ce-0475/13 - sergas...foto1.jpg foto2.jpg section 3: regulations and standards applicable legal...
TRANSCRIPT
CE-0475/13
Número: 0475 Año: 2013
Tipo de notificación:
En aplicación del artículo 12 de la Directiva 2001/95/CE
Categoría: Cosméticos
Nombre de la notificación: TINTA PARA TATUAR, marca FANTASIA, art. nº 3029, lote 1762
Código de barras:
Riesgo: Químico
Motivo: Presencia de Hidrocarburos Aromáticos Policíclicos (HAPs), benzo (a) pireno.
Observaciones del INC:
CCAA a quienes se solicita información:
01. País notificante y persona de contacto:
País: Alemania
País de origen: Estados Unidos
RAPEX Notification form
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Section 1: General information
Submission number: MS/1036/13
Case number: A12/0475/13
Creation date: 09/04/2013
Validation/distribution date: 17/04/2013
Notification type: Article 12 GPSD/Article 22 Regulation 765/2008
Version: 1
Notifying country: Germany
Author: Hoffbauer Jan
Organisation/Ministry:
Address:
City:
Phone number:
Fax number:
E-mail: [email protected]
Validator at MS level: Blume Jochen
Organisation/Ministry: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin - BAuA
Address: Friedrich-Henkel-Weg 1 - 25
City: Dortmund
Phone number:
Fax number:
E-mail: [email protected]
Section 2: Product identification
Product category: Chemical products
Product name: Lining Black
Brand: FantasiaType/number of model: Art.No. 3029Batch number/Bar code: Batch 1762; best-before date 05/2014 Customs code:
Product and packagingdescription:
Glass bottle with screw cap. 125 ml, best-before date 05/2014
Total number of items coveredby the notification:
Unknown
RAPEX Notification form
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Photos (products, packaging andlabel):
Foto3.jpgFoto1.jpgFoto2.jpg
Section 3: Regulations and standards applicable
Legal provisions (directive,decision, regulation, etc.):
§ 26 (1) and (2) in conjunction with § 4 (1)(3) LFGB – Criteria as per Council of Europe Resolution ResAP (2008) 1 - BfR statement No 044/2011 of 1.7.2011
Standards: -Proof of conformity (includingexistence of marks):
-
Is the product counterfeit?: Unknown
Certificates: No file(s) attached
Section 4: Traceability
Country of origin: United States
Countries of destination:
Germany
Contact details of the manufacturer(s):
Name: Fantasia Art Supply
Address: 5510 Broadway Blvd.
City: Garland TX, 75043
Country: United States
Contact information:
Contact address: No file(s) attached
Contact details of theexporter(s):
Unknown
Contact details of the importer(s):
Name: Fa.Magic Moon Tattooing GmbH
Address: Karolinger Ring 18-20
City: 41812 Erkelenz
Country: Germany
Contact information:
RAPEX Notification form
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Contact address: No file(s) attached
Contact details of the distributor(s):
Name: Tina Bernhard, Fix Ink Tattoo Equipment
Address: Hohenzollernstr. 79
City: 75177 Pforzheim
Country: Germany
Contact information:
Contact address: No file(s) attached
Contact details of the retailer(s):
Name: Mannheim Ink Tattoo Messe Mannheim
Address: Casterfeldstr. 89
City: 68199 Mannheim
Country: Germany
Contact information:
Contact address: No file(s) attached
Section 5: Risk description
Risk category:
Chemical
Summary of test results(description of technical defects):
A sample of the tattoo ink was found to contain 186 µg/kg benzo(a)pyrene.
Legal provisions and standards(with clauses) against which theproduct was tested and did notcomply:
- § 26 (1) and (2) in conjunction with § 4 (1)(3) LFGB – Criteria as per Council of Europe Resolution ResAP (2008) 1 - BfR statement No 044/2011 of 1.7.2011
Risk assessment andconclusions:
In a statement on the health assessment of PAHs in tattoo products, the Federal Institute for Risk Assessment (BfR) concludes that the PAH content of tattoo products should be reduced to a technically unavoidable minimum. The BfR bases its recommendations on the Council of Europe’s criteria on the safety of tattoo inks. The benzo[a]pyrene content should be less than 5 µg/kg, since it is classified as carcinogenic. The benzo[a]pyrene content in the sample is 186 µg/kg, which means that the tattoo ink in question constitutes a health risk (carcinogenic).
Information on known incidentsand accidents:
None.
Tests reports: Probenahmebericht.pdf
Gutachten.pdf
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Section 6: Measures
Type of measures: Voluntary measures
Authority/economic operatortaking notified measures:
Tina Bernhard, Fix Ink Tattoo Equipment
Category of measures: Withdrawal of the product from the market
Date of entry into force: Unknown
Duration: Unknown
Scope: National
Notification sent by a produceror a distributor under Article5(3) of the GPSD:
No file(s) attached
Adopted measures: Rückruf.doc
Section 7: Confidentiality
Is the notification confidential?: No
Section 8: Other
Additional information:
Other attachments: No file(s) attached