COSMETICS: H RAPEX RECALLS
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1 COSMETICS: H RAPEX RECALLS H RAPEX - PRODUCT CATEGORY Total recalls H : 897 Total 2015 : H RAPEX - NOTIFYING COUNTRIES - GLOBAL
2 H RAPEX - OF 1.6% 1.1% 2.5% 2.0% 5.4% 6.8% 6.0% 47.7% China UE MEMBER Unknown United States Japan India Turkey Pakistan Sum of other countries (<1%) 26.9% Countries <1% : Taiwan, Republic of Korea, Hong Kong, Vietnam, Mexico, Bangladesh, Ivory Coast, Thailand, Switzerland, Albania, South Africa, Indonesia, United Arab Emirates, Canada, Nigeria, Morocco, Jordan, Serbia, Peru, Cameroon FOCUS ON COSMETICS AND OTHER CHEMICAL PRODUCTS H12016 RAPEX NOTIFICATIONS BY PRODUCT CATEGORY Total CPCH recalls H : 63 (=7% of total recalls) Total 2015 : 76 (=4% of total recalls) H RAPEX NOTIFYING COUNTRIES
3 FOCUS ON COSMETICS AND OTHER CHEMICAL PRODUCTS MEASURES ADOPTED BY THE NOTIFYING 37% 63% 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 taken by economic operators: 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. H RAPEX - OF 3% 3% 3% 21% United States Unknown China Germany Greece India Poland Ivory Coast Pakistan Belgium 5% South Africa United Kingdom 5% 13% Taiwan United Arab Emirates 6% Spain Hungary 6% 8% 11% Jordan Cameroon Nigeria H RAPEX - NOTIFIED PRODUCTS BY RISK TYPE Chemical Microbiological 1 Health risk / other Microbiological Health risk / other 80% Choking Microbiological Health risk / other
4 RISK DETAILS (CLASSIFICATION PER PRODUCT) PRODUCT SUBSTANCES VALUE REQUIREMENTS / RECOMMENDATIONS NOTIFYING OF MEASURES ADOPTED BY NOTIFYING Bath gel Bath soap Form/colour/size => mistaken for foodstuff 3.5 x 105 cfu/g Aerobic mesophilic bacteria, yeast and mold: < 1 x 103 CFU per g - - Spain United Kingdom Body lotion Methylisothiazolinone (MI) % Rinse-off products: 0,0015% max for the mixture of CMIT/MIT. Obligation of labeling Greece Greece Estonia United States Measures taken by economic operators: Recall of the product from end users, Warning consumers of the risks, (By: Importer) Children's make-up set Isopropylparaben 0.07% per weight Forbidden substance France Germany Measures taken by economic operators: product from the market (By: Distributor) Eau de Parfum Eau de Toilette Eau de Toilette Eye shadow Labeling=> Allergenic substances: Linalool, Citral, Hydroxycitronellal, Lilial, Coumarin, Farnesol and Hexylcinnamaldehyd Labeling=> Allergenic substances: Limonen, Linalool, Benzyl alcohol, Citronellol, Geraniol, Citral, Hydroxycitronellal, Lilial, Farnesol, Amylcinnamyl aldehyd, Lyral, Hexylcinnamaldehyd and Benzyl salicylate Labeling=> Allergenic substances: Limonen, Linalool, Cinnamaldehyd, Eugenol, alfa-isomethylionon, Lilial, Coumarin, Amylcinnamyl aldehyd, Lyral and Hexylcinnamaldehyd 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 United Arab Emirates Czech Republic Belgium Non reported Forbidden substance Romania Unknown Eyebrow dye p-phenylenediamine (PPD) 2.1% by weight Forbidden substance Ireland Poland Measures taken by economic operators: (By: Distributor) Facial toner bacteria >1 300 cfu/g < 1 x 103 UFC par g ou ml (ISO 17516) Czech Republic India Fancy-dress make-up Methylisothiazolinone 276 mg/kg Rinse-off products: 0,0015% max for the mixture of CMIT/MIT. Obligation of labeling Germany China Measures taken by economic operators: (By: Importer) Glue for false nails Chloroform >4.85% by weight 0,1% (entrée 32 de l'annexe XVII de REACH) Cyprus Taiwan Glue for false nails Chloroform 9.5% by weight 0,1% (entrée 32 de l'annexe XVII de REACH) Denmark China Destruction of the product, Import rejected at border Hair colouring product Sodium perborate Non reported Forbidden substance (reprotoxic category 1B) Germany South Africa Measures taken by economic operators: (By: Retailer) Hair dye Sodium perborate Non reported Forbidden substance (reprotoxic category 1B) United Kingdom Unknown product from the market Hair dye Sodium perborate Non reported Forbidden substance (reprotoxic category 1B) United Kingdom Unknown product from the market Hair dye Sodium perborate Non reported Forbidden substance (reprotoxic category 1B) United Kingdom Unknown product from the market A12/0454/16 A12/0152/16 A12/0032/16 A12/0391/16 A12/0671/16 A12/0670/16 A12/0669/16 A12/0306/16 A12/0310/16 A12/0445/16 A12/0446/16 A12/0116/16 A12/0305/16 A12/0557/16 A12/0099/16 A12/0100/16 A12/0101/16
