EUR 24886 EN - 2011

Results of European Survey on Lead in Lipsticks

P. Piccinini, M. Piecha and S. Fortaner Torrent

The mission of the JRC-IHCP is to protect the interests and health of the consumer in the framework of EU legislation on chemicals, food, and consumer products by providing scientific and technical support including risk-benefit assessment and analysis of traceability. European Commission Joint Research Centre Institute for Health and Consumer Protection Contact information Address: Paola Piccinini, T.P. 260, via E. Fermi 2749, Ispra (VA), 21027, Italy E-mail: paola.piccinini@jrc.ec.europa.eu Tel.: 0039-0332-789124 Fax: 0039-0332-785707 http://ihcp.jrc.ec.europa.eu/ http://www.jrc.ec.europa.eu/ Legal Notice Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of this publication.

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A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server http://europa.eu/ JRC 65914 EUR 24886 EN ISBN 978-92-79-18552-6 ISSN 1831-9424 (online) doi:10.2788/3600 Luxembourg: Publications Office of the European Union © European Union, 2011 Reproduction is authorised provided the source is acknowledged Printed in Italy

Contents Scope of the survey 1

Sample and Analysis 1

Results 2

Additional considerations and conclusions 4

References 6

Annex I 7

Annex II 9

1

Scope of the Survey In support to recent discussions on the content of lead in lipsticks in the International

Cooperation on Cosmetic Regulation (ICCR) and specifically in the ICCR Working

Group on Traces in Cosmetics, the JRC has undertaken a monitoring study on 113

samples to assess the content of lead in these products currently available on the

European market.

The results of this survey aim to provide regulators with the actual data for further

discussions and potential decision on maximum levels of lead in cosmetics and

specifically lipsticks. This report was prepared by the JRC for the European

Commission Directorate General for Health and Consumers.

Samples and Analysis The samples - 81 lipsticks and 32 lip glosses - were purchased during 2010/2011 in 12

EU Member States. Most of them were produced in Europe (87 %), a few in the

United States (9%) and only 1 sample was manufactured in Japan. In 3% of cases the

production site was unknown. The samples were of various colours (brown, pink,

purple and red) and were ranging from low to high prize (less than 5 Euro up to 30

Euro). The selection of samples was done with the purpose of covering as many

brands from as many companies as possible (in total 34 brands).

Prior to the actual monitoring, the JRC compared the performance of five different

analytical methods and decided to apply a method developed and in-house validated

by the US-FDA [Hepp et al., 2009]. The method was based on inductively coupled

plasma mass spectrometry (ICP-MS) after microwave digestion of the samples. All

samples were analysed in duplicate. The detection limit of the method was estimated

to be 0.04 mg lead/kg sample.

2

Results The contents of lead in the 81 lipsticks and the 32 lip glosses are shown in Annex 1

and Annex 2, respectively. Samples are listed by their lead content in descending

order. Prices are grouped as: < 5 €; 5 - 15 €; and > 15 €.

As expected the lip glosses analysed showed in general lower lead contents than

lipsticks which can be explained by a lower content of colours in lip glosses. Only one

lip gloss out of 32 (3 %) exceeded a value of 1 mg/kg, whereas 30 lipsticks out of 81

(37 %) where found to be above 1 mg/kg. More details comparing the results obtained

for lipsticks and lip glosses are shown in Table 1 and Figure 1.

Table 1: Comparison of lead contents in lipsticks and lip glosses.

Total N° N° of samples N° of samples N° of samples N° of samples Average Leadof samples Lead Lead Lead Lead (Standard Deviation)

mg/kg < 1 1-2 mg/kg 2-3 mg/kg mg/kg > 3 in mg/kgLipsticks 81 51 (63%) 22 (27%) 7 (9%) 1 (1%) 0.86 (0.74)Lip glosses 32 31 (97%) - 1 (3%) - 0.44 (0.39)

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0,50

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2,50

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3,50

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0 20 40 60 80 100

Sample number

Lead

con

tent

(mg/

Kg)

LipsticksLip Gloss

Figure 1: Lead content of the two products types of all colours, plotted in descending order.

