2016 RAPEX TOTAL RECALLS AND FOCUS ON CPCH* PRODUCTS

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1 2016 RAPEX TOTAL RECALLS AND FOCUS ON CPCH* PRODUCTS *Cosmetics, Personal Care and Household I TOTAL RECALLS 2016 RAPEX TOTAL RECALLS BY PRODUCT CATEGORY Total recalls 2016 : 1,885 Total 2015 : 1, RAPEX OF OF (>10 recalls in 2016) 958 China Germany Unknown United States France United Italy Turkey India Japan Poland Spain The Netherlands Republic of Korea Taiwan Pakistan Czech Republic Austria 1

2 RAPEX NOTIFYING COUNTRIES II FOCUS ON COSMETICS AND OTHER CHEMICAL PRODUCTS RAPEX NOTIFICATIONS BY CPCH PRODUCT CATEGORY Total CPCH recalls 2016 : 124 (~6,5% of total recalls) Total 2015 : 76 (=4% of total recalls) RAPEX OF (CPCH PRODUCTS) OF (CPCH Products) (> 5 recalls in 2016) United States India China Unknown France United Poland Germany 16 Greece 2

3 RAPEX NOTIFYING COUNTRIES (CPCH PRODUCTS) MEASURES ADOPTED BY NOTIFYING (CPCH PRODUCTS) Who took in charge the? 51, 41% 73, 59% Measures ordered by public authorities Measures taken by economic operators Measures taken by national authorities (e.g. ban on sales, withdrawal of the product from the market) or by the customs authorities (e.g. rejection of import). Measures adopted on a voluntary basis by a producer or distributor, in general without any intervention of Member State authorities. A typical example of a voluntary measure is a recall of the dangerous products from consumers by the distributor or producer. RAPEX RISK TYPE (CPCH PRODUCTS) Chemical Microbiological 17 Health risk / other Health risk / other, Microbiological Choking Chemical, Choking 99 Burns, Chemical Chemical, Microbiological 3

4 RISK DETAILS (CLASSIFICATION PER PRODUCT TYPE) PRODUCT SUBSTANCES VALUE REQUIREMENTS / RECOMMENDATIONS NOTIFYING OF MEASURES ADOPTED BY NOTIFYING Baby skincare wipes Methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) Finland China Import rejected at border Balm Camphor Recommendation for babies and children (France - ANSM ) Austria China (By: Distributor) Bath and wash gel Bath foam Bath gel Microbiology : Pseudomonas spp, and aerobic mesophilic 4,1 x 10 6 cfu/g < 1 x 10 3 cfu/g or ml Czech Republic Czech Republic - - The Netherlands China 3,5 x 10 5 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Pseudomonas : absence Greece Greece Bath products Phenol 0.04%, CMR (mutagenic category 2) France China Bath soap - - Spain United Body lotion Methylisothiazolinone (MI) 0.02% in leave-on product Estonia United States Recall of the product from end users, Warning consumers of the risks, (By: Importer) Body lotion Cholecalciferol (vitamin D3) Sweden United States, Withdrawal of the product from the market Body lotion Body wash cfu/g < 1 x 10 3 cfu/g or ml Czech Republic Czech Republic cfu/g < 1 x 10 3 cfu/g or ml The Netherlands The Netherlands (By: Manufacturer) Children's make-up set Isopropylparaben 0,07% per weight France Germany Cleaning gel Labeling Detergent has to comply with Regulation (EC) No 648/2004 : tactile warning of danger, name of substances and precautionary statements have to be indicated Day cream Decorative soap with plastic duck Deodorant Methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) di-(2-ethylhexyl) phthalate (DEHP) 26% According to the REACH Regulation, DEHP, DBP and BBP phthalates are prohibited in all toys and childcare articles Methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) Descaling solution Labeling The product has to comply with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures and with Regulation (EC) No 648/2004 on detergents Detergent/cleaning product Labeling The product has to comply with Regulation (EC) No 1272/2008 (CLP) on classification, labelling and packaging of substances and mixtures and with Regulation (EC) No 648/2004 on detergents Spain Spain Latvia Poland France Belgium Recall of the product from end users (By: Distributor) France Italy Destruction of the product, Recall of the product from end users, (By: Distributor) France Austria France Republic of Korea (By: Importer) A12/1063/16 A12/1074/16 A12/1373/16 A11/0099/16 A12/0454/16 A12/1613/16 A12/0152/16 A12/0032/16 A12/0919/16 A12/1397/16 A12/0832/16 A12/0391/16 A12/1234/16 A12/1562/16 A12/1563/16 A12/1088/16 A12/1267/16 A12/1623/16 4

