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TRANSCRIPT
English: 3E verified with the supplier provided that no SDS has been created for this product.
3E will periodically contact the supplier to reconfirm no SDS is available.
Deutsch:
3E bestätigt, dass für dieses Produkt kein Sicherheitsdatenblatt (SDB) vom Lieferanten erstellt wurde. 3E wird
regelmäßig Kontakt mit dem Lieferanten aufnehmen, um sich bestätigen zu lassen, dass (weiterhin) kein SDB
erforderlich ist.
Français:
3E a vérifié avec le fournisseur approprié qu’aucune FDS n’a été créée pour ce produit.
3E recontactera périodiquement le fournisseur pour confirmer qu’aucune FDS n’existe pour ce produit.
Español: 3E ha comprobado que el proveedor no ha creado ninguna SDS para este producto.3E contactará
periódicamente con el proveedor para asegurarse de que no exista ninguna SDS disponible.
Italiano:
3E ha verificato che nessuna SDS è stata creata per questo prodotto.3E contatterà periodicamente il
fornitore per confermare che nessuna SDS è disponibile.
中文:
3E公司已与供货商确认，本产品没有SDS。 3E公司将会定期与供货商联系，重新确认本产品没有SDS。
Regulatory Information & Documents
Regulatory Information & Documents
> Subject – Capsugel Information – Safety Data Sheet Declaration
We herewith confirm that for Empty Hard Capsules, the requirement for Safety Data Sheets is not applicable. This declaration is based on the following interpretations of United States and International law: Capsugel’s empty two piece capsules are defined as an ‘article” under United States and International Laws
• The Hard Empty Capsules manufactured and supplied by Capsugel correspond to the definition of ‘Articles’ as described in Paragraph “c” of the United States Occupational Safety and Health Administration’s Hazard Communications Standard (29 CFR 1910.1200). An ‘article’ means an object which during production is given a special shape, surface or design; which under normal conditions of use will only release minute or trace amounts of hazardous materials which will not pose a physical or health risk to employees. Capsugel certifies that its hard empty capsules are free of substances that might be considered hazardous materials.
• Article 3 of the European Regulation (EC) N° 1907/2006 also defines ‘articles’ in the same manner as 29 CFR 1910.1200.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, establishes the scope of the “Global Harmonized System” as applicable only “pure chemical substances, their dilute solutions and to mixtures of chemical substances”.
Objects defined as ‘articles” are exempt from requirements for the provision of Safety Data Sheets
• The Hazard Communication Standard in Section 1200(b)(6)(v) defines that those “materials” defined as ‘articles” under paragraph “c”, are not subject to requirements of the Standard. This includes the requirements established in Paragraph “g” requiring that chemical manufacturers and importers develop a safety data sheet for each hazardous chemical they produce or import.
• Article 31 of the European Regulation (EC) N° 1907/2006 defines that Safety Data Sheets are not required for ‘articles’.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, states “Articles" as defined in the Hazard Communication Standard (29 CFR 1910.1200) of the US Occupational Safety and Health Administration, or by similar definition, are outside the scope of the system.
For further information, please consult your customer service representative at 1-800-845-6973.
The information contained herein is intended only for the use of the individual or entity to which it is accessible and may contain information that is privileged, confidential and exempt from disclosure. It is current at the date of printing or downloading this document. It is Capsugel’s policy to provide as much information as possible on our products. As Capsugel cannot anticipate the variety of markets to which products are directed, we recommend that you consult with your internal Regulatory Affairs to assess the applicability of the information provided.
Last updated March, 2017
Greenwood, USA 535 North Emerald Road SC-29646 Greenwood T (888) 783 6361 F (888) 783 6360
Puebla, MEXICO Blvd 18 de Noviembre 1030 A C.P. 72290 Puebla, Pue. Mexico T (52) (222) 372 1524 F (52) (222) 372 1504
Regulatory Information & Documents
Regulatory Information & Documents
> Subject – Capsugel Information – Safety Data Sheet Declaration
We herewith confirm that for Empty Hard Capsules, the requirement for Safety Data Sheets is not applicable. This declaration is based on the following interpretations of United States and International law: Capsugel’s empty two piece capsules are defined as an ‘article” under United States and International Laws
• The Hard Empty Capsules manufactured and supplied by Capsugel correspond to the definition of ‘Articles’ as described in Paragraph “c” of the United States Occupational Safety and Health Administration’s Hazard Communications Standard (29 CFR 1910.1200). An ‘article’ means an object which during production is given a special shape, surface or design; which under normal conditions of use will only release minute or trace amounts of hazardous materials which will not pose a physical or health risk to employees. Capsugel certifies that its hard empty capsules are free of substances that might be considered hazardous materials.