Differences of lead content related with colour were not equally well defined. Of all

samples, red-coloured items contained on average a lower amount of lead than the

others; however the sample with the highest lead content (a lipstick, 3.75 mg/kg) was

also red. When only the 30 lipsticks with a lead content higher than 1 mg/kg are

considered, then pink-coloured samples represent the majority (37%), followed by

purple (30%), brown (23%) and red (10%). More details comparing the results

obtained for products of different colour are shown in Tables 2a-b and in Figures 2a-

b.

No specific trend was identified relating lead content with product price.

3

Table 2a: Comparison of lead contents in lipsticks of different colour.

Total N° N° of samples N° of samples N° of samples N° of samples Average Leadof samples Lead Lead Lead Lead (Standard Deviation)

mg/kg < 1 1-2 mg/kg 2-3 mg/kg mg/kg > 3 in mg/kgBrown 20 13 (65%) 5 (25%) 2 (10%) - 0.83 (0.67)Pink 29 18 (62%) 9 (31%) 2 (7%) - 0.91 (0.67)Purple 16 7 (44%) 7 (44%) 2 (12%) - 0.97 (0.70)Red 16 13 (81%) 1 (6%) 1 (6%) 1 (6%) 0.68 (0.99)

Table 2b: Comparison of lead contents in lip glosses of different colour.

Total N° N° of samples N° of samples N° of samples N° of samples Average Leadof samples Lead Lead Lead Lead (Standard Deviation)

mg/kg < 1 1-2 mg/kg 2-3 mg/kg mg/kg > 3 in mg/kgBrown 9 8 (89%) - - 1 (11%) 0.70 (0.57)Pink 10 10 (100%) - - - 0.41 (0.29)Purple 5 5 (100%) - - - 0.39 (0.13)Red 8 8 (100%) - - - 0.21 (0.16)

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0 10 20 30 40Sample number

Lead

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tent

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)

Pink Purple

Brown Red

a

Figure 2a: Lead content of lipsticks, plotted in descending order, for each colour separately.

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0 2 4 6 8 10 12Sample number

Lead

con

tent

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Pink PurpleBrown Red

b

Figure 2b: Lead content of lip glosses, plotted in descending order, for each colour separately.

4

Additional considerations and conclusions The results of this monitoring study show that in products currently on the European

market the lead content is in most cases below 1 mg/kg, with a maximum level of

3.75 mg/kg in lipsticks and 2.12 mg/kg in lip glosses. As shown in Table 3, these

results are consistent with those of similar surveys recently carried out in the United

States of America, Japan and Saudi Arabia.

Table 3: Lead content in coloured lip products: comparison among data from similar surveys.

Study N° Texture Colours Average Lead Rangeof samples (Standard Deviation) in mg/kg

in mg/kgThis work 113 Lipsticks (81) and Brown, pink, 0.74 (0.69) 0.05 - 3.75

Lip glosses (32) purple and redHepp et al., 2009 22 Lipsticks 5 shades of red 0.99 (0.88) 0.09 - 3.05Japan NIHS, 20011 95 Lipsticks; Lip glosses; N.A. N.A. 0.01 - 6.06

Lipliners; Lip pencils;Lip make up base

Lip concealerAl Saleh et al., 2009 72 Lipsticks Black, brown, green, 2.07 (5.25)** 0.27 - 36.90**

orange, pink, 1.05 (0.84)*** 0.27 - 3.41***purple and red*

* See original reference for detailed description of shades ** After elimination of the following 3 values: 2027.50; 2522.50; 3760.00 *** After further elimination of the following 3 values: 16.58; 20.43; 36.90 Thus, it appears that:

• the lead content of lip colour products currently on the EU market is significantly

lower than the target values currently recommended by different Authorities, e.g.