5 OF MEASURES ADOPTED BY NOTIFYING Eau de Parfum Labeling=> Allergenic substances: Linalool, Citral, Hydroxycitronellal, Lilial, Coumarin, Farnesol and Hexylcinnamaldehyd Eau de Toilette Labeling=> Allergenic substances : Limonen, Linalool, Cinnamaldehyd, Eugenol, alfa-isomethylionon, Lilial, Coumarin, Amylcinnamyl aldehyd, Lyral and Hexylcinnamaldehyd Eau de Toilette Eye lashes primer Eye shadow Facial toner Labeling=> Allergenic substances: Limonen, Linalool, Benzyl alcohol, Citronellol, Geraniol, Citral, Hydroxycitronellal, Lilial, Farnesol, Amylcinnamyl aldehyd, Lyral, Hexylcinnamaldehyd and Benzyl salicylate -Sodium hydroxide -Sodium lauryl sulphate Isobutylparaben and isopropylparaben >0,001% Substance must be indicated in the list of ingredients when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products >0,001% Substance must be indicated in the list of ingredients when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products >0,001% Substance must be indicated in the list of ingredients when its concentration exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products Czech Republic China Czech Republic Belgium Czech Republic United Arab Emirates on eye product Czech Republic Poland Romania Unknown >1 300 cfu/g < 1 x 10 3 cfu/g or ml Czech Republic India False nails dibutyl phtalate (DBP) < LQ annex II/675 regulation 1223/2009 Czech Republic China False nails dibutyl phtalate (DBP) < LQ annex II/675 regulation 1223/2009 Romania China False nails dibutyl phtalate (DBP) < LQ annex II/675 regulation 1223/2009 Romania Unknown False nails dibutyl phtalate (DBP) < LQ annex II/675 regulation 1223/2009 Romania China Fancy-dress make-up Methylisothiazolinone 276 mg/kg in leave-on product Foaming soap Foot cream + Pseudomonas aeruginosa and Staphylococcus aureus Germany China (By: Importer) - - France France (By: Distributor) 1,1 x 10 5 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Pseudomonas, staphylococcus : absence Estonia Russian Federation product from the market (By: Importer, Retailer) Glue for false nails Chloroform >4,85% by weight 0,1% (Entry 32, REACH Annex XVII) Cyprus Taiwan Glue for false nails Chloroform 9,5% by weight 0,1% (Entry 32, REACH Annex XVII) Denmark China Destruction of the product, Import rejected at border Hair colouring product Sodium perborate (reprotoxic category 1B) Germany South Africa (By: Retailer) Hair colouring product 2-nitro-p-phenylendiamine and barium peroxide when used as a substance in hair dye products Sweden India, A12/0671/16 A12/0669/16 A12/0670/16 A12/1157/16 A12/0306/16 A12/0445/16 A12/0356/16 A12/0733/16 A12/1263/16 A12/1264/16 A12/0446/16 A12/1627/16 A12/1747/16 A12/0116/16 A12/0305/16 A12/0557/16 A12/0917/16 Hair dye Sodium perborate (reprotoxic category 1B) United Unknown product from the market A12/0099/16 5

