�FRQILGHQWLDOLW\�RU�RWKHU�REOLJDWLRQ�RI�SURIHVVLRQDO�VHFUHF\��SURYLGHG�IRU�LQ�/DZ�RU�FRGH�RI�SUDFWLFH��DQG�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��3URFHVVLQJ�LV�FDUULHG�RXW�ZLWKLQ�WKH�ODERUDWRU\�SUHPLVHV�DQG�UHODWHV�WR�SHUVRQDO�GDWD�RI�WKH�YROXQWHHUV��SURYLGHG�WKDW�WKH�ODWWHU�KDYH�JLYHQ�WKHLU�FRQVHQW�DQG�WKDW�VXFK�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��7KH�DQRQ\PLW\�RI�WKH�YROXQWHHUV�LV�UHVSHFWHG�ZLWKLQ�DOO�VWXGLHV�FDUULHG�RXW�LQ�RXU�ODERUDWRULHV��(DFK�YROXQWHHU�FDQ�EH�LGHQWLILHG�E\�WKH�,QYHVWLJDWRU��WKH�GRFWRUV�DQG�DOO�WKH�SHUVRQV�LQ�FKDUJH�RI�WKH�VWXG\��WKDQNV�WR�KLV�SHUVRQDO�YROXQWHHUV�FRGH�

$UFKLYLQJ7KH�ODERUDWRU\�ERRN�ZKLFK�FRQWDLQV�DOO�WKH�LQIRUPDWLRQ��UDZ�GDWD�DQG�UHVXOWV��UHJDUGLQJ�WKH�VWXG\�DQG�WKH�VWXG\�UHSRUWV�DUH�NHSW�LQ�WKH�ODERUDWRU\�DUFKLYHV�GXULQJ���\HDUV�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 61: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

678'<�6800$5<���$%675$&7

$33/,&$7,21�'85,1*����+2856�2&&/86,9(�3$7&+�21����92/817((56

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/(

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

�352'8&7�1$0( .20,/,�1250$/�&,/7/(5�,&,1�.5(0���&5($0�'5<�6.,1

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�7(67�0(7+2'

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

6LQJOH�DSSOLFDWLRQ������+RXUV�RFFOXVLYH�SDWFK�WHVWV

/($9(�21��&5($0

.20,/,

�3$1(/ ���KHDOWK\�DGXOW�YROXQWHHUV

�$33/,&$7,21�$5($ 2Q�WKH�EDFN

�48$17,7<�2)�352'8&7 �����PO

�0(7+2'2/2*<�$%675$&7 7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVWPDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFKUHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQUHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHGDVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQGXQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJVFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�DQXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ�YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LVFDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFKYROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\LUULWDQW���

5(68/7 � 7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�LV������

&21&/86,21 � $FFRUGLQJ�WR�WKH�H[SHULPHQWDO�FRQGLWLRQV�RI�WKH�VWXG\��WKH�WHVW�SURGXFW��FDQ�EH�FRQVLGHUHG�DV�Non irritant UHJDUGLQJ�,WV�SULPDU\�VNLQ�WROHUDQFH�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 62: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

6NLQ�FRPSDWLELOLW\�LV�GHILQHG�DV�WKH�DEVHQFH�RI�VNLQ�LUULWDWLRQ�XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH��WDNLQJ�LQWR�DFFRXQW�REMHFWLYH�UHDFWLRQV�DV�ZHOO�DV�VXEMHFWLYH�UHVSRQVHV�VXFK�DV�VWLQJLQJ��EXUQLQJ�RU�LWFKLQJ��6NLQ�LUULWDWLRQ�LV�GHILQHG�DV�QRQ�LPPXQRORJLFDO�ORFDO�VNLQ�LQIODPPDWLRQ�

7KLV�WHVW�LQYROYHV�VLQJOH�DSSOLFDWLRQ�����KRXU�occlusive SDWFK�WHVW�7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�D�QXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ��YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LV�FDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFK�YROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\�LUULWDQW���

7KH�REMHFWLYH�RI�WKH�WHVW�LV�WR�GHWHUPLQH�ZKHWKHU�RU�QRW�WKH�SURGXFW�LV�OLNHO\�WR�LQGXFH�VNLQ�LUULWDWLRQ��XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH�FRQGLWLRQV�

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$�

1XPEHU�RI�YROXQWHHUV$�QXPEHU�RI�20�YROXQWHHUV�KDV�EHHQ�UHFUXLWHG�WR�VDWLVI\�WKH�REMHFWLYHV�RI�WKH�WHVW��

3DQHO�FKDUDFWHULVWLFV9ROXQWHHUV�DUH�VHOHFWHG�RQ�WKH�EDVLV�RI�LQFOXVLRQ�DQG�QRQ�LQFOXVLRQ�FULWHULD��7KH�YROXQWHHUV�VDWLVI\�DOO�WKH�LQFOXVLRQ�FULWHULD�DQG�DUH�QRW�LQ�FRQIOLFW�ZLWK�DQ\�RI�WKH�QRQ�LQFOXVLRQ�FULWHULD�DQG�KDG�D�PHGLFDO�H[DPLQDWLRQ��KHDOWK�FHUWLILFDWH��DQG�D�GHUPDWRORJLFDO�H[DPLQDWLRQ��7KH�YROXQWHHUV�DUH�FOHDUO\�LQIRUPHG��YHUEDOO\�DQG�LQ�ZULWLQJ��UHJDUGLQJ�WKH�QDWXUH�RI�WKH�VWXG\��WKH�WLPHWDEOH��FRQVWUDLQWV�DQG�SRVVLEOH�ULVNV��7KH\�JLYH�WKHLU�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�

,QFOXVLRQ�FULWHULD? ,QIRUPHG�YROXQWHHUV�ZKR�DJUHH�WR�IROORZ�WKH�FRQGLWLRQV�VSHFLILHG? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�DJH����������\HDUV�ROG�? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�JHQGHU����IHPDOH�DQG�RU�PDOH? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�RULJLQ�DQG�KHDOWK�? IUHH�IURP�DQ\�GHUPDWRORJLFDO�SUREOHPV�RQ�WKH�DUHD�VWXGLHG? PHHW�WKH�VSHFLILF�VWXG\�FULWHULD�RQ�VNLQ�W\SH? SURRI�RI�KRPH�DGGUHVV��VRFLDO�VHFXULW\�QXPEHU? DEOH�WR�XQGHUVWDQG�WKH�*UHHN�ODQJXage�DQG�WKH�VWXG\�UHTXLUHPHQWV

1RQ�LQFOXVLRQ�FULWHULD? YROXQWHHUV�ZKR�GRHV�QRW�PHHW�WKH�LQFOXVLRQ�FULWHULD? SUHJQDQF\�RU�QXUVLQJ�FRQGLWLRQ�? LUULWDWHG�VNLQ�RQ�WHVW�VLWH�V�? EOHPLVKHV��PDUNV��H�J��WDWWRRV��VFDUV��VXQEXUQ��RQ�WKH�WHVW�VLWH�V�? PHGLFDWLRQ�ZKLFK�PD\�DIIHFW�VNLQ�UHVSRQVH�DQG�RU�SDVW�PHGLFDO�KLVWRU\? SUHVHQWLQJ�VNLQ�SDWKRORJ\�ZKLFK�PD\�LQWHUIHUH�ZLWK�WKH�DLP�V��RI�WKH�VWXG\�? SUHVHQWLQJ��FRQWDFW�DOOHUJ\�WR�RQH�RI�WKH�LQJUHGLHQWV�RI�WKH�WHVWHG�SURGXFW? SDUWLFLSDWLRQ�LQ�DQRWKHU�VLPXOWDQHRXV�VWXG\�? SDUWLFLSDWLRQ�LQ�D�SUHYLRXV�VWXG\�ZLWKRXW�DQ�DSSURSULDWH�UHVW�SHULRG�EHWZHHQ�VWXGLHV? PLQRUV�RU�PDMRUV�SURWHFWHG�E\�WKH�ODZ�DQG�SHRSOH�DGPLWWHG�LQ�D�VDQLWDU\�RU�VRFLDO�LQVWLWXWLRQ�IRU�RWKHU�SXUSRVH�WKDQ�

UHVHDUFK? SHUVRQV�GHSULYHG�RI�OLEHUW\�E\�OHJDO�RU�DGPLQLVWUDWLYH�GHFLVLRQ��SDWLHQWV�LQ�HPHUJHQF\�VLWXDWLRQ? YROXQWHHUV�ZKR�UHIXVHG�WR�JLYH�WKHLU�IUHH�DQG�LQIRUPHG�FRQVHQW�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 63: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

6WXG\�FRQVWUDLQWV'XULQJ�WKH�OHQJWK�RI�WKH�VWXG\��WKH�YROXQWHHUV�DUH�DVNHG�

? 1RW�WR�SXW�DQ\�SURGXFW��DOVR�ZDWHU�RQ�WKH�SDWFKHV�DUHD�? 1RW�WR�KDYH�D�EDWK��QHLWKHU�WR�H[SRVH�WKHPVHOYHV�WR�89�? 7R�DYRLG�DOO�LQWHQVH�VSRUWLYH�DFWLYLWLHV�WKDW�FRXOG�UHPRYH�WKH�SDWFK�? 1RW�WR�WDNH�DVSLULQ��DQWL�KLVWDPLQLFV��FRUWLFRLGV��DQWL�LQIODPPDWRULHV�DQG�DQ\�RWKHU�WUHDWPHQW�GHFUHDVLQJ�RU�

DYRLGLQJ�LQIODPPDWLRQV�RU�DOOHUJLHV�RU�LQWHUIHULQJ�ZLWK�WKH�VNLQ�PHWDEROLVP�

9ROXQWHHUV�ZLWKGUDZDOV3DUWLFLSDQWV�ZLOO�EH�ZLWKGUDZQ�IRU�WKH�IROORZLQJ�UHDVRQV�

? WKH\�GR�QRW�IROORZ�WKH�FRQGLWLRQV�RI�WKH�6WXG\�,QIRUPDWLRQ�6KHHW�? WKH\�VXIIHU�DQ\�LOOQHVV�RU�DFFLGHQW�RU�GHYHORS�DQ\�FRQGLWLRQ�GXULQJ�WKH�VWXG\�ZKLFK�FRXOG�DIIHFW�WKH�RXWFRPH�RI�WKH�

VWXG\�? WKH\�QR�ORQJHU�ZLVK�WR�SDUWLFLSDWH�LQ�WKH�VWXG\�

7(67�0$7(5,$/

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

�352'8&7�1$0( .20,/,�1250$/�&,/7/(5�,&,1�.5(0���&5($0�'5<�6.,1

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�6725$*(�&21',7,216

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

/($9(�21��&5($0

.20,/,

$�VDPSOH�RI�WKH�WHVWHG�SURGXFW�LV�NHSW�DW�WKH�4$&6�ODERUDWRULHV�IRU���PRQWK�DIWHU�WKH�HQG�RI�WKH�VWXG\��$IWHU�WKLV�GDWH�DQGXQOHVV�FRQWUDU\�UHTXLUHPHQW�IURP�WKH�VWXG\�VSRQVRU��WKH�SURGXFW�ZLOO�EH�GHVWUR\HG�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 64: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

0(7+2'�35,1&,3/(

7KH�SULQFLSOH�RI�WKH�VWXG\�LV�EDVHG�RQ�WKH�VLQJOH�DSSOLFDWLRQ�RI�����PO�RI�WHVWHG�SURGXFW��RQ�WKH�VNLQ�RI�WKH�EDFN�RI�DGXOW�YROXQWHHUV��7KH�SURGXFW�LV�NHSW�LQ�FRQWDFW�ZLWK�WKH�VNLQ�IRU����KRXUV�XQGHU�occlusive SDWFK�

(TXLSPHQW

7KH�HTXLSPHQW�XVHG�IRU�WKH�occlusive SDWFK�LV�FRPSRVHG�RI�D�VPDOO�SODVWLF�FDYLW\�RI������FP²�ZLWK�D�ILOWHU�WLVVXH�DW�WKH�ERWWRP�ZKLFK�LV�PDGH�WR�UHFHLYH�WKH�SURGXFW�WR�WHVW��$OO�WKLV�LV�IL[HG�WR�D�K\SRDOOHUJHQLF�QRQ�ZRYHQ�DGKHVLYH�WDSH�

'RVH�OHYHO

7KH�DPRXQW�RI�WHVW�PDWHULDO�DSSOLHG�WR�HDFK�SDWFK�����PO�LV�VXIILFLHQW�WR�ILOO�WKH�FKDPEHU�DQG�VDWXUDWH�WKH�SDG�ZLWKRXW�RYHUIORZLQJ�IURP�LW�ZKHQ�DSSOLHG�WR�WKH�VNLQ�

7HVW�PDWHULDO�DSSOLFDWLRQ

7KH�DUHD�RQ�ZKLFK�WKH�SDWFK�LV�DSSOLHG�LV�SUHYLRXVO\�FOHDQHG�XS�ZLWK�GHPLQHUDOLVHG�ZDWHU�DQG�GULHG�ZLWK�FHOOXORVH�FRWWRQ�ZRRO�WLVVXH�7KH�SDWFKHV�DUH�SXW�RQ�WKH�EDFN�RI�WKH�YROXQWHHU�7KH�SURGXFWV�DUH�WHVWHG�SXUH�RU�GLOXWHG�GHSHQGLQJ�RQ�WKHLU�W\SH�DQG�WKHLU�XVH��? 0RVWO\��WKH�SURGXFWV�DUH�WHVWHG�SXUH��? 5LQVH�RII�SURGXFWV�DUH�WHVWHG�GLOXWHG�DW�����? 'HWHUJHQWV�DUH�WHVWHG�GLOXWHG�DW�����? +\GURSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�GHPLQHUDOLVHG�ZDWHU? /LSRSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�PLQHUDO�RLO�? 3RZGHUV�DUH�SXW�SXUH�LQ�WKH�SDWFK�VPDOO�FDYLW\�DQG�WKHQ�PRLVWHQHG�VXIILFLHQWO\�ZLWK�D�GURS�RI�PLQHUDO�RLO�LQ�RUGHU�

WR�WR�HQVXUH�JRRG�FRQWDFW�ZLWK�WKH�VNLQ�DQG�DYRLG�WKH�SURGXFW�GLVSHUVLRQ�ZKLOH�DSSO\LQJ�WKH�SDWFK�7KH�SDWFKHV�WKXV�SUHSDUHG�DUH�OHIW�LQ�FRQWDFW����KRXUV�

1HJDWLYH�FRQWUROV

:KLOVW�WKLV�DFWLYLW\�LV�DOZD\V�EH�RQ�D�FDVH�E\�FDVH�EDVLV�DQG�ZLOO�GHSHQG�RQ�WKH�QDWXUH�DQG�W\SH�RI�VWXG\��WKH�PRVW�FRPPRQ�DSSURDFK�LV�WR�FRPSDUH�WKH�UHVXOWV�REWDLQHG�IRU�WKH�WHVW�PDWHULDOV�ZLWK�WKRVH�RI�VXLWDEOH�SRVLWLYH�DQG�RU�QHJDWLYH�FRQWUROV��RU�ZLWK�VLPLODU�PDWHULDOV�$��QHJDWLYH��FRQWURO�LV�D�SDWFK�ZLWKRXW�DQ\�SURGXFW��DSSOLHG�LQ�WKH�VDPH�FRQGLWLRQV�DV�WKH�SURGXFW�WR�EH�WHVWHG�? LI�WKH�SURGXFW�LV�WHVWHG�SXUH��HPSW\�SDWFK�? LI�WKH�SURGXFW�LV�WHVWHG�GLOXWHG��SDWFK�ZLWK�����PO�RI�WKH�VROYHQW�XVHG��GHPLQHUDOLVHG�ZDWHU�RU�PLQHUDO�RLO��

9LVXDO�DVVHVVPHQW

7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ��6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU�ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 65: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

(;$03/(�2)�6&25,1*�6&$/(

(5<7+(0$

�� �QR�HYLGHQFH�RI�HU\WKHPD

���� �PLQLPDO�RU�GRXEWIXO�HU\WKHPD

�� �VOLJKW�UHGQHVV��VSRWW\�DQG�GLIIXVH

�� �PRGHUDWH��XQLIRUP�UHGQHVV

�� �VWURQJ�XQLIRUP�UHGQHVV

�� �ILHU\�UHGQHVV

'5<1(66��6&$/,1*�

�� �QR�HYLGHQFH�RI�VFDOLQJ

���� �GU\�ZLWKRXW�VFDOLQJ��DSSHDUV�VPRRWK�DQG�WDXW

�� �ILQH�PLOG�VFDOLQJ

�� �PRGHUDWH�VFDOLQJ

�� �VHYHUH�VFDOLQJ�ZLWK�ODUJH�IODNHV

2('(0$

� �DEVHQFH�RI�RHGHPD

�� �SUHVHQFH�RI�RHGHPD

(;$03/(�2)�6&25,1*�6&$/(

7KH�UHVXOWV�REWDLQHG�DUH�FRPSDUHG�WR�WKRVH�REWDLQHG�RQ�WKH�FRQWURO�]RQH��7KH�$YHUDJH�,UULWDWLRQ�,QGH[��RU�3ULPDU\�6NLQ,UULWDWLRQ��LV�FDOFXODWHG�DV�WKH�DYHUDJH�RI�UHDGLQJV��REWDLQHG�RQ��WKH�YROXQWHHUV�SRSXODWLRQ�

�1XPEHU�RI�YROXQWHHUV

YRO���WR�YRO�Q�PDUNV�7���> @� QXPEHU�RI�UHDGLQJV

&ODVVLILFDWLRQ�RI�WKH�LUULWDQW�SRWHQWLDO

$YHUDJH�LUULWDWLRQ�LQGH[ &ODVVLILFDWLRQ

�������� 1RQ�LUULWDQW

����������� 9HU\�VOLJKWO\�LUULWDQW

����������� 6OLJKWO\�LUULWDQW

�������� 0RGHUDWHO\�LUULWDQW

�������� ,UULWDQW

!����� 9HU\�LUULWDQW

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 66: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76

3DQHO�GHVFULSWLRQ7KLV�VWXG\�LQFOXGHV����KHDOWK\�DGXOW�YROXQWHHUV�ZKRP�FKDUDFWHULVWLFV�DUH�GHVFULEHG�EHORZ�

9ROXQWHHUV�FKDUDFWHULVWLFV

(YHQWV�RFFXUHG�GXULQJ�WKH�VWXG\

� ���� ) �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ) �� 1RUPDO�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 6HQVLWLYH�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 6HQVLWLYH�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ) �� 6HQVLWLYH�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� 0 �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

92/�,'92/817((5

&2'( 6(; $*( &+$5$&7(5,67,&6

1RQH�RI�WKH�YROXQWHHUV�VHOHFWHG�WRRN�D�WUHDWPHQW�FRQWUDLQGLFDWHG�ZLWK�WKH�VWXG\�

6WXG\�ZLWKGUDZDOV1R�ZLWKGUDZDO�RI�WKH�VWXG\�KDSSHQHG�

6NLQ�UHDFWLRQV1R�VNLQ�UHDFWLRQ�ZDV�QRWLFHG�E\�WKH�GHUPDWRORJLVW�RQ�WKH�UHIHUHQFH�DUHD�IRU�DOO�WKH�YROXQWHHUV�

5HVXOWV�DQDO\VLV5HVXOWV�REWDLQHG�IRU�HDFK�YROXQWHHU�DV�ZHOO�DV�WKH�FRUUHVSRQGLQJ�LUULWDWLRQ�LQGH[�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 67: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�',675,%8725�352'8&7�0$18)$&785('�%<�5(&(,37�'$7( ���������678'<�3(5,2' ����������������������/$%�,' ������������352'8&7�1$0( .20,/,�1250$/�&,/7/(5�,&,1�.5(0���&5($0�'5<�6.,1

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�6&$�<,/',=

�678'<�6321625�/27

�6725$*(�&21',7,216

127�/,67('

�%5$1'�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

/($9(�21��&5($0.20,/,

(5<7+(0$ '5<1(66 2('(0$7RWDO�UHDGLQJV

��KUV

� ���� ) ��

� ���� ŋ ��

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� ŋ ��

� ���� ŋ ��

� ���� ŋ ��

� ���� ŋ ��

�� ���� ŋ ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� ) ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� 0 ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ŋ ��

92/�,'92/817((5

&2'(6(; $*(

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

7RWDO�UHDGLQJ���KUV��DOO�YROXQWHHUV �

1XPEHU�RI�UHDGLQJV �

7RWDO�LUULWDWLRQ���QXPEHU�RI�UHDGLQJV �

,UULWDWLRQ�LQGH[ ����

5HVXOW 1RQ�LUULWDQW

$IWHU����KRXUV�RI�DSSOLFDWLRQ��QR�VNLQ�UHDFWLRQ�ZDV�REVHUYHG��E\�WKH�GHUPDWRORJLVW�RQ�WKH�DUHD�WUHDWHG�7KH�DYHUDJH�LUULWDWLRQ�LQGH[�REWDLQHG�LV�HTXDO�WR������

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 68: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76��FRQWLQXHG�

7KLV�GRFXPHQW�KDV�EHHQ�HOHFWURQLFDOO\�VLJQHG�E\�WKRVH�QDPHV�WKDW�DSSHDU�RQ�WKLV�UHSRUW�DQG�DUH�WKH�DXWKRUL]HG�VLJQDWRULHV�

',6&866,21�$1'�&21&/86,21

,Q�WKH�H[SHULPHQWDO�FRQGLWLRQV��DIWHU�D�VLQJOH�DSSOLFDWLRQ�RI������PO�RI�WKH�SURGXFW�XQGHU�RFFOXVLYH�SDWFK�DQG�GXULQJ���KRXUV��RQ����KHDOWK\�DGXOW�YROXQWHHUV�DQG�DFFRUGLQJ�WR�WKH�VFDOH�XVHG�IRU�WKH�LQWHUSUHWDWLRQ�RI�WKH�UHVXOWV��WKH�.20,/,1250$/�&,/7/(5�,&,1�.5(0���&5($0�'5<�6.,1�FDQ�EH�FRQVLGHUHG�DV�1RQ�LUULWDQW�UHJDUGLQJ�LWV�SULPDU\�VNLQ�WROHUDQFH�

5(68/76�$87+(17,&,7<

7KH�VWXG\�FRQFHUQHG�E\�WKLV�UHSRUW�ZDV�FDUULHG�RXW�XQGHU�P\�UHVSRQVLELOLW\��DFFRUGLQJ�WR�WKH�H[SHULPHQWDO�SURWRFRO�DQG�WKHTXDOLW\�SODQ�RI�WKH�4$&6�/WG�ODERUDWRU\��DQG�IROORZV�WKH�JRRG�FOLQLFDO�SUDFWLFHV�$OO�WKH�REVHUYDWLRQV�DQG�GDWD�UHFRUGHG�GXULQJ�WKLV�WULDO�DUH�UHSRUWHG�LQ�WKLV�VWXG\�UHSRUW�

,�FHUWLI\�WKH�UHUHDGLQJ�RI�WKLV�UHSRUW�DQG�GR�DJUHH�ZLWK�LWV�FRQWHQW

'DWH�������������

6WXG\�0DQDJHU��

3ULQWHG�QDPH����'LPLWULRV�7]RXYDOLV

'DWH�������������

,QYHVWLJDWLQJ�GRFWRU��

3ULQWHG�QDPH����&KULVWRV�3UHYH]DV

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KH�GLOXWLRQ�RI�WKH�VDPSOH�WHVWHG��GHSHQGV�RQ�WKH�W\SH�RI�SURGXFW�VHH�SDJH�����7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\�ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 69: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7�(�6�7���5�(�3�2�5�7�����������

3�$�7�&�+����7�(�6�7����5�(�3�2�5�7

.20,/,�6,9,�6$%81�*8/�%$+&(6,���/,48,'�62$3�526(�*$5'(1

6&$�<,/',=�.$*,7�9(�.,6,6(/�%$.,0�85(7,0�$�6�

3DJH���RI��������������

6(37(0%(5�����

Page 70: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�352'8&7�1$0( .20,/,�6,9,�6$%81�*8/�%$+&(6,���/,48,'�62$3�526(�*$5'(1

678'<�5(3257

���+2856�3$7&+�7(676.,1�72/(5$1&(�$66(660(17

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�0(7+2'

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

���+RXUV�RFFOXVLYH�SDWFK�WHVWV

5,16('��/,48,'�62$3

.20,/,

7$%/(�2)�&217(176

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

678'<�6800$5<���$%675$&7

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$

7(67�0$7(5,$/

0(7+2'�35,1&,3/(

&$/&8/$7,216

5(68/76

',6&866,21�$1'�&21&/86,21

5(68/76�$87+(17,&,7<

��

��

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/($33/,&$7,21�'85,1*����+2856�2&&/86,9(�3$7&+�21����92/817((56

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 71: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(*8/$725<��&21),'(17,$/,7<�$1'�$5&+,9,1*

5HJXODWRU\7KH�VWXG\�KDV�EHHQ�FRQGXFWHG�E\�VXLWDEO\�WUDLQHG��TXDOLILHG�DQG�H[SHULHQFHG�SHUVRQQHO�LQ�DFFRUGDQFH�ZLWK�WKH�'HFODUDWLRQ�RI�+HOVLQNL��������DQG�VXEVHTXHQW�UHYLVLRQV��:RUOG�0HGLFDO�$VVRFLDWLRQ��������&RXQFLO�IRU�,QWHUQDWLRQDO�2UJDQL]DWLRQV�RI�0HGLFDO�6FLHQFHV�DQG�WKH�:RUOG�+HDOWK�2UJDQL]DWLRQ��������DQG�WDNLQJ�LQWR�FRQVLGHUDWLRQ�WKH�UHTXLUHPHQWV�RI�'LUHFWLYHV���������(&�DQG�������8�(&�UHODWLQJ�WR�WKH�LPSOHPHQWDWLRQ�RI�JRRG�FOLQLFDO�SUDFWLFH�LQ�WKH�FRQGXFW�RI�FOLQLFDO�WULDOV�RQ�PHGLFLQDO�SURGXFWV�IRU�KXPDQ�XVH�DQG�WKH�&2/,3$�*XLGHOLQHV�HGLWHG�RQ������IRU�WKH�´3URGXFW�7HVW�*XLGHOLQHV�IRU�WKH�$VVHVVPHQW�RI�+XPDQ�6NLQ�&RPSDWLELOLW\µ��

3UHFDXWLRQV�KDYH�EHHQ�WDNHQ�WR�DYRLG�WKH�SRVVLELOLW\�WKDW�SDUWLFLSDQWV�LQ�WKH�VWXG\�PLJKW�H[SHULHQFH�XQGHVLUDEOH�HIIHFWV��

(WKLFDO�UHTXLUHPHQWV�ZKLFK�KDYH�EHHQ�WDNHQ�LQWR�FRQVLGHUDWLRQ�LQ�WKH�SODQQLQJ�RI�WKH�VWXG\��LQFOXGH�L��SDUWLFLSDQWV�DUH�LQIRUPHG�YROXQWHHUV�VHOHFWHG�DIWHU�DSSOLFDWLRQ�RI�LQFOXVLRQ�QRQ�LQFOXVLRQ�FULWHULD�LL��SDUWLFLSDQWV�DUH�DZDUH�RI�WKH�SXUSRVH�DQG�QDWXUH�RI�WKH�VWXG\�DQG�RI�DQ\�IRUHVHHDEOH�ULVNV�LQYROYHG�LQ�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�DQG�KDYH�JLYHQ�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�WKH�VWXG\�VWDUWV�LLL��D�VDIHW\�HYDOXDWLRQ�KDV�EHHQ�FRQGXFWHG�RQ�WKH�SURGXFW�WHVWHG��EHIRUH�WKH�VWXG\�VWDUWV��LY��WKH�WHVW�SURFHGXUHV�FRQIRUPV�WR�QDWLRQDO�UHJXODWLRQV��Y��WKH�(WKLFDO�5HYLHZ�&RPPLWWHH�LQFOXGH�PHGLFDO��QRQ�PHGLFDO��DSSURSULDWH�H[SHUWV�DQG�OD\�PHPEHUV��LW�KDV�FRQVLGHU�WKH�JHQHUDO�HWKLFV�RI�WKH�WHVW�DQG�YHULILHG�WKDW�WKH�VDIHW\�DQG�LQWHJULW\�RI�WKH�SDUWLFLSDQWV�LQ�WKH�WHVW�DUH�SURWHFWHG��WDNLQJ�LQWR�DFFRXQW�LQIRUPDWLRQ�RQ�WKH�LQJUHGLHQW�V��YL��DOO�UHDVRQDEOH�FDUH�KDV�EHHQ�WDNHQ�WR�DYRLG�FDXVLQJ�H[FHVVLYH�VNLQ�UHDFWLRQV�RU�RWKHU�DGYHUVH�KHDOWK�HIIHFWV�LQ�WKH�SDUWLFLSDQWV�GXULQJ�WKH�VWXG\�YLL��VDIHW\�SURFHGXUHV�DUH�LQ�SODFH�LQ�WKH�HYHQW�RI�DQ\�XQH[SHFWHG�DGYHUVH�UHDFWLRQV��LQFOXGLQJ�DSSURSULDWH�PHGLFDO�FRYHU�YLLL��YROXQWHHUV�DUH�UHZDUGHG�IRU�WKHLU�WLPH��LQFRQYHQLHQFH��HWF���EXW�WKH�UHZDUG�LV�QRW�VR�JUHDW�WKDW�LW�ZRXOG�SHUVXDGH�WKHP�WR�SDUWLFLSDWH�

&RQILGHQWLDOLW\5HTXLUHPHQWV�RI�/DZ�����������RQ�WKH�3URWHFWLRQ�RI�,QGLYLGXDOV�ZLWK�UHJDUG�WR�WKH�3URFHVVLQJ�RI�3HUVRQDO�Data�DUH�WDNHQ�LQWR�FRQVLGHUDWLRQ��3URFHVVLQJ�RI�YROXQWHHUV�SHUVRQDO�GDWD�LV�FDUULHG�RXW�E\�GRFWRUV�RU�RWKHU�SHUVRQV�UHQGHULQJ�PHGLFDO�VHUYLFHV��SURYLGHG�WKDW�WKH�&RQWUROOHU�LV�ERXQG�E\�PHGLFDO�FRQILGHQWLDOLW\�RU�RWKHU�REOLJDWLRQ�RI�SURIHVVLRQDO�VHFUHF\��SURYLGHG�IRU�LQ�/DZ�RU�FRGH�RI�SUDFWLFH��DQG�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��3URFHVVLQJ�LV�FDUULHG�RXW�ZLWKLQ�WKH�ODERUDWRU\�SUHPLVHV�DQG�UHODWHV�WR�SHUVRQDO�GDWD�RI�WKH�YROXQWHHUV��SURYLGHG�WKDW�WKH�ODWWHU�KDYH�JLYHQ�WKHLU�FRQVHQW�DQG�WKDW�VXFK�GDWD�DUH�QHLWKHU�WUDQVIHUUHG�QRU�GLVFORVHG�WR�WKLUG�SDUWLHV��7KH�DQRQ\PLW\�RI�WKH�YROXQWHHUV�LV�UHVSHFWHG�ZLWKLQ�DOO�VWXGLHV�FDUULHG�RXW�LQ�RXU�ODERUDWRULHV��(DFK�YROXQWHHU�FDQ�EH�LGHQWLILHG�E\�WKH�,QYHVWLJDWRU��WKH�GRFWRUV�DQG�DOO�WKH�SHUVRQV�LQ�FKDUJH�RI�WKH�VWXG\��WKDQNV�WR�KLV�SHUVRQDO�YROXQWHHUV�FRGH�

$UFKLYLQJ7KH�ODERUDWRU\�ERRN�ZKLFK�FRQWDLQV�DOO�WKH�LQIRUPDWLRQ��UDZ�GDWD�DQG�UHVXOWV��UHJDUGLQJ�WKH�VWXG\�DQG�WKH�VWXG\�UHSRUWV�DUH�NHSW�LQ�WKH�ODERUDWRU\�DUFKLYHV�GXULQJ���\HDUV�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 72: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

678'<�6800$5<���$%675$&7

$33/,&$7,21�'85,1*����+2856�2&&/86,9(�3$7&+�21����92/817((56

$66(660(17�2)�6.,1�72/(5$1&(�2)�$�&260(7,&�352'8&7�$)7(5�$�6,1*/(

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

�352'8&7�1$0( .20,/,�6,9,�6$%81�*8/�%$+&(6,���/,48,'�62$3�526(�*$5'(1

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�7(67�0(7+2'

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

6LQJOH�DSSOLFDWLRQ������+RXUV�RFFOXVLYH�SDWFK�WHVWV

5,16('��/,48,'�62$3

.20,/,

�3$1(/ ���KHDOWK\�DGXOW�YROXQWHHUV

�$33/,&$7,21�$5($ 2Q�WKH�EDFN

�48$17,7<�2)�352'8&7 �����PO

�0(7+2'2/2*<�$%675$&7 7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVWPDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFKUHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQUHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHGDVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQGXQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJVFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�DQXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ�YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LVFDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFKYROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\LUULWDQW���

5(68/7 � 7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�LV������

&21&/86,21 � $FFRUGLQJ�WR�WKH�H[SHULPHQWDO�FRQGLWLRQV�RI�WKH�VWXG\��WKH�WHVW�SURGXFW��FDQ�EH�FRQVLGHUHG�DV�Non irritant UHJDUGLQJ�,WV�SULPDU\�VNLQ�WROHUDQFH�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 73: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

7<3(�$1'�2%-(&7,9(�2)�7+(�678'<

6NLQ�FRPSDWLELOLW\�LV�GHILQHG�DV�WKH�DEVHQFH�RI�VNLQ�LUULWDWLRQ�XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH��WDNLQJ�LQWR�DFFRXQW�REMHFWLYH�UHDFWLRQV�DV�ZHOO�DV�VXEMHFWLYH�UHVSRQVHV�VXFK�DV�VWLQJLQJ��EXUQLQJ�RU�LWFKLQJ��6NLQ�LUULWDWLRQ�LV�GHILQHG�DV�QRQ�LPPXQRORJLFDO�ORFDO�VNLQ�LQIODPPDWLRQ�

7KLV�WHVW�LQYROYHV�VLQJOH�DSSOLFDWLRQ�����KRXU�occlusive SDWFK�WHVW�7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ���6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU��D�GHUPDWRORJLVW��ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��7KH�TXDQWLILFDWLRQ�RI�WKH�VNLQ�LUULWDWLRQ�LV�JLYHQ�WKURXJK�D�QXPHULF�VFDOH��HU\WKHPD��RHGHPD��GU\QHVV�GHVTXDPDWLRQ��YHVLFOHV���7KH�DYHUDJH�LUULWDQW�VFRUH�RI�WKH�SURGXFW�WR�EH�WHVWHG�LV�FDOFXODWHG�IURP�WKH�DYHUDJH�RI�WKH�TXRWDWLRQV�REWDLQHG�IRU�HDFK�YROXQWHHU��DOORZLQJ�WR�UDQN�WKH�SURGXFW�IURP��QRQ�LUULWDQW�WR�YHU\�LUULWDQW���

7KH�REMHFWLYH�RI�WKH�WHVW�LV�WR�GHWHUPLQH�ZKHWKHU�RU�QRW�WKH�SURGXFW�LV�OLNHO\�WR�LQGXFH�VNLQ�LUULWDWLRQ��XQGHU�QRUPDO�FRQGLWLRQV�RI�XVH�DQG�UHDVRQDEO\�IRUHVHHDEOH�PLVXVH�FRQGLWLRQV�

3$1(/�678',('��,1&/86,21���121�,1&/86,21�&5,7(5,$�

1XPEHU�RI�YROXQWHHUV$�QXPEHU�RI�20�YROXQWHHUV�KDV�EHHQ�UHFUXLWHG�WR�VDWLVI\�WKH�REMHFWLYHV�RI�WKH�WHVW��

3DQHO�FKDUDFWHULVWLFV9ROXQWHHUV�DUH�VHOHFWHG�RQ�WKH�EDVLV�RI�LQFOXVLRQ�DQG�QRQ�LQFOXVLRQ�FULWHULD��7KH�YROXQWHHUV�VDWLVI\�DOO�WKH�LQFOXVLRQ�FULWHULD�DQG�DUH�QRW�LQ�FRQIOLFW�ZLWK�DQ\�RI�WKH�QRQ�LQFOXVLRQ�FULWHULD�DQG�KDG�D�PHGLFDO�H[DPLQDWLRQ��KHDOWK�FHUWLILFDWH��DQG�D�GHUPDWRORJLFDO�H[DPLQDWLRQ��7KH�YROXQWHHUV�DUH�FOHDUO\�LQIRUPHG��YHUEDOO\�DQG�LQ�ZULWLQJ��UHJDUGLQJ�WKH�QDWXUH�RI�WKH�VWXG\��WKH�WLPHWDEOH��FRQVWUDLQWV�DQG�SRVVLEOH�ULVNV��7KH\�JLYH�WKHLU�ZULWWHQ�LQIRUPHG�FRQVHQW�EHIRUH�SDUWLFLSDWLRQ�LQ�WKH�VWXG\�

,QFOXVLRQ�FULWHULD? ,QIRUPHG�YROXQWHHUV�ZKR�DJUHH�WR�IROORZ�WKH�FRQGLWLRQV�VSHFLILHG? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�DJH����������\HDUV�ROG�? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�JHQGHU����IHPDOH�DQG�RU�PDOH? ZKHUH�DSSURSULDWH�RI�UHOHYDQW�RULJLQ�DQG�KHDOWK�? IUHH�IURP�DQ\�GHUPDWRORJLFDO�SUREOHPV�RQ�WKH�DUHD�VWXGLHG? PHHW�WKH�VSHFLILF�VWXG\�FULWHULD�RQ�VNLQ�W\SH? SURRI�RI�KRPH�DGGUHVV��VRFLDO�VHFXULW\�QXPEHU? DEOH�WR�XQGHUVWDQG�WKH�*UHHN�ODQJXage�DQG�WKH�VWXG\�UHTXLUHPHQWV

1RQ�LQFOXVLRQ�FULWHULD? YROXQWHHUV�ZKR�GRHV�QRW�PHHW�WKH�LQFOXVLRQ�FULWHULD? SUHJQDQF\�RU�QXUVLQJ�FRQGLWLRQ�? LUULWDWHG�VNLQ�RQ�WHVW�VLWH�V�? EOHPLVKHV��PDUNV��H�J��WDWWRRV��VFDUV��VXQEXUQ��RQ�WKH�WHVW�VLWH�V�? PHGLFDWLRQ�ZKLFK�PD\�DIIHFW�VNLQ�UHVSRQVH�DQG�RU�SDVW�PHGLFDO�KLVWRU\? SUHVHQWLQJ�VNLQ�SDWKRORJ\�ZKLFK�PD\�LQWHUIHUH�ZLWK�WKH�DLP�V��RI�WKH�VWXG\�? SUHVHQWLQJ��FRQWDFW�DOOHUJ\�WR�RQH�RI�WKH�LQJUHGLHQWV�RI�WKH�WHVWHG�SURGXFW? SDUWLFLSDWLRQ�LQ�DQRWKHU�VLPXOWDQHRXV�VWXG\�? SDUWLFLSDWLRQ�LQ�D�SUHYLRXV�VWXG\�ZLWKRXW�DQ�DSSURSULDWH�UHVW�SHULRG�EHWZHHQ�VWXGLHV? PLQRUV�RU�PDMRUV�SURWHFWHG�E\�WKH�ODZ�DQG�SHRSOH�DGPLWWHG�LQ�D�VDQLWDU\�RU�VRFLDO�LQVWLWXWLRQ�IRU�RWKHU�SXUSRVH�WKDQ�

UHVHDUFK? SHUVRQV�GHSULYHG�RI�OLEHUW\�E\�OHJDO�RU�DGPLQLVWUDWLYH�GHFLVLRQ��SDWLHQWV�LQ�HPHUJHQF\�VLWXDWLRQ? YROXQWHHUV�ZKR�UHIXVHG�WR�JLYH�WKHLU�IUHH�DQG�LQIRUPHG�FRQVHQW�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 74: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

6WXG\�FRQVWUDLQWV'XULQJ�WKH�OHQJWK�RI�WKH�VWXG\��WKH�YROXQWHHUV�DUH�DVNHG�

? 1RW�WR�SXW�DQ\�SURGXFW��DOVR�ZDWHU�RQ�WKH�SDWFKHV�DUHD�? 1RW�WR�KDYH�D�EDWK��QHLWKHU�WR�H[SRVH�WKHPVHOYHV�WR�89�? 7R�DYRLG�DOO�LQWHQVH�VSRUWLYH�DFWLYLWLHV�WKDW�FRXOG�UHPRYH�WKH�SDWFK�? 1RW�WR�WDNH�DVSLULQ��DQWL�KLVWDPLQLFV��FRUWLFRLGV��DQWL�LQIODPPDWRULHV�DQG�DQ\�RWKHU�WUHDWPHQW�GHFUHDVLQJ�RU�

DYRLGLQJ�LQIODPPDWLRQV�RU�DOOHUJLHV�RU�LQWHUIHULQJ�ZLWK�WKH�VNLQ�PHWDEROLVP�

9ROXQWHHUV�ZLWKGUDZDOV3DUWLFLSDQWV�ZLOO�EH�ZLWKGUDZQ�IRU�WKH�IROORZLQJ�UHDVRQV�

? WKH\�GR�QRW�IROORZ�WKH�FRQGLWLRQV�RI�WKH�6WXG\�,QIRUPDWLRQ�6KHHW�? WKH\�VXIIHU�DQ\�LOOQHVV�RU�DFFLGHQW�RU�GHYHORS�DQ\�FRQGLWLRQ�GXULQJ�WKH�VWXG\�ZKLFK�FRXOG�DIIHFW�WKH�RXWFRPH�RI�WKH�

VWXG\�? WKH\�QR�ORQJHU�ZLVK�WR�SDUWLFLSDWH�LQ�WKH�VWXG\�

7(67�0$7(5,$/

�',675,%8725

�352'8&7�0$18)$&785('�%<

�5(&(,37�'$7( ��������

�678'<�3(5,2' ���������������������

�/$%�,' �����������

�352'8&7�1$0( .20,/,�6,9,�6$%81�*8/�%$+&(6,���/,48,'�62$3�526(�*$5'(1

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�

6&$�<,/',=

�678'<�6321625

�/27

�6725$*(�&21',7,216

127�/,67('

�%5$1'

�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

5,16('��/,48,'�62$3

.20,/,

$�VDPSOH�RI�WKH�WHVWHG�SURGXFW�LV�NHSW�DW�WKH�4$&6�ODERUDWRULHV�IRU���PRQWK�DIWHU�WKH�HQG�RI�WKH�VWXG\��$IWHU�WKLV�GDWH�DQGXQOHVV�FRQWUDU\�UHTXLUHPHQW�IURP�WKH�VWXG\�VSRQVRU��WKH�SURGXFW�ZLOO�EH�GHVWUR\HG�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 75: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

0(7+2'�35,1&,3/(

7KH�SULQFLSOH�RI�WKH�VWXG\�LV�EDVHG�RQ�WKH�VLQJOH�DSSOLFDWLRQ�RI�����PO�RI�WHVWHG�SURGXFW��RQ�WKH�VNLQ�RI�WKH�EDFN�RI�DGXOW�YROXQWHHUV��7KH�SURGXFW�LV�NHSW�LQ�FRQWDFW�ZLWK�WKH�VNLQ�IRU����KRXUV�XQGHU�occlusive SDWFK�

(TXLSPHQW

7KH�HTXLSPHQW�XVHG�IRU�WKH�occlusive SDWFK�LV�FRPSRVHG�RI�D�VPDOO�SODVWLF�FDYLW\�RI������FP²�ZLWK�D�ILOWHU�WLVVXH�DW�WKH�ERWWRP�ZKLFK�LV�PDGH�WR�UHFHLYH�WKH�SURGXFW�WR�WHVW��$OO�WKLV�LV�IL[HG�WR�D�K\SRDOOHUJHQLF�QRQ�ZRYHQ�DGKHVLYH�WDSH�

'RVH�OHYHO

7KH�DPRXQW�RI�WHVW�PDWHULDO�DSSOLHG�WR�HDFK�SDWFK�����PO�LV�VXIILFLHQW�WR�ILOO�WKH�FKDPEHU�DQG�VDWXUDWH�WKH�SDG�ZLWKRXW�RYHUIORZLQJ�IURP�LW�ZKHQ�DSSOLHG�WR�WKH�VNLQ�

7HVW�PDWHULDO�DSSOLFDWLRQ

7KH�DUHD�RQ�ZKLFK�WKH�SDWFK�LV�DSSOLHG�LV�SUHYLRXVO\�FOHDQHG�XS�ZLWK�GHPLQHUDOLVHG�ZDWHU�DQG�GULHG�ZLWK�FHOOXORVH�FRWWRQ�ZRRO�WLVVXH�7KH�SDWFKHV�DUH�SXW�RQ�WKH�EDFN�RI�WKH�YROXQWHHU�7KH�SURGXFWV�DUH�WHVWHG�SXUH�RU�GLOXWHG�GHSHQGLQJ�RQ�WKHLU�W\SH�DQG�WKHLU�XVH��? 0RVWO\��WKH�SURGXFWV�DUH�WHVWHG�SXUH��? 5LQVH�RII�SURGXFWV�DUH�WHVWHG�GLOXWHG�DW�����? 'HWHUJHQWV�DUH�WHVWHG�GLOXWHG�DW�����? +\GURSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�GHPLQHUDOLVHG�ZDWHU? /LSRSKLOLF�SURGXFWV�DUH�GLOXWHG�LQ�PLQHUDO�RLO�? 3RZGHUV�DUH�SXW�SXUH�LQ�WKH�SDWFK�VPDOO�FDYLW\�DQG�WKHQ�PRLVWHQHG�VXIILFLHQWO\�ZLWK�D�GURS�RI�PLQHUDO�RLO�LQ�RUGHU�

WR�WR�HQVXUH�JRRG�FRQWDFW�ZLWK�WKH�VNLQ�DQG�DYRLG�WKH�SURGXFW�GLVSHUVLRQ�ZKLOH�DSSO\LQJ�WKH�SDWFK�7KH�SDWFKHV�WKXV�SUHSDUHG�DUH�OHIW�LQ�FRQWDFW����KRXUV�

1HJDWLYH�FRQWUROV

:KLOVW�WKLV�DFWLYLW\�LV�DOZD\V�EH�RQ�D�FDVH�E\�FDVH�EDVLV�DQG�ZLOO�GHSHQG�RQ�WKH�QDWXUH�DQG�W\SH�RI�VWXG\��WKH�PRVW�FRPPRQ�DSSURDFK�LV�WR�FRPSDUH�WKH�UHVXOWV�REWDLQHG�IRU�WKH�WHVW�PDWHULDOV�ZLWK�WKRVH�RI�VXLWDEOH�SRVLWLYH�DQG�RU�QHJDWLYH�FRQWUROV��RU�ZLWK�VLPLODU�PDWHULDOV�$��QHJDWLYH��FRQWURO�LV�D�SDWFK�ZLWKRXW�DQ\�SURGXFW��DSSOLHG�LQ�WKH�VDPH�FRQGLWLRQV�DV�WKH�SURGXFW�WR�EH�WHVWHG�? LI�WKH�SURGXFW�LV�WHVWHG�SXUH��HPSW\�SDWFK�? LI�WKH�SURGXFW�LV�WHVWHG�GLOXWHG��SDWFK�ZLWK�����PO�RI�WKH�VROYHQW�XVHG��GHPLQHUDOLVHG�ZDWHU�RU�PLQHUDO�RLO��

9LVXDO�DVVHVVPHQW

7UHDWPHQW�VLWHV�DUH�DVVHVVHG�EHIRUH�WKH�ILUVW�DSSOLFDWLRQ�RI�WHVW�PDWHULDO��EDVHOLQH��DQG�DIWHU�WUHDWPHQW�DW����PLQXWHV�DIWHU�SDWFK�UHPRYDO��1HJDWLYH�FRQWUROV�DUH�XVHG�WR�IDFLOLWDWH�HYDOXDWLRQ��6NLQ�UHDFWLRQV�DUH�VFRUHG�WKURXJKRXW�WKH�WHVW�E\�WKH�VDPH�H[SHULHQFHG�DVVHVVRU�ZKR�PDGH�WKH�EDVHOLQH�DVVHVVPHQW�DQG�XQGHU�WKH�VDPH�OLJKWLQJ�VRXUFH��IROORZLQJ�D�SUH�GHILQHG�VFRULQJ�VFDOH��

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 76: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

(;$03/(�2)�6&25,1*�6&$/(

(5<7+(0$

�� �QR�HYLGHQFH�RI�HU\WKHPD

���� �PLQLPDO�RU�GRXEWIXO�HU\WKHPD

�� �VOLJKW�UHGQHVV��VSRWW\�DQG�GLIIXVH

�� �PRGHUDWH��XQLIRUP�UHGQHVV

�� �VWURQJ�XQLIRUP�UHGQHVV

�� �ILHU\�UHGQHVV

'5<1(66��6&$/,1*�

�� �QR�HYLGHQFH�RI�VFDOLQJ

���� �GU\�ZLWKRXW�VFDOLQJ��DSSHDUV�VPRRWK�DQG�WDXW

�� �ILQH�PLOG�VFDOLQJ

�� �PRGHUDWH�VFDOLQJ

�� �VHYHUH�VFDOLQJ�ZLWK�ODUJH�IODNHV

2('(0$

� �DEVHQFH�RI�RHGHPD

�� �SUHVHQFH�RI�RHGHPD

(;$03/(�2)�6&25,1*�6&$/(

7KH�UHVXOWV�REWDLQHG�DUH�FRPSDUHG�WR�WKRVH�REWDLQHG�RQ�WKH�FRQWURO�]RQH��7KH�$YHUDJH�,UULWDWLRQ�,QGH[��RU�3ULPDU\�6NLQ,UULWDWLRQ��LV�FDOFXODWHG�DV�WKH�DYHUDJH�RI�UHDGLQJV��REWDLQHG�RQ��WKH�YROXQWHHUV�SRSXODWLRQ�

�1XPEHU�RI�YROXQWHHUV

YRO���WR�YRO�Q�PDUNV�7���> @� QXPEHU�RI�UHDGLQJV

&ODVVLILFDWLRQ�RI�WKH�LUULWDQW�SRWHQWLDO

$YHUDJH�LUULWDWLRQ�LQGH[ &ODVVLILFDWLRQ

�������� 1RQ�LUULWDQW

����������� 9HU\�VOLJKWO\�LUULWDQW

����������� 6OLJKWO\�LUULWDQW

�������� 0RGHUDWHO\�LUULWDQW

�������� ,UULWDQW

!����� 9HU\�LUULWDQW

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 77: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76

