Non-containing Guarantee for Containing-prohibited Substances (Product/Packaging Parts) Revised on Feb. 20, 2013
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* Please make sure to affix a sign of a person in charge on the format.
* When the change occurs after the documents have been submitted or 4M change occurs even if their documents have nochange, please resubmit relevant documents. The following are surely true and correct for the product with the deliverable number shown below in respect to containing of the chemical substances specified on the Exhibit Form-B "ODC Containing-prohibited Chemical Substances List" (Revised on Feb. 20, 2013) Please choose the parts from the drop down list in accordance with Product parts Required Required Not required Required Required the usage, then answer the required item. Packaging parts Not required Not required Required Non-containing Non-containing of (JIG-101) Non-containing of (JIG-201) Non-containing of ODC Delivery starting date of RoHS compliant of Europe RoHS Deliverable number Deliverable description Containing- Containing-prohibited Substances Containing-prohibited Substances Directive prohibited Substances Note 1) Substances Note 2) Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Note 1: If corresponding to exemptions, it will be excluded from containing judgment, therefore, please check the box of Non-contained. Note 2: While Containing-prohibited substances (JIG) also include RoHS regulated substances, please complete the column for Non-containing of (JIG-101) Containing-prohibited Substances related to non RoHS-regulated substances. Note 3: If corresponding to exemptions, it will be excluded from containing judgment, therefore, please check the box of Non-contained. In case of, however, containing, please enter the name of the substance. Note 4: For the date of delivery, please enter the date on which the first lot was delivered or the date before such a delivery. It is not required to check the box of 'From the first delivery'. If the start day for the delivery cannot be identified, do not enter the date and check the box of 'From the first delivery'. Oki Data Containment-prohibited Chemical Substances List (Form-B Attachment ) Revised on 2013.2.20 1 Containment-prohibited Substances designated by Europe RoHS Directive
Any containment rate greater than 100 ppm (0.01wt%) by weight in homogeneous material.
2 Hexavalent Chromium/Hexavalent Chromium Compounds
Any containment rate greater than 1000 ppm (0.1wt%) by weight in homogeneous material.
Any containment rate greater than 1000 ppm (0.1wt%) by weight in homogeneous material.
Any containment rate greater than 1000 ppm (0.1wt%) by weight in homogeneous material.
Any containment rate greater than 1000 ppm (0.1wt%) by weight in homogeneous material.
Any containment rate greater than 1000 ppm (0.1wt%) by weight in homogeneous material.
* The chemical substances of No.1, 2, 3, and 4 are enabled to be contained when corresponding to the application exclusion items of EU RoHS Directive. 2. Containment-prohibited Substances (JIG-A Note 1): Including the RoHS 6 substances
Certain Azocolourants and Azodyes (which form certain aromatic amines) in textile and leather
The rate of content should be 30ppm or less(0.003% or less by weight) in finished textile or leather articles
The rate of content should be 100 ppm or less(0.01% or less by weight) in homogeneous material
The rate of content should be 5ppm or less(0.0005% or less by total weight) in battery
4 Hexavalent Chromium/Hexavalent Chromium Compounds
The rate of content should be 1,000ppm or less 0.1% or less by weight) in homogeneous material
The rate of content should be 1,000ppm or less 0.1 % or less by weight in a survey unit.
6 Lead chromate molybdate sulphate red(C.I. Pigment Red 104)
The rate of content should be 1,000ppm or less 0.1 % or less by weight in a survey unit.
7 Lead sulfochromate yellow(C.I. Pigment Yellow 34)
The rate of content should be 1,000ppm or less 0.1 % or less by weight in a survey unit.
The rate of content should be 1,000ppm or less 0.1 % or less by weight in a survey unit.
9 Potassium hydroxyoctaoxodizincate dichromate
The rate of content should be 1,000ppm or less 0.1 % or less by weight in a survey unit.
The rate of content should be 1,000ppm or less 0.1 % or less by weight in a survey unit.
