Nutrition & Health

Quality & Regulatory Product Information

Vitamin E 500 FG Date: 05 Aug 2019

PRD 30079657 Page 1 of 5

® = Registered trademark of BASF ™ = Trademark of BASF

With the rising complexity of the regulatory environment and customers' growing demand for
product quality and safety worldwide, companies need to provide information related to an
increasing number of different regulatory issues.

At the same time fast information flow is a key requirement for success.

In order to assist you in a rapid execution, BASF Nutrition & Health established a Quality &
Regulatory Product Information package (Q&R PI) which will provide you with a
comprehensive summary of all required regulatory, quality, and safety information.

We have gained positive feedback from a large number of our customers who were able to
accelerate their submission process. We are convinced that this package will also support you
in your daily business.

If you have any further questions or need additional support, please contact your BASF sales
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This document and any information provided herein is for your guidance only. All information is given in good faith
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SELLER MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, BY FACT OR LAW,
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
 Status: 05 Aug 2019

Quality & Regulatory Product Information for:

Vitamin E 500 FG

1. Identity

a) Name (of the active ingredient): DL-alpha-tocopheryl acetate, AL-alpha-tocopherol acetate, all-
rac-alpha-tocopherol acetic acid ester, racemic 5,7,8-
b) CAS - No. (of the active ingredient): 7695-91-2

2. Technical Information including product description/composition

[x ] See attached “Technical Information”

3. Specification

[x ] See attached “Product Specification”

4. Manufacturing of the product

Manufacturer

[ ] BASF
[x ] The product is manufactured by a contract manufacturer
according to the BASF specification

Country of origin USA

(according to Council Regulation (EC) No. 952/2013 laying down the Union Customs Code)

Manufacturing Process (active substance)

[ ] animal
[ ] by fermentation
[ ] mineral
[ ] plant
[x] synthetic
[ ] other information:

5. Storage recommendations

[x ] See attached "Technical Information"

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Vitamin E 500 FG

6. Compliance to international standards (active substance)

[x ] European Pharmacopoe (EP)

'all-rac-alpha-tocopheryl acetate'
[x ] US Pharmacopoe (USP)
'Vitamin E'
[ ] EU regulation laying down specifications for food additives

[x ] Food Chemical Codex (FCC)

'all-rac-alpha-tocopheryl acetate'
[ ] Joint FAO/WHO Expert Committee on Food Additives (JECFA)

[ ] Code of Federal Regulations (CFR)

[x ] GRAS
GRAS 21 CFR 182.8890
[ ] Novel Food

[ ] Other

7. Contaminants/ Residues

a) Heavy metals
[x ] See attached "Product Specification"
[ ] Other

b) Mycotoxins
[x] See attached statement

c) Pesticides
[x] See attached statement

d) Dioxins, PCBs
[x] See attached statement

e) PAHs
[x] See attached statement

f) Melamine
[x ] See attached statement

8. Residual Solvents

[x] See attached statement

[ ] Residual solvents are not to be expected from the production process
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Vitamin E 500 FG

9. BSE/TSE status

[ ] Animal origin
[x] Vegetable origin
[x] Based on mineral oil/natural gas
[x] Inorganic
[x] See attached statement

10. GMO Information (Genetically Modified Organism)

[x] Produced without genetic engeneering

[x] Not containing detectable GMO-DNA
[ x] No labelling required according to Regulations (EC) 1829/2003 and 1830/2003 (and
amendments)
[x] See attached statements

11. Allergen information

[x] See attached statement

12. Microbiological status

[x] Part of the specification / Part of certificate of analysis

[ ] Considered to be not relevant

13. Irradiation information

[x] See attached statement

14. Diet suitability (based on standard product composition)

Suitable for
[x ] vegans
[x ] lacto vegetarians
[x ] ovo-lacto vegetarians
[x ] lactose intolerants
[x ] coeliacs (gluten intolerants)
[ ] other:

15. Kosher status

[x] See attached Kosher certificate

16. Halal status

[x] See attached Halal certificate
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Vitamin E 500 FG

17. Nutritional information

[x] See attached information

18. Quality documentation

HACCP status / Food Safety Policy

[x] See attached Food Safety Policy

FSSC 22000 (incl. HACCP-System)

[ ] See attached certificate

GMP
[ ] Pharma (See attached certificate)
[ ] Dietary Supplements (See attached certificate)
[ ] Food (See attached certificate)
[ ] Compliance (See attached information)

ISO 9001
[x] See attached certificate

19. Safety & Environment

[x] Material Safety Data Sheet

Available on special request; please contact your BASF Sales representative

[ ] Responsible Care® in combination with Sustainable Solutions Steering®

See attached Statement on Environmental Management Systems

[x] BASF Environmental Policy see

http://shopping-list.nutrition-and-health.basf.com/pdf/environmental_policy.pdf

[ ] ISO 14001
(See attached certificate)

This document including all the attachments is not intended for regulatory submissions. There is no
automatic updating service. For regulatory support, please contact your BASF Sales representative.

This document, or any answers or information provided herein by BASF, does not constitute a legally
binding obligation of BASF. While the descriptions, designs, data and information contained herein are
presented in good faith and believed to be accurate, it is provided for your guidance only. Because
many factors may affect processing or application/use, we recommend that you make tests to determine
the suitability of a product for your particular purpose prior to use. It does not relieve our customers from
the obligation to perform a full inspection of the products upon delivery or any other obligation. NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING
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