• Article 3 of the European Regulation (EC) N° 1907/2006 also defines ‘articles’ in the same manner as 29 CFR 1910.1200.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, establishes the scope of the “Global Harmonized System” as applicable only “pure chemical substances, their dilute solutions and to mixtures of chemical substances”.
Objects defined as ‘articles” are exempt from requirements for the provision of Safety Data Sheets
• The Hazard Communication Standard in Section 1200(b)(6)(v) defines that those “materials” defined as ‘articles” under paragraph “c”, are not subject to requirements of the Standard. This includes the requirements established in Paragraph “g” requiring that chemical manufacturers and importers develop a safety data sheet for each hazardous chemical they produce or import.
• Article 31 of the European Regulation (EC) N° 1907/2006 defines that Safety Data Sheets are not required for ‘articles’.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, states “Articles" as defined in the Hazard Communication Standard (29 CFR 1910.1200) of the US Occupational Safety and Health Administration, or by similar definition, are outside the scope of the system.
For further information, please consult your customer service representative at 1-800-845-6973.
The information contained herein is intended only for the use of the individual or entity to which it is accessible and may contain information that is privileged, confidential and exempt from disclosure. It is current at the date of printing or downloading this document. It is Capsugel’s policy to provide as much information as possible on our products. As Capsugel cannot anticipate the variety of markets to which products are directed, we recommend that you consult with your internal Regulatory Affairs to assess the applicability of the information provided.
Last updated March, 2017
Greenwood, USA 535 North Emerald Road SC-29646 Greenwood T (888) 783 6361 F (888) 783 6360
Puebla, MEXICO Blvd 18 de Noviembre 1030 A C.P. 72290 Puebla, Pue. Mexico T (52) (222) 372 1524 F (52) (222) 372 1504
Regulatory Information & Documents
Regulatory Information & Documents
> Subject – Capsugel Information – Safety Data Sheet Declaration
We herewith confirm that for Empty Hard Capsules, the requirement for Safety Data Sheets is not applicable. This declaration is based on the following interpretations of United States and International law: Capsugel’s empty two piece capsules are defined as an ‘article” under United States and International Laws
• The Hard Empty Capsules manufactured and supplied by Capsugel correspond to the definition of ‘Articles’ as described in Paragraph “c” of the United States Occupational Safety and Health Administration’s Hazard Communications Standard (29 CFR 1910.1200). An ‘article’ means an object which during production is given a special shape, surface or design; which under normal conditions of use will only release minute or trace amounts of hazardous materials which will not pose a physical or health risk to employees. Capsugel certifies that its hard empty capsules are free of substances that might be considered hazardous materials.
• Article 3 of the European Regulation (EC) N° 1907/2006 also defines ‘articles’ in the same manner as 29 CFR 1910.1200.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, establishes the scope of the “Global Harmonized System” as applicable only “pure chemical substances, their dilute solutions and to mixtures of chemical substances”.
Objects defined as ‘articles” are exempt from requirements for the provision of Safety Data Sheets
• The Hazard Communication Standard in Section 1200(b)(6)(v) defines that those “materials” defined as ‘articles” under paragraph “c”, are not subject to requirements of the Standard. This includes the requirements established in Paragraph “g” requiring that chemical manufacturers and importers develop a safety data sheet for each hazardous chemical they produce or import.
• Article 31 of the European Regulation (EC) N° 1907/2006 defines that Safety Data Sheets are not required for ‘articles’.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, states “Articles" as defined in the Hazard Communication Standard (29 CFR 1910.1200) of the US Occupational Safety and Health Administration, or by similar definition, are outside the scope of the system.
For further information, please consult your customer service representative at 1-800-845-6973.