20 mg/kg in Germany1, or 10 mg/kg in Canada2 for products not to be

intentionally used in the oral cavity;

• in more than 70% of cases, it is also lower than the maximum level for certain

types of food as regulated in the EU, such as bivalve molluscs (1.5 mg/kg) and

cephalopods (1.0 mg/kg), which are not expected to be consumed daily; it is,

however, higher than the corresponding limit for other foods of frequent

1 Bundesinstitut für Risikobewertung (BfR), 2006 "Kosmetische Mittel: BfR empfiehlt

Schwermetallgehalte über Reinheitsanforderungen der Ausgangsstoffe zu regeln.", Stellungnahme Nr. 025/2006 des BfR vom 05. April 2006, at: http://www.bfr.bund.de/cm/343/kosmetische_mittel_bfr_empfiehlt_schwermetallgehalte_ueber.pdf

2 Health Canada, 2009, “Draft Guidance on Heavy Metal Impurities in Cosmetics,” http://www.hc-sc.gc.ca/cps-spc/legislation/consultation/_cosmet/metal-metaux-consult-eng.php

5

consumption (e.g. meat and vegetables, 0.1 mg/kg)3. The correlation with limits in

food is considered relevant in view of the fact that up to 75% of dermally applied

lipstick is likely to be ingested4. However, the very low amount of application and

thereby ingestion needs to be taken into consideration.

In conclusion, the present survey seems to prove that obtaining a finished product

with a lead content in the range of 1 to 2 mg/kg represents the norm rather than the

exception for manufacturers present on the EU market.

3 European Commission 2006; "Commission Regulation (EC) No 1881/2006 of 19 December 2006

setting maximum levels for certain contaminants in foodstuffs", at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1881:20100701:EN:PDF

4 Value considered within the ICCR Working Group "Traces", based on FDA data.

6

References Al-Saleh I., Al-Enazi S., Shinwari N, 2009: "Assessment of lead in cosmetic

products", Regulatory Toxicology and Pharmacology 54 (2009) 105–113.

Health Canada, 2009, “Draft Guidance on Heavy Metal Impurities in Cosmetics,”

http://www.hc-sc.gc.ca/cps-spc/legislation/consultation/_cosmet/metal-metaux-

consult-eng.php, accessed on 21.06.2011

Hepp N.M, Mindak W.R, Cheng J., 2009: "Determination of total lead in lipstick:

Development and validation of a microwave-assisted digestion, inductively coupled

plasma–mass spectrometric method", J. Cosmet. Sci., 60, 405–414 (2009).

Japan National Institute for Health and Safety, 2011 " Lead content in cosmetic

products available in Japan", distributed at the 15th meeting of the Working Group

"Traces" of the International Cooperation of Cosmetic Regulators. April 4th (2011).

7

Annex I: Lead content in Lipsticks. Sample

code Lead content

(mg/kg) Standard Deviation (mg/kg)

Country of purchase

Brand Colour category

Price range (€)

C-135 3.75 0.24 NL G red 5 - 15 C-16 2.61 0.11 FI R pink 5 - 15 C-81 2.45 0.03 ES X purple 5 - 15 C-18 2.29 0.07 FI R red 5 - 15 C-22 2.29 0.05 FI AE purple 5 - 15 C-68 2.11 0.12 MT AD pink 5 - 15

C-122 2.06 0.01 AT A brown 5 - 15 C-144 2.05 0.05 LT AE brown 5 - 15 C-142 1.96 0.12 LT X pink 5 - 15 C-134 1.92 0.02 NL X pink 5 - 15 C-87 1.77 0.11 ES AE brown 5 - 15

C-132 1.71 0.23 NL M pink 5 - 15 C-17 1.67 0.07 FI R brown 5 - 15

C-197 1.59 0.08 PT T brown 5 - 15 C-177 1.51 0.08 CZ U pink 5 - 15 C-23 1.43 0.01 FI R pink 5 - 15