5 PRODUCT SUBSTANCES VALUE REQUIREMENTS / RECOMMENDATIONS NOTIFYING OF MEASURES ADOPTED BY NOTIFYING Hair dye Sodium perborate Non reported Forbidden substance (reprotoxic category 1B) United Kingdom South Africa Import rejected at border 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, (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, (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 ) Belgium China Measures taken by economic operators: Recall of the product from end users (By: Importer) Belgium United States Measures taken by economic operators: (By: Importer) Haircare product Isobutylparaben Non reported Forbidden substance Czech Republic Germany Hand cream Isobutylparaben Non reported Forbidden substance Romania Hungary Henna body colour Phenol >3.37% by weight Forbidden substance. CMR, (mutagenic category 2) Germany Pakistan Measures taken by economic operators: Recall of the product from end users (By: Importer) Henna Body Colour Phenol >3.6% by weight Forbidden substance. CMR, (mutagenic category 2) Germany Pakistan Measures taken by economic operators: product from the market (By: Retailer) Holi Colour Powder Holi Colour Powder Ink For Permanent Make-Up bacteria + talc and dye CI bacteria + particule size => labeling CI cfu/g < 1 x 103 UFC par g ou ml (ISO 17516) Germany India Measures taken by economic operators: product from the market (By: Distributor) cfu/g < 1 x 103 UFC par g ou ml (ISO 17516) Germany India Measures taken by economic operators:, Recall of the product from end users (By: Distributor) Nickel 24 mg/kg <LQ Germany Germany Measures taken by economic operators: Recall of the product from end users (By: Manufacturer) A12/1765/15 A12/0469/16 A12/0694/16 A11/0051/16 A12/0307/16 A12/0380/16 A12/0777/16 A11/0060/16 A12/0748/16 A12/0731/16 Ink For Permanent Make-Up Insecticide Spray Nickel Arsenic Lead Presence of dichloromethane up to 30% by weight => need of safety cap 22 mg/kg 6.8 mg/kg 3.3 mg/kg Nickel: <LQ arsenic and lead < 2 mg/kg Germany China Measures taken by economic operators: (By: Distributor) - - France Belgium Measures taken by economic operators: Recall of the product from end users (By: Distributor) Make Up Cream Microbiology: mold cfu/g Aerobic mesophilic bacteria, yeast and mold: < 1 x 103 CFU per g or ml (ISO 17516) and < 1 x 102 CFU/g or ml sensitive products Ireland China Nail Polish Remover Dibutyl phtalate (DBP) Non reported < LQ annex II/675 regulation 1223/2009 Romania United States A12/0712/16 A12/0237/16 A12/0181/16 A12/0755/16 Peeling Cream Isobutylparaben, Non reported Forbidden substance Czech Republic Spain Sauna scent Labeling and warning of danger (CLP) - - Finland Poland A12/0127/16 A12/0470/16