The rate of content should be 1,000ppm or less 0.1% or less by weight) in homogeneous materialThe rate of content should be 300 ppm or less(0.03 % or less by weight) in surface coating of cables/cords (thermoset/
thermoplastic coating). The rate of content should be 40ppm or less(0.004 % or less by total weight) in battery.
No Intentionally added, and the rate of content should be 1000 ppm or less(0.1% or less by weight) in homogeneous
material. The rate of content should be 1ppm or less(0.0001 % or less by total weight) in battery.
The rate of content should be 1,000ppm or less 0.1 % or less by weight) in homogeneous material
No Intentionally added, and the rate of content should be 1,000ppm or less 0.1 % or less by weight) in homogeneous
16 Polychlorinated Biphenyls (PCBs) and specific substitutions
The rate of content should be 50ppm or less 0.005 % or less by weight) in homogeneous material
18 Polychlorinated Naphthalenes (more than 3 chlorine atoms)
20 Shortchain Chlorinated Paraffins (C10 – C13)
The rate of content should be 1,000ppm or less 0.1 % or less by weight in survey unit.
No Intentionally added, and the rate of content should be 1,000ppm or less 0.1 % or less by weight) of tin in homogeneous
21 Tri-substiituted organostannic compounds
No Intentionally added, and the rate of content should be 1000 ppm or less(0.1% or less by weight) in survey unit.
No Intentionally added, and the rate of content should be 1,000ppm or less 0.1 % or less by weight) in homogeneous
23 PerFluoroOctane Sulfonate acid (PFOS) and salts
Phenol, 2-(2H-benzotriazol-2-yl)-4, 6-bis (1,1-dimethylethyl) |;
2-(2H-1, 2, 3-benzotriazol-2-yl)-4,6-di-tert-butylphenol
The rate of content should be 0.1ppm or less 0.00001 % or less by weight) in homogeneous material
The rate of content should be 1,000ppm or less 0.1 % or less by weight) of tin in homogeneous material
The rate of content should be 1,000ppm or less 0.1 % or less by weight) of tin in homogeneous material
* The chemical substance of No.23 is regarded as "Non-containing" if corresponding to the exceptional use for the application.
Note 1: JIG (Joint Industrial Guideline) is the guideline for survey of chemical substance containment in electric and electronic devices, that is developed by the joint work between Japan (JGPISSI: Japan Green
Procurement Survey Standardization Initiative), USA (EIA: Electronic Industries Alliance) and Europe (EICTA: European Information & Communications and Consumer Electronics Technology Industry
The restricted substances for packaging materials JIG-201 Note 2)
The restricted substances for packaging materials
No Intentionally added in wood for packaging item.
The rate of content should be 30ppm or less(0.003% or less by weight) in finished textile or leather articles for packaging
3 Azocolourants and azodyes which form certain aromatic amines
The rate of content should be 1,000ppm or less
0.1 % or less by weight) in packaging item.
The rate of content should be 1,000ppm or less
0.1 % or less by weight) of tin in packaging item.
The rate of content should be 1,000ppm or less
0.1 % or less by weight) of tin in textile for packaging item.
The rate of content should be 1,000ppm or less
0.1 % or less by weight) in packaging item.
No Intentionally added, and the total rate of contents of 4 types of Specific Heavy Metals should be 100ppm or less (0.01%
or less by weight) in each packaging material.
No Intentionally added for fumigation of wood pallets
10 Phenol,2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylethyl)
11 Polychlorinated biphenyls (PCBs) and specific substitutes
12 Polychlorinated naphthalenes (more than 3 chlorine atoms)
The rate of content should be 50ppm or less
0.005 % or less by weight) in each packaging material.
14 Shortchain chlorinated paraffins (C10 – C13)
The rate of content should be 1,000ppm or less
0.1 % or less by weight) in packaging item.
No Intentionally added, and the rate of content should be 1,000ppm or less
0.1 % or less by weight) of tin in packaging
15 Tri-substituted organostannic compounds
No Intentionally added, and the rate of content should be 1,000ppm or less
0.1 % or less by weight) in packaging item.