The information contained herein is intended only for the use of the individual or entity to which it is accessible and may contain information that is privileged, confidential and exempt from disclosure. It is current at the date of printing or downloading this document. It is Capsugel’s policy to provide as much information as possible on our products. As Capsugel cannot anticipate the variety of markets to which products are directed, we recommend that you consult with your internal Regulatory Affairs to assess the applicability of the information provided.
Last updated March, 2017
Greenwood, USA 535 North Emerald Road SC-29646 Greenwood T (888) 783 6361 F (888) 783 6360
Puebla, MEXICO Blvd 18 de Noviembre 1030 A C.P. 72290 Puebla, Pue. Mexico T (52) (222) 372 1524 F (52) (222) 372 1504
Regulatory Information & Documents
Regulatory Information & Documents
> Subject – Capsugel Information – Safety Data Sheet Declaration
We herewith confirm that for Empty Hard Capsules, the requirement for Safety Data Sheets is not applicable. This declaration is based on the following interpretations of United States and International law: Capsugel’s empty two piece capsules are defined as an ‘article” under United States and International Laws
• The Hard Empty Capsules manufactured and supplied by Capsugel correspond to the definition of ‘Articles’ as described in Paragraph “c” of the United States Occupational Safety and Health Administration’s Hazard Communications Standard (29 CFR 1910.1200). An ‘article’ means an object which during production is given a special shape, surface or design; which under normal conditions of use will only release minute or trace amounts of hazardous materials which will not pose a physical or health risk to employees. Capsugel certifies that its hard empty capsules are free of substances that might be considered hazardous materials.
• Article 3 of the European Regulation (EC) N° 1907/2006 also defines ‘articles’ in the same manner as 29 CFR 1910.1200.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, establishes the scope of the “Global Harmonized System” as applicable only “pure chemical substances, their dilute solutions and to mixtures of chemical substances”.
Objects defined as ‘articles” are exempt from requirements for the provision of Safety Data Sheets
• The Hazard Communication Standard in Section 1200(b)(6)(v) defines that those “materials” defined as ‘articles” under paragraph “c”, are not subject to requirements of the Standard. This includes the requirements established in Paragraph “g” requiring that chemical manufacturers and importers develop a safety data sheet for each hazardous chemical they produce or import.
• Article 31 of the European Regulation (EC) N° 1907/2006 defines that Safety Data Sheets are not required for ‘articles’.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, states “Articles" as defined in the Hazard Communication Standard (29 CFR 1910.1200) of the US Occupational Safety and Health Administration, or by similar definition, are outside the scope of the system.
For further information, please consult your customer service representative at 1-800-845-6973.
The information contained herein is intended only for the use of the individual or entity to which it is accessible and may contain information that is privileged, confidential and exempt from disclosure. It is current at the date of printing or downloading this document. It is Capsugel’s policy to provide as much information as possible on our products. As Capsugel cannot anticipate the variety of markets to which products are directed, we recommend that you consult with your internal Regulatory Affairs to assess the applicability of the information provided.
Last updated March, 2017
Greenwood, USA 535 North Emerald Road SC-29646 Greenwood T (888) 783 6361 F (888) 783 6360
Puebla, MEXICO Blvd 18 de Noviembre 1030 A C.P. 72290 Puebla, Pue. Mexico T (52) (222) 372 1524 F (52) (222) 372 1504
Regulatory Information & Documents
Regulatory Information & Documents
> Subject – Capsugel Information – Safety Data Sheet Declaration
We herewith confirm that for Empty Hard Capsules, the requirement for Safety Data Sheets is not applicable. This declaration is based on the following interpretations of United States and International law: Capsugel’s empty two piece capsules are defined as an ‘article” under United States and International Laws
• The Hard Empty Capsules manufactured and supplied by Capsugel correspond to the definition of ‘Articles’ as described in Paragraph “c” of the United States Occupational Safety and Health Administration’s Hazard Communications Standard (29 CFR 1910.1200). An ‘article’ means an object which during production is given a special shape, surface or design; which under normal conditions of use will only release minute or trace amounts of hazardous materials which will not pose a physical or health risk to employees. Capsugel certifies that its hard empty capsules are free of substances that might be considered hazardous materials.
• Article 3 of the European Regulation (EC) N° 1907/2006 also defines ‘articles’ in the same manner as 29 CFR 1910.1200.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, establishes the scope of the “Global Harmonized System” as applicable only “pure chemical substances, their dilute solutions and to mixtures of chemical substances”.