6 PRODUCT SUBSTANCES VALUE REQUIREMENTS / RECOMMENDATIONS NOTIFYING OF MEASURES ADOPTED BY NOTIFYING Sauna scent Shampoo & Bath gel Shampoo & bath gel Shampoo & Bath gel Labeling and warning of danger (CLP) - - Finland Poland Measures taken by economic operators: Destruction of the product (By: Distributor) >6.8 x 10 6 cfu/g Aerobic mesophilic bacteria, yeast and mold: < 1 x 103 CFU per g 1.5 x cfu/g Aerobic mesophilic bacteria, yeast and mold: < 1 x 103 CFU per g 1.1 x cfu/g Aerobic mesophilic bacteria, yeast and mold: < 1 x 103 CFU per g Greece Greece Greece Greece Greece Greece Skin care Nickel % by weight <LQ France Jordan Measures taken by economic operators: (By: Importer) Skin lightening product Clobetasol propionate (corticosteroid) 0.04 % by weight < LQ annex II/300 regulation 1223/2009 France Ivory Coast Skin lightening product Hydroquinone 1.99% by weight Forbidden substance, except for: Skin lightening product Hydroquinone 1.8% by weight Forbidden substance, except for: Skin lightening product Hydroquinone 3.83% by weight Forbidden substance, except for: Skin lightening product Hydroquinone Non reported Forbidden substance, except for: Skin lightening product Hydroquinone 3.4% by weight Forbidden substance, except for: Skin lightening product Hydroquinone 3.56% by weight Forbidden substance, except for: Skin lightening product Hydroquinone 9.6% by weight Forbidden substance, except for: \ Skin lightening product Hydroquinone 3.9% by weight Forbidden substance, except for: United Kingdom Cameroon Recall of the product from end users United Kingdom Nigeria Import rejected at border United Kingdom Ivory Coast Import rejected at border Ireland Unknown Measures taken by economic operators: (By: Retailer) Ireland Unknown Measures taken by economic operators: (By: Retailer) Ireland Unknown Measures taken by economic operators: (By: Retailer) France Unknown France Ivory Coast Suncream for children Labeling - - Germany Germany Measures taken by economic operators: (By: Manufacturer) Talcum powder bacteria >6 300 cfu/g < 1 x 103 UFC par g ou ml (ISO 17516) Ireland India Measures taken by economic operators: (By: Retailer) A12/0471/16 A12/0453/16 A12/0455/16 A12/0456/16 A12/0732/16 A12/0721/16 A12/0003/16 A12/0004/16 A12/0005/16 A12/0229/16 A12/0230/16 A12/0231/16 A12/0720/16 A12/0771/16 A12/0745/16 A12/0313/16
7 PRODUCT SUBSTANCES VALUE REQUIREMENTS / RECOMMENDATIONS NOTIFYING OF MEASURES ADOPTED BY NOTIFYING SGS Group Management SA 2016 All rights reserved - SGS is a registered trademark of SGS Group Management SA Aromatic amine o-toluidine 48 mg/kg <LQ Italy United States Aromatic amines o-anisidine 40 mg/kg <LQ Denmark United States Aromatic amines o-anisidine and Aniline Barium Aromatic amines o-anisidine and o-toluidine Aromatic amines o-toluidine 2.4-diaminotoluene 2-methyl-5-nitroaniline >5 ppm for each > ppm 24 mg/kg and 31 mg/kg 92 mg/kg 2780 mg/kg 46 mg/kg <LQ Denmark United States <LQ Italy United States <LQ Italy United States Barium mg/kg < 50 mg/kg Germany United States Measures taken by economic operators: (By: Distributor) Benzo(a)pyrene = polycyclic aromatic hydrocarbons (PAH)s Benzo(a)pyrene = polycyclic aromatic hydrocarbons (PAH)s bacteria 0.5 mg/kg Benzo(a)pyrene (BaP) < mg/kg total amount of PAHs < 0.5 mg/kg 0.2 mg/kg total PAHs 29.5 mg/kg Benzo(a)pyrene (BaP) < mg/kg total amount of PAHs < 0.5 mg/kg Denmark United States Germany Unknown Measures taken by economic operators: (By: Distributor) > cfu/g < 1 x 103 UFC par g ou ml (ISO 17516) Germany United States Teeth whitening gel Sodium perborate Non reported Forbidden substance (reprotoxic category 1B) Malta Germany Measures taken by economic operators: 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 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 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 Teeth whitening strips Hydrogen peroxide 6% by weight >0,1% and <6% of H2O2 present or degaged only if it's sold by a SGS IS THE WORLD S LEADING INSPECTION, VERIFICATION, TESTING AND CERTIFICATION COMPANY The Netherlands China The Netherlands United States The Netherlands United States The Netherlands United States A12/0483/16 A12/0035/16 A12/0036/16 A12/0347/16 A12/0166/16 A12/0203/16 A12/0034/16 A12/0644/16 A11/0023/16 A12/0126/16 A12/0340/16 A12/0328/16 A12/0329/16 A12/0330/16
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