6 OF MEASURES ADOPTED BY NOTIFYING Hair dye Sodium perborate (reprotoxic category 1B) United Unknown product from the market Hair dye Sodium perborate (reprotoxic category 1B) United Unknown product from the market Hair dye o-aminophenol Sweden United States Hair dye o-aminophenol Sweden Canada, Withdrawal of the product from the market Hair dye Sodium perborate (reprotoxic category 1B) United South Africa Import rejected at border Hair dye pomade Dye Solvent Red 23 (CI 26100), Solvent Yellow 33 (CI 47000) and Solvent Green 3 (CI 61565) Sweden United Hair straightening product Formaldehyde >4,7% - Nail hardening products, For purposes other than inhibiting the development of micro-organisms in the product : 5 % as formaldehyde - As preservatives : oral products : 0,1% (free formaldehyde); other products : 0,2% (free formaldehyde), Not to be used in aerosol dispensers (sprays), labelled mandatory if concentration in the finished product exceeds 0,05 % (with the warning contains formaldehyde ) Hair straightening product Formaldehyde >2,3% - Nail hardening products, For purposes other than inhibiting the development of micro-organisms in the product : 5 % as formaldehyde - As preservatives : oral products : 0,1% (free formaldehyde); other products : 0,2% (free formaldehyde), Not to be used in aerosol dispensers (sprays), labelled mandatory if concentration in the finished product exceeds 0,05 % (with the warning contains formaldehyde ) (By: Retailer) Belgium China Recall of the product from end users (By: Importer) Belgium United States (By: Importer) Haircare product Isobutylparaben Czech Republic Germany A12/0100/16 A12/0101/16 A12/0918/16 A12/0923/16 A12/1765/15 A12/0920/16 A12/0469/16 A12/0694/16 A11/0051/16 Hand cream Isobutylparaben Romania Hungary Hand cream Microbiology : Pseudomonas aeruginosa and aerobic mesophilic 9,7 x 10 5 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Pseudomonas : absence Germany France Recall of the product from end users (By: Importer) Henna body colour Phenol >3,37% by weight, CMR (mutagenic category 2) Germany Pakistan Recall of the product from end users (By: Importer) Henna body colour Phenol >3,6% by weight, CMR (mutagenic category 2) Germany Pakistan product from the market (By: Retailer) Henna body colour Phenol 1.84%, CMR (mutagenic category 2) Germany Pakistan Recall of the product from end users (By: Retailer) Henna Hair Colour Sodium perborate (reprotoxic category 1B) Ireland India (By: Retailer) Herbal shampoo 1,6x10 4 cfu /g < 1 x 10 3 cfu/g or ml Czech Republic India A12/0307/16 A12/0924/16 A12/0380/16 A12/0777/16 A12/1199/16 A12/0953/16 A12/1040/16 6

7 OF MEASURES ADOPTED BY NOTIFYING Holi colour powder + talc and dye CI cfu/g < 1 x 10 3 cfu/g or ml Germany India A11/0060/16 Holi colour powder + particule size => labeling CI cfu/g < 1 x 10 3 cfu/g or ml Germany India A12/0748/16 Incense stick A12/1360/16 A12/1358/16 A12/1359/16 Ink for permanent makeup Ink for permanent makeup Insecticide spray Liquid soap Liquid soap - Nickel - Arsenic - Lead 22 mg/kg 6,8 mg/kg 3,3 mg/kg Nickel : <LQ arsenic and lead < 2 mg/kg Germany China (By: Distributor) Nickel 24 mg/kg <LQ Germany Germany Recall of the product from end users (By: Manufacturer) Presence of dichloromethane up to 30% by weight => need of safety cap - - France Belgium Recall of the product from end users (By: Distributor) - - France France (By: Distributor) - - France France (By: Distributor) A12/1364/16 A12/1367/16 A12/1368/16 A12/1487/16 A12/1488/16 A12/1640/16 A12/1641/16 A12/1642/16 A12/0712/16 A12/0731/16 A12/0237/16 A12/1625/16 A12/1628/16 7