3DQHO�GHVFULSWLRQ7KLV�VWXG\�LQFOXGHV����KHDOWK\�DGXOW�YROXQWHHUV�ZKRP�FKDUDFWHULVWLFV�DUH�GHVFULEHG�EHORZ�

9ROXQWHHUV�FKDUDFWHULVWLFV

(YHQWV�RFFXUHG�GXULQJ�WKH�VWXG\

� ���� ) �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ) �� 1RUPDO�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ) �� 6HQVLWLYH�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 6HQVLWLYH�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 6HQVLWLYH�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ) �� 6HQVLWLYH�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� 0 �� 1RUPDO�VNLQ

�� ���� ) �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

�� ���� ŋ �� 1RUPDO�VNLQ

92/�,'92/817((5

&2'( 6(; $*( &+$5$&7(5,67,&6

1RQH�RI�WKH�YROXQWHHUV�VHOHFWHG�WRRN�D�WUHDWPHQW�FRQWUDLQGLFDWHG�ZLWK�WKH�VWXG\�

6WXG\�ZLWKGUDZDOV1R�ZLWKGUDZDO�RI�WKH�VWXG\�KDSSHQHG�

6NLQ�UHDFWLRQV1R�VNLQ�UHDFWLRQ�ZDV�QRWLFHG�E\�WKH�GHUPDWRORJLVW�RQ�WKH�UHIHUHQFH�DUHD�IRU�DOO�WKH�YROXQWHHUV�

5HVXOWV�DQDO\VLV5HVXOWV�REWDLQHG�IRU�HDFK�YROXQWHHU�DV�ZHOO�DV�WKH�FRUUHVSRQGLQJ�LUULWDWLRQ�LQGH[�

3DJH���RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

�����������

Page 78: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

�',675,%8725�352'8&7�0$18)$&785('�%<�5(&(,37�'$7( ���������678'<�3(5,2' ����������������������/$%�,' ������������352'8&7�1$0( .20,/,�6,9,�6$%81�*8/�%$+&(6,���/,48,'�62$3�526(�*$5'(1

�&(57,),&$7(�,' �����������������������

6&$�<,/',=�6&$�<,/',=

�678'<�6321625�/27

�6725$*(�&21',7,216

127�/,67('

�%5$1'�352'8&7�7<3(

4$&6�/WG

$ZD\�IURP�KHDW�DQG�OLJKW

5,16('��/,48,'�62$3.20,/,

(5<7+(0$ '5<1(66 2('(0$7RWDO�UHDGLQJV

��KUV

� ���� ) ��

� ���� ŋ ��

� ���� ) ��

� ���� ) ��

� ���� ) ��

� ���� ŋ ��

� ���� ŋ ��

� ���� ŋ ��

� ���� ŋ ��

�� ���� ŋ ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� ) ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ) ��

�� ���� 0 ��

�� ���� ) ��

�� ���� ŋ ��

�� ���� ŋ ��

92/�,'92/817((5

&2'(6(; $*(

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

� � � �

7RWDO�UHDGLQJ���KUV��DOO�YROXQWHHUV �

1XPEHU�RI�UHDGLQJV �

7RWDO�LUULWDWLRQ���QXPEHU�RI�UHDGLQJV �

,UULWDWLRQ�LQGH[ ����

5HVXOW 1RQ�LUULWDQW

$IWHU����KRXUV�RI�DSSOLFDWLRQ��QR�VNLQ�UHDFWLRQ�ZDV�REVHUYHG��E\�WKH�GHUPDWRORJLVW�RQ�WKH�DUHD�WUHDWHG�7KH�DYHUDJH�LUULWDWLRQ�LQGH[�REWDLQHG�LV�HTXDO�WR������

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������

Page 79: THE REPORT FROM DERMATOLOGICAL RESEARCH OF … · Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition

$66(660(17�2)�+80$1�6.,1�&203$7,%,/,7<4XDOLW\�$VVXUDQFH��&RQWURO�6\VWHPV�/WG����$QWLJRQLV�6W�����������0HWDPRUIRVL��*UHHFH

7HO��������������������)D[��������������������HPDLO��LQIR#TDFV�JU���ZHEVLWH��ZZZ�TDFV�JU

5(68/76��FRQWLQXHG�

7KLV�GRFXPHQW�KDV�EHHQ�HOHFWURQLFDOO\�VLJQHG�E\�WKRVH�QDPHV�WKDW�DSSHDU�RQ�WKLV�UHSRUW�DQG�DUH�WKH�DXWKRUL]HG�VLJQDWRULHV�

',6&866,21�$1'�&21&/86,21

,Q�WKH�H[SHULPHQWDO�FRQGLWLRQV��DIWHU�D�VLQJOH�DSSOLFDWLRQ�RI������PO�RI�WKH�SURGXFW�XQGHU�RFFOXVLYH�SDWFK�DQG�GXULQJ���KRXUV��RQ����KHDOWK\�DGXOW�YROXQWHHUV�DQG�DFFRUGLQJ�WR�WKH�VFDOH�XVHG�IRU�WKH�LQWHUSUHWDWLRQ�RI�WKH�UHVXOWV��WKH�.20,/,�6,9,6$%81�*8/�%$+&(6,���/,48,'�62$3�526(�*$5'(1�FDQ�EH�FRQVLGHUHG�DV�1RQ�LUULWDQW�UHJDUGLQJ�LWV�SULPDU\�VNLQ�WROHUDQFH�

5(68/76�$87+(17,&,7<

7KH�VWXG\�FRQFHUQHG�E\�WKLV�UHSRUW�ZDV�FDUULHG�RXW�XQGHU�P\�UHVSRQVLELOLW\��DFFRUGLQJ�WR�WKH�H[SHULPHQWDO�SURWRFRO�DQG�WKHTXDOLW\�SODQ�RI�WKH�4$&6�/WG�ODERUDWRU\��DQG�IROORZV�WKH�JRRG�FOLQLFDO�SUDFWLFHV�$OO�WKH�REVHUYDWLRQV�DQG�GDWD�UHFRUGHG�GXULQJ�WKLV�WULDO�DUH�UHSRUWHG�LQ�WKLV�VWXG\�UHSRUW�

,�FHUWLI\�WKH�UHUHDGLQJ�RI�WKLV�UHSRUW�DQG�GR�DJUHH�ZLWK�LWV�FRQWHQW

'DWH�������������

6WXG\�0DQDJHU��

3ULQWHG�QDPH����'LPLWULRV�7]RXYDOLV

'DWH�������������

,QYHVWLJDWLQJ�GRFWRU��

3ULQWHG�QDPH����&KULVWRV�3UHYH]DV

3DJH����RI���

5HVXOWV�UHIHU�WR�WKH�VDPSOH�DV�UHFHLYHG�DQG�DQDO\VHG�RQ�WKH�VSHFLILF�SHULRG��7KH�GLOXWLRQ�RI�WKH�VDPSOH�WHVWHG��GHSHQGV�RQ�WKH�W\SH�RI�SURGXFW�VHH�SDJH�����7KHVH�UHVXOWV�VKRXOG�QRW�EH�UHSURGXFHG�RWKHU�WKDQ�LQ�IXOO�DQG�RQO\�ZLWK�WKH�ZULWWHQ�DSSURYDO�RI�WKH�ODERUDWRU\�

7KH�VDPSOHV�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���PRQWK�IURP�WKH�HQG�WHVW�GDWH�7KH�VWXG\�UHSRUW�DQG�UDZ�GDWD�ZLOO�EH�VWRUHG�E\�WKH�ODERUDWRU\�GXULQJ���\HDUV�

�����������