C-143 1.43 0.16 LT X pink 5 - 15 C-138 1.40 0.37 NL AG purple 5 - 15 C-211 1.37 0.10 BE AG purple > 15 C-131 1.33 0.01 NL M purple 5 - 15 C-156 1.32 0.01 LT Z pink < 5 C-130 1.30 0.02 NL AF brown 5 - 15 C-172 1.22 0.07 CZ A brown 5 - 15 C-164 1.21 0.06 DE Y red 5 - 15 C-149 1.16 0.05 LT Q purple 5 - 15 C-215 1.11 0.07 BE D purple 5 - 15 C-169 1.07 0.06 CZ Q pink 5 - 15 C-102 1.05 1.01 IT O pink < 5 C-152 1.04 0.02 LT AE purple 5 - 15 C-207 1.02 0.05 GB B purple 5 - 15 C-223 0.98 0.07 BE AG pink > 15 C-170 0.97 0.26 CZ Q pink 5 - 15 C-162 0.91 0.01 DE Y brown 5 - 15 C-140 0.77 0.03 NL M red 5 - 15 C-163 0.62 0.10 DE I pink < 5 C-150 0.59 0.05 LT Y pink 5 - 15 C-206 0.58 0.05 GB B red 5 - 15 C-181 0.58 0.01 CZ AI pink > 15 C-208 0.57 0.01 GB F pink > 15 C-171 0.54 0.09 CZ Q brown 5 - 15 C-192 0.53 0.19 PT F brown > 15 C-190 0.51 0.01 PT F pink > 15 C-151 0.50 0.17 LT Y purple 5 - 15 C-165 0.47 0.22 DE AB red 5 - 15 C-220 0.47 0.05 BE AG purple > 15 C-101 0.46 0.05 IT O purple < 5 C-161 0.46 0.01 DE AB brown < 5 C-145 0.43 0.15 LT R red 5 - 15

8

Annex I (continued): Lead content in Lipsticks. Sample

code Lead content

(mg/kg) Standard Deviation (mg/kg)

Country of purchase

Brand Colour category

Price range (€)

C-148 0.42 0.03 LT AE brown 5 - 15 C-159 0.41 0.12 DE AB pink < 5 C-178 0.39 0.03 CZ A brown 5 - 15 C-146 0.39 0.01 LT R pink 5 - 15 C-180 0.39 0.01 CZ AI pink > 15 C-213 0.37 0.01 BE D pink 5 - 15 C-160 0.35 0.01 DE AB brown < 5 C-187 0.33 0.01 PT E pink > 15 C-196 0.32 0.02 PT D pink 5 - 15 C-200 0.32 0.04 PT T brown 5 - 15 C-157 0.31 0.02 DE AB purple < 5 C-139 0.31 0.02 NL AC purple < 5 C-224 0.29 0.01 BE P red > 15 C-173 0.28 0.02 CZ Q red 5 - 15 C-182 0.28 0.03 CZ Q pink 5 - 15 C-158 0.28 0.01 DE AB brown < 5 C-214 0.26 0.01 BE D red 5 - 15 C-136 0.25 0.04 NL M brown 5 - 15 C-154 0.25 0.08 LT Q brown 5 - 15 C-183 0.25 0.01 CZ Q pink 5 - 15 C-205 0.25 0.05 GB S purple 5 - 15 C-212 0.24 0.05 BE D pink 5 - 15 C-195 0.20 0.02 PT D brown 5 - 15 C-155 0.20 0.10 LT AA pink < 5 C-193 0.19 0.04 PT D red 5 - 15 C-179 0.17 0.08 CZ Q pink 5 - 15 C-153 0.17 0.04 LT Y red 5 - 15 C-133 0.11 0.01 NL Q purple 5 - 15 C-147 0.10 0.02 LT Q red 5 - 15 C-194 0.08 0.01 PT Q red 5 - 15 C-221 0.07 0.05 BE AF brown > 15 C-103 0.05 0.01 IT O red < 5 C-219 0.03 0.01 BE F red > 15