8 OF MEASURES ADOPTED BY NOTIFYING Liquid soap Liquid soap - - France France (By: Distributor) - - France France (By: Distributor) Make up cream Microbiology : mold 27 x 10 6 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Ireland China Manicure kit Chloroform 5.25% 0,1% (Entry 32, REACH, Annex XVII) Denmark China Recall of the product from end users Nail polish remover Dibutyl phtalate (DBP) < LQ annex II/675 regulation 1223/2009 Romania United States Peeling cream Isobutylparaben, Czech Republic Spain Peeling cream Salicylic acid Rinse-off hair products : < 3% Other products : < 2% Permanent make-up Nickel 51,8 mg/kg and 48,2 mg/kg Sauna scent Sauna scent Shampoo & Bath gel Shampoo & bath gel Shampoo & Bath gel Shampoo & Bath gel Shower gel/liquid soap Labeling and warning of danger (CLP) Labeling and warning of danger (CLP) Microbiology : Pseudomonas spp, and aerobic mesophilic Microbiology : Pseudomonas spp, and aerobic mesophilic Microbiology : Pseudomonas spp, and aerobic mesophilic Finland United Nickel : <LQ Germany United States - - Finland Poland - - Finland Poland Destruction of the product (By: Distributor) >6,8 x 10 6 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Pseudomonas : absence 1,5 x 10 6 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Pseudomonas : absence 1,1 x 10 6 cfu/g Aerobic mesophilic, yeast and mold : < 1 x 10 3 cfu/g or ml Pseudomonas : absence Greece Greece Greece Greece Greece Greece cfu/g < 1 x 10 3 cfu/g or ml Czech Republic Greece - - France France (By: Distributor) Skin care Nickel 0,0017% by weight <LQ France Jordan (By: Importer) Skin cleansing cream Enterobacter gergoviae cfu/g Microbial contamination should be masterized United United Skin cream Enterobacter gergoviae 2 x 10 6 cfu/g Microbial contamination should be masterized United United Skin cream and tonic - Betamethasone - Triclosan 0,054% and 0,044% Skin lightening cream Hydroquinone 9,6% by weight, except for : Recall of the product from end users (By: Manufacturer) Recall of the product from end users (By: Manufacturer) Germany China Recall of the product from end users, Warning consumers of the risks (By: Importer) France Unknown A12/1629/16 A12/1630/16 A12/0181/16 A12/0054/16 A12/0755/16 A12/0127/16 A12/1057/16 A12/0892/16 A12/0470/16 A12/0471/16 A12/0453/16 A12/0455/16 A12/0456/16 A12/1135/16 A12/1626/16 A12/0732/16 A12/1433/16 A12/1421/16 A12/1075/16 A12/0720/16 8

9 OF MEASURES ADOPTED BY NOTIFYING Skin lightening cream Clobetasol propionate (corticosteroid) 0,04 % by weight < LQ annex II/300 regulation 1223/2009 France Ivory Coast Skin lightening cream Hydroquinone 1.95%, except for : Skin lightening cream Hydroquinone 2.10%, except for : Skin lightening product Hydroquinone 1,99% by weight, except for : Skin lightening product Hydroquinone 1,8% by weight, except for : Skin lightening product Hydroquinone 3,83% by weight, except for : Skin lightening product Hydroquinone 2.50%, except for : Skin product Methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) 0.20% Skin-lightening product Hydroquinone, except for : Skin-lightening product Hydroquinone 3,4% by weight, except for : Skin-lightening product Hydroquinone 3,56% by weight, except for : Skin-lightening product Hydroquinone 3,9% by weight, except for : Skin-lightening product Hydroquinone, except for : Germany United States (By: Distributor) Germany United States (By: Distributor) United Cameroon Recall of the product from end users United Nigeria Import rejected at border United Ivory Coast Import rejected at border Germany United States (By: Retailer) Latvia Poland Ireland Unknown (By: Retailer) Ireland Unknown (By: Retailer) Ireland Unknown (By: Retailer) France Ivory Coast Portugal Ivory Coast Import rejected at border Suncream for children Labeling - - Germany Germany (By: Manufacturer) Sunscreen Methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) Sunscreen product UV filter non listed A sunscreen product has to contain allowed UV filters listed in the Cosmetic Regulation Talcum powder Benzo(a)pyrene = polycyclic aromatic hydrocarbons (PAH)s Portugal United (By: Distributor) Sweden France, Withdrawal of the product from the market (By: Distributor, Retailer) >6 300 cfu/g < 1 x 10 3 cfu/g or ml Ireland India (By: Retailer) > cfu/g < 1 x 10 3 cfu/g or ml Germany United States 0,5 mg/kg benzo(a)pyrene (BaP) < 0,005 mg/kg total amount of PAHs < 0,5 mg/kg Denmark United States Aromatic amines o-anisidine 40 mg/kg <LQ Denmark United States - Aromatic amines o-anisidine and aniline - Barium >5 ppm for each > ppm <LQ Denmark United States A12/0721/16 A12/1065/16 A12/1077/16 A12/0003/16 A12/0004/16 A12/0005/16 A12/0925/16 A12/1490/16 A12/0229/16 A12/0230/16 A12/0231/16 A12/0771/16 A12/0968/16 A12/0745/16 A12/0893/16 A12/1213/16 A12/0313/16 A11/0023/16 A12/0034/16 A12/0035/16 A12/0036/16 9