Note 2: JIG (Joint Industrial Guideline) is the guideline for survey of chemical substance containment in electric and electronic devices, that is developed by the joint work between
Japan (JGPISSI: Japan Green Procurement Survey Standardization Initiative), USA (EIA: Electronic Industries Alliance) and Europe (EICTA: European Information
& Communications and Consumer Electronics Technology Industry Association).
JIG-201 is the guideline specialize to the packaging materials for the electric and electronic products.
Note3: The report for row No9 (methyl bromide) shall include not only the palette manufacturing process but the any treatment process from raw woods.
If methyl bromide is included check the "include" box and write down the CAS No in column of substance name. 4. Containment-prohibited Substances designated by ODC
19 Cyanides compounds except for Acrylonitrile)
20 (limited to parathion methylparathion methyldemeton and EPN)
N,N'-ditolyl-p-phenylenediamine, N-tolyl-N'-xylyl-p-phenylenediamine and
11 2,2,2-Trichloro-1,1-bis(4-chlorophenyl)ethanol
The Law concerning Examination and Regulation of Manufacture, etc. of Chemical Substances (Class 1 Specified Chemical Substance),
Law Concerning Special Measures against Dioxins,
Non-containing Guarantee for Containing-prohibited Substances (Product/Packaging Parts) When the containment of the "containment-prohibited/terminated Revised on Feb. 20, 2013 substances" designated by OKI are not contained.
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Name of person in charge/Signature Jiro Oki
* Please make sure to affix a sign of a person in charge on the format.
* When the change occurs after the documents have been submitted or 4M change occurs even if their documents have nochange, please resubmit relevant documents. The following are surely true and correct for the product with the deliverable number shown below in respect to containing of the chemical substances specified If included, enter CAS No. in on the Exhibit Form-B "ODC Containing-prohibited Chemical Substances List" (Revised on Feb. 20, 2013) Name of substance Please choose the parts from the drop down list in accordance with Product parts Required Required Not required Required Required the usage, then answer the required item. Packaging parts Not required Not required Required Non-containing Non-containing of (JIG-101) Non-containing of (JIG-201) Non-containing of ODC Delivery starting date of RoHS compliant of Europe RoHS Deliverable number Deliverable description Containing- Containing-prohibited Substances Containing-prohibited Substances Directive prohibited Substances Note 1) Substances Note 2) Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): **/**/**** Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Packaging Not contained Not contained Contained Contained product (mm/dd/yyyy): **/**/**** Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant Not contained Not contained Contained Contained product (mm/dd/yyyy): Contained Contained (Name of substance (Name of substance From the first delivery Not contained Not contained Delivery starting date of RoHS compliant When you have more than 9 deliverables to be Not contained Not contained Contained Contained product (mm/dd/yyyy): entered, please add the lines. Contained Contained (Name of substance (Name of substance From the first delivery Note 1: If corresponding to exemptions, it will be excluded from containing judgment, therefore, please check the box of Non-contained. Note 2: While Containing-prohibited substances (JIG) also include RoHS regulated substances, please complete the column for Non-containing of (JIG-101) Containing-prohibited Substances related to non RoHS-regulated substances. Note 3: If corresponding to exemptions, it will be excluded from containing judgment, therefore, please check the box of Non-contained. In case of, however, containing, please enter the name of the substance. Note 4: For the date of delivery, please enter the date on which the first lot was delivered or the date before such a delivery. It is not required to check the box of 'From the first delivery'. If the start day for the delivery cannot be ide
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NOMBRE DEL MEDICAMENTO Pantoprazol Bluefish 20 mg comprimidos gastrorresistentes COMPOSICIÓN CUALITATIVA Y CUANTITATIVA Cada comprimido gastrorresistente contiene 20 mg de pantoprazol (como 22.55 mg pantoprazol sódico sesquihidratado). Para consultar la lista completa de excipientes, ver sección 6.1. FORMA FARMACÉUTICA Comprimidos gastrorresistentes. Los comprimidos son amarill