9

Annex II: Lead Content in Lip Glosses. Sample

code Lead content

(mg/kg) Standard Deviation (mg/kg)

Country of purchase

Brand Colour category

Price range (€)

C-204 0.33 0.06 GB C brown > 15 C-129 0.27 0.13 NL D purple 5 - 15 C-216 0.48 0.06 BE D purple 5 - 15 C-217 0.08 0.02 BE D red 5 - 15 C-218 0.64 0.09 BE D brown 5 - 15 C-188 0.27 0.01 PT E red > 15 C-189 0.52 0.04 PT E brown > 15 C-209 0.29 0.07 GB F pink > 15 C-210 0.56 0.01 BE H purple > 15 C-222 0.71 0.04 BE H pink > 15 C-127 2.12 0.17 NL J brown < 5 C-174 0.07 0.02 CZ K pink < 5 C-185 0.19 0.01 PT L red > 15 C-137 0.65 0.03 NL M brown 5 - 15 C-201 0.27 0.08 GB N purple 5 - 15 C-106 0.20 0.08 IT O pink < 5 C-107 0.38 0.03 IT O purple < 5 C-108 0.24 0.01 IT O brown < 5 C-191 0.44 0.02 PT P brown > 15 C-198 0.81 0.04 PT Q pink 5 - 15 C-199 0.23 0.05 PT Q red 5 - 15 C-141 0.41 0.02 LT U brown 5 - 15 C-176 0.94 0.16 CZ U brown 5 - 15 C-168 0.18 0.07 DE V red < 5 C-166 0.49 0.02 DE Y pink 5 - 15 C-167 0.50 0.03 DE Y pink 5 - 15 C-175 0.03 0.01 CZ Y pink 5 - 15 C-128 0.56 0.23 NL Z red 5 - 15 C-25 0.79 0.06 FI AE pink 5 - 15

C-184 0.24 0.08 CZ AE pink 5 - 15 C-202 0.06 0.02 GB AH red 5 - 15 C-203 0.09 0.02 GB AH red 5 - 15

European Commission EUR 24886 EN – Joint Research Centre – Institute for Health and Consumer Protection Title: Results of European Survey on Lead in Lipsticks Author(s): P. Piccinini, M. Piecha and S. Fortaner Torrent Luxembourg: Publications Office of the European Union 2011 – 9 pp. – 21.0 x 29.7 cm EUR – Scientific and Technical Research series – 1831-9424 (online) ISBN 978-92-79-18552-6 doi:10.2788/3600 Abstract In support to recent discussions on the presence of lead in lipsticks in the International Cooperation on Cosmetic Regulation (ICCR), the JRC carried out a survey on 113 samples, bought on the European market in 2010-2011, to determine their content of lead. The method used for the analysis was in-house validated by the US Food and Drug Administration. It is based on the microwave digestion of lipsticks followed by ICP-MS determination. In total, 81 lipsticks and 32 lip glosses of 34 different brands were purchased in 12 EU Member States. Their price ranged from less than 5 up to 30 euro and colours varied among brown, pink, purple and red. Lip glosses showed in general lower levels of lead than lipsticks. Only one lip gloss out of 32 (3 %) exceeded a value of 1 mg/kg, whereas 30 lipsticks out of 81 (37 %) where found to be above 1 mg/kg. The influence of colour on the presence of lead was not very clear. For instance, even though red-coloured items contained on average a lower amount of lead than the others, the sample with the highest content (3.75 mg/kg) was a red lipstick. The results of this monitoring study show that in products currently on the European market the lead content is in most cases below 1 mg/kg, with a maximum level of 3.75 mg/kg in lipsticks and 2.12 mg/kg in lip glosses. In conclusion, the present survey seems to prove that obtaining a finished product with a lead content in the range of 1 to 2 mg/kg represents the norm rather than the exception for manufacturers present on the EU market.

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