10 OF MEASURES ADOPTED BY NOTIFYING SGS Group Management SA 2017 All rights reserved - SGS is a registered trademark of SGS Group Management SA - Aromatic amines o-toluidine - 2,4-diaminotoluene - 2-methyl-5-nitroaniline 92 mg/kg 2780 mg/kg 46 mg/kg <LQ Italy United States Barium mg/kg < 50 mg/kg Germany United States (By: Distributor) Aromatic amines o-anisidine and o-toluidine 24 mg/kg and 31 mg/kg <LQ Italy United States Aromatic amine o-toluidine 48 mg/kg <LQ Italy United States Benzo(a)pyrene = polycyclic aromatic hydrocarbons (PAH)s Polycyclic aromatic hydrocarbons (PAH)s (including benzo(a)pyrene) 0,2 mg/kg total PAHs 29,5 mg/kg 16,9 mg/kg (0,1 mg/kg) benzo(a)pyrene (BaP) < 0,005 mg/kg total amount of PAHs < 0,5 mg/kg level of benzo(a)pyrene (BaP) does not exceed 0,005 mg/kg and the total amount of PAHs do not exceed 0,5 mg/kg Germany Unknown (By: Distributor) Germany United States Destruction of the product (By: Retailer) Teeth whitening gel Sodium perborate (reprotoxic category 1B) Malta Germany Recall of the product from end users (By: Distributor) Teeth whitening product Hydrogen peroxide 8,8% by weight >0,1% and <6% of H2O2 present or degaged only if it's sold by a dental practitioner, If not <0,1% Teeth whitening strips Hydrogen peroxide 12,7% by weight >0,1% and <6% of H2O2 present or degaged only if it's sold by a dental practitioner, If not <0,1% Teeth whitening strips Hydrogen peroxide 10,6% by weight >0,1% and <6% of H2O2 present or degaged only if it's sold by a dental practitioner, If not <0,1% Teeth whitening strips Hydrogen peroxide 6% by weight >0,1% and <6% of H2O2 present or degaged only if it's sold by a dental practitioner, If not <0,1% Teeth whitening strips Hydrogen peroxide 3.06% >0,1% and <6% of H2O2 present or degaged only if it's sold by a dental practitioner, If not <0,1% Toothpaste FOR FURTHER INFORMATION consumer.products@sgs.com - Phenol - 200mg/kg SGS IS THE WORLD S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY, CMR (mutagenic category 2) < 1 x 10 3 cfu/g or ml The Netherlands China The Netherlands United States The Netherlands United States The Netherlands United States Czech Republic United States France India A12/0166/16 A12/0203/16 A12/0347/16 A12/0483/16 A12/0644/16 A12/1084/16 A12/0126/16 A12/0340/16 A12/0328/16 A12/0329/16 A12/0330/16 A12/1499/16 A12/1089/16

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