Objects defined as ‘articles” are exempt from requirements for the provision of Safety Data Sheets
• The Hazard Communication Standard in Section 1200(b)(6)(v) defines that those “materials” defined as ‘articles” under paragraph “c”, are not subject to requirements of the Standard. This includes the requirements established in Paragraph “g” requiring that chemical manufacturers and importers develop a safety data sheet for each hazardous chemical they produce or import.
• Article 31 of the European Regulation (EC) N° 1907/2006 defines that Safety Data Sheets are not required for ‘articles’.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, states “Articles" as defined in the Hazard Communication Standard (29 CFR 1910.1200) of the US Occupational Safety and Health Administration, or by similar definition, are outside the scope of the system.
For further information, please consult your customer service representative at 1-800-845-6973.
The information contained herein is intended only for the use of the individual or entity to which it is accessible and may contain information that is privileged, confidential and exempt from disclosure. It is current at the date of printing or downloading this document. It is Capsugel’s policy to provide as much information as possible on our products. As Capsugel cannot anticipate the variety of markets to which products are directed, we recommend that you consult with your internal Regulatory Affairs to assess the applicability of the information provided.
Last updated March, 2017
Greenwood, USA 535 North Emerald Road SC-29646 Greenwood T (888) 783 6361 F (888) 783 6360
Puebla, MEXICO Blvd 18 de Noviembre 1030 A C.P. 72290 Puebla, Pue. Mexico T (52) (222) 372 1524 F (52) (222) 372 1504
Regulatory Information & Documents
Regulatory Information & Documents
> Subject – Capsugel Information – Safety Data Sheet Declaration
We herewith confirm that for Empty Hard Capsules, the requirement for Safety Data Sheets is not applicable. This declaration is based on the following interpretations of United States and International law: Capsugel’s empty two piece capsules are defined as an ‘article” under United States and International Laws
• The Hard Empty Capsules manufactured and supplied by Capsugel correspond to the definition of ‘Articles’ as described in Paragraph “c” of the United States Occupational Safety and Health Administration’s Hazard Communications Standard (29 CFR 1910.1200). An ‘article’ means an object which during production is given a special shape, surface or design; which under normal conditions of use will only release minute or trace amounts of hazardous materials which will not pose a physical or health risk to employees. Capsugel certifies that its hard empty capsules are free of substances that might be considered hazardous materials.
• Article 3 of the European Regulation (EC) N° 1907/2006 also defines ‘articles’ in the same manner as 29 CFR 1910.1200.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, establishes the scope of the “Global Harmonized System” as applicable only “pure chemical substances, their dilute solutions and to mixtures of chemical substances”.
Objects defined as ‘articles” are exempt from requirements for the provision of Safety Data Sheets
• The Hazard Communication Standard in Section 1200(b)(6)(v) defines that those “materials” defined as ‘articles” under paragraph “c”, are not subject to requirements of the Standard. This includes the requirements established in Paragraph “g” requiring that chemical manufacturers and importers develop a safety data sheet for each hazardous chemical they produce or import.
• Article 31 of the European Regulation (EC) N° 1907/2006 defines that Safety Data Sheets are not required for ‘articles’.
• Section 1.3.2.1 of the United Nation’s “Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2003, states “Articles" as defined in the Hazard Communication Standard (29 CFR 1910.1200) of the US Occupational Safety and Health Administration, or by similar definition, are outside the scope of the system.
For further information, please consult your customer service representative at 1-800-845-6973.
The information contained herein is intended only for the use of the individual or entity to which it is accessible and may contain information that is privileged, confidential and exempt from disclosure. It is current at the date of printing or downloading this document. It is Capsugel’s policy to provide as much information as possible on our products. As Capsugel cannot anticipate the variety of markets to which products are directed, we recommend that you consult with your internal Regulatory Affairs to assess the applicability of the information provided.
Last updated March, 2017
Greenwood, USA 535 North Emerald Road SC-29646 Greenwood T (888) 783 6361 F (888) 783 6360
Puebla, MEXICO Blvd 18 de Noviembre 1030 A C.P. 72290 Puebla, Pue. Mexico T (52) (222) 372 1524 F (52) (222) 372 1504